Ensuring Equitable Access to a COVID-19 Vaccine: Multilateral Options for an Unequal World

Emilia Truluck
Vol. 42 Associate Editor

Since the classification of COVID-19 as a global pandemic, the United Nations General Assembly and the World Health Assembly have called for “equitable access to and fair distribution” of all health technologies required to combat the virus.[1] The World Health Organization (WHO) has been leading the global coordination efforts for a future equitable distribution of a COVID-19 vaccine via two complementary multilateral initiatives: COVAX and the COVID-19 Technology Access Pool (C-TAP).[2] COVAX, a program of the Access to COVID-19 Tools (ACT) Accelerator, is a market-based cost-sharing and vaccine development initiative launched on April 24, 2020.[3] It currently has support from 172 countries, multiple foundations, and 16 pharmaceutical companies.[4] C-TAP, a voluntary licensing and patent pooling mechanism, was proposed in March, 2020, by Costa Rica, and was launched by the WHO and thirty other countries on May 29, 2020.[5] So far, only 40 countries have joined the “Solidarity Call to Action” to participate in C-TAP.[6] Though both programs have weaknesses, they are likely the greatest hope for the equitable distribution of a COVID-19 vaccine. Without such multilateral initiatives, countries that cannot afford vaccines for their populations may be compelled to resort to compulsory licensing. The result of such a situation would likely be yet another patent war between multinational pharmaceutical companies and the countries that need, but cannot afford, their products. Cost-Sharing with COVAX COVAX is coordinated by Gavi-The Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the WHO.[7] COVAX supports the timely research, development, and manufacturing of vaccines by directly investing in manufacturers to scale up their productivity before a vaccine is approved, and by using the collective purchasing power of participating countries to negotiate competitive prices with manufacturers.[8] COVAX supports the fast and equitable distribution of vaccines by hosting the world’s largest portfolio of potential COVID-19 vaccines and administering an Advance Market Commitment (AMC) cost-sharing mechanism to ensure that lower- and middle-income countries receive enough funds to purchase enough COVID-19 vaccine doses to vaccinate 20% of their population in 2021.[9] Pharmaceutical companies, as well as a majority of high-income countries, have come out in force to support this initiative, dwarfing support for C-TAP. [10] Private charitable entities have also lent their financial support to COVAX; for example, the Bill and Melinda Gates Foundation has given $350 million to the initiative so far this year.[11] As of September 30, 2020, countries had pledged nearly $1 billion to bolster the ACT Accelerator, including the COVAX program.[12] Even many rich countries that have concluded separate bilateral deals with pharmaceutical companies have been incentivized to join COVAX to ensure that they have access to a successful vaccine.[13] The one major exception to this is the U.S., where the Trump administration has refused to work with the WHO on a COVID-19 response.[14] Critics of this decision say it endangers the U.S. by forcing the country to rely solely on bilateral agreements for vaccine access, and it strikes a major blow to the global efforts to ensure equitable distribution of a vaccine.[15] Despite the large investments made in the COVAX program, its success could be hindered by the lack of U.S. support and its reliance on the generosity of wealthy donors.[16] Knowledge Sharing with C-TAP C-TAP, unlike COVAX, acts as a knowledge-sharing mechanism rather than a cost-sharing mechanism. C-TAP encourages the voluntary licensing of COVID-19 treatments and vaccines on a non-exclusive basis to the Unitaid-run Medicines Patent Pool (MPP).[17] The MPP, initially created in response to the patent wars over HIV/AIDS drugs, aims to increase affordability and expand production of essential medicines.[18] By licensing a vaccine to the MPP, a pharmaceutical company agrees to allow for the production of its vaccine by generic manufacturers for a nominal royalty.