The revised EMA mandate will allow the Agency to closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies, and to play a key role in facilitating the development and faster approval of medicines which could treat or prevent a disease causing a public health crisis.
Welcoming the agreement today, Vice-President for Promoting our European Way of Life, Margaritis Schinas, and Commissioner for Health and Food Safety, Stella Kyriakides, made the following statement:
“Today, we are moving one step closer to a stronger European Health Union that is ready to face the next health crisis. The European Medicines Agency has been at the forefront of our work throughout the COVID-19 pandemic and has played a key role in advising, assessing and authorising vaccines and medicines to prevent and treat COVID-19. It is thanks to the rigorous assessment of EMA that our citizens can have trust and confidence that vaccines and therapeutics used in the EU are safe and effective.
A stronger EMA means that we can count on a coordinated EU response in mitigating and preventing medicine and medical devices shortages and ensuring faster approval and availability of new medicines to address crises in the future.
Today's agreement is an important step for a stronger and more resilient EU. But we also need to strengthen the European Centre for Disease Prevention and Control, adopt new rules for cross-border health treats, and set up the emergency framework for the European Health Emergency Preparedness and Response Authority.
The Commission proposals are on the table and we call on all institutions to work together to find a way forward as quickly as possible. Every day counts.”
The Regulation will now have to be formally adopted by the Council and the European Parliament before it can enter into force.
The Proposal for a Regulation on serious cross-border threats to health and the Proposal to extend the mandate of the European Centre for Disease Prevention and Control are still under negotiation. The proposal on a framework of urgent measures related to medical countermeasures will be adopted by the Council.
Together, these proposals reflect the lessons learnt from COVID-19 and form the basis for a strong European Health Union.
In its proposal for a European Health Union in November 2020, the Commission focused on crisis preparedness and response measures including revising the mandate of the European Medicines Agency to provide stronger surveillance, scientific analysis and guidance in preparation for an and during health crises. The EMA proposal would be the first of the crisis-related proposals to be adopted.
For More Information
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
- Publication date
- 28 October 2021