REPORT on the proposal for a regulation of the European Parliament and of the Council on the European Union Drugs Agency

7.12.2022 - (COM(2022)0018 – C9‑0010/2022 – 2022/0009(COD)) - ***I

Committee on Civil Liberties, Justice and Home Affairs
Rapporteur: Isabel Santos

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council on the European Union Drugs Agency

(COM(2022)0018 – C9‑0010/2022 – 2022/0009(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2022)0018),

– having regard to Article 294(2) and Article 168(5) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9‑0010/2022),

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

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

– having regard to the opinion on the Committee on Budgets,

– having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs (A9-0289/2022),

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.

 

Amendment  1

 

Proposal for a regulation

Recital 2

Text proposed by the Commission	Amendment
(2) The European Monitoring Centre for Drugs and Drug Addiction was set up to provide factual, objective, reliable and comparable information concerning drugs, drug addiction and their consequences at Union level to provide the Union and the Member States with evidence to inform policymaking and guide initiatives to tackle drugs and thus give them added value when, in their respective areas of competence, they take measures or decide on action to address the drugs phenomenon. The creation of the European Monitoring Centre for Drugs and Drug Addiction has manifestly improved the availability of information on drugs and drug addiction across Europe.	(2) The European Monitoring Centre for Drugs and Drug Addiction was set up to provide factual, objective, reliable and comparable information concerning drugs, drug addiction and their consequences in the Union and to provide the countries participating in the work of the Centre with an overall view of that information and evidence to inform policymaking and guide initiatives to tackle drugs and thus give them added value when, in their respective areas of competence, they take measures or decide on action to address the drugs phenomenon. The work of the European Monitoring Centre for Drugs and Drug Addiction has manifestly improved the availability of information on drugs and drug addiction, and their consequences, across Europe and internationally.

Amendment  2

 

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) Whereas its general objective is still valid and should be retained, Regulation (EC) No 1920/2006 as such no longer fits for addressing the current and future drug challenges. Therefore, the mandate of the European Monitoring Centre for Drugs and Drug Addiction should be revised, including its replacement and renaming into “European Union Drugs Agency” (‘the Agency’). Since substantial amendments to Regulation (EC) No 1920/2006 are needed to accommodate the common approach for Union decentralised agencies48 and to take account of the developments of the drug phenomenon, in the interest of clarity that Regulation should be replaced by a new Regulation.	(3) Whereas its general objective is still valid and should be retained, Regulation (EC) No 1920/2006 as such no longer fits for addressing the current and future drug challenges. Therefore, the mandate of the European Monitoring Centre for Drugs and Drug Addiction should be revised, including its replacement, strengthening and renaming into “European Union Drugs Agency” (‘the Agency’). Since substantial amendments to Regulation (EC) No 1920/2006 are needed to accommodate the common approach for Union decentralised agencies48, to reflect the balanced, evidence-based, integrated and multidisciplinary approach enshrined in the Union strategies on drugs while incorporating a gender equality, age and health equity perspective, and to take account of the developments of the drug phenomenon, in the interest of clarity and efficiency, that Regulation should be replaced by a new Regulation.
__________________	__________________
48 Joint Statement of the European Parliament, the Council of the EU and the European Commission on decentralised agencies of 19 July 2012, https://european-union.europa.eu/sites/default/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.	48 Joint Statement of the European Parliament, the Council of the EU and the European Commission on decentralised agencies of 19 July 2012, https://european-union.europa.eu/sites/default/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.

Amendment  3

 

Proposal for a regulation

Recital 4

Text proposed by the Commission	Amendment
(4) The main focus of Regulation (EC) No 1920/2006 was on health-related issues. However, addressing also drug markets and drug supply issues, is necessary to understand the impacts of the drug phenomenon on public health, reduce the availability of drugs in the Union and curb drug demand. Health- and supply-related issues are intrinsically linked. The Agency should therefore address the drug phenomenon more holistically.	(4) The main focus of Regulation (EC) No 1920/2006 was on health-related issues, which should continue to be the main focus and a priority for the Agency. However, addressing also drug markets and drug supply issues, is also necessary to understand the impacts of the drug phenomenon on public health, reduce the availability of drugs in the Union and curb drug demand. Health- and supply-related issues are intrinsically linked. The Agency should therefore address the drug phenomenon more holistically in its approach in order to provide factual, objective, reliable, comparable and Union-wide data and analysis. The approach of the Agency to addressing the drug phenomenon should incorporate a human rights, gender equality, age, public health, health equity and social perspective in relation to drugs, drug use, drug use disorders and addictions, prevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration, recovery, drug supply, including illicit production and trafficking, and other relevant drug-related issues and their consequences.

Amendment  4

 

Proposal for a regulation

Recital 5

Text proposed by the Commission	Amendment
(5) The work of the Agency should be carried out with due regard to the respective powers of the Union and its Member States in the area of drugs. It should cover the various facets of the drugs phenomenon and the solutions applied. In doing so, the Agency should be guided by relevant strategies and action plans adopted by the Union, in particular the applicable EU Drugs Strategy and Action Plan.	(5) The work of the Agency should be carried out with due regard to the respective powers of the Union and its Member States in the areas of drugs and the protection and improvement of public health. It should cover the various facets of the drugs phenomenon and the solutions applied. In doing so, the Agency should be guided by and reflect the balanced, evidence-based, integrated and multidisciplinary approach enshrined in the relevant strategies and action plans adopted by the Union, in particular the applicable EU Drugs Strategy and Action Plan.

Amendment  5

 

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In pursuing its activities, the Agency should cooperate with other Union agencies and bodies, in particular the European Union Agency for Law Enforcement Cooperation (Europol), the European Union Agency for Law Enforcement Training (CEPOL), the European Union Agency for Criminal Justice Cooperation (Eurojust), the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC), and the European Education and Culture Executive Agency (EACEA), and should take account of their activities in order to avoid duplication. Cooperation should also take place on an international level with relevant authorities and bodies in third countries and on the United Nations level.	(6) In pursuing its activities, the Agency should cooperate with other relevant Union bodies, offices and agencies within their respective mandates, and should take account of their activities in order to avoid duplication. Cooperation should also take place on an international level with relevant authorities and bodies in third countries, in particular candidate countries, potential candidate countries and countries covered by the European Neighbourhood Policy, and on the United Nations level. It is necessary that such cooperation comply with international human rights norms.

Amendment  6

 

Proposal for a regulation

Recital 6 a (new)

Text proposed by the Commission	Amendment
	(6a) In order to attain maximum efficiency in addressing the drugs phenomenon, the Agency should actively cooperate with the scientific community, organisations of healthcare professionals, academia, the affected communities, civil society organisations, including organisations of people who use drugs, and other relevant stakeholders.

Amendment  7

 

Proposal for a regulation

Recital 7

Text proposed by the Commission	Amendment
(7) Poly-substance use, that is the concomitant use of one or more psychoactive substance or type of substance, whether licit or illicit, when those substances are taken together with drugs, is becoming increasingly common. Therefore, the Agency should address other substance-based addictions when those substances are taken together with drugs by developing monitoring systems that would consider, instead of focusing only on one substance, heroin for example, the important role played by concurrent or sequential use of other substances as well, such as non-controlled opioids or misused medications.	(7) The Agency’s work should pay due regard to poly-substance use because it is becoming increasingly common.

Amendment  8

 

Proposal for a regulation

Recital 9

Text proposed by the Commission	Amendment
(9) The collection, analysis and dissemination of data should continue to be the main task of the Agency. The standard data is collected through the national focal points, which should remain one of the main data providers for the Agency. Additional, closer to real-time data sources are increasingly available through innovative data collection methods. Therefore, the Agency should have access to all data available to get a holistic picture of the drug phenomenon in the Union and the external factors influencing it.	(9) The collection, analysis and dissemination of data should continue to be the main task of the Agency. When collecting, analysing and disseminating data, the Agency should comply with the legal framework on the processing of personal data and should not disseminate any data which would make it possible to identify individuals or small groups of individuals. The standard data is collected through the national focal points, which should remain one of the main data providers for the Agency. Additional, closer to real-time data sources are increasingly available through innovative data collection methods. Therefore, the Agency should have access to all data available to get a holistic picture of the drug phenomenon in the Union and the external factors influencing it.

Amendment  9

 

Proposal for a regulation

Recital 9 a (new)

Text proposed by the Commission	Amendment
	(9a) The national focal points are important players with respect to improving data collection methodologies and tools and developing relevant guidelines for their implementation.

Amendment  10

 

Proposal for a regulation

Recital 10

Text proposed by the Commission	Amendment
(10) The data requirements of the Agency should be mirrored in the national focal points. They should be empowered within the Member States to receive all relevant data from the different national authorities. Data collection in the Member States should be streamlined as far as possible to avoid double reporting and duplication of efforts.	(10) The data requirements of the Agency should be mirrored in the national focal points. They should be empowered within the Member States to receive all relevant data from the different national authorities. Data collection in the Member States should be streamlined as far as possible to avoid double reporting and duplication of efforts and should comply with fundamental rights and data protection law.

Amendment  11

 

Proposal for a regulation

Recital 11

Text proposed by the Commission	Amendment
(11) In order to facilitate and structure data collection, information exchange, both qualitative and quantitative, and to support the establishment of an integrated and interoperable monitoring system enabling real-time monitoring, the Agency should have an appropriate digital solution. This should allow for the automation of data and information management and exchange. Such solution should also facilitate the real-time monitoring of technology-enabled drug markets, including the darknet.	(11) In order to facilitate and structure data collection, information exchange, both qualitative and quantitative, and to support the establishment of an integrated and interoperable monitoring system enabling real-time monitoring, the Agency should develop and apply the appropriate digital solutions necessary for the performance of its tasks.

Amendment  12

 

Proposal for a regulation

Recital 14

Text proposed by the Commission	Amendment
(14) The drug phenomenon is becoming more and more technology-enabled, as was shown again during the COVID-19 pandemic where a greater adoption of new technologies to facilitate drug distribution has been observed. It is estimated that about two-thirds of the offers on darknet markets are drug-related. Drug trading is using different platforms, including social media networks and mobile applications. This development is mirrored in responses to the drug phenomenon, with an increased use of mobile applications and e-health interventions. The Agency, together with other relevant Union agencies and avoiding duplication of efforts, should monitor such developments as part of its holistic approach to the drug phenomenon.	(14) The drug phenomenon is becoming more and more technology-enabled, as was shown again during the COVID-19 pandemic where a greater adoption of new technologies to facilitate drug distribution has been observed. It is estimated that about two-thirds of the offers on darknet markets are drug-related. Drug trading is using different platforms, including social media networks and mobile applications. This development is mirrored in responses to the drug phenomenon, with an increased use of internet communications, mobile applications and e-health interventions. The Agency, together with other relevant Union agencies and avoiding duplication of efforts, should monitor such developments as part of its holistic approach to the drug phenomenon. Taking into account technological advancements and more sophisticated encryption methods, the Agency should be able to recommend appropriate digital solutions to Member States in order to tackle the drug phenomenon in a coordinated and coherent manner.

Amendment  13

 

Proposal for a regulation

Recital 16

Text proposed by the Commission	Amendment
(16) Based on the strengthened monitoring by the Agency and the experience gained in the risk assessment of new psychoactive substances, the Agency should develop general threat assessment capabilities. A more proactive capacity to rapidly identify new threats and inform the development of counter-measures is urgently needed as the dynamic nature of the modern drug phenomenon means that related challenges can rapidly spread across borders.	(16) Based on the strengthened monitoring by the Agency and the experience gained in the risk assessment of new psychoactive substances, the Agency should develop general health and security threat assessment capabilities. A more proactive capacity to rapidly identify new threats and inform the development of counter-measures is urgently needed as the dynamic nature of the modern drug phenomenon means that related challenges can rapidly spread across borders.

Amendment  14

 

Proposal for a regulation

Recital 17

Text proposed by the Commission	Amendment
(17) As dangerous substances might lead to harm for public health, the Agency should be able to issue alerts. To support such a function, the Agency should develop a European drug alert system, accessible by national authorities. Such a system should facilitate the rapid exchange of information that may require rapid actions to safeguard public health, safety, and security. The Agency should be able to inform not only national authorities, but also potential users of these substances.	(17) As dangerous substances might lead to harm for public health, the Agency should be able to issue alerts. To support such a function, the Agency should develop a European drug alert system, accessible by national authorities. Such a system should facilitate the rapid exchange of information that may require rapid actions to safeguard public health, social and human rights, safety, and security. The Agency should be able to inform not only national authorities, but also potential users of these substances.

Amendment  15

 

Proposal for a regulation

Recital 21

Text proposed by the Commission	Amendment
(21) To further the knowledge in this area and support Member States, the Agency should define and finance relevant projects, such as the development of reference standards on new drugs, the elaboration of toxicological or pharmacological studies, and drug profiling. Such an approach would support the sharing of information between relevant laboratories and would decrease the costs for individual laboratories.	(21) To further the knowledge in this area and support Member States, the Agency should define and finance relevant projects, such as the development of reference standards on new drugs, the elaboration of toxicological or pharmacological studies, the implementation of innovative approaches to research, and drug profiling. Such an approach would support the sharing of information between relevant laboratories and would decrease the costs for individual laboratories. The projects that the Agency finances and the amounts invested in each project should be included in the Agency’s annual work programme and be made public.

