European Commission president proposes new legislation to boost pharma competitiveness
The newly reelected president of the European Commission on Thursday proposed two legislative priorities that will affect the pharmaceutical industry, one aims to boost the competitiveness of its pharmaceutical sector and the other would tackle drug shortages by reducing dependence on medical treatments and ingredients sourced from outside the region.These policy initiatives were announced by incoming president Ursula von der Leyen in an address to the European Parliament in Strasbourg France just before she was reelected for another five-year term.
The first legislative initiative, the European Biotech Act in 2025, is part of broader strategy for the EU life sciences sector to “support our green and digital transitions and develop high-value technologies.”
Von der Leyen said the proposal aims to “make it easier to bring biotech from the laboratory to factory and then onto the market.”
The legislation also aims to “create the conditions for researchers to thrive” by providing the infrastructure and laboratories for researchers to test and develop their ideas, and by strengthening the collaboration between research departments, higher education and business to attract new talent.
Von der Leyen also proposed a Critical Medicines Act to combat shortages of critical medicines and ingredients, including antibiotics, insulin, and painkillers, which have been in “severe” shortage. It aims to reduce dependencies on critical medicines and ingredients sourced outside of Europe, particularly for products with few suppliers.
The proposal, she said, “will be part of our work to complete the European Health Union with diversified supply chains, access to the most advanced treatments, more resilient health systems and strategic inventories of key medicines.”
While details on these policies were scarce, similar proposals have emerged from the EU. Last December, the EU’s European Economic and Social Committee (ESESC) drafted an opinion that would create a Critical Medicines Act. And In March 2024, the European Commission published a communication proposing to establish the EU Biotech and Biomanufacturing Initiative to boost the competitiveness of the biotech sectors.
Other plans are to issue a new chemicals industry package, aiming to simplify REACH and provide clarity on “forever chemicals,” or per- and polyfluoroalkyl substances (PFAS).
The European Federation of Pharmaceuticals Industries and Associations (EFPiA) announced its support for the Biotech Act.
"We are pleased to see the ambition to support European life sciences through a dedicated life sciences strategy, included in the political guidelines and presented to the European Parliament by President von der Leyen earlier today. The dedicated life sciences strategy, which includes plans for a new Biotech Act, is an important part of the wider drive to boost European competitiveness over the next five years,” said EFPIA’s director-general, Nathalie Moll.
Proposal; EFPIA comment
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