EC’s plans for updating pharma legislation unveiled 11 May 2023

The European Commission’s (EC) long-awaited proposals for reforming pharma legislation have been published.

The main thrust of the proposals is to create a single EU market for medicines to replace existing fragmentation and improve access for EU citizens. The update comes about following the EC’s adoption of a Pharmaceutical Strategy for Europe in November 2020, which began the largest reform of its pharmaceutical legislation in 20 years.

EU Commissioner for Health and Food Safety, Stella Kyriakides, stated that the proposal would “ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion. It is a reform which ensures that Europe remains attractive for business, and our pharmaceutical industry a global innovation powerhouse.”

However, while the pharma industry has supported greater unification of the market, driven by innovation and market pricing, it has spoken out against some aspects of the proposed changes. These include the suggestion of penalties for any medicine that is not available across all Member States within two years of approval, plus the reduction in market exclusivity for patented drugs from ten to eight years.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) President said, “Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk.”

The proposals now move to amendment and approval with the European Parliament, after which they will be presented in a new Directive and Regulation, replacing the current pharma legislation.