Equitable COVID Vaccine Distribution and Access: Enforcing International Legal Obligations under Economic, Social, and Cultural Rights and the Right to Development

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Editor’s Note: This post was prepared in advance of my remarks for the 12 February 2021 Global Webinar of the Notre Dame Eck Institute of Global Health (“Are we all in this together? Assessing and addressing equitable access and distributive justice in global supply chains during major disease outbreaks”)

By this time, US pharmaceutical companies such as Pfizer, Moderna, Oxford/AstraZeneca, and Novavax have led the charge in the global race to mass produce the most effective vaccines against COVID-19, with Russia’s Sputnik vaccine and China’s Sinovac vaccine heavily marketed to developing countries unable to purchase the most effective US vaccines. (The latest to join the fray is the single-shot Janssen vaccine produced by US drug maker Johnson & Johnson, which does not have the same effectiveness rate as the other US-made vaccines but also does not pose the same temperature and distribution challenges as its more effective predecessors Pfizer and Moderna.) The race to vaccinate is also a race involving moving targets, since new variants of COVID-19 are not only increasing the transmissibility of the virus, but potentially require retooling of the vaccines themselves to ensure continued effectiveness. Although the United States under the Biden Administration recently declared its intention to join the World Health Organization-led COVAX facility, the prospects for rapid global distribution of COVID vaccines remain grim.  The Economist recently published the following map by the Economist Intelligence Unit, providing estimates of scheduled or anticipated COVID vaccine distribution throughout the world:

The conventional wisdom put forward is that our global predicament is simply an inevitable product of global gaps in scientific innovation that impede widespread development and access to vaccines, the sobering realities of global market distribution and vastly different fiscal, technological, and public health infrastructure resources between G-20 countries and the rest of the world, and even a reasonable “vaccine nationalism” practiced by the United States and Europe – the home of the most effective COVID vaccines – in relation to the domestic legal obligations of these governments seeking to put their own populations first.  Not only do these factors place the populations of the developing world at even greater risk of exacerbated health and mortality problems from COVID and associated comorbidities, but it also makes them most vulnerable to the predatory tactics of the emerging “black markets” for COVID vaccines as well as fraudulent acts of vaccine imposters.

International law has much to say about the ongoing, deliberate, and protracted construction of this predicament on most of the populations of the developing world – as well as upon the most vulnerable depressed populations within the developed world for whom vaccine access and distribution remains elusive.  In this post, I discuss the recent failed attempts in January 2021 by South Africa and India to secure a waiver at the World Trade Organization against the usual guarantees of intellectual property protection under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (e.g. similar to the TRIPS waiver for essential medicines), in light of States’ continuing international obligations under the International Covenant on Economic, Social and Cultural Rights and the right to development under both the 1986 Declaration on the Right to Development and the pending draft Convention on the Right to Development.

Flexibilities within the TRIPS Agreement for Public Health Emergencies

Article 31 of the TRIPS Agreement specifically provides for a flexible situation for patented materials to be used by WTO Members under the following strict terms:

“Article 31: Other Use Without Authorization of a Right Holder

Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

(a)  authorization of such use shall be considered on its individual merits;
(b)  such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;
(c)  the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;
(d)  such use shall be non-exclusive;
(e)  such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;
(f)  any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;
(g)  authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;
(h)  the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;
(i)  the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
(j)  any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
(k)  Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;
(l)  where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be exploited without infringing another patent (“the first patent”), the following additional conditions shall apply:
(i)  the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;
(ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and
(iii)  the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.” (Emphasis added.)

Significantly, WTO Members interpreted the flexibilities in Article 31 of the TRIPS Agreement in the 2001 Doha Declaration on TRIPS and Public Health, where they emphasized that:

“3. We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices.

4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

5. Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include:

     a. In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its      objectives and principles.

    b.  Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.

    c. Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

    d. The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4.” (Emphasis added.)

WTO Members thereafter amended Article 31 of the TRIPS Agreement in its 6 December 2005 Decision, which introduced Article 31bis, a provision that permitted a waiver for Article 31(f) for countries that lacked domestic manufacturing capabilities to instead import cheaper generic drugs produced in other countries, consistent with the WTO 30 August 2003 Decision on the Implementation of Paragraph 6 of the Doha Declaration on TRIPS and Public Health.  This amendment of the TRIPS Agreement took effect on 23 January 2017.  

India and South Africa’s proposal for a TRIPS waiver for COVID vaccines were tabled until early 2021, with a European Union official quoted as having said that “There is no evidence that intellectual property rights are a genuine barrier for accessibility of COVID‐​19‐​related medicines and technologies.” Previous posts here at EJIL:Talk! explored the possibility of resorting to the national security exception in Article 73 of the TRIPS Agreement, as well as internal mechanisms within the TRIPS agreement and the WTO multilateral trade regime as a whole, to try and resolve this impasse within the confines of world trade law. 

