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What Is the EU Biotech Act

– and Why Does It Matter?

The EU Biotech Act is a major new legislative proposal from the European Commission – the part of the EU that proposes new rules for the entire EU area. The aim is to make biotechnology stronger and more competitive in Europe. 

This means that the EU wants to create new rules and frameworks  so that research, development and production of  biotechnology products (e.g. medicines, treatments and advanced technologies) can happen faster, more easily and in Europe instead of in other countries. 
 
Biotechnology is the use  of living  organisms, cells or biological processes  to solve problems or make products – e.g. new medicines, new ways of detecting diseases, or better biological solutions in health, agriculture and the environment. 

What is biotechnology?

Biotechnology is about using living things — such as cells, bacteria or other biological processes — to create solutions and develop useful products.

 

For example, biotechnology can be used to:

    • Develop new medicines

    • Detect diseases earlier or more accurately

    • Create advanced treatments like gene therapy

    • Improve health technologies

It also plays a role beyond healthcare, including agriculture and environmental solutions.

In healthcare, biotechnology is especially important in research and clinical trials, where new treatments are tested and developed.

 

You can read more about the proposed legislation directly from the EU here: European Commission – Biotech Act proposal

Why does the EU want a Biotech Act?

The European Commission believes that Europe is falling behind countries like the United States and China when it comes to biotech research and investment.

 

So the EU wants to:

    • Make Europe more attractive for research and companies

    • Make rules clearer and more consistent across countries

    • Speed up certain processes

    • Encourage more investment in biotech companies

In simple terms: The EU wants Europe to stay competitive and strong in medical innovation.

What does the proposal actually include?
 
The Biotech Act includes several different ideas.
 
1. “Strategic projects”
Some biotech projects could receive a special status called “strategic projects.”
This means they may get extra support and coordination at EU level.
 
2. More funding opportunities
The proposal includes plans for an EU investment pilot.
This would help biotech companies get access to money for research and development — especially when projects are risky but promising.
 
3. Artificial intelligence (AI) and data
The Act also supports using AI and better data systems in biotechnology.
For example:
            • Supporting AI tools in medicine development
            • Creating environments to test new technologies safely
4. Changes to clinical trial rules
One important part of the proposal updates the EU Clinical Trials Regulation (CTR).
The goal is to:
            • Shorten approval timelines
            • Make cooperation between EU countries easier
            • Simplify certain procedures
This could make it easier to run multinational clinical trials in Europe.
However, these changes are mainly about improving efficiency — not specifically about patient access.
What does this mean for patients?
Some of the changes — especially in clinical trials — might help reduce delays and administrative barriers.
But it is important to understand something clearly:
 
> The EU Biotech Act is mainly designed to improve competitiveness and economic strength in Europe.
 
> Improving patient access is mentioned, but it is not the main focus of the proposal.
 
For example: The proposal talks about cross-border cooperation between countries when approving trials. But it does not clearly guarantee cross-border access for patients who want to participate in a clinical trial in another EU country.
 
This is an important topic for initiatives like EU-X-CT.
What does the EU Biotech Act mean for citizens and patients? 
 
1. Faster access to new treatments 
When rules become simpler and approval processes faster, new medicines and treatments can reach patients sooner. This can be particularly important for people with rare diseases, fewer treatment options or serious diseases where time is of the essence. 
 
2. More research in Europe 
The EU Biotech Act could mean that more biotech companies choose to do their research and production in Europe rather than in other countries. This could create more jobs, more local innovation and a stronger European health industry. 
Read more about EU Bietech Act here
What Is the EU Biotech Act?