[19] Some pharmaceutical companies have found it useful to engage with the MPP to manufacture HIV/AIDS antiretroviral drugs, not only to bolster goodwill, but also because negotiating with the MPP once was more efficient than negotiating with many different generic drug manufacturers in multiple low-income countries.[20] Nonetheless, after the MPP for a COVID-19 vaccine was announced, multinational pharmaceutical companies expressed “confusion” and “resistance” and the U.S. refused to offer its support.[21] C-TAP would not only provide for greater vaccine production capacity and a more affordable COVID-19 vaccine, but it would also help low-income countries obtain significant numbers of vaccines without relying solely on the generosity of wealthy donor countries. Enabling middle- and low-income countries to produce, distribute, and trade their own COVID-19 vaccines is particularly important when wealthy countries have already engaged in bilateral negotiations with pharmaceutical companies to secure 51% of the world’s future COVID-19 vaccine doses for their own populations.[22] If the intellectual properties connected to an eventual COVID-19 vaccine were made widely available by the MPP, then generics could supplement the vaccine pool, countering the effects of wealthy countries’ hoarding. The Resort to Compulsory Licensing If the eventual creators of a COVID-19 vaccine do not participate in either COVAX or C-TAP, they may end up giving low-income countries no choice but to engage in compulsory licensing. Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), binding on all WTO members, gives countries experiencing national emergencies the rights to issue compulsory patents to produce generic versions of essential drugs without trying to negotiate for a voluntary license first.[23] Additionally, a 2017 amendment to TRIPS allows compulsory licensing to be used not only for domestic production, but also for export to meet the public health needs of other low-income countries.[24] Five countries, including Canada and Israel, have already adopted compulsory license policies for an eventual COVID-19 vaccine, while South Africa and India have submitted a joint proposal to the WTO to waive a number of other intellectual property protections for a COVID-19 vaccine.[25] Compulsory licensing may become a vital leveraging tool for low-income countries to encourage pharmaceutical companies to voluntarily join the MPP.[26] However, it is in the interests of most stakeholders that low-income countries do not feel obligated to engage in compulsory licensing. For low-income countries, engaging in compulsory licensing requires a level of expertise and legal sophistication that is more often found in middle-income countries, and both low- and middle-income countries are often hindered by the threat of retaliation and trade sanctions from pharmaceutical companies and high-income countries.[27] From the perspective of pharmaceutical companies, there is a concern that broad use of compulsory licensing would destroy incentives for investment in research and development.[28] In order to encourage pharmaceutical companies to engage with low-income countries, some have raised voluntary licensing as a preventive strategy against compulsory licensing.[29] Ultimately, engaging with the voluntary patent pool of C-TAP could be the best option for both low-income countries and pharmaceutical companies during the COVID-19 pandemic.  Without such engagement, the world risks yet another patent war—a war that will have far too many human casualties.

[1] G.A. Res. 74/274, ¶¶ 2, 5 (Apr. 20, 2020); World Health Organization, Assembly Res. A73/Conf./1 Rev.1, OP4 (May 18, 2020). [2] See Solidarity Call to Action, World Health Organization 2 (June 2, 2020), https://www.who.int/docs/default-source/coronaviruse/solidarity-call-to-action/solidarity-call-to-action-01-june-2020.pdf?sfvrsn=a6c4b03d_4. [3] See The COVAX facility, World Health Organization 3 (2020), https://www.who.int/publications/m/item/the-covax-facility. [4] See 172 Countries and Multiple Candidate Vaccines Engaged in COVID-19 Vaccine Global Access Facility, World Health Organization (Aug. 24, 2020), https://www.who.int/news/item/24-08-2020-172-countries-and-multiple-candidate-vaccines-engaged-in-covid-19-vaccine-global-access-facility; UN