The Biotech Act: A blueprint for a strong, resilient, and fair Health Union

How many more patients must we fail before we admit that Europe’s health innovation system is broken? How many more families, searching desperately for a treatment, must we send on an impossible journey of roadblocks and closed doors?

The reality today is that the one specialist who understands their rare condition may practise in another country. The clinical trial that offers a flicker of hope may be in another. And their medical history may sit in a system that doctors elsewhere just cannot access. 

This is not a failure of science. Europe has pioneering research, deep clinical expertise, and brilliant digital health initiatives. It is a failure of political will: we have allowed these assets to remain fragmented across a labyrinth of national rules and procedures. So far, this has been holding back progress and, ultimately, costing lives.

The European Biotech Act is an opportunity to start fixing this. As the Parliament’s rapporteur for this file in the Public Health committee, my goal is to shape it into a blueprint for a Europe that connects its strengths and delivers for its people.

It must be a health-driven blueprint. With health applications accounting for over 75% of the biotech sector’s value and jobs, I am convinced the Act can be a cornerstone of a stronger European Health Union, with patients at its centre.

From building blocks to an ecosystem that delivers

World-class assets in research and data are not enough. To deliver for citizens, we must build a thriving, interconnected health-innovation ecosystem. The Biotech Act has greater potential than its name indicates. Instead of betting on a single technology, it must help bridge the gap between Europe’s scientific excellence and its implementation in our healthcare systems. 

We must finally translate innovation from bench to bedside.

This means unleashing the power of the assets we already have. We can leverage a responsible, AI-driven approach to dramatically speed up the discovery of new therapies, connecting our European Health Data Space and the 1+ Million Genomes initiative to find answers faster than ever before. 

It also means to keep building on excellence.

Our 24 European Reference Networks (ERNs), which connect over 1,600 specialist centres across more than 350 hospitals, are a prime example of how European collaboration saves lives. The Act must now recognise them for what they are: the strategic infrastructure of our European health ecosystem.

When that happens, ERNs will then be empowered with stable, ringfenced funding and a stronger, formal role across the entire research lifecycle. This is our opportunity to establish clear cross-border pathways so that expertise can travel to the patient, and the patient to the expertise.

And then, let’s make bold choices. Let’s use regulatory sandboxes to bring novel therapies forward, in a controlled but agile way. Let’s build high-speed, multi-country clinical trials designed not just for bureaucratic convenience, but to help patients that have run out of options.

Forging a resilient Health Union

Europe’s resilience must begin at home. For too long, internal fragmentation has weakened our health security and deepened the very dependencies we now seek to escape. Strengthening our strategic autonomy in health is a necessity, and the Biotech Act can serve this by fostering a predictable environment that encourages investment in cutting-edge biomanufacturing. 

But resilience also comes from shared capacity. Rather than duplicating efforts in every country, we should aim for a smart, connected, hub-and-spoke network of manufacturing infrastructure that serves the needs of cross-border patients. By leveraging the strength of European collaboration, we can ensure that a patient in a smaller Member State has access to the most advanced therapies on the same terms as one in a larger one. 

But this must not concentrate innovation in a few traditional hubs. Solidarity is a founding principle of our Union, and true resilience comes from shared capacity. The Act must incentivise research and manufacturing capabilities across all Member States, so that patients in smaller countries have access to innovation on the same terms as those in larger ones. 

Each single Member States is small next to the US or China. But together, they are a continent with scale to drive innovation. 

Innovation that serves patients

As we build this ecosystem, our European values must be our guide. Speed can never come at the expense of our standards. Patient safety, equity, and fundamental rights are the bedrock of our approach, and they are not for sale. 

Our vision is of an innovation ecosystem that delivers fair and equitable access for all. I will be working to build a balanced framework that rewards real breakthroughs, attracts capitals, and de-risks investments – especially in areas like rare and ultra-rare diseases, where markets haven’t been able to cater to patients who need it the most.

I believe that affordable treatments can reach patients in good time, while also easing the pressure on our health systems, and safeguarding the sustainability of our social model.

The task before us is to turn a patchwork of excellence into a world-leading ecosystem. By adopting a health-driven blueprint that connects our assets, empowers our shared infrastructure, and embeds solidarity at its core, the Biotech Act can deliver a stronger, more resilient, and fairer European Health Union. 

The European Parliament is ready to build an ambitious position, and I stand ready to work hand in hand with the Commission and the Council to deliver a transformative act.