EU Policymakers · ATLAS
Bruno GAUTRAIS
European Commission · Head of Unit · SANTE
What Bruno GAUTRAIS has said (4)
- “It's very late. I sincerely hope that it will be this week and even by the middle of this week. Unfortunately, it couldn't be. We have not been able to do it before. I would also like to express a word of caution there. Again, it's gathering the sources used. But despite that, the efforts with the Critical Medicines Alliance, with the dedicated study by ERA and santé. So the commission on this, it was very difficult to gather data and hard facts and figures that could really be used to quantify the impact. So there again, prudence, you may not find in that document that will come very soon also because the situation is very complex and will address a number of products in various member states. Uh, so again, some uh, expectations to be managed on that front. But it will come again very, very soon now. And sorry again for this delay. Thank you.”
Public and private sectors role in healthcare services
- “Thank you very much for your kind words, Mr. Chairman, and thank you for giving us the floor. And we would like first to express our gratitude for the intense work that and the high level of priority you've put and assigned to this draft report on the Critical Medicines Act, as highlighted several times today. Already, this initiative is indispensable to ensuring that essential medicines are accessible to all citizens across the European Union at all times. As you know, the Critical Medicines Act aims at reinforcing EU manufacturing capacity and reducing our dependencies on third countries and single suppliers of critical medicines and their active ingredients. Reforming public procurement practices is indeed a key tool to reach this objective. It's necessary to move away from approaches based solely on the lowest price and to incentivize supply chain resilience. In the meantime, we acknowledge the need for sufficient flexibility given the variety of critical medicines potentially hundreds if not thousands, of different medicinal products with very different challenges and market situations. This flexibility is reflected in our proposal. By giving Procurers the latitude to select the most appropriate procurement criteria or requirement on the further framing of public procurement requirements, including the European preference and the streamlining of collaborative procurement procedures. The Commission will, of course, analyze the proposed changes. So we are really committed to engage constructively throughout the legislative process, and we welcome again the clear message and support overall to this proposal. I and would like again to thank you for the cooperation and commitment. And I'm sure that together we can reach, uh, a good text that will help, uh, citizens having access to the medicines they need. Thank you.”
"Buy European" provisions
- “Thank you very much, Mr. Chairman, for giving me the floor. First we would like to thank, uh, the Parliament, this House and this committee, especially for the hard work on this text and the high level of priority given to it. This is very welcome, as we believe that this initiative is indispensable to ensuring that essential medicines are accessible to all citizens across the European Union at all times. So that means that we are, of course, ready and happy to help and continue the constructive dialogue with the House whenever there would be a need. Um, maybe a few points and I won't be long just to say that, of course, we aim to maintain the environmental standards, while of course keeping safety and health at the heart of the proposal. Um, and this is more about streamlining, uh, facilitating the work, the administrative work linked to repatriating production than lowering standards. Nevertheless, we hear the call for streamlining the various legislation for making it easier and quicker to get the necessary permits. I think that's also part of the intention of the proposal. I know the call for a centralized portal, or at least data transparency. That's interesting. Just of course, this is not the place this proposal to. Let's say work or redo the environmental legislation, but be aware that we work very closely.”
Public and private sectors role in healthcare services
- “No problem. Thank you. Uh, yeah. We work very closely for those who are responsible for the legislation. But here also, I think the call for simplification and not adding additional burden is listened to and very clear. Um, one last comment just to and it's about Amr and other provisions. Uh, it's clear that these proposals is goes hand in hand with the pharma legislation revision proposal, which is not a trilogue stage. Uh, and this CMA proposal is the industrial side of this overall, uh, necessity to revise the pharmaceutical landscape, favoring innovation but also competitiveness. So that's it. And one last, uh, information. There is a staff working document recapitulating the evidence which was used for the drafting of this proposal. And it has been published, made available to the Parliament on Tuesday evening and made publicly available yesterday. Thank you for your attention. And again, thank you for the hard work on this proposal.”
Pharma IPRs