President, Honourable Members,

We are nearing the end of a one of the most challenging and most consequential years in recent memory.

The feeling I have when I look back over 2020, is that I am heartbroken that so many people lost their lives or livelihoods.

But I feel pride and gratitude when I think of how frontline workers and health professionals sacrificed, how neighbours rallied around each other, and how the EU came together to support its citizens and Member States.

I am also reminded of the old saying that those who do not learn from history are condemned to repeat it.

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 economies.

It has highlighted the vital importance of solidarity.

And it has amplified structural vulnerabilities in our health systems.

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 this opportunity to discuss it with you.

The 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.

The Pharmaceutical Strategy was in my mission letter from President von der Leyen one year ago. When I saw it there, I already knew that we were facing a challenging situation in Europe, but I never imagined we would be presenting this Strategy during the COVID-19 crisis. It has changed a lot, and we have adjusted many things in this Strategy from what we have learned during this pandemic.

It focuses on four key areas:

  • First and foremost, improving patients’ access to affordable medicines.
  • Second, 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.
  • 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 (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.
  • Fourth, promoting EU influence and competitiveness at global level and ensuring a level playing field for EU operators.

The Pharmaceutical Strategy aims to cover the entire lifecycle of a medicine -- from research, through clinical trials and authorisation, to consumption and safe disposal.

 

Honourable Members,

The current pharmaceutical legislation has served us well. However, we are now living a vastly different reality.

We have to undertake a holistic review of the pharmaceutical legislation and make the necessary improvements so that it is fit for today’s world.

Over the next two years, we will be hard at work on the pharmaceutical legislation reform. This reform will address all the angles I just mentioned, putting the patient at the centre and ensuring that our pharmaceutical industry maintains its global leadership.

The same applies to the framework for medicines for children and rare diseases.

However, this 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 industry can use and exchange health 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 incentives 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 – industry and patient associations in particular – by establishing a structured dialogue to better understand vulnerabilities in the supply chain and identify sustainable solutions.

There are thousands of EU 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 we would want them to have, that would give them a better quality of life and hope.

The way forward is to encourage innovation and to make sure that no matter where you live, no matter what Member State you belong to, you have equal access to safe, affordable and medicines. The road is not going to be easy. This Strategy is a vision, with actions that we will be developing over the next 4 years.

We already have a front running pharmaceutical industry in Europe, but we can do better. And we now have the opportunity to do so. It is now up to all of us, and I do believe that if we work together, we can bring about new legislation and actions that will change the reality for access to medicines for citizens across Member States. This is a responsibility that we will do our best to stand up to.

Thank you.