In light of the next WTO TRIPS Council discussions on these proposals scheduled on 10 and 11 March 2021, I argue that WTO Members that are also parties to the International Covenant on Economic, Social and Cultural Rights (with its 171 States Parties, including, most especially, Member States of the European Union, and with the United States being a signatory to this treaty and thus minimally prohibited under Article 18 of the Vienna Convention on the Law of Treaties from defeating the objects and purposes of the ICESCR) also bear separate and distinct obligations under international human rights law that must be taken into consideration apart from specific treaty provisions in the WTO Agreements.  Furthermore, the same States – especially the vaccine-producing States – must also take into consideration their respective duties to respect, protect, and fulfill the right to development, which includes NOT taking measures or actions that impede or prevent individuals and peoples from contributing, enjoying, and participating in their “economic, social, cultural, or political development, in which all human rights and fundamental freedoms can be fully realized” [Article 1(1) of the 1986 Declaration on the Right to Development], or even more strongly under Article 4 of the pending Draft Convention on the Right to Development, the rights of individuals and peoples to “participate in, contribute to and enjoy economic, social, cultural, civil and political development that is consistent with and based on all other human rights and fundamental freedoms.”  The right to development has particular salience for the meaning of development as the key objective of world trade law, especially since the very Preamble to the WTO Agreement refers to “expanding the production of and trade in goods and services, while allowing for the optimal use of the world’s resources in accordance with the objective of sustainable development”.  

Legal Obligations of WTO Members that are States Parties or signatories to the ICESCR

WTO Members that will participate in the March 2021 TRIPS Council deliberations on the proposed TRIPS waiver for global access to COVID vaccines must be mindful, first and foremost, that they already are under continuing international legal obligations to ensure international cooperation under the terms of Article 2(1) of the ICESCR: “to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means…” (Italics added.). This includes the unequivocal obligation under Article 1(2) of the ICESCR: “in no case may a people be deprived of its own means of subsistence.”  Considering that millions in the developing world – especially the least developed low income countries – are already being pushed to extreme poverty as a direct result of the impacts of COVID 19 crises, the years of man-made delay in global vaccination and access to affordable and effective COVID vaccines as shown in The Economist Intelligence Unit graphic above clearly stands to further deprive millions of peoples in the developing world of their own means of subsistence.  The delays in global vaccination and access also impede the progressive realization of ICESCR rights to the highest attainable standard of physical and mental health, as well as associated rights under the ICESCR such as the rights to education and work, both of which are already severely impacted in the global pandemic.  (See the UN Special Rapporteur’s Report on the impact of COVID-19 on the right to education here, as well as the UN Office of the High Commissioner for Human Rights’ statement on the impact of COVID-19 on businesses and workers here.). This is precisely why all UN Special Rapporteurs unanimously stressed in their 21 January 2021 Statement that there must be “equitable access for all” to COVID vaccines.

Most importantly, the right to the highest attainable standard of physical and mental health under ICESCR Article 12 also makes it explicit in ICESCR Article 12(2)(c) and (d) that “the steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for..(c) the prevention, treatment, and control of epidemic, endemic, occupational and other diseases; and (d) the creation of conditions which would assure to all medical service and medical attention in the event of sickness.” (Emphasis and italics added.). Thus, the baseline duty to cooperate under Article 2(1) of the ICESCR in relation to the right to health under Article 12 of the ICESCR is all too clear that cooperation MUST include that which is necessary to prevent, treat, and control epidemics, including global pandemics such as COVID-19.  Under Article 23 of the ICESCR, international action to realize all economic, social, and cultural rights under the Covenant can include “furnishing technical assistance”.  Passing India and South Africa’s proposal for a TRIPS waiver for COVID-19 vaccines can well be subsumed under the international action contemplated to furnish such technical assistance, in line with the baseline obligations to cooperate to realize all ICESCR rights under Article 2(1) of the ICESCR, and to avoid steadily or drastically depriving any of the peoples of the developing world of their own means of subsistence under Article 1(2) of the ICESCR.

