In Europe, as in the world at large, COVID-19 sparked renewed concern about global health threats and a push towards developing international legal rules to ensure more integrated cooperation strategies for pandemic prevention, preparedness, and response at both regional and international levels.Reference Burci¹ Amid the pandemic, the European Union (EU) reached an unprecedented level of commitment in the field of global health law and governance, seeking to assert its role as a leading global actor in line with one of the European Commission’s political priorities — “A stronger Europe in the world” (2019–2024).

The EU became a key diplomatic player in the response to COVID-19. Despite criticisms of its positions on intellectual property and vaccine equity, the EU also took a proactive and engaged stance to advance global health law through the World Health Organization (WHO),Reference Meier and Finch² contributing to both the amendments of the International Health Regulations (IHR) and the negotiation of a Pandemic Agreement. Its actions under a “Team Europe” approachReference Koch³ have laid the foundations for improved leadership in global health at a time of profound changes in global health governance.

This column provides an overview of the political processes and structural reforms that have framed a new EU approach to emergency preparedness and response, with this paradigm shift leading to the creation of the European Health Union and to the development of a new EU Global Health Strategy. Examining the building blocks of this strengthened and comprehensive European health policy — advancing new strategic priorities for global governance — this article analyzes the rising EU role in global health, calling for further research on this EU contribution to global health law.

Building a European Health Union with a Global Vision

The need for strengthened coordination in addressing public health emergencies (PHEs), within Europe and globally, led EU institutions to take significant steps towards more synergic collective action. Early examples of closer EU collaboration in the COVID-19 response are seen in the EU Vaccines Strategy⁴ and the EU COVID-19 digital certificate.⁵ In November 2020, the European Commission elaborated the concept of a “European Health Union” (EHU).Reference Gallina⁶ Based on an idea put forward by EU President Ursula von der Leyen in her State of the Union address,⁷ the Commission’s vision for building an EHU would meet the need for a stronger health security framework to pursue a triple objective — of protecting better the health of European citizens, addressing future pandemics more effectively, and improving the resilience of health systems.Reference Bergner⁸

To translate this vision into practice, the European Commission took steps to launch a wave of reforms to revamp the EU legal, policy, and institutional framework. In 2021, the Commission created the Health Emergency Preparedness and Response Authority (HERA), a new Directorate-General designed to strengthen the development, manufacturing, procurement, and equitable distribution of critical medical countermeasures in times of PHEs.⁹ The Commission also launched a revised Pharmaceutical Strategy to make medicines more available, affordable, and innovative across the Union.¹⁰ By promoting a high level of quality, efficacy, and safety standards, these proposed reforms aimed to support the global competitiveness and leadership of the European pharmaceutical industry.

The adoption of a set of legislative proposals in 2022 added complementary pillars to the EHU architecture. The EU legal framework related to serious cross-border health threats was strengthened with new rules intended to ensure robust preparedness planning at both EU and national levels, a more integrated surveillance system, and a better capacity for risk assessment and targeted response.¹¹ Most significantly, these rules introduced the possibility to declare a PHE at Union level, a move that would trigger increased coordination and activate the emergency framework to guarantee the supply of crisis-relevant medical countermeasures within the Union.¹² At the same time, the EU extended and reinforced the mandates of:

With the EHU’s internal capacities substantially improved by the first round of reforms, the EU institutions started reflecting in May 2022 on how to leverage the Union’s contribution to global health law and security — and strengthen its external action accordingly.Reference Bengtsson¹⁵

The EU Global Health Strategy

A new EU Global Health Strategy (GHS) was adopted in November 2022 to encapsulate the European Commission’s new vision of the EU role in global health, designing a robust external dimension of the EHU “rooted in the universal values of human rights, equity, solidarity and cooperation.”¹⁶ Heralded at the G7 Health Ministerial meeting in Berlin, the GHS relaunched the EU’s global health agenda and positioned health as an essential pillar of EU external policy, with a view to shaping a “new global health order” while promoting and sharing EU values and guiding principles.¹⁷

