European Health Union: a stronger role for the European Medicines Agency
Recently (25 January 2022), as part of the on-going work to build a strong European Health Union, the Council has adopted the Regulation revising the mandate of the European Medicines Agency (EMA), taking an important step towards EMA's reinforcement in crisis preparedness and management for medicinal products and medical devices. The new rules will allow the Agency to closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies and facilitate faster approval of medicines which could treat or prevent a disease causing a public health crisis. The adoption of a stronger mandate for EMA is part of the European Health Union package proposed by the Commission in November 2020.
Welcoming the adoption, Vice-President for Promoting our European Way of Life, Margaritis Schinas, recently said:
“Today's adoption marks a milestone for European citizens who have been expecting the EU to put together the tools we need to respond swiftly and efficiently in case of a health crisis. In the past two years, the European Medicines Agency has been a key player in the EU's response to the COVID-19 pandemic, notably in advising, assessing and authorising vaccines and medicines to prevent and treat COVID-19. We promised this to EU citizens and we are delivering!”
Commissioner for Health and Food Safety, Stella Kyriakides, recently made the following statement:
“Today we are taking an important step towards making a strong European Health Union a reality. The European Medicines Agency is a regulator of global renown that has been at the forefront of the EU's work to ensure that safe and effective vaccines and therapeutics could reach our citizens during the COVID-19 pandemic. With a reinforced Agency, we can ensure that essential medicines and medical devices are available for citizens at all times and that new medicines for emergency situations can be approved faster. A strong European Health Union is a vision we all share, the European Parliament and the Member States alike and I would like to thank them for their commitment and dedication to put this important work in motion.”
Thanks to its reinforced mandate, the Agency can facilitate a coordinated EU-level response to health crises by:
- monitoring and mitigating the risk of shortages of critical medicines and medical devices;
- providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;
- coordinating studies to monitor the effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;
- coordinating clinical trials for medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;
- transferring the expert panels of the Medical Device Regulation to the Agency.
The legislation also formally establishes the Medicines and Medical Devices Shortages Steering Group and the Emergency Task Force, working on the above tasks.
Latest News from
European Semester Spring Package: Sustaining a green and sustainable recovery in the face of increased uncertainty24/05/2022 10:25:00
The European Commission's 2022 European Semester Spring Package provides Member States with support and guidance two years on from the first impact of the COVID-19 pandemic and in the midst of Russia's ongoing invasion of Ukraine.
Commission (Eurostat) publishes 2022 report on Sustainable Development Goals in the European Union24/05/2022 09:25:00
Eurostat, the statistical office of the European Union, yesterday published the ‘Sustainable development in the European Union – 2022 monitoring report on progress towards the SDGs in an EU context', which provides a statistical overview of progress towards the Sustainable Development Goals (SDGs) in the EU.
State aid: Commission approves €16 million Finnish scheme to support farmers in context of Russia's invasion of Ukraine23/05/2022 16:33:00
The European Commission has approved a €16 million Finnish scheme to support the agricultural sector in the context of Russia's invasion of Ukraine.
Hong Kong: EU report sees a continued deterioration of fundamental freedoms23/05/2022 15:25:00
The European Commission and the High Representative recently (20 May 2022) reported on political and economic developments in the Hong Kong Special Administrative Region.
Increased support for EU farmers through rural development funds23/05/2022 14:33:00
The European Commission proposed an exceptional measure funded by the European Agricultural Fund for Rural Development (EAFRD) to allow Member States to pay a one-off lump sum to farmers and agri-food businesses affected by significant increases in input costs.
Macao: EU report highlights increasing challenges to political rights and fundamental freedoms23/05/2022 13:25:00
The European Commission and the High Representative recently (20 May 2022) reported on political and economic developments in the Macao Special Administrative Region, covering 2021.
EU disburses €600 million in Macro-Financial Assistance to Ukraine23/05/2022 12:38:00
The European Commission, on behalf of the EU, recently (20 May 2022) disbursed €600 million in Macro-Financial Assistance (MFA) to Ukraine. Following Russia's unprovoked and unjustified invasion, this urgent financial support helps Ukraine address its acute financing gap related to its exceptional humanitarian and defence needs.
State aid: Commission approves €500 million Luxembourgish scheme to support companies in context of Russia's invasion of Ukraine23/05/2022 11:33:00
The European Commission has approved a €500 million Luxembourgish guarantee scheme to support companies across sectors in the context of Russia's invasion of Ukraine.