The EU Biotech Act Has Been Delayed — Here's What That Means

By Jackie Mulryne and Eleri Abreo, Arnold & Porter

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 the EU and Member State levels, and this is thought to have driven investment into other regions.

To help tackle this problem, the introduction of a new EU Biotech 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 March 20, 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 finalized, 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, and
• streamlining EU legislation and implementation.

The European Commission has 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 standardized 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 finalized by mid-2025 and is intended to lay the foundations for the act.

Stakeholders’ 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 harmonize regulations and speed up the process of bringing biotech products to market, as well as increasing public awareness and understanding of the industry.

On April 25, 2024, EUCOPE, EFPIA, and other industry stakeholders signed a joint industry statement supporting the Commission’s initiative. While these organizations 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 January 20, 2025, EuropaBio, the industry association for biotechnology in Europe, published its vision paper for the act. It outlined three 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 11 industry organizations, including the U.K.’s BioIndustry Association, to raise the profile of biosolutions on the European agenda, while 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 modernizing 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 April 17, 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 that is already up and running is the EU Biotech Hub, established in January 2025. The hub supports companies, especially startups and SMEs, to bring innovative biotech products to the EU market. It 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, and
• rules and requirements with which companies must comply when developing and marketing biotech products.

A version of this article was originally published as a blog post on Arnold & Porter’s BioSlice blog. It is republished here with permission.

About The Authors:

Jacqueline Mulryne is a partner on Arnold & Porter’s life sciences team. She provides regulatory, policy, and compliance advice to companies in pharmaceutical and medical technology sectors as well as cosmetics and foods. She supports companies on a broad range of issues including intellectual property rights, clinical research, market authorization, and market access strategy.

Eleri Abreo is a senior associate at Arnold & Porter focusing on life sciences and healthcare regulations. She advises clients in sectors including in vitro diagnostics, tissues, cells, and blood, with a special interest in complex products.