{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T03:19:35Z","timestamp":1787627975282,"version":"build-2736575974"},"reference-count":105,"publisher":"Cambridge University Press (CUP)","issue":"3","license":[{"start":{"date-parts":[[2025,7,22]],"date-time":"2025-07-22T00:00:00Z","timestamp":1753142400000},"content-version":"unspecified","delay-in-days":202,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100018694","name":"HORIZON EUROPE Marie Sklodowska-Curie Actions","doi-asserted-by":"publisher","award":["101061575"],"award-info":[{"award-number":["101061575"]}],"id":[{"id":"10.13039\/100018694","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2025]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The \u201cEU Vaccines Strategy\u201d launched by the European Commission in June 2020 aimed to ensure vaccine safety, equitable access, affordability, swift distribution, and global solidarity for COVID-19 vaccines. This study critiques the Commission\u2019s centralized procurement approach, focusing on Advance Purchase Agreements (APAs) through a literature review, policy analysis, and a case study of the EU-AstraZeneca\u2019s APA. It identifies critical challenges, including transparency deficits, accountability gaps, and anticompetitive practices by vaccine producers that undermine equitable access. Drawing on these insights, the study proposes the FACER Framework \u2014 Fairness, Accountability, Competition Law, Ethics of Innovation, and Resilience \u2014 a novel model integrating the Treaty on the European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU) oversight with ethical principles. By embedding legal and moral accountability, FACER offers EU policymakers a robust tool to enhance vaccine strategy and equity in future health crises.<\/jats:p>","DOI":"10.1017\/jme.2025.10141","type":"journal-article","created":{"date-parts":[[2025,7,22]],"date-time":"2025-07-22T05:45:17Z","timestamp":1753163117000},"page":"388-397","source":"Crossref","is-referenced-by-count":1,"title":["Competition Law and Ethics of Innovation as Catalysts for Fairness: Reimagining the EU\u2019s COVID-19 Vaccine Strategy"],"prefix":"10.1017","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0202-3156","authenticated-orcid":false,"given":"Mina","family":"Hosseini","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05m7pjf47","id-type":"ROR","asserted-by":"publisher"}],"name":"University College Dublin"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2025,7,22]]},"reference":[{"key":"S1073110525101411_r64","unstructured":"64. \u201cHJI Takes South African Government to Court to Blow the Lid on COVID Vaccine Procurement Secrecy,\u201d Health Justice Initiative, July 24, 2023, https:\/\/healthjusticeinitiative.org.za\/2023\/07\/24\/hji-takes-south-african-government-to-court-to-blow-the-lid-on-covid-vaccine-procurement-secrecy (last visited May 11, 2025)."},{"key":"S1073110525101411_r103","unstructured":"103. See Draghi, supra note 77."},{"key":"S1073110525101411_r71","doi-asserted-by":"publisher","DOI":"10.1080\/17441692.2020.1760915"},{"key":"S1073110525101411_r36","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1111\/twec.13183","article-title":"How COVID-19 Vaccine Supply Chains Emerged Amid a Pandemic","volume":"45","author":"Bown","year":"2022","journal-title":"World Economy"},{"key":"S1073110525101411_r39","doi-asserted-by":"crossref","unstructured":"39. OECD Policy Responses to Coronavirus (COVID-19), \u201cEnhancing public trust in COVID-19 vaccination: The role of governments\u201d (Organisation for Economic Co-operation and Development, 2021), https:\/\/doi.org\/10.1787\/eae0ec5a-en.","DOI":"10.1787\/eae0ec5a-en"},{"key":"S1073110525101411_r74","doi-asserted-by":"publisher","DOI":"10.4337\/9781803927268.00030"},{"key":"S1073110525101411_r45","unstructured":"45. \u201cCoronavirus: The EU and AstraZeneca agree on COVID-19 vaccine supply and on ending litigation,\u201d European Commission (Cypress), September 3, 2021, https:\/\/cyprus.representation.ec.europa.eu\/news\/coronavirus-eu-and-astrazeneca-agree-covid-19-vaccine-supply-and-ending-litigation-2021-09-03_en (last visited May 11, 2025)."