To be eligible, products must meet one of the following:

• Developed by means of biotechnological processes
• Advanced Therapy Medicinal Products (ATMPs)
• Veterinary medicinal products for zoonotic diseases developed via biotech processes

AND all of the following:

• Have a patent which qualifies for the granting of such supplementary protection certificate, or an existing SPC
• Contains a new active substance distinctly different from that of any authorised medicinal product in the Union
• Mechanism of action distinctly different and shows a level of safety and efficacy which is at least equivalent to that of any authorised medicinal product in the Union for the same disease
• The clinical trials evaluating the efficacy of the medicinal product and supporting its marketing authorisation were conducted in more than two Member States
• At least a manufacturing step, excluding packaging, quality testing and certification is performed in the Union

Note: A product must also be protected either by a supplementary protection certificate or by a patent which qualifies for the granting of supplementary protection certificates.

There are linguistic uncertainties and differences between existing legal and regulatory terminology and the wording used in this proposal.

Due to the ambiguity, and political importance of the extension, we expect this wording to change substantially over the course of this legislation.

Under the current wording, small molecules, substances of human/animal origin and some vaccines are excluded. The requirement for “distinct” mechanism of action excludes ‘incremental’ innovation. Treatments for diseases without the patient populations in the EU to run the trials would also be ineligible.

This incentive is likely to encourage some developers of cutting edge, first-in-class products to run their clinical trials and manufacturing in the EU. This seems to be the primary aim.

The incentive is unlikely, however, to be strong enough to encourage the development of additional cutting edge, first-in-class products in and of themselves.

The strength of the incentive depends on the product eligible. An additional year of SPC protection could be worth hundreds of millions of dollars in incentives for some products, whereas it may not be relevant for others who have market exclusivity or data protection as their last line of intellectual property protection against competition, and therefore would not benefit from the additional year of SPC (see Figure 4). Even for those products which do benefit from the SPC extension, however, this additional year comes multiple years after asset investment decisions and so has a weakened pull.

The value of the additional year of SPC is also tempered by the limited competition biologic products face. Many medicines that receive extended protection under the SPC may not actually face competition from similar products once their protection ends. For example, most biological medicines—more than 70%—do not have rival biosimilars on the market. However, this could change in the future because new rules are making it easier and quicker for companies to develop biosimilars. Specifically, the requirements for large clinical trials (Phase III) are being reduced, and regulatory changes are making it simpler for biosimilar manufacturers to use patented inventions for testing purposes (Bolar exemption).

For Payers, this additional year of protection comes at a financial expense, and so this proposal is likely to receive pushback from EU Member States.

For the Health Biotechnology Investment Pilot, the Commission and the EIBG would set out the eligibility rules and parameters. It will be managed by the EIB Group and the European Investment Fund.

In contrast, the EU Late-Stage Capital Booster Pilot would be led by private sector operators or consortia, potentially involving market infrastructure actors and investors. The EU/Member States would offer administrative support and possible co-financing. The focus is to improve access to capital markets, strengthen cross border investment flows within the EU and expand the pool of credible investors.

Financial support: The Health Biotechnology Investment Pilot aims to mobilise public and private capital to narrow a €40 billion annual investment gap, ensuring the sector's long-term competitiveness and strategic autonomy.

Funding would come from the Commission’s proposed European Competitiveness Fund which ringfences €20.4 billion for the period of 2028-2034 for “health, biotechnology, agriculture and bioeconomy”.

The Pilot will blend equity tools and guarantee mechanisms with venture style debt structured to reflect biotechnology’s distinct risk profile. It can fund development at either end, from applied research, technology transfer and spin offs, to industrial scale up and the build out of production capacity.

Administrative support: The EU Health Biotechnology Support Network will offer guidance—particularly to SMEs, start-ups, and scale-ups—on navigating legal frameworks, regulatory requirements, and available funding opportunities at both Union and national levels. The EU Health Biotechnology Support Network will also support health biotechnology strategic projects as well as high-impact health biotechnology strategic projects.

The application process for the Health Biotechnology Investment Pilot will be detailed in future guidance. The EU Late-Stage Capital Booster Pilot’s application process occurs via the ‘high-impact health biotechnology strategic project’ process, as detailed below.

The Pilots and support measures are primarily designed for operators within the Union's biotechnology ecosystem, with a particular focus on those lacking access to capital or scale-up resources:

• SMEs, start-ups, and scale-ups: These are the primary beneficiaries, recognised as facing the biggest hurdles in accessing funding for industrial scale-up and navigating regulatory pathways.
• Research and Academic Institutions: Eligible when participating in consortia or as users of the infrastructures provided by strategic projects (e.g., testing facilities).
• Non-profit developers: Organisations active in relevant biotechnology sectors across the internal market are specifically mentioned as eligible for administrative and technical support.
• Pharma companies, including large multinational companies may not be the focus but they are not excluded.

If these Pilots succeed in their aims of crowding in billions of euros per annum of public and private capital into EU biotech, then it will have a substantive impact on translational R&D in the Union, across the entire translational lifecycle. That is a big question mark but there is significant ambition in this proposal.

Priority Regulatory Status: Strategic projects are granted ‘priority status’ at the national level, ensuring the fastest possible processing of permits and authorisations to significantly reduce time-to-market.

Single Point of Contact: Member States must provide a dedicated single point of contact to coordinate the entire administrative process, reducing complexity and acting as the sole interface for the project promoter.

