The path to a European Health Union.

The European Union has historically left health policy decisions to individual member states, cooperating only on issues like cross-border healthcare and medicine safety. However, the COVID-19 pandemic underscored the need for collective action across borders. In response, in October 2020, European Commission President Ursula von der Leyen called for the creation of a "European Health Union". This initiative aims to enhance the protection of European citizens' health, bolster pandemic preparedness, and strengthen healthcare systems. So far, the initiative has not led to major contestation. This might be because the proposals under this heading have been rather piecemeal and are not generally seen as being part of a comprehensive vision for identifying areas where EU intervention benefit national health policy. In this contribution we propose a path forward in terms of content and process for developing a more comprehensive vision on the policy content and the process. In so doing, we are not debating the need for a European Health Union. We take for granted that the existing European Health Union presents an opportunity to deliver, now and in the future, the added benefit of harmonizing, centralizing, or coordinating health-related laws, institutions, policies and actions at EU level.

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.

This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LMICs' reliance on EU internal regulation, standards, or methods (ex. market authorisation); 'soft' forms of EU influence (ex. research funding, capacity building). This study illustrates that EU policy makers adopt measures with the potential to influence medicines in LMICs despite limited evidence of their positive and/or negative impact(s). The EU's fragmented internal and external actions in fields related to pharmaceuticals reveal the need for principles for global equitable access to medicines to guide EU policy.

Esta revisión exploratoria sintetiza la evidencia disponible sobre el impacto que ejercen las leyes, las políticas y las regulaciones de la Unión Europea (UE) sobre el acceso a los medicamentos en países de bajo y mediano ingreso (PBMI) que no pertenecen a la UE. La búsqueda se realizó en ocho bases de datos académicas, incluyendo literatura gris. Se incluyeron publicaciones en cuatro idiomas entre 1995 y 2021. Como resultado principal se encontró que la UE ejerce su influencia sobre los productos farmacéuticos en los PBMI a través de tres mecanismos principales: i) acuerdos explícitos entre la UE y los PBMI, por ejemplo, acuerdos de ascensión a la UE o tratados comerciales, ii) utilización de la normativa, estándares o métodos de la UE por parte de los PBMI (reliance) para, por ejemplo, autorizar el ingreso de nuevos medicamentos a partir de la autorización previa por parte de la UE) y, iii) formas blandas de influencia de la UE, por ejemplo, a través de financiación a la investigación o al desarrollo de capacidades locales. Esta revisión revela que los tomadores de decisión de la UE adoptan medidas que, a pesar de la escasa evidencia que sustenta su impacto, positivo o negativo, tienen el potencial de influir en el acceso a los medicamentos de los PBMI. El accionar fragmentado de la UE respecto a los productos farmacéuticos, tanto a nivel interno como externo, son una clara muestra de la necesidad de crear principios que guíen las políticas de la UE frente al acceso equitativo a los medicamentos a nivel global.

Public support for European cooperation in the procurement, stockpiling and distribution of medicines.

BACKGROUND: The COVID-19 outbreak has heightened ongoing political debate about the international joint procurement of medicines and medical countermeasures. The European Union (EU) has developed what remains largely contractual and decentralized international procurement cooperation. The corona crisis has broadened and deepened public debate on such cooperation, in particular on the scope of cooperation, solidarity in the allocation of such cooperation, and delegation of cooperative decision-making. Crucial to political debate about these issues are public attitudes that constrain and undergird international cooperation. METHODS: Our survey includes a randomized survey experiment (conjoint analysis) on a representative sample in five European countries in March 2020, informed by legal and policy debate on medical cooperation. Respondents choose and rate policy packages containing randomized mixes of policy attributes with respect to the scope of medicines covered, the solidarity in conferring priority access and the level of delegation. RESULTS: In all country populations surveyed, the experiment reveals considerable popular support for European cooperation. Significant majorities preferred cooperation packages with greater rather than less scope of medicines regulated; with priority given to most in-need countries; and with delegation to EU-level rather than national expertise. CONCLUSION: Joint procurement raises delicate questions with regard to its scope, the inclusion of cross-border solidarity and the delegation of decision-making, that explain reluctance toward joint procurement among political decision-makers. This research shows that there is considerable public support across different countries in favor of centralization, i.e. a large scope and solidarity in the allocation and delegation of decision-making.

Towards more comprehensive health law and policy research.

In this comment, and drawing on the papers in the special issue, we ask: what are the core questions for the future of research into health law and policy, and European health law and policy more specifically? We first sketch the general functions and values of health law and policy. We then outline how these functions and values are affected by globalisation and Europeanisation, on the one hand, and technological change and digitalisation, on the other. In light of these developments we carve out some questions for future research and the implications of this agenda for the academic community that is working on European health law and policy.