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The EU's new health programme: EU4Health

05-11-2020

On 28 May 2020, the European Commission adopted a proposal for a regulation on the establishment of a programme for the Union's action in the field of health for the 2021-2027 period (EU4Health programme). It was announced as part of the Next Generation EU recovery instrument, aimed at countering the impact of the coronavirus pandemic. The July European Council meeting reduced the programme's budget from the initially proposed €9.4 billion to €1.7 billion. In its report, European Parliament's Committee ...

On 28 May 2020, the European Commission adopted a proposal for a regulation on the establishment of a programme for the Union's action in the field of health for the 2021-2027 period (EU4Health programme). It was announced as part of the Next Generation EU recovery instrument, aimed at countering the impact of the coronavirus pandemic. The July European Council meeting reduced the programme's budget from the initially proposed €9.4 billion to €1.7 billion. In its report, European Parliament's Committee on the Environment, Public Health and Food Safety proposes, inter alia, to restore EU4Health's initial budget. Parliament is expected to vote on the report during the November I plenary session. This would open the way for trilogue negotiations.

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

29-10-2020

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 the forthcoming 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 will run until 20 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. The legislative process is in its early stages. In Parliament, the Committee on Employment and Social Affairs is in charge of the file. The working party on social questions is dealing with it in the Council. First edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

EU4Health programme

01-10-2020

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. Under the proposal, EU4Health would be a stand-alone, dedicated funding programme with a 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. Under the proposal, EU4Health would be a stand-alone, dedicated funding programme with a budget of €10.4 billion (in current prices). However, during the ongoing negotiations on the EU's next multiannual financial framework (MFF) for the 2021-2027 period and NGEU, the budget for EU4Health has been reviewed downwards compared with what was originally proposed. According to the 21 July 2020 European Council conclusions, the programme will be allocated €1.7 billion. Stakeholders broadly welcome the proposal, but generally regret the European Council's reduction of the financial envelope allocated to it. In a July 2020 resolution on the European Council conclusions, Parliament criticised the proposed cuts to EU4Health. In Parliament, the Committee on the Environment, Public Health and Food Safety (ENVI) is responsible for the file. The rapporteur's June 2020 draft report proposes several amendments to the Commission proposal. ENVI Members tabled further amendments in July. The committee is expected to vote on the report in October. In the Council, the proposal is being examined at the level of the working party on public health. First edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Coronavirus vaccines strategy

29-09-2020

On 17 June 2020, the European Commission presented a strategy to accelerate the development, manufacturing and deployment of vaccines against the coronavirus disease (Covid-19). The strategy aims to secure high quality, safe, effective and affordable Covid-19 vaccines for all in the EU within 12-18 months, if not earlier. To this end, the Commission has started to enter into advance purchase agreements with vaccine producers on behalf of the EU Member States. With the Coronavirus Global Response ...

On 17 June 2020, the European Commission presented a strategy to accelerate the development, manufacturing and deployment of vaccines against the coronavirus disease (Covid-19). The strategy aims to secure high quality, safe, effective and affordable Covid-19 vaccines for all in the EU within 12-18 months, if not earlier. To this end, the Commission has started to enter into advance purchase agreements with vaccine producers on behalf of the EU Member States. With the Coronavirus Global Response initiative and its participation in the COVAX facility, the EU is also positioning itself as a leader of global solidarity effort to speed up universal access to vaccines.

The EU's public health strategy post-Covid-19

07-07-2020

The coronavirus pandemic has put European health systems under enormous strain, revealing gaps in the way public health emergencies are addressed. The European Commission's proposal for a new EU Health programme, EU4Health, aims to fill these gaps. During the European Parliament's July plenary session, the Commission and the Council are to make statements on the EU's public health strategy after coronavirus, followed by a debate with Members. A resolution is due to be voted later in the week.

The coronavirus pandemic has put European health systems under enormous strain, revealing gaps in the way public health emergencies are addressed. The European Commission's proposal for a new EU Health programme, EU4Health, aims to fill these gaps. During the European Parliament's July plenary session, the Commission and the Council are to make statements on the EU's public health strategy after coronavirus, followed by a debate with Members. A resolution is due to be voted later in the week.

