How the Biotech Act should reinforce the public trust in Europe’s health systems

Today, European patients wait on average more than 578 days to access new medicines after approval from the European Medicines Agency with a significant variation between the EU member states. At the same time, less than half of innovative medicines approved between 2020 and 2023 were available for patients in 2024. Most recently, drug launches in EU countries fell by 35% in the 10 months since Trump’s Most Favoured Nation policy came into effect.

In other words, the EU stands at a crossroads where we risk eroding trust in our healthcare systems if we fail to act. This is not only about strengthening our economy – it is equally about strengthening citizens’ confidence that Europe can continue to deliver access to high-quality and innovative healthcare when it matters most – to save and to improve lives.

In Europe, we have a long-standing tradition of world-leading research and innovative health care systems. In addition to supporting a high quality of life in Europe, this has given us a unique competitive edge in biotechnology and medical innovation. However, we are still behind when it comes to letting our patients get access to this innovation. With the US and China increasingly hostile trade policy and massive investments in life sciences, we can no longer take our competitive edge for granted. Without stronger investment in biotechnology and faster access to innovation, Europe risks falling behind in the global race for next-generation therapies. This is a question of security, autonomy and the credibility of our promise to deliver equitable access to health care for our citizens. 

This is why the Biotech Act must not become a half-hearted attempt to support the European pharmaceutical industry. It must become a fully-fledged strategic response to a new geopolitical reality.

Europe cannot afford another piece of legislation that recognises the problem without fixing it. This is why one of my key priorities for the Biotech Act is to deliver a faster, predictable and coherent European pathway from discovery to patient access.

In my view, the smartest way to achieve this is by creating a more joined-up European approach to working with for example clinical trials. We need more, and not less Europe, to deliver on this. 

In response to fierce global competition and harmful policies such as Most Favoured Nation, a more centralised decision-making process is long overdue. Right now, our companies still have to navigate through 27 different systems across Europe – consequently slowing down ethics approvals, clinical trials, delaying patient access, and pushing investment towards regions that can offer a clearer and faster route from discovery to market. To me the response to this is clear: we need a 28th regime for biotechnology and a real single market for clinical trials. This is the level of ambition that we need in order to remove barriers and give companies the predictability they need to make long-term decisions to continue to invest in Europe. 

Europe’s share of global clinical trials has halved over the last decade. This amounts to approximately 60,000 fewer clinical trial opportunities for European patients between 2013 and 2023.

For many European patients, clinical trials are not an alternative — they are their only option to get access to life-saving medicines, especially when it comes to rare diseases, cancers and paediatric diseases. We cannot allow them to be left behind.

This is just another reason why a more centralised and more coordinated European approach to approving and running multi-country clinical trials must be the answer. Our patients count on Europe finally moving beyond fragmentation and building a system that delivers faster access and clearer rules. A system that would save lives. 

At the same time, access to innovation must not depend on where a patient was born or where they live. Yet today, geography still determines treatment opportunities across Europe. Now, we have an opportunity to both build equitable access to medicine and to solve the patient volume and data volume problem that holds back our research and development of next-generation treatments like cell and gene therapies – the personalised medicines of the future. By establishing and funding European strategic projects and centres of excellence for advanced therapies (ATMPs), the Biotech Act must therefore build infrastructure that will benefit every European in every EU country by supporting multi-country clinical trials and cross-border pathways for both diagnosis and clinical care.

Because a Europe where innovation and access to life-saving care is unevenly distributed is a Europe where citizen trust will inevitably erode. With the Biotech Act, delivering for every European is our democratic and moral imperative.

Ultimately, the Biotech Act is a test of whether Europe can deliver on its promises to our citizens. If we want to rebuild trust in our health care systems, we must show that we are able to act with urgency, coherence and ambition. The choices we make now will not only shape our future competitiveness, but the lives and livelihoods of millions of people across Europe. I will fight for a high level of ambition when I negotiate this seminal legislation, and I hope my fellow legislators will join me in sharing this responsibility.