Debate: A pharmaceutical strategy for Europe
Date: MONDAY, 22 NOVEMBER 2021
Speaker: Stella Kyriakides
Language: EN

Ms Regimenti, you mentioned innovation. We will be adopting our framework to better promote progress and new possibilities. Ms Weiss, on intellectual property (IP), in the context of this strategy, we are taking a close look at how to further optimise intellectual property incentives to boost innovation, address unmet needs and ensure at the same time market entry and continuous supply.  I want to touch on two points that were raised by Ms Véronique Trillet-Lenoir and Ms Moretti, both of whom mentioned the fact that we need to find the right balance between incentives for innovation and the need for access to affordable medicines, and to say that an impact assessment will be carried out for major changes to the legislative framework, which will inform the policy changes to strike the right balance. With this strategy, we will further support the public—private partnership programmes to boost research.  Ms Moretti, I’m going to quote you because you said that this is a report we can be proud of, and that we need to look at patients’ dignity. These really are key elements to the centre of this report. You mentioned a true European Union of health. Ms Metz, we will propose to reform our pharmaceutical legislation to ensure the environmental sustainability of the manufacturing process and to strengthen environmental risk assessment requirements.  I think it was Ms Kopcińska who raised the issue of biosimilars and generics, and I think that this is a very important question since generic and biosimilar medicines can provide patients with accessible and affordable treatments. We envisage to reform the pharmaceutical legislation to better promote competition with such products and remove barriers that delay their timely entry to market, allowing for lower prices and hence improving affordability and access to medicines.  I cannot fail to pick up that I heard some points being raised on points that I had answered in a previous debate here earlier in the afternoon, discussing – or rather disputing – the science and effectiveness of vaccines, and I’m just going to repeat what I said in an earlier debate. The science speaks of the effectiveness of vaccines. They are safe and effective, they protect against loss of life and serious disease, and this is the science that we are basing our strategy on, and on which the European Centre for Disease Prevention (ECDC) will also be publishing its latest risk assessment.  Ms Glavak, yes, we will look at the challenges raised. Mr Luena, you raised a point on the Orphan Medicinal Products Regulation, and I think that this is important because the evaluation of the legislation of medicines for rare diseases in children showed that both legislative instruments have stimulated research and the development of medicines, but that there are also a number of shortcomings. We will be addressing these within the strategy and, with industry, will be looking at the way that we can build across to address the weaknesses that we have seen. Many of you have raised the importance of innovation and the success of recent months in reaching safe and effective vaccines and that we can do more, and this is our point. I think it was Ms Paulus who raised the importance of the level playing field. I think that this is extremely important in terms of strengthening our cooperation with our international partners to ensure the environmental sustainability of active pharmaceutical ingredients imported from non—EU countries. Yes, we have taken on board much of what we are learning, and have learnt, from the COVID—19 pandemic, and we have already made some adaptations to our framework, for example by facilitating the way we approve future variant vaccines through post—authorisation changes. As part of the pharmaceutical strategy, we are assessing how these flexibilities can be used in the future, and we will of course make necessary changes in the system where required. Mr Kympouropoulos, I listened to you very carefully. Yes, we need to create – and that’s what we’re working towards, dear Stelios – a common framework, and this is exactly what we aim to do. There were some points raised on where we are now with the pandemic. I will not go back to the discussion, but what I can say is that we are convinced that the EU strategy that we have followed, in terms of safe and effective vaccines available for all citizens of the European Union with equity, has proven to be a success. Last, but not least, Mr Olekas, on the joint procurement of medicines: yes, it’s proved its importance and it’s proved its strength. We’re already using this in the European therapeutics strategy, and many of you mentioned cancer. Just to let you know that Europe’s Beating Cancer Plan is in motion and already has many of the actions that we had aimed for being put in place. Ms Niebler, sound pharmaceutical strategy, diversification and support were your words. Yes, we can do this if we work together.  Finally, there was so much to answer and I’m not sure I covered everything, but I just want to close with a word of thanks to Ms Dolors Montserrat and all the rapporteurs, and to just say that access to medicines is my key priority as Health and Food Safety Commissioner. There should be no first and second—class patients in the European Union. Everyone in the European Union should have access to the same treatments. The inequalities that we see are simply not acceptable. I am not saying that this is going to be easy and I’m not saying that we’re not going to meet challenges, but I am saying that we need to see change. I am also saying that we can all work together, with the Member States and with everyone in this Parliament, and really deliver no more and no less than what European citizens and patients expect from us.