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

One year ago, we presented the new pharmaceutical strategy for Europe in this House, the strategy that will shape our pharmaceutical policy for the coming decades and aims to ensure that all patients can access the medicines they need, when they need them. This is a fundamental right. It is a crucial part of our collective effort to recover from the pandemic, stronger and more resilient than before. That is why I truly welcome Parliament’s report on the pharmaceutical strategy. Let me thank the rapporteur, Ms Montserrat, and the shadow rapporteurs, for this very important work. I am encouraged that you support the objectives of the strategy, but more than that, that you share its ambition. This speaks well for the strategy’s implementation, and in particular the legislative proposals. One of the first deliverables on a flagship initiative is the political agreement on the Regulation on Health Technology Assessment (HTA), which is expected to be endorsed next month. Strengthened EU cooperation on HTA will help Member States to take more timely and evidence—based decisions on new treatments and improve patients’ access to new innovation. Another early deliverable is the Health Emergency Preparedness and Response Authority (HERA), which you have already mentioned and which became operational last month. HERA fills a major gap in the EU’s health security framework. It will improve the development, manufacturing, procurement and distribution of key medical countermeasures, including medicines, in the EU. It will push for innovation in areas where we need it most, for example in antibiotics. In addition, the Clinical Trials Regulation becomes applicable in January and will facilitate innovation and more patient—oriented and coordinated development of medicines. Political agreement was reached at the end of last month on the strengthened mandate of the European Medicines Agency to provide for better monitoring and mitigation of shortages, and of critical medicines. To further strengthen the resilience of EU health systems, we have launched a structured dialogue with actors in the pharmaceuticals manufacturing value chain, public authorities, the research community, health professionals and patient organisations to look more strategically at the issue of security of supply. This first phase of the dialogue – the gathering of information – has now been concluded. In the second phase we will reflect on possible policy measures to ensure security of supply of medicines, active pharmaceutical ingredients and raw materials and ultimately reinforce our open strategic autonomy. Honourable Members, we are still in the early stages of the pharmaceutical strategy, but we are taking concrete steps to deliver real benefits to citizens, and there are more to come. We are working intensively on the evaluation and revision of pharmaceutical legislation. The revision of the legislation on medicines for rare diseases and for children is progressing. Both are expected at the end of next year. We are making good progress in implementing the EU strategy on pharmaceuticals in the environment. We have seen that we need stronger supply chains to address dependencies on third countries in terms of raw materials and medicines. Before ending I want to stress two important points. Firstly, this is about patients. We are putting the patient at the centre of our pharmaceutical policy every step of the way. The overarching goal here is to ensure innovation that addresses unmet medical needs, and this innovation provides affordable medicines that can reach patients across the EU. Secondly, this is a complex process, and our success depends on collaboration. We need to work together with all relevant stakeholders, and we are confident that we can. We can reduce shortages of medicines and improve access and affordability; we can support innovation and sustainability in our pharmaceutical sector; and we can deliver concrete, lasting benefits to patients.  At the end of the day this translates into healthier citizens, more accessible and more resilient health systems, and stronger and more equal societies. Once again, thank you to Ms Montserrat and all those who contributed to this significant report and I look forward to hearing the discussion.