EUCOPE welcomes the European Commission’s Communication on boosting biotechnology and biomanufacturing in the EU

On 20 March, the European Commission’s published the Communication on Building the future with nature: Boosting biotechnology and biomanufacturing in the EU, proposing a series of targeted actions to boost biotechnology and biomanufacturing in the EU. While focussing on the entire biotech sector, the Communication dedicates an important space to health biotech.

EUCOPE sees the Communication and its objectives as a step in the right direction to strengthen the EU biotech sector. It is important that the Commission’s initiative recognises a thriving EU biotech ecosystem is of strategic importance to ensure EU competitiveness, as well as it identifies key challenges and potential solutions. EUCOPE will look forward to any concrete actions that the Commission will undertake to implement the Communication on Biotech, to ensure this initiative becomes really impactful. We trust the Commission will take up all necessary actions under its new mandate, after the June elections of the European Parliament.

Key Elements

The Communication acknowledges that the EU biotechnology and biomanufacturing sector faces several challenges, among other in research and technology transfer to the market, intellectual property, regulatory complexity or access to finance. Thus, the Commission proposes a set of eight actions to address these challenges, such as leveraging research and boosting innovation, streamlining regulatory pathways, fostering public and private investments, using AI and generative AI. These proposals might result, among others, in establishing an EU Biotech Hub by end of 2024 and a possible EU Biotech Act.

The Commission recognises the important role health biotech play in the EU. Pharma biotech invest in outbreaking research in Europe, including in vaccines and mRNA technology. This can have a huge impact on infectious diseases, cancers, rare diseases and cardiovascular diseases. Generative AI can play an important role to facilitate drug discovery or understand complex genetic disorders.

The Communication highlights the important of a strong and predictable IP framework and stresses several measures under the ongoing revision of the pharmaceutical legislation that will be important for health biotech, such as regulatory sandboxes and clearer rules on advanced therapy medicinal products (ATMPs). To improve the regulatory framework, the Commission will also launch a study on the implementation of the Clinical Trial Regulation by end of 2024.

The Commission will assess how HERA Invest can support promising SMEs and, more generally, how to provide better financial support to health biotech. The Commission will also encourage the deployment of technologies across EU regions through Regional Innovation Valleys, for instance related to biotech health security.