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Boosting cooperation on health technology assessment

15-07-2021

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While ...

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While Member States could choose to delay participation in the joint work until three years after the rules enter into force, it would become mandatory after six years. Stakeholders broadly welcomed the Commission proposal. National parliaments, however, are divided in their appreciation of it. The provisional agreement, applauded by some stakeholders, has been criticised by the pharmaceutical industry, in particular, for its lack of ambition. The European Parliament adopted its final position at first reading on 14 February 2019. In the Council, work was carried out under seven consecutive presidencies. On 24 March 2021, the co-legislators reached a provisional agreement in interinstitutional trilogue negotiations. The Council's Permanent Representatives Committee endorsed the provisional agreement on 30 June 2021. Parliament's ENVI committee voted in favour of the text on 13 July 2021. Council and then Parliament are expected to formally adopt it in the coming months. Fourth edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Mental health and the pandemic

09-07-2021

While the pandemic is primarily a physical health crisis, it has also had widespread impact on people's mental health, inducing, among other things, considerable levels of fear, worry, and concern. The growing burden on mental health has been referred to by some as the 'second' or 'silent' pandemic. While negative mental health consequences affect all ages, young people, in particular, have been found to be at high risk of developing poor mental health. Specific groups have been particularly hard ...

While the pandemic is primarily a physical health crisis, it has also had widespread impact on people's mental health, inducing, among other things, considerable levels of fear, worry, and concern. The growing burden on mental health has been referred to by some as the 'second' or 'silent' pandemic. While negative mental health consequences affect all ages, young people, in particular, have been found to be at high risk of developing poor mental health. Specific groups have been particularly hard hit, including health and care workers, people with pre-existing mental health problems, and women. The pandemic has also appeared to increase inequalities in mental health, both within the population and between social groups. To address the population's increased psycho-social needs, the World Health Organization Regional Office for Europe established an expert group on the mental health impacts of Covid-19 in the European region. The Organisation for Economic Co-operation and Development has issued analyses and guidance on mental health in general and the pandemic's impact on mental health in particular. At European Union level, a December 2020 European Commission communication addressed the pandemic's impact on mental health. In May 2021, the Commission organised a major online stakeholder event, and published best practice examples of solutions presented. A July 2020 European Parliament resolution recognises mental health as a fundamental human right, calling for a 2021-2027 EU action plan on mental health. Members of the European Parliament have also called on the Commission to put mental health at the heart of EU policymaking. Stakeholders broadly rally around calls for programmes and funding to improve citizens' mental health, not least to respond to the pandemic's long-term implications.

Przedłużenie mandatu Europejskiej Agencji Leków

01-07-2021

11 listopada 2020 r. Komisja Europejska przyjęła wniosek w sprawie wzmocnienia Europejskiej Agencji Leków (EMA). Proponowane rozporządzenie umożliwi EMA m.in. lepsze przewidywanie ewentualnych niedoborów produktów leczniczych i zapewnienie ich terminowego rozwoju, aby poprawić zdolności UE do reagowania na stany zagrożenia zdrowia publicznego. 22 czerwca 2021 r. parlamentarna Komisja Ochrony Środowiska Naturalnego, Zdrowia Publicznego i Bezpieczeństwa Żywności przyjęła sprawozdanie w tej sprawie. ...

11 listopada 2020 r. Komisja Europejska przyjęła wniosek w sprawie wzmocnienia Europejskiej Agencji Leków (EMA). Proponowane rozporządzenie umożliwi EMA m.in. lepsze przewidywanie ewentualnych niedoborów produktów leczniczych i zapewnienie ich terminowego rozwoju, aby poprawić zdolności UE do reagowania na stany zagrożenia zdrowia publicznego. 22 czerwca 2021 r. parlamentarna Komisja Ochrony Środowiska Naturalnego, Zdrowia Publicznego i Bezpieczeństwa Żywności przyjęła sprawozdanie w tej sprawie. Ma ono zostać poddane pod głosowanie podczas lipcowej sesji plenarnej, co pozwoli ustalić stanowisko negocjacyjne Parlamentu i utoruje drogę do negocjacji międzyinstytucjonalnych.