Welcomes Nearly $1 Billion in Recent Pledges, World Health Organization (Sept. 30, 2020), https://www.who.int/news/item/30-09-2020-un-welcomes-nearly-1-billion-in-recent-pledges-to-bolster-access-to-lifesaving-tests-treatments-and-vaccines-to-end-covid-19. [5] International Community Rallies to Support Open Research and Science to Fight COVID-19, World Health Organization (May 29, 2020), https://www.who.int/news/item/29-05-2020-international-community-rallies-to-support-open-research-and-science-to-fight-covid-19. [6] Endorsements of the Solidarity Call to Action, World Health Organization, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool/endorsements-of-the-solidarity-call-to-action (last visited Nov. 1, 2020). [7] Seth Berkley, COVAX Explained, Gavi (Sept. 3, 2020), https://www.gavi.org/vaccineswork/covax-explained. [8] Id. [9] Id. [10] See Saeed Shah, Developing Countries Push to Limit Patent Protections for Covid-19 Vaccines, Wall Street Journal (Sept. 17, 2020, 11:59 AM), https://www.wsj.com/articles/developing-countries-push-to-limit-patent-protections-for-covid-vaccines-11600355170. [11] Elana Lyn Gross, Gates Foundation Donates $150 Million to Distribute COVID-19 Vaccine To Developing Nations, Forbes (Aug. 7, 2020, 3:47 PM), https://www.forbes.com/sites/elanagross/2020/08/07/gates-foundation-donates-150-million-to-distribute-covid-19-vaccine-to-developing-nations-as-they-struggle-with-accelerating-pandemic/#68447d6cb243. [12] UN Welcomes Nearly $1 Billion in Recent Pledges, supra note 4. [13] See Seth Berkley, What is the COVAX Pillar, Why Do We Need It and How Will It Work?, Gavi (June 26, 2020), https://www.gavi.org/vaccineswork/gavi-ceo-dr-seth-berkley-explains-covax-pillar. [14] See Emily Rauhala and Yasmeen Abutaleb, U.S. Says it Won’t Join WHO-linked Effort to Develop, Distribute Coronavirus Vaccine, Washington Post (Sept. 1, 2020, 2:42 PM), https://www.washingtonpost.com/world/coronavirus-vaccine-trump/2020/09/01/b44b42be-e965-11ea-bf44-0d31c85838a5_story.html. [15] Id. [16] Id. [17] Solidarity Call to Action, supra note 2. [18] See Fabrice Delaye, Medicines Patent Pool can be conduit for access to affordable Covid-19 treatments, Heidi News (June 1, 2020, 16:37), https://www.heidi.news/geneva-solutions/medicines-patent-pool-proposed-as-main-conduit-for-inexpensive-covid-19-treatments. See also Sudip Chaudhuri, Making Covid-19 Medical Products Affordable, South Centre: SouthViews 3 (June 16, 2020), https://www.southcentre.int/wp-content/uploads/2020/06/SouthViews-Chaudhuri.pdf. [19] See Delaye. [20] See, e.g., William Worley, COVID-19 Puts a Spotlight on the Medicines Patent Pool, Devex (June 22, 2020), https://www.devex.com/news/covid-19-puts-a-spotlight-on-the-medicines-patent-pool-97461. [21] Ed Silverman, Pharma Leaders Shoot Down WHO Voluntary Pool for Patent Rights on COVID-19 Products, STAT (May 28, 2020), https://www.statnews.com/pharmalot/2020/05/28/who-voluntary-pool-patents-pfizer/. [22] See Small Group of Rich Nations Have Bought Up More Than Half the Future Supply of Leading COVID-19 Vaccine Contenders, Oxfam International (Sept. 17, 2020), https://www.oxfam.org/en/press-releases/small-group-rich-nations-have-bought-more-half-future-supply-leading-covid-19. [23] See Trade-Related Aspects of Intellectual Property Rights art. 31, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1867 U.N.T.S. 154 (as amended Jan. 23, 2017) [hereinafter TRIPS]. See also Compulsory Licensing of Pharmaceutical and TRIPS, World Trade Organization, https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm (last visited Oct. 19, 2020). [24] Id. [25] See Bruno Stagno-Ugarte, Protecting the profits of a few could prevent vaccine access for all, The hill (Oct. 14, 2020, 4:30 PM), https://thehill.com/opinion/international/521029-protecting-the-profits-of-a-few-could-prevent-vaccine-access-for-all. [26] See, e.g., Chauduri, supra note 19, at 7. [27] Dina Halajian, Inadequacy of TRIPS & the Compulsory License: Why Broad Compulsory Licensing is Not a Viable Solution to the Access Medicine Problem, 38 Brook. J. Int’l L. 1191, 1211—1213 (2013). [28] Id. [29] See Daniel D. Kim, Voluntary Licensing of Pharmaceuticals: The Strategy Against Compulsory Licensing, 8 Intell. Prop. Brief 63 (2016).