Administrative Support: Promoters can request assistance with regulatory compliance, permitting, and public communication.

Preferential Funding Access: Strategic projects receive prioritised consideration for Union financial support, including from the potential multi-billion-euro EU Competitiveness Fund. They also benefit from facilitated networking with private investors and the European Investment Bank (high-impact projects only).

Strategic Support & Networking: Promoters gain access to the EU Health Biotechnology Support Network and regulatory sandboxes providing expert guidance on regulatory pathways.

Potential new collaborative structures

The Commission is considering establishing dedicated legal entities, such as European Partnerships, to pool expertise and share risk between public and private actors. These could become important vehicles for implementing and scaling ‘health biotechnology strategic projects’.

1. National assessment and designation
   

   Member States begin by appointing a ‘competent authority’ responsible for determining whether a proposal meets the criteria for a health biotechnology strategic project. This authority verifies compliance and, where appropriate, issues the formal recognition decision.

2. Eligibility criteria
   

   To qualify, a project located in the Union must make a substantial contribution to at least one of the following objectives:

   • Strengthening industrial capacity, for example through new or expanded biomanufacturing facilities, digital or AI integration, or reduced reliance on non-EU suppliers.
   • Scaling critical infrastructure by establishing or improving pilot, testing and demonstration sites, including those deploying New Approach Methodologies that replace animal testing.
   • Accelerating innovation with breakthrough technologies, AI enabled tools, or giving SMEs and start ups access to advanced production and laboratory capabilities.
   • Addressing skills shortages by attracting talent, expanding training in areas such as data science and AI, or creating stronger university industry collaborations.
   • Enhancing health threat preparedness by developing medical countermeasures for priority risks.


3. The application process
   Project promoters must submit an application to the designated authority in the Member State where the project is located. Cross border projects benefit from mutual recognition: once one Member State grants designation, others must follow.


4. Assessment and decision
   Upon receiving a complete dossier, the authority has one month to complete its evaluation. If the necessary requirements are met, it issues a reasoned decision granting the project health biotechnology strategic projects status. Member States are expected to ensure a fair and transparent process, including accessible mechanisms to resolve disputes.

The designated national authority of a Member State must assess the application within one month of receiving a complete application and communicate a reasoned decision.

1. Eligibility criteria for high impact status

To qualify as a high impact project, an initiative must first meet the general requirements for a strategic health biotechnology project (above). It must then demonstrate high impact through its scale, scope or cross border relevance.

2. A two step designation process

High impact status is awarded through a dual system that combines national assessment with EU level approval.

2.1. Member State assessment

The project promoter submits an application to the designated national authority in the country where the project is located. The application must include evidence that the project meets the criteria. The authority has one month to review the dossier and share its assessment report with the Commission.

2.2. Commission decision

The European Commission then issues an implementing act to approve or reject the application. Its decision must consider the views of the European Health Biotechnology Steering Group, which provides strategic oversight.

Alternative pathway: Union level calls for proposals

Projects may also obtain high impact status directly through Commission run calls under Union funding programmes. Selection through these calls confers high impact designation without requiring the two tier process.

• High-Impact Biotechnology Testing Environments: Strategic projects accelerating AI-driven innovations. They will provide trusted, integrated experimental, computational, and data-driven capabilities (such as wet-labs and pilot-lines) to safely test and validate advanced health biotechnology.
• Biotechnology Data Quality Accelerators: Entities providing technical assistance to data holders to standardise, annotate, and verify the provenance of their datasets. Their remit is to transform fragmented data into "AI-ready" infrastructure that supports advanced research and innovation across the Union, and supports the implementation of the European Health Data Space.
• Call for Proposals & Data Safeguards: Data quality accelerators may be recognised by the Commission via competitive calls for proposals.

Industrial Scale-Up & Capital Access:

• Biotechnology Development Accelerators: Projects providing trusted testing or demonstration facilities that replicate real-world, GMP-compliant biomanufacturing processes. These bridge the gap between research and industrial deployment, allowing for process validation and small-batch manufacturing for early clinical trials.
• Centres of Excellence for Advanced Therapies: Projects specifically designed to reinforce the Union's capability in Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies. They integrate research, regulatory science, and manufacturing to accelerate clinical translation and patient access.
• EU Late-Stage Capital Booster Pilot Projects (see above): Initiatives led by private-sector operators or consortia designed to overcome the shallow nature of EU public equity markets. They facilitate cross-border investment and improve the visibility of biotechnology issuers to help scale-ups access late-stage capital.

Biosecurity & Threat Preparedness:

• EU Biothreat Radar Projects: Projects dedicated to pathogen cross border surveillance and early threat detection. They build infrastructure for clinical and environmental sampling and advanced metagenomic sequencing, sharing data rapidly to enable a Union-wide response to novel biological threats.
• Biodefence Capability Projects: Projects focused on preventing the misuse of biotechnologies. They provide rapid surge capacity for safe sampling, sequencing, and the manufacturing of medical countermeasures, as well as the development of tools to detect and attribute genetic engineering.

Faster permitting, priority regulatory handling and a single point of contact would cut administrative delays and shorten time to market. But they are only one side of the story, money is the other.

For start ups and scale ups, easier access to public and blended funding makes it simpler to build capacity or expand into later stage development. But for global companies, the change will depend on whether the EU can mobilise funding at the scale this proposal aims at – no easy feat.