Amendment  16

 

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) Since the Agency has access to data and the necessary scientific experience to develop and promote evidence-based prevention strategies, it should be involved in prevention work, in particular exchange of best practices and implementable research results in drug prevention, drug-related crime prevention and the prevention of drug-related harms, including the elaboration of quality standards for drug prevention (European Drug Prevention Quality Standards) or of a curriculum providing decision- and policy-makers with the knowledge about the most effective evidence-based prevention interventions and approaches (European Union Prevention Curriculum)	(22) Since the Agency has access to data and the necessary scientific experience to develop and promote evidence-based, gender-sensitive and age-appropriate interventions and best practices on harm reduction, treatment, recovery, care and rehabilitation, and policies and awareness raising, it should be involved in drug prevention and the prevention of drug-related harms, including the elaboration of quality standards for drug prevention (European Drug Prevention Quality Standards) or of a curriculum providing decision- and policy-makers with the knowledge about the most effective evidence-based prevention interventions and approaches (European Union Prevention Curriculum), especially how to reach high-risk populations.

Amendment  17

 

Proposal for a regulation

Recital 23

Text proposed by the Commission	Amendment
(23) Given its Union perspective, the Agency should be able to evaluate national measures and training, for example on prevention, treatment, harm reduction and other related measures, in view of their compliance with the latest scientific state of play and of their proven usefulness. Member States or relevant professional bodies should be given the possibility to use the accreditation or certification as a quality label for their work.	(23) Given its Union perspective, the Agency should be able to evaluate national measures and training, for example on prevention, including gender-sensitive and age-appropriate prevention, treatment, harm reduction, recovery and other related measures, in view of their compliance with the latest scientific state of play and of their proven effectiveness. Member States or relevant professional bodies should be given the possibility to use the accreditation or certification as a quality label for their work.

Amendment  18

 

Proposal for a regulation

Recital 25

Text proposed by the Commission	Amendment
(25) The responsibilities of the Agency in the area of international cooperation should be defined in more clear terms in order to allow it to fully engage in such activities and respond to requests from third countries and bodies. The Agency should be able to contribute to the development and implementation of the external dimension of the Union’s drugs policy and the leadership role of the Union at multilateral level as a means to ensure the efficient and coherent implementation of the Union drug policies internally and at international level. In order that the Agency can allocate adequate levels of resources to this task, the work on international cooperation should be part of the core tasks of the Agency. It should be based on an international cooperation framework of the Agency, which should be in line with the Union priorities on international cooperation and should be revised on a regular basis to ensure that it adequately reflects international developments.	(25) International cooperation should be a core task of the Agency with responsibilities defined in clear terms in order to allow it to fully engage in such activities and respond to requests from third countries and bodies. The Agency should be able to offer adequate scientific and evidence-based tools for the development and implementation of the external dimension of the Union’s drugs policy and the leadership role of the Union at multilateral level as a means to ensure the efficient and coherent implementation of the Union drug policies internally and at international level. Work in that area should be based on an international cooperation framework of the Agency, which should be in line with the Union priorities on international cooperation and guided by the United Nations Sustainable Development Goals. The Agency should revise the international cooperation framework on a regular basis in order to ensure that it adequately reflects international developments.

Amendment  19

 

Proposal for a regulation

Recital 26

Text proposed by the Commission	Amendment
(26) In order to help Union funding for security research to develop its full potential and address the needs of drugs policy, the Agency should assist the Commission in identifying key research themes, drawing up and implementing the Union framework programmes for research and innovation that are relevant to the Agency’s objectives. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, it should not receive funding from that programme in order to avoid a potential conflict of interest. Finally, the Agency should participate in Union-wide initiatives addressing research and innovation to ensure that technologies necessary for its activities are developed and available for use.	(26) In order to help Union funding for security and health research to develop its full potential and address the needs of drugs policy, the Agency should assist the Commission in identifying key research themes and in drawing up and implementing the Union framework programmes for research and innovation that are relevant to the Agency’s objectives. Where the Agency assists the Commission in identifying key research themes and in drawing up and implementing a Union framework programme, it should not receive funding from that programme and should take all necessary measures in order to avoid conflicts of interest. Finally, the Agency should participate in Union-wide initiatives addressing research and innovation to ensure that technologies necessary for its activities are developed and available for use. Planned research and innovation activities should be set out in the single programming document containing the Agency’s multiannual and annual work programme.

Amendment  20

 

Proposal for a regulation

Recital 27

Text proposed by the Commission	Amendment
(27) The Management Board should be assisted by an Executive Board to prepare its decisions. The Agency should be headed by an Executive Director. A Scientific Committee should continue assisting the Management Board and the Executive Director with regard to relevant scientific matters.	(27) The Management Board should be assisted by an Executive Board to prepare its decisions. The Agency should be headed by an Executive Director. A Scientific Committee should continue assisting the Management Board and the Executive Director with regard to relevant scientific matters. When appointing people to positions within the administrative and management structure of the Agency, including the Management Board, due consideration should be paid to their professional backgrounds and to the gender balance of the structure in question.

Amendment  21

 

Proposal for a regulation

Recital 27 a (new)

Text proposed by the Commission	Amendment
	(27a) In order to ensure the independent functioning and integrity of the Agency, the Management Board should adopt practical arrangements for the prevention and management of conflicts of interest, giving due consideration to the recommendations of the European Ombudsman. Those arrangements should ensure, in particular, that senior representatives of the Agency do not undermine its integrity during or after their term of office.

Amendment  22

 

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) The national focal points should be one of the main data providers to the Agency. It is necessary to set minimum requirements for their creation by Member States and their certification by the Agency. In order to guarantee the adequate functioning of the national focal points, they should be set up on a permanent basis, with a dedicated budget and a certain degree of independence in carrying out their function.	(28) The national focal points should be one of the main data providers to the Agency. It is necessary to set minimum requirements for their creation by Member States and their certification by the Agency. In order to guarantee the adequate functioning of the national focal points, they should be set up on a permanent basis, with a dedicated budget, appropriate human resources and a certain degree of independence in carrying out their function.

Amendment  23

 

Proposal for a regulation

Recital 29

Text proposed by the Commission	Amendment
(29) The Agency should be properly resourced to carry out its tasks and granted an autonomous budget. It should be mainly financed by a contribution from the general budget of the Union. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors of the European Union.	(29) The Agency should be adequately resourced to carry out the tasks, objectives and responsibilities assigned to it under this Regulation. That should be properly reflected in the multiannual financial framework by means of a dedicated and ambitious budget. The Agency should be mainly financed by a contribution from the general budget of the Union with the necessary appropriations drawn exclusively from unallocated margins under the relevant heading of the multiannual financial framework or through the mobilisation of the relevant special instruments. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors of the European Union.

Amendment  24

 

Proposal for a regulation

Recital 30

Text proposed by the Commission	Amendment
(30) Fees improve the funding of an agency and may be considered for specific issues that can be clearly separated from the core tasks of the agency. Any fees levied by the Agency should cover its costs for providing the respective services.	(30) Fees could improve the funding of the Agency and may, to the extent that such fees are duly justified and necessary, be considered for specific activities that can be clearly separated from the core tasks of the agency. The method by which fees levied by the Agency are calculated should be transparent, and such fees should cover only the Agency’s human and financial costs for providing those non-core services. An annual independent external audit, separate from the annual audit undertaken by the Court of Auditors, which specifically focuses on such fees should be undertaken and transmitted to the European Parliament.

Amendment  25

 

Proposal for a regulation

Recital 35

Text proposed by the Commission	Amendment
(35) The Agency should cooperate closely with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its work programme, notably to avoid duplication of work and to ensure access to all data and tools needed for carrying out its mandate.	(35) The Agency should cooperate closely, in full compliance with fundamental rights and data protection rules, with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its work programme, notably to avoid duplication of work and to ensure access to all data and tools needed for carrying out its mandate.

Amendment  26

 

Proposal for a regulation

Recital 35 a (new)

Text proposed by the Commission	Amendment
	(35a) In order to raise awareness at Union level, the Agency should establish a structured cooperation with relevant civil society organisations for the purposes of regular and extensive consultation and regular and extensive exchange of information, without transferring any decision-making power to such civil society organisation.

Amendment  27

 

Proposal for a regulation

Article 3 – paragraph 1 – point 3

Text proposed by the Commission	Amendment
(3) ‘poly-substance use’ means the concomitant use of one or more psychoactive substance or type of substance, whether licit or illicit, when those substances are taken together with drugs;	(3) ‘poly-substance use’ means the consumption of one or more psychoactive substance or type of substance, whether illicit or licit, in particular medicinal products, alcohol or tobacco, at the same time as the consumption of drugs, or the sequential consumption of one or more such substance or type of substance, within a short period of time, together with drugs;

Amendment  28

 

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission	Amendment
The Agency shall provide the Union and its Member States with factual, objective, reliable and comparable information, early warning and risk assessment at Union level concerning drugs, drug addiction, drug markets and their consequences, and to recommend appropriate and concrete, evidence-based actions on how to address the related challenges in a timely manner.	The Agency shall:

Amendment  29

 

Proposal for a regulation

Article 4 – paragraph 1 – point a (new)

Text proposed by the Commission	Amendment
	(a) provide the Union and its Member States with factual, objective, reliable and comparable information, early warning and risk assessment at Union level concerning drugs, drug markets, drug use, drug use disorders, drug addictions, prevention, treatment, care, risk and harm reduction, rehabilitation, social reintegration, recovery, drug supply and other relevant drug related issues and their consequences; and

Amendment  30

 

Proposal for a regulation

Article 4 – paragraph 1 – point b (new)

Text proposed by the Commission	Amendment
	(b) recommend appropriate and concrete evidence-based actions on how to address the challenges set out in point (a) in an efficient and timely manner.

Amendment  31

 

Proposal for a regulation

Article 4 – paragraph 1 a (new)

Text proposed by the Commission	Amendment
	In carrying out its tasks, the Agency shall ensure full compliance with fundamental rights and data protection rules, act in a transparent, objective, impartial and scientifically rigorous manner, and take an evidence-based, integrated, balanced and multidisciplinary approach to the drugs phenomenon. That approach shall incorporate human rights, gender, age, public health, health equity and social perspectives.

Amendment  32

 

Proposal for a regulation

Article 5 – paragraph 1 – point a – point 1

Text proposed by the Commission	Amendment
(1) the collection of information and data pursuant to Article 6(1);	(1) the collection and analysis of information and data pursuant to Article 6(1);

Amendment  33

 

Proposal for a regulation

Article 5 – paragraph 1 – point a – point 2

Text proposed by the Commission	Amendment
(2) the dissemination of information and data pursuant to Article 6(5); and	(2) the dissemination of information, data and results of analyses pursuant to Article 6(5) and

Amendment  34

 

Proposal for a regulation

Article 5 – paragraph 1 – point a – point 3

Text proposed by the Commission	Amendment
(3) the monitoring of the drug phenomenon, encompassing the public health, safety and security dimension, pursuant to Article 7.	(3) the monitoring of the drug phenomenon, encompassing the public health, social and human rights, safety and security dimension, pursuant to Article 7.

Amendment  35

 

Proposal for a regulation

Article 5 – paragraph 1 – point b – point 2

Text proposed by the Commission	Amendment
(2) threat assessment and preparedness pursuant to Article 12;	(2) health and security threat assessment and preparedness pursuant to Article 12;

Amendment  36

 

Proposal for a regulation

Article 5 – paragraph 1 – point c – point 1

Text proposed by the Commission	Amendment
(1) the development, expansion and promotion of Union-wide prevention programmes and campaigns pursuant to Article 16;	(1) the development and promotion of evidence-based interventions, best practices and awareness raising pursuant to Article 16;

Amendment  37

 

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission	Amendment
3. The Agency shall act in an objective, impartial and scientifically rigorous manner when carrying out and implementing the tasks referred to in paragraph 1.	deleted

Amendment  38

 

Proposal for a regulation

Article 5 – paragraph 4

Text proposed by the Commission	Amendment
4. The Agency shall improve coordination between national and Union action in its areas of activity and facilitate exchanges of information between decision-makers, researchers, specialists and those involved in drug-related issues in governmental and non-governmental organisations.	4. The Agency shall support and improve coordination between national and Union action in its areas of activity and facilitate exchanges of information between decision-makers, researchers, specialists and those involved in drug-related issues in governmental and non-governmental organisations.

Amendment  39

 

Proposal for a regulation

Article 5 – paragraph 4 a (new)

Text proposed by the Commission	Amendment
	4a. In cooperation with civil society organisations, the Agency shall develop a communication strategy in order to raise public awareness and actively disseminate information about its work.