Global Health Summit

12-05-2021

The Global Health Summit – jointly hosted by the European Commission and Italy, as chair of the Group of Twenty (G20) – will take place on 21 May 2021 in Rome. Bringing together leaders, heads of international and regional organisations and representatives of global health bodies, it will provide a platform for sharing lessons learned from the coronavirus pandemic. The discussions will feed into a declaration of principles that can guide multilateral cooperation and joint action to prevent future ...

The Global Health Summit – jointly hosted by the European Commission and Italy, as chair of the Group of Twenty (G20) – will take place on 21 May 2021 in Rome. Bringing together leaders, heads of international and regional organisations and representatives of global health bodies, it will provide a platform for sharing lessons learned from the coronavirus pandemic. The discussions will feed into a declaration of principles that can guide multilateral cooperation and joint action to prevent future health crises. Meanwhile, in a parallel process initiated by European Council President Charles Michel, world leaders are calling for an international treaty on pandemics.

EU4Health programme

22-04-2021

On 28 May 2020, the European Commission adopted a proposal for a regulation on a new health programme (EU4Health) for 2021 to 2027. Announced as part of the Next Generation EU (NGEU) recovery instrument, according to the Commission, the EU4Health programme is intended to boost the EU's preparedness for major cross-border health threats and improve health systems' resilience. EU4Health would be a stand-alone, dedicated funding programme with an originally proposed budget of €10.4 billion (in current ...

On 28 May 2020, the European Commission adopted a proposal for a regulation on a new health programme (EU4Health) for 2021 to 2027. Announced as part of the Next Generation EU (NGEU) recovery instrument, according to the Commission, the EU4Health programme is intended to boost the EU's preparedness for major cross-border health threats and improve health systems' resilience. EU4Health would be a stand-alone, dedicated funding programme with an originally proposed budget of €10.4 billion (in current prices). However, during the negotiations on the 2021-2027 multiannual financial framework (MFF) and NGEU, the budget for EU4Health was revised downwards, with the July 2020 European Council conclusions allocating the programme €1.7 billion. On 14 December 2020, Parliament and Council reached a provisional agreement on the programme, including a budget of €5.1 billion. Stakeholders had broadly welcomed the proposal, but generally regretted the European Council's reduction of the financial envelope allocated to it. The co-legislators' December agreement on an increased budget was thus positively received. After adoption by the Parliament and Council in March 2021, based on the text agreed in trilogue, the final act was signed by the presidents of the co-legislators on 24 March 2021. Regulation (EU) 2021/522 entered into force on 27 March 2021 and applies retroactively from 1 January 2021. Third edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Building up resilience to cross-border health threats: Moving towards a European health union

20-04-2021

On 11 November 2020, the European Commission put forward a proposal for a regulation on serious cross-border threats to health. In the light of lessons learned from the Covid-19 crisis, it aims to strengthen the EU's health security by revising Decision No 1082/2013/EU (the 'Cross-Border Health Threats Decision'). The proposal was presented in a package that also includes proposals to strengthen the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), ...

On 11 November 2020, the European Commission put forward a proposal for a regulation on serious cross-border threats to health. In the light of lessons learned from the Covid-19 crisis, it aims to strengthen the EU's health security by revising Decision No 1082/2013/EU (the 'Cross-Border Health Threats Decision'). The proposal was presented in a package that also includes proposals to strengthen the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), as first steps towards a European health union. Stakeholders widely welcome the proposal and the package. Some say it could be improved further, suggesting concrete elements, while others think it should go beyond crisis preparedness. Still others consider it a springboard to a bigger role for the European Union (EU) in health. Parliament has repeatedly called for stronger cooperation on health, for a new regulation to replace the Cross-Border Health Threats Decision, and for revised mandates of both the ECDC and the EMA. Parliament's Committee on the Environment, Public Health and Food Safety is responsible for the file and the rapporteur's draft report is expected to be presented in committee on 22 April 2021. In Council, work is ongoing in the working party on pharmaceuticals and medical devices. First edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Limits on exposure to carcinogens and mutagens at work: Fourth proposal

