European Parliament resolution of 14 February 2019 on the situation in Chechnya and the case of Oyub Titiev (2019/2562(RSP))

P8_TA(2019)0115 RC-B8-0107/2019

The European Parliament,

–  having regard to its previous resolutions on the situation in Chechnya, in particular those of 8 February 2018 on ‘Russia, the case of Oyub Titiev and the Human Rights Centre Memorial’(1) and 23 October 2014 on ‘the closing-down of the NGO Memorial (winner of the 2009 Sakharov Prize) in Russia’(2),

–  having regard to the statement by the Chairs of its Committee on Foreign Affairs and Subcommittee on Human Rights of 12 January 2018 calling for the immediate release of the human rights defender Oyub Titiev,

–  having regard to the EU Statement of 19 January 2018 on human rights violations concerning the Memorial Human Rights Centre in Russia and to the statements by the Spokesperson of the European External Action Service (EEAS) of 11 January 2018 on the detention of the Director of the Memorial Human Rights Centre in the Chechen Republic and of 27 June 2018 on the cases of Russian human rights defenders Oyub Titiev and Yuri Dmitriev,

–  having regard to Article 5 of the Universal Declaration of Human Rights and Article 7 of the International Covenant on Civil and Political Rights, both of which provide that no one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment, and to which the Russian Federation is a party,

–  having regard to the United Nations Declaration on Human Rights Defenders, adopted by the UN General Assembly on 9 December 1998,

–  having regard to the Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms,

–  having regard to the Constitution of the Russian Federation, in particular Chapter 2 thereof on Human and Civil Rights and Freedoms,

–  having regard to the seventh periodic report of the Russian Federation, which was considered by the UN Human Rights Committee at its 3 136th and 3 137th meetings on 16 and 17 March 2015,

–  having regard to the OSCE Rapporteur’s Report under the Moscow Mechanism on Alleged Human Rights Violations and Impunity in the Chechen Republic of the Russian Federation of 21 December 2018,

–  having regard to the European Union Guidelines on Human Rights Defenders,

–  having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

A.  whereas the Russian Federation, as a signatory to the Universal Declaration of Human Rights, the European Convention on Human Rights and the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, has committed itself to the principles of democracy, the rule of law and respect for fundamental freedoms and human rights;

B.  whereas the Russian Federation’s international commitments include the obligation to protect human rights defenders; whereas the 2012 law on ‘foreign agents’ severely restricts NGOs’ ability to work independently and effectively; whereas under this law, the Memorial Human Rights Centre has been designated as a ‘foreign agent’ by the Ministry of Justice of the Russian Federation;

C.  whereas Chechnya has experienced a dramatic deterioration in the human rights situation over the past few years, which effectively prevents independent journalists and human rights activists from continuing their work without putting their own lives and the lives of their family members, friends and colleagues at risk; whereas the numerous reports of systematic and serious human rights abuses in Chechnya demonstrate the failure of the Chechen and Russian authorities to uphold the rule of law;

D.  whereas Oyub Titiev, the director of the Chechnya office of Memorial, was arrested on 9 January 2018 and officially indicted and remanded on trumped-up charges of illegal acquisition and possession of narcotics; whereas these accusations have been denied by Oyub Titiev and denounced by other NGOs and human rights defenders as fabricated and as an attempt to obstruct his, and his organisation’s, work on human rights;

E.  whereas the courts extended the detention of Oyub Titiev several times before court hearings begun in Shali City Court in Chechnya on 19 July 2018; whereas the verdict is imminent and expected for mid-February 2019; whereas Oyub Titiev risks being adjudged guilty of a crime he did not commit and spending up to ten years in prison;

F.  whereas Oyub Titiev’s family has faced harassment and threats coercing them to leave Chechnya; whereas Memorial was targeted by other actions in 2018, including an arson attack against its offices in Ingushetia on 17 January 2018, an attack on Mr Titiev’s lawyer’s car in Dagestan on 22 January 2018 and an attack against the head of the Memorial office in Dagestan on 28 March 2018; whereas since the murder in 2009 of Oyub Titiev’s predecessor as director of the Chechnya office of Memorial, Natalia Estemirova, the perpetrators of this crime have still not been brought to justice;

G.  whereas Memorial is one of the last remaining organisations continuing work on human rights in Chechnya – namely to document and expose human rights violations, to assist the victims of such violations and to help them seek justice – and has probably been attacked in retaliation for exposing and seeking justice for human rights violations; whereas Memorial was awarded the European Parliament’s Sakharov Prize for Freedom of Thought in 2009 and in 2018 Oyub Titiev was awarded the Franco-German Prize for Human Rights and Rule of Law (December), the Václav Havel Human Rights Prize (October) and the Moscow Helsinki Human Rights Group Award (May);

H.  whereas Chechen officials have repeatedly threatened human rights defenders or denounced their work and have failed to publicly condemn threats of violence against them, thereby creating and perpetuating a climate of impunity for the perpetrators of acts of violence against human rights defenders; whereas victims therefore largely refrain from seeking justice as they fear retaliation by local authorities;

1.  Reiterates its call for the immediate release of Oyub Titiev, the director of the Memorial Human Rights Centre office in Chechnya, who was detained on 9 January 2018 and accused of illegal acquisition and possession of drugs and is expected to receive his verdict by mid-February 2019; urges the Chechen authorities to ensure full respect for Oyub Titiev’s human and legal rights, including his right to a fair trial, unhindered access to his lawyer and to medical care, and protection from judicial harassment and criminalisation;

2.  Strongly condemns the repeated public statements by Chechen officials denouncing the work of human rights defenders and organisations or targeting specific persons, as well as their failure to publicly condemn and investigate threats and acts of violence against these groups and individuals;

3.  Expresses its deep concerns over the worrying trend of arrests, attacks and intimidation of independent journalists, human rights defenders and their supporters, and ordinary citizens alike, which appear to be part of coordinated campaigns; considers the case of Oyub Titiev to be illustrative of numerous other prosecution cases built on fabricated evidence that underpins the flawed justice system in the Chechen Republic and the Russian Federation; recalls that similar charges related to drug possession have also been brought against Caucasus Knot journalist Zhalaudi Geriev and human rights activist Ruslan Kutaev, and calls for them also to be released;

4.  Urges the authorities of both the Republic of Chechnya and the Russian Federation to put an end to the harassment and persecution of their citizens and to end the climate of impunity for the perpetrators of acts of violence against human rights defenders, their family members, colleagues and supporters and their organisations;

5.  Calls on the Russian Federation to protect all its citizens with full respect for their human rights, to abide by its own Constitution and legislation, and to honour its international commitments to respect the rule of law and the fundamental freedoms and human rights of all its citizens, including those who dedicate their time, resources and work to defending the rights of their fellow citizens;

6.  Calls on the Russian authorities to repeal the 2015 law on ‘undesirable organisations’ and the 2012 law on ‘foreign agents’, as well as all other related legislation, which has consistently been used to harass and attack human rights defenders and civil society organisations; expresses concern at the fact that some Russian NGOs have had to shut down in order to avoid being tarnished with the stigma of being ‘foreign agents’ and to avoid legal persecution;

7.  Calls for an immediate end to the harassment and arrests of human rights defenders in Chechnya pursued on the grounds of fabricated accusations, to attacks on their colleagues and family members and to the intimidation of their supporters, which appear to serve the aim of impeding and ultimately ending the legitimate and useful work of their organisations;

8.  Repeats its call on the Commission, the EEAS and the Member States to continue to closely monitor the human rights situation in Chechnya, including the trial of Oyub Titiev, to call for an immediate cessation of the aforementioned human rights violations, to raise the cases of all persons prosecuted for political reasons in relevant meetings with Russian representatives, and to continue to offer swift and efficient assistance to the victims of persecution and their family members, including when dealing with asylum requests;

9.  Calls on the Commission to engage with international human rights organisations active in the Russian Federation and with Russian human rights organisations and civil society despite the Russian law on ‘foreign agents’ and to continue to offer support to Memorial and other such organisations;

10.  Calls on international sports personalities and artists to refrain from participating in public events in Chechnya or events sponsored by the leadership of the Chechen Republic; reiterates its support for a European Union ‘Magnitsky Act’, which should sanction the perpetrators of serious human rights violations, and calls on the Council to pursue its work on this matter without delay; stresses, in this regard, that the perpetrators of human rights abuses in the Chechen Republic of the Russian Federation should not be granted EU visas nor be allowed to keep assets in EU Member States;

11.  Instructs its President to forward this resolution to the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the Council, the Commission, the governments and parliaments of the Member States, the Council of Europe, the Organisation for Security and Cooperation in Europe, the President, the Government and Parliament of the Russian Federation, and the Chechen authorities.

(1) OJ C 463, 21.12.2018, p. 31. (2) OJ C 274, 27.7.2016, p. 21.

European Parliament resolution of 14 February 2019 on Zimbabwe (2019/2563(RSP))

P8_TA(2019)0116 RC-B8-0110/2019

The European Parliament,

–  having regard to its previous resolutions on Zimbabwe,

–  having regard to the final report of the EU Electoral Observation Mission (EOM) on the 2018 harmonised elections in Zimbabwe and to the letter issued on 10 October by the Chief Observer of the EU EOM to President Mnangagwa on the key findings of the Final Report,

–  having regard to the statement of 17 January 2019 by the spokesperson of the Vice President/High Representative on the situation in Zimbabwe,

–  having regard to the statements of 24 July 2018 and 18 January 2019 by the spokesperson for the UN High Commissioner for Human Rights on Zimbabwe,

–  having regard to the Joint Communiqué issued following the EU-African Union Ministers of Foreign Affairs meeting on 21 and 22 January 2019,

–  having regard to the monitoring report from the Zimbabwe Human Rights Commission in the aftermath of the 14 January to 16 January 2019 ‘Stay Away’ and subsequent disturbances,

–  having regard to the report of the Zimbabwean Commission of Inquiry into the 1 August post-election violence,

–  having regard to the statement of 2 August 2018 by the spokesperson of the VP/HR on the elections in Zimbabwe,

–  having regard to the joint statement of 2 August 2018 by international election observation missions to Zimbabwe’s harmonised elections denouncing the excessive use of force by the police and army to quell protests,

–  having regard to the joint local statement of 9 August 2018 of the EU Delegation, the Heads of Mission of EU Member States present in Harare and the Heads of Mission of Australia, Canada and the United States on the targeting of opposition in Zimbabwe,

–  having regard to the conclusions of 22 January 2018 of the Council of the EU in light of the ongoing political transition in Zimbabwe,

–  having regard to Council Decision (CFSP) 2017/288 of 17 February 2017 amending Decision 2011/101/CFSP concerning restrictive measures against Zimbabwe(1),

–  having regard to the African Charter on Human and Peoples’ Rights of June 1981, which Zimbabwe has ratified,

–  having regard to the Constitution of Zimbabwe,

–  having regard to the Cotonou Agreement,

–  having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

A.  whereas the people of Zimbabwe suffered for many years under an authoritarian regime led by President Mugabe that maintained its power through corruption, violence, elections plagued by irregularities and a brutal security apparatus;

B.  whereas on 30 July 2018, Zimbabwe held its first presidential and parliamentary elections following the resignation of Robert Mugabe in November 2017; whereas the elections offered the country the opportunity to break with the history of contentious elections marked by abuse of political and human rights and state-sponsored violence;

C.  whereas on 3 August 2018, the Zimbabwe Electoral Commission (ZEC) declared Emmerson Mnangagwa winner of the presidential election with 50.8 % of votes against 44.3 % for the opposition candidate Nelson Chamisa; whereas the results were immediately contested by the opposition who claimed that the elections were rigged; whereas the Constitutional Court dismissed these allegations for lack of evidence and President Mnangagwa was officially re-invested on 26 August for a new mandate;

D.  whereas the final report of the EU EOM states that the figures presented by the ZEC contained many anomalies and inaccuracies and raised enough questions to lead to doubts as to the accuracy and reliability of the numbers presented;

E.  whereas the day after the election, the delay in announcing the results had already led to an outbreak of post-electoral violence that left six people dead and many injured during protests called by the opposition; whereas international observers, including the EU, condemned the violence and the excessive use of force by the army and internal security forces;

F.  whereas the Zimbabwe Human Rights Commission published a statement on 10 August 2018 ‘on the 2018 harmonised elections and the post-election environment’ confirming that protesters were assaulted by military forces, expressing deep concern about the brutality and violent conduct of the police and stating that the fundamental rights of demonstrators were violated; whereas the Commission has called on the government to set up a national dialogue;

G.  whereas on taking his oath of office in Harare on 26 August 2018, President Emmerson Mnangagwa promised a brighter, shared future for all Zimbabweans, transcending party lines, with a government unwavering in its commitment to constitutionalism, entrenching the rule of law, the principle of separation of powers, the independence of the judiciary and policies that would attract both domestic and global capital;

H.  whereas in September 2018 President Mnangagwa set up a commission of inquiry which, in December 2018, concluded that the demonstrations which caused extensive damage to property and injury were incited and organised by both security forces and members of the MDC Alliance, and that the deployment of the military was justified and in accordance with the Constitution; whereas the report was rejected by the opposition; whereas the commission called for an investigation within the security forces and prosecution of those who had committed crimes, and recommended compensation for victims;

I.  whereas political tensions have increased dramatically since the elections and reports of violence persist, seriously putting at risk the democratic trajectory initiated in the country;

J.  whereas the collapse of the economy, lack of access to social services, and the rise in the price of the most basic of commodities pushed people to anger; whereas between 14 and 18 January 2019, Zimbabwe witnessed a surge in protests and demonstrations during a so-called national shutdown at the initiative of the Zimbabwe Congress of Trade Unions (ZCTU), following a 150 % increase in fuel prices; whereas the protests were also in response to rising poverty, the poor state of the economy, and declining living standards;

K.  whereas, faced with this protest movement, on 14 January 2019 the government denounced a ‘deliberate plan to undermine the constitutional order’ and assured that it ‘will respond appropriately to those who conspire to sabotage peace’;

L.  whereas the riot police responded with excessive violence and human rights abuses, including the use of live ammunition, arbitrary arrests, abductions, the raiding of medical facilities treating victims of the repression, fast-tracking and mass trials of those arrested, the torturing of people under arrest, cases of rape and the destruction of private and public property;

M.  whereas the Human Rights Commission appointed by the government made public a report which reveals that soldiers and the police had used systematic torture;

N.  whereas more than 17 people have been killed and hundreds injured; whereas around one thousand people have been arrested, including children aged between 9 and 16, and about two thirds of those arrested were denied bail; whereas many are still being illegally detained and have allegedly been beaten and assaulted while in custody;

O.  whereas evidence shows that the army has been largely responsible for the acts of murder, rape and armed robbery; whereas hundreds of activists and opposition officials remain in hiding;

P.  whereas the government’s response to protests has been widely condemned as ‘disproportionate’ and ‘excessive’ by human rights observers and local and international actors, including the EU;

Q.  whereas the interruption of telecommunications has become a tool used by the regime to block the coordination of demonstrations organised on social networks; whereas mobile and land-line communications, as well as the internet and social media channels, were repeatedly blocked to prevent access to information and communication and in order to mask the massive human rights violations which the state was preparing to commit; whereas the Zimbabwe High Court declared that the use of the Interception of Communications Act to suspend online communications was illegal;

R.  whereas the authorities organised a massive door-to-door search for protestors, dragging from their homes peaceful protestors, human rights defenders, political activists, prominent civil society leaders and their relatives;

S.  whereas neighbouring countries such as South Africa have become a hub for Zimbabweans fleeing political oppression and economic hardship;

T.  whereas the police have continuously misused existing laws, such as the Public Order and Security Act (POSA), to justify the curb on opposition members and human rights activists, and to ban lawful and peaceful demonstrations;

U.  whereas Zimbabwe’s record with regard to human rights and democracy is one of the poorest in the word; whereas Zimbabwean people and human rights defenders continue to suffer attacks, hate speech, smear campaigns, acts of intimidation and harassment, and there have been regular reports of acts of torture;

V.  whereas the President called for a national dialogue that started on 6 February and invited all political parties to take part, but the Movement for Democratic Change (MDC), the main opposition party, refused to participate;

W.  whereas Zimbabwe is a signatory to the Cotonou Agreement, Article 96 of which stipulates that respect for human rights and fundamental freedoms is an essential element of ACP-EU cooperation;

1.  Underlines its unanimous desire for Zimbabwe to become a peaceful, democratic and prosperous nation in which all citizens are treated well and equally under the law and where the organs of the state act on behalf of the citizens and not against them;

2.  Strongly condemns the violence that occurred during the recent protests in Zimbabwe; firmly believes that peaceful protest is part of a democratic process and that excessive force in response must be avoided in all circumstances;

3.  Urges President Mnangagwa to remain true to his inaugural promises, to move rapidly to take control of the situation and to put Zimbabwe back on a path of reconciliation and respect for democracy and the rule of law;

4.  Urges the Zimbabwean authorities to put an immediate end to abuses by security forces and to promptly and impartially investigate all allegations of excessive use of force by police and state officials in order to establish individual responsibilities, with a view to ensuring accountability; recalls that the country’s constitution establishes an independent body to investigate complaints of police and military misconduct, but that the government has yet to set it up;

5.  Urges the Government of Zimbabwe to withdraw urgently all military personnel and the youth militia deployed across the country that are terrorising residents in clear violation of the Zimbabwean Constitution;

6.  Believes that freedom of assembly, association and expression are essential components of any democracy; stresses that expressing an opinion in a non-violent way is a constitutional right for all Zimbabwean citizens and reminds the authorities of their obligation to protect the right of all citizens to protest against their deteriorating social and economic conditions; calls on the government to put an end to the specific targeting of leaders and members of the ZCTU;

7.  Underlines the fundamental role that the opposition plays in a democratic society;

8.  Urges the Zimbabwean authorities to immediately and unconditionally release all political prisoners;

9.  Calls on the Government of Zimbabwe to immediately stop the harassment and criminalisation of civil society actors and recognise the legitimate role of human rights defenders;

10.  Asks the Zimbabwean Government to conform to the provisions of the UN Declaration on Human Rights Defenders and the international human rights instruments ratified by Zimbabwe;

11.  Is deeply concerned about reported violations of due process through fast-tracking and mass trials; insists that the judiciary must uphold the rule of law and ensure that its independence and the right to a fair trial is respected in all circumstances; denounces all arrests made without bringing forward charges;

12.  Calls on the Zimbabwean authorities to undertake a prompt, thorough, impartial and independent investigation into allegations of human rights violations and abuses, including rape and sexual violence by security forces, and to bring those responsible to justice; demands that access to medical services should be universally provided to the victims of such sexual violence without fear of retribution;

13.  Condemns the internet shutdown that allowed the authorities to conceal the human rights abuses committed by the army and internal security forces and to obstruct independent reporting and documentation of abuses during the crackdown and immediately after the election; stresses that access to information is a right that must be respected by the authorities in accordance with their constitutional and international obligations;

14.  Denounces the abusive use and restrictive nature of POSA, and urges the Zimbabwean authorities to align legislation with international standards for the protection and promotion of human rights;

15.  Expresses particular concern at the economic and social situation in Zimbabwe; recalls that the country’s main problems are poverty, unemployment and chronic malnutrition and hunger; considers that these problems can only be solved through the implementation of ambitious policies on employment, education, health and agriculture;

16.  Calls on all political actors to exercise responsibility and restraint, and in particular to refrain from inciting violence;

17.  Reminds the Government of Zimbabwe that the support of the European Union and its Member States in the context of the Cotonou Agreement, and for trade, development, and economic assistance, is conditional on its respecting the rule of law and the international conventions and treaties to which it is party;

18.  Recalls that long-term support hinges on comprehensive reforms rather than mere promises; calls for European engagement with Zimbabwe to be value-driven and firm in its positioning towards the Zimbabwean authorities;

19.  Urges the government to immediately implement the recommendations on post-election violence made by the Commission of Inquiry, in particular the promotion of political tolerance and accountable leadership, and the setting up of a national dialogue conducted in a credible, inclusive, transparent and accountable way;

20.  Notes the government’s will to deliver on reform commitments; stresses, however, that these reforms should be political as well as economic; encourages the government, the opposition, civil society representatives and religious leaders to engage on an equal footing in a national dialogue in which human rights are respected and protected;

21.  Calls on the government to fully implement the recommendations made by the EU EOM, especially with regard to the rule of law and an inclusive political environment; underlines the ten priority recommendations identified by the EOM and set out in the letter of 10 October 2018 from the Chief Observer to President Mnangagwa – namely, in order to create a level playing field for all political parties, to ensure a clearer and coherent legal framework; to strengthen ZEC by making it truly independent and transparent, thereby restoring confidence in the electoral process; to ensure that strengthening ZEC’s independence makes it free from governmental oversight in the approval of its regulations; and to create a more inclusive electoral process;

22.  Calls on the EU delegation and EU Member State embassies in Zimbabwe to continue their close monitoring of developments in the country and to use all appropriate tools to support human rights defenders, civil society organisations and trade unions, to promote the essential elements of the Cotonou Agreement and to support pro-democracy movements;

23.  Calls on the EU to step up its political dialogue with Zimbabwe on human rights on the basis of Article 8 of the Cotonou Agreement;

24.  Calls on the European Council to review its restrictive measures against individuals and entities in Zimbabwe, including those measures currently suspended, in the light of accountability for recent state violence;

25.  Urges the international community, notably the Southern African Development Community (SADC) and the African Union (AU), to give more active assistance to Zimbabwe to find a sustainable democratic solution to the current crisis;

26.  Urges neighbouring countries to comply with the provisions of international law and to protect those fleeing violence in Zimbabwe with the provision of asylum, especially in the short term;

27.  Instructs its President to forward this resolution to, the Council, the Commission, the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the EEAS, the Government and the Parliament of Zimbabwe, the governments of the South African Development Community and the African Union, and the Secretary-General of the Commonwealth.

(1) OJ L 42, 18.2.2017, p. 11.

European Parliament resolution of 14 February 2019 on women’s rights defenders in Saudi Arabia (2019/2564(RSP))

P8_TA(2019)0117 RC-B8-0111/2019

The European Parliament,

–  having regard to its previous resolutions on Saudi Arabia, in particular those of 11 March 2014 on Saudi Arabia, its relations with the EU and its role in the Middle East and North Africa(1), of 12 February 2015 on the case of Mr Raif Badawi, Saudi Arabia(2), of 8 October 2015 on the case of Ali Mohammed al-Nimr(3), of 31 May 2018 on the situation of women’s rights defenders in Saudi Arabia(4), and of 25 October 2018 on the killing of journalist Jamal Khashoggi in the Saudi consulate in Istanbul(5),

–  having regard to the statements of 29 May 2018 by the Spokesperson for the UN High Commissioner for Human Rights on recent arrests in Saudi Arabia, and of 31 July 2018 on the arbitrary detentions of human rights defenders and activists in Saudi Arabia, including women’s rights activists,

–  having regard to the statement of 12 October 2018 by several UN Special Rapporteurs calling for the immediate release of all women’s rights defenders,

–  having regard the report by the Office of the United Nations High Commissioner for Human Rights (OHCHR) of December 2017,

–  having regard to Saudi Arabia’s membership of the UN Human Rights Council and of the UN Commission on the Status of Women (CSW), as well as its membership of the Executive Council of the CSW as of January 2019,

–  having regard to the speech by Commissioner Christos Stylianides, on behalf of the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy (VP/HR), in the European Parliament debate of 4 July 2017 on Saudi Arabia’s election as a member of the CSW,

–  having regard to the opening speech of the VP/HR at the 5th EU-League of Arab States ministerial meeting stating: ‘and let me say that cooperation between Europe and the Arab world was never so important and, I believe, has never been so necessary’,

–  having regard to the UN Convention on the Elimination of all Forms of Discrimination Against Women (CEDAW),

–  having regard to the concluding observations of 9 March 2018 of the Committee on the Elimination of All Forms of Discrimination against Women on the combined third and fourth periodic reports of Saudi Arabia,

–  having regard to the report of the Detention Review Panel into Women Activist Detainees in Saudi Arabia,

–  having regard to the anti-harassment bill approved by the Saudi Shura Council on 28 May 2018,

–  having regard to the Universal Periodic Review (UPR) of Saudi Arabia of November 2018,

–  having regard to the Reporters Without Borders 2018 World Press Freedom Index ranking Saudi Arabia 169th of 180 countries,

–  having regard to the International Covenant on Civil and Political Rights (ICCPR) of 1966,

–  having regard to the International Covenant on Economic, Social and Cultural Rights ICESCR) of 1966,

–  having regard to the Universal Declaration of Human Rights of 1948,

–  having regard to the EU Guidelines on Human Rights Defenders,

–  having regard to the awarding of the Sakharov Prize for Freedom of Thought and Expression to the Saudi blogger Raif Badawi in 2015,

–  having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

A.  whereas activists arrested by the Saudi authorities for their women’s rights activism remain detained without charge; whereas the activists include Loujain al-Hathloul, Aziza al-Yousef, Eman al-Nafjan, Nouf Abdulaziz, Mayaa al-Zahrani, Samar Badawi, Nassima al-Sada, Shadan al-Anezi, Abir Namankani, Amal al-Harbi and Hatoon al-Fassi, all of whom are women’s rights activists, as well as male supporters of the movement, including Mohammed al-Rabea; whereas these activists are known for their campaign against the ban on women driving and support of abolishing the male guardianship system; whereas they were arrested ahead of the anticipated lifting of the ban on women driving on 24 June 2018; whereas some of them will reportedly be referred for trial to the Specialised Criminal Court which was originally established to try detainees held in connection with terrorism offences;

B.  whereas human rights defender Israa al-Ghomgham, from the region of Qatif, is still facing arbitrary detention; whereas the death penalty imposed on her has recently been dropped, but unspecified charges are still being levelled against her; whereas there are concerns about Ms al-Ghomgham’s physical and mental wellbeing;

C.  whereas reports maintain that Saudi interrogators have tortured, maltreated and sexually abused at least three of the women activists detained in May 2018; whereas family members of the women activists, such as the parents of Loujain al-Hathloul, are subject to travel bans;

D.  whereas Saudi Arabia’s Ministry of Media has dismissed the allegations of torture of detainees in the Kingdom as baseless reports;

E.  whereas activist Loujain al-Hathloul has been detained since March 2018 after attending a review session on Saudi Arabia at the UN Committee on the Elimination of Discrimination against Women; whereas she was placed in solitary confinement between May and September 2018, during which time her parents report that she was tortured;

F.  whereas a delegation from the Saudi Human Rights Commission visited Loujain al-Hathloul after the publication of the reports about her torture; whereas they could not guarantee her protection; whereas a public prosecutor subsequently visited her to record her testimony;

G.  whereas Loujain al-Hathloul has been nominated for the 2019 Nobel Peace Prize;

H.  whereas Saudi Arabia still has some of the tightest restrictions imposed on women, in spite of recent government reforms aimed at boosting women’s rights in the employment sector; whereas the Saudi political and social system remains discriminatory, effectively making women into second-class citizens, allows no freedom of religion and belief, seriously discriminates against the country’s large foreign workforce and severely represses all voices of dissent;

I.  whereas Saudi Arabia has a range of discriminatory laws, in particular the legal provisions relating to personal status, the situation of women migrant workers, the Civil Status Code, the Labour Code, the Nationality Act and the system of male guardianship, under which women’s enjoyment of the majority of their rights under CEDAW is subject to authorisation by a male guardian;

J.  whereas under the male guardianship system, Saudi women are deprived of even the most basic control over their lives; whereas discriminatory laws relating to marriage and divorce remain in place, and women are required by law to obtain the permission of a male guardian to enrol in higher education, seek employment, travel or marry; whereas Saudi women with foreign spouses, unlike their male counterparts, cannot pass on their nationality to their children or spouses;

K.  whereas Saudi Arabia’s general reservation to CEDAW is, according to the Committee on the Elimination of Discrimination against Women, incompatible with the object and purpose of the Convention and impermissible under Article 28 thereof;

L.  whereas since Crown Prince Mohammed bin Salman Al Saud came to power in June 2017, many outspoken human rights defenders, activists and critics have been arbitrarily detained, or unjustly sentenced to lengthy prison terms simply for exercising their right to freedom of expression;

M.  whereas the Vision 2030 reform agenda, which aims to bring about the economic and social transformation of the country, including through women’s empowerment, should have been a real opportunity for Saudi women to secure their legal emancipation, which is absolutely crucial for the full enjoyment of their rights under CEDAW; whereas, however, the recent wave of arrests and alleged torture of women’s rights activists runs counter to this aim, and may distract from the reform agenda; whereas the Vision 2030 decree lacks a proper legal framework;

N.  whereas freedom of expression and freedom of the press and media, both online and offline, are crucial preconditions and catalysts for democratisation and reform, and are essential checks on power;

O.  whereas Saudi Arabia has one of the highest execution rates in the world; whereas between 2014 and 2017, the average number of executions per year was at least 126; whereas the authorities impose the death penalty for non-violent offences, such as drug smuggling, treason, and adultery; whereas offences such as apostasy, which under international human rights law should not be criminalised, have also resulted in the application of the death penalty;

P.  whereas Saudi Arabia’s UN Human Development Index value for 2018 is 0.853 – positioning it 39th out of 188 countries and territories; whereas Saudi Arabia has a UN Gender Inequality Index value of 0.234, ranking it 39th out of 189 countries in the 2017 index; whereas the country has a UN Gender Development Index (GDI) of 0.877 (ranked 39th in the world);

1.  Strongly condemns the detention of the women human rights defenders who campaigned for the lifting of the driving ban, as well as of all peaceful human rights defenders, journalists, lawyers and activists, and expresses its shock at the credible reports of systematic torture against several of them, including Loujain al-Hathloul;

2.  Calls on the Saudi authorities to immediately and unconditionally release these women’s rights defenders and all human rights defenders, lawyers, journalists and other prisoners of conscience detained and sentenced merely for exercising their right to freedom of expression and for their peaceful human rights work, and to allow international independent monitors to meet with detained women human rights defenders;

3.  Urges the Saudi authorities to facilitate the access of independent medical doctors to the detainees; emphasises that the treatment of all detainees, including human rights defenders, while in detention, must adhere to the conditions set out in the Body of Principles for the Protection of All Persons under Any Form of Detention or Imprisonment adopted by means of UN General Assembly Resolution 43/173 of 9 December 1988;

4.  Insists that independent monitors should include observers from the EU Delegation to Saudi Arabia or the EU institutions, as well as UN human rights mandate-holders, such as the Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, or international NGOs;

5.  Insists that the Saudi Authorities put an end to all forms of harassment, including at judicial level, against Loujain al-Hathloul, Aziza al-Yousef, Eman al-Nafjan, Nouf Abdulaziz, Mayaa al-Zahrani, Samar Badawi, Nassima al-Sada, Shadan al-Anezi, Abir Namankani, Amal al-Harbi, Hatoon al-Fassi, Israa Al-Ghomgham, Mohammed al-Rabea and all other human rights defenders in the country, so that they are able to carry out their work without unjustified hindrance or fear of reprisals against them and their families;

6.  Condemns the ongoing repression and torture of human rights defenders, including women’s rights defenders, in Saudi Arabia, which undermines the credibility of the reform process in the country; denounces the continued systemic discrimination against women and girls in Saudi Arabia;

7.  Urges Saudi Arabia to publicly guarantee the safety of all detained activists, allow the detained women access to lawyers and family members, provide evidence of their wellbeing, and release those jailed solely for peacefully advocating reform;

8.  Praises and supports the Saudi women’s rights defenders who are seeking equal and fair treatment in their society and those who have defended human rights despite the difficulties they have to face;

9.  Is deeply concerned about the prevalence of gender-based violence in Saudi Arabia, which remains largely underreported and undocumented, and which has been justified citing retrograde reasons such as the need to discipline women under men’s guardianship; urges the Saudi authorities to adopt comprehensive legislation to specifically define and criminalise all forms of gender-based violence against women, in particular female genital mutilation, rape, including marital rape, sexual assault and sexual harassment, and to remove all the obstacles women face in their access to justice; expresses profound disquiet about the reports of a prevailing practice of child marriage;

10.  Deplores the existence of the male guardianship system, whereby authorisation from a male guardian is still expected in a number of areas, including international travel, accessing healthcare services, choosing one’s residency, marriage, filing complaints with the justice system, and leaving state-run shelters for abused women and detention centres; underlines that this system is a reflection of the deep-rooted patriarchal system that rules the country; urges the Saudi Government to immediately abolish the male guardianship system and repeal other laws that discriminate against women and girls;

11.  Notes the recent adoption of a law under which Saudi women can be notified by text message if they are being divorced, to protect them from having their marriage ended without their knowledge; emphasises that this law does nothing to address the fact that Saudi women can only obtain divorces in exceedingly limited cases, such as with their husband’s consent or if their husband has harmed them;

12.  Expresses concern over the government web services with which male guardians can track women, specify when and how they can cross Saudi borders, and get close to real-time SMS updates when they travel;

13.  Welcomes the lifting of the driving ban for women inside the Kingdom as part of the Vision 2030 agenda;

14.  Calls on the Saudi authorities to revise the Law on Associations and Foundations of December 2015 in order to allow women activists to organise themselves and to work freely and independently without undue interference by the authorities; further urges the revision of the Anti-Terrorist Law, the Anti-Cybercrime Law and the Press and Publications Law, which are repeatedly used to prosecute human rights defenders, as well as of all discriminatory provisions present in the legal system, including in areas such as inheritance;

15.  Calls on the Saudi authorities to ratify the ICCPR, lift the reservations made to CEDAW and ratify the Optional Protocol to CEDAW, so that Saudi women can fully enjoy the rights enshrined in the Convention, and to end child marriages, forced marriages and the compulsory dress code for women; urges Saudi Arabia to extend a standing invitation to all Special Procedures of the UN Human Rights Council to visit the country;

16.  Stresses that the exercise of the rights to freedom of expression and of peaceful association and assembly are protected under international human rights law; calls on the Saudi authorities to allow independent press and media and ensure freedom of expression online and offline, as well as freedom of association and peaceful assembly for all inhabitants of Saudi Arabia; urges the Saudi authorities to remove the restrictions placed on human rights defenders, which prohibit them from speaking out on social media and to the international media;

17.  Calls on the Saudi authorities to introduce an immediate moratorium on the use of the death penalty as a step towards its abolition; calls for a review of all death sentences to ensure that the trials preceding them adhered to international standards;

18.  Recommends sending an ad-hoc delegation from the Subcommittee on Human Rights (DROI) and the Committee on Women’s Rights and Gender Equality (FEMM) before the end of the current mandate to Saudi Arabia in order to visit the imprisoned women and hold the necessary meetings with the Saudi authorities;

19.  Takes note of the EU-Saudi engagement and encourages further dialogue;

20.  Regrets the inefficient statements by the European External Action Service (EEAS) and the Member States on the cases of the women human rights defenders detained since May 2018;

21.  Calls on the VP/HR, the EEAS and the Member States to bring up the cases of Loujain al-Hathloul, Eman al-Nafjan, Aziza al-Yousef, Samar Badawi, Nassima al-Sada and all other women human rights defenders in their dialogues with the Saudi authorities, and to demand their release; insists that, pending their release, EU diplomats should call on the Saudi authorities to guarantee their safety and to pursue full investigations into the reports of torture;

22.  Calls for the Commission and Parliament to look into the lack of listings of Saudi Arabia within the EU transparency register;

23.  Calls on the VP/HR, the EEAS and the Member States to bring up the cases of Israa al-Ghomgham, her husband Mousa al-Hashim, and their four co-defendants Ahmed al-Matrood, Ali Ouwaisher, Khalid al-Ghanim and Mujtaba al-Muzain in their dialogues with the Saudi authorities and to demand their release; calls, furthermore, for the case of Sheikh Salman al-Awda to be brought up and for his release to be demanded;

24.  Calls on the VP/HR, the EEAS and the Member States to establish a unified position to ensure that the European diplomatic services in Saudi Arabia systematically use the mechanisms envisaged in the EU Guidelines on Human Rights Defenders, including public statements, diplomatic démarches, monitoring of trials and prison visits, in relation to the Saudi women’s rights defenders detained since May 2018;

25.  Calls for a European Parliament resolution to be tabled on the situation of human rights defenders in Saudi Arabia at the next session of the UN Human Rights Council; calls for the EU, at the next Human Rights Council and at the Commission on the Status of Women, to raise the issue of membership of states with questionable human rights records, including in relation to respect for women’s rights and gender equality; calls for the EU to propose the appointment of a Special Rapporteur on Human Rights in Saudi Arabia at the UN Human Rights Council;

26.  Calls, once again, on the Saudi authorities to put a stop to any further flogging of Raif Badawi, and to release him immediately and unconditionally; insists that all senior representatives of the EU, notably the VP/HR and all Commissioners, systematically raise the case of Raif Badawi in their contacts with their Saudi counterparts, and request to meet with him during their visits to the country; commits to stepping up its efforts in support of his release; calls on its President to travel to Riyadh in order to bring up the case of the Sakharov Prize laureates directly with the authorities;

27.  Calls on the VP/HR, the EEAS and the Member States to ensure full implementation of the EU Guidelines on Human Rights Defenders, and to expand their protection and support for human rights defenders, particularly women human rights defenders; calls on the VP/HR to report on the current state of military and security cooperation between the Member States and the Saudi regime;

28.  Reiterates its call for the Council to reach a common position in order to impose an EU-wide arms embargo on Saudi Arabia, and to respect Common Position 2008/944/CFSP(6); calls for an embargo on the export of surveillance systems and other dual-use items that may be used in Saudi Arabia for the purposes of the repression of its citizens, including women human rights defenders; is alarmed by the use of these weapons and of cyber surveillance technology by the Saudi Arabian authorities; reminds the Member States that their continued arms deals with Saudi Arabia are in contravention of the EU’s common position on arms exports; calls for the EEAS to propose, and for the Council to adopt, the use of restricted measures against Saudi Arabia in response to breaches of human rights, including asset freezes and visa bans;

29.  Urges the VP/HR, the EEAS and the Member States to continue conducting a dialogue with Saudi Arabia on human rights, fundamental freedoms and the troubling role of the country in the region; expresses its readiness to hold a constructive and open dialogue with the Saudi authorities, including parliamentarians, on the implementation of their international human rights commitments; calls for an exchange of expertise on justice and legal matters in order to strengthen the protection of individual rights in Saudi Arabia;

30.  Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the European External Action Service, the UN Secretary-General, the UN High Commissioner for Human Rights, the Commission on the Status of Women, the UN Human Rights Council, H.M. King Salman bin Abdulaziz Al Saud and Crown Prince Mohammad bin Salman Al Saud, the Government of the Kingdom of Saudi Arabia, and the Secretary-General of the Centre for National Dialogue of the Kingdom of Saudi Arabia.