},{"key":"S1073110525101411_r2","unstructured":"2. Id."},{"key":"S1073110525101411_r59","unstructured":"59. Auken and Others v. Commission; Courtois and Others v. Commission, joined cases T-689\/21 and T-761\/21, ECLI:EU:T:2024:476 appealed as Case C-631\/24 P, judgment not yet available https:\/\/curia.europa.eu\/juris\/liste.jsf?num=C-631\/24&language=en (last visited May 11, 2025)."},{"key":"S1073110525101411_r37","unstructured":"37. European Commission, Pharmaceutical Strategy for Europe 2020 (November 25, 2020), https:\/\/health.ec.europa.eu\/system\/files\/2021-02\/pharma-strategy_report_en_0.pdf."},{"key":"S1073110525101411_r72","unstructured":"72. See World Health Organization, supra note 57."},{"key":"S1073110525101411_r96","unstructured":"96. In certain circumstances, pharmaceutical companies may undertake a process called \u201cevergreening\u201d or \u201cproduct hopping\u201d to prolong the patent protection of a specific drug. This process may entail minor adjustments to the drug, such as reformulating the active ingredient or modifying it from a tablet to a transdermal patch. The primary incentive behind evergreening is to enable sustained monopoly patent regulation over the benefits generated by patent-protected products. Evergreening is in the grey areas and loopholes within patent law, allowing pharmaceutical companies to extend their exclusive rights. See (Lvyngar, 2015) ."},{"key":"S1073110525101411_r7","doi-asserted-by":"crossref","first-page":"37","DOI":"10.7172\/1689-9024.YARS.2022.15.25.2","article-title":"The Resurrection of the Comfort Letter: Back to the Future?","volume":"15","author":"\u00dcnekba\u015f","year":"2022","journal-title":"Yearbook of Antitrust and Regulatory Studies (YARS)"},{"key":"S1073110525101411_r6","doi-asserted-by":"publisher","DOI":"10.1108\/TG-07-2020-0142"},{"key":"S1073110525101411_r25","unstructured":"25. See ECA Report, supra note 24, at 20."},{"key":"S1073110525101411_r17","unstructured":"17. See Hosseini, supra note 8."},{"key":"S1073110525101411_r98","unstructured":"98. Commission Proposal for a Regulation of the European Parliament and of the Council on Compulsory Licensing for Crisis Management and Amending Regulation (EC) 816\/2006, COM (2023) 224 final (April 27, 2023), https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex:52023PC0224 (last visited March 1, 2025)."},{"key":"S1073110525101411_r30","unstructured":"30. European Commission, Replies of the European Commission to the European Court of Auditors\u2019 Special Report EU COVID-19 Vaccine Procurement: Sufficient Doses Secured After Initial Challenges, but Performance of the Process Not Sufficiently Assessed (2022), at 3."},{"key":"S1073110525101411_r65","unstructured":"65. The Health Justice Initiative v. The Minister of Health, case No. 10009\/22, High Court of South Africa, Gauteng Division, Pretoria, August 17, 2023."},{"key":"S1073110525101411_r51","unstructured":"51. For a review of the supply chain of each of the COVID-19 vaccines, including AZ, see ECA Report, supra note 24."},{"key":"S1073110525101411_r14","first-page":"29","article-title":"European Union Research Strategies on Vaccines","volume":"89","author":"Hansen","year":"1997","journal-title":"Developments in Biological Standardisation"},{"key":"#cr-split#-S1073110525101411_r61.1","unstructured":"61. Charter of Fundamental Rights of the European Union (CFR), arts. 11, 42, 2012 O.J. (C 326) 391 and European Convention for the Protection of Human Rights and Fundamental Freedoms, art. 10, Nov. 4, 1950, 213 U.N.T.S. 221"},{"key":"#cr-split#-S1073110525101411_r61.2","unstructured":"Regulation (EC) No 1049\/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ (L 145), 31.5.2001, at 43-48."