The 2023 European Commission proposal and the 2024 European Parliament proposal for the EU pharmaceutical legislation: policy content analysis

Abstract

A revision of the pharmaceutical legislation is ongoing at the European Level. The European Commission proposed a first draft in April 2023, and the European Parliament has adopted a position on the proposal in April 2024. The proposal consists of a new Directive and a new Regulation, with the aim of integrating different provisions that have been introduced over time. The proposal aims at encouraging the industry in conducting research and developing technologies that reach patients, while addressing market failures. We discuss both general and targeted incentives that are proposed, as well as the provisions to foster access to medicines for all patients in the European Union. Although the legislative process has not been completed yet, an analysis of the texts that have been debated in the early stages, vis-à-vis the legislation in force, can inform on the most relevant and debated issues and on the aspects the reform is most likely to affect.