The European life sciences sector is navigating a turbulent regulatory environment. Recent developments across the UK and EU highlight how policy disputes, sustainability initiatives, and trade barriers are shaping the future of pharmaceutical and medical technology access. From stalled negotiations over drug pricing to new environmental rules and tariff concerns, companies must adapt quickly to maintain resilience and patient access.
UK Medicines Payment Scheme Stalemate
Negotiations between the UK government and the Association of the British Pharmaceutical Industry (ABPI) have ended without agreement on reforms to the Voluntary Scheme for Branded Medicines, Pricing, Access and Growth (VPAG). The current scheme requires manufacturers to repay 23.5% of their revenues from branded medicines sold to the National Health Service (NHS)—a rate much higher than that of other European markets.
Pharma companies argue that these repayment rates threaten innovation and discourage investment in the UK. AbbVie and Eli Lilly both exited the scheme in 2023, citing unsustainable repayment demands. ABPI warned that unless rates are reduced to internationally competitive single-digit levels, the UK risks falling behind in research, development, and patient access to new treatments. The impasse underscores the delicate balance between government cost controls and fostering a competitive life sciences environment.
Sustainability Rules and MedTech Concerns
The EU’s Carbon Border Adjustment Mechanism (CBAM), intended to encourage cleaner production of imported goods, has raised red flags for medical device manufacturers. MedTech Europe warned that extending CBAM to device components would create significant technical and financial burdens. Many devices are assembled from hundreds of globally sourced components, making compliance complex and costly.
While the EU’s push toward greener supply chains aligns with broader climate goals, the industry cautions that hasty implementation could backfire. Higher costs may deter EU-based production or shift manufacturing outside the bloc, potentially undermining both sustainability and patient access to affordable devices.
EMA Speeds Up Scientific Advice
Not all news from Europe is challenging. The European Medicines Agency (EMA) recently reported positive results from a two-year pilot of its PRIME priority medicines scheme. By introducing expedited pathways for scientific advice requests, the agency reduced turnaround times by 37%.
This improvement is a meaningful step toward faster patient access to innovative therapies. Shorter regulatory timelines can help companies optimize trial design and bring breakthrough medicines to market sooner, particularly in areas of unmet medical need. However, the EMA also emphasized the importance of balancing speed with rigor, ensuring that scientific advice remains thorough and reliable.
Tariff Tensions Between the U.S. and EU
Trade policy has also become a pressing concern. The European Federation of Pharmaceutical Industries and Associations (EFPIA) expressed alarm over new U.S. tariffs on branded pharmaceuticals shipped from the EU. While generics received more favorable treatment, branded drugs will face a tariff rate of up to 15%.
Industry leaders warn that such measures divert billions away from research and development while disrupting already fragile supply chains. EFPIA has called for urgent dialogue with the European Commission and Member States to secure exemptions for innovative medicines, stressing that collaborative discovery and patient care should not be compromised by trade disputes.
Conclusion
Taken together, these developments reveal both opportunities and risks for the European pharmaceutical and medical device sectors. Governments are grappling with competing priorities: keeping healthcare costs in check, meeting climate goals, and protecting domestic industries, while companies seek regulatory clarity and global competitiveness.
For stakeholders, these shifts highlight the importance of proactive regulatory intelligence and strategic planning. Firms that monitor evolving policies and engage early with regulators will be better positioned to safeguard market access and ensure uninterrupted patient care.
At EMMA International, we help life science companies navigate complex regulatory and policy environments, from pricing pressures to sustainability requirements and global supply chain challenges. By providing actionable intelligence and compliance strategies, we enable organizations to adapt quickly and maintain their focus on delivering safe, effective, and innovative products to patients worldwide.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Association of the British Pharmaceutical Industry (2025). Statement on VPAG Negotiations.
MedTech Europe (2025). Response to Carbon Border Adjustment Mechanism Consultation.
European Medicines Agency (2025). PRIME Scheme Pilot Report.
European Federation of Pharmaceutical Industries and Associations (2025). Statement on U.S.-EU Tariffs.