A pharmaceutical strategy for Europe: First steps

24-06-2020

On 1 June 2020, the European Commission published a roadmap for a pharmaceutical strategy for Europe. The strategy will have the overall goal of ensuring Europe's supply of safe and affordable medicines and supporting the European pharmaceutical industry's innovation efforts. Two consultations (on the roadmap and the strategy, respectively), are currently under way. Adoption of the strategy is envisaged for the fourth quarter of 2020.

On 1 June 2020, the European Commission published a roadmap for a pharmaceutical strategy for Europe. The strategy will have the overall goal of ensuring Europe's supply of safe and affordable medicines and supporting the European pharmaceutical industry's innovation efforts. Two consultations (on the roadmap and the strategy, respectively), are currently under way. Adoption of the strategy is envisaged for the fourth quarter of 2020.

European Centre for Disease Prevention and Control: During the pandemic and beyond

18-06-2020

The European Centre for Disease Prevention and Control (ECDC) is a decentralised European Union (EU) agency based in Stockholm, Sweden. It began operating in 2005. Its mission is to identify, assess and communicate current and emerging threats to human health posed by infectious diseases. The ECDC is governed by a management board. Its director, Andrea Ammon, is guided by an advisory forum composed of the Member States' competent bodies, which also serves as an information exchange platform. The ...

The European Centre for Disease Prevention and Control (ECDC) is a decentralised European Union (EU) agency based in Stockholm, Sweden. It began operating in 2005. Its mission is to identify, assess and communicate current and emerging threats to human health posed by infectious diseases. The ECDC is governed by a management board. Its director, Andrea Ammon, is guided by an advisory forum composed of the Member States' competent bodies, which also serves as an information exchange platform. The ECDC also works with partnerships and networks. For the 2020 financial year, the ECDC's budget is €60.4 million. Its 2020 establishment plan provides for a total of 286 staff. The ECDC's main activities include: surveillance, epidemic intelligence and response; scientific advice; microbiology; preparedness; public health training; and country support. Its disease-specific activities are organised within horizontal disease programmes. Its organisational chart was restructured in January 2020. The ECDC is playing an important part in the EU's response to the unfolding coronavirus pandemic. Among other things, it provides systematically updated risk assessments, guidance and advice on public health response activities to EU Member States and the European Commission. Stakeholders have nevertheless criticised the ECDC's handling of the pandemic, while remarking on the ECDC's lack of authority and executive power. In a recent resolution, the European Parliament called the ECDC's competences, budget and staff to be strengthened. A similar call was made in a joint Franco-German initiative, and will reportedly be a topic for the upcoming trio of EU Council presidencies. A strong role for the ECDC is also among the initiatives announced by the Commission under its recovery plan for Europe.

Addressing shortages of medicines

28-04-2020

Medicines shortages have been a growing problem in the European Union (EU) in recent years. As the coronavirus outbreak unfolds, the risk of bottlenecks in the supply of medicines to patients has become particularly high. More broadly, problems with the availability of, and access to, new medicines – most frequently associated with high-priced medicines – have also been a central topic in political debates for some time now. The causes underlying medicines shortages are complex and multi-dimensional ...

Medicines shortages have been a growing problem in the European Union (EU) in recent years. As the coronavirus outbreak unfolds, the risk of bottlenecks in the supply of medicines to patients has become particularly high. More broadly, problems with the availability of, and access to, new medicines – most frequently associated with high-priced medicines – have also been a central topic in political debates for some time now. The causes underlying medicines shortages are complex and multi-dimensional. The European Commission links them to manufacturing problems, industry quotas, legal parallel trade, but also to economic aspects, such as pricing (which is a competence of the Member States). The coronavirus crisis has brought to the fore the geopolitical dimension of these shortages, that is, the EU's dependency on countries beyond its boundaries, especially China and India, for the production of many active pharmaceutical ingredients and medicines. Solutions to the problem are believed to entail collaboration and joint action, as well as the involvement of multiple stakeholders, including regulators, industry, patients, healthcare professionals, and international players. The Organisation for Economic Co-operation and Development and the World Health Organization, in particular, are conducting work to improve access to medicines. Medicines supply-chain stakeholders have all weighed in on the debate, offering explanations and recommendations for addressing the problem. Key EU institutions, several Council presidencies and the Member States have addressed the challenge of shortages and more broadly, that of safeguarding access to medicines, through various initiatives. The European Parliament has specifically addressed the issue in a March 2017 resolution. Ensuring the availability of medicines and overcoming supply-chain problems revealed by the coronavirus crisis are also expected to be important topics in the Commission's forthcoming pharmaceutical strategy.

