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The European Union as a Global Health Actor: Challenges and Opportunities

Published online by Cambridge University Press:  16 December 2024

Stefania Negri*
Affiliation:
UNIVERSITY OF SALERNO, FISCIANO, ITALY
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Abstract

The COVID-19 pandemic served as a catalyst to build a stronger European Health Union to protect the health of Europeans and to develop a new Global Health Strategy to contribute to global health security. In positioning itself as a key player in global health governance, the EU seeks to assert its responsibility as a global health actor and deepen its leadership in global health law.

Type
Columns: Global Health Law
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This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
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© The Author(s), 2024. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

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:

• the European Centre for Disease Prevention and Control (ECDC) — enabling it to host a new excellence network of EU reference laboratories and to create an EU Health Task Force for effective and timely operational support to EU countries;Reference Kokki and Ammon13 and

• the European Medicines Agency (EMA) — conferring broadened functions to prepare for, prevent, coordinate, and manage the impact of PHEs on medicines and medical devices, including monitoring and mitigating systemic shortages.Reference Cooke14

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

As emphasized by the Council of the European Union in its conclusions on the EU Global Health Strategy, the Union 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.”

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:

• deliver better health and well-being throughout the life course,

• strengthen health systems and advance towards universal health coverage, and

• prevent and combat health threats applying a One Health approach.20

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.

Acknowledgments

I would like to express my deepest gratitude to Prof. Benjamin Mason Meier for his unconditional and constant support, for providing thoughtful feedback on an earlier draft, and for offering valuable suggestions for improvement. I also thank Bret Berry for assistance with citation formatting.

The author has no conflicts of interest to disclose.

Footnotes

About This Column

Lawrence O. Gostin and Benjamin Mason Meier serve as the section editors for Global Health Law. Professor Gostin is University Professor at Georgetown University and the Founding Linda D. & Timothy J. O’Neill Professor of Global Health Law at Georgetown University Law Center and Director of the World Health Organization Collaborating Center on National and Global Health Law. Professor Meier is a Professor of Global Health Policy at the University of North Carolina at Chapel Hill and a Senior Scholar at the O’Neill Institute for National and Global Health Law. This column features timely analyses and perspectives on law, policy, and justice in global health.

