Debate: European Medicines Agency
Date: WEDNESDAY, 7 JULY 2021
Speaker: Stella Kyriakides
Language: EN

The necessity of a stronger mandate for the European Medicines Agency became apparent very quickly. We needed to permanently monitor the shortages of critical medicines, we need to report on the risk of shortages of medical devices during crisis and to catalyse the development and the faster approval of medicines with fast-track scientific advice and rolling reviews. We need to act rapidly and we need to act together as a Union.  I want to thank Parliament and all your efforts to reach an agreement on the European Medicines Agency proposal. This is a proposal which is part of a package of three initiatives that aim to build a strong European Health Union, and together with the proposal to strengthen the European Centre for Disease Prevention and Control (ECDC) and our cross-border health threats framework, this package is our collective response to learn from the current pandemic and be better prepared for future crises. And as the honourable Member just said, we need to be proactive, not only reactive, to public health crises.  Honourable Members, it’s our responsibility that people have access to critical medicines and medical devices during current and future crises. Throughout this pandemic, I want to show you and share with you that the European Medicines Agency really stepped up its work considerably, but based on temporary and on exceptional measures so that we could have the type of commitment and we could meet the many challenges we were faced with. And they have done a wonderful, wonderful job. But we now need to put this arrangement on a permanent footing. We need to stabilise these ad hoc structures we created that will catalyse the development and the faster approval of medicines to treat or prevent disease causing a public health crisis. It’s for these reasons that these negotiations need to move forward and quickly to a conclusion.  The progress made so far by Parliament and Council on the European Medicines Agency proposal is a welcome step in the right direction and I want to thank you for your engagement and for your very active contribution.  I welcome the fact that the amendments tabled by Parliament retain the level of ambition of the original proposal and do not mark a significant departure from its policy objective, and I share that level of ambition with you. But there are just two points I want to raise. Some of the amendments put forward by Parliament should be looked at again. This applies particularly to the delay of the date of application for medical devices by one year and the creation of a European medicine supply database. If we defer the rules and the application of the rules for medical devices, then we are also at the risk of deferring the enhanced level of protection for citizens. And the medicines supply database goes far beyond the scope of the proposal and would result in duplication and substantial additional costs. So instead, we need to maximise synergies with existing national systems so that our efforts are as efficient and effective as possible.  Honourable Members, a stronger European Medicines Agency is a centrepiece of a strong European Health Union. We are building its mandate and it must be strengthened as we look at the pandemic as a stronger, wiser, more resilient and better prepared Union. We are called to demonstrate that we can move quickly and decisively to tackle the challenges facing us and to strengthen the structures and systems that protect our health. We have already done it together on EU4Health and on the digital COVID-19 certificates and the Council has already made considerable progress and adopted its general approach on 15 June.  Now, as we start the interinstitutional negotiations under the Slovenian Presidency, let me assure you that the Commission will play its part in reaching a quick and effective agreement, and you can count on my support. Together, we can translate these proposals into concrete and long-lasting protection for citizens in times of crisis. We need a strong European Health Union, a health union which will deliver nothing more and nothing less than what citizens deserve and what citizens expect from us. And this is not about taking away competences. It’s about being better prepared, and it’s about standing up to what we now need to do. And you can count on me being there with the level of ambition that you are pushing forward with as well.