The EU Raises Its Biotech Ambition — EUCOPE Welcomes the Act’s Strategic Direction

Brussels, 17 December 2025 – The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) recognises the publication of the European Biotech Act Part I, as a promising initiative. This Act acknowledges biotechnology and biomanufacturing as strategic pillars for the EU’s competitiveness, health resilience and scientific leadership.

EUCOPE strongly supports the political commitment of the Commission’s proposals to creating a more favourable environment for biotech innovators across the EU, particularly small and mid-sized companies developing cell and gene therapies, orphan medicines, advanced diagnostics, biosecurity, and other breakthrough technologies.

“The Biotech Act sends a clear signal that the EU intends to compete globally in biotechnology. This is a pivotal moment for the EU’s innovation ecosystem. We welcome the Commission’s ambition to build a more future-proof, agile and investment-friendly environment for biotech developers,” said Dr. Alexander Natz, EUCOPE Secretary General.

Initial assessment of the Commission’s proposals

EUCOPE welcomes key elements of the Act, which include:

• Strengthening the EU intellectual property framework, notably through the introduction of a targeted SPC extension for certain biotechnologically derived medicinal products and ATMPs, recognising the complexity, risk and long development timelines associated with these innovations and sending an important signal to support EU-based research and investment;;
• Reducing clinical trial authorisation timelines, through proposed amendments to the EU Clinical Trials Regulation that significantly shorten approval timelines, strengthen cross-border coordination via an enhanced role for the Reporting Member State, and simplify procedures for multinational, low-intervention and ATMP clinical trials, thereby improving the EU’s attractiveness for research, investment and patient access;
• Streamlining and simplifying regulatory frameworks, by reducing duplication, improving coherence across interlinked regulations, and expanding the use of regulatory sandboxes at EU and national level to introduce greater flexibility, legal certainty and support for innovative therapies that do not fit existing regulatory pathways.

It is also positive to see that regulatory improvements go hand-in-hand with dedicated funding tools that incentivise start-ups, SMEs and mid-cap biopharmaceutical companies to carry out R&D in the EU, especially in high-risk research areas. These measures have the potential to improve the EU’s attractiveness for R&D, strengthen biomanufacturing capabilities, and accelerate the development of innovative therapies for patients. Building an attractive and robust clinical trial framework will help improve access to innovative therapies.

EUCOPE will continue engaging with the Commission, European Parliament and Member States to ensure that the Biotech Act leads to a coherent, future-oriented framework that reduces fragmentation, supports investment, and strengthens the EU’s global competitiveness. The Act promises improvements across the entire discovery and development process, bringing benefits to researchers, industry, and ultimately patients. This full ecosystem is warmly welcomed by EUCOPE.

Bold and clear policy is needed by the EU and its Member States in the context of a more volatile global ecosystem. The Biotech Act should not be seen in isolation, but one part of a broader effort to establish a stronger legislative ecosystem driving pharmaceutical innovation. The challenges the European healthcare systems face cannot be addressed in silos. EUCOPE sees the Biotech Act as a commendable step in the right direction.

EUCOPE’s commitment

EUCOPE and its members stand ready to work with policymakers and stakeholders in implementing the Biotech Act and shaping the broader policy environment – from regulatory processes and manufacturing frameworks to incentives, data use and workforce development – to ensure that the EU remains a world leader in biotech innovation.

“The opportunities for the EU are significant, but so is the competition. With the right policies in place, the EU can be a global centre of excellence for biotech innovation” added Dr. Alexander Natz, EUCOPE Secretary General.