The EU Biotech Act is a crucial opportunity to strengthen Europe’s life sciences leadership

• The EU Biotech Act is a positive step toward strengthening Europe’s biotechnology ecosystem and BMS commends the Commission’s initiative to propose legislation prioritising industrial policy. 
  The initiative recognises the strategic roles of biotechnology in driving medical innovation, economic growth and patient access to transformative therapies. 
• However, Europe’s global competitiveness in biotechnology is under increasing pressure, especially vis-à-vis the United States & China. Europe faces a steep decline in clinical trials, lower investment, slower regulatory processes and a fragmented innovation environment. 
• Europe has the opportunity to reverse these trends by increasing its ambition for the Biotech Act to strengthen Europe’s innovation ecosystem, attract investment and ensure patients benefit more rapidly from scientific breakthroughs.

To deliver on this ambition, the Biotech Act should prioritise action in three key areas

Clinical Trials: Create a truly streamlined European research ecosystem

• Reduce regulatory duplication by broadening the scope of the Core Dossier to be the basis of the Marketing Authorisations and ensure continuity across the product lifecycle.
• Address fragmentation in ethics reviews through the creation of a streamlined ethical review with the RMS Ethics Committee performs the ethical review and member states keep core member state competence review responsibility.  
• Strengthen the Clinical Trials Information System (CTIS) by ensuring interoperability with EU regulatory and health data systems and supporting complex and adaptive trial designs.  

Advanced Therapy Medicinal Products (ATMPs): Enable Europe to lead in next-generation therapies

• Mobilise EU and national funding to support treatment centres to become ATMP ready, logistics infrastructure, and infrastructure for patient monitoring and management.
• Strengthen real-world evidence generation through a European registry or improved interoperability between national registries.
• Support scalable ATMP manufacturing, including production automation
• Scalable workforce readiness, including fast-track training of healthcare professionals on the handling of and treatment with ATMPs outside the oncology and haematology

Intellectual Property: Enhance Europe’s innovation incentives

• Expand eligibility for supplementary protection certificates (SPCs) extensions to therapies at least partially developed or manufactured using biotechnology processes, including combinations with chemical entities. 
• Provide further flexibility and clarity in conditionalities attached to the SPC extension to maximise its positive impact. 
• In the medium term, build on the Biotech Act I and introduce mechanisms for early resolution of patent disputes to strengthen legal certainty while securing the right balance between robust patent enforcement and the timely market entry for generics and biosimilars.

Clinical trials

Clinical trials are the backbone of Europe’s life sciences leadership and are critical to translating scientific discovery into meaningful patient benefit. They are also essential to maintaining Europe’s attractiveness as a destination for R&Dⁱⁱⁱ. Despite recent reforms, the clinical trial landscape in Europe remains fragmented and inefficient, characterised by duplicative assessments and sometimes contradictory, disconnected systems and lengthy timelines across Member States. 

The EU Biotech Act provides the opportunity to establish a centralised, risk-based, and innovation-friendly framework, better connecting scientific advice, development, and regulatory decision-making. Streamlined multi-country trials will accelerate development timelines and ensure faster access to innovative therapies for patientsⁱⁱ.

Advanced Therapy Medicinal Products (ATMPs)

Advanced Therapy Medicinal Products (ATMPs), currently approved for use in   rare genetic diseases and small patient populations with haematological malignancies, continue to be investigated in more prevalent conditions, including solid tumours and autoimmune diseases. Such broadening of the use of ATMP’s may increase the potential patient population from thousands to millions, highlighting the need for fit-for-purpose policy frameworks such as the Biotech Act to support scalable manufacturing, adaptive regulatory pathways, and sustainable access models. Europe has the scientific expertise to lead globally in ATMPS, including CAR-T, autologous, allogeneic and in vivo therapies. Achieving this requires regulatory frameworks that are flexible yet maintain high standards of quality, safety, and efficacy, alongside a pan-European ecosystem integrating industrial-scale manufacturing and digital systems. The Act can help strengthen Europe’s capacity to develop, manufacture, and deliver these complex therapies at scale ^iv.

Intellectual Property (IP)

A strong and predictable IP framework underpins Europe’s competitiveness in life sciences by attracting investment and supporting high-risk and long-term innovation efforts to develop complex therapies such as biologics and ATMPS ^v. While Europe has attempted to revamp its IP framework for medicines through the revision of the Pharmaceutical Legislation, the changes brought forth erode the system rather than enhancing it to truly place Europe as a global leader in innovation and R&D. The EU Biotech Act offers an opportunity to rectify the course by driving IP incentives such as SPCs above global standards, thus helping address Europe’s competitive disadvantage relative to the US and sustain Europe’s attractiveness as a priority destination for investment in life sciences ⁱⁱ.

Our recommendations for an ambitious Biotech Act

We call on policymakers and competent authorities to ensure the Biotech Act delivers its full strategic impact for Europe by prioritising the following: 

1. Clinical Trials:

BMS welcomes the efforts set out in the Biotech Act to simplify and streamline the Clinical Trials  Regulation, the shortening of authorisation timelines, the strengthened role of the Reporting Member State, and the inclusion of AI and sandboxes to future-proof the clinical  trial framework.