Amendment  40

 

Proposal for a regulation

Article 5 – paragraph 7

Text proposed by the Commission	Amendment
7. In carrying out and implementing the tasks referred to in paragraph 1, the Agency shall cooperate actively with other Union decentralised agencies and bodies, in particular Europol, Eurojust, the European Medicines Agency, the European Centre for Disease Prevention and Control, civil society organisations and other relevant stakeholders, to attain maximum efficiency in monitoring, assessing and responding to the drugs phenomenon.	7. In order to attain maximum efficiency in monitoring, assessing and responding to the drugs phenomenon, the Agency shall, in carrying out and implementing its tasks, cooperate actively with all of the following:

Amendment  41

 

Proposal for a regulation

Article 5 – paragraph 7 – point a (new)

Text proposed by the Commission	Amendment
	(a) other relevant Union bodies, offices and agencies, within the limits of their mandates, in particular Europol, Eurojust, the European Union Agency for Fundamental Rights, the European Union Agency for Law Enforcement Training (CEPOL), the European Medicines Agency, the European Centre for Disease Prevention and Control and the European Foundation for the Improvement in Living and Working Conditions (Eurofound);

Amendment  42

 

Proposal for a regulation

Article 5 – paragraph 7 – point b (new)

Text proposed by the Commission	Amendment
	(b) other international bodies, offices and agencies, in particular the UN Economic and Social Council and the UN Narcotics Board; and

Amendment  43

 

Proposal for a regulation

Article 5 – paragraph 7 – point c (new)

Text proposed by the Commission	Amendment
	(c) the scientific community, academia, civil society organisations, in particular the Civil Society Forum on Drugs, and affected communities, including people who use drugs;

Amendment  44

 

Proposal for a regulation

Article 6 – paragraph 1 – point a

Text proposed by the Commission	Amendment
(a) collect all relevant information and data, including information and data communicated by the national focal points, resulting from research, available from open sources, and data emanating from Union, non-governmental sources and competent international organisations;	(a) collect relevant information and data, including information and data communicated by the national focal points, resulting from research, available from open sources, and data emanating from Union, non-governmental sources and competent international organisations and bodies;

Amendment  45

 

Proposal for a regulation

Article 6 – paragraph 1 – point b

Text proposed by the Commission	Amendment
(b) collect information and data needed for the monitoring of poly-substance use as referred to in Article 7(1), point (c);	(b) collect information and data needed for the monitoring of poly-substance use and its consequences as referred to in Article 7(1), point (ac);

Amendment  46

 

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission	Amendment
2. The Agency shall collect relevant national data through the national focal points. It shall also cooperate closely with other national, European and international organisations and bodies that already have information of this kind.	2. The Agency shall collect relevant national data through the national focal points. It shall also cooperate closely with other national, European and international organisations and bodies that already have information of this kind. The Agency may use additional national sources of information.

Amendment  47

 

Proposal for a regulation

Article 6 – paragraph 4 – subparagraph 1

Text proposed by the Commission	Amendment
The Agency may develop the necessary digital solutions through which information and data are managed and automatically exchanged.	The Agency shall develop the necessary digital solutions through which information and data are collected, validated, analysed, reported, managed and exchanged, including in an automated manner.

Amendment  48

 

Proposal for a regulation

Article 6 – paragraph 4 – subparagraph 2

Text proposed by the Commission	Amendment
If such digital solutions are developed, they shall:	deleted
(a) enable the automated collection of data, including open source information, while keeping the possibility of manual data provision available;
(b) apply artificial intelligence for data validation, analysis and automated reporting;
(c) allow for the computerised handling and exchange of information, data and documents.

Amendment  49

 

Proposal for a regulation

Article 6 – paragraph 5 – point b

Text proposed by the Commission	Amendment
(b) ensuring wide dissemination of its analysis, conclusions and reports;	(b) ensuring wide dissemination of its analysis, conclusions and reports, including to the scientific community, civil society organisations and affected communities, including people who use drugs, with the exception of classified and sensitive non-classified data;

Amendment  50

 

Proposal for a regulation

Article 6 – paragraph 5 – point e

Text proposed by the Commission	Amendment
(e) providing information on quality standards, innovative best practices and implementable research results in the Member States and facilitating the exchange and implementation of such standard and practices.	(e) providing information on quality standards, innovative best practices, innovative and implementable research results in the Member States and facilitating the exchange and implementation of such standard and practices.

Amendment  51

 

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 1 a (new)

Text proposed by the Commission	Amendment
	Where relevant, the Agency may disseminate information and data disaggregated by Member State, gender, age, disability and socio-economic status, in accordance with the relevant national legal framework and Union data protection law.

Amendment  52

 

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission	Amendment
6. The Agency shall not collect any data making it possible to identify individuals or small groups of individuals. It shall refrain from any transmission of information relating to specific individuals.	6. The Agency shall not disseminate or transmit any data making it possible to identify individuals or small groups of individuals.

Amendment  53

 

Proposal for a regulation

Article 7 – title

Text proposed by the Commission	Amendment
Monitoring of the drug phenomenon	Monitoring of the drug phenomenon and sharing of best practices

Amendment  54

 

Proposal for a regulation

Article 7 – paragraph 1 – point a

Text proposed by the Commission	Amendment
(a) the drugs phenomenon in the Union holistically, through epidemiological and other indicators, covering the health, safety and security aspects, including the implementation of the applicable Union strategies on drugs;	(a) the drugs phenomenon in the Union holistically, through epidemiological and other indicators, covering the public health, social and human rights, social reintegration, safety and security aspects thereof, including the implementation of the applicable Union strategies on drugs;

Amendment  55

 

Proposal for a regulation

Article 7 – paragraph 1 – point a a (new)

Text proposed by the Commission	Amendment
	(aa) evidence-based best practices and innovative approaches to respond to the public health, social and human rights, safety and security aspects of the drugs phenomenon in the participating countries;

Amendment  56

 

Proposal for a regulation

Article 7 – paragraph 1 – point a b (new)

Text proposed by the Commission	Amendment
	(ab) emerging trends in the Union and internationally with respect to drug use, drug use disorders, drug addictions and related health risks and harm in so far as they impact the participating countries;

Amendment  57

 

Proposal for a regulation

Article 7 – paragraph 1 – point a c (new)

Text proposed by the Commission	Amendment
	(ac) poly-substance use and its consequences, in particular the increased risks of health and social problems, the social determinants of drug use, drug use disorders and drug addictions, and the implications for policies and responses;

Amendment  58

 

Proposal for a regulation

Article 7 – paragraph 1 – point a d (new)

Text proposed by the Commission	Amendment
	(ad) drug and poly-substance use and its consequences from an age and gender perspective, in particular its impact on gender-based violence;

Amendment  59

 

Proposal for a regulation

Article 7 – paragraph 1 – point c

Text proposed by the Commission	Amendment
(c) poly-substance use and its consequences, in particular the implications for policies and responses arising from the interaction between the use of drugs with one or more psychoactive substance or type of substance, whether licit or illicit; including the increased risks of health and social problems, which may occur when drugs and other psychoactive substances are consumed at the same time or sequentially within a short period of time or when different substances are produced or sold together; the need to consider the common causes of drug use and addictions; and the implications for monitoring and exchange of best practices, which arise when policies and responses target multiple substances holistically;	deleted

Amendment  60

 

Proposal for a regulation

Article 7 – paragraph 1 – point d

Text proposed by the Commission	Amendment
(d) drug-related problems and the solutions applied, in particular the implementation of innovative best practices and research results;	deleted

Amendment  61

 

Proposal for a regulation

Article 7 – paragraph 1 – point h

Text proposed by the Commission	Amendment
(h) Technology-enabled drug markets, in cooperation with Europol within their respective mandates.	deleted

Amendment  62

 

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the Commission	Amendment
2. Based on its monitoring activities, the Agency shall identify innovative best practices and develop them further. The Agency shall provide and share information on innovative best practices in the Member States and facilitate the exchange of such practices among the Member States.	2. Based on its monitoring activities, the Agency shall develop and identify innovative and evidence-based best practices, share them with the Member States and facilitate the exchange of such practices among them.

Amendment  63

 

Proposal for a regulation

Article 7 – paragraph 3

Text proposed by the Commission	Amendment
3. The Agency shall undertake regular foresight exercises, taking into account the information available. It shall develop, on that basis, relevant predictions for the development of future drugs policy.	3. The Agency shall provide data, analysis and best practices to, and share the latest evidence-based policy recommendations with, the Commission and the Member States, provided that such data, analysis, best practices and policy recommendations concern Union and national policies which address the phenomenon of drug addictions. The Agency shall develop, on that basis, relevant scenarios for the development of future drugs policy. The Agency shall undertake regular foresight exercises, taking into account the information available.

Amendment  64

 

Proposal for a regulation

Article 9 – paragraph 2 – point f a (new)

Text proposed by the Commission	Amendment
	(fa) information on the health-related risks associated with new psychoactive substances;

Amendment  65

 

Proposal for a regulation

Article 9 – paragraph 3

Text proposed by the Commission	Amendment
3. For the purpose of the initial report, the Agency shall use information, which is at its disposal.	3. For the purpose of the initial report, the Agency shall use information, which is at its disposal, including information obtained pursuant to Article 8.

Amendment  66

 

Proposal for a regulation

Article 9 – paragraph 4

Text proposed by the Commission	Amendment
4. Where the Agency considers it necessary, it shall request the national focal points to provide additional information on the new psychoactive substance. The national focal points shall provide that information within two weeks of receipt of the request.	4. Where the Agency considers it necessary, it shall request the national focal points and the relevant stakeholders, including the scientific community, healthcare professionals, civil society organisations and affected communities, to provide additional information on the new psychoactive substance. The national focal points and the relevant stakeholders, as applicable, shall provide that information within two weeks of receipt of the request.

Amendment  67

 

Proposal for a regulation

Article 9 – paragraph 10 a (new)

Text proposed by the Commission	Amendment
	10a. Where appropriate, the Agency shall disseminate the initial report to the relevant stakeholders, including the scientific community, civil society organisations and affected communities, for the purpose of raising awareness.

Amendment  68

 

Proposal for a regulation

Article 10 – paragraph 3 – point c

Text proposed by the Commission	Amendment
(c) an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects;	(c) an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects and in relation to drug-related deaths, including where they are a result of overdoses;

Amendment  69

 

Proposal for a regulation

Article 10 – paragraph 3 – point d

Text proposed by the Commission	Amendment
(d) an analysis of the social risks associated with the new psychoactive substance – in particular its impact on social functioning, public order and criminal activities, and the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance;	(d) an analysis of the social risks associated with the new psychoactive substance – in particular its impact on social functioning and social marginalisation, public order and criminal activities, and the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance;

Amendment  70

 

Proposal for a regulation

Article 10 – paragraph 3 – point f a (new)

Text proposed by the Commission	Amendment
	(fa) available information on recommended evidence-based demand reduction, harm reduction and recovery responses to minimise the risks and harms associated with the new psychoactive substance;

Amendment  71

 

Proposal for a regulation

Article 10 – paragraph 6 a (new)

Text proposed by the Commission	Amendment
	6a. Where appropriate, the Agency shall disseminate the risk assessment report or the combined risk assessment report to the relevant stakeholders, including the scientific community, civil society organisations and affected communities, for awareness-raising purposes.

Amendment  72

 

Proposal for a regulation

Article 12 – title

Text proposed by the Commission	Amendment
Threat assessment and preparedness	Health and security threat assessment and preparedness

Amendment  73

 

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission	Amendment
1. The Agency shall develop a strategic general threat assessment capability to identify at an early stage new developments of the drugs phenomenon that have a potential to impact negatively on public health, safety and security and, through doing so, to help increase the preparedness of the relevant stakeholders to respond to new threats in a timely and effective manner.	1. The Agency shall develop a strategic evidence-based health and security threat assessment capability to identify at an early stage new developments of the drugs phenomenon that have a potential to impact negatively on public health, social matters, safety and security in the Union and, through doing so, to help increase the preparedness of the relevant stakeholders to respond to new threats in a timely and effective manner.

Amendment  74

 

Proposal for a regulation

Article 12 – paragraph 2 – subparagraph 1

Text proposed by the Commission	Amendment
The Agency shall set out a set of criteria to evaluate when to trigger a threat assessment.	The Agency shall set out a set of objective criteria to evaluate when to trigger a health and security threat assessment.

Amendment  75

 

Proposal for a regulation

Article 12 – paragraph 2 – subparagraph 2

Text proposed by the Commission	Amendment
A threat assessment may be launched by the Agency on its own initiative based on an internal appraisal of signals arising from routine monitoring, research or other appropriate information sources. A threat assessment may also be launched at the request of the Commission or of a Member State, if the defined criteria are met.	A health and security threat assessment may be launched by the Agency on its own initiative based on an internal appraisal of signals arising from routine monitoring, research or other appropriate information sources. A health and security threat assessment may also be launched at the request of the Commission or of a Member State, if the defined criteria are met.

Amendment  76

 

Proposal for a regulation

Article 12 – paragraph 3

Text proposed by the Commission	Amendment
3. A threat assessment shall consist of a rapid evaluation of existing information and, where necessary, the collection of new information through the Agency’s information networks. The Agency shall develop appropriate scientific rapid assessment methods.	3. A health and security threat assessment shall consist of a rapid evaluation of existing information and, where necessary, the collection of new information through the Agency’s information networks. The Agency shall develop appropriate scientific rapid assessment methods.

Amendment  77

 

Proposal for a regulation

Article 12 – paragraph 4

Text proposed by the Commission	Amendment
4. The threat assessment report shall describe the identified threat, the current situation based on available evidence, the potential outcomes in the event of no action, and set out options for preparedness and response that may be adopted to mitigate the threat identified. It may also contain potential follow-up measures to be adopted. The threat assessment report shall be sent to the Commission and the Member States, as appropriate.	4. The health and security threat assessment report shall describe the identified threat, the current situation based on available evidence, the potential outcomes in the event of no action, and set out options for preparedness and response that may be adopted to mitigate and to respond to the threat identified, including evidence-based interventions on demand reduction, risk and harm reduction and recovery. It may also contain potential follow-up measures to be adopted. The health and security threat assessment report shall be sent to the Commission and to the Member States. Where appropriate, the Agency shall disseminate health and security threat assessment reports to relevant stakeholders, including the scientific community, healthcare professionals, civil society organisations and affected communities. The Agency shall make summaries of those reports publicly available on its website.

