EU Pharmaceutical Reform: A Delicate Negotiation

03 Aug 2023

The European Commission may well be flexible over its proposals on data protection periods, but it is unlikely to give ground on plans to restructure the European Medicines Agency and to introduce a new temporary emergency marketing authorization, says lawyer Vincenzo Salvatore.

European Commission headquarters in Brussels, Belgium on July 1st, 2021 — The European Commission is proposing a wide-ranging pharma legislative reform • Source: Shutterstock

After a long wait, a couple of leaks and a few postponements, the European Commission’s recently released proposal for a new regulation and a new directive repealing the current provisions on medicinal products in the EU has already generated reservations and push-back across the board amongst major stakeholders. In short, nobody seems to be happy with it.

About The Author

Vincenzo Salvatore is of counsel at law firm BonelliErede, leader of the firm’s Healthcare and Life Sciences Focus Team, and a former head of the legal service at the European Medicines Agency.