(1) OJ C 378, 9.11.2017, p. 64. (2) OJ C 310, 25.8.2016, p. 29. (3) OJ C 349, 17.10.2017, p. 34. (4) Texts adopted, P8_TA(2018)0232. (5) Texts adopted, P8_TA(2018)0434. (6) Council Common Position 2008/944/CFSP of 8 December 2008 defining common rules governing control of exports of military technology and equipment, OJ L 335, 13.12.2008, p. 99.

European Parliament legislative resolution of 14 February 2019 on the proposal for a regulation of the European Parliament and of the Council on a mechanism to resolve legal and administrative obstacles in a cross-border context (COM(2018)0373 – C8-0228/2018 – 2018/0198(COD))

P8_TA(2019)0118 A8-0414/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0373),

–  having regard to Article 294(2) and third paragraph of Article 175 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0228/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  having regard to the opinion of the Committee of the Regions of 5 December 2018(2),

–  having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Regional Development and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0414/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Regulation (EU) .../... of the European Parliament and of the Council on a mechanism to resolve legal and administrative obstacles in a cross-border context

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular the third paragraph of Article 175 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(3),

Having regard to the opinion of the Committee of the Regions(4),

Acting in accordance with the ordinary legislative procedure(5),

Whereas:

(1)  The third paragraph of Article 175 of the Treaty on the Functioning of the European Union (TFEU) provides for specific actions to be decided upon outside the Funds which are the subject of the first paragraph of that Article, in order to achieve the objective of social and economic cohesion envisaged by the TFEU. The harmonious development of the entire Union territory and greater economic, social and territorial cohesion imply the strengthening of territorial cooperation. To this end it is appropriate to adopt the measures necessary to improve the implementation conditions for actions of territorial cooperation.

(2)  Article 174 TFEU recognises the challenges faced by border regions and provides that the Union should pay particular attention to these regions, when developing and pursuing actions leading to the strengthening of the Union’s economic, social and territorial cohesion. Due to the increase in the number of land and maritime borders, the Union and its immediate neighbours in the European Free Trade Association ('EFTA') have 40 internal land borders.

(2a)   To improve the life of citizens in cross-border regions on maritime borders or in cross-border regions between the Member States and third countries, the application of this Regulation and the use of a mechanism to resolve legal and administrative obstacles should be extended to all border regions of the Union, while respecting Union law. [Am. 1]

(3)  In its Communication 'Boosting growth and cohesion in EU border regions'(6) ('the Border Regions Communication') the Commission sets out that over the past decades, the European integration process has helped internal border regions to transform from mainly peripheral areas into areas of growth and opportunities. The completion of the Single Market in 1992 has boosted Union productivity and reduced costs through the abolition of customs formalities, harmonisation or mutual recognition of technical rules and lower prices as a result of competition; intra-EU trade has increased by 15 % over 10 years; additional growth has been generated and around 2,5 million more jobs have been created.

(4)  The Border Regions Communication has also given evidence of the fact that there still exist a number of legal barriers in border regions, especially those related to health services, labour regulation, taxes, business development, and barriers linked to differences in administrative cultures and national legal frameworks. Neither European Territorial Cooperation funding nor the institutional support to cooperation by the European groupings of territorial cooperation (EGTCs) is sufficient alone to address the resolution of those barriers which constitute real obstacles to effective cooperation.

(5)  Since 1990, programmes under the European Territorial Cooperation goal, better known as 'Interreg'(7) have supported cross-border cooperation programmes along Union border regions, including those with EFTA countries. It has financed thousands of projects and initiatives that have helped improve European integration. The main achievements of Interreg programmes include: increased trust, higher connectivity, improved environment, better health and economic growth. From people-to-people projects via infrastructure investments and support to institutional cooperation initiatives, Interreg has made a genuine difference to border regions and has contributed to their transformation. Interreg has also supported cooperation on certain maritime borders. However, legal obstacles are much less an issue for maritime border regions because of the physical impossibility to cross the border daily or several times per week for work, education and training, shopping, the use of facilities and services of general economic interest or a combination or for rapid emergency interventions.

(6)  Financial support by Interreg to cross-border cooperation has been complemented by the EGTCs, set up since 2006 under Regulation (EU) No 1082/2006 of the European Parliament and of the Council(8). However, pursuant to the first subparagraph of Article 7(4) of Regulation (EC) No 1082/2006, EGTCs cannot exercise regulatory powers to resolve legal and administrative obstacles in cross-border context.

(7)  In its Border Regions Communication, the Commission referred among other measures to an initiative started under the Luxembourg Presidency in 2015: A number of Member States are considering the merits of a new instrument to simplify cross-border projects by making it possible, on a voluntary basis and agreed by the competent authorities in charge, for the rules of one Member State to apply in the neighbouring Member State. This would apply to an individual project or action limited in time, located within a border region and initiated by local or regional authorities.

(8)  Even though a number of effective mechanisms for cross-border cooperation already exist at inter-governmental, regional and local level in certain regions of the Union, they do not cover all border regions in the Union. In order to complement the existing systems, it is therefore necessary to set up a voluntary mechanism to resolve legal and administrative obstacles in all border regions ('the Mechanism'), but this does not prevent the creation of alternative comparable mechanisms according to specific needs at national, regional or local level. [Am. 2]

(9)  In full respect of the constitutional and institutional set-up of the Member States, the use of the Mechanism should be is voluntary with regard to those border regions of a given Member State where another effective mechanism exists or could be set up with the neighbouring Member State. It should consist of two measures: the signature and the conclusion of a European Cross-Border Commitment (the 'Commitment') or the signature of a European Cross-Border Statement (the 'Statement'). It should be possible for Member States to choose using an instrument which they consider to be more beneficial. [Am. 3]

(9a)   The competent authorities of the Member States, countries, entities or regions involved should adopt, in accordance with their constitutional and legally defined specific competencies, the proposed ad hoc legal solution before concluding and signing the Commitment or signing the Statement pursuant to this Regulation. [Am. 4]

(10)  The Commitment should be self-executing, meaning that pursuant to the conclusion of the Commitment certain legal provisions of one Member State are to be applied on the territory of the neighbouring Member State. It should also be acceptable that the Member States are to adopt a legislative act to allow for the conclusion of a Commitment, in order to prevent national legislation formally adopted by a legislative body from being derogated from by an authority other than that legislative body and in breach of legal clarity and transparency or both.

(11)  The Statement would still require a legislative procedure in the Member State. The authority concluding the Statement should make a formal statement that it will trigger by a certain deadline the legislative procedure necessary to amend the normally applicable national law and to apply, by way of an explicit derogation, the law of a neighbouring Member State, in order to remove obstacles to the implementation of joint cross-border projects. [Am. 5]

(12)  Legal obstacles are predominantly felt by persons interacting on land borders, such as cross-border workers, because people cross borders on a daily or weekly basis. In order to concentrate the effect of this Regulation to the regions closest to the border and with the highest degree of integration and interaction between neighbouring Member States, this Regulation should apply to cross-border regions within the meaning of the territory covered by neighbouring land or maritime border regions in two or more Member States at NUTS level 3 regions(9). This should not prevent Member States from applying the Mechanism also to maritime and external borders other than those with EFTA countries, on a voluntary basis in relation to all parties concerned. [Am. 6]

(13)  In order to coordinate the tasks of different authorities which in some Member States will include national and regional legislative bodies, within a given Member State and between those of one or more neighbouring Member States, each Member State which opts for the Mechanism should be obliged to set up a national and, where applicable appropriate, regional Cross-border Coordination Points and define their tasks and competencies during the different steps of the Mechanism covering initiation, conclusion, implementation and monitoring of Commitments and Statements. [Am. 7]

(14)  The Commission should set up a coordination point at Union level, as announced in the Border Regions Communication. That coordination point should liaise with the different national and, where relevant, regional Cross-border Coordination Points. The Commission should set up and maintain a database on Commitments and Statements in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council(10).

(15)  This Regulation should set out the procedure to conclude a Commitment or Statement and describe in detail the different steps; preparation and submission of an initiative document, a preliminary analysis by the Member State which is to apply the legal provisions of the neighbouring Member State, preparation of the Commitment or Statement to be concluded and finally the conclusion procedure both for the Commitment and the Statement. The elements to be covered in the initiative document, the draft and final Commitments and Statements should also be set out in detail as well as the applicable deadlines.

(16)  More specifically, this Regulation should define who can be an initiator of a joint project. As the Mechanism should improve the implementation of joint cross-border projects, the first group should be bodies initiating or both initiating and implementing such joint project. The term project should be understood in a broad sense, covering both a specific item of infrastructure or a number of activities with regard to a certain territory or both. Secondly, a local or regional authority located in a given cross-border region or exercising public power in that cross-border region should be empowered to take the initiative to apply national law which constitutes an obstacle, but the amendment of or derogation from that law is outside their institutional competence. Thirdly, bodies set up for cross-border cooperation located in or covering at least partially a given cross-border region, including EGTCs, or similar bodies to organise cross-border development in a structured way should be initiator. Finally, bodies specialised in cross-border cooperation which may also be aware of effective resolutions found elsewhere in the Union for a comparable issue should also be enabled to start an initiative. In order to create synergy of bodies directly affected by the obstacle and those expert in cross-border cooperation in general, all groups may initiate the Mechanism jointly.

(17)  The key actor in the Member States requested to conclude a Commitment or Statement should be the respective national or regional Cross-border Coordination Point which is to liaise with all competent authorities in its Member State and with its counterpart in the neighbouring Member State. It should also be clearly established that the Cross-border Coordination Point may decide whether a procedure leading to the conclusion of a Commitment or a Statement is to be launched or whether for one or more legal obstacles a resolution has already found which could be applied. On the other hand, it should also be established that the Member State the legal provisions of which are to be applied in the other Member State may refuse such application outside its territory. Any decision should be duly justified and communicated in due time to all the partners. [Am. 8]

(18)  This Regulation should establish detailed rules on the implementation, application and monitoring of Commitments and Statements to be concluded and signed.

(19)  The implementation of a self-executing Commitment should consist in the application of national provisions of another Member State when implementing joint projects. This should mean either the amendment of legally binding administrative acts already adopted in accordance with the normally applicable national law or, where this has not yet been done, the adoption of new administrative acts based on the legislation of another Member State within a deadline agreed by all the partners in order to be able to launch joint projects in due time. Where several authorities are each competent for different aspects of a complex legal obstacle, the Commitment should be accompanied by a timetable for each of these aspects. Respecting the subsidiarity principle, the adoption and transmission of those amended or new administrative acts should follow the national law on administrative procedures. [Am. 9]

(20)  The implementation of Statements should mainly consist in the preparation and submission of a legislative proposal to amend existing national law or to derogate from it. After adoption, those amendments or derogations should be made public and then also implemented like the Commitments by the amendment and adoption of legally binding administrative acts.

(21)  Based on the legally binding acts, the respect for the obligations and rights of the addressees thereof should be monitored. Member States should be allowed to decide whether that monitoring is entrusted to the authorities of the Member State which transferred its legal provisions because those authorities are more familiar with those rules or whether that monitoring is entrusted to the authorities of the Member State where those provisions are applied because those authorities are more familiar with the remaining legal system of the committing Member States and the law governing the addressees.

(22)  The protection of persons resident in cross-border regions directly or indirectly affected by the application and monitoring of a Commitment and the amended legislation pursuant to a Statement, who consider themselves wronged by acts or omissions by the application should be clarified. Both for Commitment and Statement, the law of the neighbouring Member State would be applied in the committing Member State as incorporated into its own legislation and the legal protection should therefore be in the remit of the courts of the committing Member States even where persons have their legal residence in the transferring Member State. The same principle should apply for the legal redress against the Member State whose administrative act is challenged. However, a different approach should apply to legal redress against the monitoring of the application of the Commitment or Statement. Where an authority from the transferring Member State has accepted to monitor the application of the amended legal provisions of the committing Member State and can act with regard to persons resident in the cross-border area on behalf of the authorities of the committing Member State, but in its own name, the competent courts should be those of the Member State where those persons have their legal residence. On the other hand, where the competent transferring authority cannot act in its own name, but in the name of the competent committing authority, the competent courts should be those of the committing Member State, regardless of the legal residence of the person.

(23)  This Regulation should set out rules on its implementation, the monitoring of its application and on the obligations of the Member States with regard to their national implementing rules.

(24)  In order to establish a database according to Article 8 7, implementing powers should be conferred on the Commission to lay down rules on its running, on the protection of data and the model to be used when information on the implementation and on the use of the Mechanism is submitted by Cross-border Coordination Points. Those powers should be exercised in accordance with the advisory procedure under Regulation (EU) No 182/2011 of the European Parliament and of the Council(11). For practical and coordination purposes, the ‘Coordination Committee for the European Structural and Investment Funds’ should be the committee competent for the procedure of adoption of implementing acts. [Am. 10]

(25)  The national implementing rules are to specify which border regions of a given Member State are covered by the Commitment or the Statement. Consequently, the Commission will be in a position to assess whether for the border which is not mentioned the Member State has opted for a different mechanism. [Am. 11]

(26)  This Regulation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, in particular the right to the protection of personal data (Article 8), the right to education (Article 14), the freedom to choose an occupation and the right to engage in work (Article 15), in particular the freedom to seek employment, to work, to exercise the right of establishment and to provide services in any Member State, the freedom to conduct business (Article 16), access to social security and social assistance (Article 34), access to health care (Article 35), and access to services of general economic interest (Article 36) and a high level of environmental protection in accordance with the principle of sustainable development (Article 37). [Am. 12]

(27)  The conditions for territorial cooperation should be created in accordance with the subsidiarity principle enshrined in Article 5(3) of the Treaty on European Union (TEU). Member States have undertaken individual, bilateral or even multilateral initiatives to resolve legal border obstacles. However, those mechanisms do not exist in all Member States or not for all borders of a given Member State. The financing instruments (mainly Interreg) and the legal instruments (mainly EGTCs) provided at Union level so far have not been sufficient to resolve legal border obstacles throughout the Union. The objectives of the proposed action can consequently not be sufficiently achieved by the Member States, either at central level or at regional and local level, but can rather, by reason of the scale or effects of the proposed action, be better achieved at Union level. Further action by the Union legislator is therefore needed.

(28)  In accordance with the principle of proportionality, as set out in Article 5(4) TEU, the content and form of Union action should not exceed what is necessary to achieve the objectives of the Treaties. The recourse to the specific Mechanism set up under this Regulation to resolve legal obstacles in cross-border regions is voluntary and in no way precludes the use of alternative comparable instruments. Where a Member State decides, on for a specific border joint project with one or more neighbouring Member States, to continue to resolve legal obstacles in a specific cross-border region under the effective mechanisms it has set up at national level or which it has set up formally or informally, together with one or more neighbouring Member States, the Mechanism set up under this Regulation does not need to be selected. Likewise, where a Member State decides, on for a specific border joint project with one or more neighbouring Member States, to join an existing effective mechanism set up formally or informally by one or more neighbouring Member States, provided that mechanism allows for accession, again, the Mechanism set up under this Regulation does not need to be selected. Finally, where a Member State decides together with one or more neighbouring Member States, to set up formally or informally a new effective mechanism to resolve legal obstacles hampering the implementation of a joint project in cross-border regions, the Mechanism set up under this Regulation does not need to be selected. This Regulation does therefore not go beyond what is necessary in order to achieve its objectives for those cross-border regions, for which Member States have no efficient mechanisms to resolve legal obstacles in place. [Am. 13]

(28a)   This Regulation should comply with the subsidiarity principle. It does not affect, by any means, the sovereignty of Member States nor contradict their constitutions. [Am. 14]

HAVE ADOPTED THIS REGULATION:

CHAPTER I

General provisions

Article 1

Subject matter

1.  This Regulation sets up a voluntary mechanism to allow for the application in one Member State, with regard to a single joint project in a cross-border region, of the legal provisions from another Member State, where the application of the legal provisions of the former would constitute a one or more legal obstacle obstacles hampering the implementation of a joint Project ('the Mechanism'). [Am. 15]

2.  The Mechanism shall consist of one of the following measures:

(a)  the conclusion of a European Cross-Border Commitment, which is self-executing,

(b)  the conclusion of a European Cross-Border Statement which would require a legislative procedure in the Member State.

3.  This Regulation also lays down

(a)  the organisation and tasks of Cross-border Coordination Points in the Member States,

(b)  the coordinating role of the Commission with respect to the Mechanism,

(c)  the legal protection of persons resident in a cross-border region or those who live there for a limited period with regard to the Mechanism. [Am. 16]

Article 2

Scope

1.  This Regulation applies to cross-border regions as defined in point (1) of Article 3.

2.  Where a Member State comprises several territorial entities with legislative powers, this Regulation shall also apply to those territorial entities including their respective authorities or legal provisions.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1)  'cross-border region' means the territory covered by neighbouring land or maritime border regions in two or more Member States at NUTS level 3 regions; [Am. 17]

(2)  'joint project' means any item of infrastructure with an impact in a given cross-border region or any service of general economic interest provided in a given cross-border region, regardless of whether this impact appears on both sides of the border or only on one side thereof; [Am. 18]

(3)  'legal provision' means any legal or administrative provision, rule or administrative practice applicable to a joint project, regardless whether adopted or implemented by a legislative or executive body;

(4)  'legal obstacle' means any legal provision with regard to the planning, development, staffing, financing or functioning of a joint project that obstructs the inherent potential of a border region when interacting across the border;

(5)  'initiator' means the actor who identifies the one or more legal obstacle obstacles and triggers the Mechanism by submitting an initiative document; [Am. 19]

(6)  'initiative document' means the document prepared by one or more initiators to trigger the Mechanism;

(7)  'committing Member State' means the Member State on the territory of which one or more legal provisions from a transferring Member State will apply under a given European Cross-border Commitment (the “Commitment”) or European Cross-border Statement (the “Statement”) or where, in the absence of an appropriate legal provision, an ad hoc legal resolution will be established;

(8)  'transferring Member State' means the Member State whose legal provisions will apply in the committing Member State under a given Commitment or Statement;

(9)  'competent committing authority' means the authority in the committing Member State competent to accept the application of the legal provisions of the transferring Member State on its territory under a given Commitment or, in the case of a Statement, to commit itself to starting the legislative procedure needed for a derogation from its domestic legal provisions;

(10)  'competent transferring authority' means the authority in the transferring Member State competent for the adoption of the legal provisions which will apply in the committing Member State and for its application on its own territory or for both;

(11)  'area of application' means the area in the committing Member State where the legal provision of the transferring Member State or an ad hoc legal resolution shall apply.

Article 4

Member States' options for resolving legal obstacles

1.  Member State shall either States may opt for the Mechanism or opt for existing other ways to resolve legal obstacles hampering the implementation of a joint project in cross-border regions on a specific border with one or more neighbouring Member States. [Am. 20]

2.  A Member State may also decide, with regard to a specific border joint project in cross-border regions, with one or more neighbouring Member States, to join an existing effective way set up formally or informally by one or more neighbouring Member States or shall apply the Mechanism in respect of the Statement. [Am. 21]

3.  Member States may also use apply the Mechanism in cross-border regions on maritime borders or to a joint project in a cross-border regions region between one or more Member States and one or more third countries or one or more overseas countries and territories on a voluntary basis in relation to all parties concerned. [Am. 22]

4.  Member States shall inform the Commission about any decision taken under this Article.

Article 5

Cross-border Coordination Points

1.  Where a Each Member State opts for the Mechanism, it shall establish or designate one or more Cross-border Coordination Points in one of the following ways: [Am. 23]

(a)  designate, at national or regional level or at both levels, a Cross-border Coordination Point as a separate body;

(b)  set up a Cross-border Coordination Point within an existing authority or body, at national or regional level;

(c)  entrust an appropriate authority or body with the additional tasks as national or regional Cross-border Coordination Point.

2.  Committing Member States and transferring Member States shall also determine:

(a)  whether it is the Cross-border Coordination Point or a competent committing/transferring authority which may conclude and sign a Commitment and decide the applicable national law will be derogated from the date of the entry into force of that Commitment; or

(b)  whether it is the Cross-border Coordination Point or a competent committing/transferring authority which may sign a Statement and state formally therein that the competent committing authority will do the necessary as to legislative or other acts be taken by the competent legislative bodies in that Member State by a given deadline.

3.  The Member States shall inform the Commission of the designated Cross-border Coordination Points by the date of the start of application of this Regulation.

Article 6

Tasks of Cross-border Coordination Points

1.  Each Cross-border Coordination Point shall have at least the following tasks:

(a)  implement the procedure set out in Articles 10 and 11;

(b)  coordinate the preparation, signature, implementation and monitoring for all Commitments and Statements concerning the territory of its Member State;

(c)  build up and maintain a database covering all Cross-border Coordination Points concerning the territory of its Member State;

(d)  liaise, where they exist, with the Cross-border Coordination Points in the neighbouring Member State or States and with the Cross-border Coordination Points in other territorial entities with legislative powers of its own Member State or another Member State; [Am. 24]

(e)  liaise with the Commission;

(f)  support the Commission as regards its database on Statements and Commitments.

2.  Each Member State or each territorial entity with legislative powers in that Member State may decide to entrust the respective Cross-border Coordination Point also with the following tasks:

(a)  where applicable, to conclude Commitments or Statements pursuant to Articles 16(2) and 17(2);

(b)  upon request from a given initiator, support that initiator by, among other things, identifying the competent committing authority in the same Member State or the competent transferring authority in another Member State;

(c)  upon request from a given competent committing authority located in another Member State without its own Cross-border Coordination point, perform the preliminary analysis of an initiative document; [Am. 25]

(d)  monitor the implementation of all Commitments and Statements concerning the territory of its Member State;

(e)  remind the competent committing authority to comply with the deadlines established by in a given Commitment or Statement and request a reply within a given deadline;

(f)  inform the authority supervising the competent committing authority on any missed deadlines as established in a given Commitment or Statement.

3.  Where at least one among several legal obstacles concerns an issue of legislative competence at national level, the national Cross-border Coordination Point shall assume the tasks set out in Articles 9 to 17 and coordinate with the relevant regional Cross-border Coordination Point or Points in the same Member State, unless the Member State has decided that the tasks set out in Articles 14 to 17 are entrusted to a competent committing authority at national level.

4.  Where none of the legal obstacles concerns an issue of legislative competence at national level, the competent regional Cross-border Coordination Point shall assume the tasks set out in Articles 9 to 17 and coordinate, with the other regional Cross-border Coordination Point or Points in the same Member States, in the cases where more than one territorial entity is concerned by the joint project, unless the Member State has decided that the tasks set out in Articles 14 to 17 are entrusted to a national Cross-border Coordination Point. That competent regional Cross-border Coordination Point shall keep the national Cross-border Coordination Point informed about any Commitment or Statement procedure.

Article 7

Coordination tasks of the Commission

1.  The Commission shall fulfil the following coordination tasks:

(a)  liaise with the Cross-border Coordination Points;

(b)  create, publish and keep an up-dated list database of all national and regional Cross-border Coordination Points; [Am. 26]

(c)  set up and maintain a database on all Commitments and Statements.

1a.   The Commission shall prepare a supporting communication strategy with the aim of:

(a)  promoting the exchange of best practices;

(b)  providing practical information and interpretation of the subject area and the thematic focus of this Regulation; and

(c)  clarifying the precise procedure for concluding a Commitment or Statement. [Am. 27]

2.  The Commission shall adopt an implementing act with regard to the functioning of the database referred to in point (c) of paragraph 1 and the forms to be used when information on the implementation and on the use of the Mechanism is submitted by Cross-border Coordination Points. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 23(2).

CHAPTER II

Procedure for concluding and signing a Commitment or for signing a Statement

Article 8

Preparation and submission of the initiative document

1.  The initiator shall identify the one or more legal obstacle obstacles with regard to the planning, development, staffing, financing or functioning of a joint project. [Am. 28]

2.  The initiator shall be one of the following:

(a)  the public or private body responsible for initiating or both initiating and implementing a joint project;

(b)  one or more local or regional authorities located in a given cross-border region or exercising public power in that cross-border region;

(c)  a body with or without legal personality set up for cross-border cooperation located in or covering at least partially a given cross-border region, including European groupings of territorial cooperation under Regulation (EC) No 1082/2006, Euroregions, Euregios and similar bodies;

(d)  an organisation set up on behalf of cross-border regions with the aim to promote the interests of cross-border territories and to facilitate the networking of players and the sharing of experiences, such as the Association of European Border Regions, the Mission Opérationnelle Transfrontalière or the Central European Service for Cross-border Initiatives; or

(e)  several of the entities referred to in points (a) to (d) jointly.

3.  The initiator shall prepare an initiative document drafted in accordance with Article 9.

4.  The initiator shall submit the initiative document to the competent Cross-border Coordination Point of the committing Member State and send a copy to the competent Cross-border Coordination Point of the transferring Member State.

Article 9

Content of the initiative document

1.  The initiative document shall include at least the following elements:

(a)  a description of the joint project and of its context, of the one or more corresponding legal obstacle obstacles in the committing Member State as well as of the rationale for resolving the one or more legal obstacle obstacles; [Am. 29]

(b)  a list of the specific legal provisions of the transferring Member State resolving the one or more legal obstacle obstacles or, where no appropriate legal provision exists, a proposal for an ad hoc legal resolution; [Am. 30]

(c)  a justification for the area of application;

(d)  the foreseeable duration or, where duly justified, its unlimited duration;

(e)  a list of the competent committing authority or authorities;

(f)  a list of the competent transferring authority or authorities.

2.  The area of application shall be limited to the minimum necessary for the effective implementation of the joint project.

Article 10

Preliminary analysis of the initiative document by the committing and transferring Member State or States [Am. 31]

1.  The competent Cross-border Coordination Point of the committing Member State shall analyse the initiative document. It shall liaise with all competent committing authorities and with the national or, where relevant, other regional Cross-border Coordination Points in the committing Member State and with the national Cross-border Coordination Point in the transferring Member State. [Am. 32]

1a.   Within three months of receipt of an initiative document, the competent Cross-border Coordination Point of the transferring Member State shall send its preliminary reaction to the competent Cross-border Coordination Point of the committing Member State. [Am. 33]

2.  Within three six months after receipt of the initiative document the competent Cross-border Coordination Point of the committing Member State shall take one or more of the following actions, to be transmitted to the initiator in writing: [Am. 34]

(a)  inform the initiator that the initiative document was prepared in accordance with Article 9 and is therefore admissible;

(b)  request, if necessary, the submission of a revised initiative document or of additional specific information while setting out why and in which aspect the initiative document is not considered sufficient;

(c)  inform the initiator about its assessment that there is no legal obstacle while setting out the reasons and also referring to the means of legal redress against that decision under the law of the committing Member State;

(d)  inform the initiator about its assessment that the one or more legal obstacle consists obstacles consist in one of the cases listed in Article 12(4) and describe the commitment of the competent committing authority, to change or adapt that legal obstacle; [Am. 35]

(e)  inform the initiator about its assessment that the one or more legal obstacle consists obstacles consist in one of the situations under Article 12(4) while setting out its reasons to refuse to change or adapt that legal obstacle and referring to the means of legal redress against that decision under the law of the committing Member State; [Am. 36]

(f)  commit itself towards the initiator to find a resolution to the legal obstacle or obstacles within six months, either by signing a Commitment with the Cross-border Coordination point of the transferring Member State or with the competent transferring authority, as designated by the transferring Member State, or by proposing an ad hoc legal resolution within the legal framework of the committing Member State;

(fa)   redirect the initiator to opt for an existing mechanism as referred to in Article 4(2) to resolve one or more legal obstacles hampering the implementation of the joint project or to directly transmit the initiative document to the competent body under the corresponding mechanism; [Am. 37]

(fb)   inform the initiator that one or more of the Member States concerned have decided not to resolve one or more of the legal obstacles identified by the initiator while setting out the reasons for that decision in writing. [Am. 38]

3.  In duly justified cases, the competent committing authority may extend the deadline referred to in point (f) of paragraph 2 once, by a maximum of six months and shall inform the initiator and the transferring Member State accordingly, while setting out the reasons in writing.

Article 11

Preliminary analysis of the initiative document by the transferring Member State

Upon receipt of an initiative document, the competent Cross-border Coordination Point of the transferring Member State shall also carry out the tasks listed in Article 10(2) and may send its preliminary reaction to the competent Cross-border Coordination Point of the committing Member State. [Am. 39]

Article 12

Follow-up on the preliminary analysis of the initiative document

1.  Where the competent Cross-border Coordination Point of the committing Member State requests a revised initiative document or additional specific information, it shall analyse the revised initiative document or the additional specific information or both and take, within three six months after receipt thereof, the actions as if the initiative document was submitted for the first time. [Am. 40]

2.  Where the competent Cross-border Coordination Point of the committing Member State considers that the revised initiative document is still not prepared in accordance with Article 10 or that the additional specific information is still not sufficient, it shall, within three six months after receipt of the revised initiative document, inform the initiator in writing about its decision to end the procedure. This decision shall be duly justified. [Am. 41]

3.  Where the analysis by the competent Cross-border Coordination Point of the committing Member State or the competent committing authority concludes that the one or more legal obstacle obstacles described in the initiative document are based on a misunderstanding or misinterpretation of the relevant legislation or on the lack of sufficient information about the relevant legislation, the procedure ends by informing the initiator about the assessment that there is no legal obstacle. [Am. 42]

4.  Where the one or more legal obstacle obstacles consist only in an administrative provision, rule or administrative practice of the committing Member State or in an administrative provision, rule or administrative practice clearly distinct from a provision adopted under a legislative procedure and can therefore be changed or adapted without a legislative procedure, the competent committing authority shall inform the initiator in writing its refusal or willingness to change or adapt the relevant administrative provision, rule or administrative practice within eight months. [Am. 43]

5.  In duly justified cases, the competent committing authority may extend the deadline referred to in paragraph 4 once by a maximum of eight months and shall inform the initiator and the transferring Member State accordingly, while setting out the reasons in writing.

Article 13

Preparation of the draft Commitment or Statement

The Cross-border Coordination Point or the competent committing authority of the committing Member State shall draw up a draft Commitment or a draft Statement in accordance with Article 14, based on the initiative document.

Article 14

Content of the draft Commitment and draft Statement

1.  The draft Commitment shall include at least the following elements:

(a)  the description of the joint project and of its context, of the one or more corresponding legal obstacle obstacles as well as of the rationale for resolving the one or more legal obstacle obstacles; [Am. 44]

(b)  the list of the specific legal provision or provisions constituting the one or more legal obstacle obstacles and which shall therefore not apply to the joint project; [Am. 45]

(c)  the area of application;

(d)  the duration of the application and a justification for that duration;

(e)  the competent committing authority or authorities;

(f)  the specific legal provision of the transferring Member State which shall apply to the joint project;

(g)  the proposal of the ad hoc legal resolution, where no appropriate legal provision exists in the legal framework of the transferring Member State;

(h)  the competent transferring authority or authorities;

(i)  the authority or authorities from the committing Member State competent for the implementation and monitoring;

(j)  the authority or authorities from the transferring Member State which are proposed to be designated jointly for the implementation and monitoring;

(k)  the date of its entry into force.

The date of entry into force referred to in point (k) shall be either the date when the last of the two Cross-border Coordination Points or competent authorities have signed or the date when it has been notified to the initiator.

2.  In addition to the elements listed in paragraph 1, the draft Commitment shall also include a date of application which may be

(a)  set at the same date as its entry into force;

(b)  set with retroactive effect;

(c)  deferred to a date in the future.

3.  In addition to the elements listed in paragraph 1, the draft Statement shall also include a formal statement of the date or dates by which each competent committing authority shall submit a formal proposal to the respective legislative body in order to amend the national legal provisions accordingly.

The date referred to in the first subparagraph shall not be later than twelve months after the conclusion of the Statement.

Article 15

Transmission of the draft Commitment or draft Statement

1.  Where the competent committing authority has prepared the draft Commitment or draft Statement, it shall transmit this draft to the competent Cross-border Coordination Point of the committing Member State:

(a)  within a maximum of three six months after having transmitted information under Article 10(2) or Article 12(1) and (2); [Am. 46]

(b)  within a maximum of eight months pursuant to Article 12(4) and (5).

2.  Where the competent Cross-border Coordination Point of the committing Member State has prepared the draft Commitment or draft Statement or where it has received it from the competent committing authority it shall transmit this draft to the competent Cross-border Coordination Point of the transferring Member State within the periods referred to in point (a) or (b) of paragraph 1.

3.  In both cases, a copy shall also be sent for information to the initiator.

Article 16

Tasks of the transferring Member State in concluding and signing the Commitment or in signing the Statement

1.  The competent Cross-border Coordination Point of the transferring Member State shall examine the draft Commitment or draft Statement received pursuant to Article 15 and, within a maximum of three six months after receipt of the draft and after consulting the competent transferring authorities, take one or more of the following actions: [Am. 47]

(a)  agree with the draft Commitment or draft Statement, sign two original copies and send one back to the competent Cross-border Coordination Point of the committing Member State;

(b)  agree with the draft Commitment or draft Statement, after correcting or supplementing the information referred to in points (f) and (h) of Article 14(1), sign two original copies of the revised draft Commitment or draft Statement and send one back to the competent Cross-border Coordination Point of the committing Member State;

(c)  refuse to sign the draft Commitment or draft Statement and transmit a detailed justification to the competent Cross-border Coordination Point of the committing Member State;

(d)  refuse to sign the draft Commitment or draft Statement and send back an amended draft as regards the information referred to in points (c), (d) and, where relevant, (g) of Article 14(1), as well as for the draft Commitment the information referred to under Article 14(2), with a justification for the amendments to the competent Cross-border Coordination Point of the committing Member State.