},{"key":"S1073110525101411_r58","unstructured":"58. The White House. \u201cWithdrawing the United States from the World Health Organization,\u201d Presidential action, January 20, 2025, https:\/\/www.whitehouse.gov\/presidential-actions\/2025\/01\/withdrawing-the-united-states-from-the-worldhealth-organization\/ (last visited May 11, 2025)."},{"key":"S1073110525101411_r19","unstructured":"19. EU FAB: Flexible Vaccine Manufacturing Network for EU Preparedness (Publications Office of the European Union, 2023), https:\/\/op.europa.eu\/en\/publication-detail\/-\/publication\/765e4851-3fcd-11ee-829f-01aa75ed71a1 (last visited May 11, 2025)."},{"key":"S1073110525101411_r31","unstructured":"31. See European Commission, Comfort letter: coordination in the pharmaceutical industry to increase production and to improve supply of urgently needed critical hospital medicines to treat COVID-19 patients, COMP\/OG \u2013 D(2020\/044003) (Brussels, April 8, 2020); European Commission, Comfort letter: Cooperation at a Matchmaking Event \u2013 Towards COVID-19 vaccines upscale production, COMP\/E-1\/GV\/BV\/nb (2021\/034137) )Brussels, March 25, 2021)."},{"key":"S1073110525101411_r32","first-page":"1","article-title":"The EU Vaccines Strategy: A Missed Opportunity for EU Public Health?","volume":"15","author":"Della Corte","journal-title":"European Journal of Risk Regulation"},{"key":"S1073110525101411_r66","unstructured":"66. See European Commission, \u201cEuropean Health Union: Commission Secures Agreement with BioNTech-Pfizer on the Delivery of COVID-19 Vaccines,\u201d press release, May 26, 2023, https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_23_2865 (last visited May 11, 2025)."},{"key":"S1073110525101411_r82","unstructured":"82. See ECA Report, supra note 24."},{"key":"S1073110525101411_r84","first-page":"8","volume-title":"Competition Law in the EU: Principles, Substance, Enforcement","author":"Van De Gronden","year":"2024"},{"key":"S1073110525101411_r91","volume-title":"Ex-post Evaluation: EU Competition Enforcement and Acquisitions of Innovative Competitors in the Pharma Sector Leading to the Discontinuation of Overlapping Drug Research and Development Projects Final Report","year":"2024"},{"key":"S1073110525101411_r18","unstructured":"18. Regulation (EU) 2021\/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union\u2019s action in the field of health (\u2018EU4Health Programme\u2019) for the period 2021-2027, and repealing Regulation (EU) No 282\/2014, OJ (L 107), March 26, 2021: at 1."},{"key":"S1073110525101411_r67","unstructured":"67. M. Fick, \u201cExclusive: EU May Pay More for Pfizer COVID Shots in Return for Lower Volume,\u201d Reuters, January 27, 2023, https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/eu-may-pay-more-pfizer-covid-shots-return-lower-volume-2023-01-27 (last visited March 1, 2025)."},{"key":"S1073110525101411_r50","unstructured":"50. J.Deutsch and C. Gijs, \u201cBelgian Secretary of State Accidentally Reveals EU Vaccine Prices,\u201d Politico, December 17, 2020, https:\/\/www.politico.eu\/article\/belgian-secretary-of-state-accidentally-reveals-eu-vaccine-prices\/ (last visited May 11, 2025)."},{"key":"S1073110525101411_r79","doi-asserted-by":"crossref","first-page":"1371","DOI":"10.1038\/s41598-024-84027-6","article-title":"Balancing Fairness and Efficiency in Dynamic Vaccine Allocation During Major Infectious Disease Outbreaks","volume":"15","author":"Dai","year":"2025","journal-title":"Scientific Reports"},{"key":"S1073110525101411_r99","unstructured":"99. A. McMahon, \u201cEU\u2019s Compulsory Licensing Proposals, Patents and Crisis Preparedness,\u201d BMJ Blogs, May 4, 2023, https:\/\/blogs.bmj.com\/medical-ethics\/2023\/05\/04\/eus-compulsory-licensing-proposals-patents-and-crisis-preparedness-some-steps-in-the-right-direction-but-more-to-do-for-future-pandemic-preparedness (last visited March 1, 2025)."