Today, the Council has adopted its position on the November 2020 Commission proposal to give the European Medicines Agency (EMA i) a stronger role in crisis preparedness and management. This proposal would allow the EMA to facilitate activities such as monitoring and mitigating the risk of medicines shortages, providing scientific advice on medicines to treat disease caused by a crisis, and coordinating clinical trials. Welcoming the adoption of the Council position, Commissioner in charge of Health & Food Safety Stella Kyriakides i made the following statement:
“The European Medicines Agency has been an essential partner in our response to the COVID-19 pandemic. But the crisis has shown that we cannot take for granted the availability of medicines and medical equipment to treat patients. A reinforced agency will allow us to react quickly, efficiently, and in a coordinated manner to any future emergency.
I am pleased that the Council has endorsed our ambitious proposal so swiftly, and progress needs to follow equally quickly on our proposals to strengthen the mandate of the European Centre for Disease Prevention and Control and closer cooperation on cross-border health threats.
Strong EU i Agencies are crucial for our collective response to health threats or crises and they need to be fully equipped to play the role we expect and need from them.
I want to thank the Portuguese presidency for the work achieved in the past six months and I look forward to continue working with the European Parliament and Council on turning our vision for a strong European Health Union into a reality.”
Following the adoption of the Council's position, known as ‘general approach' on the Commission's proposal, the European Parliament is due to adopt its position at its July plenary. The Council, Parliament and European Commission will then negotiate the text of the Commission proposal, known as “trilogue”, to reach an agreement under the Slovenian Presidency.
Negotiations on the other two proposed regulations, for a reinforced European Centre for Disease Prevention and Control and a revised Regulation on cross-border health threats are also moving forward. The Commission will continue to work closely with the European Parliament and Council on all three proposals towards a swift adoption. As announced in the European Health Union package, the Commission will also propose a new European Health Emergency Preparedness and Response Authority (HERA) in the autumn. This will strengthen the European Health Union with better EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access and distribution of needed countermeasures.
On 11 November 2020, the Commission proposed a European Health Union package to strengthen crisis preparedness and response in Europe. The package includes three draft regulations to improve health crisis management in the Union. They intend to strengthen the mandates of the European Medicines Agency and the European Centre for Disease Prevention and Control and set up stronger coordination for cross-border health threats, including being able to declare an EU-level public health emergency.
Under the new regulation, the European Medicines Agency will be able to facilitate a coordinated Union-level response to health crises by:
-monitoring and mitigating the risk of shortages of critical medicines and medical devices
-providing scientific advice on medicines which may have the potential to treat, prevent or diagnose the diseases causing those crises
-coordinating studies to monitor the effectiveness and safety of vaccines
-coordinating clinical trials.
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