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Following the European Council’s publication of its position on the proposed update to the European pharmaceutical legislation in June 2025, further discussions are ongoing with publication expected during 2026

The European Union is currently undertaking a significant revision of its pharmaceutical legislation with the overarching goals of ensuring timely and equitable access to safe, effective, and affordable medicines for all patients across the EU, enhancing the security of the supply of medicines, maintaining an environment conducive to pharmaceutical research and development, improving the environmental sustainability of medicines, and addressing antimicrobial resistance.

A multilayered framework of intellectual property rights and regulatory protections exists across the EU to support the investment required for pharmaceutical research and development.

The European Union is currently refining its pharmaceutical legislation, with proposals from the European Commission now in advanced stages of debate between the European Parliament and the Council. As of October 2025, the core requirements have not been finalised and remain under trilogue negotiation.