The current EU regulatory landscape for biotechnology is widely viewed as insufficient to be able to exploit the full potential of such technologies. Regulatory hurdles exist at EU and Member State level, and this is thought to have driven investment into other regions.
To help tackle this problem, the introduction of a new EU Biotech Act (the Act) has been proposed by the Commission to encourage innovation in areas such as health technology assessment and clinical trials. A simpler regulatory landscape, with no reduction to safety standards, will be a central aim of the Act.
However, it was announced on 20 March 2025 that the Act has been delayed until the third quarter of 2026 (initially due in the last quarter of 2025). As such, it remains to be seen what shape the Act will take, including whether any changes will be limited to setting out general guidelines, or whether it will take the form of a binding legal instrument, imposing specific measures to which Member States and EU institutions must adhere. Various studies and papers have been developed following the announcement of the proposed Act, and it is hoped that as these are finalised, they will provide further insight into what we can expect.
European Commission's biotech strategy
The proposed Act forms part of the European Commission's wider strategies within the life sciences and biotech space, as announced in its March 2024 report on "Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU". Objectives for the Act include:
- increasing public awareness and acceptance of biotechnology and biomanufactured products
- providing assurances to citizens about responsible use, safety and sustainability of biotechnology
- streamlining EU legislation and implementation
It is said the Act will: "reduce any fragmentation, explore potential simplification, and shorten the time to market for biotech innovations; as well as regulatory obstacles that arise at national...levels which impede an effective single market."
In the report, the European Commission also announced a study assessing how the current legislation applicable to biotechnology and biomanufacturing could be further standardised across EU policies, to simplify the regulatory framework and make it quicker for biotech products to be brought to market. This study is due to be finalised by mid-2025 and is intended to lay the foundations for the Act.
Stakeholder's views
While the exact form that the Act will take is not yet clear, various stakeholders have expressed their views. General themes that have emerged include the need to harmonise regulations and speed up the process of bringing biotech products to market, as well as increasing public awareness and understanding of the industry.
On 25 April 2024, EUCOPE, EFPIA and other industry stakeholders signed a joint industry statement supporting the Commission's initiative. While these organisations welcomed the prospect of the Act, they also identified four urgent areas requiring immediate attention, which are thought to be stalling investment in innovation:
- Streamline and align regulatory pathways
- Ensure access to feedstocks for biomanufacturing
- Reflect financing of innovation and scale up, including within EU taxonomy
- Improve public understanding and recognition of biotech within a strong Europe
On 20 January 2025, EuropaBio, the industry association for biotechnology in Europe, published its vision paper for the Act. It outlined 3 pillars that the Act should address to meet EU ambitions for"competitiveness, sustainability, health and strategic autonomy":
- Faster Financing – through the establishment of a 'Biotech for Europe Initiative' to secure speed and scale of finance for biotechnology through public and private pathways
- Simpler EU – by creating a streamlined and predictable legislative environment for biotechnology and biomanufacturing
- Stronger Together – to facilitate the delivery of biotechnology within regional and global value chains
Furthermore, a European Biosolutions Coalition has been established by eleven industry organisations, including the UK's BioIndustry Association, to raise the profile of biosolutions on the European agenda, whilst simultaneously highlighting the importance of streamlining the regulatory framework for biosolutions across the EU and in Member States. The Coalition recently published a Manifest and policy recommendations paper, setting out various recommendations and proposals. Examples of initiatives included within the proposals include increasing investment, simplifying the framework for approving biosolutions, and modernising novel food regulation.
The EU Biotech Hub
The Act is closely linked to wider EU initiatives, including the "Strategy for European Life Sciences", for which the Commission called for evidence in March 2025 (closed 17 April 2025), and the Commission's public consultation on the upcoming EU Bioeconomy Strategy, which is due for adoption by the end of 2025.
One initiative which is already up and running is the EU Biotech Hub (the Hub), established in January 2025. The Hub supports companies, especially startups and SMEs, to bring innovative biotech products to the EU market. The Hub has been designed as a one-stop operational tool to support businesses by providing critical resources that will ease and simplify navigation of the regulatory framework, and offer support to assist scale-up. This includes information on:
- sources of EU funding for biotech and biomanufacturing companies
- research infrastructure to support research and development
- intellectual property protection
- rules and requirements with which companies must comply when developing and marketing biotech products
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