},{"key":"S1073110525101411_r77","volume-title":"The Future of European Competitiveness \u2013 In-Depth Analysis and Recommendations","author":"Draghi","year":"2024"},{"key":"S1073110525101411_r100","unstructured":"100. A. Eglovtich, \u201cPharma Groups Slam EU\u2019s Compulsory Licensing Proposal,\u201d Regulatory Focus, 14 August 2023], https:\/\/www.raps.org\/news-and-articles\/news-articles\/2023\/8\/pharma-groups-slam-eu%E2%80%99s-compulsory-licensing-propo (last visited March 1, 2025)."},{"key":"S1073110525101411_r102","unstructured":"102. European Commission, \u201cProposal for a Regulation of the European Parliament and of the Council on Compulsory Licensing for Crisis Management and Amending Regulation (EC) 816\/2006,\u201d COM (2023) 24."},{"key":"S1073110525101411_r8","doi-asserted-by":"publisher","DOI":"10.1093\/jaenfo\/jnae037"},{"key":"S1073110525101411_r48","doi-asserted-by":"crossref","first-page":"1133","DOI":"10.1017\/glj.2021.50","article-title":"Best Efforts in the Taxonomy of Obligation\u2014The Case of the EU Vaccine Contracts","volume":"22","author":"Schanze","year":"2021","journal-title":"German Law Journal"},{"key":"S1073110525101411_r55","volume-title":"Vaccine Injury Compensation Programmes: An Overview","author":"Doyle","year":"2021"},{"key":"S1073110525101411_r62","unstructured":"62. \u201cEuropean Union: General Court Rules European Commission Must Grant Wider Access to COVID-19 Vaccine Purchase Agreements,\u201d Library of Congress Global Legal Monitor, September 4, 2024, https:\/\/www.loc.gov\/item\/global-legal-monitor\/2024-09-04\/european-union-general-court-rules-european-commission-must-grant-wider-access-to-covid-19-vaccine-purchase-agreements\/ (last visited May 11, 2025)."},{"key":"S1073110525101411_r42","unstructured":"42. C. Martuscelli, \u201cPfizer CEO Pulls Out of Testifying to EU Parliament COVID Panel,\u201d Politico, October 10, 2022, https:\/\/www.politico.eu\/article\/pfizer-ceo-albert-bourla-pulls-out-of-testifying-to-eu-parliament-covid-panel\/ (last visited March 1, 2025)."},{"key":"S1073110525101411_r26","unstructured":"26. See ECA Report, supra note 24, at 23"},{"key":"S1073110525101411_r94","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2020-106795"},{"key":"S1073110525101411_r57","unstructured":"57. See World Health Organization, \u201cWHO Member States Conclude Negotiations and Make Significant Progress on Draft Pandemic Agreement,\u201d news release, April 16, 2025, https:\/\/www.who.int\/news\/item\/16-04-2025-who-member-states-conclude-negotiations-and-make-significant-progress-on-draft-pandemic-agreement (last visited May 11, 2025)."},{"key":"S1073110525101411_r95","unstructured":"95. Making the Most of EU Advance Purchases of Medicines (BEUC, 2021), https:\/\/euagenda.eu\/publications\/making-the-most-of-eu-advance-purchases-of-medicines (last visited March 1, 2025) at 4."},{"key":"S1073110525101411_r15","unstructured":"15. European Commission, \u201cSafe COVID-19 Vaccines for Europeans,\u201d https:\/\/commission.europa.eu\/strategy-and-policy\/coronavirus-response\/safe-covid-19-vaccines-europeans_en (last visited May 11, 2025)"},{"key":"S1073110525101411_r13","volume-title":"EU Framework Programme Processes: Adoption, Implementation, Evaluation","author":"Reillon","year":"2018"},{"key":"S1073110525101411_r11","unstructured":"11. The APAs between the Commission and the COVID-19 vaccine producers were based on \u201cthe Commission Decision C(2020) 4192 final on approving the agreement with Member States on procuring Covid-19 vaccines on behalf of the Member States and related procedures. As provided for in Article 4(5)(b) of Council Regulation (EU) 2016\/369 of 15 March 2016 on the provision of emergency support within the Union as amended by Council Regulation (EU) 2020\/521 of 14 April 2020 activating the emergency support under Regulation (EU) 2016\/369, and amending its provisions taking into account the COVID-19 outbreak.