Unavailable and unaffordable medicines (i.e. vaccines and therapeutics) increasingly threaten health systems and political and economic stability. These issues arise from the current model of drug research and development (R&D), an area in which the European Union (EU) has amassed significant power, and with it, the potential to shape medicines access globally.
The EU regulates medicines on Europe’s internal market through its law, policy and institutions (e.g. European Medicines Agency). Yet, this internal action also exercises normative power beyond the EU, in low- and middle-income countries (LMICs). These and other potential global ‘side effects’ of the EU’s internal regulation could be an important key to increasing access to medicines for infectious, non-communicable, and rare/orphan diseases in LMICs, and specifically in the EU’s Southern Neighbourhood (i.e. Middle East and North Africa), where medicines access is lacking. Knowledge about these external impacts of the EU is lacking, which also means that they are not accounted for in EU law- and policymaking. Following the COVID-19 outbreak, the EU is expanding its power over pharmaceutical development, which makes elucidating the EU’s responsibility and its impacts in this area, is as urgent as ever.
This project seeks to unpack the EU’s legal and ethical responsibilities towards access to medicines in developing countries, and to understand the actual impact of the EU’s pharmaceutical policy on making medicines available for patients globally. It includes two intertwined components: a global study primarily supported by a NWO Veni grant and a study of the Middle Eastern and North Africa region (also known as the EU’s Southern Neighbourhood) primarily supported by a NWO Hestia grant.
This project addresses the question: How should the EU act towards pharmaceuticals considering its own principles and values, and the impact of its laws and policies on access to medicines in LMICs? It uses doctrinal legal research, mixed-methods case studies (qualitative document analysis, key informant interviews, quantitative legal epidemiology), and evidence synthesis. First, this project develops a normative and legal guide for the EU’s future action towards pharmaceuticals globally. Second, this project conceptualises how the impacts of EU law and policy on medicines access in LMICs are achieved and modulated using case studies of orphan medicines and vaccines. Finally, this project develops and tests a legal impact model that, together with an interactive decision tree, can guide future EU action towards pharmaceuticals in line with its own principles and values.
This project asks the question: Could the EU’s internal pharmaceutical regulation help improve access to innovative medicines in the Middle Eastern & North Africa (MENA) region, thereby creating a win-win for EU and MENA patients? It is embedded within and focuses on the second part of the above Veni project. First, this project analyses (quantifies) the relationship between the EU’s internal drug regulation and the market approval of innovative medicines in six EU Southern Neighbourhood countries (Algeria, Egypt, Jordan, Lebanon, Syria, Tunisia). Second, this project builds pathways to further understand the factors that influence this EU-developing country relationship in two qualitative case studies (Jordan, Syria).
Prof. Fatima Suleman, University of Kwa-Zulu Natal
Dr. Carlos Durán, Utrecht University Medical Centre
Prof. Frank Cobelens, University of Amsterdam / Amsterdam Institute for Global Health & Development
dr. Ellen ‘t Hoen, Medicines Law & Policy