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Multivalue Ethical Framework for Fair Global Allocation of a COVID-19

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Multivalue Ethical Framework for Fair Global Allocation of a COVID-19 Clinical ethics Multivalue ethical framework for fair global J Med Ethics: first published as 10.1136/medethics-2020-106516 on 12 June 2020. Downloaded from allocation of a COVID-19 vaccine Yangzi Liu ,1 Sanjana Salwi,1 Brian Drolet2 1School of Medicine, Vanderbilt ABSTRact by a global scarcity of vaccines, increasing vaccine University, Nashville, Tennessee, The urgent drive for vaccine development in the midst price and worsening inequity and disparity. There- USA 2 fore, it is unlikely that donations from high- income Center for Biomedical Ethics of the current COVID-19 pandemic has prompted public and Society, Vanderbilt and private organisations to invest heavily in research countries or through organisations like GAVI will University Medical Center, and development of a COVID-19 vaccine. Organisations ensure fair distribution of a pandemic vaccine Nashville, Tennessee, USA globally have affirmed the commitment of fair global without a solid ethical framework for allocation. access, but the means by which a successful vaccine This piece analyses four allocation paradigms and Correspondence to can be mass produced and equitably distributed synthesises their ethical considerations to develop a Ms Yangzi Liu, Vanderbilt model to fit the COVID-19 pandemic. University School of Medicine, remains notably unanswered. Barriers for low- income Nashville, TN 37232, USA; countries include the inability to afford vaccines as well yangzi. liu@ vanderbilt. edu as inadequate resources to vaccinate, barriers that are Principle 1: Ability to develop or to purchase exacerbated during a pandemic. Fair distribution of Vaccine distribution is currently determined by two Received 27 May 2020 a pandemic vaccine is unlikely without a solid ethical Accepted 4 June 2020 primary considerations: (1) ability to develop and framework for allocation. This piece analyses four test and (2) ability to purchase. Five multinational allocation paradigms: ability to develop or purchase; companies produce most of the world’s vaccines reciprocity; ability to implement; and distributive justice, and negotiate with the private and public sector and synthesises their ethical considerations to develop an for purchasing.7 Perhaps not surprisingly, the US allocation model to fit the COVID-19 pandemic. government has already attempted to purchase exclusive access to one COVID-19 vaccine candi- date, and surely others will do the same.8 This kind INTRODUCTION of nationalistic approach results in unethical and Never in modern history has there been such an inequitable allocation based on citizenship and a urgent drive for vaccine development as in midst country’s ability to pay.9 of the current COVID-19 pandemic. Recognising The H1N1 pandemic illustrates several problems the tremendous health and economic benefits of with the pay-to- play method of vaccine distribution. a vaccine, public and private organisations have In 2009, high- income countries placed advanced invested heavily in research and development, orders for the H1N1 vaccine and purchased virtu- with remarkable fast tracking of clinical trials.1 2 ally the entire global supply. Meanwhile, certain However, the means by which a successful vaccine countries attempted to protect their own supply can be mass produced and equitably distributed by awarding contracts domestically. For example, http://jme.bmj.com/ remains notably unanswered. Australia prohibited its main manufacturer from On 24 April 2020, the WHO, in partnership exporting the vaccine. Although the USA had with humanitarian and private sector organisations, initially pledged to donate 10% of their vaccine affirmed a commitment towards fair global access to purchases, due to shortages, the Secretary of Health ‘safe, quality, effective, and affordable COVID-19 and Human Services indefinitely postponed dona- diagnostics, therapeutics and vaccines’.3 Their tions to meet national need and no vaccines were on October 1, 2021 by guest. Protected copyright. Access to COVID-19 Tools (ACT) Accelerator has redistributed.10 These events highlight the inad- also promised ‘equitable deployment’.4 While the equacy of a donation-based system and why the President of the USA has refused further support of WHO course is likely to fail. the WHO and the USA is conspicuously absent in the countries subsidising ACT, the rest of the world Principle 2: Reciprocity is expected to pledge resources. However, history In 2006, the WHO acknowledged that Australian has shown that such well- intentioned pledging companies had used samples provided by Indo- is likely to be insufficient and ensuring equitable nesia to create and patent a H5N1 vaccine without distribution of