Debate: Medicine shortages and strategic healthcare autonomy in the EU
Date: TUESDAY, 3 OCTOBER 2023
Speaker: Stella Kyriakides
Language: EN

It was in fact, I think MEP Socal, who started off today saying that there should be no first and second class citizens in access to medicines. One of your other colleagues – and in many ways you have all said this – said that we all need to work together to address shortages, but also to make sure that not only do we address shortages, but patients have access to affordable medicines and have access to innovation. So in order to do this, I have said from the beginning we need to have all players on board. We need to have industry on board. We need to have supply chain holders or stakeholders on board. We need to have Member States and their health systems on board. And, of course, we need to have all the EU and the institutions on board. Now in the pharmaceutical reform that we have put forward – and this needs to be absolutely clear – we are looking at strengthening our pharmaceutical sector in Europe and to keep it as a global frontrunner and keep it as a frontrunner in innovation. So I will not agree with the statement that I have heard saying that our reform will be discouraging innovation. I believe that we can collectively feel proud of what we have achieved in the last three or four years, in putting together a strong European health Union. Let’s just remind ourselves what we have done together and with your support. And I think that this always needs to be said. We have extended the mandate of the European Medicines Agency, which allows them really to be able to be proactive. Now in the area also of shortages, we’ve created a new agency or authority HERA, which comes to support the efforts that we are doing. And we have put forward a new proposal on a pharma reform.  Now, I mentioned in my opening remarks that we are coming forward with a communication. I wanted to just say in two seconds what this will be, because it is important that you’re aware of this. This is going to be a toolbox of actions which will be enhancing the availability and security of supply of medicines at all times. It will have short-term measures to present, prevent and respond to critical shortages, with the solidarity Member States, for which the Member States have been calling for a long while.  We’re going to have an earlier adoption of the list of critical medicines. Many of you have asked, What are we doing with that? I just wanted to say that this will be prepared and we will be putting this forward by the end of this year. It will also be looking at guidance on procurement of medicines, but it will also be looking at what we’re going to be doing in the long term with additional measures that we need to do to have structural change, building the right environment for investment and the right structures through, for example, EU FAB, so that we have solidarity.  We will be looking at the possibility of stockpiling in our communication and also a revision of the joint procurement. So I’m looking forward to this communication coming forward and being able to present it to you and discussing it with you. In terms of the re-shore of production of all critical medicines to the EU, I want to just say two words. Open strategic autonomy is a major political objective of the Commission, and I think it is also a major lesson learned from the COVID crisis, and we want to de-risk, but we do not want to decouple from the global economy. The vulnerabilities analysis of the Union list of critical medicines will be informing us, because you need to see this as a toolbox on which medicines we need to diversify in terms of supply or reshoring. There is no one size-fits-all-approach, so we really need to base ourselves on medicines. We are going to have, and this is already in the reform that I hope that you will be debating as quickly as possible, we have proposed a new European alert system. We need to have earlier notification of shortages and of withdrawals so that we can have prevention plans of shortages and stronger EU coordination and mechanisms.  In terms of APIs, many of you have said this and I will not repeat myself, but in order to ensure this, we need to have a healthy environment for the pharmaceutical and the biopharmaceutical industries in the EU. We need to look at manufacturing flexibility and skilled labour, and this can help us build up the situation that we are working towards to have more secure supply chains and local EU production in order to enable a healthy environment.  On funding, a lot of financial instruments can already support strong medicines production, for instance, from the Recovery and Resilience Facility at the EU level and the recently proposed STEP mechanism supports innovative biotechnology, and also national funds can be made available. Because there was a very clear question on the issue of the Critical Medicines Act – and I don’t want to not answer that, I’m sorry I have gone over time, but so much has been said – we are open to explore a new approach for the Critical Medicines Act. I’ve said this before, but this legislative initiative requires very thorough preparation. We need to assess the industrial, the trade and the commercial dimensions and the immediate legislative priority for us – and I think for all of us now – is this pharmaceutical reform, which proposes a toolbox to address shortages and boost our security of supply in a structured way.  This is what we need in a European Health Union. We have achieved over the past 20 years – and the last time there was a reform I think was 19 years ago – is to have safe and effective medicines in the EU. But what we have not achieved is to have a single market for medicines and that’s what we are putting forward in our pharmaceutical reform.  I’m counting on your support for a swift discussion and adoption of this legislation, because ultimately it is the best way forward to mitigate shortages and to ensure that all medicines reach all patients whenever they need them. That’s what we’re all committed to do here.