EU: Council Agrees on Position for the 'Pharma Package'
The European Council has adopted its negotiating position on the major reform of EU pharmaceutical laws, the 'Pharma Package', and is now ready to start talks with the European Parliament.
Key Goals of the Pharma Package
The reform aims to build a fairer, more competitive, and resilient pharmaceutical sector in the EU. It focuses on:
- Fair access to safe, effective, and affordable medicines for all EU citizens
- Simpler, more efficient regulation to boost industry competitiveness
- Better supply security, with tools to prevent medicine shortages
- Lower environmental impact through stricter enforcement
Council’s Position – Key Amendments
- Data protection: 8 years of regulatory data protection for innovative medicines
- Market exclusivity: 1 year of market protection, extendable to 2 years if certain pre-defined key objectives are met
- Supply obligations: Member states can now require marketing authorisation holders to supply adequate amounts of a medicine
- Transferable exclusivity voucher: May only be used in the 5th year of data protection and if annual EU sales stay below €490 million in previous 4 years
- Generic medicine boost: Expanded ‘Bolar exemption’ allows earlier steps toward market entry of generic and biosimilar medicinal products, including participation in public tenders
Next Steps
Negotiations with the European Parliament will follow, aiming for final adoption once the legal language is finalized.
Source:
European Council: Press releases
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
