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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.

Economic impact of epidemics and pandemics

27-02-2020

Despite significant medical progress over the last centuries, infectious diseases such as influenza or malaria still represent a considerable threat to society. While some are endemic to specific geographical regions, others can spread, becoming epidemics or pandemics, as is the case with the coronavirus crisis currently developing. While the first and most crucial aspect of an epidemic is, and will always remain, the loss of human life, the spread of a virus can also have important repercussions ...

Despite significant medical progress over the last centuries, infectious diseases such as influenza or malaria still represent a considerable threat to society. While some are endemic to specific geographical regions, others can spread, becoming epidemics or pandemics, as is the case with the coronavirus crisis currently developing. While the first and most crucial aspect of an epidemic is, and will always remain, the loss of human life, the spread of a virus can also have important repercussions for national or regional economies. The evidence reported in various studies indicates that epidemic disease impacts on a country's economy through several channels, including the health, transportation, agricultural and tourism sectors. At the same time, trade with other countries may also be impacted, while the interconnectedness of modern economies means that an epidemic can also implicate international supply chains. These considerations, as well as the fact that rapid urbanisation, increasing international travel and climate change all render epidemic outbreaks a global and not simply a local phenomenon, imply that it is important for all countries to take necessary measures to counter this threat. In this context, several initiatives have been proposed, ranging from a single measure (e.g. investing in new antibiotics), to broader solutions to be adopted by developing and developed countries alike. In the European Union (EU), healthcare organisation and provision are Member State prerogatives and responsibilities. The EU's actions in this area therefore aim at complementing national policies to help Member States face common challenges, such as epidemics. This support takes place via coordination and exchange of best practices between EU countries and health experts, financial support under Instruments for co-financing, (e.g. the Horizon 2020 research programme and European Fund for Strategic Investments), and the adoption of relevant legislation. The European Parliament has taken the opportunity, through own-initiative resolutions, to highlight the need for further actions.

Addressing health inequalities in the European Union: Concepts, action, state of play

19-02-2020

Tackling socially determined inequalities in health, both between and within European Union (EU) Member States, is still a major challenge. This analysis describes the main concepts and gives examples for health inequalities across the EU. It then presents an overview of the work accomplished at international and EU levels. It shows, in particular, how the EU institutions, bodies and agencies have contributed to reducing health inequalities, notwithstanding that Member States have the main responsibility ...

Tackling socially determined inequalities in health, both between and within European Union (EU) Member States, is still a major challenge. This analysis describes the main concepts and gives examples for health inequalities across the EU. It then presents an overview of the work accomplished at international and EU levels. It shows, in particular, how the EU institutions, bodies and agencies have contributed to reducing health inequalities, notwithstanding that Member States have the main responsibility for health policy. The analysis then goes on to depict stakeholder views, before closing with an outlook on avenues for further action.

Europe's Beating Cancer plan: Launch of an EU-wide debate

31-01-2020

On 4 February 2020, on the occasion of World Cancer Day, the European Commission will initiate a broad stakeholder debate on the proposed Europe's Beating Cancer plan, to be rolled out towards the end of the year. The launch event will be held in the European Parliament in Brussels, supported by the MEPs Against Cancer Interest Group. It will bring together political leaders, representatives from international organisations, health ministries, leading academics, scientists and health professionals ...

On 4 February 2020, on the occasion of World Cancer Day, the European Commission will initiate a broad stakeholder debate on the proposed Europe's Beating Cancer plan, to be rolled out towards the end of the year. The launch event will be held in the European Parliament in Brussels, supported by the MEPs Against Cancer Interest Group. It will bring together political leaders, representatives from international organisations, health ministries, leading academics, scientists and health professionals, the private sector and non-governmental organisations, and cancer patients and survivors.

Cross-border threats to health: EU action on preparedness and response

10-01-2020

Serious threats to health – such as those due to infectious disease outbreaks or environmental factors – do not respect borders. They do, however, require cross-border cooperation and a coordinated response. Decision No 1082/2013/EU is the framework for European Union action on health emergencies. It provides for information exchange, risk assessment and joint procurement, among other mechanisms. The EU-level response is coordinated by the Health Security Committee. The European Centre for Disease ...

