Biopharmaceutical sector welcomes EU Biotech Act

The draft EU Biotech Act I is designted to boost health biotech in Europe, speed up clinical trials, support scale-ups, and strengthen innovation and investment.

Health Commissioner Olivér Várhelyi highlighted the importance of pharmaceutical and health biotech, noting that health-related biotechnology accounts for around 80 % of the sector’s overall value, making it a key driver of innovation and economic growth across the EU.

The Biotech Act I aims to accelerate innovation, reduce regulatory hurdles, and improve conditions for growth and scale-up for European biotech companies. Its main focus areas are clinical trials and financing for biotech scale-ups, with broader food-related biotechnology expected to be covered in a subsequent legislative stage.

Speeding up clinical trials in Europe

The Act seeks to make the EU Clinical Trials Regulation more workable. Proposed measures include binding timelines, a stronger role for lead Member States, reduced duplication of authority requests, and improved coordination among national ethics committees, particularly for multinational studies. Safety and informed-consent standards remain unchanged.

The Commission also plans to increase digital and AI-supported processes via the Clinical Trials Information System (CTIS), accelerate handling of protocol amendments, and reduce delays for complex or adaptive trial designs. A new initiative, FAST EU, will further streamline trial approvals and strengthen EU-wide coordination in emergencies.

Claire Skentelbery, Director General of EuropaBio, said: “Europe has world-class science, but innovation only benefits patients if it can move quickly from the lab to the clinic. Measures that reduce duplication and uncertainty in clinical trials are essential if Europe wants to remain an attractive place to develop new therapies.”

New financing instrument for biotech scale-ups

As announced earlier, the Act introduces a new European Investment Bank (EIB) financing instrument targeting biotech scale-ups. Around €1bn in EIB own-resources will be channelled through an InvestEU-backed venture debt instrument to companies that have outgrown grants but are not yet ready for public markets. The instrument is expected to leverage significant private investment. Launch is planned for 2026–2027, independent of the legislative timetable.

Nathalie Moll, Director General of EFPIA, said: “Without competitive access to capital, Europe risks discovering medicines that are ultimately developed and commercialised elsewhere. Predictable regulation and growth capital must go hand in hand if Europe wants to translate scientific excellence into patient access and industrial strength.”

Industry reaction

German industry association BioDeutschland welcomed the Biotech Act I as an important step forward for medical biotechnology and medical technology, citing faster market access, simpler regulatory processes, and improved scale-up support.

The association urged swift implementation and a broad view of the biotech ecosystem, noting that biotechnology is a platform technology with applications across sectors. Stakeholders are calling for the second part of the EU Biotech Act, expected next year, to address food and industrial biotechnology and provide a more concrete framework than the Commission’s bioeconomy strategy.

Contract research organisations also emphasised the need for clear regulation for Europe’s clinical research infrastructure. EUCROF representatives stressed that streamlined and coordinated trial approvals are essential to keeping multinational studies in Europe and maintaining the continent’s global research leadership.