The European Commission has set out proposals for a BioTech Act which is aimed at creating a “world-leading health biotech industry that delivers for European patients.”
The proposed act will incentivise companies to carry out research and production within the EU, accelerate clinical trials and authorisations across member states, and fast-track the development of innovative therapies. The legislation seeks to simplify EU regulations to reduce costs with, for example, single regulatory pathways for complex innovative products. The proposals also include revising rules on clinical trials and advanced therapy medicinal products.
The European Commission has said that biotechnology is one the fastest growing sectors in the EU, contributing some €40 billion to the European economy, and accounting for more than 900 000 jobs, 75% of which are in the health care sector.
However, the Commission also says that Europe is missing out on the benefits of biotechnology, which include new treatments, personalised medicines and more precise diagnosis, due to a lack of funding, regulatory bottlenecks and barriers to innovation. As a result, the bloc is lagging its global competitors, despite its strong scientific base: 21% of the world’s top biotech publications are authored by EU scientists. "Despite its strong scientific base, Europe is trailing its competitors when it comes to advancements in biotechnology," the Commission said.
For example, the Commission says that the EU’s global share of venture capital investment in health biotech stands at just 7%, and the its global share of commercial clinical trials fell from 22% to 12% in just 10 years. “A combination of structural barriers, issues accessing capital and overly complex regulation is prompting innovative European start-ups and scientists increasingly to move abroad,” it said.
With health biotech accounting for more than 80% of the value of the EU’s biotechnology sector, the proposed Biotech Act is focused on health, but it does include food and feed, and proposes to amend specific parts of the EU health and food regulations to “adapt the whole ecosystem to the needs of modern society and this fast growing sector,” the Commission added.
The Commission says that the Act focuses on industrial policy measures and simplification. In particular, it will boost access to funding to support the growth and scale-up EU biotech companies. There has already been some progress here, with the European Commission and the European Investment Bank (EIB) setting out an initiative making €10 billion of investment available in 2026-2027 to the biotech and life sciences sector. The finance will help address the current investment gap as well as mobilising public-private investment into promising health solutions.
“Under investment is a major stumbling block for Europe’s biotech companies and a serious obstacle for our innovative start-ups. The BioTech EU project should contribute to reversing that trend,” Olivér Várhelyi, Commissioner for Health and Animal Welfare, said.
Harnessing the use of AI, data and digital solutions in the biotech sector; simplifying and accelerating the regulatory process; and providing biosecurity safeguards to protect against the misuse of biotechnologies and boost the EU’s biodefence capabilities are also encompassed in the BioTech Act.
“These measures, each of which is interconnected and mutually reinforcing, will make the EU a more attractive place for innovation and development in the biotech sector,” the Commission said.
The BioTech Act is part of a wider group of measures which have been developed to improve the health of the EU’s citizens. Other measures include the Safe Hearts Plan, said to be the ‘first ever comprehensive EU approach’ to tackling cardiovascular disease, which costs the European economy €282 billion each year.
Medical devices are also included in the measures, which will seek to simplify rules on their use and support the digitalisation of procedures. The European Medicines Agency will also have a stronger role in coordination at EU level as well as offering more companies scientific, technical and regulatory expertise.
The proposals for the BioTech Act and simplification of the Medical Devices and in Vitro Diagnostics Regulations are now set to be submitted to the European Parliament and Council for adoption.
Further reading on biotechnology:
- Life sciences: Why execs are cautiously optimistic about 2026
- Autonomous labs and AI to boost biotech research
- Biotech investment slumps in 2022, but UK innovation remains ‘magnet for global pharma’
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