\u201d See, for example, ADVANCE PURCHASE AGREEMENT (\u201cAPA\u201d) for the development, production, advance purchase and supply of a COVID-19 vaccine for EU Member States, SANTE\/2020\/C3\/049, https:\/\/commission.europa.eu\/system\/files\/2021-01\/curevac_-_redacted_advance_purchase_agreement_0.pdf (last visited May 11, 2025)."},{"key":"S1073110525101411_r35","doi-asserted-by":"crossref","first-page":"2804","DOI":"10.1016\/j.vaccine.2023.03.036","article-title":"Divergent COVID-19 Vaccine Policies: Policy Mapping of Ten European Countries","volume":"41","author":"Van Kessel","year":"2023","journal-title":"Vaccine"},{"key":"S1073110525101411_r27","doi-asserted-by":"publisher","DOI":"10.1080\/17441692.2015.1043743"},{"key":"S1073110525101411_r21","unstructured":"21. See European Commission, \u201cCoronavirus Global Response: The Commission\u2019s Contribution to the COVID-19 Vaccine Global Access Facility (COVAX),\u201d press release, September 18, 2020, https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_20_1694 (last visited March 1, 2025) and S.L. Greer, \u201cNational, European, and Global Solidarity: COVID-19, Public Health, Vaccines,\u201d Eurohealth 26, no. 2 (2020): 104\u2013108, https:\/\/iris.who.int\/bitstream\/handle\/10665\/336277\/Eurohealth-26-2-104-108-eng.pdf?sequence=1&isAllowed=y. (last visited May 8, 2025)."},{"key":"S1073110525101411_r23","doi-asserted-by":"publisher","DOI":"10.1017\/9781009282406"},{"key":"S1073110525101411_r9","unstructured":"9. COM\/2020\/245, Communication from the Commission to the European Parliament, The European Council, The Council and the European Investment Bank, EU Strategy for COVID-19 vaccines final, https:\/\/commission.europa.eu\/strategy-and-policy\/coronavirus-response\/public-health\/eu-vaccines-strategy_en (last visited March 7, 2025); Directorate-General for Health and Food Safety, Directorate-General for International Partnerships, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: EU Strategy on Global Health - Strengthening the EU\u2019s Contribution to Global Health (European Commission, 2022), https:\/\/health.ec.europa.eu\/publications\/eu-global-health-strategy-better-health-all-changing-world_en (last visited May 11, 2025)."},{"key":"S1073110525101411_r47","unstructured":"47. \u201c\u2018Best Reasonable Efforts\u2019 means (a) in the case of AstraZeneca, the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a Vaccine at the relevant stage of development or commercialization having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world but taking into account efficacy and safety; and (b) in the case of the Commission and the Participating Member States, the activities and degree of effort that governments would undertake or use in supporting their contractor in the development of the Vaccine having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world.\u201d (European Commission & AstraZeneca, Advance Purchase Agreement (\u201cAPA\u201d) for the Production, Purchase and Supply of a COVID-19 Vaccine in the European Union, Ares(2020)440071, August 27, 2020 [hereinafter referred to as Commission and AstraZeneca, 2020)."},{"key":"S1073110525101411_r53","unstructured":"53. L. Burger and P. Aripaka, \u201cAstraZeneca to Be Exempt from Coronavirus Vaccine Liability Claims in Most Countries,\u201d Reuters, July 30, 2020, https:\/\/www.reuters.com\/article\/us-astrazeneca-results-vaccine-liability\/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUSKCN24V2EN (last visited May 11, 2025)."},{"key":"S1073110525101411_r22","doi-asserted-by":"crossref","first-page":"800","DOI":"10.1016\/S0140-6736(20)31873-0","article-title":"Legal Agreements: Barriers and Enablers to Global Equitable COVID-19 Vaccine Access","volume":"396","author":"Phelan","year":"2020","journal-title":"Lancet"},{"key":"S1073110525101411_r69","unstructured":"69. See ECA Report, supra note 24."