Amendment  78

 

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission	Amendment
5. The Agency shall cooperate closely with other Union decentralised agencies and bodies, Union and international organisations in carrying out a threat assessment by involving them in the assessment as appropriate. Where the potential threat is already subject to an analysis under another Union mechanism, the Agency shall not carry out a threat assessment.	5. The Agency shall cooperate closely with Member States, other Union bodies, offices and agencies and international organisations in carrying out a health and security threat assessment by involving them in the assessment as appropriate. Where the potential threat is already subject to an analysis under another Union mechanism, the Agency shall not carry out a health and security threat assessment.

Amendment  79

 

Proposal for a regulation

Article 12 – paragraph 6

Text proposed by the Commission	Amendment
6. With the agreement of the Commission, the Agency shall conduct threat assessments on drug related threats emerging from outside the Union, which have the potential to impact public health, safety and security within the Union.	6. With the agreement of the Commission, the Agency shall conduct health and security threat assessments on drug related threats emerging from outside the Union, which have the potential to impact public health, social matters, safety and security within the Union.

Amendment  80

 

Proposal for a regulation

Article 12 – paragraph 6 a (new)

Text proposed by the Commission	Amendment
	6a. The Agency shall monitor the evolution of new developments of the drugs phenomenon as referred to in paragraph 1 and update the threat assessments accordingly.

Amendment  81

 

Proposal for a regulation

Article 13 – paragraph 2 – introductory part

Text proposed by the Commission	Amendment
2. Member States shall immediately notify the Agency of any information relating to the appearance of a serious direct or indirect drug-related risk to human health, safety or security as well as any information that may be useful for coordinating a response whenever they become aware of such information, such as:	2. Member States shall immediately notify the Agency of any information relating to the appearance of a serious direct or indirect drug-related risk to human health, social aspects, safety or security as well as any information that may be useful for coordinating a response whenever they become aware of such information, such as:

Amendment  82

 

Proposal for a regulation

Article 13 – paragraph 2 – point f a (new)

Text proposed by the Commission	Amendment
	(fa) social and human rights risks;

Amendment  83

 

Proposal for a regulation

Article 13 – paragraph 2 – point f b (new)

Text proposed by the Commission	Amendment
	(fb) safety and security risks;

Amendment  84

 

Proposal for a regulation

Article 13 – paragraph 3

Text proposed by the Commission	Amendment
3. The Agency shall analyse and assess the available information and data on potential serious risks to human health and complement it with any scientific and technical information it may have available from the early warning system referred to in Article 8 and other threat assessments undertaken in accordance with Article 12, from other Union agencies and bodies and from international organisations, in particular the World Health Organisation. The Agency shall take into account information obtained through its data collection tools and from open source information.	3. The Agency shall analyse and assess the available information and data on potential serious risks to human health and complement it with any scientific and technical information it may have available from the early warning system referred to in Article 8 and other threat assessments undertaken in accordance with Article 12, from other Union agencies and bodies and from international organisations, in particular the World Health Organisation. The Agency shall take into account information obtained through its data collection tools and from open source information and consultations with relevant stakeholders, including the scientific community, academia, civil society organisations and affected communities.

Amendment  85

 

Proposal for a regulation

Article 13 – paragraph 8

Text proposed by the Commission	Amendment
8. The Agency may develop an alert system through which it can directly reach and address people who use or potentially use drugs.	8. In close cooperation with the relevant national authorities, in particular the national focal points, and with relevant stakeholders, including the scientific community, civil society organisations and affected communities, the Agency shall develop an alert system to make information on identified risks available, where appropriate, to people who use or potentially use specific drugs.

Amendment  86

 

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission	Amendment
2. The network shall act primarily as a forum for generating data and information exchange on new developments and trends, organising training to enhance the competence of forensic drug experts, supporting the implementation of quality assurance schemes and supporting the further harmonisation of data collection and analytical methods.	2. The network shall act primarily as a forum for generating data and information exchange on new developments and trends, organising training to enhance the competence of forensic drug and toxicology experts, supporting the implementation of quality assurance schemes and supporting the further harmonisation of data collection and analytical methods.

Amendment  87

 

Proposal for a regulation

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
5. The network shall closely cooperate with existing networks and organisations active in this area. The network referred to in Article 31 shall be informed regularly about the work of the network of forensic and toxicological laboratories.	5. The network shall closely cooperate with existing networks and organisations active in this area and shall take into account their work in order to avoid overlaps. The network referred to in Article 31 shall be informed regularly, and at least twice a year, about the work of the network of forensic and toxicological laboratories.

Amendment  88

 

Proposal for a regulation

Article 16 – title

Text proposed by the Commission	Amendment
Prevention campaigns	Evidence-based interventions, best practices and awareness raising

Amendment  89

 

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission	Amendment
1. The Agency shall design, develop and promote Union-wide programmes and campaigns for the prevention of drug-related problems and raising awareness of the adverse effects of drugs.	1. The Agency shall develop and promote scientific, evidence-based and gender-sensitive interventions, which take into account the age dimension, and best practices on prevention, risk and harm reduction, treatment, recovery, care and rehabilitation and awareness raising of the adverse effects of drugs.

Amendment  90

 

Proposal for a regulation

Article 16 – paragraph 2

Text proposed by the Commission	Amendment
2. The programmes and campaigns referred to in paragraph 1 shall be in line with the political orientations set out in the applicable EU Drugs Strategy and Action Plan. They shall address important dimensions of the drug phenomenon, shall be targeted to specific groups and be informed by the Agency’s collection of evidence and best practice.	2. The interventions, best practices and awareness raising referred to in paragraph 1 shall be in line with international human rights norms and political orientations set out in the applicable EU Drugs Strategy and Action Plan. They shall ensure a balanced approach to demand reduction, harm reduction and recovery interventions, be adapted to the national context where necessary and be implemented at the national level. They may be targeted to specific groups.

Amendment  91

 

Proposal for a regulation

Article 16 – paragraph 3

Text proposed by the Commission	Amendment
3. The Agency shall develop and promote the implementation of quality standards for drug prevention and provide or support training pursuant to Article 19.	3. The Agency shall develop and promote the implementation of quality standards for drug prevention, risk and harm reduction, treatment, recovery, care and rehabilitation, update them as appropriate and provide or support training pursuant to Article 19.

Amendment  92

 

Proposal for a regulation

Article 16 – paragraph 4

Text proposed by the Commission	Amendment
4. The Agency shall assist Member States in developing national prevention campaigns in the area of its mandate, including the development of prevention programmes aimed at the reduction of drug-related criminality and prevention of the exploitation of vulnerable individuals within the drug market.	4. The Agency shall assist Member States in developing national interventions in the area of its mandate, including in relation to the prevention of drug use and the related impact on health.

Amendment  93

 

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission	Amendment
2. The Agency shall support the Member States in implementing their national drug strategies, quality standards and innovative best practices and it shall facilitate exchanges of information between national decision-makers.	2. The Agency shall support the Member States in implementing their national drug strategies, quality standards and innovative best practices and it shall facilitate exchanges of information between national authorities and experts.

Amendment  94

 

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission	Amendment
3. In supporting policy evaluation, the Agency shall act independently and shall be guided by its scientific standards.	3. In supporting policy evaluation, the Agency shall act independently and shall be guided by its scientific standards and an evidence-based approach.

Amendment  95

 

Proposal for a regulation

Article 19 – paragraph 1 – introductory part

Text proposed by the Commission	Amendment
The Agency shall, within the scope of its mandate, in accordance with the staffing and budgetary resources at its disposal and in coordination with other Union decentralised agencies and bodies:	The Agency shall, within the scope of its mandate and in coordination with other Union bodies, offices and agencies:

Amendment  96

 

Proposal for a regulation

Article 20 – paragraph 1 – point f

Text proposed by the Commission	Amendment
(f) promote the incorporation of data on drugs and drug addiction gathered in the Member States or emanating from the Union into international monitoring and drug-control programmes, particularly those established by the UN and its specialised agencies, without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Drug Conventions;	(f) promote the incorporation of all relevant data on drugs covered by this Regulation and gathered in the Member States or emanating from the Union into international monitoring and drug-control programmes, particularly those established by the UN and its specialised agencies, without prejudice to Member States' obligations with regard to transmission of information under the provisions of the United Nations Drug Conventions;

Amendment  97

 

Proposal for a regulation

Article 20 – paragraph 1 – point h

Text proposed by the Commission	Amendment
(h) support third countries in developing their drug policies in accordance with the principles of the Union drug strategies, including through providing support to the independent evaluation of their policies.	(h) support third countries, in particular candidate countries, in developing their drug policies in accordance with the principles of the Union drug strategies, including through providing support to the independent evaluation of their policies and provide support to, and establish dialogue with, civil society organisations working in the field of drugs in those countries.

Amendment  98

 

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission	Amendment
2. The international cooperation framework referred to in paragraph 1, point (a), shall take into account the relevant policy documents of the Union and consider the developments of the drug phenomenon, in particular trafficking routes and drug production areas. It shall set out the priority countries or regions for cooperation and the key outcomes of the cooperation. The Agency shall evaluate and review the international cooperation framework regularly.	2. The international cooperation framework referred to in paragraph 1, point (a), shall seek to further strengthen and support third countries' efforts to address drug issues in an evidence-based, integrated, balanced and multidisciplinary manner and in full compliance with international human rights norms. That international cooperation framework shall take into account the relevant policy documents of the Union and consider the developments of the drug phenomenon. It shall set out the priority countries or regions for cooperation and the key outcomes of the cooperation. It shall take into account the activities undertaken by the Member States. The Agency shall evaluate and review accordingly the international cooperation framework regularly.

Amendment  99

 

Proposal for a regulation

Article 20 – paragraph 3 – subparagraph 1

Text proposed by the Commission	Amendment
The Agency shall transfer, at the request of the Commission and with the approval of the Management Board, its know-how and provide technical assistance to third countries.	The Agency shall transfer, at the request of the Commission and with the approval of the Management Board, its know-how and provide technical assistance to third countries, in particular candidate countries, potential candidate countries and countries covered by the European Neighbourhood Policy.

Amendment  100

 

Proposal for a regulation

Article 20 – paragraph 3 – subparagraph 2

Text proposed by the Commission	Amendment
Technical assistance shall focus in particular on setting up or consolidating national focal points, national data collection systems and national early warning systems, and subsequently assist the creation and strengthening of structural links with the early warning system referred to in Article 8 and the network referred to in Article 31. If the third country so requests, the Agency may provide a certification for these national bodies.	Technical assistance shall focus in particular on setting up or consolidating national focal points, national data collection systems and national early warning systems and on the promotion of best practices in the field of prevention, risk and harm reduction, recovery, treatment, care and rehabilitation, and subsequently assist the creation and strengthening of structural links with the early warning system referred to in Article 8 and the network referred to in Article 31. If the third country so requests, the Agency may provide a certification for these national bodies.

Amendment  101

 

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission	Amendment
1. The Agency shall assist the Commission and the Member States in identifying key research themes, drawing up and implementing the Union framework programmes for research and innovation activities that are relevant to achieve its general task set out in Article 4. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, the Agency shall not receive funding from that programme.	1. The Agency shall assist the Commission and the Member States in identifying key research themes, drawing up and implementing the Union framework programmes for research and innovation activities that are relevant to achieve its general and specific tasks set out in Articles 4 and 5. In doing so, the Agency shall pay due attention to the gender and age dimensions and take into consideration intersectionality as a cross-cutting principle. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, the Agency shall not receive funding from that programme.

Amendment  102

 

Proposal for a regulation

Article 21 – paragraph 2

Text proposed by the Commission	Amendment
2. The Agency shall proactively monitor and contribute to research and innovation activities to achieve its general task set out in Article 4, support related activities of Member States, and implement its research and innovation activities regarding matters covered by this Regulation, including the development, training, testing and validation of algorithms for the development of tools. The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 49.	2. The Agency shall proactively monitor and contribute to research and innovation activities to achieve its general and specific tasks set out in Articles 4 and 5, support related activities of Member States, and implement its research and innovation activities regarding matters covered by this Regulation, including the development, training, testing and validation of algorithms for the development of tools. The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 49.

Amendment  103

 

Proposal for a regulation

Article 21 – paragraph 5

Text proposed by the Commission	Amendment
5. The Agency shall make public information on its research projects, including demonstration projects, the cooperation partners involved and the project budget.	5. The Agency shall ensure full compliance with transparency and conflict of interest rules and make public information on its research projects, including demonstration projects. Such information shall include the cooperation partners involved and the project budget.

Amendment  104

 

Proposal for a regulation

Article 22 – paragraph 1 a (new)

Text proposed by the Commission	Amendment
	The members of the Agency’s administrative and management structure shall not have any financial or other interests that could affect their impartiality. They shall act in the public interest and carry out their activities in an independent, impartial and transparent manner, and shall make an annual declaration of their financial interests. All indirect interests which could affect their impartiality, including in the pharmaceutical industry, shall be entered in a register that is held by the Agency and is accessible to the public upon request.