2.  In Member States where the competent transferring authority shall sign a Commitment or Statement, the competent Cross-border Coordination Point of the transferring Member State shall send, in accordance with points (a) and (b) of paragraph 1, one of the two original copies signed by the competent transferring authority to the competent Cross-border Coordination Point of the committing Member State. [Am. 48]

3.  Where the transferring Member State agrees in accordance with point (a) or (b) of paragraph 1 to sign a Commitment or a Statement, it shall, in addition, explicitly confirm or refuse that the competent authority or authorities which are proposed to be designated jointly for the implementation and monitoring of the Commitment or the Statement pursuant to point (j) of Article 14(1) shall assume those tasks to be carried out in the area of application.

Article 17

Tasks of the committing Member State in concluding and signing the Commitment or in signing the Statement

1.  The competent Cross-border Coordination Point of the committing Member State shall examine the reply transmitted by the competent Cross-border Coordination Point of the transferring Member State and take, within a maximum of one month three months after its receipt one or more of the following actions, to be transmitted to the competent transferring authority in writing: [Am. 49]

(a)  in the case of point (a) of paragraph 2 Article 16(1), finalise the Commitment or the Statement, sign two three original copies and send one back to the competent Cross-border Coordination Point of the transferring Member State for signature; [Am. 50]

(b)  in the case of point (b) of paragraph 2 Article 16(1), amend the Commitment or the Statement as regards the information in the draft Commitment or the draft Statement covered by points (f) and (h) of Article 14(1) accordingly, finalise the Commitment or Statement, sign two three original copies and send one back to the competent Cross-border Coordination Point of the transferring Member State for signature; [Am. 51]

(c)  in the case of point (c) of paragraph 2 Article 16(1), inform the initiator and the Commission, while adding the justification as set out by the competent transferring authority; [Am. 52]

(d)  in the case of point (d) of paragraph 2 Article 16(1), consider the amendments and either proceed as under point (b) of this paragraph or relaunch a second procedure proceed as under Article 9 point (c) of this paragraph setting out why some or all of the amendments could not be accepted by the competent committing authority. [Am. 53]

2.  Upon receipt of the Commitment or the Statement, as also signed by the competent Cross-border Coordination Point or competent transferring authority in the cases of point (a) or (b) of paragraph 1 or, where the competent Cross-border Coordination Point of the transferring Member State has reacted positively under the second procedure of point (d) of paragraph 1, the competent Cross-border Coordination Point of the committing Member State shall: [Am. 54]

(a)  transmit the final Commitment or Statement to the initiator;

(b)  transmit the second original copy to the competent Cross-border Coordination Point of the transferring Member State;

(c)  send a copy to all competent committing authorities;

(d)  send a copy to the coordination point at Union level; and

(e)  request the competent service in the committing Member State responsible for official publications to publish the Commitment or the Statement.

CHAPTER III

Implementation and monitoring of Commitments and Statements

Article 18

Implementation of the Commitment

1.  The information referred to under point (c) of Article 17(2) and sent to all competent committing authorities concerned, shall be accompanied by a timetable, by which each of those authorities shall, where relevant, amend any administrative act adopted under the applicable law with regard to the joint project and adopt any administrative act necessary to apply the Commitment to the joint project in order to apply to it the legal provision of the transferring Member State or an ad hoc legal resolution.

2.  A copy of the timetable shall be sent to the national and, where relevant, regional Cross-border Coordination Point of the committing Member State.

3.  Any administrative act referred to in paragraph 1 shall be adopted and notified to the initiator, in particular to the public or private body responsible for initiating or both initiating and implementing a joint project, in accordance with the national law applicable to such administrative acts.

4.  Once all administrative acts with regard to a given joint project are adopted, the Cross-border Coordination Point of the committing Member State shall inform the Cross-border Coordination Point of the transferring Member State and the coordination point at Union level.

5.  The Cross-border Coordination Point of the transferring Member State shall inform, where relevant, the competent transferring authorities.

Article 19

Implementation of the Statement

1.  Each competent committing authority listed in a Statement under Article 14(3) shall submit by the respective date fixed in the signed Statement a formal proposal to the respective legislative body in order to amend the national legal provisions accordingly.

2.  In case the respective date fixed in the signed Statement cannot be respected, in particular in view of upcoming elections for the competent legislative body, the competent committing authority shall inform in writing the initiator as well as the competent Cross-border Coordination Point of both the committing and the transferring Member States.

3.  Once a formal proposal has been submitted to the respective legislative body, the respective competent committing authority shall up-date in writing the initiator as well as the competent Cross-border Coordination Point of both the committing and the transferring Member States about the monitoring in the respective legislative body, and this every six months after the date of formal submission.

4.  Upon entry into force of the amending legislative act or its publication in the official Gazette or both, each competent committing authority shall amend any administrative act adopted under the applicable national law with regard to the joint project and adopt any administrative act necessary to apply the amended legal provisions to the joint project.

5.  Any administrative act as referred to in paragraph 4 shall be adopted and notified to the initiator, in particular where this initiator is a public or private body responsible for initiating or both initiating and implementing a joint project, in accordance with the national law applicable to such administrative acts.

6.  Once all administrative acts with regard to a given joint project are adopted, the Cross-border Coordination Point of the committing Member State shall inform the Cross-border Coordination Point of the transferring Member State and the coordination point at Union level.

7.  The Cross-border Coordination Point of the transferring Member State shall, where relevant, inform the competent transferring authorities.

Article 20

Monitoring of Commitments and Statements

1.  Based on the administrative acts referred to in Articles 18(1) and 19(4), the committing and transferring Member States shall decide whether the monitoring of the application of a Commitment or of the amended national legislation pursuant to a Statement shall be entrusted to the authorities of the transferring Member State, in particular due to their expertise with the legal provisions transferred, or to the authorities of the committing Member State.

2.  Where the monitoring of the application of the transferred legal provisions is entrusted to the authorities of the transferring Member State, the committing Member State shall decide, in agreement with transferring Member States, whether the authorities of the transferring Member State shall act with regard to the addressees of the monitoring tasks on behalf and in the name of the authorities of the committing Member State or on behalf, but in their own name.

CHAPTER IV

Legal protection against the application and monitoring of Commitments and Statements

Article 21

Legal protection against the application of a Commitment or Statement

1.  Any person resident in the territory covered by a Commitment or Statement or, although not resident in that territory, being user of a service of general economic interest provided in that territory ('person resident in the cross-border region'), who considers itself wronged by the acts or omissions by the application, pursuant to a Commitment or a Statement, of a legal provision of a transferring Member State shall be entitled to seek legal redress before the courts of the committing Member State.

2.  However, the competent courts for legal redress against any administrative acts adopted under Article 18(3) and 19(5) shall be exclusively the courts of the Member State whose authorities issued the administrative act.

3.  Nothing in this Regulation shall deprive persons from exercising their national constitutional rights of appeal against authorities which are parties of a Commitment in respect of:

(a)  administrative decisions in respect of activities which are being carried out pursuant to a Commitment;

(b)  access to services in their own language; and

(c)  access to information.

In these cases the competent courts shall be those of the Member State under whose constitution the rights of appeal arise.

Article 22

Legal protection against the monitoring of Commitments or Statements

1.  Where the competent transferring authority has accepted to monitor the application of the legal provisions of the transferring Member State in the relevant area and can act in its own name towards persons resident in the cross-border region of the committing Member State, the competent courts for legal redress against any action or omission by that authority shall be the courts of the Member State where those persons have their legal residence.

2.  Where the competent transferring authority has accepted to monitor the application of the legal provisions of the committing Member State on the territory of the committing Member State, but cannot act on its own name towards persons resident in the cross-border region, the competent courts for legal redress against any action or omission by that authority shall be only the courts of the committing Member State, including for persons having their legal residence in the transferring Member State.

CHAPTER V

Final provisions

Article 23

Committee procedure

1.  The Commission shall be assisted by the Coordination Committee for the European Structural and Investment Funds established by Article 108(1) of Regulation (EU) No .../... [new CPR]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Article 24

Implementing provisions in the Member States

1.  Member States shall make such provisions as are appropriate to ensure the effective application of this Regulation

2.  By ... [date of application of this Regulation], Member States shall inform the Commission accordingly of any provisions adopted under paragraph 1.

3.  The Commission shall render public the information received from the Member States.

Article 25

Reporting

1.  By dd mm yyyy [i.e. the first day of the month following the date of entry into force of this Regulation + five three years], the Commission shall present a report to the European Parliament, the Council and the Committee of the Regions assessing the application of this Regulation based on indicators on its effectiveness, efficiency, relevance, European added value and scope for simplification.

2.   In the report referred to in paragraph 1, the Commission shall make particular reference to this Regulation’s geographical and thematic scope as defined in points (1) and (2) of Article 3 respectively.

3.   Before the report is prepared, the Commission shall carry out a public consultation with the various actors involved, including local and regional authorities and civil society organisations. [Am. 55]

Article 26

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from ... [the first day of the month following the date of entry into force of this Regulation + one year].

However, Article 24 shall apply from ... [the first day of the month following the date of entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament For the Council

The President The President

(1) OJ C 440, 6.12.2018, p. 124. (2) OJ C ... (3) OJ C 440, 6.12.2018, p. 124. (4) OJ C ... (5) Position of the European Parliament of 14 February 2019. (6) Communication from the Commission to the Council and the European Parliament 'Boosting growth and cohesion in EU border regions' - COM(2017)0534, 20.9.2017. (7) Five programming periods of Interreg have succeeded each other: INTERREG I (1990-1993), INTERREG II (1994-1999), INTERREG III (2000-2006), INTERREG IV (2007-2013) and INTERREG V (2014-2020). (8) Regulation (EC) No 1082/2006 of the European Parliament and of the Council of 5 July 2006 on a European grouping of territorial cooperation (EGTC) (OJ L 210, 31.7.2006, p. 19). (9) Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1). (10) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (11) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

European Parliament legislative resolution of 14 February 2019 on the draft Council implementing decision approving the conclusion by Eurojust of the Agreement on Cooperation between Eurojust and Georgia (13483/2018 – C8-0484/2018 – 2018/0813(CNS))

P8_TA(2019)0119 A8-0065/2019

(Consultation)

The European Parliament,

–  having regard to the Council draft (13483/2018),

–  having regard to Article 39(1) of the Treaty on European Union, as amended by the Treaty of Amsterdam, and Article 9 of Protocol No 36 on transitional provisions, pursuant to which the Council consulted Parliament (C8-0484/2018),

–  having regard to Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime(1), and in particular Article 26a(2) thereof,

–  having regard to Rule 78c of its Rules of Procedure,

–  having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinion of the Committee on Legal Affairs (A8-0065/2019),

1.  Approves the Council draft;

2.  Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.  Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament;

4.  Instructs its President to forward its position to the Council and the Commission.

(1) OJ L 63, 6.3.2002, p. 1.

European Parliament legislative resolution of 14 February 2019 on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018)0051 – C8-0024/2018 – 2018/0018(COD))

P8_TA(2019)0120 A8-0289/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0051),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0024/2018),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Czech Chamber of Deputies, the German Bundestag, the French Senate and the Polish Sejm, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Economic and Social Committee of 23 May 2018(1)

–  having regard to Rules 59 and 39 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A8-0289/2018),

1.  Adopts its position at first reading hereinafter set out(2);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Regulation (EU) .../... of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 Articles 114 and 168(4) thereof, [Am. 1]

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(3),

Having regard to the opinion of the Committee of the Regions(4),

Acting in accordance with the ordinary legislative procedure(5),

Whereas:

(1)  The development of health technologies is a key driver of economic growth and innovation in the Union. It forms key to achieving the high level of health protection that health policies must ensure, for the benefit of all citizens. Health technologies are an innovative sector of the economy which form part of an overall market for healthcare expenditure that accounts for 10 % of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment. [Am. 2]

(1a)  Expenditure on medicines stood at 1,41 % of GDP in 2014 and accounted for 17,1 % of overall health expenditure, of which it is a major component. Health expenditure in the Union amounts to 10 % of GDP, i.e. EUR 1 300 000 million per annum, EUR 220 000 million of which is pharmaceutical expenditure and EUR 110 000 million expenditure on medical devices. [Am. 3]

(1b)  The Council conclusions of 16 June 2016 and the European Parliament resolution of 2 March 2017 on EU options for improving access to medicines(6) highlighted that there are many barriers to access to medicine and innovative technologies in the Union, with the main barriers being the lack of new treatments for certain diseases and the high price of medicines, which in many cases do not have added therapeutic value. [Am. 4]

(1c)  Marketing authorisations for medicinal products are granted by the European Medicines Agency on the basis of the principles of safety and efficacy. Normally the national health technology assessment agencies assess comparative effectiveness, because marketing authorisations are not accompanied by a comparative effectiveness study. [Am. 5]

(2)  Health Technology Assessment (HTA) is an a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added therapeutic value of a health technology in comparison with other new or existing health technologies. [Am. 6]

(2a)  As the World Health Organization (WHO) stated at the 67th World Health Assembly in May 2014, HTA has to be a tool in support of universal health coverage. [Am. 7]

(2b)  HTA should be instrumental in promoting innovation which offers the best outcomes for patients and society as a whole and is a necessary tool for ensuring the proper application and use of health technologies. [Am. 8]

(3)  HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, (which form the ‘HTA Core model’) four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches. [Am. 9]

(3a)  Health professionals, patients and health institutions need to know whether or not a new health technology represents an improvement on existing health technologies, in terms of benefits and risks. Joint clinical assessments therefore aim to identify the added therapeutic value of new or existing health technologies in comparison with other new or existing health technologies, by undertaking a comparative assessment based on comparative trials against the current best proven intervention (‘standard treatment’) or against the current most common treatment where no such standard treatment exists. [Am. 10]

(4)  HTA is an important tool for promoting high-quality innovation, steering research towards addressing the unmet diagnostic, therapeutic or procedural needs of healthcare systems as well as steering clinical and social priorities. HTA can also improve scientific evidence used to inform clinical decision-making, efficiency in use of resources, the sustainability of health systems, patient access to these health technologies, and the competitiveness of the sector through greater predictability and more efficient research. Member States use the outcome of HTA is used to augment the scientific evidence that informs decisions to introduce health technologies into their systems, i.e. to inform decisions concerning the allocation of budgetary on how to allocate resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients. [Am. 11]

(4a)  Cooperation in the field of HTA can also play a role throughout the health technology cycle: in the early developmental stage through ‘horizon scanning’ in order to pinpoint technologies that will have a major impact; in the early dialogue and scientific advisory stages; in better study design to ensure greater research efficiency; and in the core stages of the overall assessment, once the technology is already established. Finally, HTA can help in decision-making on divestment in cases where a technology becomes obsolete and unsuitable compared to better alternative options that are available. Greater collaboration between Member States in the field of HTA should also help improve and harmonise standards of care as well as diagnostic and new-born screening practices across the Union. [Am. 12]

(4b)  Cooperation in the field of HTA can extend beyond pharmaceutical products and medical devices. It can also cover areas such as diagnostics used to supplement treatment, surgical procedures, prevention, screening and health promotion programmes, information and communications technology (ICT) tools, health-care organisation plans and integrated care processes. Different demands are involved in assessing different technologies, depending on their specific features, meaning that a cohesive approach which can cater for these different technologies is needed in the field of HTA. Moreover, in specific areas such as treatments for rare diseases, paediatric medicines, precision medicine and advanced therapies, the added value of cooperation at Union level is likely to be even greater. [Am. 13]

(5)  The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment can result in health technology developers being confronted with multiple and divergent a duplication of requests for data. It can also lead to both duplications and variations in outcomes that could increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market. In some justified cases where the specificities of the national and regional healthcare systems and priorities need to be taken into account, a complementary assessment on certain aspects might be necessary. However, assessments that are not relevant for decisions in certain Member States could delay the implementation of innovative technologies and thus access of patients to beneficial innovative treatments. [Am. 14]

(6)  While Member States have carried out some joint assessments within the framework of the EU co-funded joint actions. the production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. Use of the results of the Those assessments were carried out in three stages, under Article 15 of Directive 2011/24/EU of the European Parliament and of the Council(7), and through three joint actions, including their joint clinical assessments, at Member State-level has remained low, meaning that the duplication of each with specific objectives and a specific budget: EUnetHTA 1, 2010 to 2012 (EUR 6 million); EUnetHTA 2, 2012 to 2015 (EUR 9,5 million); and EUnetHTA 3, launched in June 2016 with an end date of 2020 (EUR 20 million). Given the timescales for those actions and in the interests of continuity, this Regulation establishes a more sustainable way of ensuring the continuation of the joint assessments. The main outcomes of the cooperation to date include the ‘HTA Core Model’ assessment model, which provides a framework for HTA reports; a database for sharing projects that are planned, ongoing or recently published by individual agencies (POP database); a data- and knowledge base for the storage of information and the stage reached in the assessment of promising technologies, or on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed request for supplementary studies arising from the HTA; and a set of methodological guides and support tools for HTA agencies, including guidelines for adapting reports from one country to another. [Am. 15]

(6a)  However, within the joint actions, the production of output has been inefficient and, in the absence of a sustainable model of cooperation, relying on project-based cooperation. Use of the results of the joint actions, including their joint clinical assessments, at Member State-level has remained low, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed. [Am. 16]

(7)  The Council In its Conclusions of December 2014 on innovation for the benefit of patients(8), the Council acknowledged the key role of health technology assessment and as a health policy tool to support evidence-based, sustainable and equitable choices in health care and health technologies for the benefit of patients. The Council further called on the Commission to continue to support cooperation in a sustainable manner, and asked for joint work between Member States on HTA to be enhanced and for opportunities for cooperation on exchange of information between competent bodies to be explored. In addition, in its Conclusions of December 2015 on personalised medicine for patients, the Council invited Member States and the Commission to strengthen HTA methodologies applicable to personalised medicine, and the Council Conclusions of June 2016 on strengthening the balance in the pharmaceutical systems in the European Union and its Member States provided further evidence that Member States see clear added value in cooperation on HTA. The joint report of October 2016 of the Commission's DG for Economic and Financial Affairs and the Economic Policy Committee further called for enhanced European cooperation on HTA. [Am. 17]

(8)  The European Parliament, in its resolution of 2 March 2017(9) on EU options for improving access to medicines called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value of medicines and relative effectiveness of health technologies compared with the best available alternative that takes into account the level of innovation and benefit for patients. [Am. 18]

(9)  In its 2015 Communication on upgrading the single market,(10) the Commission declared its intention to introduce an initiative on HTA to increase coordination in order to avoid multiple assessments of a product in different Member States and improve the functioning of the Single Market for health technologies.

(10)  In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA. That approximation should guarantee the highest quality standards and be aligned to best available practice. It should not stimulate a convergence towards the lowest common denominator nor force HTA bodies with more expertise and higher standards to accept lower requirements. It should rather lead to an improvement of the HTA capacity and quality at the national and regional level. [Am. 19]

(11)  In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology., and in particular, to ensure that the The joint clinical assessment conclusions are confined to findings relating provided for by this Regulation constitutes a scientific analysis of the relative effects of health technology on efficacy, safety and effectiveness, commonly referred to as clinical outcomes, that is evaluated in relation to the comparative effectiveness of a health technology indicators currently deemed appropriate and chosen groups or subgroups of patients, taking into account the HTA Core Model criteria. It will include consideration of the degree of certainty on the relative outcomes, based on the available evidence. The outcome of such joint clinical assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence. The assessment conducted by each Member State as part of its national appraisal therefore falls outside the scope of this Regulation. [Am. 20]

(12)  In order to ensure a wide application of harmonised rules and to foster collaboration among Member States on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, thereby reducing waste and ineffectiveness in healthcare, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council(11), which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council(12) which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views. A selection of medical devices for joint clinical assessment should be made based on specific criteria, given the need for greater clinical evidence concerning all of those new health technologies. [Am. 21]

(13)  In order to ensure that joint clinical assessments carried out on health technologies remain accurate, and relevant, of high quality and based on the best scientific evidence available at any given time, it is appropriate to establish conditions a flexible, regulated procedure for the updating of assessments, in particular where when new evidence or additional data becomes available subsequent to the initial assessment has the potential to and such new evidence or additional data may augment the scientific evidence and thus increase the accuracy quality of the assessment. [Am. 22]

(14)  A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility and proven expertise for overseeing the carrying out of joint clinical assessments and other joint work within the scope of this Regulation. [Am. 23]

(15)  In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national or regional HTA authorities and bodies which inform decision-making to conduct such assessments, as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the need to provide possibility of providing expertise on the HTA of medicinal products and medical devices. The organisational structure should respect the distinctive mandates of the sub-groups conducting the joint clinical assessments and the joint scientific consultations. Any conflict of interest should be avoided. [Am. 24]

(15a)  Transparency and public awareness of the process is essential. All clinical data being evaluated should have therefore the highest level of transparency and public awareness in order to gain confidence in the system. In case there is confidential data for commercial reasons, the confidentiality needs to be clearly defined and justified and the confidential data well delimitated and protected. [Am. 25]

(16)  In order that the harmonised procedures fulfil their internal market objective and reach their aim of improving innovation and the quality of clinical evidence, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments them. According to national needs, Member States should have the right to complement the joint clinical assessments with additional clinical evidence and analyses to account for differences in comparators or the national specific treatment setting. Such complementary clinical assessments should be duly justified and proportionate and should be notified to the Commission and the Coordination Group. In addition, compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the clinical added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as the non-clinical data and criteria specific to the Member State concerned, at national and/or regional level. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement. [Am. 26]

(16a)  In order for the clinical assessment to be used for the purposes of the national reimbursement decision, it should ideally concern the population for which the drug would be reimbursed in a given Member State. [Am. 27]

(17)  The time-frame for joint clinical assessments for medicinal products should, in as far as possible, be fixed by reference to the time-frame applicable to the completion of the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients. As a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation. [Am. 28]

(17a)  The joint scientific consultation, when addressing orphan medicinal products, has to ensure that any new approach should not result in unnecessary delays for the orphan medicinal products assessment compared to the current situation and taking into account the pragmatic approach undergone through the EUnetHTA. [Am. 29]

(18)  The establishment of a time-frame for the joint clinical assessments for medical devices health technologies should take into account the highly decentralised market access pathway time-frames set out in Regulation (EC) No 726/2004 for completing the centralised procedure for authorising medicines and the CE conformity marking for medical devices and provided for in Regulation (EU) 2017/745 and the CE conformity marking for in vitro diagnostic medical devices provided for in Regulation (EU) 2017/746 of the European Parliament and of the Council(13). In any event, those assessments must take into account the availability of appropriate scientific evidence data and supporting data in the quantity required to carry out a joint clinical assessment, As the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it and should be possible for assessments of such devices to take place following market launch of medical devices in a time-frame as close as possible to their marketing authorisation, in the case of medicines, and, in any case, without unjustified and unnecessary delay. [Am. 30]

(19)  In all cases any event the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results, and not delay or interfere without delaying or interfering with the CE marking of medical devices or market access of health technologies. This work should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out pursuant to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation. [Am. 31]

(19a)  HTA work covered under this Regulation should be separate and distinct from regulatory assessments of the safety and efficacy of health technologies carried out pursuant to other Union legislative acts and should have no bearing on other aspects falling outside the scope of this Regulation adopted in accordance with other Union legislative acts. [Am. 32]

(19b)  In the case of orphan medicinal products, the joint report should not re-assess the criteria of the orphan designation. However, assessors and co-assessors should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product, as well as the possibility of using or generating additional relevant data for the purpose of assessing a medicinal product in the context of a joint clinical assessment. [Am. 33]

(19c)  Regulation (EU) 2017/745 concerning medical devices and Regulation (EU) 2017/746 concerning in vitro diagnostic medical devices provide for the authorisation of such devices on the basis of the principles of transparency and safety and not on efficacy. However, the gradual increase in the supply of medical devices to address clinical conditions has heralded a paradigm shift towards a new model in which the market is highly fragmented, innovation is chiefly incremental and clinical evidence is lacking, which means that closer cooperation and more frequent exchanges of information between assessment bodies are needed. It is therefore necessary to move towards a centralised authorisation system that assesses devices on the basis of safety, efficacy and quality. It is also one of the areas in which Member States are calling for greater collaboration via a future European HTA. Currently 20 Member States, together with Norway, have HTA systems for medical devices in place and 12 Member States, together with Norway, have established guidelines and are engaging in initial dialogues. EUnetHTA has been conducting high-quality evaluations of the relative efficacy of medical devices based on a methodology that can be taken as a benchmark for this Regulation. [Am. 34]

(20)  In order to facilitate effective participation by Health technology developers in joint clinical assessments, such developers should, in appropriate cases, be afforded an opportunity to engage in can conduct joint scientific consultations with the Coordination Group or working groups set up for this purpose and composed of professionals from national or regional assessment bodies to obtain guidance on the clinical needs of research and the optimal design of studies to obtain the best possible evidence and data that is likely to be required for the purposes of clinical assessment maximise research efficiency. Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies. [Am. 35]

(20a)  Joint scientific consultations should concern the clinical study design, the determination of best comparators based on the best medical practice in the interest of patients. The consultation process should be transparent. [Am. 36]

(21)  Joint clinical assessments and Joint scientific consultations could necessitate the sharing of commercially confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature. [Am. 37]

(21a)  Joint clinical assessments necessitate all available clinical data and publicly available scientific evidence from health technology developers. The clinical data employed, the studies, the methodology and the clinical results used should be made public. The highest possible level of public openness in scientific data and assessments will allow progress to be made in biomedical research and ensure the highest possible level of confidence in the system. Where commercially sensitive data is shared, the confidentiality of such data should be protected by presenting it in an anonymised format with the redaction of reports before publication, preserving the public interest. [Am. 38]

(21b)  According to the European Ombudsman, where information in a document has implications for the health of individuals (such as information on the efficacy of a medicine), the public interest in disclosure of that information will generally defeat any claim of commercial sensitivity. Public health should always prevail over commercial interests. [Am. 39]

(22)  In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems, as well as to steer research strategically. Such scanning should facilitate the prioritisation of technologies that are to be selected by the Coordination Group for joint clinical assessment. [Am. 40]

(23)  The Union should continue to support voluntary cooperation on HTA between Member States in other areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems. Such voluntary cooperation should also facilitate synergies with initiatives under the digital single market strategy in relevant digital and data-driven areas of health and care with a view to the provision of additional real world evidence relevant for HTA. [Am. 41]

(24)  In order to ensure the inclusiveness and transparency of the joint work, the Coordination Group should engage and consult widely with interested parties and stakeholders. However, In order to preserve the integrity objectivity, transparency and quality of the joint work, rules should be developed to ensure the independence, public openness and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest. [Am. 42]

(24a)  Dialogue between the Coordination Group and patient organisations, consumer organisations, health non-governmental organisations, health experts and professionals should be ensured, especially through a stakeholder network, with a guarantee of the independence, transparency and impartiality of the decisions taken. [Am. 43]

(24b)  In order to ensure efficient decision-making and facilitate access to medicines, an appropriated cooperation between decision-makers at key stages of the medicines’ life-cycle is important. [Am. 44]

(25)  In order to ensure a uniform approach to the joint work provided for in this Regulation, implementing powers the Coordination Group, composed of national and/or regional authorities and bodies responsible for health technology assessment, with proven capacity, independence and impartiality, should be conferred on draw up the methodology for ensuring high quality of work as a whole. The Commission to establish should endorse, by means of implementing acts, that methodology and a common procedural and methodological framework for clinical assessments, procedures for joint clinical assessments and procedures for joint scientific consultations. Where appropriate, and in justified cases, distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the Commission should take into account the results of the work already undertaken in the EUnetHTA Joint Actions, It should also take into account and in particular the methodological guidelines and evidence submission templates, initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives should be taken into account. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(14). [Am. 45]

(25a)  The methodological framework, in accordance with the Declaration of Helsinki, should guarantee high quality and high clinical evidence by choosing the most appropriate benchmarks. It should be based on high standards of quality, the best available scientific evidence, stemming primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews; and should take into account clinical criteria that are useful, relevant, tangible, concrete and tailored to suit the given clinical situation, with preference given to end points. The documentation to be provided by the applicant should relate to the most up-to-date and public data. [Am. 46]

(25b)  Any specificities in the methodology, such as for vaccines, should be justified and adapted to very specific circumstances, should have the same scientific rigour and the same scientific standards, and should never be to the detriment of the quality of health technologies or clinical evidence. [Am. 47]

(25c)  The Commission should provide administrative support for the joint work of the Coordination Group, which, after consultation with the stakeholders, should submit the final report on this work. [Am. 48]

(26)  In order to ensure that this Regulation is fully operational and to adapt it to technical and scientific development, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to The Commission in respect of the contents of documents to be submitted, reports, and summary reports of should adopt implementing acts on procedural rules for the joint clinical assessments, the contents of documents for requests, and reports of joint scientific consultations, and the rules for selecting stakeholders. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.(15) In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts systematically should be granted access to meetings of Commission expert groups dealing with the preparation of delegated acts. [Am. 49]

(27)  In order to ensure that sufficient resources are available for the joint work and stable administrative support provided for under this Regulation, the Union should provide ensure stable and permanent public funding under the Multiannual Financial Framework for the joint work and voluntary cooperation, and as well as for the support framework to support these activities. The funding should cover the costs of producing joint clinical assessment and joint scientific consultation reports. Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group. The Commission should establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments for research on unmet medical needs. Under no event can those fees be used to fund the joint work provided for in this Regulation. [Am. 50]

(28)  In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication, as well as all information on the procedure, methodology, training and interests of assessors of and participants in the stakeholder network, and the reports and results of the joint work, which should be made public. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data. [Am. 51]

(28a)  Cooperation should be based on the principle of good governance, which encompasses transparency, objectivity, independent experience and fair procedures. Trust is a precondition for successful cooperation and can only be achieved if all stakeholders make genuine commitments and if there is access to high-quality experience, capacity-building and the highest quality of execution. [Am. 52]

(28b)  Since there is currently no commonly agreed definition of what constitutes high-quality innovation or added therapeutic value, the Union should adopt definitions of these terms with the agreement or consensus of all parties. [Am. 53]

(29)  In order to ensure the smooth establishment and operation of Union-level joint assessments, as well as to safeguard their quality, it is appropriate to provide for a transitional period allowing a progressive expansion of the number of joint assessments carried out annually. The number of assessments to be carried out should be determined with due regard for the resources available and the number of Member States participating with a view to reaching full capacity by the end of the transitional period. The establishment of such a transitional period should also afford Member States an opportunity to fully align their national systems with the framework for joint work in terms of resource allocation, timing, and prioritisation of assessments.

(30)  During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States. This should not affect the obligation of Member States to apply harmonised rules to clinical assessments carried out at a national level. Moreover, during the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work. Clinical assessments which have started in Member States before the application of this Regulation should be continued, unless Member States decide to stop them. [Am. 54]

(31)  In order to ensure that the support framework continues to be as efficient and cost-effective as possibleAfter the transitional period and before the harmonised system for HTA established under this Regulation becomes mandatory, the Commission should submit an impact assessment report on the implementation whole of the provisions on procedure that has been introduced. That impact assessment report should evaluate, among other criteria, the progress made in relation to patients access to new health technologies and the functioning of the internal market, the impact on the quality of innovation and on the sustainability of health systems, as well as the appropriateness of the scope of the joint clinical assessments and on the functioning of the support framework. no later than two years after the end of the transitional period. The report may in particular consider whether there is a need to move this support framework to a Union agency and introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint work. [Am. 55]

(32)  The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme. The results of that evaluation should also be communicated to the European Parliament and Council. [Am. 56]

(33)  Directive 2011/24/EU provides that the Union is to support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States. As those matters are governed by this Regulation, Directive 2011/24/EU should be amended accordingly.

(34)  Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments at national level and establish a framework of mandatory joint clinical assessments of certain of the health technologies at Union level falling under the scope of this Regulation, cannot be sufficiently achieved by the Member States alone but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, [Am. 57]

HAVE ADOPTED THIS REGULATION:

Chapter I

General Provisions

Article 1

Subject Matter

1.  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, this Regulation establishes: [Am. 58]

(a)  a support framework and procedures for cooperation on the clinical assessment of health technology assessment at Union level; [Am. 59]

(b)  common rules methodologies for the clinical assessment of health technologies. [Am. 60]

2.  This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them. Furthermore, this Regulation shall not interfere with the exclusive national competence of Member States for national pricing or reimbursement decisions. [Am. 61]

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)  'medicinal product' means a medicinal product for human use as defined in Directive 2001/83/EC of the European Parliament and of the Council(16);

(b)  'medical device' means a medical device as defined in Regulation (EU) 2017/745;

(ba)  ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Regulation (EU) 2017/746; [Am. 62]

(bb)  ‘assessment of a medical device' means the assessment of a method composed of more than one medical device or a method composed of a medical device and a defined care chain of other treatments; [Am. 63]

(c)  'health technology' means a health technology as defined in Directive 2011/24/EU;

(d)  'health technology assessment' means a multidisciplinary comparative assessment process, based on clinical and non-clinical assessment domains, which compiles and evaluates the available evidence about the clinical and non-clinical issues related to the use of a health technology;

(e)  'joint clinical assessment' means a compilation and evaluation of the available the systematic collection of scientific evidence on a information and its comparative evaluation and a synthesis of these procedures, the comparison of the health technology in comparison question with one or more other health technologies or existing procedures, constituting a benchmark for a particular clinical indication and, based on the best available clinical scientific evidence and on patient relevant clinical criteria, taking into account the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies or procedures addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology; [Am. 64]

(f)  'non-clinical assessment' means the part of a health technology assessment based on the following non-clinical domains of health technology assessment: the cost and economic evaluation of a health technology, and ethical, organisational, social, and legal aspects related to its use;

(g)  'collaborative assessment' means a clinical assessment of a medical device carried out at Union level by a number of interested health technology assessment authorities and bodies participating on a voluntary basis;

(ga)  ‘appraisal’ means drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria in the national care context; [Am. 65]

(gb)  ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life and adverse events. [Am. 202]

Article 3

The Member State Coordination Group on Health Technology Assessment

1.  The Member State Coordination Group on Health Technology Assessment (the 'Coordination Group') is hereby established.

2.  Member States shall designate their national or regional authorities and bodies responsible for health technology assessment as members at national level as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups. [Am. 66]

3.  The Coordination Group shall act by consensus, or, where necessary, vote by simple qualified majority. There shall be one vote per Member State.

Procedures undertaken by the Coordination Group shall be transparent with meeting minutes and votes documented and made publicly available, including any dissensions. [Am. 203]

4.  Meetings of the Coordination Group shall be co-chaired by the Commission, without the right to vote, and a co-chair elected from annually from among the members of the group for a set term to be determined in its rules of procedure on a rotating basis. Co-chairs shall perform purely administrative functions. [Am. 68]

5.  Members of the Coordination Group, being national or regional assessment authorities or bodies, shall appoint their representatives in the Coordination Group and the sub-groups in which they are members, on an ad-hoc or permanent basis. and inform. Member States may terminate such appointments where it is warranted by the requirements of the appointment. However, in view of the workload, the composition of sub-groups, or the specific knowledge required, there may be more than one expert assessor for each Member State, without prejudice to the principle that, for the purposes of decision-taking, each Member State shall have one vote only. The appointments shall take into account the expertise necessary in order to achieve the objectives of the sub-group. The European Parliament, the Council and the Commission of their, shall be informed of all appointments and possible terminations of appointment. and any subsequent changes. [Am. 69]

6.  In order to ensure high quality of work, members of the Coordination Group, and their appointed representatives shall be drawn from national or regional health technology assessment agencies or bodies responsible for that field. respect the principles of independence,

Members serving in the Coordination Group, and experts and assessors in general, shall not have financial interests in any type of health technology developer industry or insurance company that may affect their impartiality., and They shall undertake to act independently and in the public interest and shall make an annual declaration of interests. Those declarations of interests shall be recorded on the IT platform referred to in Article 27 and shall made accessible to the public.

At every meeting, members of the Coordination Group shall declare any specific interest that may be considered to adversely affect their independence in relation to agenda items. When a conflict of interest arises, the member of the Coordination Group concerned shall withdraw from the meeting whilst the relevant items of the agenda are being dealt with. The procedural rules for conflicts of interest shall be laid down in accordance with point (a)(iiia) of Article 22(1).

