During the plenary session (23-26 November) in the European Parliament in Brussels, MEPs debate the Pharmaceutical strategy for Europe. Opening statement by by Stella KYRIAKIDES, European Commissioner for Health and Food Safety. This transcription speech is the result of an automatic process. Check against delivery.

Brussels

debate

plenary session

healthcare safety (T)

KYRIAKIDES, Stella (CY, EC)

Coronavirus outbreak (T)

Pharmaceutical strategy for Europe: Opening statement by Stella KYRIAKIDES, European Commissioner for Health and Food Safety

SOUNDBITE (Original), Othmar KARAS (EPP, AT), EP Vice President, Ladies and gentlemen, the sitting is resumed. We come to the Commission statement on the pharmaceutical strategy for Europe. I would like to inform members that today for all of the debates of this part session, the agreed proceedings are that we will have no catch-the-eye procedure. I know that some people are not happy about this, but that's the situation and there are no blue cards, so we don't want to have any discrimination between those people who are in the rooms or those who are connected by our European Parliament Liaison Offices.

SOUNDBITE (Original), Othmar KARAS (EPP, AT), EP Vice President, So no blue cards. As I said, there are remote connexions forseen from the Parliament's Liaison Offices in the member states. So our next item on the agenda is the Commission statement on the pharmaceutical strategy for Europe. So Commissioner Kyriakides has the floor.

SOUNDBITE (Original), Othmar KARAS (EPP, AT), EP Vice President, We cannot accept individual remarks or interventions. Madame Commissioner, the floor is yours. No, colleague, it's not acceptable, thank you. Colleague, could you please sit down? Our colleague, please take your seat. Madam Commissioner the floor is yours.No, it's not acceptable. I explained very clear why it is not acceptable. And please, please sit down and give the Commissioner the floor. Stop, please. Madam Commissioner.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, Mr President, thank you so much, colleagues, honourable members, we are nearing the end of one of the most challenging and most consequential years in recent memory. First of all, as I look back on 2020, the feeling I have is of being heartbroken for so many lives that have been lost.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, But I also feel pride and gratitude when I think of all the frontline workers and all the doctors and nurses who have sacrificed, how neighbours have rallied around each other and how the European Union came together to support citizens and member states. 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, 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 is 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, Yesterday, we adopted an ambitious pharmaceutical strategy 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, It has changed a lot and we have adjusted many things in this strategy from what we have learnt in this pandemic. So 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, Third, building strategic autonomy, developing resilient and diversified supply chains, and addressing the root causes of shortages of medicines. This includes a European Health Emergency Response Authority here, 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, So the pharmaceutical strategy aims to care to cover the whole lifecycle 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 undertake a holistic view of the pharmaceutical legislation and make the necessary improvements so that it fits for today's world.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, Over the next two years, we will work hard on the reform of the pharmaceutical legislation. This reform would 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, 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, 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, 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'll also take actions to make medicines more environmentally friendly.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, 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'll strengthen coordination with key stakeholders and industry and patient associations by establishing a structural dialogue to better understand vulnerabilities in the supply chain.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, I want to just 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.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, And the way forward with this is to encourage innovation. And to make sure that no matter where you live, no matter what state, what 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 can and we do now have the opportunity.

SOUNDBITE (Original), Stella KYRIAKIDES, European Commissioner for Health and Food Safety, So it's up to all of us. I believe 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 of medicines to citizens across the member states. And this is a responsibility that we will definitely do our best to stand up to. Thank you.