Biotech and Biomanufacturing Initiative
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The GPL must be central to the EU’s strategy for healthcare resilience through global biotechnology competitiveness. It has to empower Europe’s innovators, especially small and growing biotechnology companies, and reprioritise our significant life science sector. We should increase rather than decrease baseline incentives, remove the seven-year time limit for Orphan Designation, increase Orphan Market Exclusivity and avoid definitions that restrict Europe’s rare disease progress. This enables Europe to grow as a global hub for research excellence and be a home for novel medicines, with the beneficiaries being patients, economies and healthcare systems.
Europe is at the crucial point facing a choice between becoming a global biotechnology innovation hub or a follower. With the revision of the Pharmaceutical Legislation it is imperative for the EU to promote an enabling environment for biopharmaceutical innovation in order to remain competitive in the global context and ensure that groundbreaking treatments are accessible to European patients.