Confronting ‘Development’ under WTO Law with the Right to Development

The March 2021 TRIPS Council deliberations on a proposed TRIPS waiver for global access to COVID vaccines is also an important international moment to reevaluate our understanding of development, which still has significant dissonances between the world trade regime that focuses more narrowly on economic development, and the right to development, which is more broadly premised on economic, social, cultural, and political development that is based on all human rights and fundamental freedoms.  It is seriously concerning that in 2021, the European Union’s alleged position to resist the proposed TRIPS waiver is that there is supposedly no evidence of intellectual property creating any impediment for the accessibility of COVID-19 vaccines.  This position demonstrates a troublingly myopic understanding of accessibility.  As the Committee on Economic, Social, and Cultural Rights emphasized in General Comment 14 on the right to health, accessibility is a multi-dimensional problem:

(b) Accessibility. Health facilities, goods and services have to be accessible to everyone without discrimination, within the jurisdiction of the State party. Accessibility has four overlapping dimensions:

Non-discrimination: health facilities, goods and services must be accessible to all, especially the most vulnerable or marginalized sections of the population, in law and in fact, without discrimination on any of the prohibited grounds;

Physical accessibility: health facilities, goods and services must be within safe physical reach for all sections of the population, especially vulnerable or marginalized groups, such as ethnic minorities and indigenous populations, women, children, adolescents, older persons, persons with disabilities and persons with HIV/AIDS. Accessibility also implies that medical services and underlying determinants of health, such as safe and potable water and adequate sanitation facilities, are within safe physical reach, including in rural areas. Accessibility further includes adequate access to buildings for persons with disabilities;

Economic accessibility (affordability): health facilities, goods and services must be affordable for all. Payment for health-care services, as well as services related to the underlying determinants of health, has to be based on the principle of equity, ensuring that these services, whether privately or publicly provided, are affordable for all, including socially disadvantaged groups. Equity demands that poorer households should not be disproportionately burdened with health expenses as compared to richer households;

Information accessibility: accessibility includes the right to seek, receive and impart information and ideas concerning health issues. However, accessibility of information should not impair the right to have personal health data treated with confidentiality.

With the effective COVID vaccines originating primarily from the United States (and their supply partners in Europe), the major impediments to access are logistical and scientific (e.g. having the facilities and distribution infrastructure necessary to be able to house and timely distribute Pfizer and Moderna vaccines that require certain cooler temperatures), economic (e.g. having the supply chain networks and readily available fiscal resources to procure a steady stream of tranches of the COVID vaccines, given the ‘auction’-like mechanisms to purchase the vaccines and the ‘black market’ problems arising in relation to COVID vaccines), and non-discriminatory (e.g. are the distribution policies by the vaccine producers consistent with laws prohibiting discrimination on any of the prohibited grounds, and if so, is there related information to ensure public monitoring and audit that such distributions within countries and around the world are legally non-discriminatory?). 

The fact that COVID vaccines will not be reaching most of the developing world according to the same timeline as the developed world should be evidence enough that the US and EU’s heavy reliance on intellectual property protections – sans the mitigating, alleviating, and tempering protections of economic, social, and cultural rights – is the major impediment for the developing world to achieve equitable and meaningful access to effective COVID vaccines primarily produced from the United States and their European supply partners.  The lack of transparency and international cooperation to avoid further delaying distribution to the most vulnerable populations in low income countries that have been hardest hit by this global pandemic – further exacerbating their public health crises and destroying their economies – makes it all too clear that we remain far from realizing the right to development as economic, social, cultural, civil, and political development premised on, and consistent with, all human rights and fundamental freedoms.  We hope that the March 2021 TRIPS Council deliberations prove us wrong, and that its outcome restores global trust and faith in the world trade regime.

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Ruth Lopert says

February 3, 2021

Thank you for these insights. I wonder though, how does one determine what is 'equitable' in this context? Distributing vaccine to all countries according to population size, for example, seems one reasonable approach. But couldn't it be argued that distribution according to need is also 'equitable'? There may be a scientific basis for a seemingly skewed distribution toward countries with the highest prevalence of disease (as a proxy for need) for example, which would substantially skew the distribution priorities

Diane Desierto says

February 3, 2021

Many thanks Ruth for these observations. I would agree with you that prevalence matters, but one must also take into account that not only is there allegations of underreported COVID cases and associated incidences of comorbidities in least developed low income countries (due to lack of testing and other health facilities, similar to previous epidemiological crises such as SARS, H1N1, Ebola), under the multidimensional understanding of health espoused under the ICESCR and adopted at the UN, our understanding of health precarities should also extend beyond reported prevalence or incidence of COVID. Recovery rates from COVID remain very high in the developed world, and for good reason, given their superior therapeutic capacities and health infrastructures, overall opportunities for wellness and long-term well-being. This is not necessarily the case in low income countries that suffer from population density, weaker health infrastructures and health care systems, have less provisioning for social protection to safeguard against economic shocks and unemployment from lockdowns, and where a prolonged pandemic without a vaccine will understandably have multiplier effects on health vulnerabilities. I would take other factors into account in examining equitability when it comes to vaccine distribution and access, precisely because the right to the highest attainable standard of physical and mental health is, as recognized by the Committee on Economic Social and Cultural Rights, an inherently multidimensional right.