On 16 December 2025, the European Commission presented a legislative proposal entitled the European Biotech Act, with the aim of promoting the development of the biotechnology and biomanufacturing sector across the European Union. The text was introduced in response to a twofold need:
to close the competitive gap with major global players such as the United States and China, which are making substantial investments in biotechnology and biomanufacturing;
to translate Europe’s scientific excellence into high value‑added products and solutions, while attracting the creation and retention of innovative start‑ups within the European continent.
Regulatory barriers, high costs, lengthy authorisation timelines and the lack of competitive manufacturing facilities have so far limited the large‑scale adoption of biotechnological innovations within the internal market.
The proposal seeks to establish a regulatory and strategic support framework to enhance the Union’s competitiveness in the biotech sector, by fostering investment, industrial capacity and business creation; to accelerate market access for biotechnological products through more streamlined and predictable procedures; and to maintain high standards of safety, protection of health and environmental safeguarding.
The European Biotech Act is structured around several interconnected “pillars” addressing specific obstacles along the biotech innovation pathway:
a) Facilitated access to financing
The proposal предусматриes the creation of a new EU investment facility to support start‑ups and small and medium‑sized enterprises (SMEs), with the objective of mobilising public and private resources estimated at up to approximately EUR 10 billion in the first years. This mechanism is intended to help smaller companies secure sufficient capital for experimentation, development and scaling up of production.
b) Regulatory simplification and acceleration of procedures
The Biotech Act proposes the harmonisation and simplification of certain existing rules, reducing the time and costs associated with authorisations for clinical trials and new advanced therapies. This includes regulatory procedures that are more streamlined and proportionate to risk; tools such as regulatory sandboxes to test innovative technologies in a controlled environment under regulatory supervision; and greater consistency between national and European regulatory frameworks.
c) Strengthening manufacturing capacity and infrastructure
The proposal encourages investment in advanced biomanufacturing facilities and centres of excellence, enabling large‑scale production to be carried out within Europe rather than outsourced abroad. It also aims to address the shortage of specialised skills in areas such as R&D, regulatory affairs, data science and industrial‑scale manufacturing.
d) Use of data, artificial intelligence and digitalisation
The new framework promotes the integration of digital technologies and artificial intelligence throughout the entire process — from research to production — in order to increase efficiency, quality and safety.
e) Biosecurity and ethical safeguards
The proposal maintains high levels of protection for health and the environment, with measures designed to prevent the misuse of biotechnologies and to ensure an appropriate balance between innovation and responsibility.
If adopted in a form similar to the initial proposal, the legislation is expected to shorten the time required to bring new therapies to market, with positive effects on patient access to innovative treatments; increase biotech investment in Europe, making the continent more attractive to public and private capital; strengthen industrial autonomy by reducing dependence on non‑EU suppliers for critical technologies in the healthcare and biomanufacturing sectors; and support the creation of new highly specialised jobs and the development of advanced skills.
The proposal presented by the Commission must now be discussed, amended and approved by the Council of the European Union and the European Parliament. This legislative process will require several months of negotiation before final adoption and entry into force.
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