Revolution In The EU Pharmaceutical Legislation Ahead

Prepared By Adam Tuszyner, Registration Documentation Specialist, Pharmacovigilance Specialist

In April 2023, the European Commission proposed revised pharmaceutical legislation to address medicine shortages, unequal access to therapies, and antimicrobial resistance. Proposed changes include reducing regulatory protection, improving medicines availability, introducing transferable vouchers for antimicrobials, and reducing environmental impact.

The legislation is welcomed by practitioners, patients, and generic drug manufacturers, but may require innovative developers to revise their plans. Feedback from public institutions and patient organizations has been positive, but the pharmaceutical industry has criticized the reduction in regulatory protection and the introduction of transferable vouchers for antibiotics. Additionally, in October 2023, the European Parliament (EP) proposed its own revisions with diverging stance on several matters.

The conflicting proposals of EC and EP are poised to instigate further revisions and consultations, a course of action that is likely to extend overall several months before the final version is ratified. Until then, readers can access this article for suggestions on how pharmaceutical companies should adjust their strategies to account for reduced data and market protection.