EU Biotech Act public consultation opens for input
The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.
The European Commission is seeking help from the public to fine tune its plans to accelerate biotechnology products from lab to factory to market.
The EU Biotech Act, which forms part of the Commission’s broader Strategy for Life Sciences, aims to improve the competitiveness of European biotech companies and ease their regulatory challenges.
A public consultation on the proposed Act will run until 10 November 2025, after which its responses will feed into the EC’s impact assessment of the legislative designs.
As the EC moves to improve the size and competitiveness of the EU’s biotech sector it will assess the biotech plans in terms of:
Speed and streamlining: improving ‘time-to-market’, particularly for biotech start-ups, with a view to simplifying the regulatory environment. This also feeds into the Commission’s existing work in areas such as the reform of pharmaceutical legislation.
Financing: targeting access to new capital for companies at seed phase, as well as looking at how existing activities, incentives and funding schemes could be improved.
Biotechnology is going to be a key pillar to bring forward a completely new set of therapies, much more quickly available for the patients, but also a completely new way of innovation”
Scale: helping the sector tap into the EU’s existing infrastructure so that more development and production work can be carried out in the region. As part of this there could be support for new biotech clusters or centres of excellence, and biomanufacturing will be a particular focus.
Skills: Upskilling academic developers with entrepreneurial skills will be one area for this strand, alongside a potential programme to attract R&D, manufacturing and entrepreneurial global talent.
Data and AI: As the role of artificial intelligence (AI) in biotech increases, the Commission sees AI testing facilities – or ‘AI Factories’ – as essential to enabling biotech companies and organisations to use data effectively. A role is also seen for AI to complement initiatives such as the European Health Data Space and its access to anonymised real world health data.
The exact timelines for the EU Biotech Act have yet to be confirmed, but the legislation’s adoption is currently planned for the third quarter of 2026 as the EC looks to further boost the sector.
Outlining Europe’s biotech vision at last month’s BIO International Convention in Boston, Health and Animal Welfare Commissioner Olivér Várhelyi said: “Biotechnology is going to be a key pillar to bring forward a completely new set of therapies, much more quickly available for the patients, but also a completely new way of innovation.
“In that, we want to build on our strength, which is the availability of high-quality healthcare data, a substantive innovation capacity in Europe and still a huge manufacturing capacity in Europe. But for this to happen, we need to do things differently.”
