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Coronavirus testing: Contributing to efforts to stem the second wave

07-12-2020

The coronavirus (Covid-19) pandemic remains a major threat to public health in the European Union (EU). Testing is considered an essential aspect of the response to the pandemic. There are different types of coronavirus tests, each having its own merits and limitations. The timing of tests is also critical. Among the tests that detect current infection, (rapid) antigen tests have recently come to the fore. In view of a resurgence of coronavirus cases, the European Commission adopted on 28 October ...

The coronavirus (Covid-19) pandemic remains a major threat to public health in the European Union (EU). Testing is considered an essential aspect of the response to the pandemic. There are different types of coronavirus tests, each having its own merits and limitations. The timing of tests is also critical. Among the tests that detect current infection, (rapid) antigen tests have recently come to the fore. In view of a resurgence of coronavirus cases, the European Commission adopted on 28 October 2020 a recommendation for a common EU testing approach for Covid-19. It addresses key points linked to testing capacities and resources, as well as rapid antigen tests. This was followed on 18 November by a recommendation on the use of rapid antigen tests for the diagnosis of Covid-19, which provides guidance on how to select rapid antigen tests, when they are appropriate and who should perform them. It also calls for validation and mutual recognition of tests and their results. EU and international public health bodies, including the European Centre for Disease Prevention and Control and the World Health Organization, have given testing recommendations and outlined strategies and objectives. Several Member States have started to use rapid antigen tests in practice. Testing policies range from testing only people who both have symptoms and also meet specific criteria, to testing anyone with symptoms, to open public testing, including asymptomatic people. In a September 2020 resolution, the European Parliament called for the adoption and implementation of a common testing strategy under which test results would be recognised in all Member States. Since the outbreak of the pandemic, coronavirus testing has rapidly evolved and will continue to play an important role. New methods are emerging, including 'out of the box' options.

Europe's Beating Cancer plan - Pre-legislative synthesis of national, regional and local positions on the European Commission proposal

26-11-2020

This briefing forms part of an EPRS series offering syntheses of the pre-legislative state of play and consultation on key European Commission priorities during the current five-year term. It summarises the state of affairs in the relevant policy field, examines how the existing policy is working on the ground, and, where possible, identifies best practice and ideas for the future on the part of governmental organisations at all levels of European system of multilevel governance. EPRS analysis of ...

This briefing forms part of an EPRS series offering syntheses of the pre-legislative state of play and consultation on key European Commission priorities during the current five-year term. It summarises the state of affairs in the relevant policy field, examines how the existing policy is working on the ground, and, where possible, identifies best practice and ideas for the future on the part of governmental organisations at all levels of European system of multilevel governance. EPRS analysis of the positions of partner organisations at European, national, regional and local levels suggests that they would like the following main considerations to be reflected in discussion of the forthcoming Europe's Beating Cancer plan: * Submissions from all four levels of governance highlight the EU's key role in prevention, including as regards cancer-causing environmental factors and tobacco consumption. Input obtained refers to the active role Europe's local and regional actors can play in putting prevention into practice. * European and national levels point to predictive diagnostic tools and novel approaches in cancer medicine. Regional actors advocate for closer cooperation between primary care and hospital care in early diagnosis. Both the regional and local levels would like the EU to help improve screening. * Equitable access to cancer care is featured across all levels. National input raises the issue of availability and affordability of medicines. The local level underscores the merits of ambulatory care, and sees a role for the EU in the creation of local coordination platforms for doctors and patients. * The European level addresses cancer after-care in the local community and cancer survivorship and rehabilitation. Both the regional and local levels recommend fostering personalised care and follow-up for cancer patients. * European and national input stresses the importance of EU-wide cancer research cooperation, information sharing and better deployment of (big) data. Attention is drawn to improving information, communication, education and awareness-raising for both the wider public and healthcare professionals, with regional input encouraging the development of new technologies to ease doctor-patient communication. * All levels would like Europe's Beating Cancer plan to address health inequalities in cancer. EU-level action is considered key to help reduce socioeconomic and geographical disparities, and tackle differences in cancer prevalence and survival rates. A 'health in all policies' approach is supported.

Das neue Gesundheitsprogramm der EU: EU4Health

05-11-2020

Am 28. Mai 2020 nahm die Kommission einen Vorschlag für eine Verordnung über ein Aktionsprogramm der Union im Bereich der Gesundheit für den Zeitraum 2021–2027 („Programm EU4Health“) an. Es wurde im Rahmen des EU-Aufbauinstruments „Next Generation EU“ angekündigt, mit dem die Auswirkungen der Coronavirus-Pandemie bewältigt werden sollen. Auf der Tagung des Europäischen Rates im Juli wurde die Mittelausstattung des Programms von den ursprünglich vorgeschlagenen 9,4 Mrd. EUR auf 1,7 Mrd. EUR gekürzt ...

Am 28. Mai 2020 nahm die Kommission einen Vorschlag für eine Verordnung über ein Aktionsprogramm der Union im Bereich der Gesundheit für den Zeitraum 2021–2027 („Programm EU4Health“) an. Es wurde im Rahmen des EU-Aufbauinstruments „Next Generation EU“ angekündigt, mit dem die Auswirkungen der Coronavirus-Pandemie bewältigt werden sollen. Auf der Tagung des Europäischen Rates im Juli wurde die Mittelausstattung des Programms von den ursprünglich vorgeschlagenen 9,4 Mrd. EUR auf 1,7 Mrd. EUR gekürzt. In seinem Bericht schlägt der Ausschuss für Umweltfragen, öffentliche Gesundheit und Lebensmittelsicherheit des Europäischen Parlaments unter anderem vor, die ursprünglichen Mittelansätze des Programms EU4Health wiedereinzusetzen. Das Parlament wird voraussichtlich im Rahmen der der November-I-Plenartagung über den Bericht abstimmen. Dann könnten die Trilogverhandlungen beginnen.

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.

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