vaccines globally will be challenging. Indonesian consent. As a result, Indonesia stopped Since 2000, the international company GAVI has sharing viral samples with the WHO for risk assess- © Author(s) (or their leveraged donations from public and private sectors ment and management, creating a significant barrier employer(s)) 2020. No 5 commercial re- use. See rights to subsidise vaccinations for low- income countries. to virus global surveillance. Indonesia’s actions and permissions. Published Although GAVI has significantly increased vaccina- bring attention to another global inequity, in which by BMJ. tion rates in these nations, the current pandemic developing countries help to produce vaccines but 11 To cite: Liu Y, Salwi S, raises specific ethical and practical concerns. During do not subsequently benefit from them. These Drolet B. J Med Ethics Epub usual times, the largest barriers to vaccination for historical events establish the need for a system of ahead of print: [please low- income countries include the inability to afford reciprocity, which improves equitable vaccine distri- include Day Month Year]. vaccines and supplies as well as inadequate health- bution to countries involved in drug development. doi:10.1136/ 6 medethics-2020-106516 care systems and resources to vaccinate. However, Reciprocity is well established in research ethics and during a pandemic, these barriers are exacerbated some clinical trial participants may have post- trial Liu Y, et al. J Med Ethics 2020;0:1–3. doi:10.1136/medethics-2020-106516 1 Clinical ethics access to medications.12 Recently, a similar recommendation has and result in treatment delays, further contributing to more J Med Ethics: first published as 10.1136/medethics-2020-106516 on 12 June 2020. Downloaded from been proposed to prioritise those who participate in COVID-19 severe disease burden. On a local level, prioritised groups should vaccine and treatment research in recognition of the risk they include immunocompromised patients, persons with comorbid assume and to encourage research participation.9 Therefore, illnesses, the elderly and lower socioeconomic groups. In a countries that share viral samples or have participants in clinical global sense, the populations of developing countries are most trials should receive priority for vaccine supplies. at risk due to lack of food and clean water, as well as sanita- tion hazards that lead to increased infectious disease transmis- Principle 3: Ability to implement sion. Furthermore, without access to acute care in developing Although no single ethical principle can guide vaccine allocation, countries, prevention with a vaccine may be the only available some consideration must be made for utilitarian considerations, intervention. Distributive justice requires prioritisation of devel- 9 13 14 which prioritise saving the most lives or life years. Vaccine oping countries when distributing vaccines, in particular at the deployment is inherently a resource- intensive endeavour that expense of developed nations that will try to influence vaccine requires specialised transportation, trained personnel for admin- access by the ability to pay. Although this seems infeasible, it is istration and an intact public health infrastructure for identifying not impossible. need and surveillance.15 Thus, to maximise vaccine benefits and reduce waste due to improper utilisation, allocation frameworks should consider a country’s ability to vaccinate. A multivalue ethical framework for vaccine stewardship However, this approach will bias against countries that do Given the inevitable demand for the COVID-19 vaccine and not have the resources and infrastructure for successful vaccine the high burden of disease already placed on many countries, there is a need for an equitable global framework for vaccine deployment. Therefore, before allocating based on this principle, 2 all reasonable efforts should be taken to redistribute human and distribution. Without advanced planning and thoughtful execu- supply chain resources to alleviate these inherent inequalities. tion, pre- existing health and socioeconomic disparities will Otherwise, disparities are perpetuated (and amplified) by a util- only be exacerbated by this pandemic. It seems inevitable that itarian approach to allocation, as low-income countries with high- income countries will obtain and use the bulk of vaccines, poor health outcomes have less access to preventative treatment. while lower income countries are in far greater need. Planning After the acute pandemic response, interpandemic years should for distribution must begin as the vaccine is being developed so focus on building up resources in low-income countries. that a paradigm is ready when distribution begins. Otherwise, the framework loses efficacy as national interests for developed Principle 4: Distributive justice
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