},{"key":"S1073110525101411_r73","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1016\/j.jval.2020.12.008","article-title":"How Should the World Pay for a Coronavirus Disease (COVID-19) Vaccine?","volume":"24","author":"Towse","year":"2021","journal-title":"Value in Health"},{"key":"S1073110525101411_r60","unstructured":"60. Regulation (EC) No. 1049\/2001 of the European Parliament and of the Council of 30 May 2001 Regarding Public Access to European Parliament, Council and Commission Documents, art. 4, para. 1(b), para. 2, indent 1, 2001 O.J. (L 145) 43."},{"key":"S1073110525101411_r43","unstructured":"43. \u201cVaccines: contract between European Commission and AstraZeneca now published,\u201d European Commission (Malta), January 29, 2021, https:\/\/malta.representation.ec.europa.eu\/news\/vaccines-contract-between-european-commission-and-astrazeneca-now-published-2021-01-29_en (last visited May 11, 2025)."},{"key":"S1073110525101411_r68","unstructured":"68. X. Becerra, \u201cLetter to COVID-19 Vaccine Manufacturers,\u201d U.S. Department of Health and Human Services, July 13, 2023, https:\/\/www.hhs.gov\/about\/news\/2023\/07\/13\/letter-covid-19-vaccine-manufacturers.html (last visited May 11, 2025)."},{"key":"S1073110525101411_r75","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1017\/S0008197322000241","article-title":"Addressing Vaccine Inequity During the COVID-19 Pandemic: The TRIPS Intellectual Property Waiver Proposal and Beyond","volume":"81","author":"Thambisetty","year":"2022","journal-title":"Cambridge Law Journal"},{"key":"S1073110525101411_r81","unstructured":"81. M. Stevis-Gridneff, \u201cHow Europe Sealed a Pfizer Vaccine Deal With Texts and Calls,\u201d New York Times, April 28, 2021, https:\/\/www.nytimes.com\/2021\/04\/28\/world\/europe\/european-union-pfizer-von-der-leyen-coronavirus-vaccine.html (last visited May11, 2025)."},{"key":"S1073110525101411_r46","first-page":"1","article-title":"Intellectual Property Rights and Advance Purchase Agreements in a Crisis","author":"Slade","year":"2023","journal-title":"Intellectual Property Quarterly"},{"key":"S1073110525101411_r86","unstructured":"86. See, for example, Commission Decision of 10 February 2021, case AT.40394 \u2013 Aspen, 2021 OJ (C 47) 1, https:\/\/ec.europa.eu\/competition\/antitrust\/cases\/dec_docs\/40394\/40394_4303_6.pdf (last visited May 11, 2025)."},{"key":"S1073110525101411_r88","unstructured":"88. See TEU arts. 2, 3(3); TFEU arts. 168(1), 222."},{"key":"S1073110525101411_r5","unstructured":"5. Directive 2001\/83\/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use."},{"key":"S1073110525101411_r93","unstructured":"93. While legal accountability (rooted in the values of Article 2 Treaty on European Union (TEU)) is essential, the COVID-19 experience showed that legal frameworks alone may lag behind rapidly evolving health crises or fail to cover all ethical expectations, especially in areas like IP waivers or the global equitable distribution of vaccines. Therefore, incorporating moral accountability bridges the gap between the letter of the law and societal ethical expectations."},{"key":"S1073110525101411_r104","unstructured":"104. See Draghi, supra note 77."},{"key":"S1073110525101411_r90","unstructured":"90. B. Lundqvist, \u201cKiller Acquisitions and Other Forms of Anticompetitive Collaborations in Time of Corona, Part II, BRICS Competition Law and Policy Series,\u201d Working Paper WP22\/2022\/01 (2022), https:\/\/wp.hse.ru\/data\/2022\/05\/12\/1836989718\/WP22_2022_01____.pdf (last visited May 11, 2025)."},{"key":"S1073110525101411_r16","unstructured":"16. European Commission, \u201cHealth Emergency Preparedness and Response Authority,\u201d https:\/\/commission.europa.eu\/about\/departments-and-executive-agencies\/health-emergency-preparedness-and-response-authority_en (last visited May 11, 2025)."},{"key":"S1073110525101411_r92","unstructured":"92. See Draghi, supra note 77."