Amendment  105

 

Proposal for a regulation

Article 23 – paragraph 2 – point a

Text proposed by the Commission	Amendment
(a) one independent expert particularly knowledgeable in the field of drugs designated by the European Parliament, with the right to vote;	(a) two independent experts particularly knowledgeable in the field of drugs designated by the European Parliament, with the right to vote;

Amendment  106

 

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission	Amendment
3. Each member of the Management Board shall have an alternate. The alternate shall represent the member in her/his absence.	3. Each member of the Management Board shall have an alternate. The alternate shall represent the member in her/his absence and may attend the meetings of the Management Board.

Amendment  107

 

Proposal for a regulation

Article 23 – paragraph 4

Text proposed by the Commission	Amendment
4. Members of the Management Board and their alternates shall be appointed in light of their knowledge in the field of drugs and drug addiction, taking into account relevant managerial, administrative and budgetary skills. All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the Management Board's work. All parties shall aim to achieve a balanced representation between women and men on the Management Board.	4. Members of the Management Board and their alternates shall be appointed in light of their knowledge in the fields set out in Article 4(1), point (a), taking into account relevant managerial, administrative and budgetary skills. All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the Management Board's work. All parties shall aim to achieve a gender balanced representation on the Management Board.

Amendment  108

 

Proposal for a regulation

Article 23 – paragraph 5

Text proposed by the Commission	Amendment
5. The Management Board may invite, as observers, representatives of international organisations with which the Agency cooperates in accordance with Article 53.	5. The Management Board may invite, as observers, representatives of international organisations with which the Agency cooperates in accordance with Article 53 and representatives from relevant civil society organisations.

Amendment  109

 

Proposal for a regulation

Article 23 – paragraph 6

Text proposed by the Commission	Amendment
6. The term of office for members and their alternates shall be four years. That term may be renewable.	6. The term of office for members and their alternates shall be four years. That term may be renewed once.

Amendment  110

 

Proposal for a regulation

Article 24 – paragraph 1 – point i

Text proposed by the Commission	Amendment
(i) adopt rules for the prevention and management of conflicts of interest in respect of its members, the members of the Executive Board, Scientific Committee, and the European Information Network on Drugs and Drug Addiction (Reitox), as well as of seconded national experts and other staff not employed by the Authority as referred to in Article 44, and shall publish annually on its website the declarations of interests of the Management Board members;	(i) adopt rules for the prevention and management of conflicts of interest in respect of its members, the members of the Executive Board, Scientific Committee, and the European Information Network on Drugs and Drug Addiction (Reitox), as well as of seconded national experts and other staff not employed by the Agency as referred to in Article 44, and shall publish annually on its website the declarations of interests of the Management Board members;

Amendment  111

 

Proposal for a regulation

Article 24 – paragraph 1 – point l

Text proposed by the Commission	Amendment
(l) approve the level of minimum co-financing referred to in Article 32(7);	(l) approve the level of minimum co-financing referred to in Article 32(6);

Amendment  112

 

Proposal for a regulation

Article 24 – paragraph 1 – point n

Text proposed by the Commission	Amendment
(n) adopt its rules of procedure;	(n) adopt and make publicly available its rules of procedure, including practical arrangements for the prevention and management of conflicts of interest,;

Amendment  113

 

Proposal for a regulation

Article 24 – paragraph 1 – point t

Text proposed by the Commission	Amendment
(t) approve the list of experts to be used to extend the Scientific Committee in accordance with Article 10(4);	(t) approve the list of experts to be used to extend the Scientific Committee in accordance with Article 30(6);

Amendment  114

 

Proposal for a regulation

Article 28 – paragraph 2

Text proposed by the Commission	Amendment
2. Where necessary, because of urgency, the Executive Board may take certain provisional decisions instead of the Management Board, in particular on administrative management matters, including the suspension of the delegation of the appointing authority powers and budgetary matters.	2. Where necessary, because of urgency, the Executive Board may take certain provisional decisions instead of the Management Board, in particular on administrative management matters, including the suspension of the delegation of the appointing authority powers and budgetary matters. The conditions for taking such provisional decisions shall be set out in the rules of procedure of the Management Board.

 

Amendment 115 

Proposal for a regulation

Article 28 – paragraph 3 – subparagraph 3

Text proposed by the Commission	Amendment
The Executive Director shall take part in the meetings of the Executive Board, but shall not have the right to vote. The Executive Board may invite other observers to attend its meetings.	The Executive Director shall take part in the meetings of the Executive Board. The Executive Board may invite other observers to attend its meetings.

Amendment  116

 

Proposal for a regulation

Article 28 – paragraph 4

Text proposed by the Commission	Amendment
4. The term of office of members of the Executive Board shall be four years. The term of office of members of the Executive Board shall end when their membership of the Management Board ends.	4. The term of office of members of the Executive Board shall be four years. That term may be renewed once. The term of office of members of the Executive Board shall end when their membership of the Management Board ends.

Amendment  117

 

Proposal for a regulation

Article 29 – paragraph 5 – point g

Text proposed by the Commission	Amendment
(g) proposing to the Commission, after consulting the Management Board, the amount of fees in accordance with Article 37;	(g) proposing to the Management Board, the amount of fees in accordance with Article 37;

Amendment  118

 

Proposal for a regulation

Article 29 – paragraph 5 – point i

Text proposed by the Commission	Amendment
(i) protecting the financial interests of the Union by applying preventive measures against fraud, corruption and any other illegal activities, without prejudicing the investigative competence of OLAF and EPPO, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by imposing effective, proportionate and dissuasive administrative, including financial penalties;	(i) protecting the financial interests of the Union by applying preventive measures against fraud, corruption and any other illegal activities, without prejudicing the investigative competence of OLAF and EPPO, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by imposing effective, proportionate and dissuasive administrative, including financial penalties and by reporting any criminal conduct to the EPPO in respect of which the EPPO could exercise its competence in accordance with Article 24 of Regulation (EU) 2017/1939;

Amendment  119

 

Proposal for a regulation

Article 29 – paragraph 6

Text proposed by the Commission	Amendment
6. The Executive Director shall decide whether it is necessary to locate one or more staff in one or more Member States for the purpose of carrying out the Agency's tasks in an efficient and effective manner. Before deciding to establish a local office, the Executive Director shall obtain the prior consent of the Commission, the Management Board and the host Member State(s) concerned. The decision shall specify the scope of the activities to be carried out at the local office in a manner that avoids unnecessary costs and duplication of administrative functions of the Agency. A headquarters agreement with the host Member State(s) concerned may be concluded.	6. The Executive Director may decide to post one or more liaison officers to the Union institutions and to relevant Union bodies, offices and agencies for the purpose of carrying out the Agency's tasks in an efficient and effective manner. The Executive Director shall obtain the prior consent of the Commission and the Management Board. The decision shall specify the scope of the activities to be carried out by the liaison officers in a manner that avoids unnecessary costs and duplication of administrative functions of the Agency.

Amendment  120

 

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
1. The Scientific Committee shall consist of at most fifteen scientists appointed by the Management Board in view of their scientific excellence and their independence, following the publication of a call for expression of interest in the Official Journal of the European Union. The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant fields linked to the objectives of the Agency.	1. The Scientific Committee shall be composed of no less than ten and no more than fifteen scientists appointed by the Management Board in view of their scientific excellence and their independence, following the publication of a call for expression of interest in the Official Journal of the European Union. Before making appointments to the Scientific Committee, the Management Board shall consult the competent committee of the European Parliament. The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant fields linked to the objectives of the Agency. All parties involved in the selection and appointment of scientists to the Scientific Committee shall aim to achieve gender balance in that committee.

Amendment  121

 

Proposal for a regulation

Article 33 – paragraph 2 – point a

Text proposed by the Commission	Amendment
(a) coordinate at national level the activities related to drug-related data collection and monitoring;	(a) coordinate at national level the activities related to drug-related data collection and monitoring, and discussions on relevant indicators;

Amendment  122

 

Proposal for a regulation

Article 33 – paragraph 2 – point d

Text proposed by the Commission	Amendment
(d) collect, analyse and interpret in an objective manner at national level all relevant information on drugs, drug addiction, drug markets, drug supply and crime-related issues as well as on policies and solutions applied, needed for the Agency to comply with Article 6. In doing so, the national focal point shall bring together experience from different sectors – in particular health, justice and law enforcement – and cooperate with experts and national organisations active in the field of drugs policy;	(d) collect, analyse and interpret in an objective manner at national level all relevant information on drugs, drug addiction, drug markets, drug supply and crime-related issues as well as on policies and solutions applied, needed for the Agency to comply with Article 6. In doing so, the national focal point shall bring together experience from different sectors – in particular health, justice and law enforcement – and shall cooperate with experts, national organisations, the scientific community, civil society organisations and other relevant stakeholders active in the field of drugs policy;

Amendment  123

 

Proposal for a regulation

Article 33 – paragraph 2 – point h

Text proposed by the Commission	Amendment
(h) provide the Agency with information on new trends in the use of existing psychoactive substances or new combinations of psychoactive substances, which pose a potential risk to public health as well as information on possible measures related to public health;	(h) provide the Agency with information on new trends and challenges in the use of existing psychoactive substances or new combinations of psychoactive substances, which pose a potential risk to public health as well as information on possible measures related to public health;

Amendment  124

 

Proposal for a regulation

Article 33 – paragraph 2 a (new)

Text proposed by the Commission	Amendment
	2a. The national focal points shall monitor, analyse and interpret relevant information in the fields set out in Article 4(1), point (a), and shall provide information on the policies and solutions adopted.

Amendment  125

 

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission	Amendment
3. The national focal point shall have the right to collect from other national authorities, bodies, agencies and organisations all the information it needs to carry out its tasks in accordance with paragraph 2. The national focal point shall maintain an extensive network of national partners and data providers for the collection of such information.	3. The national focal point shall cooperate, as necessary, with relevant national and regional authorities, bodies, agencies and organisations for the collection of all the information it needs to carry out its tasks in accordance with paragraph 2. The national focal point shall maintain an extensive network of national partners and data providers for the collection of such information.

Amendment  126

 

Proposal for a regulation

Article 33 – paragraph 3 a (new)

Text proposed by the Commission	Amendment
	3a. When collecting data pursuant to this Article, the national focal points shall ensure, where possible, that the data collected are disaggregated by gender. The national focal points shall consider the gender-sensitive aspects of drugs policy when collecting and presenting data pursuant to this Article. The national focal points shall not transmit any data which would make it possible to identify individuals or small groups of individuals. The national focal points shall not transmit information relating to specific individuals.

Amendment  127

Proposal for a regulation

Article 35 – paragraph 1

Text proposed by the Commission	Amendment
1. By 15 December of each year, the Management Board shall adopt a draft single programming document containing multi-annual and annual programming as well as all the documents listed in Article 32 of Commission Delegated Regulation (EU) 2019/71522, based on a draft put forward by the Executive Director, after consulting the Scientific Committee, taking into account the opinion of the Commission, and in relation to multiannual programming after consulting the European Parliament. It shall forward it to the European Parliament, the Council and the Commission by 31 January of the following year.	1. By 15 December of each year, the Management Board shall adopt a draft single programming document containing multi-annual and annual programming as well as all the documents listed in Article 32 of Commission Delegated Regulation (EU) 2019/71522, based on a draft put forward by the Executive Director, after consulting the Scientific Committee, taking into account the opinion of the Commission, and in relation to multiannual programming after consulting the European Parliament. Where the Management Board decides not to take into account elements of the opinion of the Commission or of the Scientific Committee, it shall provide a thorough justification. The obligation to provide a thorough justification shall also apply to the elements raised by the European Parliament when it is consulted. The Management Board shall forward the single programming document to the European Parliament, the Council and the Commission by 31 January of the following year.
The Single Programming Document shall become definitive after final adoption of the general budget and if necessary shall be adjusted accordingly.	The Single Programming Document shall become definitive after final adoption of the general budget and if necessary shall be adjusted accordingly.
__________________	__________________
22 Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, (OJ L 122, 10.5.2019, p. 1).	22 Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, (OJ L 122, 10.5.2019, p. 1).

Amendment  128

Proposal for a regulation

Article 35 – paragraph 2 – subparagraph 2

Text proposed by the Commission	Amendment
Annual or multi-annual programming shall include the information about the implementation of the international cooperation framework referred to in Article 20 and the actions linked to this strategy.	Annual or multi-annual programming shall include the information about the implementation of the international cooperation framework referred to in Article 20 and the actions linked to this strategy. It shall also include the Agency’s planned research and innovation activities referred to in Article 21.

Amendment  129

 

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission	Amendment
2. The Agency's budget shall be balanced in terms of revenue and of expenditure.	2. The Agency's budget shall be balanced in terms of revenue and of expenditure. The Agency shall be awarded an adequate budget to ensure sufficient staff and equipment in order to allow it to achieve the objectives and tasks set out in this Regulation.

Amendment  130

 

Proposal for a regulation

Article 36 – paragraph 3 – point c

Text proposed by the Commission	Amendment
(c) the fees paid for services rendered in accordance with Article 37; and	(c) the fees paid for services rendered in accordance with Article 37;

Amendment  131

 

Proposal for a regulation

Article 36 – paragraph 3 – point d

Text proposed by the Commission	Amendment
(d) any financial contributions from the organisations and bodies and third countries referred to in Articles 53 and 54, respectively.	(d) any financial contributions from the organisations and bodies and third countries referred to in Articles 53 and 54, respectively; and.

