European Health Union: European Commission welcomes step towards better access to medicines and medical devices during crisis
Today (15 June), the Council has adopted its position on the November 2020 Commission proposal to give the European Medicines Agency (EMA) 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 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 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, and;
- coordinating clinical trials.
Joint statement by EU institutions: EU clears way for the EU Digital COVID Certificate
On 14 June, the presidents of the three EU institutions, the European Parliament, the Council of the EU and the European Commission attended the official signing ceremony for the Regulation on the EU Digital COVID Certificate, marking the end of the legislative process.
On this occasion Presidents David Sassoli and Ursula von der Leyen and Prime Minister António Costa said: “The EU Digital COVID Certificate is a symbol of what Europe stands for. Of a Europe that does not falter when put to the test. A Europe that unites and grows when faced with challenges. Our Union showed again that we work best when we work together. The EU Digital COVID Certificate Regulation was agreed between our institutions in the record time of 62 days. While we worked through the legislative process, we also built the technical backbone of the system, the EU gateway, which is live since 1 June.
"We can be proud of this great achievement. The Europe that we all know and that we all want back is a Europe without barriers. The EU Certificate will again enable citizens to enjoy this most tangible and cherished of EU rights – the right to free movement. Signed into law today, it will enable us to travel more safely this summer. Today we reaffirm together that an open Europe prevails.”
Commissioner Sinkevičius in Sweden to discuss forests and biodiversity
Commissioner Sinkevičius is visiting Sweden today (14 June) to discuss the Commission's upcoming EU Forest Strategy and the proposals on EU-driven deforestation and forest degradation with ministers, members of the Swedish Parliament, NGO and academia representatives, and other actors. The Forest Strategy, as announced in the 2030 Biodiversity Strategy, will cover the whole forest cycle and promote the multifunctional use of forests, aiming at ensuring healthy and resilient forests that contribute significantly to biodiversity and climate goals, reduce and respond to natural disasters, and secure livelihoods. A key deliverable under the European Green Deal, the Biodiversity Strategy also pledged to plant 3 billion trees by 2030. The Commission aims to secure this year during COP 15 global meeting on biodiversity an international agreement to address the nature crisis similar to the Paris Agreement on climate.
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