The European Commission has proposed a new single market for medicines in the European Union (EU) to create an attractive and innovation-friendly environment for the research, development, and production of medicines.
The Commission's revision of EU medicines legislation is aimed at making medicines more available, accessible and affordable while supporting innovation, boosting the competitiveness and attractiveness of the EU pharmaceutical industry, and promoting higher environmental standards.
The review includes proposals for a new directive and regulation, revising and replacing existing medicines legislation, including medicines for children and rare diseases. The review also aims to create a single market for medicines that will ensure that all patients across the EU have timely and equal access to safe, effective and affordable medicines.
To achieve these goals, the reform addresses the entire life cycle of medicines, including measures to tackle antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through the One Health approach. The reform aims to enhance availability and ensure that medicines can always be provided to patients, regardless of where they live in the EU.
Measures will be put in place for greater transparency of public funding of drug development and incentives will be provided for the production of comparative clinical data. The scientific evaluation and approval of medicines will be speeded up, and the regulatory burden will be reduced through simplification of procedures and digitization.
Regulatory protection of up to 12 years for innovative medicines, combined with existing intellectual property rights, will ensure that Europe remains an attractive hub for investment and innovation. The reform introduces new requirements for the monitoring of drug shortages by national authorities and the European Medicines Agency (EMA) and a stronger coordinating role for the EMA.
[Information from official announcement]