Katrina Perehudoff and Kaja Ippel recently published a research article in the Journal of Health Policy, Politics and Law, wherein wherein they analyse which political factors influence the production of the EU’s internal market legislation establishing incentives for biomedical R&D. This paper was selected to be part of a special issue organised by the EU Health Governance network on the Political Determinants of Health and the European Union.

This analysis (using Rushton and Williams’ framework for analysing global health policy) first identifies the EU institutions and actors involved in the legislative processes of the Union’s internal market action on biotechnology (Directive 98/44/EC) and orphan medicines (Regulation 141/2000). Secondly, the salient frames and paradigms invoked by the EU institutions throughout these processes are described. Lastly, a critical analysis is conducted which concerns the role of power and authority of these institutions and communities in relation to the frames and paradigms they use by combining evidence from official documents with academic literature. The persuasiveness of these political factors is illustrated by the relative success or defeat of key global health amendments. These amendments enjoyed relative ‘success’ in the negotiation of the Biotechnology Directive, i.e. by acknowledging a place of origin requirement, albeit in a recital. This is in contrast to their ‘defeat’ in the Orphan Regulation, where an amendment proposing a Community strategy on R&D for tropical diseases was rejected.

This paper concludes that global human rights and global biomedical paradigms were advanced through the EC’s policy proposals and/or the EP’s amendments motivated by the pursuit of global health equity and addressing patients’ medical needs worldwide. Whether or not these proposals/amendments were adopted in the final text reflects a unique combination of political factors that suggest that the EU was an internally fragmented and highly politicised political player on global health matters in the late 1990s.

This research arises in part from funding awarded to Katrina Perehudoff from the Netherlands Organisation of Scientific Research (NWO), the Amsterdam University Funds, and the UvA Amsterdam Centre for European Studies. Part of this research was conducted within the Master International and European Law at the University of Amsterdam.