Organ donation and transplantation: Facts, figures and European Union action

03-04-2020

The issue of organ donation and transplantation gained renewed political momentum as one of the initial health priorities of the current Croatian Presidency of the Council of the EU. There are two types of organ donation: deceased donation and living donation. Organ transplantation has become an established worldwide practice, and is seen as one of the greatest medical advances of the 20th century. Demand for organ transplantation is increasing, but a shortage of donors has resulted in high numbers ...

The issue of organ donation and transplantation gained renewed political momentum as one of the initial health priorities of the current Croatian Presidency of the Council of the EU. There are two types of organ donation: deceased donation and living donation. Organ transplantation has become an established worldwide practice, and is seen as one of the greatest medical advances of the 20th century. Demand for organ transplantation is increasing, but a shortage of donors has resulted in high numbers of patients on waiting lists. Medical, legal, religious, cultural, and ethical considerations apply to organ donation and transplantation. In the EU, transplants must be carried out in a manner that shows respect for fundamental rights and for the human body, in conformity with the Council of Europe's binding laws, and compliant with relevant EU rules. World Health Organization principles also apply. Organ donation rates across the EU vary widely. Member States have different systems in place to seek people's consent to donate their organs after death. In the 'opt-in' system, consent has to be given explicitly, while in the 'opt-out' system, silence is tantamount to consent. Some countries have donor and/or non-donor registries. Responsibility for framing health policies and organising and delivering care lies primarily with the EU Member States. The EU has nevertheless addressed organ donation and transplantation through legislation, an action plan and co-funded projects, and the European Parliament has adopted own-initiative resolutions on aspects of organ donation and transplantation. Stakeholders have submitted a joint statement on a shared vision for improving organ donation and transplantation in the EU. An evaluation of the EU's action plan identified the need for a new, improved approach. Innovative products and procedures, such as artificially grown organs and 3D bio-printing, might lend themselves as future possibilities to reduce our reliance on organ donors.

What can the EU do to alleviate the impact of the coronavirus crisis?

16-03-2020

The novel coronavirus (COVID-19) outbreak has now been declared a pandemic by the World Health Organization. Alleviating the human effects of the crisis is paramount, but repercussions are being felt across many sectors. European Union institutions are unanimous in calling for solidarity among Member States, and for Europe to offer support, within its remit, to its Member States in their response to the common challenge. On 10 March 2020, Heads of State or Government of the EU countries held a videoconference ...

The novel coronavirus (COVID-19) outbreak has now been declared a pandemic by the World Health Organization. Alleviating the human effects of the crisis is paramount, but repercussions are being felt across many sectors. European Union institutions are unanimous in calling for solidarity among Member States, and for Europe to offer support, within its remit, to its Member States in their response to the common challenge. On 10 March 2020, Heads of State or Government of the EU countries held a videoconference on COVID-19, to discuss how to coordinate the EU-level response. EU leaders stressed the need for a joint European approach and close coordination with the European Commission. Priorities were identified, to be followed up on 'at all levels immediately'. The measures that are – or could be – envisaged range across different policy areas. As an immediate response, European Commission President Ursula von der Leyen formed a coronavirus response team. Further measures were announced in a European coronavirus response on 13 March 2020. Planned – and potential – health and preparedness measures include reinforcing the EU's role in joint procurement, bolstering cooperation in disease management and control, and potentially widening the remit of the European reference networks. Greater controls on people crossing external EU borders are also proposed. Monetary, budgetary and macroeconomic measures include, for instance, those taken to ease the impact of the coronavirus emergency on the aviation industry. Moreover, the EU and the Member States, the European Central Bank, and the International Monetary Fund can also take steps to help people and firms. The EU budget has been mobilised to provide funds to reinforce preparedness and containment measures, as well as research into the virus. Furthermore, cross-border health threats, such as that posed by COVID 19, could be taken into account when shaping the multiannual financial framework for 2021-2027.

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