In order to ensure transparency and public awareness of the process and to promote confidence in the system, all clinical data being evaluated shall have the highest level of transparency and public communication. Where data is confidential for commercial reasons, its confidentiality shall be clearly defined and justified and the confidential data shall be well delimitated and protected. [Am. 70]

7.  The Commission shall publish a an up-to-date list of the designated members of the Coordination Group and its sub-groups and other experts, together with their qualifications and areas of expertise and their annual declaration of interest, on the IT platform referred to in Article 27.

The information referred to in the first subparagraph shall be updated by the Commission annually and whenever considered necessary in the light of possible new circumstances. Those updates shall be publicly accessible. [Am. 71]

8.  The Coordination Group shall:

(a)  adopt rules of procedure for the conduct of its meetings and update them where necessary;

(b)  coordinate and approve the work of its sub-groups;

(c)  ensure cooperation cooperate with relevant Union level Union-level bodies to facilitate additional evidence generation necessary for its work; [Am. 72]

(d)  ensure appropriate involvement of consultation of relevant stakeholders in and experts when pursuing its work. Such consultations shall be documented, including publicly available declarations of interest from the stakeholders consulted and shall be incorporated in the final joint assessment report; [Am. 73]

(e)  establish sub-groups for the following:

(i)  joint clinical assessments;

(ii)  joint scientific consultations;

(iii)  identification of emerging health technologies;

(iv)  voluntary cooperation;

(v)  preparation of the annual work programmes and annual reports, and updates of the common rules and working documents.

9.  The Coordination Group may meet in different configurations for the following categories of health technology: medicinal products, medical devices, and other health technologies.

10.  The Coordination Group may establish separate sub-groups for the following categories of health technology: medicinal products, medical devices, and other health technologies.

10a.  The rules of procedure of the Coordination Group and its sub-groups, the agendas for their meetings, the decisions adopted, and the details of votes and explanations of votes, including minority opinions, shall, in any event, be accessible to the public. [Am. 74]

Article 4

Annual Work Programme and Annual Report

1.  The sub-group designated in accordance with Article 3(8)(e) shall prepare an annual work programme for approval by the Coordination Group by 31 December of each year.

2.  The annual work programme shall set out the joint work to be carried out in the calendar year following its approval, covering:

(a)  the planned number of joint clinical assessments and the types of health technologies to be assessed;

(b)  the planned number of joint scientific consultations;

(c)  voluntary cooperation.

Points (a), (b) and (c) of the first subparagraph shall be determined according to the extent of their impact on patients, public health or health care systems. [Am. 75]

3.  In the preparation of the annual work programme, the designated sub-group shall:

(a)  have regard to the annual study on emerging health technologies referred to in Article 18;

(b)  take into account the resources available to the Coordination Group for the joint work;

(c)  consult the Commission and the stakeholder network, at annual meetings under Article 26, on the draft annual work programme and take into account its opinion their comments. [Am. 76]

4.  The designated sub-group shall prepare an annual report for approval by the Coordination Group by 28 February of each year.

5.  The annual report shall provide information on the joint work carried out in the calendar year preceding its approval.

5a.  Both the annual report and the annual work programme shall be published on the IT platform referred to in Article 27. [Am. 77]

Chapter II

Joint Work on Health Technology Assessment at Union Level

Section 1

Joint Clinical Assessments

Article 5

Scope of Joint Clinical Assessments

1.  The Coordination Group shall carry out joint clinical assessments on:

(a)  medicinal products subject to the authorisation procedure provided for in Regulation (EC) No 726/2004, including where an amendment has been made to the Commission Decision to grant a marketing authorisation based on a change in the therapeutic indication or indications for which the original authorisation was granted, with the exception of medicinal products authorised under Articles 10 and 10a of Directive 2001/83/EC;

(aa)  other medicinal products not subject to the authorisation procedure provided for in Regulation (EC) No 726/2004 where the health technology developer has opted for the centralised authorisation procedure, provided that the medicinal products in question constitute a major technical, scientific or therapeutic innovation, or their authorisation is in the interest of public health; [Am. 78]

(b)  medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation and considered to be a significant innovation and with potential significant impact on public health or health care systems; [Am. 79]

(c)   in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation and considered to be a significant innovation and with potential significant impact on public health or health care systems. [Am. 80]

2.  The Coordination Group shall select the medical devices referred to in paragraph 1 points (b) and (c) for joint clinical assessment based on the following criteria:

(a)  unmet medical needs;

(b)  potential impact on patients, public health, or healthcare systems;

(c)  significant cross-border dimension;

(d)  major Union-wide added value;

(e)  the available resources;

(ea)  the need for greater clinical evidence; [Am. 81]

(eb)  at the request of the health technology developer. [Am. 82]

Article 6

Preparation of Joint Clinical Assessment Reports

1.  The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group.

The joint clinical assessment report shall be accompanied by a summary report, and which shall contain at least the clinical data compared, the end-points, the comparators, the methodology, the clinical evidence used, and conclusions as regards efficacy, safety, and relative efficacy, the limits of the assessment, diverging views, a summary of the consultations carried out, and the observations made. They shall be prepared in accordance with the requirements in this laid down by the Coordination Group and shall be made public, regardless of the report´s conclusions.

For medicinal products referred to in point (a) of Article and the requirements established pursuant to Articles 11, 22, and 23 5(1), the joint clinical assessment report shall be adopted by the Coordination Group within 80-100 days in order to ensure compliance with timelines for pricing and reimbursement set out in Council Directive 89/105/EEC(17). [Am. 83]

2.  The designated sub-group shall request relevant the health technology developers developer to submit all available up-to-date documentation containing the information, data and evidence studies, including both negative and positive results, that is necessary for the joint clinical assessment. That documentation shall include the available data from all tests performed and from all the studies in which the technology was used, both of which are of paramount importance to ensure that assessments are of high quality.

For medicinal products referred to in point (a) of Article 5(1), the documentation shall at least include:

(a)  the submission file;

(b)  an indication of the marketing authorisation status;

(c)  if available, the European public assessment report (EPAR), including the Summary of Product Characteristics (SPC); the European Medicines Agency shall provide the relevant adopted scientific assessment reports to the Coordination Group;

(d)  where applicable, the results of additional studies requested by the Coordination Group and available to the health technology developer;

(e)  where applicable and if available to the health technology developer, already available HTA reports on the health technology concerned;

(f)  information on studies and study registries available to the health technology developer.

Health technology developers shall be obliged to submit all of the requested data.

Assessors may also access public databases and sources of clinical information, such as patient registries, databases or European Reference Networks, where such access is deemed necessary to complement the information provided by the developer and to perform a more accurate clinical assessment of the health technology. The reproducibility of the assessment implies that such information shall be made public.

The relationship between evaluators and health technology developers shall be independent and impartial. Developers of health technologies may be consulted but shall not actively participate in the evaluation process. [Am. 84]

2a.  The Coordination Group may justifiably consider, in the case of orphan medicines, that there is no substantive reason or additional evidence to support further clinical analysis beyond the significant benefit assessment already carried by the European Medicines Agency. [Am. 85]

3.  The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The assessor and a co-assessor shall be different from those previously appointed under Article 13(3) except in exceptional and justified situations where the necessary specific expertise is not available, and subject to approval of the Coordination Group. The appointments shall take into account the scientific expertise necessary for the assessment. [Am. 86]

4.  The assessor, with the assistance of the co-assessor, shall prepare the draft joint clinical assessment report and the summary report.

5.  The conclusions of the joint clinical assessment report shall be limited to the following include: [Am. 87]

(a)  an analysis of the relative effects effectiveness and safety of the health technology being assessed on the patient-relevant health outcomes in terms of the clinical end-points relevant to the clinical entity and patient group chosen for the assessment, including mortality, morbidity and quality of life, and compared to one or more comparator treatments to be determined by the Coordination Group; [Am. 88]

(b)  the degree of certainty on the relative effects based on the best available clinical evidence and compared to the best standard therapies. The assessment shall be based on the clinical end-points established in accordance with international standards of evidence-based medicine, in particular with regard to improving the state of health, shortening the duration of the disease, prolonging survival, reducing side effects or improving the quality of life. Reference shall also be made to subgroup-specific differences. [Am. 89]

The conclusions shall not include an appraisal.

The assessor and the co-assessor shall make sure that the choice of relevant patient groups is representative of the participating Member States in order to enable them to take appropriate decisions on funding these technologies from national health budgets. [Am. 90]

6.  Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended. Where new clinical data become available during the process, the health technology developer concerned shall also proactively communicate this new information to the assessor. [Am. 205]

7.  The members of the designated sub-group or the Coordination Group, in a minimum period of 30 working days, shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report. The Commission may also provide comments. [Am. 92]

8.  The assessor shall provide the draft joint clinical assessment report and the summary report to the submitting health technology developer and set a time-frame in which the developer may submit for comments. [Am. 93]

9.  The designated sub-group shall ensure that stakeholders, including Patients, consumer organisations, health professionals, NGOs, other health technology developer associations and clinical experts, are given an opportunity to provide may submit comments during the preparation of the draft joint clinical assessment report and the summary report and set within a time-frame in which they may submit comments set by the designated sub-group.

The Commission shall make public the declarations of interest of all consulted stakeholders in the IT platform referred to in Article 27. [Am. 94]

10.  Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the designated sub-group and to the Commission Coordination Group for comments. The Commission shall publish all comments, which shall be duly answered, on the IT platform referred to in Article 27. [Am. 95]

11.  The assessor, with the assistance of the co-assessor, shall take into account the comments of the designated sub-group and the Commission Coordination Group and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for a final approval. [Am. 96]

12.  The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple qualified majority of Member States.

Diverging positions and the grounds on which those positions are based shall be recorded in the final report.

The final report shall include a sensitivity analysis if there is one or more of the following elements:

(a)  different opinions on the studies to be excluded on the grounds of severe bias;

(b)  diverging positions if studies shall be excluded as they do not reflect the up-to-date technological development; or

(c)  controversies as to the definition of irrelevance thresholds regarding patient-relevant endpoints.

The choice of the one or more comparators and patient-relevant endpoints shall be medically justified and documented in the final report.

The final report shall also include the results of the joint scientific consultation carried out in accordance with Article 13. The scientific consultation reports shall be made public upon completion of the joint clinical assessments. [Am. 206]

13.  The assessor shall ensure the removal of any information of a commercially sensitive nature from that the approved joint clinical assessment report and the summary report contain the clinical information which is the subject of the assessment and set out the methodology and studies used. The assessor shall consult the developer on the report before its publication. The developer shall have 10 working days to notify the assessor about any information it considers to be confidential and to justify its commercially sensitive nature. As a last resort, the assessor and the co-assessor shall decide as to whether the developer’s claim of confidentiality is justified. [Am. 98]

14.  The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission, which shall include both reports on the IT platform. [Am. 99]

14a.  Upon receipt of the approved joint clinical assessment report and summary report, the submitting health technology developer may notify its objections in writing to the Coordination Group and the Commission within seven working days. In such a case, the developer shall provide detailed grounds for its objections. The Coordination Group shall evaluate the objections within seven working days and shall revise the report, as necessary.

The Coordination Group shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document setting out how the objections of the submitting health technology developer and the Commission were addressed. [Am. 100]

14b.  The joint clinical assessment report and the summary report shall be ready in not less than 80 days and not more than 100 days, except in justified cases where, owing to clinical necessity, the process needs to be accelerated or delayed respectively. [Am. 101]

14c.  Where the submitting health technology developer withdraws the application for a marketing authorisation, giving reasons, or where the European Medicines Agency terminates an assessment, the Coordination Group shall be informed so that it terminates the joint clinical assessment procedure. The Commission shall publish the reasons for withdrawal of the application or termination of the assessment on the IT platform referred to in Article 27. [Am. 102]

Article 7

The List of Assessed Health Technologies

1.  Where The Commission considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the approved report and the approved summary report, regardless of whether or not it has been adopted, in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group. [Am. 103]

2.  Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedural procedural legal requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report of the assessment, giving reasons. [Am. 104]

3.  The designated sub-group shall consider the conclusions referred to in paragraph 2 and invite the health technology developer to submit comments by a specified deadline. The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the health technology developer. The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group. Article 6, paragraphs 12 to 14 shall apply Commission, from a procedural point of view, prior to a final opinion. [Am. 105]

4.  Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies. [Am. 106]

5.  If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall decline to include the name of the health technology which is the subject of the assessment shall be included in the List, together with the summary report of the assessment and the Commission’s comments, and all of which shall be published on the IT platform referred to in Article 27. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non-inclusion negative report. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report. [Am. 107]

6.  For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish, on the IT platform referred to in Article 27, the approved joint clinical assessment report and summary report on the IT platform referred to in Article 27 as well as all the comments by stakeholders and interim reports, and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List. [Am. 108]

Article 8

Use of Joint Clinical Assessment Reports at Member State Level

1.  For the health technologies included on the List of Assessed Health Technologies or in respect of which a joint clinical assessment has been initiated, Member States shall: [Am. 109]

(a)  not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a use the joint clinical assessment has been initiated reports in their health technology assessments at Member State level; [Am. 110]

(b)  apply not duplicate the joint clinical assessment reports, in their health technology assessments at Member State level. [Am. 111]

1a.  The requirement set out in point (b) of paragraph 1 shall not prevent Member States or regions from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non-clinical data and evidence specific to the Member State concerned which were not included in the joint clinical assessment and which are necessary to complete the health technology assessment or the overall pricing and reimbursement process.

Such complementary assessments may compare the technology concerned against a comparator which represents the best available and evidence-based standard of care in the Member State concerned and which, despite that Member State´s request during the scoping phase, was not included in the joint clinical assessment. They may also assess the technology in a care context specific to the Member State concerned, based on its clinical practice, or the setting chosen for reimbursement.

Any such measure shall be justified, necessary and proportionate to achieving this aim, shall not duplicate work done at Union level and shall not unduly delay patient access to those technologies.

Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so. [Am. 112]

2.  Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by submit information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27, on how account has been taken of the joint clinical assessment report in the health technology assessment at Member State level as well as other clinical data and additional evidence taken into account so that the Commission may facilitate the exchange of this information among Member States. [Am. 113]

Article 9

Updates of Joint Clinical Assessments

1.  The Coordination Group shall carry out updates of joint clinical assessments where:

(a)  the Commission Decision to grant the marketing authorisation of a medicinal product referred to in Article 5(1)(a) was conditional on the fulfilment of additional post-authorisation requirements;

(b)  the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available within the deadline set in that report; [Am. 114]

(ba)  at the request of a Member State or a health technology developer that considers that there is new clinical evidence; [Am. 115]

(bb)  five years after the assessment, significant new clinical evidence exist, or earlier when new evidence or clinical data emerges. [Am. 116]

1a.  In the cases referred to under points (a), (b), (ba) and (bb) of the first subparagraph, the technology developer shall submit the additional information. In the event of a failure to do so, the earlier joint assessment would no longer fall within the scope of Article 8.

The ‘EVIDENT’ database shall be maintained to gather clinical evidence as it arises from the real-life use of health technology and to monitor the results in terms of health. [Am. 117]

2.  The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.

Updates of joint clinical assessments are requested when new information has been published or made available which was not available at the time of the initial joint report. When an update of the joint clinical assessment report is requested, the member who proposed it can update the joint clinical assessment report and propose it for adoption by other Member States by mutual recognition. When updating the joint clinical assessment report, the Member State shall apply the methods and standards as laid down by the Coordination Group.

Where Member States cannot agree on an update, the case is referred to the Coordination Group. The Coordination Group shall decide whether to carry out an update based on the new information.

When an update is approved by mutual recognition or after the Coordination Group’s decision, the joint clinical assessment report is considered updated. [Am. 118]

3.  Updates shall be carried out in accordance with the procedural rules established pursuant to Article 11(1)(d).

Article 10

Transitional Arrangements for Joint Clinical Assessments

During the transitional period referred to in Article 33(1):

(a)  the Coordination Group shall:

(i)  base the annual number of planned joint clinical assessments on the number of Member States participating and the resources available to it;

(ii)  select medicinal products referred to in Article 5(1)(a) for joint clinical assessment based on the selection criteria referred to in Article 5(2).

(b)  members of the Coordination Group from Member States not participating in joint clinical assessments shall not:

(i)  be appointed as assessors or co-assessors;

(ii)  comment on the draft joint clinical assessment reports and summary reports;

(iii)  take part in the approval process of the final joint clinical assessment reports and summary reports;

(iv)  take part in the preparation and approval process on the parts of the annual work programmes on joint clinical assessments;

(v)  be subject to the obligations set out in Article 8 as regards the health technologies which have undergone joint clinical assessment.

Article 11

Adoption of Detailed Procedural Rules for Joint Clinical Assessments

1.  The Commission shall in accordance with this Regulation, develop, by means of implementing acts, procedural rules for: [Am. 119]

(a)  submissions of information, data and evidence by health technology developers; [Am. 120]

(b)  the appointment of assessors and co-assessors;

(c)  determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments; [Am. 121]

(d)  updates of joint clinical assessments;

(e)  cooperation with the European Medicines Agency on the preparation and update of joint clinical assessments of medicinal products;

(f)  cooperation with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices. [Am. 122]

2.  Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).

Section 2

Joint Scientific Consultations

Article 12

Requests for Joint Scientific Consultations

1.  Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning data and evidence likely to be required as part of a joint the clinical assessment aspects for the optimal design of scientific studies and research to obtain the best scientific evidence, improve predictability, align research priorities and enhance the quality and efficiency of said research, in order to obtain the best evidence. [Am. 123]

Health technology developers of medicinal products may request that the joint scientific consultation takes place in parallel with the process of receiving scientific advice from the European Medicines Agency pursuant to Article 57(1)(n) of Regulation (EC) No 726/2004. In such a case, it shall make that request at the time of submitting an application for scientific advice to the European Medicines Agency.

2.  In considering the request for joint scientific consultation, the Coordination Group shall take into account the following criteria:

(a)  the likelihood that the health technology under development will be the subject of a joint clinical assessment in accordance with Article 5(1);

(b)  unmet medical needs;

(c)  potential impact on patients, public health, or healthcare systems;

(d)  significant cross-border dimension;

(e)  major Union-wide added value;

(f)  the available resources;

(fa)  Union clinical research priorities. [Am. 124]

3.  Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2.

Joint scientific consultations shall not prejudice the objectivity and independence of joint technological assessments nor its results or conclusions. The assessor and co-assessor appointed to carry them out pursuant to Article 13(3) shall not be the same as the assessor and co-assessor appointed pursuant to Article 6(3) for the joint technological assessment.

The subject and the summarised substance of the consultations shall be published on the IT platform referred to in Article 27. [Am. 125]

Article 13

Preparation of Joint Scientific Consultation Reports procedure [Am. 126]

1.  Following the acceptance of a request for a joint scientific consultation in accordance with Article 12 and on the basis of its annual work programme, the Coordination Group shall designate a sub-group to oversee the preparation of the joint scientific consultation report on behalf of the Coordination Group.

The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the procedural rules procedure and documentation established pursuant to Articles 16 and 17. [Am. 127]

2.  The designated sub-group shall request the health technology developer to submit the available and up-to-date documentation containing the all stages of information processing, data and evidence studies necessary for the joint scientific consultation, such as available data from all tests performed and from all the studies in which the technology was used. A tailored clinical assessment pathway may be developed for orphan medicinal products due to the limited number of patients enrolled in clinical trials and/or the lack of a comparator. All that information shall be made publicly available, upon completion of the joint clinical assessments.

The designated sub-group and the health technology developer concerned shall hold a joint meeting based on the documentation described in first subparagraph. [Am. 128]

3.  The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation, who shall not be the same as the assessor and a co-assessor to be appointed pursuant to Article 6(3). The appointments shall take into account the scientific expertise necessary for the assessment. [Am. 129]

4.  The assessor, with the assistance of the co-assessor, shall prepare the draft joint scientific consultation report.

5.  Where, at any stage in the preparation of the draft joint scientific consultation report, the assessor considers that additional evidence from a health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request the additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.

6.  The members of the designated sub-group shall provide their comments during the preparation of the draft joint scientific consultation report.

7.  The assessor shall provide the draft joint scientific consultation report, and provide it to the submitting health technology developer and set for comments, setting a time-frame in which the developer may submit comments for those comments. [Am. 130]

8.  The designated sub-group shall ensure that stakeholders, including health technology developer, patients, health professionals and clinical experts are given an opportunity to provide may submit comments during the preparation of the draft joint scientific consultation. report and set a time-frame in which they may submit comments. [Am. 131]

9.  Following receipt and consideration of any information and comments provided in accordance with paragraphs 2, 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments. All comments, which shall be public and answered when required, shall be published on the IT platform referred to in Article 27, following finalisation of the joint clinical assessment. The published comments shall include stakeholders comments and any differences of opinion expressed by members of the sub-group in the course of the procedure. [Am. 132]

10.  Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice the time-frame. [Am. 133]

11.  The assessor, with the assistance of the co-assessor, shall take into account the comments of the members of the designated sub-group and submit the final draft joint scientific consultation report to the Coordination Group.

12.  The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simple qualified majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4. [Am. 207]

Article 14

Joint Scientific Consultation Reports

1.  The Coordination Group shall communicate the approved joint scientific consultation report to the requesting health technology developer at the latest 10 working days following its approval.

2.  The Coordination Group shall include anonymised summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27. That information shall include the subject of the consultations and the comments.

The scientific consultation reports shall be made public upon completion of the joint clinical assessments. [Am. 135]

3.  Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology referred to in Article 5 for which a joint scientific consultation has been initiated, unless additional clinical data and evidence were not taken into account and such data and evidence are considered necessary. Such national and where the contents of the request are the same as those covered by the joint scientific consultation consultations shall be submitted to the Commission for publication on the IT platform referred to in Article 27. [Am. 136]

Article 15

Transitional Arrangements for Joint Scientific Consultations

During the transitional period referred to in Article 33(1):

(a)  the Coordination Group shall base the annual number of planned joint scientific consultations on the number of Member States participating and the resources available to it;

(b)  members of the Coordination Group from Member States not participating in joint scientific consultations shall not:

(i)  be appointed as assessors or co-assessors;

(ii)  comment on the draft joint scientific consultation reports;

(iii)  take part in the approval process of the final joint scientific consultation reports;

(iv)  take part in the preparation and approval process on the parts of the annual work programmes on joint scientific consultations.

Article 16

Adoption of Detailed Procedural Rules for Joint Scientific Consultations

1.  The Commission shall develop, by means of implementing acts, procedural rules for:

(a)  submissions of requests from health technology developers; and their involvement in the preparation of joint scientific consultation reports; [Am. 137];

(b)  the appointment of assessors and co-assessors;

(c)  determining the detailed procedural steps and their timing;

(d)  the consultation of submission of comments by patients, health professionals, patient associations, social partners, non-governmental organisations, clinical experts and other relevant stakeholders; [Am. 138]

(e)  cooperation with the European Medicines Agency on joint scientific consultations on medicinal products where a health technology developer requests the consultation to be carried out in parallel with a process for scientific advice from the Agency;

(f)  cooperation with the expert panels referred to in Article 106(1) of Regulation (EU) 2017/745 on the joint scientific consultations on medical devices.

2.  Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).

Article 17

Documentation and Rules for Selecting Stakeholders for Joint Scientific Consultations

The Commission shall be empowered to adopt delegated implementing acts in accordance with Article 31 Articles 30 and 32 concerning: [Am. 139]

(a)  the contents of procedure for: [Am. 140]

(i)  requests from health technology developers for joint scientific consultations;

(ii)  dossiers of information, data and evidence to be submitted by health technology developers for joint scientific consultations;

(iii)  joint scientific consultation reports;

(iiia)  stakeholder involvement for the purpose of this section, including rules on conflict of interest. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with a conflict of interest shall not participate in the process. [Am. 141]

(b)  the rules for determining the stakeholders to be consulted for the purpose of this Section. [Am. 142]

Section 3

Emerging Health Technologies

Article 18

Identification of Emerging Health Technologies

1.  The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems.

2.  In the preparation of the study, the Coordination Group shall consult:

(a)  health technology developers;

(b)  patient and consumer organisations and health professionals at its annual meeting; [Am. 143]

(c)  clinical experts;

(d)  the European Medicines Agency including on the pre-notification of medicinal products prior to marketing authorisation applications;

(e)  the Medical Devices Coordination Group established in Article 103 of Regulation (EU) 2017/745.

2a.  When preparing the study, the Coordination Group shall ensure that commercially confidential information provided by the health technology developer is adequately protected. To that end, the Coordination Group shall give the health technology developer an opportunity to submit comments with respect to the contents of the study and shall take due account of those comments. [Am. 144]

3.  The conclusions of the study shall be summarised in the Coordination Group's annual report and shall be taken into account in the preparation of its annual work programmes.

Section 4

Voluntary Cooperation on Health Technology Assessment

Article 19

Voluntary Cooperation

1.  The Commission shall support any further cooperation and the exchange of scientific information among Member States on the following issues: [Am. 145]

(a)  non-clinical assessments on health technologies;

(b)  collaborative assessments on medical devices;

(c)  health technology assessments on health technologies other than medicinal products or medical devices;

(d)  the provision of additional evidence necessary to support health technology assessments;

(da)  clinical assessments of medicinal products and medical devices carried out by Member States; [Am. 146]

(db)  measures relating to compassionate use in clinical practice in order to improve the evidence basis and to create a register for this purpose; [Am. 147]

(dc)  the development of best medical practice guides based on scientific evidence; [Am. 148]

(dd)  disinvestment in obsolete technologies; [Am. 149]

(de)  the tightening of the rules on clinical evidence generation and its monitoring. [Am. 150]

2.  The Coordination Group shall be used to facilitate the cooperation referred to in paragraph 1.

3.  The cooperation referred to in paragraph 1 points (b), and (c) (c), (db) and (de) may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23. [Am. 151]

4.  The cooperation referred to in paragraph 1 shall be included in the annual work programmes of the Coordination Group and the results of the cooperation shall be included in its annual reports and the IT platform referred to in Article 27.

Chapter III

Rules for Clinical Assessments

Article 20

Harmonised Rules for Clinical Assessments

1.  The common procedural rules and methodology established in accordance with Article 22 and the requirements established in accordance with Article 23 shall apply to:

(a)  joint clinical assessments carried out in accordance with Chapter II.

(b)  clinical assessments of medicinal products and medical devices carried out by Member States. [Am. 152]

1a.  Where relevant and appropriate, Member States shall be encouraged to apply the common procedural rules and methodology referred to in this Regulation for the clinical assessment of medicinal products and medical devices not falling within the scope of this Regulation and carried out by Member States at national level. [Am. 153]

Article 21

Clinical Assessment Reports

1.  Where a clinical assessment is carried out by a Member State, that Member State shall provide the Commission with the clinical assessment report and summary report at the latest 30 working days after the completion of the health technology assessment.

2.  The Commission shall publish the summary reports referred to in paragraph 1 in the IT platform referred to in Article 27 and make the clinical assessment reports available to other Member States through that IT platform.

Article 22

Common Procedural Rules and Methodology

1.  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, and after consulting all relevant stakeholders, the Commission shall adopt implementing acts concerning: [Am. 154]

(a)  procedural rules for:

(i)  ensuring that health technology authorities and bodies the members of the Coordination Group carry out clinical assessments in an independent and transparent manner, free from conflicts of interest, in accordance with Article 3(6) and (7); [Am. 155]

(ii)  the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments, subject to the provisions of the previous articles; [Am. 156]

(iii)  the consultation comments of patients, health professionals, consumer organisations, clinical experts, and other stakeholders in clinical assessments and the duly justified replies, subject to the provisions of the previous articles; [Am. 157]

(iiia)  addressing potential conflicts of interest; [Am. 158]

(iiib)  ensuring that the assessment of medical devices is able to take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real world data. The appropriate time point shall be identified in cooperation with relevant stakeholders. [Am. 159]

(b)  methodologies used to formulate the contents and design of clinical assessments in order to guarantee the quality of the process, a penalty mechanism in the event of non-compliance by the technology developer with the requirements concerning the available information to be provided. [Am. 160]

1a.  Within [6 months] from the date of entry into force of this Regulation, the Coordination Group shall draw up a draft implementing regulation concerning the methodologies to be consistently used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. The methodologies shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. In any case, the methodologies shall comply with the following criteria:

(a)  the methodologies are based on high standards of quality, the best available scientific evidence, stemming, where practically feasible and ethically justifiable, primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews;

(b)  the assessments of relative effectiveness are based on end-points which are relevant to the patient with useful, relevant, tangible and specific criteria suited to the clinical situation concerned;

(c)  the methodologies take into account the specificities of new procedures and certain types of medicinal products with less clinical evidence available at the time of the marketing authorisation (such as orphan medicinal products or conditional marketing authorisations). However, any such lack of evidence does not prevent the generation of additional evidence required to be post monitored and which may require post-assessment and shall not affect patients security or scientific quality;

(d)  the comparators are the reference comparators for the clinical entity concerned and the best and/or most commonly used technological or process based comparator;

(e)  for medicinal products, the technology developers, for the purpose of clinical assessment, provide the coordination group with the dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. That dossier shall include the clinical study report;

(f)  the information to be provided by the health technology developer relates to the most up-to-date and public data. Failure to comply with that requirement may trigger a penalty mechanism;

(g)  clinical trials are the studies par excellence in the biomedical field, so the use of another type of study, for example, epidemiological studies, may be carried out in exceptional cases and shall be fully justified;

(h)  common methods as well as data requirements and outcome measures take into account the specificities of medical devices and in vitro diagnostic medical devices;

(i)  regarding vaccines, the methodology takes into account the lifelong effect of a vaccine through an appropriate time horizon of the analyses; indirect effects such as herd immunity; and elements independent from the vaccine as such, for example coverage rates linked to programmes;

(j)  where practically feasible and ethically justifiable, the health technology developer conducts at least one randomised controlled clinical trial, comparing its health technology in terms of clinically relevant outcomes with an active comparator considered among the best current proven intervention at the time the trial was designed (standard treatment), or the most common intervention when no standard treatment exists. The technology developer shall provide the data and results of conducted comparative trials in the documentation dossier submitted for the joint clinical assessment.

In the case of a medical device, the methodology shall be adapted to its characteristics and specificities, taking as a basis the methodology already developed by EUnetHTA.

The Coordination Group shall submit the draft implementing regulation to the Commission for endorsement.

Within [3 months] of receipt of the draft measure, the Commission shall decide whether to endorse it by means of an implementing act adopted in accordance with the examination procedure referred to in Article 30(2).

Where the Commission intends not to endorse a draft measure or to endorse it in part or where it proposes amendments, it shall send the draft back to the Coordination Group, setting out the reasons. Within a period of [6 weeks], the Coordination Group may amend the draft measure on the basis of the Commission’s indications and proposed amendments, and resubmit it to the Commission.

If, on the expiry of the [6-week period], the Coordination Group has not submitted an amended draft measure, or has submitted a draft measure that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the implementing regulation with the amendments it considers relevant or reject it.

In the event that the Coordination Group does not submit a draft measure to the Commission within the time limit in accordance with [paragraph 1], the Commission may adopt the implementing regulation without a draft having been submitted from the Coordination Group. [Am. 208/rev]

2.  Implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 30(2).

Article 23

Contents of Submission and Report Documents and Rules for Selecting Stakeholders

The Commission shall be empowered to adopt delegated acts in accordance with Coordination Group, following the same procedure set up in point (a) of Article 31 concerning 2(1) shall establish: [Am. 162]

(a)  the contents format and templates of: [Am. 163]

(i)  dossiers of information, data and evidence to be provided by health technology developers for clinical assessments;

(ii)  clinical assessment reports;

(iii)  summary clinical assessment reports.

(b)  the rules for determining the stakeholders to be consulted for the purposes of Section 1 of Chapter II and of this Chapter, notwithstanding Article 26. [Am. 164]

Chapter IV

Support Framework

Article 24

Union Funding [Am. 165]

1.  The financing of the work of the Coordination Group and its sub-groups and activities in support of that work involving its cooperation with the Commission, with the European Medicines Agency, and with the stakeholder network referred to in Article 26 shall be ensured by the Union. The Union's financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council(18).

2.  The funding referred to in paragraph 1 shall include funding for the participation of Member States' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations. Assessor and co-assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.

2a.  The Union shall ensure stable and permanent public funding for the joint work on HTA that shall be conducted without the direct or indirect funding by developers of health technologies. [Am. 166]

2b.  The Commission may establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments which it shall use to finance research regarding unmet medical needs or clinical priorities. Such a system of charges shall under no circumstances used to finance activities under this Regulation. [Am. 167]

Article 25

Commission Support for the Coordination Group

The Commission shall support the work of the Coordination Group. In particular the Commission shall:

(a)  host on its premises and co-chair – with the right to speak, but not to vote – the meetings of the Coordination Group; [Am. 168]

(b)  provide the secretariat for the Coordination Group and provide administrative, scientific and IT support; [Am. 169]

(c)  publish on the IT platform referred to in Article 27 the Coordination Group's annual work programmes, annual reports, summary minutes of its meetings, and reports and summary reports of joint clinical assessments;

(d)  verify that the work of the Coordination Group is carried out in an independent and transparent manner, in accordance with the established rules of procedure; [Am. 170]

(e)  facilitate cooperation with the European Medicines Agency on the joint work on medicinal products including the sharing of confidential information;

(f)  facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of confidential information. [Am. 171]

Article 26

Stakeholder Network

1.  The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications, such as legitimacy, representation, transparency and accountability.

The organisations to be addressed by the open call for applications shall be patient associations, consumer organisations, non-governmental organisations in the field of health, health technology developers and health professionals.

Best practices in preventing conflict of interest shall apply to the selection of members of the stakeholder network.

The European Parliament shall have two representatives in the stakeholder network. [Am. 172]

2.  The Commission shall publish the list of stakeholder organisations included in the stakeholder network. Stakeholders shall not have conflict of interest and their declarations of interests shall be published in the IT platform. [Am. 173]

3.  The Commission shall organise ad-hoc meetings a meeting between the stakeholder network and the Coordination Group at least once a year in order to promote a constructive dialogue. The roles of the stakeholder network shall include: [Am. 174]

(a)  update stakeholders exchange of information on the work of the Coordination group and the assessment process; [Am. 175]

(b)  provide for an exchange of information on the work of the Coordination Group participation in seminars or workshops or specific actions on particular aspects; [Am. 176]

(ba)  supporting access to real-life experiences on diseases and their management and on the actual use of health technologies, in the interests of a better understanding of the value which stakeholders attach to the scientific evidence provided during the assessment process; [Am. 177]

(bb)  contributing to more focused and efficient communication with and between stakeholders in order to support their role in the safe and rational use of health technologies; [Am. 178]

(bc)  drawing up a list of priorities for medical research; [Am. 179]

(bd)  seeking input into the annual work programme and the annual study prepared by the Coordination Group. [Am. 180]

The interests and the founding documents of the stakeholders, as well as a summary of annual meetings and possible activities, shall be published on the IT platform referred to in Article 27. [Am. 181]

4.  On the request of the Coordination Group, the Commission shall invite patients, health professionals and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers. [Am. 182]

5.  On the request of the Coordination Group, the stakeholder network shall support the Coordination Group in the identification of patient and clinical expertise for the work of its sub-groups.

