Introduction
As discussed in our previous blogpost (link), on 16 December 2025, the European Commission (“Commission”) released its Proposal for the European Biotech Act (“Biotech Act”) (see here).
This blogpost focuses on Chapter II of the Proposal (“Union Health Biotechnology and Biomanufacturing”), which introduces a framework for the recognition of “health biotechnology strategic projects” (“Strategic Projects”) and “high impact health biotechnology strategic projects” (“High Impact Strategic Projects”), together with a package of regulatory and support measures aimed at accelerating their development and deployment in the Union.
Recognition of Strategic and High-Impact Strategic Projects
Strategic Projects – Eligibility Criteria and Recognition Procedure
Criteria. Under Article 3 of the Proposal, projects located in the Union may qualify as Strategic Projects when they make a “substantial contribution” to at least one of the five alternative objectives listed in Article 3(1), and where, within that objective, they perform at least one of the specified activities.
By way of example, a project contributing to the objective of “strengthening the industrial capacity and value chains in the health biotechnology sector” by “creating or upgrading industrial scale biomanufacturing sites with innovative, sustainable, safe and digitally enabled processes and technologies” (Article 3(1)(a)(iii)), may be recognised as a Strategic Project.
As currently drafted, the eligibility criteria for recognition as a Strategic Project are broadly worded and potentially allow for a wide range of projects to be recognised as Strategic Projects.
Procedure. Applications for recognition are submitted by the project promoter – defined as any undertaking or consortium of undertakings – to the authority designated by the Member State on whose territory the project is located (“designated authority”). After receiving the complete application, the designated authority has one month to adopt a reasoned decision approving or rejecting the request.
High-Impact Strategic Projects – Additional Criteria and Two-Tier Recognition Procedure
Criteria. High-Impact Strategic Projects constitute a sub-category of Strategic Projects. In addition to meeting the criteria applicable to Strategic Projects, such projects must demonstrate, “by virtue of [their] scale, scope or cross-border relevance, a strong systemic and catalytic potential within the Union’s biotechnology ecosystem to accelerate innovation and enhance the translation of research into market applications” (Article 4).
The Proposal empowers the Commission to adopt implementing acts specifying the circumstances in which a project is deemed to have such strong systemic and catalytic potential. It also already identifies certain categories of projects falling within this framework, including biotechnology development accelerators (Article 5), centres of excellence for advanced therapies (Article 6), and biotechnology data quality accelerators (Article 33).
Procedure. Given their systemic and cross-border relevance and the benefits associated with their status, recognition of High-Impact Strategic Projects is subject to a two-tier procedure involving both the national designated authority and the Commission. Following the application from the project promoter, the designated authority has one month to assess the application and transmit its assessment report to the Commission. Where the designated authority concludes that the project fulfils the conditions for designation, the Commission adopts an implementing act approving or rejecting the application, taking into account both the assessment report and the views of the European Health Biotechnology Steering Group.
Regulatory and Support Measures
Priority Status and Accelerated Permit-Granting Process
Both Strategic and High Impact Strategic Projects will benefit from priority status in permit-granting procedures. The Proposal requires Member States to grant such projects the highest national significance status available under national law, where such a status exists, and to ensure that all relevant permitting and licensing procedures are treated in the most rapid manner in accordance with Union and national law. High Impact Strategic Projects will have priority status over Strategic Projects.
To give effect to this priority status, the Proposal requires that the “permit-granting process” be completed within ten months for Strategic Projects and eight months for High Impact Strategic Projects.
The permit-granting process is defined broadly and covers “all relevant permits to build, expand, convert and operate health biotechnology strategic projects and high impact health biotechnology strategic projects (…)”, including building permits and environmental assessments and authorisations, where required.
To facilitate and coordinate this process, Member States must designate single points of contact (“SPCs”). These SPCs correspond to the SPCs responsible for coordinating and facilitating environmental assessments under the Proposal for a Regulation on speeding-up environmental impact assessments (see here). The SPCs also provide information on available administrative, financial and technical support measures.
Administrative, Financial and Technical Support
Strategic Projects and High Impact Strategic Projects will also benefit from a coordinated package of administrative, financial and technical support from both Member States and the Union.
At national level, Member States must provide administrative support to projects located on their territory. This includes assistance with regulatory compliance and reporting obligations, support and facilitation of permitting and authorisation procedures, and assistance with public information and engagement to increase public acceptance of projects. High Impact Strategic Projects benefit from priority access to these administrative support measures.
From a financing perspective, the Proposal allows Member States, subject to applicable State aid rules, to make use of existing public support frameworks, including national promotional banks and other public support instruments. High Impact Strategic Projects may also be given particular consideration for Union financial support, including in the form of blended financing, where permitted under the basic acts of the relevant Union programmes.
Networks and Governance
Beyond project-level support, the Proposal also seeks to insert Strategic Projects and High Impact Strategic Projects in a broader biotechnology ecosystem. To this end, the Proposal provides for the establishment of, and cooperation between, networks composed of Strategic Projects’ and High Impact Strategic Projects’ promoters, as well as other relevant actors.
The Proposal also provides for the establishment of an EU Health Biotechnology Support Network, consisting of national and regional antennas in the Member States, which will assist and support project promoters in identifying the relevant applicable rules, as well as funding, scaling-up and networking opportunities.
Finally, the Proposal establishes the European Health Biotechnology Steering Group which, among other tasks, will provide advice to the Commission and the Member States to facilitate the implementation of the Biotech Act and foster the exchange of best practices.
Mathilde Raebisch of Covington & Burling LLP contributed to the preparation of this article.
This blog is based on the wording of the Commission’s proposal published on 16 December 2025. This wording could significantly change in the course of the legislative process. Our Brussels, Dublin, Frankfurt and London teams will continue to monitor this legislation and stand ready to answer any questions you may have.