31-03-2021

The European Commission has proposed to amend Directive 2004/37/EC, by expanding its scope and by including and/or revising occupational exposure limit values for a number of cancer- or mutation-causing chemical agents. The initiative is proceeding in steps and has now become a continuous process. Following on from three previous legislative amendments, which covered a total of 26 priority chemical agents, the present (fourth) proposal addresses an additional three. The proposal was announced as ...

The European Commission has proposed to amend Directive 2004/37/EC, by expanding its scope and by including and/or revising occupational exposure limit values for a number of cancer- or mutation-causing chemical agents. The initiative is proceeding in steps and has now become a continuous process. Following on from three previous legislative amendments, which covered a total of 26 priority chemical agents, the present (fourth) proposal addresses an additional three. The proposal was announced as one of the first measures of the Commission's commitment to fight cancer under Europe's Beating Cancer Plan. Broad discussions with scientists and social partners fed into all four proposals. The Commission's feedback period on the proposal ran until November 2020. While broadly welcoming the proposal, professional organisations, trade unions and patient groups would like carcinogenic and mutagenic hazardous medicines as well as substances toxic for reproduction to be brought within the scope of the current proposal. Parliament's Committee on Employment and Social Affairs (EMPL) is in charge of the file. The rapporteur's draft report was considered in the EMPL meeting on 27 January 2021 and adopted on 25 March 2021. The Council agreed its position on 25 November 2020. Second edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Europe's Beating Cancer plan: Quick overview and initial reactions

24-03-2021

On 3 February 2021, the European Commission presented Europe's Beating Cancer plan, slightly delayed on account of the pandemic. The plan is a key European Union (EU) public health initiative and a cornerstone of the European health union process launched in November 2020. Responsibility for health lies primarily with the governments of the individual EU Member States. Europe's Beating Cancer plan sets out actions to support, coordinate or supplement Member States' efforts at every stage of the disease ...

On 3 February 2021, the European Commission presented Europe's Beating Cancer plan, slightly delayed on account of the pandemic. The plan is a key European Union (EU) public health initiative and a cornerstone of the European health union process launched in November 2020. Responsibility for health lies primarily with the governments of the individual EU Member States. Europe's Beating Cancer plan sets out actions to support, coordinate or supplement Member States' efforts at every stage of the disease: from prevention, early detection, diagnosis and treatment, to an improved quality of life for cancer patients and survivors. Cross-cutting themes include research and innovation, digital and personalised medicine, and action to reduce cancer inequalities across the EU. A particular focus will be on childhood cancers. The plan consists of 10 flagship initiatives and 32 supporting actions, to be rolled out over the coming years. Implementation will be monitored by means of a roadmap and progress indicators, and the Commission will establish an EU cancer plan implementation group. With a €4 billion budget, the plan will make use of all available funding instruments, including the new EU4Health programme, Horizon Europe, and the Digital Europe programme. EU institutional actors and public and private stakeholders have widely commented on Europe's Beating Cancer plan. While non-governmental organisations and industry associations broadly welcome the plan and its ambition, some have criticised specific elements. The European Parliament's Special Committee on Cancer is working on an own-initiative report that will be Parliament's contribution to Europe's Beating Cancer plan. Health and Food Safety Commissioner Stella Kyriakides has stressed that Parliament and its special committee has played an important role in shaping the plan, and will also be instrumental during its implementation.

