EFPIA and Vaccines Europe (VE) call for clear, predictable and supportive legislation under the upcoming EU Biotech Act, a unique opportunity to make Europe a global leader in biotechnology and life sciences.

In its response to the European Commission’s public consultation, EFPIA and VE urge coordinated action to boost Europe’s competitiveness, strengthen its biotech ecosystem and attract investment from world-leading pharmaceutical innovators. With Europe’s share of global pharmaceutical investment and clinical trials declining, and other regions rapidly advancing, urgent action is needed to keep innovation and high-value R&D in Europe.

The Biotech Act can reverse this trend and make the EU the fastest, most predictable and most innovation-friendly region for biotechnology. EFPIA and VE highlight key priorities:

• Strengthen Europe’s IP framework – enhance data protection, reform SPCs and ensure IP rules that truly reward innovation.
• Simplify and harmonise clinical trials – faster, coordinated approvals and reliance mechanisms across Member States.
• Ensure end-to-end regulatory oversight – a connected EU system, with the EMA in a stronger coordinating role, keeping pace with innovation.
• Create a coherent framework for advanced manufacturing – align overlapping rules, adapt to scientific progress, and enable agile production.
• Expand funding and investment – support SMEs and unlock private capital through EU-backed guarantees and pension reforms.
• Harness digitalisation and AI – balance data sharing with competitive IP and fit-for-purpose, risk-based rules on AI use in medicines lifecycle to accelerate innovation for patients.

EFPIA Director General Nathalie Moll said:

“Innovation depends on an ecosystem built on scientific excellence, predictable regulation, and competitive investment conditions. The Biotech Act offers a defining moment for Europe to reclaim leadership in life sciences, revitalise its innovation ecosystem, and ensure that future generations of patients benefit from the discoveries and technologies developed here.

The sense of urgency and recognition of how important an updated operating environment is for attracting pharmaceutical investment to Europe is clear and the sector is fully behind the Act.”

Sibilia Quilici, Executive Director of Vaccines Europe, said:

“Vaccines are a cornerstone of Europe’s resilience and health security, playing a vital role in preventing disease and supporting strong healthcare systems. The Biotech Act is an opportunity to recognise vaccines as a strategic investment for Europe’s health and competitiveness, supported by policies that foster research, encourage manufacturing, and simplify regulatory pathways. By strengthening the conditions for vaccine innovation, Europe can continue to lead globally and ensure that future generations benefit from cutting-edge European science.”