References

Burci, G.L., “The COVID-19 Pandemic and the Development of Global Health Law: Managing Crises or Achieving Structural Changes?Journal of Global Health Law 1 (2024): 825, available at <https://www.elgaronline.com/view/journals/jghl/1/1/article-p8.xml> (last visited September 23, 2024).CrossRefGoogle Scholar
Meier, B.M. and Finch, A., “Seventy-five Years of Global Health Lawmaking under the World Health Organization: Evolving Foundations of Global Health Law through Global Health Governance,” Journal of Global Health Law 1 (2024): 2649, available at <https://www.elgaronline.com/view/journals/jghl/1/1/article-p26.xml> (last visited September 23, 2024).CrossRefGoogle Scholar
Koch, S. et al., “COVID-19 as a Critical Juncture for EU Development Policy? Assessing the Introduction and Evolution of ‘Team Europe’,” Journal of European Integration 46, no. 4 (2024): 411431, available at <https://www.tandfonline.com/doi/full/10.1080/07036337.2023.2299928#abstract> (last visited September 23, 2024).CrossRefGoogle Scholar
European Commission, “EU Strategy for COVID-19 vaccines,” COM 245 (2020) (June 17, 2020), available at <https://eur-lex.europa.eu/legal-content/EN/TXT/ ?uri=CELEX%3A52020DC0245> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
Regulation (EU) 2021/953 of June 14, 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic, OJ L 211, available at <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R0953> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
European Commission, “Building a European Health Union: Reinforcing the EU’s Resilience for Cross-Border Health Threats,” COM 724 (Nov. 11, 2020) available at <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0724> (last visited September 23, 2024); see Gallina, S., “Preparing Europe for Future Health Threats and Crises: The European Health Union,” Euro Surveillance 28, no. 5 (2023): 2300066, 13; V.P. Andriukaitis and G.A. Cerniauskas, eds., European Health Union: A Blueprint for Generations (Vilnius: Foundation for Progressive European Studies, 2023).Google ScholarPubMed
President of the European Commission, “State of the Union 2020: Building the World We Want to Live in: A Union of Vitality in a World of Fragility,” (Sept. 16, 2020) available at <https://state-of-the-union.ec.europa.eu/state-union-2020_en> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
Bergner, S., “The Role of the European Union in Global Health: The EU’s Self-perception(s) within the COVID-19 Pandemic,” Health Policy 127 (2023): 511, available at <https://www.sciencedirect.com/science/article/pii/S0168851021002542> (last visited September 23, 2024).CrossRefGoogle ScholarPubMed
Commission Decision of Sept. 16, 2021, establishing the Health Emergency Preparedness and Response Authority, C6712 final (2021), available at <https://eur-lex.europa.eu/legal-content/EN/ TXT/?uri=CELEX%3A32021D0929% 2802%29> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
European Commission, “Pharmaceutical Strategy for Europe,” COM 761 (Nov. 25, 2020), available at <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761> (last visited September 23, 2024); On 26 April 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation. Complete information on the reform of the EU pharmaceutical legislation is available at <https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en> (last visited September 23, 2024).+(last+visited+September+23,+2024);+On+26+April+2023+the+Commission+adopted+a+proposal+for+a+new+Directive+and+a+new+Regulation+which+revise+and+replace+the+existing+general+pharmaceutical+legislation.+Complete+information+on+the+reform+of+the+EU+pharmaceutical+legislation+is+available+at++(last+visited+September+23,+2024).>Google Scholar
Regulation (EU) 2022/2371 of Nov. 23, 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU, OJ L 314, available at <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2371> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
Council Regulation (EU) 2022/2372 of Oct. 24, 2022, on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level, OJ L 314, available at <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2372> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
Regulation (EU) 2022/2370 of Nov. 23, 2022 amending Regulation (EC) No 851/2004 establishing a European Centre for Disease Prevention and Control, OJ L 314, available at <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2370> (last visited September 23, 2024); see Kokki, M. and Ammon, A., “Preparing Europe for Future Health Threats and Crises — Key Elements of the European Centre for Disease Prevention and Control’s Reinforced Mandate,” Euro Surveillance 28, no. 3 (2023): 2300033, 13.Google ScholarPubMed
Regulation (EU) 2022/123 of Jan. 25, 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices, OJ L 20, available at <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0123> (last visited September 23, 2024); see Cooke, E., “Preparing Europe for Future Health Threats and Crises — The European Medicines Agency; Ensuring Safe and Effective Medicines and Medical Devices,” Euro Surveillance 27, no. 42 (2022): 2200798, 14.Google ScholarPubMed
Bengtsson, L., “The New EU Global Health Strategy: Reflections on Context and Content,” European Policy Analysis (August 2022):118, at 2, available at <https://www.sieps.se/globalassets/publikationer/2022/2022_15epa.pdf> (last visited September 23, 2024).Google Scholar
European Commission, “EU Global Health Strategy — Better Health for All in a Changing World,” (November 2022) available at <https://health.ec.europa.eu/publications/eu-global-health-strategy-better-health-all-changing-world_en> (last visited September 23, 2024).CrossRef+(last+visited+September+23,+2024).>Google Scholar
Commissioners Stella Kyriakides and Jutta Urpilainen, “Towards a new EU Global Health Strategy,” Brussels (May 19, 2022) available at <https://ec.europa.eu/commission/presscorner/detail/en/statement_22_3128> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
European Commission, “Global Gateway,” available at <https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/stronger-europe-world/global-gateway_en> (last visited September 23, 2024); European Investment Bank, “Global Gateway: EU Steps up Support for Global Health and Equitable Access to Health Products and Local Manufacturing” (Oct. 26, 2023), available at <https://www.eib.org/en/press/all/2023-396-global-gateway-eu-steps-up-support-global-health-equitable-access-health-products-local-manufacturing> (last visited September 23, 2024).+(last+visited+September+23,+2024);+European+Investment+Bank,+“Global+Gateway:+EU+Steps+up+Support+for+Global+Health+and+Equitable+Access+to+Health+Products+and+Local+Manufacturing”+(Oct.+26,+2023),+available+at++(last+visited+September+23,+2024).>Google Scholar
European Commission, “EU Global Health Strategy: Better Health for All in a Changing World,” (November 2022), available at <https:// health.ec.europa.eu/publications/euglobal-health-strategy-better-health-allchanging-world_en> (last visited September 23, 2024).CrossRef+(last+visited+September+23,+2024).>Google Scholar
M. Bayerlein and P.A. Villarreal, “’One Health’ and Global Health Governance: Design and Implementation at the International, European, and German Levels, SWP Comment No. 43, Stiftung Wissenschaft und Politik (SWP), (July 2023) available at <https://www.econstor.eu/bitstream/10419/279932/1/1853807982.pdf> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
McKee, M. et al., “The EU Has a Global Health Strategy: The Challenge Will Be in the Implementation,” The Lancet 402 (2023): 10251027, available at <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00328-8/fulltext> (last visited September 23, 2024); I. Kickbusch, “The External Dimension of the European Health Union – the New EU Global Health Strategy,” in Andriukaitis and Cerniauskas, supra note 6, at 237–256.CrossRefGoogle Scholar
Burci, G.L. and Kümmel, B., “Global Health Diplomacy: The Process of Developing Global Health Law and Policy,” in Gostin, L.O. and Meier, B.M. (eds.), Global Health Law & Policy (New York: Oxford, 2023): 119144; E. Bozzini and D. Sicurelli, “The EU and the Pandemic Treaty: From Agenda-Setter to Troubled Deal Maker,” IAI Commentaries 24/36, 1–6 (July 2024) available at <https://www.iai.it/sites/default/files/iaicom2436.pdf> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
Council of the European Union, “EU Global Health Strategy — Better Health for All in a Changing World — Council Conclusions,” (Jan. 29, 2024) available at <https://data.consilium.europa.eu/doc/document/ST-5908-2024-INIT/en/pdf> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
See O’Neill’s Gostin on WHO’s Declaration of Mpox as a Global Public Health Emergency (Aug. 14, 2024) available at <https://oneill.law.georgetown.edu/press/oneills-gostin-on-whos-declaration-of-mpox-as-a-global-public-health-emergency/> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
I. Kickbusch and F. Pérez-Cañado, “The EU Global Health Strategy, One Year On: Early Achievements and Challenges Ahead,” Think Global Health (December 12, 2023), available at <https://www.thinkglobalhealth.org/article/eu-global-health-strategy-one-year> (last visited September 23, 2024).+(last+visited+September+23,+2024).>Google Scholar
Emmerling, T. et al., eds., The European Union as a Global Health Actor (Singapore: World Scientific, 2016).CrossRefGoogle Scholar