The European Pharmaceutical Legislation Revision – Status Update and Ongoing Challenges

Description: For the first time in nearly two decades, the European general pharmaceutical legislation is undergoing a full review. Both the Directive and the Regulation, which together govern medicines approval and supervision, are being reworked, with the aim of achieving an efficient regulatory system that keeps the E.U. competitive in global innovation while ensuring affordable patient access to medicines. Many provisions in the European Commission’s proposal package have sparked fierce debate in the European Parliament and the European Council. Among the most contentious topics are regulatory protection periods, a proposed transferable exclusivity voucher for innovative antimicrobials, and new definitions for “high unmet” and “unmet” medical need, as well as a proposed requirement for cross-E.U. market launch. Lingering differences on these issues will likely push the package into the next Parliament.


The session will provide an overview of the current status of negotiations among E.U. governmental bodies, highlighting the areas of agreement and persistent gaps. Industry experts and regulators will share their views on the package, with an emphasis on potential impact on industry, regulators, patients and other stakeholders. Some questions to discuss include: What are the anticipated benefits and challenges introduced through the new provisions? Would those provisions fulfill the goal of stimulating innovation while ensuring affordable and accessible medicines? How might the changes impact operations, product development, competitiveness, and product approval?