Amendment  132

 

Proposal for a regulation

Article 36 – paragraph 3 – point d a (new)

Text proposed by the Commission	Amendment
	(da) Union funding under indirect management or in the form of ad hoc grants in accordance with the financial rules applicable to the Agency and with the provisions of the relevant instruments supporting the policies of the Union.

Amendment  133

 

Proposal for a regulation

Article 36 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission	Amendment
	The amount and origin of any revenue as referred to in points (b), (c) (d) and (da) of the first subparagraph of this paragraph shall be included in the annual accounts of the Agency and clearly detailed in the annual report on the Agency's budgetary and financial management referred to in Article 40(2).

Amendment  134

 

Proposal for a regulation

Article 37 – paragraph 1 – introductory part

Text proposed by the Commission	Amendment
1. The Agency may charge fees for the following:	1. The Agency may charge fees for the following services where they are clearly separated from the tasks of the Agency laid down in this Regulation:

Amendment  135

 

Proposal for a regulation

Article 37 – paragraph 1 – point a

Text proposed by the Commission	Amendment
(a) training programmes;	(a) training programmes other than those referred to in Article 19;

Amendment  136

 

Proposal for a regulation

Article 37 – paragraph 1 – point b

Text proposed by the Commission	Amendment
(b) certain support activities for Member States that have not been identified as a priority but could be beneficially conducted if supported by national resources;	(b) necessary and duly justified support activities for Member States other than those provided for in this Regulation that have not been identified as a priority but could be beneficially conducted if supported by national resources;

Amendment  137

 

Proposal for a regulation

Article 37 – paragraph 1 – point d

Text proposed by the Commission	Amendment
(d) certification of national bodies set up in third countries pursuant to Article 20(3);	(d) certification of national bodies set up in third countries, in particular candidate countries, pursuant to Article 20(3);

Amendment  138

 

Proposal for a regulation

Article 37 – paragraph 1 – point e

Text proposed by the Commission	Amendment
(e) other services falling within its mandate and rendered at the request of a participating country which require the investment of resources in the support of national activities.	(e) other customised services falling within its mandate and rendered at the request of a participating country which require the investment of additional resources in the support of national activities.

Amendment  139

 

Proposal for a regulation

Article 37 – paragraph 2

Text proposed by the Commission	Amendment
2. At the proposal of the Executive Director, the Management Board of the Agency shall set the amount of the fees and the way in which they are paid.	2. At the proposal of the Executive Director, the Management Board of the Agency shall set the amount of the fees and the way in which they are paid in a transparent manner and after having consulted the Commission. Those fees shall cover only the human and financial costs associated with the provision of the services set out in paragraph 1.

Amendment  140

 

Proposal for a regulation

Article 37 – paragraph 4

Text proposed by the Commission	Amendment
4. Fees should be set at a level such as to avoid a deficit or a significant accumulation of surplus in the budget. Should a significant positive balance in the budget, resulting from the provision of the services covered by fees, become recurrent, a revision of the level of the fees, or of the Union contribution, shall become mandatory. In case a significant negative balance results from the provision of the services covered by fees, a revision of the level of the fees shall become mandatory.	4. Fees should be set at a level such as to avoid a deficit or a significant accumulation of surplus in the budget. Should a significant positive balance in the budget, resulting from the provision of the services covered by fees, become recurrent, a revision of the level of the fees, or of the Union contribution, shall become mandatory. In case a significant negative balance results from the provision of the services covered by fees, the level of the fees shall be revised.

Amendment  141

 

Proposal for a regulation

Article 37 – paragraph 4 a (new)

Text proposed by the Commission	Amendment
	4a. An annual external audit shall be undertaken with regard to the fees collected by the Agency. The Agency shall transmit the results of such audits to the European Parliament without delay.

Amendment  142

Proposal for a regulation

Article 38 – paragraph 9

Text proposed by the Commission	Amendment
9. For any building project likely to have significant implications for the budget of the Agency, the provisions of Delegated Regulation (EU) 2019/71566 apply.	9. For any building project likely to have significant implications for the budget of the Agency, the provisions of Commission Delegated Regulation (EU) 2019/71566 apply.
_________________	_________________
66 OJ L 122, 10.5.2019, p. 1.	66 OJ L 122, 10.5.2019, p. 1.

Amendment  143

 

Proposal for a regulation

Article 43

Text proposed by the Commission	Amendment
Article 43	Article 28a
Executive Director	Executive Director
1. The Executive Director shall be engaged as a temporary agent of the Agency under Article 2, point (a), of the Conditions of Employment of Other Servants.	1. The Executive Director shall be engaged as a temporary agent of the Agency under Article 2, point (a), of the Conditions of Employment of Other Servants. The Executive Director shall be responsible for the day-to-day management of the Agency.
2. The Executive Director shall be appointed by the Management Board, from a list of candidates proposed by the Commission, following an open and transparent selection procedure.	2. The Executive Director shall be appointed by the Management Board, from a list of candidates proposed by the Commission, following an open and transparent selection procedure. Before appointment to a first term, the candidate selected by the Management Board for the post of Executive Director shall be invited, without delay, to make a statement before the competent committee of the European Parliament and answer questions put by Members of that committee. After hearing the statement and the responses, the European Parliament may adopt an opinion on the matter. The Management Board shall take due account of that opinion when appointing the Executive Director. Where the European Parliament is of the opinion that no candidate sufficiently fulfils the requirements for the post, the open selection procedure shall recommence.
3.  For the purpose of concluding the contract with the Executive Director, the Agency shall be represented by the Chairperson of the Management Board.	3.  For the purpose of concluding the contract with the Executive Director, the Agency shall be represented by the Chairperson of the Management Board.
4.  The term of office of the Executive Director shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the Executive Director's performance and the Agency's future tasks and challenges.	4.  The term of office of the Executive Director shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the Executive Director's performance and the Agency's future tasks and challenges.
5. The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 4, may extend the term of office of the Executive Director once, for no more than five years.	5. The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 4, may extend the term of office of the Executive Director once, for no more than five years. Before the Management Board takes its decision to extend the term of office, the Executive Director may be invited to appear before the competent committee of the European Parliament and answer questions put by members of that committee.
6.  An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period.	6.  An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period.
7. The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission.	7. The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission. The European Parliament and the Council shall be informed of the reasons for such removal.
8.  The Management Board shall reach decisions on appointment, extension of the term of office or removal from office of the Executive Director on the basis of a two-thirds majority of its members with voting rights.	8.  The Management Board shall reach decisions on appointment, extension of the term of office or removal from office of the Executive Director on the basis of a two-thirds majority of its members with voting rights.
	8a. Where called upon by the European Parliament or by the Council to attend a hearing on any matter linked to the Agency's activities, the Executive Director shall attend.

(Article 43 in its entirety is placed after Article 28.)

Amendment  144

Proposal for a regulation

Article 51 – paragraph 1

Text proposed by the Commission	Amendment
1. No later than [OP please insert the date = five years after the date referred to in Article 63], and every 5 years thereafter, the Commission shall assess the Agency’s performance in relation to its objectives, mandate, tasks and location in accordance with Commission guidelines. The evaluation shall, in particular, address the possible need to modify the mandate of the Agency, and the financial implications of any such modification.	1. No later than [OP please insert the date = five years after the date referred to in Article 63], and every 5 years thereafter, the Commission shall assess the Agency’s performance in relation to its objectives, mandate, tasks and location in accordance with Commission guidelines. The evaluation shall, in particular, address the possible need to modify the mandate of the Agency, and the financial implications of any such modification. It shall pay particular attention to the changes to the Agency's mandate and tasks introduced by this Regulation.

Amendment  145

Proposal for a regulation

Article 53 – paragraph 3 a (new)

Text proposed by the Commission	Amendment
	3a. The Agency shall publish working arrangements entered into pursuant to this Article on its website.

Amendment  146

 

Proposal for a regulation

Article 55 – title

Text proposed by the Commission	Amendment
Consultation of civil society organisations	Cooperation with civil society organisations

Amendment  147

 

Proposal for a regulation

Article 55 – paragraph 1

Text proposed by the Commission	Amendment
The Agency shall maintain a close dialogue with relevant civil society organisations active in the fields covered by this Regulation at national, Union or international level.	The Agency shall maintain structured cooperation with relevant non-governmental and civil society organisations, and affected communities within Europe and active in the fields covered by this Regulation, to ensure the regular and extensive consultation and exchange of information with civil society. To that end, the Agency shall appoint a person within the Agency responsible for managing that cooperation, under the authority of the Executive Director.

Amendment  148

 

Proposal for a regulation

Article 55 – paragraph 1 a (new)

Text proposed by the Commission	Amendment
	The cooperation referred to in the first paragraph shall be open to all interested and qualified stakeholders based in participating countries and shall include the Civil Society Forum on Drugs. To that end, the Commission and the Member States shall make available to the Civil Society Forum on Drugs appropriate and sustainable financial means and reinforced administrative support.

Amendment  149

 

Proposal for a regulation

Article 55 – paragraph 1 b (new)

Text proposed by the Commission	Amendment
	The Agency shall publish the names and the declared conflict of interests of stakeholders involved in its work on its website.

 

 

EXPLANATORY STATEMENT

The Rapporteur hereby presents the underlying reasons to the amendments introduced in the current draft report on the proposal for a Regulation of the European Parliament and of the Council on the European Union Drugs Agency 2022/0009(COD), proposed by the European Commission on 12 January 2022, and aimed at succeeding to Regulation (EC) No 1920/2006.

 

The European Commission’s proposal aims at strengthening the mandate of the European Monitoring Centre for Drugs and Drug Addiction, transforming it into the European Union Drugs Agency. This contemplates a revision of its organization and capabilities to properly equip the soon-to-be agency with the right tools to be able to, more efficiently and more timely, identify and address current and future challenges related to drugs in the EU. 

 

The Rapporteur welcomes the overall objective of the expansion, considering that increased resources and enhanced powers are essential to allow the agency to continue providing the European Union and its member states with factual, objective, reliable and comparable information at European level on drugs and drug addiction and their consequences.

 

In particular, the Rapporteur highlights the importance of the agency being provided with a strengthened monitoring and analysis capacity system, but also with a faster and efficient early warning system aimed at reacting to emerging threats and trends. Coupled with this stronger capacity of response, the Rapporteur welcomes the additional budget allocation of EUR 63 Million and 40 additional posts that will make the revised mandate a reality. Of equal importance to the Rapporteur is the possibility for the agency to engage more actively in international cooperation role, while affirming the external dimension of the Union’s drugs policy and the leadership role of the Union in this field at multilateral level.

 

However, the Rapporteur regrets the excessive focus that the proposal places on law enforcement, supply, security and control-related issues in detriment of harm reduction and health-related issues giving, therefore, raise to a certain imbalance throughout the text. For this reason, a number of amendments proposed by the Rapporteur aim at making sure that the health, social and human rights dimension continues to be given adequate emphasis in the Agency’s mandate.

 

Moreover, the Rapporteur sees with concern that the budgetary impact of the additional financial resources for the agency will be offset during the current Multiannual Financial Framework through a compensatory reduction from programmed spending under Heading 4: Migration and Border Management.

 

The Rapporteur also looks with apprehension to the proposed reduction of the presence of European Parliament representatives on the EMCDDA Management Board and takes the view that the experts designated by the EP should continue to be two as it is the case today

 

Last but not least, the Rapporteur strongly disapproves the lack of a comprehensive civil society involvement, able to meaningfully take part in the work developed by the Agency, and insists that relevant provisions should be included in the regulation for this purpose.

 

 

The Rapporteur takes good note of the general approach adopted by the French Presidency of the Council, considering it, in many aspects, a significant improvement to the European Commission’s proposal. Therefore, the Rapporteur gets inspiration and adopts some of the solutions that the text provides. Furthermore, the Rapporteur has proposed a large number of amendments as a result of all the meetings and consultations held with the shadows of all political groups involved, as well as following exchanges with the BUDG Rapporteur, responsible for the respective opinion, the European Commission, the French Presidency of the Council, the EMCDDA Director, the two European Parliament representatives on the EMCDDA Management Board, and the representatives from civil society organizations. After such extensive and encompassing work, the rapporteur expects that these proposals can form a good and solid basis for swift agreement, first in the European Parliament, and later on in the interinstitutional negotiations.

 

OPINION OF THE COMMITTEE ON BUDGETS (30.8.2022)

for the Committee on Civil Liberties, Justice and Home Affairs

on the proposal for a regulation of the European Parliament and of the Council on the European Union Drugs Agency

(COM(2022)0018 – C9‑0010/2022 – 2022/0009(COD))

Rapporteur for opinion: Niclas Herbst

 

SHORT JUSTIFICATION

While the COVID-19 pandemic devastated businesses and workers across the European Union, drug markets showed remarkable resilience. Those producing and trafficking illegal drugs continued to profit from the damage they do to people’s lives, particularly those in marginalised groups. Drugs sellers have embraced new technologies, with use of encrypted messaging services, social media and e-commerce, very often on the darknet. At the same time, people using drugs are increasingly experimenting with poly-substance use, consuming more than one drug or substance at the same time. The drugs phenomenon is therefore exhibiting increasing complexity and moving with increasing speed.

