EuropaBio asked Charles River Associates to research the potential impact of the proposed changes included within the EU’s General Pharmaceutical Legislation (GPL) to Europe’s innovation ecosystem, with a particular focus on its impact on the growth of emerging and small biotechnology companies. The proposal is to revise the pharmaceutical legal framework in the European Union (EU). This includes introducing a new Directive and a new Regulation aimed at modernizing and streamlining the current system. These proposals are set to replace the existing general pharmaceutical legislation, namely Directive 2001/83/EC and Regulation (EC) No 726/2004. Additionally, they will reform Regulation (EC) No 1901/2006, which focuses on medicines for children (known as the ‘Pediatric Regulation’), and Regulation (EC) No 141/2000, which addresses medicines for rare diseases (referred to as the ‘Orphan Regulation’). The research involved a three-phase approach including:
- A literature review of recent government and non-government perspectives in the European pharmaceutical landscape and existing analysis of the proposed GPL
- An analysis of the roles that different tiers of companies play in the development of new medicines, the sources of funding and the role of partnerships
- An interview program with senior executives from biotechnology companies of different sizes from start-ups to mature, national biotechnology trade associations and key investors in the life science venture capital space
