On April 26th 2023, the European Commission released their proposals for a new Pharmaceutical Directive and Pharmaceutical Regulation in order to revamp pharmaceutical laws within the EU.1 This follows the Pharmaceutical Strategy for Europe published in November 2020 in which the Commission set out their plans for a future-proof, patient-orientated pharmaceutical landscape in the EU in order to fit the current landscape and combat any future crises. The updates aim to revise general legislation as well as legislation around paediatric medicines and rare diseases.
The revision aims to address five main objectives:
- Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines.
- Enhance security of supply and ensure medicines are always available to patients, regardless of where they live in the EU.
- Offer an attractive, innovation- and competitiveness friendly environment for research, development, and production of medicines in Europe.
- Make medicines more environmentally sustainable.
- Address antimicrobial resistance (AMR) through a One Health approach, encompassing human health, animal health and the environment.
The revision of the pharmaceutical directive has come under scrutiny from leading organisations across Europe. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) have published a response to the Pharmaceutical Package in which they support the overall objectives of the reform, however have concerns that some of the “other provisions will undermine R&D, innovation, and EU competitiveness”.4 Based on the commissions proposal, they have drafted five initial recommendations.
- Adopt a predictable and stable incentive framework that rewards and drives innovation in a globally competitive ecosystem
- Consider the policy proposals developed by the OD Expert Group, to improve the OMP incentive framework
- Maintain the existing Regulatory Data Protection period of eight years
- Better implement the existing cross-border healthcare legislation to improve patients’ access across all EU Member States
- Adopt a careful approach to avoid duplication of work and additional burdens on small and mid-sized companies
The legislative proposals will now be submitted to the European Parliament and Council for discussion and finalisation. Given the scale of the revisions, the largest in over 20 years, it is unlikely the final legislation will be adopted before 2025.
This article has been updated from EU aims to revamp European pharmaceutical laws.
- Reform of the EU Pharmaceutical Legislation. European Commission. Updated 26/04/23. Accessed 26/04/23. https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en
- Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance. European Commission. Published 26/04/23. Accessed 27/04/23. https://health.ec.europa.eu/system/files/2023-04/com_2023_190_1_act_en.pdf
- Pharmaceutical Strategy for Europe. European Commission. Published 25/11/20. Accessed 27/04/23. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761
- EUCOPE’s statement on the Commission’s proposal for the EU Pharmaceutical Package. Published 26/04/23. Accessed 27/04/23. https://www.eucope.org/eucopes-statement-on-the-commissions-proposal-for-the-eu-pharmaceutical-package/