The European Commission has unveiled a comprehensive reform package for pharmaceutical legislation, centered on creating a unified single market for medicines across the European Union. The landmark proposal aims to address current market fragmentation that has led to inequitable access to medicines among member states and inefficiencies in healthcare systems.
Single Market Vision and Access Requirements
Stella Kyriakides, EU Commissioner for Health and Food Safety, emphasized the reform's core objective: "We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion." The plan introduces controversial measures, including penalties for pharmaceutical companies that fail to make approved medicines available across all member states within two years.
The European Federation of Pharmaceutical Industries & Associations (EFPIA) has expressed concerns about this approach. EFPIA Director General Nathalie Moll argues that "fixing the tenfold variation in access to new medicines across the EU requires all partners to urgently get round the table and address the real issues, rather than unworkable EU-level legislation."
Market Exclusivity Changes Spark Industry Pushback
A significant point of contention is the proposed reduction in market exclusivity periods for new medicines from 10 to 8 years. However, the legislation offers potential extensions up to 12 years for companies that meet specific criteria, such as:
- Making medicines available to all EU patients
- Conducting comparative studies
- Addressing new indications or unmet medical needs
EFPIA President Hubertus von Baumbach warns that these changes "risk sabotaging Europe's life sciences industry" and could diminish European competitiveness in global healthcare innovation.
Streamlined Approval Process and Emergency Measures
The reform package introduces several efficiency improvements:
- Reduction of EMA review time from 210 to 180 days
- Shortened Commission approval period from 67 to 46 days
- Target to reduce the current 400-day average between submission and market authorization
Additionally, the legislation establishes a framework for compulsory licensing during public health emergencies, reflecting lessons learned from the COVID-19 vaccine rollout challenges.
Innovation and Environmental Considerations
The reform addresses emerging healthcare challenges through various initiatives:
- Introduction of data exclusivity vouchers to incentivize antimicrobial resistance (AMR) drug development
- Measures to enhance pharmaceutical product environmental sustainability
- Reduced administrative burden for drug developers
Legal expert Jacqueline Mulryne of Arnold & Porter notes that while the proposals attempt to balance innovation and patient access, "industry will need to follow the developments closely and engage with the various consultations to ensure its views are heard."
The proposed legislation will undergo review and potential amendments by the European Parliament and Council before being formalized into a new Directive and Regulation, replacing existing pharmaceutical legislation.
