What is the EU Biotech Act?

The European Biotech Act is a major new EU legislative initiative aimed at strengthening Europe’s biotechnology and biomanufacturing sectors and transforming Europe’s ability to translate scientific excellence into commercially viable products, manufacturing capability and patient benefit. The Act is part of a wider European drive to strengthen competitiveness, economic security and strategic autonomy in key economic sectors.

The first legislative package, proposed by the European Commission in December 2025, has a strong focus on health biotechnology. It includes a proposed regulation establishing measures to strengthen Europe’s biotechnology and biomanufacturing sectors, along with a proposed Directive addressing specific aspects of genetically modified microorganisms and organ processing. Measures in the Act include:

• regulatory simplification,
• improvements to clinical trial processes,
• support for strategic biotechnology projects,
• improved access to finance,
• greater use of AI and data, and
• new regulatory approaches for innovative technologies.

The proposals are now progressing through the EU’s legislative procedures and will go through several rounds of negotiation between the European Parliament and Council before final adoption.

A second phase of EU action, focused on the wider biotechnology ecosystem beyond health, is also anticipated for late 2026.

The EU Biotech Act and ATMPs

For advanced therapies, the significance of the European Biotech Act goes beyond individual regulatory changes. Europe has world-class scientific expertise. Across its universities, research institutes, hospitals and biotechnology companies, the EU continues to generate groundbreaking discoveries in cell, gene and other advanced therapies. The challenge is turning that potential into a system that enables cutting-edge European therapies to reach patients efficiently and at a sustainable cost.

Europe has not always been successful at connecting scientific discovery with clinical development, manufacturing, commercial scale-up and patient access. Strong individual parts of the ecosystem do not automatically create a functioning end-to-end system. Europe’s challenge, therefore, is not simply an innovation gap. It is also an execution gap.

For an ATMP developer deciding where to conduct clinical trials, manufacture a product, raise capital or build infrastructure, speed, predictability and connectivity matter. Other global regions, including the United States and China, are competing aggressively to attract precisely these activities. Closing this execution gap is critical if Europe is to retain the economic and societal value generated by its scientific excellence.

The potential significance of the European Biotech Act lies in its attempt to build a more connected pathway from discovery through development, clinical trials and manufacturing to patient access.

One Large but Still Fragmented European Market

The scale of the European market is a major strategic asset, but biotechnology and advanced therapy developers do not always experience Europe as a single, integrated ecosystem.

Medicines regulation has been substantially harmonised at EU level, but important aspects of healthcare delivery, reimbursement, procurement and healthcare budgets remain national responsibilities.

Clinical research capability and manufacturing capacity also vary across Europe, while centres of excellence in research, clinical development, manufacturing and patient care are not always sufficiently connected. For ATMP developers, this fragmentation is particularly challenging. Advanced therapies frequently target relatively small patient populations, require highly specialised manufacturing and logistics, involve complex clinical pathways and demand substantial upfront investment. Fragmentation therefore adds cost and complexity precisely where developers need scale, predictability and coordination.

The strategic challenge for Europe is less about reducing individual regulatory burdens and more about making the European ecosystem function effectively as a whole.

How the EU Biotech Act Could Help

The European Biotech Act seeks to create a more competitive and predictable environment for biotechnology by addressing several points along the development pathway. For advanced therapy developers, some of the most significant proposed measures include:

• Faster and more efficient clinical development, including amendments to the Clinical Trials Regulation and specific provisions intended to facilitate clinical trials involving certain advanced investigational therapies.
• A 12-month extension on the Supplementary Protection Certificates (SPCs) for eligible biotechnology-derived medicinal products and ATMPs, intended to incentivise biotechnology development and manufacturing within the EU.
• New regulatory tools for novel health biotechnology products, designed to enable earlier and more structured engagement where emerging technologies do not fit easily within existing regulatory frameworks.
• Greater use of artificial intelligence and data, including measures to support the application of AI across biotech research and development and improved regulatory interaction.
• Hospital exemption harmonisation; clarifying the “Hospital Exemption” pathway currently used in some EU countries and in so doing creating uniform standards to ensure this pathway is appropriately used.
• Improved access to investment, including an EU health biotechnology investment pilot intended to mobilise greater private and public investment into the sector.
• Recognition and support for strategic biotechnology projects, including a specific model for Centres of Excellence for advanced therapies.