As a cornerstone of the Global Gateway strategy — a European Commission initiative to invest in infrastructure projects worldwide, with health as one of the five key areas of intervention¹⁸ — the GHS serves as a roadmap to guide EU action in global health until 2030.¹⁹ The GHS sets three major interrelated priorities:

To successfully achieve these priorities, the GHS outlines twenty guiding principles and concrete lines of action to operationalize them, establishing a new permanent monitoring mechanism to assess progress and ensure EU accountability.Reference McKee²¹

The Strategy highlights the importance of stronger international rules and multilateral cooperation mechanisms — with the reinforced role of the WHO at its core and the alignment of EU and WHO priorities as a primary concern. The GHS calls for ensuring a stronger EU role in international organizations — firstly through the WHO — and for strengthening engagement with key global health stakeholders. It positions the EU as a global health leader that is capable of driving international cooperation in health through equal-footing partnerships guided by shared values and common policy priorities. This cooperation has been advanced in WHO global health law reforms, where EU leadership has been instrumental in the 2024 IHR amendments and the continuing negotiation of a Pandemic Agreement.Reference Burci, Kümmel, Gostin and Meier²² Working under the GHS, the EU seeks to fill existing gaps in global governance, avoid duplication of efforts, and ensure complementarity and coherence of action in the multilateral health system, expanding equitable and mutually-beneficial bilateral, regional, trans-regional, and global partnerships.

The Way Ahead: The Need for Better Understanding of the EU Role in Global Health Law and Governance

As emphasized by the Council of the European Union in its conclusions on the GHS, the EU and its Member States should “seize the opportunity to strengthen their impact as a global and regional actor to contribute concretely and measurably to a healthier and safer world.”²³ However, the successful implementation of the GHS requires an innovative, integrated, coordinated, and evidence-based approach, as well as new and different ways of thinking and working. Most importantly, this new paradigm will necessitate coherence in domestic and international EU actions, consistency (and defragmentation) between global and EU legal/regulatory frameworks, convergence of EU and global goals and priorities, coherent behavior in global affairs and in global health diplomacy, and a fair balance between the protection of European domestic interests and the EU ambition to be perceived as a reliable multilateral partner. This will demand synergic collective action to overcome confrontation/collision between universal and regional systems, especially in the event of a declared PHEs of both international and regional concern — something that is being put to the test in the African context following the WHO declaration of mpox as a “public health emergency of international concern” under the IHR and the declaration of “public health emergency of continental security” by the Africa Centers for Disease Control and Prevention.²⁴ Indeed, as Kickbuch and Pérez-Cañado observe, “[e]arly achievements demonstrate the [GHS’s] potential, but important challenges lie ahead in fulfilling it.”²⁵

Before the COVID-19 pandemic, the EU role in global health had long been neglected and has remained a relatively unexplored topic in global health governance.Reference Emmerling²⁶ In light of the lessons learned during the pandemic — reflected in the significant governance and legislative innovations introduced in the EU legal and institutional framework — there is now a compelling need to better understand, reconsider, and redefine the EU role within a dynamic global health order shaped by an expanding diplomatic, socio-economic, and geopolitical landscape. COVID-19 has been a driver for a more ambitious global political role, and it has pulled the EU in a more vocal and influential position in global health policy and in the development of global health law. This new scenario suggests the need for new research to understand this re-positioning of the EU in the global health arena, examining EU relationships with other international organizations and global health actors. This is what the international research group gathered under the umbrella of the newly instituted Jean Monnet Centre of Excellence “New Visions of the European Union’s Role in Global Health” (EU4GH), based at the University of Salerno, has set as its research goal until 2026, pursuing the ambition of meeting the need for an in-depth, fresh, and critical analysis of the EU role in the post-pandemic global health governance landscape, combining legal, policy, economic, social, and ethical perspectives to understand this rapid evolution in global health law.