New rules and funding to stop exodus of research and production
There is one figure that tells the stakes of the new European strategy on biotechnology better than any slogan: €38.1 billion in GDP and over 913,000 employees. This is the economic weight the biotech sector already holds in the European Union. But it is also the starting point of a challenge that Brussels admits it is losing: transforming scientific excellence into products, factories, and industrial value. With the Biotech Act, presented on December 16, 2025, the Commission is trying to change course, intervening where the European system has been stalling for years: fragmented rules, excessively long timelines, insufficient capital, and difficulties in scaling up.
The structural bottleneck: rules, timelines, and production capacity
The paradox is well-known to industry insiders. Europe produces top-tier research, with scientific capabilities comparable to the United States and China, but struggles to bring results to market. The numbers are telling: between 2015 and June 2025, approximately €219 billion in venture capital flowed into health biotech in the United States, compared to just €25 billion in the EU. It is not surprising, therefore, that 66 of the last 67 European biotech companies that went public chose non-EU stock exchanges, taking growth, skilled jobs, and value chains elsewhere.
Commenting on this, Vincenzo Salvatore, Professor of European Legislation at the University of Insubria and Partner at Simmons & Simmons, stated: «The 30 pages of the explanatory memorandum, rich with data and information on the biotech sector, the 178 recitals, the 67 articles, and the considerations set out in the accompanying 85 pages require a more careful and reasoned reading…»
Indeed, the heart of the problem, the Commission acknowledges in the document accompanying the proposal, is structural. Governance remains fragmented, authorizations are slow and inconsistent, and production capacities are underutilized. In the field of clinical trials, for example, Europe takes an average of 113 days to authorize multinational studies, compared to around 60 days for its main global competitors. Meanwhile, Europe’s share of worldwide sponsored clinical trials fell from 22% in 2013 to 12% in 2023, while China’s rose from 5% to 18%.
The Biotech Act: simplification, incentives, and strategic projects
This is the genesis of the Biotech Act, a proposed regulation aimed at creating a cohesive system and leveraging the scale of the single market as a competitive advantage. The focus is clear: health biotechnologies, considered strategic for competitiveness, industrial autonomy, and health security. The intervention covers the entire lifecycle of innovation: from research to clinical trials, from manufacturing to market access, and extending to the use of digital technologies and artificial intelligence.
As Salvatore highlights, «among the most significant measures outlined by the new Regulation are the mechanisms for accelerating clinical trial authorization procedures, the identification of strategic projects deserving priority consideration, and the provision of sandboxes».
One of the most important pillars concerns regulatory simplification. The regulation intervenes in several key legislative texts – from the Clinical Trials Regulation to advanced therapies, from the safety of substances of human origin to veterinary legislation – with the aim of reducing duplication, shortening timelines, and making the framework more predictable for investors. The stated goal is to reduce time-to-market without lowering safety standards.
Capital, manufacturing, and AI: the Innovation chain
Alongside regulations, the issue of capital remains decisive. The Biotech Act introduces an EU Health Biotechnology Investment Pilot, designed to bridge the gap in late-stage financing and mobilize public and private resources. Currently, access to capital is one of the main brakes on scaling up: according to Commission consultations, less than 7% of operators find it easy to access private equity, debt, or capital markets in Europe.
The regulation also addresses the industrial dimension, through the recognition of strategic biotech projects and accelerated authorization procedures, and looks to artificial intelligence as a cross-cutting lever for research, development, and production. In parallel, it strengthens biosecurity measures, in response to growing risks associated with the misuse of biotechnologies.
Legislative timeline and political challenge
The legislative process is just beginning. After the presentation on December 16, the text will enter discussions between the European Parliament and the Council during 2026, with the aim of reaching formal adoption by the end of the legislative term. «The ordinary legislative procedure will unfold over a period of no less than 18 months», Salvatore recalls.
In this context, the industry is watching the new direction with interest. «The Commission’s objectives are moving in the right direction to bridge Europe’s gap with its main global competitors», observes Fabrizio Greco, President of Assobiotec–Federchimica, emphasizing the importance of translating the strategy into concrete tools at the national level as well.
From laboratory to industrial platform
The favor with which the proposal has been received by initial commentators is mainly linked to its potential impact on the research and development of advanced therapies, from CAR-Ts to monoclonal antibodies, and regenerative medicine. However, much will depend on the outcome of the political debate and the final version of the text, which is not expected before 2027.
The game is afoot. Whether the Biotech Act will truly succeed in transforming Europe from a laboratory of innovation into an industrial platform for innovation will be determined in the coming years. One thing is certain: the signal sent by Brussels is clear – in biotech, standing still is no longer an option.
This article was originally published on TrendSanità .it (https://trendsanita.it/biotech-act-la-mossa-di-bruxelles-per-non-restare-solo-un-laboratorio/) and is licensed under Creative Commons Attribution-NonCommercial 4.0 International (https://creativecommons.org/licenses/by-nc/4.0/). It has been translated into English.