Considered alongside other major European initiatives — including the EU’s evolving competitiveness and innovation agenda and implementation of the Substances of Human Origin Regulation — these measures signal a broader shift in European policy. The objective is increasingly not simply to fund excellent science, but to create the conditions in which that science can be translated, manufactured and scaled in Europe.

Connecting the Pieces Through Centres of Excellence

One of the particularly interesting features of the EU Biotech Act for advanced therapies is the proposed recognition of Centres of Excellence for Advanced Therapies. This initiative is more ambitious than simply identifying existing centres of scientific excellence. Under the Commission proposal, recognised Centres would be expected to bring together several capabilities that are often separated across institutions and geographies. These include advanced infrastructure and manufacturing capability, quality and regulatory science, safety testing, clinical environments, research organisations, biotechnology developers, investors, regulators, incubation and acceleration support, and education and training. They would also be expected to help advanced therapies transition from research to commercial manufacturing and to enable cross-border access for patients from other Member States.

This matters because it reflects a wider change in how Europe is thinking about advanced therapies. Excellence in individual parts of the system is no longer enough. What matters increasingly is the ability to connect those parts into a functioning translational pathway. In practice, the EU Centres of Excellence would enable:

• Pooling advanced infrastructure and equipment, such as cleanrooms and cell-processing platforms, helping startups and SMEs scale up production without needing to build their own facilities.
• Solving the rare-disease “patient volume” problem by creating a multinational network in which a patient in one EU country can be readily referred and transferred to an ATMP Centre of Excellence in another.
• Unifying real-world evidence for ATMPs by interconnecting registries to track patient outcomes across borders, helping developers demonstrate the long-term safety and efficacy of their therapies.

From EU Legislation to Member State Execution

EU-level reform, however, can only take Europe so far. The Biotech Act can create a more enabling regulatory and investment architecture, but much of the capability required to translate advanced therapies remains distributed across Member States, institutions and healthcare systems. This means the success of the Act will ultimately depend, in part, on execution at Member State level.

Countries will need to consider how effectively they connect the entire advanced therapy pathway, from scientific discovery and clinical development through to biomanufacturing, regulatory approval, clinical delivery, evidence generation and patient access. The opportunity extends beyond compliance with a new European legislative framework — it is to build national ecosystems capable of taking full advantage of it.

For smaller Member States in particular, this creates an interesting strategic opportunity. Scale does not necessarily mean having every capability within a single institution. It can mean linking complementary national capabilities effectively, then integrating those capabilities into a wider European network.

Turning EU Ambition into Action in Ireland

Ireland’s Presidency of the Council of the European Union this year comes at a crucial point in the development of Europe’s biotechnology policy.

Ireland itself has significant strengths across biopharma research, manufacturing, higher education, clinical research and advanced therapies. As with other EU Member States, however, the challenge is how to connect these capabilities to create an ecosystem that enables promising therapies to move more efficiently from discovery to clinical and commercial application.

The Irish Government-funded RINN Centres programme represents an important attempt to address this challenge, bringing together research organisations and national capabilities through a coordinated network of research centres. Within this framework, the recently announced RINN Advanced Therapies Centre has a particular focus on advanced therapy development and delivery.

With more than €50 million in initial funding from Research Ireland, RINN Advanced Therapies brings together Trinity College Dublin, NIBRT, University College Dublin, the University of Galway, Maynooth University, University College Cork and wider partners. Its ambition is to strengthen Ireland’s position in the development, biomanufacturing and clinical delivery of personalised advanced cellular immune therapeutics. Importantly, the model is based not simply on creating additional research capacity, but on linking existing capabilities.

If initiatives like RINN Advanced Therapies can effectively connect research excellence, development capability, biomanufacturing, regulatory expertise, clinical capability and patient pathways, it presents an interesting opportunity for Europe. RINN will not end at Ireland’s borders. It is designed from the outset to link into emerging European networks, infrastructure and Centres of Excellence — giving Irish researchers and companies access to European capability, while making Ireland’s own expertise and infrastructure accessible to European partners, and ultimately creating an opportunity to demonstrate how European ambition can be translated into national execution.

The ultimate test of the European Biotech Act will not be whether Europe produces more biotech policy. It will be whether Europe becomes better at turning scientific excellence into therapies, manufacturing capability, competitive companies and patient benefit.

Ireland has an opportunity to help demonstrate how that can be done.

August 31^st 2026

Authors:

Dr. Fiona Killard-Lynch   NIBRT CSO and Director of Research and Innovation

Dr Darrin Morrissey       NIBRT CEO

Ms Irina Balkanova        Independent consultant