Article 27

IT Platform

1.  Building on the work already undertaken by the EUnetHTA Joint Actions, the Commission shall develop and maintain an IT platform containing information on: [Am. 183]

(a)  planned, on-going, and completed joint clinical assessments and Member State health technology assessments;

(b)  joint scientific consultations;

(c)  studies on the identification of emerging health technologies;

(d)  results of the voluntary cooperation between Member States;

(da)  a list of members of the Coordination Group, its sub-groups and other experts, together with their declaration of financial interests; [Am. 184]

(db)  all information whose publication is required under this Regulation; [Am. 185]

(dc)  final joint clinical assessment reports and summary reports in a lay-friendly format in all official languages of the European Union; [Am. 186]

(dd)  a list of organisations included in the stakeholder network. [Am. 187]

2.  The Commission shall ensure appropriate levels of public access to the information contained in the IT platform. for Member State bodies, members of the stakeholder network, and the general public. [Am. 188]

Article 28

Implementation Report Evaluation report on the transitional period [Am. 189]

No later than two years after At the end of the transitional period referred to in Article 33(1) 33 and before the harmonised system for health technology assessment established under this Regulation becomes mandatory, the Commission shall submit an impact assessment report on the implementation whole of the provisions on procedure that has been introduced, which shall evaluate, among other criteria, the progress made in relation to patient access to new health technologies and the functioning of the internal market, the impact on the quality of innovation, such as the development of innovative medicinal products in areas of unmet need, on the sustainability of health systems, the HTA quality and the capacity at the national and regional level, as well as the appropriateness of the scope of the joint clinical assessments and on the functioning of the support framework referred to in this Chapter. [Am. 190]

Chapter V

Final Provisions

Article 29

Evaluation and Monitoring

1.  No later than five years after the publication of the report referred to in Article 28, the Commission shall carry out an evaluation of this Regulation, and report on its conclusions.

2.  By … [one year after the date of application] at the latest, the Commission shall establish a programme for monitoring the implementation of this Regulation. The monitoring programme shall set out the means by which and the intervals at which the data and other necessary evidence will be collected. The monitoring programme shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.

3.  The annual reports of the Coordination Group shall be used as part of the monitoring programme.

Article 30

Committee Procedure

1.  The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 31

Exercise of the Delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Articles 17 and 23 shall be conferred on the Commission for an indeterminate period of time from … [insert date of entry into force of this Regulation].

3.  The delegation of power referred to in Articles 17 and 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to Articles 17 and 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. [Am. 191]

Article 32

Preparation of Implementing and Delegated Acts [Am. 192]

1.  The Commission shall adopt the implementing and delegated acts referred to in Articles 11, 16, 17 and 22, and 23, at the latest by the date of application of this Regulation. [Am. 193]

2.  When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors, and shall consider the work already undertaken in the EUnetHTA Joint Actions. [Am. 194]

Article 33

Transitional Provisions

1.  Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [3 4 years after the date of application] for medicinal products referred to in points (a) and (aa) of Article 5(1), and until ... [7 years after the date of application] for medical devices referred in Article point (b) of Article 5(1) and for in vitro diagnostic medical devices referred in point (c) of Article 5(1). [Am. 195]

2.  Member States shall notify the Commission where they intend to make use of the transitional period set out in paragraph 1 at the latest one year before the date of application of this Regulation.

3.  Member States which have delayed their participation in accordance with paragraph 1 may begin participating with effect from the next financial year after having notified the Commission at least three months before the beginning of that financial year.

Article 34

Safeguard Clause

1.  Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on the grounds set out in Article 8(1a), and on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim. [Am. 196]

2.  Member States shall notify the Commission and the Coordination Group of their intention to carry out a clinical assessment using other means together with the justifications for doing so. [Am. 197]

2a.  The Coordination Group may assess whether the request fulfils the grounds referred to in paragraph 1, and may submit its conclusions to the Commission. [Am. 198]

3.  The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved. The Commission’s decision shall be published on the IT platform referred to in Article 27. [Am. 199]

Article 35

Amendment of Directive 2011/24/EU

1.  Article 15 of Directive 2011/24/EU is deleted.

2.  References to the deleted Article shall be construed as references to this Regulation.

Article 36

Entry into Force and Date of Application

1.  This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2.  It shall apply from … [3 years after date of entry into force].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament For the Council

The President The President

(1) OJ C 283, 10.8.2018, p. 28. (2) This position corresponds to the amendments adopted on 3 October 2018 (Texts adopted, P8_TA(2018)0369). (3) OJ C 283, 10.8.2018, p. 28. (4) OJ C ... (5) Position of the European Parliament of 14 February 2019. (6) OJ C 263, 25.7.2018, p. 4. (7) Directive 2011/24/EU of 9 March 2011 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). (8) OJ C 438, 6.12.2014, p. 12. (9) European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI). (10) COM(2015)0550, p. 19. (11) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). (12) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). (13) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). (14) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (15) Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1). (16) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). (17) Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8). (18) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).

European Parliament legislative resolution of 14 February 2019 on the proposal for a regulation of the European Parliament and of the Council establishing a framework for screening of foreign direct investments into the European Union (COM(2017)0487 – C8‑0309/2017 – 2017/0224(COD))

P8_TA(2019)0121 A8-0198/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0487),

–  having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0309/2017),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 April 2018(1),

–  having regard to the opinion of the Committee of the Regions of 23 March 2018(2),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 5 December 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on International Trade and the opinions of the Committee on Industry, Research and Energy, the Committee on Foreign Affairs and the Committee on Economic and Monetary Affairs (A8‑0198/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Takes note of the statement by the Commission annexed to this resolution, which will be published in the L series of the Official Journal of the European Union together with the final legislative act;

3.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

4.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council establishing a framework for the screening of foreign direct investments into the Union

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/452.)

ANNEX TO THE LEGISLATIVE RESOLUTION

COMMISSION STATEMENT

Following the request of the European Parliament, the European Commission undertakes to:

–  share with the European Parliament the standardised forms which the European Commission will prepare to facilitate compliance of Member States with the annual reporting obligations under Article 5 of the Regulation once they are finalised, and

–  share with the European Parliament such standardised forms each year, in parallel to presenting the annual report to the European Parliament and to the Council, in accordance with Article 5(3) of the Regulation.

(1) OJ C 262, 25.7.2018, p. 94. (2) OJ C 247, 13.7.2018, p. 28.

European Parliament legislative resolution of 14 February 2019 on the proposal for a Directive of the European Parliament and of the Council on the interoperability of electronic road toll systems and facilitating cross-border exchange of information on the failure to pay road fees in the Union (recast) (COM(2017)0280 – C8-0173/2017 – 2017/0128(COD))

P8_TA(2019)0122 A8-0199/2018

(Ordinary legislative procedure – recast)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0280),

–  having regard to Article 294(2) and Article 91(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0173/2017),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 18 October 2017(1),

–  after consulting the Committee of the Regions,

–  having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts(2),

–  having regard to the letter of 24 July 2017 from the Committee on Legal Affairs to the Committee on Transport and Tourism in accordance with Rule 104(3) of its Rules of Procedure,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 28 November 2018 to approve Parliament's position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rules 104 and 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Transport and Tourism and the opinion of the Committee on Civil Liberties, Justice and Home Affairs (A8-0199/2018),

A.  whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal, and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1.  Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Directive (EU) 2019/… of the European Parliament and of the Council on the interoperability of electronic road toll systems and facilitating cross-border exchange of information on the failure to pay road fees in the Union (recast)

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2019/520.)

(1) OJ C 81, 2.3.2018, p. 181. (2) OJ C 77, 28.3.2002, p. 1.

European Parliament legislative resolution of 14 February 2019 on the proposal for a regulation of the European Parliament and of the Council on the mutual recognition of goods lawfully marketed in another Member State (COM(2017)0796 – C8-0005/2018 – 2017/0354(COD))

P8_TA(2019)0123 A8-0274/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0796),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0005/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 23 May 2018(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 28 November 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection (A8-0274/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/515.)

(1) OJ C 283, 10.8.2018, p. 19.

European Parliament legislative resolution of 14 February 2019 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 924/2009 as regards certain charges on cross-border payments in the Union and currency conversion charges (COM(2018)0163 – C8-0129/2018 – 2018/0076(COD))

P8_TA(2019)0124 A8-0360/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0163),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0129/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Central Bank of 31 August 2018(1),

–  having regard to the opinion of the European Economic and Social Committee of 11 July 2018(2),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 19 December 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs (A8-0360/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EC) No 924/2009 as regards certain charges on cross-border payments in the Union and currency conversion charges

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2019/518.)

(1) OJ C 382, 23.10.2018, p. 7. (2) OJ C 367, 10.10.2018, p. 28.

European Parliament legislative resolution of 14 February 2019 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1073/2009 on common rules for access to the international market for coach and bus services (COM(2017)0647 – C8-0396/2017 – 2017/0288(COD))

P8_TA(2019)0125 A8-0032/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0647),

–  having regard to Article 294(2) and Article 91(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0396/2017),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Irish Houses of the Oireachtas, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Economic and Social Committee of 19 April 2018(1),

–  having regard to the opinion of the Committee of the Regions(2),

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Transport and Tourism (A8-0032/2019),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Regulation (EU) .../... of the European Parliament and of the Council amending Regulation (EC) No 1073/2009 on common rules for access to the international market for coach and bus services

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(3),

Having regard to the opinion of the Committee of the Regions(4),

Acting in accordance with the ordinary legislative procedure(5),

Whereas:

(1)  The application of Regulation (EC) No 1073/2009 of the European Parliament and of the Council(6) has revealed that some operators in national markets are facing unjustified obstacles to the development of inter-urban coach services of benefit to passengers. Moreover, road passenger transport services have not kept pace with the evolving needs of citizens in terms of availability and quality and sustainable transport modes continue to have a low modal share. As a consequence, certain groups of citizens are placed at a disadvantage in terms of availability of passenger transport services, and there are more road accidents, emissions, and congestion and increased infrastructure costs due to greater use of cars. [Am. 1]

(2)  To ensure a coherent framework for the inter-urban carriage of passengers by regular coach and bus services throughout the Union, Regulation (EC) No 1073/2009 should apply to all inter-urban carriage by regular services. The scope of that Regulation should therefore be extended, but should not be applied to urban or suburban centres or conurbations and should be without prejudice to the provisions of Regulation (EC) No 1370/2007 of the European Parliament and of the Council(7). [Am. 2]

(3)  Each Member State should designate an independent and impartial regulatory body, should be designated in each Member State with the task of issuing binding opinions, to ensure the proper functioning of the road passenger transport market. That body may also be responsible for other regulated sectors such as rail, energy or telecommunications. [Am. 3]

(4)  Commercial regular service operations should not compromise the economic equilibrium of existing or granted public service contracts in accordance with Regulation (EC) No 1370/2007. For this reason, the regulatory body should be able to carry out an objective economic analysis and should have the authority, where appropriate, to propose measures necessary to ensure that this is the case. Commercial regular service operations should not compete with transport providers who have been granted exclusive rights to provide certain public passenger transport services in return for the discharge of public service obligations within the framework of a public service contract. [Am. 4]

(5)  The operation of regular services in the form of cabotage operations should be conditional on the possession of a Community licence and the use of a smart tachograph in accordance with Chapter II of Regulation (EU) No 165/2014 of the European Parliament and of the Council(8). In order to facilitate effective controls of those services by enforcement authorities, the rules regarding the issuing of Community licences should be clarified and the Internal Market Information System (IMI) module developed for the sending of posting declarations and electronic applications, enabling the inspectors carrying out the roadside checks to have direct real-time access to data and information contained in the European Register of Road Transport Undertakings (ERRU) and in the IMI and so as to ensure that social contributions are actually paid for posted bus drivers. [Am. 5]

(6)  In order to ensure fair competition in the market, operators of regular services should be provided with access rights to terminals in the Union on fair, equitable, non-discriminatory and transparent terms. The operation of a terminal should be approved by a national authority, which should verify which requirements are necessary and which must be fulfilled. Appeals against decisions rejecting or limiting access should be lodged with the regulatory body. Member States might exclude terminals that are owned and used solely by the terminal operator for its own road passenger transport services. [Am. 6]

(7)  While maintaining authorisation for regular services, certain rules regarding the authorisation procedure should be adapted.

(8)  Authorisation for both national and international regular services should be subject to an authorisation procedure. Authorisation should be granted, unless there are specific grounds for refusal attributable to the applicant, or the service would compromise the economic equilibrium of a public service contract. A distance threshold, determined by the Member States, which should in any event not exceed 100 kilometres journey distance, should be introduced to ensure that commercial regular service operations do not compromise the economic equilibrium of existing public service contracts. In the case of routes already served by more than one public service contract, it should be possible to increase that threshold. [Am. 7]

(9)  Non-resident carriers should be able to operate national regular services under the same conditions as resident carriers, as long as they have complied with road transport or other relevant provisions of national, Union and international law. [Am. 8]

(10)  Administrative formalities should be reduced as much as where possible without abandoning the controls and penalties that guarantee the correct application and effective enforcement of Regulation (EC) No 1073/2009. The journey form constitutes an unnecessary administrative burden and should therefore be abolished. [Am. 9]

(11)  Local excursions are an authorised cabotage operation and are covered by the general rules on cabotage. The article on local excursions should therefore be deleted. [Am. 10]

(12)  In view of the importance of effective enforcement of Regulation (EC) No 1073/2009, the rules on inspections at the roadside and in undertakings should be amended to include cabotage operations.

(13)  Insofar as this Regulation harmonises the rules in national markets for regular coach and bus services and access to terminals, its objectives, namely the promotion of inter-urban mobility and the increase of the modal share of sustainable passenger transport modes, cannot be sufficiently achieved by the Member States. Therefore, the Union may adopt measures, in line with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve the objectives pursued.

(14)  In order to take into account market developments and technical progress the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend Annexes I and II to Regulation (EC) No 1073/2009, and to supplement that Regulation with rules concerning the format of certificates for own-account transport operations, the format of applications for authorisations and authorisations themselves, the procedure and criteria to be followed to determine if a proposed service would compromise the economic equilibrium of a public service contract, and the reporting obligations of Member States. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in line with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (9). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as the Member States’ experts, and the European Parliament and the Council experts should systematically have access to the Commission’s expert group meetings dealing with the preparation of delegated acts. [Am. 11]

(15)  Regulation (EC) No 1073/2009 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1073/2009 is amended as follows:

(1)  in Article 1, paragraph 4 is replaced by the following:"

“4. This Regulation shall apply to national interurban road passenger services for hire or reward operated by a non-resident carrier as provided for in Chapter V, and shall be without prejudice to the provisions of Regulation (EC) No 1370/2007.”; [Am. 12]

(2)  Article 2 is amended as follows:

(a)  point 2 is replaced by the following:"

“2. ‘regular services’ means services which provide for the carriage of passengers at specified intervals along specified routes, either without intermediate stopping points or with passengers being picked up and set down at predetermined stopping points;”;

(b)  point 7 is replaced by the following:"

“7. ‘cabotage operation’ means a national road passenger transport service operated for hire or reward in a host Member State;”; [Am. 83]

(c)  the following points 9 to 11b are added:"

“9. ‘terminal’ means any an authorised facility with a minimum area of 600m2, which provides a parking place that is used by coaches and buses for the setting down or picking up alighting or boarding of passengers; [Am. 13]

10.  ‘terminal operator’ means any entity in a Member State responsible for the management of a terminal, which meets professional competence and financial capacity requirements; [Am. 14]

11.  ‘viable alternative’ means another terminal which is economically acceptable to the carrier and provides comparable infrastructure and connectivity to the terminal originally applied for, allows passengers access to other forms of public transport, and allows the carrier to operate the passenger service concerned in a similar manner to the terminal originally applied for; [Am. 15]

11a.  ‘public service contract’ means one or more legally binding acts confirming the agreement between a competent authority and a public service operator to entrust to that public service operator the management and operation of public passenger transport services subject to public service obligations; depending on the law of the Member State, the contract may also consist of a decision adopted by the competent authority taking the form of an individual legislative or regulatory act, or containing conditions under which the competent authority itself provides the services or entrusts the provision of such services to an internal operator; [Am. 16]

11b.  ‘alternative route’ means a route between the same starting point and destination taken by an existing regular service that can be used instead.ˮ; [Am. 17]

(3)  the following Article is inserted before Chapter II:"

“Article 3a

Regulatory body

1.  Each The competent authorities in each Member State shall designate a single national public regulatory body for the road passenger transport sector. That body shall be an impartial authority which is, in organisational, functional, hierarchical and decision making terms, legally distinct, transparent and independent from any other public or private entity. It shall be independent from any competent authority involved in the award of a public service contract. [Am. 18]

The regulatory body may be an existing body which is responsible for other regulated sectors services. [Am. 19]

2.  The regulatory body for the road passenger transport sector shall have the necessary organisational capacity in terms of human, financial and other resources to fulfil its duties, which shall be proportionate to the importance of that sector in the Member State concerned. [Am. 20]

2a.  Without prejudice to the powers of the national competition authorities, the regulatory body shall have the power to monitor the competitive situation in the domestic market for regular passenger transport services by road, with a view to preventing discrimination or the abuse of a dominant position in the market, including through sub-contracting. Its opinions shall be binding. [Am. 21]

3.  The regulatory body shall perform the following tasks:

4.  The regulatory body may, in exercising its tasks, request relevant information from the other competent authorities, terminal operators, applicants for authorisation and any third party involved within the territory of the Member State concerned. [Am. 25]

Information requested shall be supplied within a reasonable period set by the regulatory body, and not exceeding which shall not exceed one month. In duly justified cases, the regulatory body may extend the time limit for submission of information by a maximum of two weeks. The regulatory body shall be able to enforce requests for information by means of penalties which are effective, proportionate and dissuasive. [Am. 26]

5.  Member States shall ensure that decisions taken by the regulatory body are subject to prompt judicial review. That review may have suspensive effect only when the immediate effect of the regulatory body’s decision may cause irretrievable or manifestly excessive damages for the appellant. This provision is without prejudice to the powers of the court hearing the appeal as conferred by constitutional law of the Member State concerned. [Am. 27]

6.  Decisions taken by the regulatory body shall be made public within two weeks of their adoption.”; [Am. 28]

(4)  Article 4 is amended as follows:

(a)  paragraph 1 is replaced with the following:"

“1. International carriage of passengers and cabotage operations by coach and bus shall be carried out subject to possession of a Community licence issued by the competent authorities of the Member State of establishment.”;

(b)  in paragraph 2, the third subparagraph is replaced by the following:"

“The Commission is empowered to adopt delegated acts in accordance with Article 26 amending Annexes I and II in order to adapt them to technical progress.”;

(5)  Article 5 is amended as follows:

(a)  in paragraph 3, the fifth subparagraph is deleted;

(b)  in paragraph 5, the third subparagraph is replaced by the following:"

“The Commission is empowered to adopt delegated acts in accordance with Article 26 establishing the format of the certificates.”;

(6)  the following Article is inserted:"

“Article 5a

Access to terminals

1.  Terminal operators shall grant carriers the right to access terminals for the purpose of operating regular services including any facilities or services provided in that terminal under fair, equitable, non-discriminatory and transparent conditions.

1a.  Where terminal operators grant access, bus and coach operators shall comply with the terminal’s existing terms and conditions. [Am. 29]

2.  Terminal operators shall endeavour to accommodate all requests for access in order to ensure optimum use of terminals.

Requests for access to terminals may be refused only on the duly justified grounds of lack of capacity considerations, repeated failure to pay fees, duly documented serious and repeated infringements by the road transport operator, or other national provisions, provided they are consistently applied and do not discriminate either against particular carriers seeking access to a terminal, or their associated business models. If a request is refused, the terminal operator shall also communicate its decision to the regulatory authority. [Am. 30]

Where a terminal operator refuses a request for access, it shall is encouraged to indicate any best viable alternatives of which it is aware. [Am. 31]

3.  Terminal operators shall publish at least the following information in two or more official the respective national languages and one other official language of the Union: [Am. 32]

That information shall be made available free of charge in electronic format by the terminal operator and the regulatory body on request, and where they have websites, on those websites.

The information shall be kept up to date and amended as necessary.”;

3a.  Member States may exclude terminals that are owned and used solely by the terminal operator for its own road passenger transport services from the application of this Article. When considering an application for exclusion, regulatory bodies shall take into account the availability of viable alternatives.”; [Am. 34]

(7)  the following Article is inserted:"

“Article 5b

Procedure for granting access to terminals

1.  A carrier seeking access to a terminal shall submit an application to the terminal operator.

2.  If access cannot be granted as requested in the application, the terminal operator shall initiate consultations with all interested carriers with a view to accommodating the application. [Am. 35]

3.  The terminal operator shall take a decision on any application for access to a terminal within two months without delay and no later than one month of the date of submission of the application by the carrier. Decisions on Where access is refused, the terminal operator shall state the reasons on which they are based justify its decision. [Am. 36]

4.  Applicants may appeal against decisions by terminal operators. Appeals shall be lodged with the regulatory body.

5.  Where the regulatory body hears an appeal against a decision by a terminal operator, it shall adopt a reasoned decision within a fixed timeframe and, in any case within three weeks from receipt of all relevant information.

The decision of the regulatory body on the appeal shall be binding, subject to national law provisions regarding judicial review. The regulatory body shall be able to enforce it by means of penalties which are effective, proportionate and dissuasive. [Am. 37]

The decision shall be subject to judicial review only.";

(8)  Article 6 is amended as follows:

(a)  in paragraph 1, the first sentence of the first subparagraph is replaced by the following:"

“Authorisations shall be issued in the name of the carrier, in paper or electronic format and shall be non-transferable.”;

(b)  paragraph 4 is replaced by the following:"

“4. The Commission is empowered to adopt delegated acts in accordance with Article 26 establishing the format of the authorisations.”;

(9)  Article 7 is amended as follows:

(a)  paragraphs 1 and 2 are replaced by the following:"

“1. Applications for authorisation of regular services shall be submitted to the authorising authority in paper or electronic format.

2.  The Commission is empowered to adopt delegated acts in accordance with Article 26 establishing the format of the applications.”;

(10)  Article 8 is replaced by the following:"

“Article 8

Procedures for authorisation, procedure suspension and withdrawal of authorisation for the international carriage of passengers over a distance of less than up to 100 kilometres as the crow flies journey distance [Am. 38]

1.  Authorisations shall be issued in agreement with the competent authorities of all the Member States in whose territories passengers are picked up or set down and are carried over distances of less than defined by each Member State, up to 100 kilometres as the crow flies journey distance. The authorising authority shall send a copy of the application, together with copies of any other relevant documentation, within two weeks of receipt of the application to such competent authorities with a request for their agreement. At the same time, the authorising authority shall forward those documents to the competent authorities of other Member States whose territories are crossed, for information. [Am. 39]

2.  The competent authorities of the Member States whose agreement has been requested shall notify the authorising authority of their decision within three two months. The time limit shall be calculated from the date of receipt of the request for agreement which is demonstrated by the acknowledgement of receipt. If the competent authorities of the Member States whose agreement has been requested do not agree, they shall state the reasons. [Am. 40]

If the competent authorities of the Member States whose agreement has been requested do not reply within the time limit laid down in the first subparagraph, they shall be deemed to have given their agreement.

3.  The authorising authority shall take a decision on the application within four three months of the date of submission of the application by the carrier. [Am. 41]

4.  Authorisation shall be granted unless refusal can be justified on one or more of the objective grounds related to the public interest listed in points (a) to (d) of Article 8c(2). [Am. 42]

4a.  In the event that an international regular bus and coach service has compromised the economic equilibrium of a public service contract, due to exceptional reasons which could not have been foreseen at the time of granting the authorisation and which lay not in the responsibility of the owner of the public service contract, the Member State concerned may, with the agreement of the Commission, suspend or withdraw the authorisation to provide the service, after having given six months’ notice to the carrier. The carrier shall have the possibility to appeal such decision. [Am. 43]

5.  If one of the competent authorities does not agree to the authorisation, the matter may be referred to the Commission within two months following receipt of its reply.

6.  After having consulted the Member States of the competent authorities which disagreed, the Commission shall, within four no later than two months from receipt of the communication from the authorising authority, take a decision. The decision shall take effect 30 days after its notification to the competent authorities in the Member States concerned. [Am. 44]

7.  The Commission decision shall apply until such time as the Member States reach an agreement and the authorising authority adopts a decision on the application.”;

(11)  the following Articles are inserted:"

“Article 8a

Authorisation procedure Procedures for authorisation, suspension and withdrawal of authorisation for the international carriage of passengers over a distance of over 100 kilometres or more as the crow flies journey distance [Am. 45]

1.  The authorising authority shall take a decision on the application within without delay and no later than two months of the date of submission of the application by the carrier. [Am. 46]

2.  Authorisation shall be granted unless refusal can be justified on one or more of the grounds listed in points (a) to (c) (ca) of Article 8c(2). [Am. 47]

3.  The authorising authority shall forward to the competent authorities of all Member States in whose territories passengers are picked up or set down, as well as to the competent authorities of Member States whose territories are crossed without passengers being picked up or set down, boarding or alighting a copy of the application, together with copies of any other relevant documentation, and its assessment within two weeks of receipt of the application, with a request for their agreement. The authorising authority shall also forward the relevant documents to the competent authorities of the Member States whose territories are crossed without passengers boarding or alighting, for information. [Am. 48]

3a.  If one of the competent authorities of the Member States in whose territories passengers are boarding or alighting does not agree to the authorisation for one of the reasons set out in paragraph 2, authorisation may not be granted, but the matter may be referred to the Commission within one month of receipt of its reply. [Am. 49]

3b.  After having consulted the Member States of the competent authorities which disagreed, the Commission shall, within four months of receipt of the communication from the authorising authority, take a decision. The decision shall take effect 30 days after its notification to the Member States concerned. [Am. 50]

3c.  The Commission decision shall apply until such time as the Member States reach an agreement and the authorising authority adopts a decision on the application. [Am. 51]

Article 8b

Authorisation procedure for national regular services

1.  The authorising authority shall take a decision on the application within no later than two months of the date of submission of the application by the carrier. This may be extended to four three months where an analysis is requested in accordance with point (d) of Article 8c(2). [Am. 52]

2.  Authorisations for national regular services shall be granted unless refusal can be justified on one or more of the grounds listed in points (a) to (c) (ca) of Article 8c(2) and, if the service is carrying passengers over a distance of less up to, but no more than 100 kilometres as the crow flies journey distance, in point (d) of Article 8c(2). [Am. 53]

3.  The distance referred to in paragraph 2 may be increased to 120 kilometres if the regular service to be introduced will serve a point of departure and a destination which are already served by more than one public service contract. [Am. 54]

Article 8c

Decisions of authorising authorities

1.  Following the procedure laid down in Articles 8, 8a or 8b, the authorising authority shall grant the authorisation, grant the authorisation with limitations or reject the application. The authorising authority shall inform all the competent authorities referred to in Article 8(1) of its decision.

2.  Decisions rejecting an application, or granting authorisation with limitations, or suspending or withdrawing authorisation shall state the reasons on which they are based and, where applicable, take into account the analyses of the regulatory body. The applicant or the carrier operating the service concerned shall have the possibility to appeal the decisions of the authorising authority. [Am. 55]

Authorising authorities shall not reject an application solely on the grounds that the carrier requesting authorisation offers lower prices than those offered by other road carriers or unless the regulatory authority or other relevant national bodies establish that the applicant seeking to enter the market is planning to offer services below their normal value for an extended period of time, and that in doing so it is likely to undermine fair competition. Authorising authorities shall not reject an application solely due to the fact that the link in question is already operated by other road carriers. [Am. 60]

3.  Member States shall ensure that decisions taken by the authorising authority are subject to judicial review. That review may have suspensive effect only when the immediate effect of the authorising authority’s decision may cause irretrievable or manifestly excessive damages for the appellant. This provision is without prejudice to the powers of the court hearing the appeal as conferred by constitutional law of the Member State concerned.

Article 8d

Limitation of the right of access

1.  Member States may limit the right of access to the international and national market for regular bus and coach services if the proposed regular service carries passengers over distances of less than up to 100 kilometres as the crow flies journey distance and if the service would compromise the economic equilibrium of a public service contract, or over any distance if it occurs in an urban or suburban centre or conurbation, or meets the transport needs between it and the surrounding areas, or that the applicant has not complied with road transport or other relevant provisions of national, Union or international law. [Am. 61]

1a.  Where a competent authority has granted exclusive rights to an undertaking performing a public service in accordance with Article 3 of Regulation (EC) No 1370/2007, the protection of the exclusive rights shall only relate to the operation of public passenger transport services serving the same or alternative routes. That grant of exclusive rights shall not preclude the authorisation of new regular services where those services are not competing with the service provided in the public service contract, or operate on other routes. [Am. 62]

2.  The competent authorities that awarded a public service contract or the public service operators performing the public service contract may request the regulatory body to carry out an analysis of whether the economic equilibrium of the public service contract would be compromised.

Where such a request has been received, the regulatory body shall examine the request and may decide whether to carry out the economic analysis in accordance with point(d) of Article 8c(2)unless there are exceptional practical or other reasons justifying a decision not to do so. It shall inform the interested parties of its decision. [Am. 63]

3.  Where the regulatory body carries out an economic analysis, it shall inform all interested parties of the results of that analysis and its conclusions within six weeks as soon as possible, and no later than 3 months following receipt of all relevant information. The regulatory body may conclude that the authorisation is to be granted, is to be granted subject to conditions or is to be rejected. [Am. 64]

The conclusions of the regulatory body shall be binding on the authorising authorities.

4.  The competent authorities and the public service operators shall provide the regulatory body with the necessary information for the purposes of paragraphs 2 and 3.

5.  The Commission is empowered to adopt delegated acts in accordance with Article 26 establishing the procedure and criteria to be followed for the application of this Article, in particular in carrying out the economic analysis; [Am. 65]

5a.  Member States may further liberalise the authorisation system for national regular services with regard to authorisation procedures and kilometre thresholds."; [Am. 66]

(12)  in Article 9, the first paragraph is replaced by the following:"

“Articles 8, 8a, 8b and 8c shall apply, mutatis mutandis, to applications for the renewal of authorisations or for alteration of the conditions under which the services subject to authorisation must be carried out.”;

(13)  the title of Chapter IV is replaced by the following:"

“SPECIAL REGULAR SERVICES EXEMPT FROM AUTHORISATION”

(13a)  in Article 11, the following paragraph is added:"

"3a. A Member State may decide to require a non-resident carrier to comply with the conditions relating to the requirement of establishment, as laid down in Regulation (EC) No 1071/2009 of the European Parliament and of the Council*, in the host Member State after authorisation for a national regular service has been granted to this carrier and before the carrier starts to operate the relevant service. Such decisions shall state the reasons on which they are based. The decision shall take into account the size and duration of the activity of the non-resident carrier in the host Member State. If the host Member State establishes that the non-resident carrier does not satisfy the requirement of establishment, it may withdraw the relevant authorisations granted to it for national regular services or suspend them until the requirement is met.

______________________

* Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC (OJ L 300, 14.11.2009, p. 51).”; [Am. 67]

(14)  in Article 12, paragraphs 1 to 5 are deleted;

(15)  Article 13 is deleted; [Am. 68]

(16)  Article 15 is replaced by the following:"

“Article 15

Authorised cabotage operations

(16a)  in Article 16(1), the introductory part is replaced by the following:"

"1. The performance of the cabotage operations shall be subject, save as otherwise provided in Community legislation, to Directive 96/71/EC of the European Parliament and of the Council* and the laws, regulations and administrative provisions in force in the host Member State with regard to the following:

______________

* Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (OJ L 18, 21.1.1997, p. 1).”; [Am. 72]

(17)  Article 17 is deleted; [Am. 73]

(17a)  Article 17 is replaced by the following:"

“Article 17

Control documents for cabotage operations

1.  Cabotage operations in the form of occasional services shall be carried out under cover of a journey form as referred to in Article 12 on paper or in digital format which shall be kept on board the vehicle and be presented at the request of any authorised inspecting officer inspector.

2.  The following information shall be entered in the journey form:

3.  The journey forms shall be supplied in books as referred to in Article 12 certified by the competent authority or body in the Member State of establishment.

4.  In the case of special regular services, the contract concluded between the carrier and the transport organiser, or a certified true copy thereof, shall serve as the control document. However, a journey form shall be filled out in the form of a monthly statement.

However, a journey form shall be filled out in the form of a monthly statement.

5.  The journey forms used shall be returned to the competent authority or body in the Member State of establishment in accordance with procedures to be laid down by that authority or body. During checks, the driver shall be allowed to contact the head office, the transport manager or any other person or entity which may provide the requested documents."; [Am. 74]

(18)  in Article 19(2), the first sentence is replaced by the following:"

“2. Carriers operating cabotage or international carriage of passengers by coach and bus shall allow all inspections intended to ensure that operations are being conducted correctly, in particular as regards driving and rest periods.”;

(19)  Article 20 is replaced by the following:"

“Article 20

Mutual assistance

1.  Member States shall assist one another in ensuring the application and monitoring of this Regulation. They shall exchange information via the national contact points established pursuant to Article 18 of Regulation (EC) No 1071/2009.

2.  The regulatory bodies shall cooperate when carrying out economic analyses of whether proposed regular services would compromise a public service contract for the international operation of public transport services. The authorising authority shall consult the regulatory bodies of all other Member States through which the international regular service concerned runs and, where appropriate, shall request all necessary information from them before taking its decision.”;

(20)  Article 26 is replaced by the following:"

“Article 26

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Articles 4(2), 5(5), 6(4), 7(2), 8d(5) and 28(3) shall be conferred on the Commission for an indeterminate period of time from ... [date of entry into force of this Regulation].

3.  The delegation of power referred to in Articles 4(2), 5(5), 6(4), 7(2), 8d(5) and 28(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to Articles 4(2), 5(5), 6(4), 7(2), 8d(5) and 28(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.”;

(21)  Article 28 is replaced by the following:"

“Article 28

Reporting

1.  Each year, by 31 January at the latest, and for the first time by 31 January [… the first January following the entry into force of this Regulation] the competent authorities of the Member States shall communicate to the Commission the number of authorisations for regular services issued the previous year and the total number of authorisations for regular services valid on 31 December of that year. That information shall be given separately for each Member State of destination of the regular service. Member States shall also communicate to the Commission the data concerning cabotage operations, in the form of special regular services and occasional services, carried out during the previous year by resident carriers. [Am. 75]

2.  Each year, by 31 January at the latest and, for the first time by 31 January [… the first January following the entry into force of this Regulation], the competent authorities in the host Member State shall provide the Commission with statistics on the number of authorisations issued for cabotage operations in the form of the regular services referred to in point (c) of Article 15 during the previous year.

3.  The Commission is empowered to adopt delegated acts in accordance with Article 26 to establish the format of the table to be used for the communication of the statistics referred to in paragraphs 1 and 2 and the data to be provided.

4.  Each year, by 31 January at the latest and, for the first time by 31 January [… the first January following the entry into force of this Regulation], Member States shall inform the Commission of the number of carriers holding a Community licence as of 31 December of the previous year and of the number of certified copies corresponding to the number of vehicles in circulation on that date.

5.  By … [please insert the date calculated 5 years after the date of application of this Regulation], the Commission shall submit a report to the European Parliament and the Council on the application of this Regulation. The report shall include information on the extent to which this Regulation has contributed to a better functioning road passenger transport market system, in particular for passengers, the bus and coach workforce and the environment.". [Am. 76]

Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from [XX].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament For the Council

The President The President

(1) OJ C 262, 25.7.2018, p. 47. (2) OJ C 387, 25.10.2018, p. 70. (3) OJ C 262, 25.7.2018, p. 47. (4) OJ C 387, 25.10.2018, p. 70. (5) Position of the European Parliament of 14 February 2019. (6) Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services, and amending Regulation (EC) No 561/2006 (OJ L 300, 14.11.2009, p. 88). (7) Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70 (OJ L 315, 3.12.2007, p. 1). (8) Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport, repealing Council Regulation (EEC) No 3821/85 on recording equipment in road transport and amending Regulation (EC) No 561/2006 of the European Parliament and of the Council on the harmonisation of certain social legislation relating to road transport (OJ L 60, 28.2.2014, p. 1). (9) OJ L 123, 12.5.2016, p. 1.

European Parliament legislative resolution of 14 February 2019 on the proposal for a decision of the European Parliament and of the Council on adapting Directive 2012/27/EU of the European Parliament and of the Council on energy efficiency [as amended by Directive 2018/XXX/EU] and Regulation (EU) 2018/XXX of the European Parliament and of the Council [Governance of the Energy Union], by reason of the withdrawal of the United Kingdom from the European Union (COM(2018)0744 – C8-0482/2018 – 2018/0385(COD))

P8_TA(2019)0126 A8-0014/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0744),

–  having regard to Article 294(2), Article 192(1) and Article 194(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0482/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the undertaking given by the Council representative by letter of 30 January 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Industry, Research and Energy (A8-0014/2019),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 14 February 2019 with a view to the adoption of Decision (EU) 2019/… of the European Parliament and of the Council on amending Directive 2012/27/EU on energy efficiency and Regulation (EU) 2018/1999 on the Governance of the Energy Union and Climate Action, by reason of the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the Union

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Decision (EU) 2019/504.)