Program UE dla zdrowia na lata 2021–2027

03-03-2021

28 maja 2020 r. Komisja Europejska przyjęła wniosek dotyczący rozporządzenia w sprawie ustanowienia programu działań Unii w dziedzinie zdrowia na lata 2021–2027 (Program UE dla zdrowia). Negocjacje międzyinstytucjonalne między Parlamentem Europejskim a Radą zakończyły się 14 grudnia 2020 r. wstępnym porozumieniem w sprawie programu, włącznie z określeniem budżetu w wysokości 5,1 mld EUR. 15 stycznia 2021 r. parlamentarna Komisja Ochrony Środowiska Naturalnego, Zdrowia Publicznego i Bezpieczeństwa ...

28 maja 2020 r. Komisja Europejska przyjęła wniosek dotyczący rozporządzenia w sprawie ustanowienia programu działań Unii w dziedzinie zdrowia na lata 2021–2027 (Program UE dla zdrowia). Negocjacje międzyinstytucjonalne między Parlamentem Europejskim a Radą zakończyły się 14 grudnia 2020 r. wstępnym porozumieniem w sprawie programu, włącznie z określeniem budżetu w wysokości 5,1 mld EUR. 15 stycznia 2021 r. parlamentarna Komisja Ochrony Środowiska Naturalnego, Zdrowia Publicznego i Bezpieczeństwa Żywności zatwierdziła ostateczny tekst kompromisowy. Ma on zostać poddany pod głosowanie w pierwszym czytaniu podczas pierwszej marcowej sesji plenarnej.

Covid-19 vaccination campaigns: The public dimension

29-01-2021

The arrival of the Covid-19 vaccines marks a turning point in the fight against the coronavirus pandemic. For European Commission President Ursula von der Leyen, vaccination is about self protection and solidarity. For many people, it is also about trust. Some are hesitant to get vaccinated, while others are against vaccination on principle. According to estimates, coverage of at least 60 % to 75 % is needed to establish population immunity through vaccination. Polls show that sizeable numbers of ...

The arrival of the Covid-19 vaccines marks a turning point in the fight against the coronavirus pandemic. For European Commission President Ursula von der Leyen, vaccination is about self protection and solidarity. For many people, it is also about trust. Some are hesitant to get vaccinated, while others are against vaccination on principle. According to estimates, coverage of at least 60 % to 75 % is needed to establish population immunity through vaccination. Polls show that sizeable numbers of people in the EU are hesitant − or even opposed − to vaccination in general. As regards Covid-19 vaccination, surveys suggest that Europeans are among the most sceptical in the world. According to the World Health Organization, vaccine hesitancy is complex and context-specific, varying across time, place and vaccine. Science has identified several behavioural factors underpinning vaccine uptake. Vaccine scepticism can also be linked to trust in government and is associated with certain political mindsets. Many commentators agree that Covid-19 vaccine communication is a collective endeavour that should ideally involve institutional actors, healthcare professionals, scientists, journalists and people with standing in communities. There is a need to engage with the wider public, in particular with groups that have a low level of trust in scientists and are less favourable to vaccines. It is considered key to move towards an open dialogue that respects people's emotions, and to understand the individual values behind doubters' fears. Reaching diverse populations is deemed instrumental, as is involving political and community leaders in communication strategies. The December 2020 European Council conclusions stressed the importance of providing clear factual information on Covid-19 vaccines and countering disinformation. The European Commission is set to roll out a two-phase vaccine communication campaign complementing the Member States' efforts. The European Parliament has insisted on the need to counter the spread of unreliable, misleading and unscientific information on vaccination, and Members have repeatedly called for more transparency on the EU advance purchase agreements with vaccine developers.

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EPRS online policy roundtable: What is the future of (European) sovereignty?
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08-09-2021
EPRS online policy roundtable: Statistics, Data and Trust: Why figures matter [...]
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EPRS online Book Talk with David Harley: Matters of Record: Inside European Politics
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