Debate: Pharmaceutical strategy for Europe
Date: THURSDAY, 26 NOVEMBER 2020
Speaker: Stella Kyriakides
Language: EN

I’m also reminded of an old saying that those who do not learn from history are condemned to repeat it, and COVID-19 has taught us some harsh lessons, lessons that we are still learning. It has reminded us of the foundational role that health plays in our societies and our economies. It has highlighted the vital importance of solidarity, and this has amplified structural vulnerabilities in our health system. The Commission is determined to heed these lessons and take decisive action in partnership with the European Parliament and Member States.  Yesterday, we adopted an ambitious pharmaceutical strategy for Europe. It is an important building block in a genuine European health union and I am truly delighted to have the opportunity to discuss it with you. This strategy addresses both the short-term challenges linked to COVID-19 and the long-term challenges connected with unmet medical needs, Europe’s strategic autonomy and sustainable health systems.  I will share with you that this was a strategy that was in my mandate letter from President von der Leyen one year ago. When I saw it there, I knew that we were faced with challenges with the pharmaceutical situation in Europe, but I never imagined that we would be presenting it in the COVID—19 crisis. It has changed a lot and we have adjusted many things in this strategy from what we have learned in this pandemic.  It focuses on four key areas. First and foremost, improving patients’ access to affordable medicines. Secondly, ensuring innovation to boost the potential of our pharmaceutical industry and increasing support for unmet medical needs of patients. This includes harnessing the benefits of emerging science and technology and reducing the environmental footprint. It is no good having innovation if you cannot have this reach patients. Third, building strategic autonomy, developing resilient and diverse types of supply chains, and addressing the root causes of shortages of medicines. This includes the European Health Emergency Response Authority (HERA), which will enable the EU and its Member States to rapidly deploy the most advanced medical and other measures in the event of a health emergency. And finally, fourth, to promote EU influence and competitiveness at global level and ensure a level playing field for EU operators. So the pharmaceutical strategy aims to cover the whole life cycle of medicine, from research to clinical trials and authorisation, from consumption to safe disposal.  Honourable Members, the current pharmaceutical legislation has served us well. However, we are now living in a vastly different reality. We have to take a holistic view of the pharmaceutical legislation and make the necessary improvements to ensure it is better adapted for today’s world. Over the next two years, we will work hard on the reform of the pharmaceutical legislation. This reform will address all the angles I mentioned, but always putting the patient at the centre and always ensuring that our pharmaceutical industry maintains its global leadership. This applies to the framework for medicines, for children and rare diseases.  However, this strategy is not just about changes to legislation. We will also simplify the regulatory procedure allowing quicker access to innovative and affordable medicines for patients, such as gene-editing technologies and personalised treatments; to facilitate the development of novel antibiotics and to combat antimicrobial resistance; to increase the uptake of generics and biosimilars. We will also create a health data space where regulators and the industry can exchange data for the benefit of patients and provide for simple solutions such as electronic product information. At the same time, we will revise our system of initiatives for research and development to ensure those incentives are fair and balanced while allowing the EU industry to remain innovative and competitive worldwide. We will also take action to make medicines more environmentally friendly.  Last, but definitely not least, we aim to address shortages of medicines by reinforcing the current obligations for supply, and require an early notification of interruption. In parallel, we will strengthen coordination with key stakeholders and industry and patient associations by establishing a structural dialogue to better understand vulnerabilities in the supply chain.  I just want to end by saying a few words. There are thousands of European Union citizens who are today suffering from rare diseases, and there are thousands of families who have children with cancer, and they do not have access to the medicines that we would want them to have that would give them a better quality of life and hope. The way forward with this is to encourage innovation and to make sure that no matter where you live, no matter which Member State you belong to, you have equal access to safe and affordable and innovative medicines.  The road is not going to be easy, and this is a strategy that is a vision, and it is a vision with actions that will be developing over the next four years. We already have a very buoyant, and I would say a front-runner, in the pharmaceutical industry in Europe, but we can do better and we now have the opportunity, so it’s up to all of us – the European Parliament, the Council and definitely the Commission. If we work together, we can bring together new legislation, but also other actions that are really going to change the realities for access to medicines for citizens across the Member States, and this is a responsibility that we will definitely do our best to stand up to.