},{"key":"S1073110525101411_r4","unstructured":"4. Regulation (EU) 2020\/1043 of the European Parliament and of the Council of July 15 2020, on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19), PE\/28\/2020\/REV\/1."},{"key":"S1073110525101411_r10","doi-asserted-by":"publisher","DOI":"10.53386\/nilq.v73i2.957"},{"key":"S1073110525101411_r40","unstructured":"40. Global Vaccine Market Report 2022: A Shared Understanding for Equitable Access to Vaccines (World Health Organization, 2023): at 8."},{"key":"S1073110525101411_r24","first-page":"20","volume-title":"EU COVID-19 Vaccine Procurement: Sufficient Doses Secured After Initial Challenges, but Performance of the Process Not Sufficiently Assessed","year":"2022"},{"key":"S1073110525101411_r28","first-page":"1","article-title":"\u2018No Regrets\u2019 Purchasing in a Pandemic: Making the Most of Advance Purchase Agreements","volume":"18","author":"Thornton","year":"2022","journal-title":"Globalisation and Health"},{"key":"S1073110525101411_r33","unstructured":"33. See ECA Report, supra note 24."},{"key":"S1073110525101411_r44","unstructured":"44. See ECA Report, supra note 24, at 34."},{"key":"S1073110525101411_r80","doi-asserted-by":"publisher","DOI":"10.1080\/13501763.2021.1936129"},{"key":"S1073110525101411_r70","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2021.07.040"},{"key":"S1073110525101411_r83","unstructured":"83. See OECD, supra note 39."},{"key":"S1073110525101411_r97","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2021-107684"},{"key":"S1073110525101411_r101","unstructured":"101. See, for example, International Federation of Pharmaceutical Manufacturers & Associations, \u201cBerlin Declaration \u2013 Biopharmaceutical Industry Vision for Equitable Access in Pandemics,\u201d July 19, 2022, https:\/\/www.ifpma.org\/resource-centre\/berlin-declaration-biopharmaceutical-industry-vision-for-equitable-access-in-pandemics\/ (last visited March 1, 2025)."},{"key":"S1073110525101411_r38","volume-title":"Health as a Fundamental Value: Towards an Inclusive and Equitable Pharmaceutical Strategy for the European Union","author":"Gennet","year":"2022"},{"key":"S1073110525101411_r12","first-page":"450","volume-title":"European Union Politics","author":"Brooks","year":"2022"},{"key":"S1073110525101411_r56","unstructured":"56. World Health Organization, \u201cNo-Fault Compensation Programme for COVID-19 Vaccines Is a World First,\u201d February 22, 2021, https:\/\/www.who.int\/news\/item\/22-02-2021-no-fault-compensation-programme-for-covid-19-vaccines-is-a-world-first (last visited May 11, 2025)."},{"key":"S1073110525101411_r41","unstructured":"41. See Phelan et al., supra note 22, at 800\u2013802."},{"key":"S1073110525101411_r54","unstructured":"54. On November 22, 2021, Commissioner Kyriakides provided a written answer on behalf of the European Commission to Parliamentary question P-004007\/2021(ASW), which asked if governments had established additional protections or compensation agreements for vaccine side effects. The Commission responded that European law and the Product Liability Directive are maintained in all vaccine agreements, with liability remaining with the manufacturer. National authorities handle compensation procedures, and contracts specify that nations take responsibility for vaccine deployment and related liability: Parliamentary question | Answer for question P-004007\/21 | P-004007\/2021(ASW) | European Parliament (europa.eu). This answer is the opposite of the broad indemnity clause EU-AZ\u2019s APA ."},{"key":"S1073110525101411_r85","first-page":"224","volume-title":"Competition Law and Policy in the EC and UK","author":"Rodger","year":"2022"},{"key":"S1073110525101411_r1","doi-asserted-by":"publisher","DOI":"10.7573\/dic.2020-12-2"},{"key":"S1073110525101411_r49","unstructured":"49. S. Bosely, \u201cBelgian minister tweets EU\u2019s Covid vaccine price list to anger of manufacturers,\u201d Guardian, December 18, 2020, https:\/\/www.theguardian.com\/world\/2020\/dec\/18\/belgian-minister-accidentally-tweets-eus-covid-vaccine-price-list (last visited March 29, 2025)."