Revision of the General Pharmaceutical Legislation: Impact Assessment of European Commission and EFPIA Proposals  

Europe’s General Pharmaceutical Legislation has undergone its most significant overhaul in decades, with proposals designed to improve access to medicines, strengthen competitiveness and encourage innovation. However, balancing these objectives presents complex policy challenges that could shape the future of pharmaceutical research and development for years to come.

This report evaluates the potential impact of both the European Commission’s proposals and alternative approaches put forward by EFPIA, as quoted in BloombergFinancial Times and Reuters. Using economic modelling based on risk-adjusted net present value, it examines how changes to regulatory data protection, incentives and broader legislative reforms may influence investment decisions, product launches and Europe’s position within the global life sciences landscape. 

Beyond assessing innovation alone, the report explores the wider implications for competitiveness, small and medium-sized enterprises, patient access and the sustainability of Europe’s pharmaceutical ecosystem. It highlights the interconnected nature of policy decisions and considers how reforms designed to improve access today may also influence the development of tomorrow’s medicines. 

For policymakers, pharmaceutical leaders and market access professionals, understanding these trade-offs is critical. The report provides an evidence-based assessment of how different policy options may affect innovation, launch strategies and long-term investment across Europe.

As debate around the future of pharmaceutical legislation continues, this paper offers valuable insight into one of the defining policy discussions facing the life sciences sector.

Download the full report to explore the modelling, evidence and policy implications in greater detail.

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