European Parliament resolution of 14 February 2019 on the right to peaceful protest and the proportionate use of force (2019/2569(RSP))

P8_TA(2019)0127 B8-0103/2019

The European Parliament,

–  having regard to the EU Treaties, and in particular Articles 2, 3, 4, 6 and 7 of the Treaty on European Union (TEU),

–  having regard to the Charter of Fundamental Rights of the European Union (hereinafter ‘the Charter’),

–  having regard to the European Convention on Human Rights (ECHR) and the related case-law of the European Court of Human Rights (ECtHR),

–  having regard to its resolution of 16 January 2019 on the situation of fundamental rights in the European Union in 2017(1),

–  having regard to Rule 123(2) of its Rules of Procedure,

A.  whereas the EU is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities; whereas these values are common to the Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail;

B.  whereas the rule of law is the backbone of democracy and is one of the founding principles of the EU, operating on the basis of the presumption of mutual trust that Member States uphold respect for democracy, the rule of law and fundamental rights, as enshrined in the Charter and the ECHR;

C.  whereas the EU is committed to respecting freedom of expression and information, as well as freedom of assembly and association;

D.  whereas Article 11 of the ECHR and Article 12 of the Charter state that everyone has the right to freedom of peaceful assembly and to freedom of association with others, including the right to form and join trade unions for the protection of his or her interests;

E.  whereas Article 11 of the ECHR states that ‘no restrictions shall be placed on the exercise of these rights other than such as are prescribed by law and are necessary in a democratic society in the interests of national security or public safety, for the prevention of disorder or crime, for the protection of health or morals or for the protection of the rights and freedoms of others’;

F.  whereas Article 11 of the ECHR also states that the freedom of assembly ‘shall not prevent the imposition of lawful restrictions on the exercise of these rights by members of the armed forces, of the police or of the administration of the state’;

G.  whereas Article 12 of the Charter also states that ‘political parties at Union level contribute to expressing the political will of the citizens of the Union’;

H.  whereas freedom of association should be protected; whereas a vibrant civil society and pluralistic media play a vital role in promoting an open and pluralistic society and public participation in the democratic process, and in strengthening the accountability of governments;

I.  whereas freedom of assembly goes hand in hand with freedom of expression, as ensured by Article 11 of the Charter and Article 10 of the ECHR, stating that everyone has the right to freedom of expression, which includes the freedom to hold opinions and to receive and impart information and ideas without interference by public authorities and regardless of frontiers;

J.  whereas the exercise of these freedoms, since it carries with it duties and responsibilities, may be subject to such formalities, conditions, restrictions or penalties as are prescribed by law and are necessary in a democratic society, in the interests of national security, territorial integrity or public safety, for the prevention of disorder or crime, for the protection of health or morals, for the protection of the reputation or rights of others, for preventing the disclosure of information received in confidence, or for maintaining the authority and impartiality of the judiciary, as prescribed by Article 10 of the ECHR;

K.  whereas Article 52 of the Charter states that ‘any limitation on the exercise of the rights and freedoms recognised by this Charter must be provided for by law and respect the essence of those rights and freedoms’;

L.  whereas, in accordance with Article 4(2) of the TEU, the EU ‘shall respect [the Member States’] essential state functions, including ensuring the territorial integrity of the state, maintaining law and order and safeguarding national security’; whereas ‘in particular, national security remains the sole responsibility of each Member State’;

M.  whereas according to the case law of the ECtHR and the Court of Justice of the European Union all restrictions of fundamental rights and civil liberties must respect the principles of legality, necessity and proportionality;

N.  whereas law enforcement authorities in several Member States have been criticised for undermining the right to protest and using excessive force;

1.  Calls on the Member States to respect the rights of freedom of peaceful assembly, freedom of association and freedom of expression;

2.  Stresses that public debate is vital to the functioning of democratic societies;

3.  Condemns the adoption of restrictive laws concerning freedom of assembly in several Member States in recent years;

4.  Condemns the use of violent and disproportionate interventions by state authorities during protests and peaceful demonstrations; encourages the relevant authorities to ensure a transparent, impartial, independent and effective investigation when the use of disproportionate force is suspected or has been alleged; recalls that law enforcement agencies must always be held accountable for the fulfilment of their duties and their compliance with the relevant legal and operational frameworks;

5.  Calls on the Member States to ensure that the use of force by law enforcement authorities is always lawful, proportionate, necessary and the last resort, and that it preserves human life and physical integrity; notes that the indiscriminate use of force against crowds contravenes the principle of proportionality;

6.  Notes the important role of journalists and photojournalists in reporting cases of disproportionate violence, and condemns all instances in which they have been deliberately targeted;

7.  Believes that violence against peaceful demonstrators can never be a solution in a debate or in politics;

8.  Acknowledges that the police, among whom there have also been many casualties, are operating in difficult conditions, owing in particular to the hostility of some protesters, but also to an excessive workload; condemns every kind of violence against individuals or property by violent, militant protesters, who only come for a violent purpose and harm the legitimacy of peaceful protests;

9.  Encourages the Member States’ law enforcement officials to actively participate in training provided by the European Union Agency for Law Enforcement Training (CEPOL) on ‘Public order – policing of major events’; encourages the Member States to exchange best practices in this regard;

10.  Emphasises the importance of guaranteeing the safety of law enforcement officers, police officers and soldiers engaged in security maintenance operations during public protest demonstrations;

11.  Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States, the Council of Europe, the Organisation for Security and Cooperation in Europe and the United Nations.

(1) Texts adopted, P8_TA(2019)0032.

European Parliament resolution of 14 February 2019 on the rights of intersex people (2018/2878(RSP))

P8_TA(2019)0128 B8-0101/2019

The European Parliament,

–  having regard to Article 2 of the Treaty on European Union,

–  having regard to Articles 8 and 10 of the Treaty on the Functioning of the European Union,

–  having regard to the Charter of Fundamental Rights of the European Union, and in particular Article 21 thereof,

–  having regard to the European Social Charter, and in particular Article 11 thereof,

–  having regard to Directive 2012/29/EU of the European Parliament and of the Council of 25 October 2012 establishing minimum standards on the rights, support and protection of victims of crime(1),

–  having regard to the report published by the Commission in 2011 entitled ‘Trans and intersex people’,

–  having regard to the final reports of the Commission-funded ‘Health4LGBTI’ pilot project on health inequalities experienced by LGBTI people,

–  having regard to its resolution of 4 February 2014 on the EU Roadmap against homophobia and discrimination on grounds of sexual orientation and gender identity(2),

–  having regard to its resolution of 13 December 2016 on the situation of fundamental rights in the European Union in 2015(3),

–  having regard to the paper published in May 2015 by the European Union Agency for Fundamental Rights (FRA) entitled ‘The fundamental rights situation of intersex people’(4),

–  having regard to the FRA’s online publication of November 2017 entitled ‘Mapping minimum age requirements concerning the rights of the child in the EU’(5),

–  having regard to the FRA Fundamental Rights Report 2018,

–  having regard to the European Convention on Human Rights,

–  having regard to the European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment,

–  having regard to Resolution 2191 of the Council of Europe Parliamentary Assembly, adopted in 2017, on promoting the human rights of and eliminating discrimination against intersex people,

–  having regard to the 2015 report of the Council of Europe Commissioner for Human Rights on human rights and intersex people,

–  having regard to the Universal Declaration of Human Rights,

–  having regard to the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment,

–  having regard to the UN Convention on the Rights of the Child,

–  having regard to the UN Convention on the Rights of Persons with Disabilities,

–  having regard to the 2013 report of the UN Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment,

–  having regard to the Yogyakarta Principles (‘Principles and State Obligations on the Application of International Human Rights Law in Relation to Sexual Orientation, Gender Identity, Gender Expression and Sex Characteristics’) adopted in November 2006, and the 10 complementary principles (‘plus 10’) adopted on 10 November 2017,

–  having regard to the questions to the Council and to the Commission on the rights of intersex people (O-000132/2018 – B8-0007/2019 and O-000133/2018 – B8-0008/2019),

–  having regard to the motion for a resolution of the Committee on Civil Liberties, Justice and Home Affairs,

–  having regard to Rules 128(5) and 123(2) of its Rules of Procedure,

A.  whereas intersex individuals are born with physical sex characteristics that do not fit medical or social norms for female or male bodies, and these variations in sex characteristics may manifest themselves in primary characteristics (such as the inner and outer genitalia and the chromosomal and hormonal structure) and/or secondary characteristics (such as muscle mass, hair distribution and stature);

B.  whereas intersex people are exposed to multiple instances of violence and discrimination in the European Union and these human rights violations remain widely unknown to the general public and policymakers;

C.  whereas there is a high prevalence of surgeries and medical treatments carried out on intersex infants, although in most cases these treatments are not medically necessary; whereas cosmetic surgeries and urgent surgeries can be proposed as a package, preventing parents and intersex people from having full information on the impact of each;

D.  whereas surgeries and medical treatments are performed on intersex children without their prior, personal, full and informed consent; whereas intersex genital mutilation can have lifelong consequences, such as psychological trauma and physical impairments;

E.  whereas intersex individuals and intersex children who belong to other minority and marginalised groups are further marginalised and socially excluded and are at risk of violence and discrimination, because of their intersecting identities;

F.  whereas in most Member States surgery can be performed on an intersex child or an intersex individual with disabilities with the consent of their legal guardian, regardless of the capacity of the intersex person to decide for themselves;

G.  whereas in many cases parents and/or legal guardians are strongly pressured to make decisions without being fully informed of the lifelong consequences for their child;

H.  whereas many intersex people do not have full access to their medical records and therefore do not know that they are intersex or are not aware of the medical treatments they have been subjected to;

I.  whereas intersex variations continue to be classified as diseases, as in the World Health Organisation’s International Classification of Diseases (ICD), in the absence of evidence supporting the long-term success of treatments;

J.  whereas some intersex people will not identify with the gender they are medically assigned at birth; whereas legal gender recognition based on self-determination is only possible in six Member States; whereas many Member States still require sterilisation for legal gender recognition;

K.  whereas anti-discrimination legislation at EU level, and in most Member States, does not include discrimination based on sex characteristics, whether as a standalone category or interpreted as a form of discrimination based on sex;

L.  whereas many intersex children face human rights violations and genital mutilation in the EU when undergoing sex-normalising treatments;

1.  Notes the urgent need to address violations of the human rights of intersex people, and calls on the Commission and the Member States to propose legislation to address these issues;

Medicalisation and pathologisation

2.  Strongly condemns sex-normalising treatments and surgery; welcomes laws that prohibit such surgery, as in Malta and Portugal, and encourages other Member States to adopt similar legislation as soon as possible;

3.  Stresses the need to provide adequate counselling and support to intersex children and intersex individuals with disabilities, as well as to their parents or guardians, and fully inform them of the consequences of sex-normalising treatments;

4.  Calls on the Commission and the Member States to support organisations that work to break the stigma against intersex people;

5.  Calls on the Commission and the Member States to increase funding for intersex civil society organisations;

6.  Calls on the Member States to improve access for intersex people to their medical records, and to ensure that no one is subjected to non-necessary medical or surgical treatment during infancy or childhood, guaranteeing bodily integrity, autonomy and self-determination for the children concerned;

7.  Takes the view that pathologisation of intersex variations jeopardises the full enjoyment by intersex people of the right to the highest attainable standard of health as enshrined in the UN Convention on the Rights of the Child; calls on the Member States to ensure the depathologisation of intersex people;

8.  Welcomes the depathologisation, however partial, of trans identities in the eleventh revision of the ICD (ICD-11); notes, however, that the category of ‘gender incongruence’ in childhood pathologises non-gender-normative behaviours in childhood; calls, therefore, on the Member States to pursue the removal of this category from the ICD-11, and to bring future ICD revision into line with their national health systems;

Identity documents

9.  Stresses the importance of flexible birth registration procedures; welcomes the laws adopted in some Member States that allow legal gender recognition on the basis of self-determination; encourages other Member States to adopt similar legislation, including flexible procedures to change gender markers, as long as they continue to be registered, as well as names on birth certificates and identity documents (including the possibility of gender-neutral names);

Discrimination

10.  Deplores the lack of recognition of sex characteristics as a ground of discrimination across the EU, and therefore highlights the importance of this criterion in order to ensure access to justice for intersex people;

11.  Calls on the Commission to enhance the exchange of good practices on the matter; calls on the Member States to adopt the necessary legislation to ensure the adequate protection, respect and promotion of the fundamental rights of intersex people, including intersex children, including full protection against discrimination;

Public awareness

12.  Calls on all relevant stakeholders to carry out research concerning intersex people, taking a sociological and human rights perspective rather than a medical one;

13.  Calls on the Commission to make sure that EU funds do not support research or medical projects that further contribute to violating the human rights of intersex people, in the context of the European Reference Networks (ERNs); calls on the Commission and the Member States to support and fund research on the human rights situation of intersex people;

14.  Calls on the Commission to take a holistic and rights-based approach to the rights of intersex people and to better coordinate the work of its Directorates-General for Justice and Consumers, for Education, Youth, Sport and Culture, and for Health and Food Safety, so as to ensure consistent policies and programmes supporting intersex people, including training of state officials and the medical profession;

15.  Calls on the Commission to reinforce the intersex dimension in its multiannual LGBTI list of actions for the current period, and to begin preparing as of now a renewal of this strategy for the next multiannual period (2019-2024);

16.  Calls on the Commission to facilitate the sharing of best practices among Member States on protecting the human rights and bodily integrity of intersex people;

o
o   o

17.  Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States and the Parliamentary Assembly of the Council of Europe.

(1) OJ L 315, 14.11.2012, p. 57. (2) OJ C 93, 24.3.2017, p. 21. (3) OJ C 238, 6.7.2018, p. 2. (4) https://fra.europa.eu/en/publication/2015/fundamental-rights-situation-intersex-people (5) https://fra.europa.eu/en/publication/2017/mapping–minimum–age–requirements–concerning–rights–child–eu

European Parliament resolution of 14 February 2019 on the future of the LGBTI List of Actions (2019-2024) (2019/2573(RSP))

P8_TA(2019)0129 B8-0127/2019

The European Parliament,

–  having regard to Article 2 of the Treaty on European Union,

–  having regard to Articles 8 and 10 of the Treaty on the Functioning of the European Union,

–  having regard to the Charter of Fundamental Rights of the European Union and in particular to Article 21 thereof,

–  having regard to the Convention for the Protection of Human Rights and Fundamental Freedoms,

–  having regard to Recommendation CM/Rec(2010)5 of the Committee of Ministers of the Council of Europe to member states on measures to combat discrimination on grounds of sexual orientation or gender identity, adopted on 31 March 2010,

–  having regard to the proposal for a Council directive on implementing the principle of equal treatment between persons irrespective of religion or belief, disability, age or sexual orientation (COM(2008)0426) and to its position of 2 April 2009 on that proposal,

–  having regard to the guidelines to promote and protect the enjoyment of all human rights by lesbian, gay, bisexual, transgender and intersex (LGBTI) persons adopted by the Council of the European Union at its meeting of 24 June 2013,

–  having regard to the Council conclusions on LGBTI equality of 16 June 2016,

–  having regard to the results of the European Union lesbian, gay, bisexual and transgender survey carried out by the European Union Agency for Fundamental Rights (FRA) and published on 17 May 2013,

–  having regard to its resolution of 4 February 2014 on the EU Roadmap against homophobia and discrimination on grounds of sexual orientation and gender identity(1),

–  having regard to its resolution of 16 January 2019 on the situation of fundamental rights in the European Union in 2017(2),

–  having regard to resolution 2191(2017) of 12 October 2017 of the Parliamentary Assembly of the Council of Europe on promoting the human rights of and eliminating discrimination against intersex people,

–  having regard to the Commission’s List of Actions to advance LGBTI equality of December 2015,

–  having regard to the Commission’s annual reports from 2016 and 2017 on the implementation of the List of Actions to advance LGBTI equality,

–  having regard to the Court of Justice of the European Union (CJEU) judgment of 5 June 2018 (Relu Adrian Coman and Others v Inspectoratul General pentru Imigrări and Ministerul Afacerilor Interne)(3) and other relevant case-law of the CJEU and ECtHR,

–  having regard to the European Union Agency for Fundamental Rights report of May 2015 entitled ‘The fundamental rights situation of intersex people’,

–  having regard to the European Union Agency for Fundamental Rights report of March 2017 entitled ‘Current migration situation in the EU: Lesbian, gay, bisexual, transgender and intersex asylum seekers’,

–  having regard to the 2015 report by the Council of Europe Commissioner for Human Rights on ‘human rights and intersex people’,

–  having regard to resolution 2048(2015) of 22 April 2015 of the Parliamentary Assembly of the Council of Europe on discrimination against transgender people in Europe,

–  having regard to the UN Convention on the Elimination of all Forms of Discrimination against Women (CEDAW),

–  having regard to the Council of Europe Convention on preventing and combating violence against women and domestic violence (Istanbul Convention),

–  having regard to the question to the Commission on the future of the LGBTI List of Actions (2019-2024) (O-000006/2019 – B8-0014/2019),

–  having regard to Rules 128(5) and 123(2) of its Rules of Procedure,

A.  whereas LGBTI people continue to suffer from discrimination and violence in the European Union; whereas not all EU Member States provide legal protection for LGBTI people against discrimination;

B.  whereas Parliament, in its resolution of 4 February 2014 on the EU Roadmap against homophobia and discrimination on grounds of sexual orientation and gender identity, called on the Commission to adopt a strategy on LGBTI equality;

C.  whereas the European Council, in its conclusions on LGBTI equality of 16 June 2016, invited Member States to work together with the Commission with regard to the LGBTI List of Actions;

D.  whereas the Commission has adopted comprehensive strategic frameworks on other topics related to fundamental rights, such as disability and Roma inclusion, but has yet to take such action on LGBTI rights;

E.  whereas the List of Actions to advance LGBTI equality published by the Commission in 2015 is a non-binding, non-comprehensive strategy;

F.  whereas the Commission’s reports on the implementation of the List of Actions to advance LGBTI equality show that significant steps have been taken, but much remains to be done to ensure equality for all citizens in the EU, including LGBTI citizens;

G.  whereas although the guidelines adopted by the European Council to promote and protect the enjoyment of all human rights by lesbian, gay, bisexual, transgender and intersex (LGBTI) persons have been binding for the EU and its Member States in their external action since 2013, the EU’s lack of an internal complementing commitment poses a threat to internal and external cohesion;

H.  whereas the anti-discrimination directive remains blocked in the Council;

1.  Reiterates the recommendations of its resolution on the EU Roadmap;

2.  Notes that a backlash against gender equality, impacting LGBTI people directly, has been observed in the EU in recent years; calls on the Commission to make a commitment to tackle this backlash, to make equality and non-discrimination a priority field, and to ensure that this commitment is taken up in the work of the next Commission which will take office later in 2019;

3.  Calls on the Commission to ensure that LGBTI rights are given priority in its work programme for 2019-2024, and to strengthen cooperation among different DGs in areas where LGBTI rights should be mainstreamed, such as in education and health, as set out in the LGBTI List of Actions;

4.  Calls on the Commission to adopt another strategic document to foster equality for LGBTI people;

5.  Calls on the Commission to monitor and enforce the implementation of anti-discrimination legislation and measures to ensure the rights of LGBTI people in all areas;

6.  Calls on the Commission to continue work on the topics already included in the LGBTI List of Actions;

7.  Calls on the Commission to involve Parliament and civil society organisations in the design of its future LGBTI List of Actions;

8.  Calls on the Commission to continue awareness-raising and public communication campaigns concerning LGBTI people and their families; stresses the importance of such action at all levels, and of focusing on the benefits of diversity to society rather than on the mere normalisation of LGBTI people;

9.  Calls on the Commission to facilitate and support the Member States in their implementation of high-quality, comprehensive sexuality and relationship education programmes that provide information and education on sexual and reproductive health and rights in a way that is non-judgemental, framed positively and inclusive of LGBTI people;

10.  Calls on the Commission to take concrete measures to ensure freedom of movement for all families, including LGBTI families, in line with the recent Coman case at the CJEU;

11.  Notes that 8 Member States require sterilisation and 18 Member States require a mental health diagnosis in order to access legal gender recognition; calls on the Commission to assess whether such requirements are in line with the Charter of Fundamental Rights of the European Union;

12.  Calls on the Commission to incorporate an intersectional perspective into its future work on LGBTI rights, to take into consideration intersecting experiences of discrimination encountered by marginalised LGBTI people and to develop measures to address their specific needs, including by making funding available for specific support networks of marginalised LGBTI groups;

13.  Calls on the Commission to continue working with Member States with a view to the implementation of its future actions on LGBTI rights;

14.  Calls on the Commission to enhance the exchange of good practices on this matter; calls on the Member States to adopt the legislation required to ensure that the fundamental rights of LGBTI children are afforded adequate respect, promotion and protection, including full protection against discrimination;

15.  Instructs its President to forward this resolution to the Council, the Commission, the parliaments and governments of the Member States and the Parliamentary Assembly of the Council of Europe.

(1) OJ C 93, 24.3.2017, p. 21. (2) Texts adopted, P8_TA(2019)0032. (3) Judgment of the Court (Grand Chamber) of 5 June 2018, ECLI:EU:C:2018:385.

European Parliament resolution of 14 February 2019 on the future of the INF Treaty and the impact on the European Union (2019/2574(RSP))

P8_TA(2019)0130 RC-B8-0128/2019

The European Parliament,

–  having regard to the Treaty between the United States of America and the Union of Soviet Socialist Republics on the Elimination of their Intermediate-Range and Shorter-Range Missiles (hereinafter the ‘INF Treaty’) signed in Washington on 8 December 1987 by the then US President, Ronald Reagan, and the leader of the Soviet Union, Mikhail Gorbatchev(1),

–  having regard to the 2018 Report on Adherence to and Compliance with Arms Control, Nonproliferation, and Disarmament Agreements and Commitments prepared by the US Department of State,

–  having regard to the statement of 21 October 2018 by US President Donald Trump warning of the withdrawal of the US from the INF Treaty,

–  having regard to the statement of 2 February 2019 by the US Secretary of State on US intent to withdraw from the INF Treaty(2),

–  having regard to the statement by Russian President Vladimir Putin of 2 February 2019 stating that Russia would also suspend its participation in the treaty,

–  having regard to the statement on the INF Treaty issued by NATO Foreign Ministers on 4 December 2018(3),

–  having regard to the Global Strategy for the European Union’s Foreign and Security Policy – Shared Vision, Common Action: A Stronger Europe,

–   having regard to concerns raised in 2019 by the US and NATO regarding Russia’s failure to comply with the INF Treaty, in particular as regard its new 9M729 missile system, most recently in the statement of 1 February 2019 issued by the North Atlantic Council(4),

–  having regard to the remarks by Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy (VP/HR) Federica Mogherini at the seventh EU Non-Proliferation and Disarmament Conference, held in Brussels on 18 and 19 December 2018,

–  having regard to its resolution of 27 October 2016 on nuclear security and non-proliferation(5),

–  having regard to the joint declaration on EU-NATO cooperation signed in Brussels on 10 July 2018,

–  having regard to the UN Agenda for Disarmament(6),

–  having regard to UN Sustainable Development Goal 16, which aims to promote peaceful and inclusive societies for sustainable development(7),

–  having regard to the 2017 annual progress report on the implementation of the European Union strategy against the proliferation of weapons of mass destruction of 18 May 2018,

–  having regard to the 1968 Nuclear Non-Proliferation Treaty (NPT), with its obligations on all states to pursue nuclear disarmament in good faith and to cease the nuclear arms race,

–  having regard to the Treaty on the Prohibition of Nuclear Weapons (TPNW) adopted on 7 July 2017 by the UN General Assembly,

–  having regard to its resolution of 10 March 2010 on the Treaty on the Non-Proliferation of Nuclear Weapons(8),

–  having regard to the EU Strategy against the Proliferation of Weapons of Mass Destruction, adopted by the European Council on 12 December 2003,

–  having regard to the Council conclusions on the Ninth Review Conference of the Parties to the Treaty on the Non-Proliferation of Nuclear Weapons (8079/15),

–  having regard to the Nobel Peace Prize 2017 awarded to the International Campaign to Abolish Nuclear Weapons (ICAN), and to its statement of 1 February 2019 entitled ‘US withdrawal from INF Treaty puts Europe (and the world) at risk’,

–  having regard to Rule 123(2) and (4) of its Rules of Procedure,

A.  whereas the INF Treaty, signed in 1987 by the United States and the Soviet Union, was a unique agreement of the Cold War era, as it required both countries to destroy their stockpiles of, rather than set limits on, ground-launched nuclear and conventionally armed ballistic and cruise missiles with ranges of between 500 and 5 500 km, while prohibiting parties from possessing, producing and flight-testing these missiles;

B.  whereas, by May 1991, 2 692 missiles had been eliminated in accordance with the terms of the Treaty; whereas 10 years of on-site inspections then followed; whereas more than 3 000 missiles containing nuclear warheads were ultimately removed thanks to the INF Treaty;

C.  whereas the INF Treaty contributed to containing strategic competition between the US and the Soviet Union, and subsequently the Russian Federation, and to building and reinforcing stability in the Cold War era; whereas Europe has been the principal beneficiary of the INF Treaty, which has been fundamental in upholding its security for more than three decades; whereas the Treaty is still a pillar of international peace and stability, in particular as part of the European security architecture;

D.  whereas in 2014 the Obama administration stated that Russia was ‘in violation of its obligations under the INF Treaty not to possess, produce or flight-test a ground-launched cruise missile (GLCM) with a range capability of 500 km to 5 500 km, or to possess or produce launchers of such missiles’; whereas subsequent reports, published by the US Department of State in 2015, 2016, 2017 and 2018, reiterated US allegations of Russia’s continued violation of the Treaty;

E.  whereas the US and NATO have repeatedly questioned Russia about its missile development activities, in particular as regards the 9M729 missile system, which they consider to be in breach of the INF Treaty;

F.  whereas in December 2017, on the occasion of the 30th anniversary of the treaty, President Trump’s administration announced an ‘integrated strategy’ of diplomatic, military and economic measures, aimed at bringing Russia back into compliance; whereas these measures included diplomatic efforts through the Special Verification Commission, the launch of a military research and development programme, and economic measures against Russian entities involved in developing and producing the non-compliant missile;

G.  whereas the US and Russia have failed to address their mutual concerns by means of diplomatic dialogue; whereas the Special Verification Commission established under the Treaty to address, among other things, compliance concerns, has not been convened;

H.  whereas on 20 October 2018 President Trump announced that the US would withdraw from the Treaty, citing Russia’s non-compliance and China’s non-participation; whereas on 4 December 2018, after the meeting of NATO Foreign Ministers, the US Secretary of State, Mike Pompeo, announced that the US had found Russia in material breach of the Treaty and would suspend its obligations as a remedy effective in 60 days unless Russia returned to full and verifiable compliance;

I.  whereas on 1 February 2019 the US announced, after the 60-day deadline given for Russia to return to full compliance, that it would suspend its obligations under the INF Treaty and begin the process of withdrawing from it unless Russia, which the US believes to be in material breach of the Treaty, returned to compliance with its terms within six months; whereas NATO Secretary-General Jens Stoltenberg has called on Russia to take advantage of the six-month period offered by the US to return to full compliance;

J.  whereas on 4 December 2018 NATO Foreign Ministers released a statement acknowledging Russia’s violations of the INF Treaty and calling on Russia to return as a matter of urgency to full and verifiable compliance with the Treaty;

K.  whereas on 2 February 2019 Russia announced that it would suspend the INF Treaty and develop new types of missiles; whereas the Russian authorities have repeatedly raised concerns about NATO missile defence installations;

L.  whereas China, along with other non-signatories to the INF Treaty, has conducted a widespread proliferation of its missile arsenal, demonstrating the need for a new treaty which binds the US, Russia and China;

M.  whereas a potential end to the Treaty could lead to an escalation of tensions among nuclear states, to misunderstandings and to a new arms race;

N.  whereas the INF Treaty is a cornerstone for maintaining global strategic stability, world peace and regional security; whereas preservation of the Treaty would contribute to efforts to preserve other existing arms control and disarmament agreements, as well as creating more favourable conditions for negotiations on arms limitations, disarmament and non-proliferation; whereas the withdrawal announcements are calling into question the likelihood of the non-extension of other major arms control treaties, such as the Treaty between the United States of America and the Russian Federation on Measures for the Further Reduction and Limitation of Strategic Offensive Arms (‘New START’), which would seriously damage the international arms control regime, which has provided decades of stability regarding nuclear weapons, leaving the world with no legally binding, verifiable limits on nuclear arsenals;

O.  whereas the UN Treaty on the Prohibition of Nuclear Weapons was opened for signature by the UN Secretary-General on 20 September 2017 and has to date been signed by 70 states, of which 21 have become States Parties through ratification of accession, amongst them EU Member State Austria, with Ireland likely to deliver its instruments of ratification to the UN Secretary-General within the next few months;

P.  whereas Nobel Peace Prize laureate ICAN has called on all states to ratify the Treaty on the Prohibition of Nuclear Weapons;

1.  Supports compliance with, and the continuation and strengthening of, the INF Treaty; recalls its vital contribution to peace and security in Europe and the rest of the world and to global disarmament and non-proliferation;

2.  Expresses deep concern at the breaches of the Treaty, and the subsequent announcements by the US and then Russia regarding the suspension of their obligations under it and their withdrawal from it within a period of six months; underlines that these developments pose a threat to one of Europe’s most vital security interests, as well as to European and global security and peace; fears that these actions might result in miscalculations and misperceptions leading to a deterioration of relations between the US and Russia, an escalation of tensions, heightened nuclear and military threats and risks, and a possible return of destabilising arms races, which would be detrimental to Europe’s security and strategic stability;

3.  Expresses condemnation of Russia for continuing to breach the terms of the Treaty;

4.  Calls on the Russian Federation to return to full and verifiable compliance, in order to address the concerns raised by the US and by NATO, in response to Russia’s continuing breach of the terms of the Treaty, and urges Russia’s commitment to the long-term future of the agreement;

5.  Recognises the importance of full transparency and dialogue in the interests of building trust and confidence in the implementation of the INF Treaty and any other agreements that support strategic stability and security; in light of the above, calls on both Russia and the US to resolve the respective compliance allegations, to engage in a constructive dialogue under the auspices of the UN Security Council, the Special Verification Commission or other appropriate forums, with the aim of reducing tensions, taking into account both parties’ interests and concerns and pursuing negotiations in good faith to safeguard the INF Treaty before the effective withdrawal in August 2019, enhancing transparency and mutual monitoring and achieving stronger rules and guarantees as regards their respective missile and nuclear capabilities;

6.  Urges the VP/HR to use the six-month window to use all political and diplomatic means at her disposal to engage in dialogue with the INF States Parties in order to restore cross-border trust, while offering the EU’s mediation expertise and experience with a view to preventing the withdrawal of both the US and Russia; urges the VP/HR to push for the preservation and development of the INF Treaty and to initiate negotiations for a multilateral treaty for this category of missiles; asks the VP/HR to ensure that the EU acts as a proactive and credible security provider, including for its neighbourhood, and that it plays a strong and constructive role in developing and reinforcing the global rules-based non-proliferation efforts and arms control and disarmament architecture;

7.  Emphasises that the uncertain future of the INF Treaty should not put other arms control agreements in jeopardy; notably urges the US and Russia to extend the New START agreement, which limits the number of deployed strategic warheads on either side to 1 550, before it expires in 2021;

8.  Reiterates its full commitment to the preservation of effective international arms control, disarmament and non-proliferation regimes as a cornerstone of global and European security; is of the opinion that Europe must lead by example in order to be credible and to advance a nuclear-free free world; calls on the EU Member States to make multilateral nuclear disarmament an EU foreign and security policy priority; recalls its commitment to pursuing policies designed to move forward with the reduction and elimination of all nuclear arsenals;

9.  Believes that European security should remain indivisible; calls on all EU Member States which are also NATO members to act accordingly; calls on the VP/HR to develop a common threat assessment analysing the implications for the EU’s security should the protection that the INF Treaty provides to the Union and its citizens cease to apply and report back to Parliament in time, in accordance with Article 36 of the Treaty on European Union, and to develop thereafter a credible and ambitious nuclear disarmament strategy based on effective multilateralism;

10.  Calls on the VP/HR to bring forward proposals to mobilise EU funds and strengthen the Union’s knowledge base and expertise regarding non-proliferation, arms control and human capacities to analyse threats emanating from nuclear weapons; calls on the VP/HR to present prudent plans for how to prevent unintended or accidental use of nuclear weapons;

11.  Instructs its President to forward this resolution to the Council, the Commission, the European External Action Service, the governments and parliaments of the Member States, NATO, the United Nations, the President and Members of Congress of the United States, the President of the Russian Federation and the Members of the Russian State Duma and Federation Council.

(1) https://treaties.un.org/doc/Publication/UNTS/Volume%201657/v1657.pdf (2) https://www.state.gov/secretary/remarks/2019/02/288722.htm (3) https://www.nato.int/cps/en/natohq/official_texts_161122.htm (4) https://www.nato.int/cps/en/natohq/news_162996.htm (5) OJ C 215, 19.6.2018, p. 202. (6) https://front.un-arm.org/documents/SG+disarmament+agenda_1.pdf (7) https://sustainabledevelopment.un.org/sdg16 (8) OJ C 349 E, 22.12.2010, p. 77.