While these provisions are a step in the right direction, they are not ambitious enough to position Europe as a global leader for Clinical Trials. BMS believes that policymakers should

seize the opportunity to further centralise, simplify and accelerate processes by:

• Broadening the scope of the Core Dossier to be the basis of the MarketingAuthorisations ^vi, reducing duplication between development and approval stages and strengthening regulatory continuity across the product lifecycle.
• Creating a streamlined EU clinical trial approval model in which the RMS ethics committee conducts the ethical review and a Clinical Trials Expert Committee under the EMA adopts a single EU-level decision by majority vote across concerned Member States, with only a limited Part II assessment required for any additional Member State and objections possible only on narrow grounds related to inferior treatment or national law .
• Investing in the Clinical Trials Information System (CTIS)^vii as a strategic EU priority, ensuring its interoperability with other EU regulatory and health data systems, and the operational flexibility required to support complex and adaptive trial designs.

2. Advanced Therapy Medicinal Products (ATMPs)

BMS welcomes the initiatives outlined in the Biotech Act to speed up access to ATMPs through GMO-related exemptions for Clinical trials, the inclusion of regulatory sandboxes for novel health biotechnology products and Substances of Human Origin (SoHOs) and creating a Union-wide, cross-framework regulatory status depository to support accelerated and predictable regulatory pathways through Union-wide visibility of regulatory status across frameworks. These measures are particularly important as ATMPs may evolve from niche therapies for rare diseases toward broader therapeutic applications and larger patient populations.

While these elements mark a positive advance, BMS believes that more can be done to enable cell therapy innovation and foster investment in Europe, most notably by:

• Unlocking EU funding through coordinated EU and national instruments to invest across the full ATMP value chain, including ATMP-ready treatment centres, logistics, and infrastructure to support patient monitoring and long-term follow-up.
• Addressing the complexity of data management for RWE through interoperable national registries and establishing a voluntary EU framework for the designation of ATMP patient registries based on common technical specifications.
• Incentivising and de-risking the automation and scale-up of ATMP production, including through regulatory approaches tailored to ATMP-specific manufacturing processes.
• Strengthening the delivery and regulatory framework for ATMPs by supporting network-based centres of excellence (including treatment centres), ensuring healthcare workforce readiness, and introducing GMO-related improvements such as early EMA scientific guidance and adaptive exemption categories.

3. Intellectual Property (IP)

BMS supports the Biotech Act’s objective to strengthen incentives for the development of innovative biologics and advanced therapies through a more effective and competitive framework for supplementary protection certificates (SPCs).

While the introduction of a one-year SPC extension is a positive step, the additional limitation on the types of therapies eligible compared to the broader focus of the Biotech Act as well as the cumulative conditionalities, significantly limit the range of therapies that could benefit and thereby, its practical effect on competitiveness of the healthcare biotech sector. Considering the limited scope and the agreed extension of the Bolar research exemption in the General Pharmaceutical Legislation, the proposed extension falls short of delivering the needed enhancements to the EU IP ecosystem to support its global competitiveness. BMS believes that Europe can further strengthen its competitiveness and innovation leadership by:

• Expanding the scope of eligible therapies for the SPC extension to those that are at least partly developed or manufactured using biotechnological processes, aligning with the broader definition of “biotechnology” in article 2 of the proposal. This would also capture combinations between chemical entities and biotechnology components, in line with the focus of the Act.
• Simplifying the conditionalities for the SPC extension by replacing the current four cumulative conditions with the requirement to fulfil at least two conditions – i.e. one related to a new active substance or the mechanism of action, and one of the last two conditions linked to either clinical trials or manufacturing in the EU. This would introduce more flexibility and maximise the impact of the extension, while ensuring that it benefits best-in-class therapies and acts as an incentive for investment in the EU. Furthermore, the conditionalities can be further clarified on their substance and the timing of their assessment to ensure predictability.

Beyond the current scope of the Biotech Act I, BMS urges policymakers to introduce mechanisms for the early resolution of patent disputes. This will provide adequate legal certainty for both innovators and follow-on product manufacturers, while securing the right balance between robust patent enforcement and the timely market entry for generic and biosimilar medicines upon the expiry of relevant IP exclusivities.

The EU Biotech Act represents a critical opportunity for Europe to become a global leader in life sciences. By acting decisively to strengthen its implementation across clinical trials, advanced therapies, and intellectual property, the EU can enhance competitiveness, attract sustained investment, and accelerate patient access to innovation.

^{[i] European Commission. Proposal for a Regulation to establish measures to strengthen the Union's biotechnology and biomanufacturing sectors (European Biotech Act). 2025. Available from: https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en.}

^[ii] Ibid.

^[iii] Ibid.

^{[iv] Letta E. Much more than market – Speed, Security, Solidarity. 2024. Available from: https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-letta.pdf.}

^{[v] Joint Research Centre (JRC). Exploring the global landscape of biotech Innovation: preliminary insights from patent analysis. 2024. Available from: https://publications.jrc.ec.europa.eu/repository/handle/JRC137266.}

^{[vi] The single Core Dossier model proposed in the Biotech Act only applies to clinical trials and does not include any other significant assessment steps such as the Marketing Authorisation.}      

^{[vii] The Clinical Trials Information System (CTIS) is an EU-wide platform for managing clinical trials and sharing information between sponsors, EU/EEA authorities, and the European Commission, with a public database since January 2022.}