Changes to the EU General Pharmaceutical Legislation – will Europe still be competitive?

During the hashtagworldorphanusa Congress this week and the hashtagREPharma24 conference last week industry leaders took to the stage with a recurring theme; apprehension surrounding recent revisions to the EU Pharmaceutical legislation which could potentially impact the very heart of innovation, Europe’s allure and competitive edge.

Both EUCOPE and EFPIA align with this position, whilst they acknowledge some positive steps they emphasise the need for caution and refinement to avoid stifling innovation and competitiveness within the EU.

On April 10, 2024, the European Parliament adopted revisions to the EU’s pharmaceutical laws to improve access, affordability, and availability of medicinal products. The aim, to balance fostering innovation, especially for small and medium-sized enterprises. The reforms seek to simplify the regulatory process and expedite the availability of safe therapies, positioning the EU as a regulatory leader.

EUCOPE’s Response to Changes:
– High Unmet Medical Need (H-UMN): Persisting vague criteria for UMN and HUMN may create uncertainty in market access and affect investment decisions.
– Regulatory Data Protection (RDP) extended to 7.5 years, up to 8.5 years under conditions .& Orphan Market Exclusivity (OME) now 9 years, extendable to 11 for HUMN, changing from a standard 10-year period.
– Access & Distribution: Companies can now target P&R applications to interested Member States, though SMEs face feasibility and penalty concerns.
– Medicine Shortages & Supply Security: New measures may place undue strain on SMEs while addressing supply issues.
– Environmental Risk Assessment (ERA): Expanded ERA requirements could pose significant global obligations.
– Regulatory Network Modernisation: Incorporates faster review for key medicines and embraces RWD. Regulatory Sandboxes and EMA reorganisation are set to improve technology evaluation and regulatory processes.

EFPIA’s Response to Amendments:
EFPIA’s Director General, Nathalie Moll, expressed concerns that the changes could render Europe less competitive and attractive for R&D, potentially leading companies to relocate resources to regions with more ambitious life science strategies. Despite some improvements, there’s fear that reduced incentives could adversely affect Europe’s capability to develop new treatments. EFPIA stresses the importance of dialogue to shape legislation that supports rather than hinders the development and manufacturing of new treatments in the EU.

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