At the end of 2025, the European Commission presented the EU Biotech Act, a legislative proposal aimed at strengthening the competitiveness of the health biotechnology sector and making the European Union a more attractive environment for innovation. The initiative forms part of a broader package of measures designed to make the European system more resilient, modern, and capable of retaining investment and talent.
The Act introduces a range of measures spanning access to funding, simplification of regulatory processes, and new incentives for the development of innovative products. The political message is clear: the EU intends to reinforce its role in the global biotechnology landscape.
An initiative to be viewed in a broader context
The Biotech Act complements other key reforms already underway, including the European pharmaceutical package, proposed amendments to the medical devices regulatory framework, and the Digital Omnibus initiative.
Why the Commission is acting now?
According to the Commission, biotechnology is one of the most dynamic sectors of the European economy, growing at twice the rate of the EU average, contributing approximately €40 billion to GDP and supporting more than 900,000 jobs. Despite this, Europe continues to lose ground to other regions of the world.
The figures are telling: only a limited share of global venture capital investment in health biotech is directed to Europe, and over the past decade the proportion of clinical trials conducted in the EU has declined significantly.
Scope and definitions
The Biotech Act primarily focuses on biotechnology applied to human health but also includes targeted measures affecting related areas such as food safety, substances of human origin, and genetically modified organisms. Some amendments—particularly those concerning clinical trials—have a broader scope and apply beyond strictly biotech products.
Key elements of the proposal
Strategic projects and targeted support
The proposal introduces the concept of “health biotechnology strategic projects,” with a specific category for projects with high impact at EU level. These projects may benefit from accelerated regulatory pathways, easier access to EU funding, and dedicated support infrastructures, such as testing environments and biomanufacturing training centres.
New funding instruments
The Act provides for a pilot investment programme developed in cooperation with the EIB Group, combining equity and debt instruments tailored to the risk profile of the biotech sector. The aim is to attract private capital and strengthen long-term financing, with particular attention to small and medium-sized enterprises.
Incentives for biotech medicinal products and ATMPs
Among the most significant measures is a 12-month extension of supplementary protection certificates (SPCs) for certain biotech medicinal products and advanced therapy medicinal products, subject to specific conditions related to product innovation, the conduct of clinical trials in multiple Member States, and the presence of manufacturing activities within the EU.
Biosimilars and reduced regulatory burden
The Biotech Act further supports the development of biosimilars by encouraging the European Medicines Agency to develop guidelines that facilitate authorisation, potentially including a reduction in the clinical data required.
AI, data and clinical research
The proposal places strong emphasis on the use of artificial intelligence and health data, including through the European Health Data Space. In the area of clinical trials, it aims to significantly reduce authorisation timelines, introduce regulatory sandboxes, and establish single pathways for studies combining medicinal products and medical devices.
Biosecurity and GMOs
Alongside pro-innovation measures, the Act introduces harmonised biosecurity rules and is accompanied by a specific proposal on genetically modified microorganisms, providing simplified procedures for low-risk cases.
Expected impact and next steps
The proposal will now be examined by the European Parliament and the Council. If adopted, the EU Biotech Act could reduce development timelines and costs for biotech products, improve access to capital, and strengthen European manufacturing capacity. The potential benefits are substantial, particularly for small and medium-sized enterprises.