On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.

The Communication, while directed towards the broader biotech sector, refers to the aim to have a resilient EU biotech ecosystem to safeguard the supply of innovative and generic medicines. It recognizes the significance of vaccine and mRNA technology research for cancer, cardiovascular infectious, and rare diseases, as well as the role of AI in personalized healthcare and diagnostics, including generative AI for medicines discovery and complex genetic diseases.

At the same time, it acknowledges the challenges found in the biotech sector in the EU due to complex regulatory obstacles both nationally and at EU level; or the uncertainty over the return of their investments.

The key actions of the Communication relevant for the health sector include:


  • Support the development of advanced Generative AI models (e.g. funding)
  • Promote deployment of technologies across EU regions through Regional Innovation Valleys (RIVs, aiming for them to become sectoral centres of biotech excellence on specific issues (e.g. biotech health security)
  • Foster private and public investments and finance instruments to support biotechnology and biomanufacturing (e.g. HERA Invest; Innovative Health Initiative; Circular Bio-based Joint Undertaking (CBE JU)).


  • EU Pharmaceutical legislation reform: regulatory sandboxes; clarifying interplay with other legislations; scale up/out biomanufacturing capacities; clarifying hospital exemption for ATMPs (ongoing study on impact of the hospital exemption under ATMP legislation to biotech products availability)
  • Study on how to leverage existing assets and infrastructures for health technology to boost biomanufacturing capacity in the EU
  • Study on the implementation of the Clinical Trials Regulation (CTR) to assess its impact on clinical research; report expected to be completed by the end of 2024
  • Further improving and streamlining the clinical trial processes under ACT EU
  • Encourage elaborating and updating European standards for biotech and biomanufacturing
  • Possible EU Biotech Act
  • Support the completion of the negotiation on the reform of the legislation on supplementary protection certificates (SPCs)


  • Further encourage voluntary collaboration on pricing and reimbursement of medicines (e.g. biotech) to ensure availability
  • Explore international biotech and biomanufacturing international partnerships (e.g. with US)
  • Establish an EU Biotech Hub by end of 2024

We assume that these actions will only be implemented by the new Commission following the European Parliament elections taking place in June.