European Parliament resolution of 14 February 2019 on NAIADES II – An action programme to support inland waterway transport (2018/2882(RSP))

P8_TA(2019)0131 B8-0079/2018

The European Parliament,

–  having regard to the question for oral answer to the Commission on NAIADES II – An action programme to support inland waterway transport (O-000016/2014 – B7-0104/2014),

–  having regard to the Commission communication of 17 January 2006 on the promotion of inland waterway transport – ‘NAIADES – An Integrated Action Programme for Inland Waterway Transport’ (COM(2006)0006),

–  having regard to its resolution of 26 October 2006 on the promotion of inland waterway transport: NAIADES, an integrated European Action Programme for inland waterway transport(1),

–  having regard to the Commission communication of 10 September 2013 entitled ‘Towards quality inland waterway transport – NAIADES II’ (COM(2013)0623),

–  having regard to its resolution of 6 February 2014 on NAIADES II – An action programme to support inland waterway transport(2),

–  having regard to the Commission staff working document of 18 September 2018 entitled ‘Mid-term progress report on the implementation of the NAIADES II action programme for the promotion of inland waterway transport (covering the period 2014-2017)’ (SWD(2018)0428),

–  having regard to the Commission communication of 20 July 2016 entitled ‘EU Strategy for Low-Emission Mobility’ (COM(2016)0501),

–  having regard to its resolution of 15 December 2011 on the Roadmap to a Single European Transport Area – Towards a competitive and resource efficient transport system(3),

–  having regard to Rule 123(2) of its Rules of Procedure,

A.  whereas inland waterways link up important EU ports, cities, industrial centres and main agricultural areas, therefore making a considerable contribution to the EU goals of decarbonisation, sustainable growth and territorial cohesion;

B.  whereas a modal shift from road to inland shipping is necessary to achieve the objectives of the Paris agreement of 2015 (COP21), and whereas inland waterway transport has sufficient capacity to absorb much higher volumes of freight and passengers in order to relieve the congested European road transport system;

C.  whereas inland waterway transport is essential to diminish further negative effects of transport through more efficient use of land and energy and a reduction in noise and the number of accidents;

D.  whereas the inland waterway fleet would need to be modernised and adapted to reflect technical progress if improved environmental performance is to be achieved, thereby ensuring the competitive advantage of inland waterway transport in multimodal transport;

E.  whereas limited financial resources have been dedicated to the inland waterway sector so far, and whereas access to finance remains difficult for a sector primarily consisting of small businesses;

1.  Supports the specific actions undertaken so far and welcomes the further actions planned in the NAIADES II action programme 2014-2020;

2.  Urges the Commission to update and renew the NAIADES programme by 2020 to ensure that the potential of inland waterway transport as a safe, sustainable and effective mode of transport in the multimodal transport system can be fully exploited through a long-term EU strategy aimed at achieving a successful modal shift;

3.  Underlines that, when transport initiatives are being drafted, inland waterway transport must be considered within a holistic and long-term approach under the EU intermodal and sustainable transport policy;

4.  Emphasises that waterway tourism is a flourishing sector and that the competitiveness of important EU industries depends on reliable and cost-effective inland waterway transport for their supply of goods; calls therefore for proactive policies aimed at supporting a sustainable inland waterway sector, in particular in view of the digital, technological and environmental challenges in logistics and mobility;

5.  Notes that, by 2050, 80 % of the EU’s population will live in urban areas, increasing the demand for public transport and improved city logistics, and that it is often challenging and expensive to expand existing land infrastructure; calls on the Commission and the Member States to integrate inland navigation in urban and port policies and to fully exploit its potential for transporting goods and passengers, given that many EU cities are located along waterways, with a view to improving quality of life and reducing congestion levels;

6.  Underlines that previous action programmes have fallen short of their goals as the result of a lack of dedicated resources; calls on the Commission therefore to ensure that the NAIADES III action programme receives adequate and dedicated funding to achieve its goals, supported by a well-structured policy strategy with achievable short- and mid-term goals and a concrete roadmap that sets out, inter alia, the resources for implementation;

7.  Invites the Commission to regularly undertake market research and generate forecasts to better analyse shifting patterns for freight and passengers in inland waterway transport and to enable evidence-based policymaking and better respond to emerging trends and new markets;

8.  Underlines the importance of removing bottlenecks to achieve high-quality waterways as a condition for developing and integrating inland shipping and inland ports into the trans-European transport network (TEN-T); calls on the Commission to give funding priority under the Connecting Europe Facility to rehabilitating, adapting, upgrading and automating fairway, lock, bridge, shoreside and port infrastructure and improving cross-border sections of the core network;

9.  Emphasises, in addition to the Member States’ obligations to complete the core network by 2030, their responsibility for increasing the performance, reliability, availability and climate resilience of existing infrastructure through rehabilitation, in order to ensure the role of inland waterway transport as a trustworthy mode of transport and to promote a smart use of scarce financial resources;

10.  Welcomes the work planned and being carried out in the Atlantic, Baltic-Adriatic, Mediterranean, North Sea-Baltic, North Sea-Mediterranean, Orient-East Mediterranean, Rhine-Alpine and Rhine-Danube corridors, and the fact that, in general, more Member States are investing in the development of inland waterways and ports; calls on the Commission therefore to support the implementation of projects in the trans-European transport network (TEN-T);

11.  Points out that sufficient lock capacity is vital for effective and sustainable hinterland transport and that locks play an important role in safe water regulation management and in clean energy generation; calls on the Commission therefore to reserve sufficient grants for their rehabilitation, upgrade and renewal;

12.  Urges the Commission to privilege grants for inland waterway projects in general, since past experience with blending projects has shown that private partners were involved only in the execution of works, with the public authorities remaining responsible for financing, given the public and multi-purpose character of waterways;

13.  Notes that the digitalisation of inland waterway transport plays an important role in enhancing the efficiency, safety and environmental performance of inland navigation; calls on the Commission therefore to prepare an implementation strategy for the Digital Inland Waterway Area (DINA) and a suitable regulatory framework for connected and automated transport by water, including reviewing Directive 2005/44/EC on harmonised river information services (RIS) on inland waterways in the Community(4), taking into account existing initiatives such as the RheinPorts Information System (RPIS) and creating a solid EU-wide legal basis for cross-border data exchange of fairway, voyage, cargo and traffic information with a single point of access;

14.  Underlines the importance of integrating digital inland waterway services into the data flow of other transport modes in order to facilitate seamless multimodal door-to-door services, as the combination of the physical internet and synchromodality enhances the bundling of volumes on corridors between seaports and hinterland leading to a more balanced use of land infrastructure capacity and a reduction in congestion levels and in other negative external effects;

15.  Stresses that, in order to comply with the objectives of the Paris agreement of 2015 (COP21), the resilience and decarbonisation of the transport system should be achieved through an accelerated shift to low-carbon transport, resource efficiency and clean propulsion; points out that this transition requires corresponding standards and funding to stimulate innovative waterway management, a wider uptake of clean vessels, and retrofitting where possible, and the deployment of the necessary refuelling infrastructure;

16.  Recommends exploiting synergies between clean energy grids and waterway networks to make optimal use of hydropower generated at waterways, wind energy in ports and other clean energy sources at waterside mobility hubs for supplying transport, households and industries while minimising distribution costs;

17.  Stresses the importance of providing appropriate funding for new technology, innovation and sustainable transport infrastructure and services under current and upcoming EU programmes such as the Connecting Europe Facility, Horizon 2020, Horizon Europe, the single market, the European Regional Development Fund and the Cohesion Fund in order to stimulate the deployment of innovation and increase the environmental and digital performance of inland waterway transport; calls on the Commission to establish dedicated funding streams to realise this goal;

18.  Notes that dedicated technological research should be complemented with socioeconomic and pre-normative research to foster innovation in regulation and financing and boost engagement of market players to ensure wide market uptake;

19.  Invites the Member States to further develop national strategies to stimulate and support inland waterway transport, taking into account the current NAIADES action programmes and the upcoming European Action Programme for inland waterway transport, and to encourage regional, local and port authorities to do the same;

20.  Instructs its President to forward this resolution to the Commission and the governments and parliaments of the Member States.

(1) OJ C 313 E, 20.12.2006, p. 443. (2) OJ C 93, 24.3.2017, p. 145. (3) OJ C 168 E, 14.6.2013, p. 72. (4) OJ L 255, 30.9.2005, p. 152.

European Parliament resolution of 14 February 2019 on the implementation of Council Regulation (EC) No 1/2005 on the protection of animals during transport within and outside the EU (2018/2110(INI))

P8_TA(2019)0132 A8-0057/2019

The European Parliament,

–  having regard to Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations(1),

–  having regard to Article 13 of the Treaty on the Functioning of the European Union, which stipulates that ‘in formulating and implementing the EU’s policies, the EU and its Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals’,

–  having regard to the European Implementation Assessment on Regulation (EC) No 1/2005 on the protection of animals during transport, and its relevant annexes, as published by the European Parliamentary Research Service (EPRS)(2) in October 2018,

–  having regard to its resolution of 12 December 2012 on the protection of animals during transport(3),

–  having regard to the scientific opinion of 12 January 2011 of the European Food Safety Authority (EFSA) concerning the welfare of animals during transport(4),

–  having regard to the report from the Commission to the European Parliament and the Council of 10 November 2011 on the impact of Council Regulation (EC) No 1/2005 on the protection of animals during transport (COM(2011)0700),

–  having regard to the communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee of 15 February 2012 on the European Union Strategy for the Protection and Welfare of Animals 2012‑2015 (COM(2012)0006),

–  having regard to its Declaration No 49/2011 of 15 March 2012 on the establishment of a maximum 8‑hour journey limit for animals transported in the European Union for the purpose of being slaughtered(5),

–  having regard to the judgment of the Court of Justice of 23 April 2015(6),

–  having regard to the European Court of Auditors Special Report No 31/2018 on animal welfare in the EU(7),

–  having regard to Rule 52 of its Rules of Procedure,

–  having regard to the report of the Committee on Agriculture and Rural Development and the opinions of the Committee on the Environment, Public Health and Food Safety, the Committee on Transport and Tourism and the Committee on Petitions (A8-0057/2019),

A.  whereas the EU, as is stated in Article 13 of the Treaty on the Functioning of the European Union, considers animals not merely as goods or products or possessions, but as sentient beings, meaning that they are capable of feeling pleasure and pain; whereas EU legislation has translated this notion into measures which should ensure that animals are kept and transported under conditions that do not subject them to maltreatment, abuse, pain or suffering; whereas the EU is where animal welfare is most respected and defended, and it is an example for the rest of the world;

B.  whereas every year millions of animals are transported between Member States, within Member States and to third countries over long distances for breeding, rearing, further fattening and slaughter; whereas animals are also transported for recreation, for shows and as pets; whereas EU citizens are increasingly concerned about compliance with animal welfare standards, especially in live animal transport;

C.  whereas Parliament called in its resolution of 12 December 2012 for journey times of animals intended for slaughter to be reduced to a maximum of eight hours;

D.  whereas, according to the definition of 2008 of the World Organisation for Animal Health (OIE), animal welfare means that an animal is healthy, has enough space, is well nourished, feels safe, is free to express normal patterns of behaviour and does not suffer from feelings such as fear, pain and distress; whereas this is not the case in the vast majority of cases in live animal transport, in particular over long distances;

E.  whereas Regulation (EC) No 1/2005 on the protection of animals during transport operations applies to the transport of all live vertebrate animals carried out within the Union;

F.  whereas Member States are responsible for ensuring the correct implementation and enforcement of the Regulation at national level, including official inspections, while the Commission is responsible for ensuring that Member States implement EU legislation properly;

G.  whereas Member States are not enforcing Regulation (EC) No 1/2005 stringently or strictly enough within the EU and are not seeking its enforcement at all outside the EU;

H.  whereas the large number of infringements identified by the Commission’s DG SANTE in 2017 in several Member States would require the initiation of the relevant Treaty infringement proceedings;

I.  whereas transport is stressful for animals as it exposes them to a range of challenges deleterious to their welfare; whereas, as regards trade with certain third countries, additional animal suffering is caused by very long journeys including long delays at borders for checking documents, vehicles and the fitness of animals for transport;

J.  whereas the quality and frequency of the Member States’ inspections have a direct impact on the level of compliance with the requirements; whereas an analysis of Member States’ inspection reports reveals huge differences between Member States in terms of the number of inspections, ranging from zero to several million per annum, and the incidence of infringements, ranging from zero to 16.6 %, which suggests that Member States take different approaches to inspections, e.g. random versus risk-based strategies; whereas such differences in approach also make it impossible for data to be compared between Member States;

K.  whereas training and education of drivers to promote careful driving based on which types of animals are being transported would improve the welfare of animals during transport(8);

L.  whereas proper animal handling can result in reduced time for loading and unloading animals, reduced weight loss, fewer injuries and wounds and better meat quality;

M.  whereas there are extensive studies proving that animal welfare has an impact on meat quality;

N.  whereas the quality of stockmanship at loading and unloading, together with care in transit, should remain the primary focus in order to protect animal welfare during transport;

O.  whereas fitness for transport is a major factor in ensuring animal welfare during transport, as welfare risks during transport are greater for animals which are injured, weakened, pregnant, unweaned or sick; whereas there can be uncertainty as regards fitness for transport and stage of gestation;

P.  whereas fitness issues are responsible for the largest percentage of infringements, while documentation issues account for the second largest;

Q.  whereas there is often confusion among those responsible about what needs to be done if animals are declared unfit for transport;

R.  whereas those responsible are often uncertain as to how far an animal’s pregnancy has progressed;

S.  whereas it is particularly problematic to transport unweaned calves and lambs;

T.  whereas farmers are the party most interested keeping in their animals fit for transport and which has most to lose if transport does not comply with the existing rules;

U.  whereas there are often shortcomings in providing animals with sufficient food and water and observing the 24-hour rest period when there is a stop at a verified control post;

V.  whereas transport vehicles are often overcrowded; whereas high temperatures and inadequate ventilation inside the vehicle are a major problem;

W.  whereas there have been recent outbreaks in various Member States of infectious animal diseases such as African swine fever, avian flu and small ruminant and bovine animal diseases; whereas transport of live animals can increase the risk of spread of those diseases;

X.  whereas the transport of meat and other animal-derived products, as well as of semen and embryos, is technically and administratively easier and sometimes financially more beneficial for livestock farmers than the transport of live animals for the purpose of slaughter or breeding; whereas the Federation of Veterinarians of Europe (FVE) and the OIE emphasise that animals should be reared as close as possible to the premises in which they were born and should be slaughtered as close as possible to the point of production; whereas the availability of slaughter facilities, including mobile facilities, at or near rearing sites can help generate livelihoods in rural areas;

Y.  whereas slaughtering animals as close as possible to where they were bred would be the best way to ensure their welfare;

Z.  whereas there is an uneven spread of slaughterhouses across Member States,

AA.  whereas for some Member States and supply chains in the Union, the live transport of animals, for further production or slaughter, is important to ensure competition in the marketplace;

Recommendations

Implementation and enforcement

1.  Notes that each year millions of animals are transported live for slaughter or breeding within the EU and from the EU to third countries; considers that, where correctly implemented and enforced, Regulation (EC) No 1/2005 has a positive impact on the welfare of animals during transport; welcomes the Commission’s guidelines on the subject, but regrets that, according to the European Court of Auditors Special Report No 31/2018, those guidelines and some of the actions planned by the Commission were delayed by up to five years; notes that severe problems with transport still persist and that the enforcement of the Regulation would appear to be the primary concern of those involved in its implementation;

2.  Highlights the fact that the Committee on Petitions receives a very large number of petitions on animal welfare during transport, which frequently denounce systematic, continuous and serious violations of Council Regulation (EC) No 1/2005 by both Member States and transporters;

3.  Stresses that the suffering of animals during transport is a cause of considerable social concern; notes that, on 21 September 2017, the Commission received over one million signatures in support of the #StopTheTrucks campaign, in which EU citizens call for an end to long-distance transport;

4.  Regrets the fact that the degree of progress in implementation of Regulation (EC) No 1/2005 by Member States has been insufficient to meet the Regulation’s main objective, which is to improve animal welfare during transport, particularly in relation to the verification of journey logs and the application of penalties; calls on Member States to substantially improve compliance with the Regulation; calls on the Commission to ensure an effective and uniform enforcement of existing EU legislation on animal transport across all Member States; urges the Commission to pursue legal action against, and impose sanctions on, Member States which fail to apply the Regulation correctly;

5.  Emphasises that partial implementation is insufficient to achieve the Regulation’s overarching purpose of avoiding injury to or undue suffering of animals or their death during transport, and that greater efforts should therefore be made to prevent serious incidents which have a significant impact on animal welfare and to prosecute those responsible for them;

6.  Regrets that a number of issues related to Regulation (EC) No 1/2005 are yet to be resolved, including: overcrowding; insufficient headroom; failure to provide the required rest stops, food and water; inadequate ventilation and watering devices; transport in extreme heat; transport of unfit animals; transport of unweaned calves; the need to ascertain the pregnancy status of live animals; the extent to which the journey logs are checked; the infringement/enforcement/penalty relationship; the ‘mixed’ impact of training, education and certification; and insufficient bedding, as also identified by the European Court of Auditors in its Special Report No 31/2018 and by NGOs in complaints lodged with the Commission; calls for improvement in the abovementioned areas;

7.  Calls on all Member States to ensure that journeys are planned and executed, from departure to destination, in line with EU animal welfare requirements, taking into account the different means of transport and the range of geographical conditions across the EU and third countries;

8.  Stresses that the systematic breach of the Regulation in certain areas and some Member States leads to unfair competition resulting in an uneven playing field between operators in the different Member States, which in turn can lead to a ‘race to the bottom’ regarding animal welfare standards during transport; calls on the Commission, given that sanction levels can be more than ten times higher in some Member States than in others, to develop a harmonised EU sanction system, in order to ensure that penalties are effective, proportionate and dissuasive, taking into account repeated infringements; calls on the Commission to develop a roadmap to align sanctions across the Member States;

9.  Regrets that the Commission ignored Parliament’s resolution of 12 December 2012, and emphasises that strong and harmonised enforcement with effective, proportionate and dissuasive penalties in accordance with Article 25 of the Regulation is central to improving animal welfare during transport and that the Member States cannot restrict themselves simply to issuing recommendations and instructions; calls on the Commission to act on the call in that resolution to check the Regulation for incompatibilities with legal requirements in individual Member States;

10.  Considers that repeated infringements, where they occur in circumstances over which the transporter had control, should lead to prosecution; calls on Member States to prosecute breaches of the Regulation, especially for repeated infringements; considers that effective, proportionate and dissuasive penalties should include the confiscation of vehicles and compulsory retraining of those responsible for the welfare and transport of animals, and believes this should be harmonised through the Union; considers that the penalties should reflect the damage, scope, duration and recurrence of the infringement;

11.  Calls on the Member States to make more effective use of the strong enforcement powers conferred on them under the Regulation, including the obligation to require transporters to establish systems to prevent the recurrence of breaches and to suspend or withdraw a transporter’s authorisation; calls on the Member States to take sufficient corrective actions and introduce sanctions in order to avoid animal suffering and deter continued non-compliance on the part of operators; calls on the Member States and the Commission to aim for zero non-compliance in implementing and enforcing the Regulation;

12.  Calls on the Commission to draw up, after consultation of the National Contact Points, a list of operators who have perpetrated repeated and serious breaches of the Regulation, on the basis of inspection and implementation reports; calls on the Commission to publish frequent updates of this list, and also to promote examples of best practice in both transport and governance;

13.  Emphasises that non-compliance with the Regulation by Member States threatens its purpose of preventing the occurrence and spread of infectious animal diseases, as transport is one of the causes of the rapid spread of such diseases, including those which can be transmitted to humans; notes that vehicles often do not conform to the requirements of Article 12 of the amended Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine(9); considers, in particular, that inadequate waste storage poses risks for the spread of antimicrobial resistance and disease; calls on the Commission to develop harmonised procedures to grant approval to vessels and trucks and to take action to prevent the spreading of infectious animal diseases through transport, both within the EU and from third countries, by promoting biosecurity measures and greater animal welfare;

14.  Calls for increased cooperation between competent authorities to strengthen enforcement by using technology to create a real-time feedback loop between the Member State of the point of departure, the Member State of the point of arrival and any countries of transit; calls on the Commission to develop geolocation systems to enable tracking of the animals' location and the duration of journeys in transport vehicles, as well as any non-compliance with transport schedules; takes the view that where animals which start out in a good state of fitness arrive unfit, this should result in a full investigation, and in the event of recurrence the responsible parties in the transport chain must be immediately penalised in accordance with the law, and the owner-farmer must be entitled to compensation under national law for any resultant loss of income; further takes the view that the competent authorities should severely penalise the organiser and the certifying officer of any journey log created in the Member State of departure in the event of the log being falsely or misleadingly filled in;

15.  Considers that enforcement is particularly difficult when a journey passes through several Member States and when the various enforcement tasks (journey log approval, transporter authorisation, certification of competence and of vehicle approval, etc) are undertaken by several different Member States; calls on Member States that find breaches to notify all other Member States involved, as required by Article 26 of the Regulation, in order to prevent recurrence of the infringements and enable optimised risk assessment;

16.  Asks the Commission to submit regular reports to Parliament on the implementation and enforcement of the Regulation, including breakdown of infringements by Member State, by species and by type of infringement, in relation to the volume of live animal transport per Member State;

17.  Welcomes the cases where governments, scientists, businesses, industry representatives and national competent authorities have worked together to define best practices in order to ensure compliance with the requirements of the legislation, as is the case inter alia with the Animal Transport Guides website; calls on the Commission to disseminate and promote best practices for the Member States regarding the transport of livestock, and to support the EU animal welfare platform, promoting enhanced dialogue and the exchange of good practices between all actors; calls on the Commission to develop a new animal welfare strategy for the period 2020-2024 and to support innovation in animal transport;

18.  Calls on the Commission to continue cooperating with the OIE, EFSA and the Member States in order to support the implementation and proper enforcement of Regulation (EC) No 1/2005, with a view to promoting an enhanced dialogue on issues relating to animal welfare during transport, with a particular focus on:

19.  Calls on the Commission to assess the compatibility of the Regulation with Regulation (EC) No 561/2006 on the harmonisation of certain social legislation relating to road transport(10), as regards driving time and drivers’ rest periods;

20.  Stresses the importance of distinguishing between the responsibility of animal transport undertakings and that of farmers, as it is undertakings, and not farmers, that should be held accountable for problems arising from the transport of animals; recalls that farmers are the most interested in animal welfare, for emotional and affective reasons, but also economic reasons;

21.  Recalls that the Commission, in its role as guardian of the Treaties, is responsible for monitoring whether EU laws are applied correctly; calls on the European Ombudsman to investigate whether the Commission has consistently failed to ensure compliance with the current Regulation and whether it could thus be held responsible for maladministration;

22.  Regrets the decision taken by the Conference of Presidents not to propose the setting up of a parliamentary committee of inquiry on the welfare of animals during transport within and outside the EU, despite the support of a large number of MEPs from different political groups; recommends, therefore, that Parliament establish a committee of inquiry on the welfare of animals during transport within and outside the EU as from the beginning of the next parliamentary term in order to properly investigate and monitor alleged contraventions and maladministration in the application of Council Regulation (EC) No 1/2005 on the protection of animals during transport;

Data collection, inspections and monitoring

23.  Regrets the difficulty of carrying out a coherent analysis of the implementation of the Regulation that exists owing to differing approaches to data collection between Member States; calls on the Commission to set common minimum standards for tracing systems regarding all journeys in order to allow more harmonised data collection and assessment of the parameters monitored; calls on the Member States to step up their efforts to supply the Commission with harmonised, comprehensive and complete data on transport inspections and infringement levels; calls on the Member States to carry out more unannounced controls and to develop and apply a risk-based strategy in order to target their inspection activities on high-risk forms of transport so as to maximise the efficiency of the limited inspection resources;

24.  Notes that the Commission, according to the 2018 Court of Auditors Special Report on animal welfare in the EU, has recognised that the data reported by Member States is not sufficiently complete, consistent, reliable or detailed to permit drawing conclusions on compliance at EU level;

25.  Stresses that inspections must be carried out uniformly throughout the Union and on an adequate proportion of the animals transported each year within each Member State, in order to guarantee and maintain the proper functioning of the internal market and avoid distortions of competition within the EU; calls, in addition, on the Commission to increase the number of unannounced spot inspections by the Food and Veterinary Office (FVO) focused on animal welfare and the transport of animals; believes that differing methods of data collection and control mechanisms make it difficult to establish an accurate picture of compliance in individual Member States; calls on the Commission, therefore, to adopt a more harmonised reporting structure and to undertake further analysis of the data generated by FVO inspection reports and from Member States’ returns relating to their Multiannual National Control Plans (MANCPs); recognises that the DG SANTE audits serve as an important source of information for the Commission to assess the implementation of the current Regulation; calls on the Commission to carry out at least seven unannounced visits every year, in line with the Court of Auditors’ recommendation;

26.  Calls on the Commission to provide guidance to Member States on how the Trade Control and Expert System (TRACES) can be used to support the preparation of risk analyses for inspections regarding the transport of live animals, as recommended by the Court of Auditors in its 2018 Special Report, which notes that the authorities of the Member States responsible for transport inspections were rarely using information from TRACES to target inspections; calls for a more effective and transparent monitoring system, including public access to information collected via TRACES; further calls for an increase in the number of yearly inspections by the FVO;

27.  Calls on the Member States to increase controls across the entire production chain and, in particular, to carry out efficient and systematic inspections of animal consignments before loading, in order to halt practices that breach the Regulation and worsen conditions for the transport of animals by land or sea, such as allowing overstocked means of transport or unfit animals to continue their long journeys, or permitting the continued use of control posts with inadequate facilities for resting, feeding and watering animals in transport;

28.  Is concerned about the low level of inspections in some Member States and the low or zero level of infringements reported; questions the accuracy of inspection systems and reporting; calls on those Member States which currently conduct few inspections or none at all to carry out inspections in sufficient numbers, and to submit comprehensive inspection reports to the Commission;

29.  Calls on the Member States also to inspect intra-European transport where animals are being loaded on to vehicles in order to check compliance with the requirements of Regulation (EC) No 1/2005;

30.  Agrees with the Commission that it is good practice for competent authorities to inspect all consignments destined for non-EU countries at loading stage(11); believes that a percentage of intra-EU consignments should also be inspected at loading stage in proportion to the number of violations reported by NGOs and FVO inspections; considers that competent authorities should check at loading stage that the Regulation’s requirements on floor space and headroom are being respected, that the ventilation and water systems are operating properly, that the drinking devices are working properly and are appropriate to the species carried, that no unfit animals are loaded, and that sufficient feed and bedding are being carried;

31.  Calls on the Member States to ensure that there is a sufficient number of accessible, clean and functioning drinking facilities in keeping with the needs of each species, that the water tank has been filled and that there is a sufficient quantity of fresh litter;

32.  Calls on the Member States to ensure that the competent authorities verify that the journey logs contain realistic information, and thus comply with Article 14(1) of the Regulation;

33.  Calls on the Member States to ensure that transport vehicles comply with the minimum space requirements set out in Chapter VII of Annex I to the Regulation and that in case of high temperatures the animals are allowed correspondingly more space;

34.  Calls on the Member States to ensure that the internal height of transport vehicles meets minimum standards and that there are no gaps between the floor or vehicle wall and the partitions;

35.  Acknowledges that some progress has been made in animal transport within the EU, but is concerned at the number of reports of inappropriate vehicles being used to transport live animals by both land and sea, and calls for the monitoring and sanctioning of such practices to be stepped up; recognises that the requirements set out in Articles 20 and 21 of the Regulation regarding transport by livestock vessels are often disregarded; calls on Member States not to authorise the use of vehicles and livestock vessels which do not comply with the provisions of the Regulation, and to withdraw authorisations already issued in the event of non-compliance; calls on Member States to be more rigorous in both certification and approval procedures for vehicles and granting certificates of competence to drivers;

36.  Calls, therefore, for harmonised and binding standards for the authorisation of vehicles and vessels as means of transport for livestock, which should be issued by a central EU authority; whereas that authority should be responsible for determining the suitability of the means of transport for transporting animals in terms of the vehicles’ state and the nature of their equipment (e.g. on-board presence of an appropriate satellite navigation system);

37.  Calls on operators to provide for the thorough training of drivers and attendants in line with Annex IV to the Regulation, so as to ensure correct treatment of animals;

38.  Recognises that some Member States have ships and ports which meet the required standards, but highlights that poor conditions nonetheless prevail during maritime transport, particularly in relation to loading and offloading; calls on Member States to be more rigorous in their certification and approval procedures for vessels, to improve their pre-loading checks on livestock vessels and animal fitness, and to properly inspect loading operations in line with the Regulation; calls on Member States to provide the Commission with detailed plans of their inspection facilities; calls on the Commission to draw up, update and circulate a list of ports with adequate animal inspection facilities; further calls on the competent authorities not to approve journey logs that plan to use ports without such facilities; calls on Member States to adapt their ports and ensure due maintenance of their vessels, in order to improve the conditions of animal welfare in animal maritime transport;

39.  Calls on the Commission to approve innovative alternatives for export checks in accordance with Article 133(2) of Regulation (EU) 2016/429(12), such as platform inspections, which are an improvement for animal welfare as they have a lower stocking rate and do not require animals to be unloaded, thus shortening waiting times;

40.  Notes that the requirement of animal health certificates for transport across Member States creates a negative incentive to choose domestic destinations over the closest possible destination; calls on the Commission to use its powers under Article 144(1) of Regulation (EU) 2016/429 to adopt a delegated act that would provide a derogation for movements that pose a low risk for the spread of disease;

Journey times

41.  Insists that the journey time for all animals being transported should be only as long as necessary, taking into account the geographical differences at Member State level and in line with recital 5 of the Regulation, which states that ‘for reasons of animal welfare the transport of animals over long journeys … should be limited as far as possible’ and its recital 18, which states that ‘long journeys are likely to have more detrimental effects on the welfare of animals than short ones’;

42.  Insists that the transport time for animals, including loading and unloading time, must take into account species-specific veterinary advice, irrespective of whether land, sea or air transport is involved;

43.  Regrets the infringements of the Regulation that concern non-application or incorrect application of the specific rules concerning unweaned animals, such as calves, lambs, kids, foals and piglets, which are still on a milk diet, and calls for the introduction of more detailed measures to ensure that the welfare of these animals is fully protected during transport;

44.  Calls on the Member States to ensure that unweaned animals are unloaded for at least one hour so they can be supplied with electrolytes or milk substitutes and that they are not transported for more than eight hours in total;

45.  Calls on the Commission to provide a definition of unweaned animal per species, and to limit the journeys of unweaned animals to both a maximum distance of 50 km and a maximum duration of 1.5 hours, given the difficulty of ensuring their welfare during transport;

46.  Points out that transport planning documents often only specify placenames and fail to provide precise addresses of control, supply and assembly points, which makes controls significantly more difficult;

47.  Calls, taking into account Parliament’s resolution of 12 December 2012, for animal journey times to be as short as possible and in particular for the avoidance of long and very long journey times as well as journeys outside the EU’s borders, by employing alternative strategies, such as ensuring economically viable and fairly distributed local or mobile slaughter facilities near livestock farms, promoting short distribution circuits and direct sales, replacing, when possible, the transport of breeding animals by using semen or embryos, and transporting carcasses and meat products, as well as by means of regulatory or non-regulatory initiatives in Member States to facilitate on-farm slaughter; calls on the Commission to clearly define specific lower journey times as appropriate, for the transport of all the various species of live animals, and also for the transport of unweaned animals;

48.  Notes that a variety of requirements, as well as changing market conditions and policy decisions, have rendered small slaughterhouses economically unviable, resulting in an overall decline in their numbers; urges the Commission and local authorities in Member States to support and promote, where needed, the options of on-farm slaughter, economically viable local or mobile slaughter, and meat processing facilities within Member States, so that animals are slaughtered as close as possible to their place of rearing, which is also in the interests of maintaining employment in rural areas; calls on the Council and Commission to develop a strategy for moving towards a more regional model of livestock production in which animals are born, fattened and slaughtered in the same region, wherever practicable taking into account geographical differences, instead of being transported over extremely long distances;

49.  Urges the Commission to examine how farmers, slaughterhouses and the meat processing industry could be incentivised to slaughter animals at the nearest facility in order to prevent lengthy animal transport times and reduce emissions; calls on the Commission to facilitate innovative solutions in this regard, such as mobile slaughtering, while ensuring high animal welfare standards;

50.  Considers that in certain cases a reduction in the permitted journey times, as currently laid down in Chapter V of Annex 1 to the Regulation, would not be viable, and that therefore solutions should be found for cases where geographical circumstances and rural isolation require the transport of live animals over land and/or sea for further production or slaughter;

51.  Calls on the Member States to allow emergency slaughtering directly on the livestock and fattening farms, where appropriate, in the event that an animal is found to be unfit to be transported and where first aid measures prove ineffective, in order to avoid unnecessary animal suffering;

52.  Notes that the societal and economic value of an animal can impact on its standard of transportation; highlights that transport standards for breeding animals in the equine industry are of high quality;

53.  Calls on the Commission to develop a strategy to ensure a shift from live animal transport to a mainly meat-and-carcass and germinal products trade, given the environmental and animal welfare and health impacts of live animal transport; considers that any such strategy must address the economic factors that influence the decision to transport live animals; calls on the Commission to include transport to third countries in this strategy;

54.  Calls on the Member States to make programmes for the religious slaughter of animals available in slaughterhouses, given that a large proportion of exports of live animals are to Middle Eastern markets;

55.  Recognises the current market distortion caused by differing tariffs applied to live animals and to meat, which strongly incentivises the trade in live animals; urges the Commission, alongside its trading partners, to review this distortion with the aim of reducing the trade in live animals and, where necessary, replacing these sales with meat;

56.  Recalls that, under the current Regulation, a rest break at an approved control post is already mandatory after the maximum period of transport of domestic Equidae and domestic animals of the bovine, ovine, caprine and porcine species, where the transport time exceeds eight hours;

Animal welfare

57.  Calls on the competent authorities of the Member States to ensure that official veterinarians are present at Union exit points, tasked with verifying that animals are fit to continue their journey and that vehicles and/or vessels meet the requirements of the Regulation; notes in particular that Article 21 of the Regulation specifies that veterinarians shall check vehicles before they leave the EU, to ensure that they are not overcrowded, provide sufficient headroom, provide bedding, and are carrying sufficient feed and water, and that the ventilation and water devices are functioning correctly;

58.  Encourages the use of contingency plans for all journeys, including, for example, replacement trucks and contingency centres, to enable the transporter to respond in an effective manner to emergencies and reduce the impact of a delay or accident on the animals transported for breeding or slaughter, as is already required of transporters on long journeys under the Regulation;

59.  Insists that animal welfare legislation should be based on science and the latest technology; deplores the fact that, despite clear recommendations from EFSA and Parliament’s request in its 2012 resolution, the Commission has failed to update the rules on animal transport with the latest scientific evidence; calls on the Commission, therefore, to update the rules addressing specific needs on the basis of the latest scientific knowledge and technology, in particular as regards factors including sufficient ventilation and temperature and humidity control through air conditioning in all vehicles, appropriate drinking systems and liquid feed, particularly for unweaned animals, reduced stocking densities and specified sufficient minimum headroom, and for the vehicles to be adapted to the needs of each species; highlights the EFSA opinion’s conclusion that other aspects come into play in the welfare of animals aside from the duration of the journey, such as proper loading and unloading, as well as vehicle design;

60.  Expresses concern over journeys in which animals are watered with contaminated water that is unfit for consumption or are deprived of access to water because of malfunctioning or badly located watering devices; stresses the need to ensure that vehicles used for the transport of live animals carry sufficient water during journeys, and that in any case the amount supplied should be appropriate for the specific requirements of the animals being transported and for the number of those animals;

61.  Welcomes the Commission's commitment to develop animal-based welfare indicators which should promote better welfare outcomes for animals in transport; considers that it should develop these indicators without delay so that they can be used as a complement to current legislative requirements;

62.  Calls on the Commission to ensure that any future revision of the legislation on animal welfare during transport is based on objective and scientifically sound indicators, in order to prevent arbitrary decisions having an unjustified economic impact on livestock sectors;

63.  Insists that under EU law farmers are legally responsible for ensuring that their animals being transported will not be caused injury, harm or any undue suffering;

64.  Stresses that infringements are often due to the inadequacy of the ventilation systems of vehicles used for the road transport of live animals over long distances, and that in these situations, animals are forced into small spaces with extreme temperatures, well beyond the range of temperatures and tolerance limits set out in the Regulation;

65.  Calls on the Commission to ensure that stunning is performed, without exception, before religious ritual slaughter in all Member States;

66.  Regrets that compartments for animals do not always provide sufficient space to allow adequate ventilation inside vehicles and that natural movements for animals are prevented, often forcing them to take up unnatural positions for long periods, in clear violation of the technical rules set out in Article 6 of the Regulation and Chapter II, point 1.2 of Annex I thereto;

67.  Considers it necessary to make it compulsory for veterinarians to be present on board ships used for the transport of live animals, to report and keep count of the number of animals that die during the journeys, and to draw up emergency plans to deal with any situations at sea that might have a negative impact on the welfare of the animals being transported;

68.  Notes that farmers, transporters and competent authorities across Member States interpret and enforce Regulation (EC) No 1/2005 differently, especially with regard to the fitness of animals for transport; calls on the Commission to revise the Regulation in order to specify the requirements for transport in greater detail where necessary; urges the Commission and the Member States, in the context of a level playing field, to ensure that in future the Regulation is enforced and implemented in a harmonised and uniform way throughout the Union, in particular as regards the fitness of animals to be transported;

69.  Calls on the Commission to develop a full working definition of what constitutes animals’ fitness for transport, and to draft practical guidelines for its assessment; calls on the Member States to provide awareness-raising and information activities, including solid, regular and mandatory training courses, education and certification for drivers, transporters, traders, assembly centres, slaughterhouses, veterinarians, border agents and any other operator involved in the transport of animals in order to reduce the high levels of fitness infringements; calls on operators to ensure the thorough training of drivers and attendants in line with Annex IV to the Regulation;

70.  Calls for strict vigilance to ensure that sick, weak or lightweight animals, lactating animals, pregnant females and females not meeting the necessary weaning time are not transported;

71.  Stresses that, in accordance with Regulation (EC) No 1/2005, it is already mandatory to provide animals being transported over long distances with water, feed and rest, at suitable intervals and as appropriate to their species and age; urges the Commission to conduct more effective monitoring with a view to ensuring the full and harmonised compliance with these legal requirements on the part of all Member States;

