The pharmaceutical markets of the EU and low- and middle-income countries are intertwined, yet little is known about this relationship that affects patients’ access to medicines worldwide. On one hand, European patients rely on many new medicines that are clinically tested and produced in middle-income countries before being marketed (in Europe and worldwide). On the other hand, the EU regulates the medicines supply on its own market and, in doing so, these EU standards influence access to medicines worldwide. Whether or not the EU has conceptualized and intended its internal health law to have a global impact is unclear.
The aim of this project is to understand how the EU conceptualizes its global role in biomedical R&D that stands to partially or entirely benefit of low- and middle-income countries. This project will critically analyze the narratives used to frame (how the EU understands) the relationship between its incentives for pharmaceutical development and the potential worldwide impact of them. This project draws on two types of EU interventions, each with the primary objective to incentivize the development and marketing of new medicinal products and/or health-related technologies in Europe. The first is an EU intervention that ‘pulls’ new medicines to the market by paying for industry’s results/products (i.e. Orphan Drugs Regulation EC No. 141/2000 providing market exclusivity to manufacturers of orphan medicines). The second incentive ‘pushes’ industry to innovate by paying for its efforts (EC’s research Horizon 2020 framework programme providing research grants to pharmaceutical developers).