The 2021-2025 EU Drugs Strategy[1] and the 2021-2025 EU Drugs Action Plan[2] demand greater action at EU level to tackle the evolving drugs challenges and call on the Commission to propose an expanded mandate for the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to take into account the evolving situation. The evaluation conducted by the Commission of the EMCDDA’s work[3] underlines the valuable work done by the agency, but also highlights gaps in its mandate. This proposal seeks to fill these gaps and ensure that the revamped agency’s mandate is fit for purpose by extending it to cover poly-substance use and better monitoring and threat assessment capabilities. The proposal also beefs up data and information gathering, enables the agency to develop EU-wide prevention and awareness-raising campaigns and provides that it can issue alerts when a new dangerous substance appears on the market. Finally, since the existing EMCDDA regulation dates from 2006, the proposal brings the provisions into line with the Joint Statement of the European Parliament, the Council and the Commission on decentralised agencies of 19 July 2012 and the Common Approach[4].

Your Rapporteur welcomes the central aims of the proposal and is convinced that an expanded mandate for the drugs agency will enable more effective action both to disrupt the illicit drugs market and to protect European citizens from the dangers of drugs.

Nevertheless, in line with his approach to decentralised agency files, he considers that the policy substance of the proposal should be dealt with by the lead committee. As such, the draft opinion focuses on those areas where the Committee on Budgets can add value, therefore in particular on the financial provisions and governance rules.

Budgetary impact and financial provisions

According to the Commission proposal, the EU Drugs Agency will need an additional EUR 63 million between 2024 and 2027 compared to the MFF programming and its total staff will increase from 111 in the 2022 budget to 145 by 2027. It is of course imperative that the agency has sufficient financial and human resources to execute its reinforced mandate and it will be important to ensure that any further tasks and responsibilities that may be agreed in the final legislation are properly funded.

Your Rapporteur strongly opposes the Commission’s intention of financing the additional resources for the agency in heading 5 through a compensatory reduction of the Border Management and Visa Instrument (BMVI) programme in heading 4. The BMVI benefits from a EUR 1 billion top-up through a programme-specific adjustment agreed during the MFF negotiations, meaning there was a clear political will to reinforce the instrument precisely to deal with border management and not to provide a pot of money to reinforce agencies. The importance of this top-up has been borne out by the Ukraine crisis and the proposed increase for the BMVI in Drafting Amending Budget 3/2022. Moreover, the additional tasks assigned to the Drugs Agency under the proposal are not tasks that would otherwise be carried out under the BMVI.

Fees

The proposal introduces the possibility for the agency to charge fees for ‘non-core services’ as a means of bringing in additional revenue. Your Rapporteur’s starting point is that agencies should have the budget required to perform the tasks assigned to them by the legislator. While fee-based financing models are entirely legitimate where fees are levied for core services (e.g. the fees-based model employed by the European Medicines Agency or the European Banking Authority), it is not clear why the Drugs Agency should charge fees for services that the legislator has not considered it necessary to provide in the first place.

Moreover, the provisions governing fees lack clarity, with the nature of the services nebulously defined and the Management Board enjoying considerable leeway to determine the nature and level of fees, with no parliamentary control. As such, your Rapporteur introduces amendments to delete the provisions enabling the agency to levy fees. Greater clarity in terms of the purpose and nature of the fees and clear provisions on parliamentary scrutiny would be required to consider the introduction of such fees.

Governance, parliamentary scrutiny and transparency

Your Rapporteur introduces a number of more technical amendments to ensure that provisions in the regulation comply fully with the principles in the Common Approach. The majority of these amendments seek to enhance parliamentary scrutiny and accountability, for example with respect to the appointment of the Executive Director, and to ensure transparency in budgetary reporting.

 

AMENDMENTS

The Committee on Budgets calls on the Committee on Civil Liberties, Justice and Home Affairs, as the committee responsible, to take into account the following amendments:

Amendment  1

Proposal for a regulation

Recital 14

Text proposed by the Commission	Amendment
(14) The drug phenomenon is becoming more and more technology-enabled, as was shown again during the COVID-19 pandemic where a greater adoption of new technologies to facilitate drug distribution has been observed. It is estimated that about two-thirds of the offers on darknet markets are drug-related. Drug trading is using different platforms, including social media networks and mobile applications. This development is mirrored in responses to the drug phenomenon, with an increased use of mobile applications and e-health interventions. The Agency, together with other relevant Union agencies and avoiding duplication of efforts, should monitor such developments as part of its holistic approach to the drug phenomenon.	(14) The drug phenomenon is becoming more and more technology-enabled, as was shown again during the COVID-19 pandemic where a greater adoption of new technologies to facilitate drug distribution has been observed. It is estimated that about two-thirds of the offers on darknet markets are drug-related. Drug trading is using different platforms, including social media networks and mobile applications. This development is mirrored in responses to the drug phenomenon, with an increased use of mobile applications and e-health interventions. The Agency, together with other relevant Union agencies and avoiding duplication of efforts, should monitor such developments as part of its holistic approach to the drug phenomenon. Taking into account technological advancements and more sophisticated encryption methods, the Agency should stress the importance of adopting adequate digital solutions by Member States, in order to tackle the drug phenomenon in a coordinated, coherent and interoperable manner.

Amendment  2

Proposal for a regulation

Recital 25

Text proposed by the Commission	Amendment
(25) The responsibilities of the Agency in the area of international cooperation should be defined in more clear terms in order to allow it to fully engage in such activities and respond to requests from third countries and bodies. The Agency should be able to contribute to the development and implementation of the external dimension of the Union’s drugs policy and the leadership role of the Union at multilateral level as a means to ensure the efficient and coherent implementation of the Union drug policies internally and at international level. In order that the Agency can allocate adequate levels of resources to this task, the work on international cooperation should be part of the core tasks of the Agency. It should be based on an international cooperation framework of the Agency, which should be in line with the Union priorities on international cooperation and should be revised on a regular basis to ensure that it adequately reflects international developments.	(25) International cooperation should be a core task of the Agency, with responsibilities defined in clearer terms, in order to allow it to fully engage in such activities and respond to requests from third countries and bodies. The Agency should be able to contribute to the development and implementation of the external dimension of the Union’s drugs policy and the leadership role of the Union at multilateral level as a means to ensure the efficient and coherent implementation of the Union drug policies internally and at international level. Work in this area should be based on an international cooperation framework of the Agency, which should be in line with the Union priorities on international cooperation and should be revised on a regular basis to ensure that it adequately reflects international developments.

 

Amendment  3

Proposal for a regulation

Recital 26

Text proposed by the Commission	Amendment
(26) In order to help Union funding for security research to develop its full potential and address the needs of drugs policy, the Agency should assist the Commission in identifying key research themes, drawing up and implementing the Union framework programmes for research and innovation that are relevant to the Agency’s objectives. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, it should not receive funding from that programme in order to avoid a potential conflict of interest. Finally, the Agency should participate in Union-wide initiatives addressing research and innovation to ensure that technologies necessary for its activities are developed and available for use.	(26) In order to help Union funding for security research to develop its full potential and address the needs of drugs policy, the Agency should assist the Commission in identifying key research themes and in drawing up and implementing the Union framework programmes for research and innovation that are relevant to the Agency’s objectives. Where the Agency assists the Commission in identifying key research themes and in drawing up and implementing a Union framework programme, it should not receive funding from that programme and take all necessary measures to avoid conflicts of interest. Finally, the Agency should participate in Union-wide initiatives addressing research and innovation to ensure that technologies necessary for its activities are developed and available for use. Planned research and innovation activities should be set out in the single programming document containing the Agency’s multiannual and annual work programme.

 

Amendment  4

Proposal for a regulation

Recital 27

Text proposed by the Commission	Amendment
(27) The Management Board should be assisted by an Executive Board to prepare its decisions. The Agency should be headed by an Executive Director. A Scientific Committee should continue assisting the Management Board and the Executive Director with regard to relevant scientific matters.	(27) The Agency should be organised as follows. A Management Board, composed of representatives from the Member States and the Commission and an expert appointed by the European Parliament, should be responsible for overseeing the work of the Agency. The Member States, the Commission and the European Parliament should respect the principle of gender balance in their appointments and particularly regarding the overall composition of the Management Board. The Management Board should be assisted by an Executive Board, which should also be able to take specific decisions in clearly defined cases. The Agency should be headed by an Executive Director, who should be responsible for the day-to-day management of the Agency. A Scientific Committee should assist the Management Board and the Executive Director with regard to relevant scientific matters

 

Amendment  5

Proposal for a regulation

Recital 27 a (new)

Text proposed by the Commission	Amendment
	(27a) The Executive Director should be appointed by the Management Board based on a shortlist drawn up by the Commission and having obtained the consent of the European Parliament. The Executive Director should present the annual report of the Agency to the European Parliament and to the Council. Furthermore, the European Parliament and the Council should be able to invite the Executive Director to report on the performance of his or her duties.

Amendment  6

Proposal for a regulation

Recital 27 b (new)

Text proposed by the Commission	Amendment
	(27b) In order to ensure the independent functioning and integrity of the Agency, the Management Board should adopt practical arrangements for the prevention and management of conflicts of interest, giving due consideration to the recommendations of the European Ombudsman. Those arrangements should ensure in particular that senior representatives of the Agency do not undermine its integrity during or after their term of office.

 

Amendment  7

Proposal for a regulation

Recital 29

Text proposed by the Commission	Amendment
(29) The Agency should be properly resourced to carry out its tasks and granted an autonomous budget. It should be mainly financed by a contribution from the general budget of the Union. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors of the European Union.	(29) The Agency should be provided with the necessary human and financial resources to fulfil the objectives, tasks and responsibilities assigned to it under this regulation. It should be granted an autonomous budget. It should be mainly financed by a contribution from the general budget of the Union, with the necessary appropriations drawn exclusively from unallocated margins under the relevant heading of the multiannual financial framework and/or through the mobilisation of the relevant special instruments. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors of the European Union.

Amendment  8

Proposal for a regulation

Recital 30

Text proposed by the Commission	Amendment
(30) Fees improve the funding of an agency and may be considered for specific issues that can be clearly separated from the core tasks of the agency. Any fees levied by the Agency should cover its costs for providing the respective services.	deleted

Amendment  9

Proposal for a regulation

Recital 31

Text proposed by the Commission	Amendment
(31) The Executive Director should present the annual report of the Agency to the European Parliament and to the Council. Furthermore, the European Parliament and the Council should be able to invite the Executive Director to report on the performance of her or his duties.	deleted

Amendment  10

Proposal for a regulation

Recital 35

Text proposed by the Commission	Amendment
(35) The Agency should cooperate closely with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its work programme, notably to avoid duplication of work and to ensure access to all data and tools needed for carrying out its mandate.	(35) The Agency should cooperate closely with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its work programme, notably to avoid duplication of work and to ensure access to all data and tools needed for carrying out its mandate. In that regard, it should be possible for the Agency to engage with civil society organisations and other relevant stakeholders in order to raise awareness at Union level.

 

Amendment  11

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission	Amendment
1. The Agency shall assist the Commission and the Member States in identifying key research themes, drawing up and implementing the Union framework programmes for research and innovation activities that are relevant to achieve its general task set out in Article 4. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, the Agency shall not receive funding from that programme.	1. The Agency shall assist the Commission and the Member States in identifying key research themes and in drawing up and implementing the Union framework programmes for research and innovation activities that are relevant to achieve its general and specific tasks set out in Articles 4 and 5. Where the Agency assists the Commission in identifying key research themes, drawing up and implementing a Union framework programme, the Agency shall not receive funding from that programme. The Agency shall take all necessary measures to avoid conflicts of interest.

Amendment  12

Proposal for a regulation

Article 21 – paragraph 2

Text proposed by the Commission	Amendment
2. The Agency shall proactively monitor and contribute to research and innovation activities to achieve its general task set out in Article 4, support related activities of Member States, and implement its research and innovation activities regarding matters covered by this Regulation, including the development, training, testing and validation of algorithms for the development of tools. The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 49.	2. The Agency shall proactively monitor and contribute to research and innovation activities to achieve its general and specific tasks set out in Articles 4 and 5, support related activities of Member States, and implement its research and innovation activities regarding matters covered by this Regulation, including the development, training, testing and validation of algorithms for the development of tools. The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 49.

Amendment  13

Proposal for a regulation

Article 23 – paragraph 6

Text proposed by the Commission	Amendment
6. The term of office for members and their alternates shall be four years. That term may be renewable.	6. The term of office for members and their alternates shall be four years. That term may be renewed once.

 

Amendment  14

Proposal for a regulation

Article 24 – paragraph 1 – point b

Text proposed by the Commission	Amendment
(b) adopt the draft single programming document referred to in Article 35 before its submission to the Commission for its opinion;	(b) adopt the draft single programming document referred to in Article 35 by a majority of two-thirds of members entitled to vote in accordance with Article 23;

Amendment  15

Proposal for a regulation

Article 24 – paragraph 1 – point c

Text proposed by the Commission	Amendment
(c) adopt, having requested the opinion of the Commission, the Agency's single programming document by a majority of two-thirds of members entitled to vote in accordance with Article 23;	deleted

Amendment  16

Proposal for a regulation

Article 24 – paragraph 1 – point n

Text proposed by the Commission	Amendment
(n) adopt its rules of procedure;	(n) adopt its rules of procedure, including practical arrangements for the prevention and management of conflicts of interest;

Amendment  17

Proposal for a regulation

Article 24 – paragraph 1 – point t

Text proposed by the Commission	Amendment
(t) approve the list of experts to be used to extend the Scientific Committee in accordance with Article 10(4);	(t) approve the list of experts to be used to extend the Scientific Committee in accordance with Article 30(6);

Amendment  18

Proposal for a regulation

Article 28 – paragraph 3 – subparagraph 3

Text proposed by the Commission	Amendment
The Executive Director shall take part in the meetings of the Executive Board, but shall not have the right to vote. The Executive Board may invite other observers to attend its meetings.	The Executive Director shall take part in the meetings of the Executive Board. The Executive Board may invite other observers to attend its meetings.