72.  Stresses the need for Member States to ensure that animal transport is properly organised, taking account of weather conditions and type of transport;

73.  Stresses that when animals are required to be unloaded for a 24-hour rest period in third countries, the organiser must identify a place for rest with facilities equivalent to those of an EU control post; calls on the competent authorities to regularly inspect these facilities and not to approve journey logs if the proposed place for rest has not been confirmed to have EU-equivalent facilities;

74.  Calls on the Member States to ensure that the transport planning includes proof of a reservation, including feed, water and fresh litter, at a control post; calls on the Commission to define the requirements for the location and facilities of places of rest;

75.  Recognises that lower stocking densities and interrupting journeys to let animals rest have an adverse economic impact on transport operators which may affect the proper handling of transported animals; calls on the Commission to encourage incentives for their proper handling;

76.  Calls on the Member States to ensure an improvement in farm record-keeping on gestation periods;

77.  Calls on the Commission to formulate, on the basis of scientific findings, guidelines regarding water for animals transported in cages and conditions for transporting chicks that promote a high level of welfare;

78.  Recalls that Member States must find welfare-compliant solutions for animals at the end of their lives and production cycles;

Economic help

79.  Calls for more extensive use of the rural development measure ‘animal welfare payments’, pursuant to Article 33 of Regulation (EU) No 1305/2013(13), which provides support for high standards of animal welfare going beyond the applicable mandatory standards;

80.  Calls for the upcoming CAP reform to maintain and reinforce the link between CAP payments and improved animal welfare conditions which fully respect or go beyond the standards set out in Regulation (EC) No 1/2005;

81.  Urges support for measures to bring about a balanced distribution of slaughterhouses in the Member States that ensures that livestock numbers in a given region are taken into account;

Third countries

82.  Is concerned at the persistent reports of animal transport and welfare problems in certain third countries; notes that slaughter in certain third countries to which the EU sends animals entails extreme and prolonged suffering and regularly breaches the international standards on welfare at slaughter as laid down by the OIE; while acknowledging that demand in third countries is often for live animals, calls on the Commission and the Member States to promote a shift, when possible, towards the transport of meat or carcasses, instead of live animals, to third countries, as well as the transport of semen or embryos instead of breeding animals;

83.  Strongly criticises the statistics drawn up by the Commission on compliance with the regulation as regards the journeys made to transport live animals to non-EU countries, and stresses that they have been drawn up without any systematic checks on animal transport vehicles

84.  Requests the Commission, in its bilateral trade negotiations with third countries, to demand compliance with the EU’s animal welfare rules and to defend the internationalisation, within the framework of the World Trade Organisation, of the Union provisions on the subject;

85.  Regrets the fact that the standards practised by certain third countries are not as high as those within the EU; calls on the Commission to strengthen the existing requirements vis-à-vis the Union’s trading partners, especially regarding trade in and transport of animals, so that they are at least as stringent as EU standards; calls on Member States exporting to third countries to work with local authorities to improve animal welfare standards;

86.  Calls for consistent and full compliance with the 2015 judgment of the Court of Justice of the European Union in Case C-424/13, in which the Court ruled that, for the transport of animals involving a long journey commencing in EU territory and then continuing outside of it, the transporter, in order to be authorised to depart, must submit a journey log which is realistic in terms of compliance, with particular attention to the temperature forecast; calls on competent authorities not to approve journey logs where, in line with the Court’s ruling, animals must be unloaded for a 24-hour rest in a non-EU country except where the organiser has identified a place for that rest that provides facilities equivalent to those of a control post; recalls also, in this regard, that the only list which exists is one from 2009 for animal housing on the routes in third countries, in which precise address details are frequently lacking, thus making the necessary inspections under EU law significantly more difficult; calls on official veterinarians at exit points to check, as required by Regulation (EC) No 1/2005, that before vehicles leave the EU the provisions of the Regulation are complied with;

87.  Recalls also, in this context, the Commission proposal for a directive on the protection of persons reporting on breaches of Union law (whistleblowers) (COM(2018)0218), in particular in the context of veterinary checks;

88.  Deplores the often lengthy delays at borders and ports and draws attention to the increased pain and distress that this causes to animals; calls on Member States bordering third countries to provide rest areas where animals can be unloaded and given feed, water, rest and veterinary care so that journey logs can be correctly completed, and to open dedicated express lanes which are sufficiently staffed at customs for animals being transported in order to reduce waiting periods, without undermining the quality of sanitary and customs controls at the borders; further calls on Member States to cooperate better in planning livestock transport, in order to avoid too large a number arriving for border controls at the same time;

89.  Calls on the Commission to increase cooperation and communication, including further mutual assistance and accelerated exchange of information, between the competent authorities in all Member States and in third countries in order to reduce animal welfare and animal disease problems related to poor administration by ensuring that exporters meet the administrative requirements in full; asks the Commission to promote animal welfare internationally and to conduct initiatives to increase awareness among non-EU countries;

90.  Calls on the Commission to exert pressure on transit countries which put in place bureaucratic hurdles and security obstacles that delay unnecessarily the transport of live animals;

91.  Calls on the Member States and the Commission to pay particular attention to animal welfare infringements during waterway and maritime journeys to third countries and to assess possible breaches of legislation, such as the prohibited discharge of dead animals from vessels into the Mediterranean (often with earmarks cut off) that occurs because disposal is often not possible at the port of destination;

92.  Highlights Council Decision 2004/544/EC on the signing of the European Convention for the Protection of Animals during International Transport(14), under which transport can be any one of the following: between two Member States passing through the territory of a non-member state; between a Member State and a non-member state; or between two Member States directly;

93.  Stresses that unless animal transport standards in third countries are aligned with those of the EU and their implementation is sufficient to ensure full compliance with the Regulation, live animal transport journeys to third countries should be subject to bilateral agreements to mitigate these differences, and that in the event of failure to achieve this, they should be forbidden;

94.  Reminds Member States that, under established case-law(15), they may introduce stricter national rules for the protection of animals during transport, as long as these rules are in line with the main objective of Regulation (EC) No 1/2005;

95.  Calls on the Commission to promote the exchange of best practice and regulatory equivalence measures with third countries as regards the transport of live animals;

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96.  Instructs its President to forward this resolution to the Council and the Commission, the European Court of Auditors, the European Food Safety Authority, and the governments and parliaments of the Member States.

(1) OJ L 3, 5.1.2005, p. 1. (2) http://www.europarl.europa.eu/RegData/etudes/STUD/2018/621853/EPRS_STU(2018)621853_EN.pdf (3) OJ C 434, 23.12.2015, p. 59. (4) Official Journal of EFSA 2011:9(1):1966. (5) OJ C 251 E, 31.8.2013, p. 116. (6) Judgment of the Court (fifth chamber) of 23.4.2015, Zuchtvieh-Export v Stadt Kempten, C-424/13, ECLI:EU:C:2015:259. (7) European Court of Auditors Special Report No 31/2018 of 14 November 2018 entitled ‘Animal welfare in the EU: Closing the gap between ambitious goals and practical implementation’. (8) https://www.efsa.europa.eu/en/efsajournal/pub/1966 (9) OJ 121, 29.7.1964, p. 1977. (10) OJ L 102, 11.4.2006, p. 1. (11) ‘Final report of an audit carried out in the Netherlands from 20 February 2017 to 24 February 2017 in order to evaluate animal welfare during transport to non-EU countries’, European Commission, Directorate-General for Health and Food Safety, 2017. (12) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health ('Animal Health Law') (OJ L 84, 31.3.2016, p. 1). (13) OJ L 347, 20.12.2013, p. 347. (14) OJ L 241, 13.7.2004, p. 21. (15) Judgment of the Court (First Chamber) of 14.10.2004 - Case C-113/02, Commission of the European Communities v Kingdom of the Netherlands, and Judgment of the Court (Third Chamber) of 8.5.2008 - Case C-491/06, Danske Svineproducenter.

European Parliament resolution of 14 February 2019 on strengthening the competitiveness of the Internal Market by developing the EU Customs Union and its governance (2018/2109(INI))

P8_TA(2019)0133 A8-0059/2019

The European Parliament,

–  having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (UCC)(1), and its related delegated act (Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015)(2), implementing act (Commission Implementing Regulation (EU) 2015/2447 of 2 November 2015)(3), transitional delegated act (Commission Delegated Regulation (EU) 2016/341 of 17 December 2015)(4) and work programme (Commission Implementing Decision (EU) 2016/578 of 11 April 2016)(5),

–  having regard to the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 952/2013 to prolong the transitional use of means other than the electronic data-processing techniques provided for in the Union Customs Code (COM(2018)0085),

–  having regard to the communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee entitled ‘Developing the EU Customs Union and its governance’ (COM(2016)0813),

–  having regard to the communication from the Commission to the Council and the European Parliament entitled ‘First biennial report on progress in developing the EU Customs Union and its governance’ (COM(2018)0524),

–  having regard to the communication from the Commission to the Council and the European Parliament entitled ‘Second progress report on the implementation of the EU strategy and action plan for customs risk management’ (COM(2018)0549),

–  having regard to the report from the Commission to the Council and the European Parliament on the IT strategy for customs (COM(2018)0178),

–  having regard to its position at first reading on the Commission proposal for a directive of the European Parliament and of the Council on the Union legal framework for customs infringements and sanctions (COM(2013)0884),

–  having regard to Decision No 70/2008/EC of the European Parliament and of the Council of 15 January 2008 on a paperless environment for customs and trade(6),

–  having regard to the resolution of the European Parliament of 17 January 2017 on tackling the challenges of the Union Customs Code implementation(7),

–  having regard to the report from the Commission to the Council and the European Parliament on the implementation of the Union Customs Code and on the exercise of the power to adopt delegated acts pursuant to Article 284 thereunder (COM(2018)0039),

–  having regard to the European Court of Auditors Special Report No 19/2017 entitled ‘Import procedures: shortcomings in the legal framework and an ineffective implementation impact the financial interests of the EU’,

–  having regard to European Court of Auditors Special Report No 26/2018 entitled ‘A series of delays in Customs IT systems: what went wrong?’,

–  having regard to Council report 11760/2017 on progress made in the fight against excise fraud,

–  having regard to the report by Europol and the European Union Intellectual Property Office on counterfeiting and piracy in the European Union,

–  having regard to Rule 52 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinion of the Committee on International Trade (A8-0059/2019),

A.  whereas the Customs Union, which is 50 years old this year, is a cornerstone of the EU, as one of the world’s largest trading blocs, and whereas a fully operational Customs Union is essential for the proper functioning of the single market and frictionless trade within the EU, and is an essential part of the common commercial policy towards third countries in the interests of both EU businesses and EU citizens, as well as for the credibility of the EU, which is placed by the Customs Union in a strong position in negotiations on trade agreements with third countries;

B.  whereas the customs authorities need to strike the requisite balance between the facilitation of legitimate trade, the customs controls designed to protect the security of the Union and its citizens, consumer trust in the goods that enter the single market, and the Union’s financial and commercial interests, and are responsible for the implementation of more than 60 legal acts, in addition to the customs legal framework, for the fight against illegal trade and smuggling, and for the awarding of the status of authorised economic operator;

C.  whereas standardisation of customs information and processes plays a key role in the homogenisation of controls, especially as regards phenomena such as incorrect classification and undervaluation of imports and misreporting of the origin of goods, which are detrimental to all economic operators, but particularly so to small and medium-sized enterprises;

D.  whereas EU imports and exports totalled EUR 3 700 billion in 2017 and customs duties collected make up 15 % of the EU budget;

E.  whereas implementation of the Union Customs Code (UCC) is essential to safeguard EU own resources, in particular customs duties, and national fiscal interests, but also to safeguard European consumers and fair competition in the internal market;

F.  whereas the UCC stipulates that the electronic systems needed for its application must be deployed by 31 December 2020; whereas the digitisation of customs procedures was initiated as long ago as 2003 and enacted in 2008 with the adoption of Regulation (EC) No 450/2008 of 23 April 2008 laying down the Community Customs Code (Modernised Customs Code)(8) and of Decision No 70/2008/EC (the e-Customs Decision);

G.  whereas the digitisation of customs is a work in progress, more than 98 % of customs declarations today are electronic, and the following areas of customs are now handled through electronic systems: transit (NCTS), export control (ECS), security data (ICS), risk management (CRMS), Economic Operators Registration and Identification Number (EORI), authorisations (CDS), Authorised Economic Operators (AEO), Binding Tariff Information (EBTI), quota and tariff (QUOTA), autonomous tariff suspensions, the combined nomenclature (TARIC), surveillance of import and export (SURV2), and Registered Exporter System for certificates of origin (REX);

H.  whereas the objective of the customs programme proposed under the EU’s Multiannual Financial Framework 2021-2027 is to support the activities of, and cooperation between, the Member States’ customs authorities;

I.  whereas the United Kingdom’s withdrawal from the EU poses a challenge to the proper functioning of the Customs Union;

J.  whereas implementation of key electronic systems necessary for the full implementation of the UCC will be delayed and deferred until after 31 December 2020;

K.  whereas the Customs Union Performance tool operates by assessing the functioning of the Customs Union, on the basis of Key Performance Indicators in a range of areas such as protection of financial interests, ensuring the safety and security of EU citizens, and assessing the importance of customs in contributing to the growth and competiveness of the EU;

L.  whereas the governance of the Customs 2020 programme and hence of customs IT work is shared between the Commission, the Member States and representatives of commercial interests, in a multitude of decision-making structures whose multiplication has a lasting negative impact on the programme’s effectiveness and the management of IT projects;

M.  whereas it will be necessary, after the end of the current Customs 2020 programme and following a cost-benefit assessment of the various possible options, to overhaul the governance of the customs programmes;

1.  Highlights the work carried out every day by Member State customs authorities and by the Commission endeavouring to shield the internal market against unfair competition in the form of counterfeit and dumped products, to facilitate trade and cut back on administrative formalities, to collect revenue for national budgets and the EU budget, and to protect populations against terrorist, health-related, environmental and other threats;

2.  Points out that the Customs Union is one of the EU’s earliest achievements and can be considered one of its main success stories, as it has enabled firms established in the EU to sell their goods and invest throughout the EU, but has also allowed the EU to remove internal borders and to compete with the rest of the world; underlines that the EU’s single market would be impossible without the tariff-free environment provided by the Customs Union and the role the latter plays in overseeing imports and exports;

3.  Stresses that a fully functional Customs Union is essential to guarantee the credibility and strength of the EU and its negotiating position for the conclusion of new trade agreements; emphasises that an efficient EU Customs Union helps to facilitate legal trade and to reduce administrative burdens for legitimate traders, a consideration which is important for the development of competitive businesses; underlines the importance of ensuring effective controls - inter alia by fostering cooperation with third countries’ customs authorities - and of avoiding any undue hindrance to legal trade;

4.  Stresses that creating seamless customs processes across the Union based on a reformed IT infrastructure is pivotal; considers that digitisation has the potential to make the exchange of information and the payment of duties more transparent and accessible, in particular for small and medium-sized enterprises and for economic operators of third countries, and that it offers opportunities for simplifying customs rules and procedures;

5.  Notes that the current divergences in the level and quality of controls, customs procedures and sanctions policies at the EU’s points of entry into the Customs Union often result in distortion of trade flows, feeding the problem of ‘forum shopping’ and putting at risk the integrity of the single market; in that context, strongly requests that the Commission and the Member States address this issue;

6.  Encourages the Commission to step up its efforts to create an integrated EU customs one-stop shop that would help businesses submit all the necessary information and documents in one place and are thus able to meet all the regulatory requirements for the import, export and transit of goods;

7.  Recalls that the United Kingdom will become a third country after withdrawal from the EU, thus altering the EU’s external borders, and highlights that the Brexit process should not impact negatively on the development and governance of EU Customs;

Digitisation of customs procedures

8.  Calls on the Commission and the Member States to develop a more efficient, cost-effective and streamlined approach to the management of IT systems for customs authorities; calls, in particular, for a more precise and realistic estimate of the time and resources that will be needed, and of the scope of the individual IT projects that will help to digitise customs procedures;

9.  Deplores the fact that the implementation of the new IT systems for the Customs Union has suffered a series of delays, resulting in the request by the Commission to Parliament and the Council for an extension of the transitional period beyond the deadline of 2020 laid down in the UCC; also regrets that the Commission has provided only incomplete information in support of a further extension, particularly in the light of what falls within its remit and that of the Member States, as a result of which Parliament cannot exercise its budgetary and political oversight in an appropriate manner;

10.  Points out that, while 75 % of the European components of the IT systems needed to implement the UCC ought to be ready by December 2020, that does not mean that 75% of the IT systems will be ready by then, since 25 % of those systems is made up of national components, for which Member States are responsible and delays have been identified;

11.  Considers that the Commission and the Council must, as a matter of the utmost priority, ensure that the customs code is implemented and customs procedures digitised within the new deadline; urges the Commission and the Member States, therefore, to do their utmost to avoid further postponements; considers that, in that connection, setting up the IT architecture requires the development and deployment of 17 IT tools with major implications as regards financial and human resources; considers it imperative, therefore, that there be no duplication of effort as regards resources in how Member State and Commission IT projects are run;

12.  Calls on the Commission to update the timetable of its UCC work programme to take account of the extension to the transitional period proposed by it(9) for adoption by Parliament and the Council; calls on Parliament and the Council to work to ensure the prompt adoption of a decision on that extension while making it subject to the conditions needed for successful deployment of the customs IT architecture without prejudice to comprehensive security tests, so that any possible issues do not jeopardise the goods checks carried out by the Member States’ customs authorities; points out, as the European Court of Auditors has done, that the same causes produce the same effects, and that the process of updating the 2017 multiannual strategic plan by concentrating the introduction of six IT systems in the same year represents a major challenge and poses a major risk that the rescheduled deadlines will not be met either, so that the UCC implementation deadline could be further extended beyond 2025;

13.  Calls on the Commission to update its multiannual strategic plan by sequencing projects throughout the transition period so as to avoid, as far as possible, the concentration of deployments at the end of the period, and by establishing binding milestones, including for Member States;

14.  Calls on the Commission not to modify the statutory and technical specifications that have now been adopted for the 17 IT tools, since the scale of the projects to be carried out and the time needed to deploy them are not compatible either with the fact that the technologies involved are constantly evolving or with the inevitable legislative and regulatory changes that will take place over the period concerned;

15.  Recalls that according to the Court of Auditors, the Commission was aware of the delays but chose not to include this information in its official reporting, which prevented the stakeholders (such as the European Parliament, other EU institutions not represented in the governance structure of Customs 2020, as well as interested companies and citizens) from being fully informed of the risk of delays in real time; calls, therefore, on the Commission to report regularly and transparently on the conduct of the multiannual strategic work plan and on the setting-up of the customs electronic systems, so as not to repeat the mistakes of the previous programming, and to inform about any possible future delays while not doing so at a moment’s notice or without proper corrective actions;

16.  Invites the Commission to continuously evaluate the Customs 2020 programme and to respond to the shortcomings identified, in particular the under-utilisation of the teams of experts set up under this programme, and to make it possible to increase cooperation between customs services;

17.  Underlines that continuous policy monitoring, analysis and assessment of possible impacts are essential parts of the governance of the Customs Union; takes note of and welcomes the Commission’s work in developing a tool for the performance of the Customs Union which will eventually enable it to be systematically assessed against its strategic objectives in terms of efficiency, effectiveness and uniformity; calls on the Member States to support work on further developing this tool;

18.  Suggests to the Commission that this tool should also assess the performance of customs controls in terms of digitisation potential and data flows, in order to create even more effective risk-based controls while optimising the burden on customs authorities;

Governance, reports and funding for the Customs programme

19.  Takes note of the action being taken by the Commission and Member States to ensure uniform and coherent implementation of the customs code, in particular as regards training and through the adoption of guidelines; calls nonetheless on the Commission and Member States to step up their efforts and expand the resources deployed so as to ensure full application of the customs code adopted in 2013 and of uniform customs procedures throughout the EU; calls on the Commission, in that connection, to submit an action plan that might usefully be based on a peer review of customs practices, on the exchange of good practices, on stepped-up cooperation between customs services and on a sufficiently resourced training programme;

20.  Recalls that the Commission is undertaking work on an EU Customs Single Window environment that would permit an economic operator to submit data required for a wide range of regulatory purposes (veterinary, sanitary, environmental, etc) in a standardised format, to multiple recipients and via harmonised access points; calls on the Commission and the Member States to continue this important work;

21.  Takes note of the funding effort made under the EU budget, increasing the allocation for the next Customs programme for 2021-2027 to EUR 842 844 000 at 2018 prices; calls on the Member States also to provide the necessary human and financial resources for deployment of the national components, on which the introduction of the European electronic customs system is dependent, and calls for timely submission to it, by the Commission, of a report on deployment of the EU components and of the non-EU components developed by Member States;

22.  Highlights that customs today have to deal with a phenomenal increase in the volume of goods being bought online outside the EU in terms of controls and collection of the applicable duties, in particular as the volume of low-value goods imported into the EU is growing each year by 10-15 %; calls on the Commission and the Member States to step up their efforts in order to better tackle this challenge;

23.  Invites the Commission to propose, at the end and only at the end of the implementation of the 17 UCC-related IT systems of the Customs 2020 programme, a more effective governance structure for the conduct of customs IT projects and their updates; stresses that in view of the economic, fiscal and security challenges represented by the customs IT system, it is essential that the solution adopted should fully preserve European sovereignty;

24.  Stresses that the ‘Customs 2021-2027’ programme, by supporting Member States’ customs authorities, will help not only to increase EU budget revenues, but also to guarantee product safety, the protection of European consumers and a level playing field for EU businesses;

UK withdrawal from the European Union

25.  Stresses that the uncertainty surrounding the UK’s departure from the EU is a major challenge for European businesses; calls, therefore, on the Commission and the Member States to give stakeholders comprehensive information about the repercussions of the UK’s withdrawal in the area of customs and of certain kinds of indirect taxes (VAT and excise duties);

26.  Stresses that, following the withdrawal of the UK there must be no loopholes in the customs system – including at the external borders of the EU – that would pave the way for illicit trade or the evasion of public-law debts provided for under EU law;

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27.  Instructs its President to forward this report to the Council and the Commission.

(1) OJ L 269, 10.10.2013, p. 1. (2) OJ L 343, 29.12.2015, p. 1. (3) OJ L 343, 29.12.2015, p. 558. (4) OJ L 69, 15.3.2016, p. 1. (5) OJ L 99, 15.4.2016, p. 6. (6) OJ L 23, 26.1.2008, p. 21. (7) OJ C 242, 10.7.2018, p. 41. (8) OJ L 145, 4.6.2008, p. 1. (9) Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 952/2013 to prolong the transitional use of means other than the electronic data-processing techniques provided for in the Union Customs Code (COM(2018)0085).

European Parliament resolution of 14 February 2019 on the implementation of the legal provisions and the Joint Statement ensuring parliamentary scrutiny over decentralised agencies (2018/2114(INI))

P8_TA(2019)0134 A8-0055/2019

The European Parliament,

–  having regard to the Treaty provisions related to agencies and in particular Articles 5 and 9 of the Treaty on European Union (TEU), and Articles 15, 16, 71, 123, 124, 127, 130, 228, 263, 265, 267, 277, 282, 287, 290, 291, 298 and 325 of the Treaty on the Functioning of the European Union (TFEU),

–  having regard to the Charter of Fundamental Rights of the European Union and in particular Articles 41, 42, 43, 51 and 52 thereof,

–  having regard to the Joint Statement of the European Parliament, the Council of the EU and the European Commission on decentralised agencies of 19 July 2012 and the Common Approach annexed to it,

–  having regard to Rule 52 of its Rules of Procedure, as well as to Article 1(1)(e) of, and Annex 3 to, the decision of the Conference of Presidents of 12 December 2002 on the procedure for granting authorisation to draw up own-initiative reports,

–  having regard to the report of the Committee on Constitutional Affairs and the opinions of the Committee on Budgets, the Committee on Budgetary Control, the Committee on Economic and Monetary Affairs, the Committee on the Environment, Public Health and Food Safety and the Committee on Civil Liberties, Justice and Home Affairs (A8-0055/2019),

A.  whereas agencies play a vital role in the implementation of EU policies at European and national levels, performing a wide variety of tasks to contribute to the implementation of EU policies, such as creating networks or supporting cooperation between the EU and national authorities; whereas good cooperation between EU agencies and Member States helps bring greater efficiency and effectiveness to the work of the agencies; whereas agencies have also established cooperation among themselves through the European Union Agency Network;

B.  whereas the coordination and collaboration between the different agencies and parliamentary committees has generally been good; whereas Europol is the only agency scrutinised by Parliament jointly with national parliaments through the Joint Parliamentary Scrutiny Group;

C.  whereas agencies have been created and developed over time, on a case-by-case basis; whereas the Lisbon Treaty has formally recognised agentification of the EU executive by introducing EU agencies formally into the Treaties;

D.  whereas agencies are primarily accountable to Parliament and the Council, which must ensure that adequate scrutiny mechanisms are in place in the legislative acts governing those agencies and that those mechanisms are subsequently properly implemented; whereas agentification of the EU executive should not weaken Parliament’s control of the EU executive as provided for in Article 14 TEU;

E.  whereas the Treaties contain neither a definition of decentralised agencies, nor a general description of powers that may be conferred on agencies;

F.  whereas a number of agencies have their legal basis under Article 352 TFEU and others are created on a specific sector legal basis;

G.  whereas the 2012 Joint Statement and the Common Approach are the result of the work of the Interinstitutional Working Group on regulatory agencies, which was set up by the Commission, the European Parliament and the Council to assess the coherence, effectiveness, accountability and transparency of agencies after a proposal by the Commission in 2005 for an Interinstitutional Agreement on regulatory agencies had not received the necessary support from the Council and Parliament;

H.  whereas the Common Approach contains provisions on the structure and governance of agencies, as well as on their operation, programming of activities, funding, management of budgetary resources, budgetary procedures, accountability, controls and transparency, which help ensure parliamentary scrutiny over decentralised agencies;

I.  whereas, despite a generally positive appreciation, agencies have, in a few cases, encountered occasional distrust of their scientific and technical opinions;

Main observations

1.  Notes that mechanisms to ensure the accountability of agencies are incorporated in the Treaties, in the founding regulations of agencies, in the case-law of the European Court of Justice, as well as in the Joint Statement and the Common Approach; emphasises that through the conferral of power, Parliament has powers of scrutiny vis-a-vis decentralised agencies which are not, however, spelled out in detail in the Treaties; notes in this respect the non-binding nature of the Joint Statement and Common Approach; regrets, however, that the Institutions have not yet agreed to a binding regulatory framework;

2.  Points out that Parliament scrutinises agencies in different ways:

3.  Notes that the provisions in the founding regulations differ in varying degrees from the mechanisms for accountability and parliamentary scrutiny set out in the Common Approach, which may be due to the very different tasks and functions that agencies perform;

4.  Observes that parliamentary committees have actively carried out their scrutiny tasks despite the variety of provisions in the founding regulations;

5.  Recognises the implementation by the Union agencies of the Joint Statement and Common Approach and its roadmap; highlights, in particular, the recommendations of the Interinstitutional Working Group on Decentralised Agencies (IIWG), which were endorsed by the Conference of Presidents on 18 January 2018; notes that with the follow-up meeting of 12 July 2018, the work of the IIWG was considered achieved;

Recommendations

6.  Considers that greater efforts could be made to streamline certain provisions in the founding regulations of agencies relating to their governance and accountability mechanisms, taking into account the various types of agencies that currently exist and defining the general principles governing the relationship between the institutions of the EU and the agencies; points out that these issues should also be addressed in impact assessments whenever the establishment of an agency is proposed; underlines that agencies need to have a certain degree of organisational flexibility in order to better adapt to the tasks envisaged and the needs that arise while carrying out their duties; welcomes the cluster- and cross cluster-based internal organisation of agencies in similar domains;

7.  Calls therefore for a thorough assessment of the implementation of the Common Approach in all its aspects, with detailed analytical papers similar to those produced in 2010 with a focus on governance-related aspects, reviewing in particular the compatibility of the provisions included with Parliament’s co-decision and scrutiny powers, while taking account of the need to allow for flexibility in view of the diverse landscape of decentralised agencies;

8.  Regrets that Parliament, as the lead guarantor of respect for the principle of democracy in the EU, was not fully involved in the procedure to select the new seat of EMA and EBA; recalls in this regard its request to revise the 2012 Joint Statement and Common Approach as soon as possible and also recalls the commitment of the Council to engage in the revision thereof, inviting the Commission to provide, by April 2019, an in-depth analysis of the Joint Statement and Common Approach as regards the location of decentralised agencies;

9.  Stresses that the location of the seat of an agency should not affect the execution of its powers and tasks, its governance structure, the operation of its main organisation or the main financing of its activities;

10.  Expects the prerogatives of Parliament and Council as co-legislators to be fully respected in future decisions on the location or relocation of agencies; considers that Parliament should be systematically involved, throughout the legislative process and on equal terms with the Council and the Commission, in defining and assessing the weight of the criteria for the location of all Union bodies and agencies, in a transparent manner; points out that Parliament, the Council and the Commission made a commitment in the Interinstitutional Agreement on Better Law-Making of 13 April 2016 to sincere and transparent cooperation, and that the agreement highlights the principle of equality between the co-legislators, as enshrined in the Treaties; underlines the value of enhanced exchange of information from the initial stages of future processes for the location of agencies, as such early exchange would make it easier for the three institutions to exercise their rights and prerogatives;

11.  Believes that the decision on the location of an agency is of great importance and considers that objective criteria such as accessibility, administrative synergies and proximity to stakeholders have to be taken into account by the Union institutions in reaching the best possible decision;

12.  Asks the Commission, in line with the recommendations of the Interinstitutional Working Group on decentralised agencies’ resources, to swiftly present an evaluation of agencies with multiple locations, using a consistent approach to assess their added value by taking costs incurred into account; calls for significant measures to be taken on the basis of the results of this evaluation, with the aim of reducing the number of multiple locations, if and where appropriate;

13.  Proposes that, on the basis of a review of the Common Approach, fresh consideration should be given to drawing up an Interinstitutional Agreement (IIA) on agencies and that such agreement should contain provisions on a five-yearly review of the principles governing the establishment and functioning of agencies, drawing upon the expertise of a group of eminent persons;

14.  Considers that this IIA should respect the European Parliament’s powers in co-decision procedures and should also cover the relationship between an agency and the institutions of the Member State in which it is located, as well as transparency measures, procedures to avoid conflict of interest and to ensure gender balance among the members of the governing and advisory bodies, and the implementation of gender mainstreaming in all the activities of the agencies;

15.  Believes that in drafting such an IIA several specific suggestions to strengthen democratic oversight, improve the accountability of Union agencies and strengthen the system for reporting to Parliament should also be addressed, such as:

16.  Considers furthermore that Parliament’s role in the oversight of the governance dimension of decentralised agencies could be significantly improved; suggests, moreover, the strengthening of cooperation with the Joint Parliamentary Scrutiny Group and a revision of the rules for missions to agencies to allow for better regular contact between parliamentary committees and agencies falling under their remit;

17.  Proposes that, in the context of the five-yearly review, building on and in addition to the scrutiny activities conducted by Parliament’s committees over agencies falling within their remit, the Committee on Constitutional Affairs holds an annual debate on the functioning and governance of agencies, followed, if deemed appropriate and/or necessary, by a debate in plenary in order to facilitate a stronger and more structured system of scrutinising agency activities within Parliament; proposes moreover, given the role of agencies as intermediaries between the EU and the Member States, a period of consultation with national parliaments should they wish to make any intervention on the matter;

18.  Considers that Union agencies should apply the rules and principles of good governance and better law-making, including conducting open public consultations on their draft proposals for secondary and tertiary acts, where the domain of the agency so allows; proposes that agencies be subject to the same transparency rules as the Commission, including rules and obligations in relation to interest representatives;

19.  Stresses that, while making sure that all assignments resulting from the regulatory framework are carried out in full and within deadline, Union agencies should carefully adhere to their tasks and act in accordance with the mandates assigned to them by Parliament and the Council; considers it imperative that the Union agencies are transparent when carrying out their mandates;

20.  Proposes that all agencies should be able to submit non-binding opinions on current files within their remit;

21.  Believes furthermore that, in the event of any future changes to the Treaties, consideration should be given as to how agencies can be anchored even more firmly in the Treaties, in particular in relation to Articles 13 and 14 TEU and Articles 290 and 291 TFEU, by inserting a clear definition of the various types of agencies, the powers that can be conferred on them and general principles guaranteeing their parliamentary scrutiny;

Budgetary matters

22.  Notes that fee-financing of agencies currently amounts to around EUR 1 billion annually, which can alleviate pressure on the EU budget and can be an effective way of financing agency activities in cases where the business model so allows; expresses concern, however, at the potential conflicts of interest that can arise if agencies have to rely on membership fees as their main source of income; insists that safeguard measures need to be in place to avoid any kind of conflict of interest;

23.  Stresses the need to take into account the new climate, sustainability and environmental protection priorities within the next MFF and the tasks attributed to particular agencies for the implementation of this MFF;

24.  Notes that even though decentralised agencies share a number of similarities in terms of budgetary management, one-size-fits-all approaches have proven to be detrimental to the efficient and effective management of certain agencies; considers the 5 % reduction target for staff and the redeployment pool among agencies to be a one-off exercise; reiterates its intention to oppose any such approach in the future;

25.  Notes with concern that a number of agencies have difficulties in attracting qualified staff on account of employment conditions; believes that Union bodies need to be in a position to attract qualified staff in order to fulfil their tasks effectively and efficiently; calls, therefore, for concrete action to be taken in order to meet these goals;

26.  Notes that the strengthened cooperation between the agencies in sharing services has resulted in savings, such as those achieved by the creation of a joint procurement portal; encourages further exploration of the potential for sharing services either among the agencies themselves, or between the Commission and the agencies, with a view to creating new synergies and optimising existing ones; believes that, where applicable, further budgetary efficiency could be achieved through close cooperation on administrative support and facility management services among Union bodies and agencies in immediate proximity;

27.  Notes that agencies’ budgets should be prepared in accordance with the principle of performance-based budgeting, taking into account the agency’s objectives and the expected results of its tasks; calls for a thematic approach to the budgeting of decentralised agencies in order to better prioritise the agencies’ tasks, boost cooperation and avoid overlaps, particularly in the case of agencies working within the same policy field;

28.  Notes with concern that a number of administrative requirements are disproportionate to agencies which have not reached a certain size; expects the Commission and the Council to ensure that the applicable administrative requirements are commensurate with the financial and human resources of all agencies;

29.  Recalls that the legislative procedure results in modifications to the original Commission proposal; notes with concern that updated financial statements generally only become available at the end of the legislative procedure, if at all; recalls the twin roles of Parliament and the Council as legislative authority and budgetary authority;

30.  Welcomes the Commission’s draft revised text of the framework financial regulation for decentralised agencies and, in particular, its plans outlined therein to strengthen the governance of these agencies;

31.  Maintains, however, that a variety of issues remain unresolved, and urges the Commission to submit without delay an evaluation of agencies with multiple locations, as recommended by the IIWG, as well as proposals for possible mergers, closures and/or transfers of tasks to the Commission, on the basis of a careful in-depth analysis and using clear and transparent criteria, as was envisaged in the IIWG’s terms of reference but which was never properly examined owing to a lack of proposals to that effect from the Commission;

32.  Notes that the auditing of the decentralised agencies ‘remains under the full responsibility of the Court of Auditors, which manages all administrative and procurement procedures required and finances these’; reiterates that auditing carried out by private sector auditors has significantly increased the administrative burden on the agencies and has, as a result of the time spent on the procurement and administration of audit contracts, created additional expenditure, putting their diminishing resources under even greater strain; emphasises that it is imperative to resolve this issue in accordance with the Common Approach, within the context of the revision of the framework financial regulation; calls on all parties involved in this revision to provide clarity on this issue as a matter of urgency so as to significantly reduce the excessive administrative burden;

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33.  Instructs its President to forward this resolution to the Council and the Commission, the European Court of Auditors and the EU decentralised agencies.