Serious threats to health – such as those due to infectious disease outbreaks or environmental factors – do not respect borders. They do, however, require cross-border cooperation and a coordinated response. Decision No 1082/2013/EU is the framework for European Union action on health emergencies. It provides for information exchange, risk assessment and joint procurement, among other mechanisms. The EU-level response is coordinated by the Health Security Committee. The European Centre for Disease Prevention and Control meanwhile plays a crucial role in identifying, assessing and communicating threats to health from communicable diseases. Parliament has adopted own-initiative and legislative resolutions focusing both on the general and more specific aspects of cross-border threats to health. At global level, all EU Member States are party to the legally binding International Health Regulations that require them to develop, strengthen and maintain core public health capacities for surveillance and response. Implementation is coordinated by the World Health Organization. Going forward, Member States have expressed interest in exploiting the potential of joint procurement beyond pandemic influenza vaccines. Moreover, a joint action on strengthened International Health Regulations and preparedness in the EU has recently been launched, focusing, in particular, on countering biological and chemical terror attacks in Europe across the health, security and civil protection sectors.

World AIDS Day 2019

29-11-2019

Every year, 1 December marks World AIDS Day, proclaimed by the United Nations (UN) in 1988 and aimed mainly at raising awareness. This year's specific theme, 'Communities make a difference', draws attention to the crucial role of community health workers and communities of people living with HIV, highlighting their contribution to ending the epidemic. World AIDS Day also offers an opportunity to take stock of progress, globally and in the EU.

Every year, 1 December marks World AIDS Day, proclaimed by the United Nations (UN) in 1988 and aimed mainly at raising awareness. This year's specific theme, 'Communities make a difference', draws attention to the crucial role of community health workers and communities of people living with HIV, highlighting their contribution to ending the epidemic. World AIDS Day also offers an opportunity to take stock of progress, globally and in the EU.

Hearings of the Commissioners-designate: Stella Kyriakides - Health

26-09-2019

This briefing is one in a set looking at the Commissioners-designate and their portfolios as put forward by Commission President-elect Ursula von der Leyen. Each candidate faces a three-hour public hearing, organised by one or more parliamentary committees. After that process, those committees will judge the candidates' suitability for the role based on 'their general competence, European commitment and personal independence', as well as their 'knowledge of their prospective portfolio and their communication ...

This briefing is one in a set looking at the Commissioners-designate and their portfolios as put forward by Commission President-elect Ursula von der Leyen. Each candidate faces a three-hour public hearing, organised by one or more parliamentary committees. After that process, those committees will judge the candidates' suitability for the role based on 'their general competence, European commitment and personal independence', as well as their 'knowledge of their prospective portfolio and their communication skills'. At the end of the hearings process, Parliament votes on the proposed Commission as a bloc, and under the Treaties may only reject the entire College of Commissioners, rather than individual candidates. The Briefing provides an overview of key issues in the portfolio areas, as well as Parliament's activity in the last term in that field. It also includes a brief introduction to the candidate.

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

30-08-2019

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 substances. The initiative is proceeding in steps. The first proposal of May 2016 covered 13 priority chemical agents, the second, of January 2017, a further seven. The current (third) proposal addresses an additional five. Broad discussions with scientists and the social partners fed into all three ...

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 substances. The initiative is proceeding in steps. The first proposal of May 2016 covered 13 priority chemical agents, the second, of January 2017, a further seven. The current (third) proposal addresses an additional five. Broad discussions with scientists and the social partners fed into all three proposals. Reacting to the Commission's set of measures as a whole, trade unions have acknowledged the importance of further improving the existing framework. Actors on the employers' side have underlined the need to ensure that values are proportionate and feasible in terms of technical implementation. After adoption by the Parliament and Council, in March and May respectively, based on a text agreed in trilogue in January 2019, the final act was signed by the presidents of the co-legislators on 5 June 2019. Directive (EU) 2019/983 entered into force on 10 July 2019 and is to be transposed into national law within two years, by 11 July 2021. Third edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

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