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The Commission unveiled the proposal for Biotech Act I in December 2025, with the goal of strengthening the EU biotechnology sector and support access to capital for biotechnology companies and projects.

IPEC Europe welcomes the strategic mapping of the EU’s biotechnology ecosystem foreseen in Article 17(2a), and particularly the inclusion of key biotechnology inputs and critical intermediates in the scope of the article. This is a positive step towards recognition of the essential role that such materials play in enabling biotechnology applications, although it is not explicit that they are of pharmaceutical excipient quality. The strong focus on regulatory sandboxes for novel health biotechnology products, outlined in Article 40, also signals the EU’s commitment to innovation in health biotechnology sector.

We support the inclusion of provisions to reduce dependencies on third country suppliers for key biotechnology inputs and intermediates, as stated in Article 3(1)(iv). While we recognise that the pharmaceutical supply chain is truly global, the EU’s rigorous environmental and quality requirements help ensure that patients receive medicines of the highest quality.

Despite these positive signals for innovation, excipients are not explicitly mentioned in the proposal. This is a key gap in the text: during the COVID-19 pandemic, novel excipients such as lipid nanoparticles were critical to the success of mRNA vaccines. In addition, excipients have been valuable in the development of monoclonal antibody formulations.

Excipients should not be an afterthought in the Biotech Act. We call for excipients, and in particular novel excipients, to be explicitly recognised in the text. To this end, IPEC Europe looks forward to engaging with policymakers to ensure full recognition of the key role of excipients in biotechnology products.