A scoping review of the EU's impact on access to medicines in low- and middle-income countries

The European Union (EU) has a potential major influence on patients' global access to medicines. Historically, this influence most notably came through the EU's trade and aid agendas that intentionally targeted foreign markets. Now, the EU's own internal pharmaceutical policy appears to indirectly shape global access to medicines (ex. EU's large-scale Covid-19 vaccine procurement and export bans). To understand the ways the EU's internal and external policies impact on global access to medicines, this Scoping Review synthesises evidence of the EU's global regulatory influence and its impacts on access to medicines in non-EU low- and middle-income countries (LMICs). By searching 8 databases and grey literature, documents published in English, Spanish, Portuguese, or Russian between 1995-2021 that addressed an EU law, regulation, or policy in relation to access to medicines in LMICs were included. This review identifies three mechanisms through which EU action impacts on medicines in LMICs. One, the EU's external, treaty-based agreements with LMICs can affect their pharmaceutical trade, sales, and use. Two, EU's internal market regulation, standards, and methods are used as models or sources of inspiration for pharmaceutical governance in LMICs. Three, ‘soft' forms of EU influence manifest through the EU's technical assistance, its research and development (aid) funding, and its ‘capacity building' activities towards LMIC actors in the field of pharmaceuticals. Examples of impacts of EU action ranged from the development of new medicines primarily for LMICs, to changes in the availability of generics and on medicines spending in LMICs, and the potential for a more efficient yet less autonomous local market approval process. Most evidence of impact was not peer reviewed. This study raises the question of how to support resilient and efficient global pathways for drug development and regulation while still being responsive and accountable to the local public interest. Key messages There are 3 mechanisms through which EU action impacts on medicines in LMICs: treaty-based agreements, EU internal market regulation, and ‘soft' EU influence. EU decision makers need a reliable understanding of how the EU’s internal and external policies impact on pharmaceuticals globally.

The covid-19 pandemic: Failing forward in public health

Although most governments were heavily scrutinized and looked bad early in the COVID-19 pandemic, the EU was most noticeable for its absence. This might seem strange, for an institution whose public health role has been forged through crisis—from the thalidomide tragedy and the scandal of HIV-infected blood supplies, to “mad cow disease” and the underwhelming H1N1 influenza pandemic. A closer review of the EU’s health governance, however, reveals it to have performed exactly as expected and intended. An initial phase of disorganization and national egotism, unavoidable given that member states have historically restricted the EU’s health capacities, has been followed by a substantial new health policy agenda and a reinforcement of the EU’s market- and fiscal-based health influence. This is leading, we posit, to further integration. © The Author(s) 2021.

The European Union’s response to COVID19

While it is hard to predict what will have happened by the time of the conference, this round table will be tightly templated and coordinated. Each speaker will briefly address the challenges experienced by that country and the actions taken, and focus on explaining why those actions happened in order to draw comparative lessons about public health politics and governance.