Amendment  19

Proposal for a regulation

Article 28 – paragraph 4

Text proposed by the Commission	Amendment
4. The term of office of members of the Executive Board shall be four years. The term of office of members of the Executive Board shall end when their membership of the Management Board ends.	4. The term of office of members of the Executive Board shall be four years and may be renewed once. The term of office of members of the Executive Board shall end when their membership of the Management Board ends.

Amendment  20

Proposal for a regulation

Article 28 a (new)

Text proposed by the Commission	Amendment
	Article 28a
	Executive Director
	1.  The Executive Director shall be engaged as a temporary agent of the Agency under Article 2, point (a), of the Conditions of Employment of Other Servants. He/she shall be responsible for the day-to-day management of the Agency.
	2.  The Executive Director shall be appointed by the Management Board in accordance with the following procedure:
	(a)  on the basis of a shortlist drawn up by the Commission after a call for candidates and a transparent selection procedure, applicants will be asked to address the competent committee of the European Parliament and the Council and to reply to questions;
	(b)  the European Parliament and the Council will then give their opinions and state their preferences;
	(c)  the Management Board will appoint the Executive Director taking those opinions into account.
	3.  For the purpose of the concluding the contract with the Executive Director, the Agency shall be represented by the Chairperson of the Management Board.
	4.  The term of office of the Executive Director shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the Executive Director's performance and the Agency's future tasks and challenges.
	5.  The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 4, may extend the term of office of the Executive Director once, for no more than five years. The Management Board shall inform the European Parliament and the Council about its intention to extend the Executive Director's mandate. Before the Management Board takes its decision to extend the mandate, the Executive Director may be asked to make a declaration before the competent committee of the European Parliament and answer questions.
	6.  An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period.
	7.  The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission. The European Parliament and the Council shall be informed of the reasons.
	8.  The Management Board shall reach decisions on appointment, extension of the term of office or removal from office of the Executive Director on the basis of a two-thirds majority of its members with voting rights.
	9.  The Executive Director may be called upon at any time by the European Parliament or by the Council to attend a hearing on any matter linked to the Agency's activities.

Amendment  21

Proposal for a regulation

Article 29 – paragraph 5 – point g

Text proposed by the Commission	Amendment
(g) proposing to the Commission, after consulting the Management Board, the amount of fees in accordance with Article 37;	deleted

Amendment  22

Proposal for a regulation

Article 29 – paragraph 6

Text proposed by the Commission	Amendment
6. The Executive Director shall decide whether it is necessary to locate one or more staff in one or more Member States for the purpose of carrying out the Agency's tasks in an efficient and effective manner. Before deciding to establish a local office, the Executive Director shall obtain the prior consent of the Commission, the Management Board and the host Member State(s) concerned. The decision shall specify the scope of the activities to be carried out at the local office in a manner that avoids unnecessary costs and duplication of administrative functions of the Agency. A headquarters agreement with the host Member State(s) concerned may be concluded.	6. The Executive Director shall decide whether it is necessary to locate one or more staff in one or more Member States for the purpose of carrying out the Agency's tasks in an efficient and effective manner. Before deciding to establish a local office, the Executive Director shall obtain the prior consent of the Commission, the Management Board and the host Member State(s) concerned. The decision shall specify the scope of the activities to be carried out at the local office in a manner that avoids unnecessary costs and duplication of administrative functions of the Agency. A headquarters agreement with the host Member State(s) concerned shall be concluded.

 

Amendment  23

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
1. The Scientific Committee shall consist of at most fifteen scientists appointed by the Management Board in view of their scientific excellence and their independence, following the publication of a call for expression of interest in the Official Journal of the European Union. The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant fields linked to the objectives of the Agency.	1. The Scientific Committee shall consist of at most fifteen scientists appointed by the Management Board in view of their scientific excellence and their independence and in full respect of the principle of gender balance, following the publication of a call for expression of interest in the Official Journal of the European Union. Before making appointments to the Scientific Committee, the Management Board shall first consult the competent committee of the European Parliament. The selection procedure shall ensure that the specialist fields of the members of the Scientific Committee cover the most relevant fields linked to the objectives of the Agency.

 

Amendment  24

Proposal for a regulation

Article 35 – paragraph 1

Text proposed by the Commission	Amendment
1. By 15 December of each year, the Management Board shall adopt a draft single programming document containing multi-annual and annual programming as well as all the documents listed in Article 32 of Commission Delegated Regulation (EU) 2019/71522, based on a draft put forward by the Executive Director, after consulting the Scientific Committee, taking into account the opinion of the Commission, and in relation to multiannual programming after consulting the European Parliament. It shall forward it to the European Parliament, the Council and the Commission by 31 January of the following year.	1. By 15 December of each year, the Management Board shall adopt a draft single programming document containing multi-annual and annual programming as well as all the documents listed in Article 32 of Commission Delegated Regulation (EU) 2019/71522, based on a draft put forward by the Executive Director, after consulting the Scientific Committee, taking into account the opinion of the Commission, and in relation to multiannual programming after consulting the European Parliament. If the Management Board decides not to take into account elements of the opinion of the Commission or of the Scientific Committee, it shall provide a thorough justification. The obligation to provide a thorough justification shall also apply to the elements raised by the European Parliament when it is consulted. The Management Board shall forward the single programming document to the European Parliament, the Council and the Commission by 31 January of the following year.
The Single Programming Document shall become definitive after final adoption of the general budget and if necessary shall be adjusted accordingly.	The Single Programming Document shall become definitive after final adoption of the general budget and if necessary shall be adjusted accordingly.
__________________	__________________
22 Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, (OJ L 122, 10.5.2019, p. 1).	22 Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, (OJ L 122, 10.5.2019, p. 1).

 

Amendment  25

Proposal for a regulation

Article 35 – paragraph 2 – subparagraph 2

Text proposed by the Commission	Amendment
Annual or multi-annual programming shall include the information about the implementation of the international cooperation framework referred to in Article 20 and the actions linked to this strategy.	Annual or multi-annual programming shall include the information about the implementation of the international cooperation framework referred to in Article 20 and the actions linked to this strategy. It shall also include the Agency’s planned research and innovation activities referred to in Article 21.

Amendment  26

Proposal for a regulation

Article 36 – paragraph 3 – point c

Text proposed by the Commission	Amendment
(c) the fees paid for services rendered in accordance with Article 37; and	deleted

 

Amendment  27

Proposal for a regulation

Article 36 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission	Amendment
	The amount and origin of any revenue referred to in points (b) and (d) of the first sub-paragraph of this paragraph shall be included in the annual accounts of the Agency and clearly detailed in the annual report on the Agency's budgetary and financial management referred to in Article 40(2).

Amendment  28

Proposal for a regulation

Article 37

Text proposed by the Commission	Amendment
Article 37	deleted
Fees
1. The Agency may charge fees for the following:
(a) training programmes;
(b) certain support activities for Member States that have not been identified as a priority but could be beneficially conducted if supported by national resources;
(c) capacity-building programmes for third countries, which are not covered by separate dedicated Union funding;
(d) certification of national bodies set up in third countries pursuant to Article 20(3);
(e) other services falling within its mandate and rendered at the request of a participating country which require the investment of resources in the support of national activities.
2. At the proposal of the Executive Director, the Management Board of the Agency shall set the amount of the fees and the way in which they are paid.
3. Fees shall be proportionate to the costs of the relevant services as provided in a cost-effective way and shall be sufficient to cover those costs. Fees shall be set at such a level as to ensure that they are non-discriminatory and that they avoid placing an undue financial or administrative burden on stakeholders.
4. Fees should be set at a level such as to avoid a deficit or a significant accumulation of surplus in the budget. Should a significant positive balance in the budget, resulting from the provision of the services covered by fees, become recurrent, a revision of the level of the fees, or of the Union contribution, shall become mandatory. In case a significant negative balance results from the provision of the services covered by fees, a revision of the level of the fees shall become mandatory.

 

Amendment  29

Proposal for a regulation

Article 43

Text proposed by the Commission	Amendment
Article 43	deleted
Executive Director
1. The Executive Director shall be engaged as a temporary agent of the Agency under Article 2, point (a), of the Conditions of Employment of Other Servants.
2. The Executive Director shall be appointed by the Management Board, from a list of candidates proposed by the Commission, following an open and transparent selection procedure.
3. For the purpose of concluding the contract with the Executive Director, the Agency shall be represented by the Chairperson of the Management Board.
4. The term of office of the Executive Director shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the Executive Director's performance and the Agency's future tasks and challenges.
5. The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 4, may extend the term of office of the Executive Director once, for no more than five years.
6. An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period.
7. The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission.
8. The Management Board shall reach decisions on appointment, extension of the term of office or removal from office of the Executive Director on the basis of a two-thirds majority of its members with voting rights.

Amendment  30

Proposal for a regulation

Article 51 – paragraph 1

Text proposed by the Commission	Amendment
1. No later than [OP please insert the date = five years after the date referred to in Article 63], and every 5 years thereafter, the Commission shall assess the Agency’s performance in relation to its objectives, mandate, tasks and location in accordance with Commission guidelines. The evaluation shall, in particular, address the possible need to modify the mandate of the Agency, and the financial implications of any such modification.	1. No later than [OP please insert the date = five years after the date referred to in Article 63], and every 5 years thereafter, the Commission shall assess the Agency’s performance in relation to its objectives, mandate, tasks and location in accordance with Commission guidelines. The evaluation shall, in particular, address the possible need to modify the mandate of the Agency, and the financial implications of any such modification. It shall pay particular attention to the changes to the Agency's mandate and tasks introduced by this Regulation.

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title	European Union Drugs Agency
References	COM(2022)0018 – C9-0010/2022 – 2022/0009(COD)
Committee responsible  Date announced in plenary	LIBE 7.3.2022
Opinion by  Date announced in plenary	BUDG 7.3.2022
Rapporteur for the opinion  Date appointed	Niclas Herbst 1.2.2022
Discussed in committee	21.6.2022
Date adopted	31.8.2022
Result of final vote	+: –: 0:	32 1 4
Members present for the final vote	Rasmus Andresen, Pietro Bartolo, Olivier Chastel, Lefteris Christoforou, Andor Deli, José Manuel Fernandes, Eider Gardiazabal Rubial, Alexandra Geese, Francisco Guerreiro, Valérie Hayer, Eero Heinäluoma, Niclas Herbst, Monika Hohlmeier, Moritz Körner, Joachim Kuhs, Zbigniew Kuźmiuk, Pierre Larrouturou, Camilla Laureti, Janusz Lewandowski, Margarida Marques, Silvia Modig, Siegfried Mureşan, Lefteris Nikolaou-Alavanos, Andrey Novakov, Dimitrios Papadimoulis, Karlo Ressler, Bogdan Rzońca, Nicolae Ştefănuță, Johan Van Overtveldt, Rainer Wieland, Angelika Winzig
Substitutes present for the final vote	Rosa D’Amato, Fabienne Keller, Jan Olbrycht
Substitutes under Rule 209(7) present for the final vote	Clara Aguilera, Alessandra Basso, Vlad-Marius Botoş, Juozas Olekas

 

 

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

32	+
ECR	Johan Van Overtveldt
NI	Andor Deli
PPE	Lefteris Christoforou, José Manuel Fernandes, Niclas Herbst, Monika Hohlmeier, Janusz Lewandowski, Siegfried Mureşan, Andrey Novakov, Jan Olbrycht, Karlo Ressler, Rainer Wieland, Angelika Winzig
Renew	Vlad‑Marius Botoş, Olivier Chastel, Valérie Hayer, Fabienne Keller, Moritz Körner, Nicolae Ştefănuță
S&D	Clara Aguilera, Pietro Bartolo, o, Eider Gardiazabal Rubial, Eero Heinäluoma, Pierre Larrouturou, Camilla Laureti, Margarida Marques, Juozas Olekas
The Left	Silvia Modig, Dimitrios Papadimoulis
Verts/ALE	Rasmus Andresen, Rosa D'Amato, Alexandra Geese

 

1	-
ID	Lefteris Nikolaou‑Alavanos

 

4	0
ECR	Zbigniew Kuźmiuk, Bogdan Rzońca
ID	Alessandra Basso, Joachim Kuhs

 

Key to symbols:

+ : in favour

- : against

0 : abstention

 

 

 

PROCEDURE – COMMITTEE RESPONSIBLE

Title	European Union Drugs Agency
References	COM(2022)0018 – C9-0010/2022 – 2022/0009(COD)
Date submitted to Parliament	12.1.2022
Committee responsible  Date announced in plenary	LIBE 7.3.2022
Committees asked for opinions  Date announced in plenary