},{"key":"S1073110525101411_r87","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1007\/978-3-030-95876-3_5","volume-title":"Law and Economics of the Coronavirus Crisis","author":"Kianzad","year":"2022"},{"key":"S1073110525101411_r3","doi-asserted-by":"publisher","DOI":"10.1126\/science.abb8923"},{"key":"S1073110525101411_r34","doi-asserted-by":"publisher","DOI":"10.4324\/9781003153900-3"},{"key":"S1073110525101411_r20","unstructured":"20. See European Commission, Commission Decision of 18 June 2020 approving the agreement with Member States on procuring COVID-19 vaccines on behalf of the Member States and related procedures, C(2020) 4192 final, https:\/\/commission.europa.eu\/system\/files\/2020-09\/decision_approving_the_agreement_with_member_states_on_procuring_covid-19_vaccines_on_behalf_of_the_member_states_and_related_procedures.pdf (last visited May 11, 2025)."},{"key":"S1073110525101411_r52","unstructured":"52. \u201c14.1. Member States. Each Participating Member State shall indemnify and hold harmless AstraZeneca, its Affiliates, subcontractors, licensors, and sub-licensees, and officers, directors, employees and other agents and representatives of each (collectively, the \u201cIndemnified Persons\u201d) from and against any and all damages and liabilities, including settlements for which the Indemnifying party has given its consent pursuant to Section 14.2, and necessary legal costs relating to, resulting from or associated with claims for death, physical, mental, or emotional injury, illness, disability, or condition, fear of the foregoing, property loss or damage, and business interruption of the injured party or a Related Person of such injured person (together, \u201cLosses\u201d) relating to or arising from the use or administration of the Vaccine shipped or allocated to its jurisdiction. Such indemnification will not be available to Indemnified Persons\u2026.(REDACTED PART). Indemnification under this Section 14.1 will be available for Losses arising from the use and administration of vaccines supplied under this Agreement, regardless of when or where vaccination occurred and regardless of when or where the injury leading to the Losses occurs or is reported.\u201d (Commission and AstraZeneca, 2020)."},{"key":"S1073110525101411_r76","first-page":"1","article-title":"COVID-19 and the Cost of Vaccine Nationalism","volume":"9","author":"Hafner","year":"2022","journal-title":"Rand Health Quarterly"},{"key":"S1073110525101411_r89","unstructured":"89. See V. Moussis and A. Yamada, \u201cAbuse of Economic Dependence,\u201d Global Dictionary of Competition Law, Concurrences, https:\/\/www.concurrences.com\/en\/dictionary\/abuse-of-economic-dependence (last visited May 11, 2025)."},{"key":"S1073110525101411_r78","volume-title":"A Competitiveness Compass for the EU: A Roadmap for Growth and Innovation","year":"2025"},{"key":"S1073110525101411_r29","unstructured":"29. See Turner, supra note 27."},{"key":"S1073110525101411_r63","unstructured":"63. Courtois and Others v. Commission, case T-761\/21, EU: T:2024:477 (Gen. Ct. July 17, 2024); Commission v. Courtois and Others, case C-632\/24 P, appeal filed Sept. 27, 2024 (CJEU, pending)."}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110525101411","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,15]],"date-time":"2025-09-15T00:06:44Z","timestamp":1757894804000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110525101411\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025]]},"references-count":105,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025]]}},"alternative-id":["S1073110525101411"],"URL":"https:\/\/doi.org\/10.1017\/jme.2025.10141","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025]]}}}