European Commission Proposes Revision of Pharmaceutical Legislation

Strategic Insights -

Research on science has revealed that the European Commission proposed a draft of revised pharmaceutical legislation in April 2023, which has since been debated by the European Parliament. The proposed reform aims to integrate various provisions, encourage research and technology development, and provide incentives for the industry to address market failures. The European Parliament has adopted a position on the proposal in April 2024, and an analysis of the texts has informed on the most relevant and debated issues.

Key Takeaways:

  • The European Commission proposed a first draft of the revised pharmaceutical legislation in April 2023, which includes a new Directive and a new Regulation.
  • The proposal aims to encourage the industry to conduct research and develop technologies that reach patients, while addressing market failures.
  • The revised legislation aims to foster access to medicines for all patients in the European Union through targeted incentives and provisions.
  • The European Parliament adopted a position on the proposal in April 2024, which will inform the legislative process.
  • The reform is likely to affect several aspects of the pharmaceutical industry, including market failures, access to medicines, and research and development.

Statistics:

  • The European Commission proposed a first draft of the revised pharmaceutical legislation in April 2023.
  • The European Parliament debated and adopted a position on the proposal in April 2024.
  • The proposed reform aims to encourage the industry to conduct research and develop technologies that reach patients.
  • The revised legislation is expected to foster access to medicines for all patients in the European Union.

Sources:

  • The 2023 European Commission proposal and the 2024 European Parliament proposal for the EU pharmaceutical legislation: policy content analysis. Health Policy, 2025;161:105408.
  • NewsRx. New Science Data Have Been Reported by Researchers at University of Milan (The 2023 European Commission proposal and the 2024 European Parliament proposal for the EU pharmaceutical legislation: policy content analysis). Science Letter. September 5, 2025.