The European Commission published a targeted consultation on its planned reform of EU pharmaceutical legislation on 28 September 2020.
The purpose of the consultation is to gather feedback from market participants on the functioning of EU pharmaceutical law ahead of the Commission’s formal proposal for a regulation which is expected in Q4 of 2022. This fit-for-purpose review is part of the Commission’s wider pharmaceutical strategy and complementary to other ongoing initiatives in this context, such as the European Health Data Space.
The consultation seeks stakeholders’ feedback on a broad range of issues, including:
- The performance of the EU's pharmaceutical legislation;
- Unmet medical needs;
- Incentives for innovation;
- Antimicrobial resistance;
- Future-proofing the regulatory framework for novel products;
- Improved access to medicines;
- Competitiveness of the European markets to ensure affordable medicines;
- Repurposing of medicines;
- Security of supply of medicines;
- Quality and manufacturing of medicines;
- Environmental challenges.
The consultation will close on 21 December 2021. The consultation will be of interest to pharma and biotech companies active across the entire supply chain, as well as industry bodies, given that the outcome of the consultation may impact their respective business.