Published on Aug 19, 2025
Europe is on the brink of its first major overhaul of pharmaceutical legislation since 2004. On 26 April 2023, the European Commission introduced a sweeping reform package aimed at modernising drug rules to better serve patients, enhance supply security, support innovation, and protect the environment. The main policy aims to:
Ensure equitable access to safe, effective medicines across all EU countries
Improve competitiveness by simplifying regulation and reducing administrative burden
Prevent medicine shortages through stronger supply obligations
Promote environmental responsibility through mandatory risk assessments
On 4 June 2025, the Council of the EU reached a political agreement, paving the way for trilogue negotiations with the European Parliament and Commission.
1. Data & market exclusivity
Key exclusivity changes include:
8 years data protection with potential 2-year extensions for unmet need or broad EU launch
1 year market protection, extendable under certain conditions
Up to 12 years of orphan drug exclusivity for highly innovative or broadly available treatments
These changes aim to balance innovation incentives with faster access for patients across Member States.
2. Combatting antimicrobial resistance (AMR)
To stimulate antibiotic R&D, the legislation introduces:
Transferable data exclusivity vouchers granting up to 1 extra year of data protection
Strict eligibility criteria to ensure targeted, responsible use of the incentive
Limits on resale or transfer between companies
This mirrors global concerns over AMR while offering a novel EU-centric solution.
3. Supply chain security & generics access
The proposed legislation includes:
Legal obligations to supply all Member States during shortages
An expanded Bolar exemption, allowing generics and biosimilars earlier regulatory preparation
A future Critical Medicines Act to secure API production and reduce dependency on Asia
These changes aim to fortify Europe's supply chain resilience and encourage earlier market entry of lower-cost alternatives.
4. Environmental responsibility & regulatory efficiency
New measures will:
Require Environmental Risk Assessments (ERAs) as part of the marketing authorisation
Include obligations to reduce pharmaceutical residues in water
Shorten centralised review timelines (e.g. from 210 to 180 days) and simplify variations procedures
This aligns with the EU’s broader Green Deal goals and aims to streamline authorisation for innovative treatments.
While welcomed by some, the reforms have drawn criticism from:
Industry groups citing loss of R&D investment and global competitiveness
Patient advocates concerned about narrow definitions of “unmet need”
Environmental stakeholders pushing for stricter enforcement mechanisms
The next stage involves trilogue negotiations between the Parliament, Council, and Commission, with implementation expected in 2026–2027.
If you're involved in regulatory affairs, drug development, or market access, this legislation will affect:
Launch timelines and commercial strategy
Orphan drug planning and data protection use
Generics entry and Bolar strategy
Environmental compliance and risk planning
Supply chain obligations and partner sourcing
Want to understand the implications in detail? Check out our EU Proposed Pharmaceutical Legislation Changes training course.
This expert-led course provides a clear, practical breakdown of the legislative changes, their timelines, and how they will reshape the pharmaceutical landscape in Europe. Essential for regulatory professionals, legal teams, and strategy leads.
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Published on Aug 19, 2025 by Ella Thomas