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A medical staff member administers a dose of the Pfizer-Biotech vaccine to a person over eighty years old, in the Santa Maria della Pieta hospital in Rome, Italy.

Universal and Equitable Access to Covid-19 Vaccines, Testing, Treatments: Companies’ Human Rights Responsibilities

Questions and Answers

A medical staff member administers a dose of the Pfizer-Biotech vaccine to a person over eighty years old, in the Santa Maria della Pieta hospital in Rome, Italy, February 8, 2021. © 2021 Alessandra Tarantino/AP Photo

Introduction

The Covid-19 pandemic has exposed and exacerbated profound inequality in people’s access to health care and the resources needed to prevent, diagnose, and treat infectious disease. An October 2020 report by the United Nations Conference on Trade and Development (UNCTAD) says that there is “[s]ubstantial evidence that middle- and low-income countries have been largely priced out from access to COVID-19 related products. Despite efforts to facilitate access to COVID-19 supplies, trade statistics show that only a tiny fraction of the additional world production of COVID-19 related supplies have reached low income countries.”[1]

A recent study estimated that nearly a quarter of the world’s population may not have access to a Covid-19 vaccine until at least 2022.[2] Vaccines do not have “identical” generics and the regulatory approvals can be complex.[3] As the World Health Organization (WHO) explains, “Unlike drugs, where a generic can be made and licensed on chemical equivalence, a vaccine made in a new facility is treated as a new vaccine and has to undergo rigorous preclinical and clinical studies to be approved for use.”[4]

Many high-income governments are wholly or substantially subsidizing private companies’ research and development of vaccines, including by contracting to purchase millions of doses of successful vaccines in advance. High-income governments have prebooked vaccines largely for their own populations in ways that undermine universal and equitable access to a safe and effective vaccine. For example, a September 2020 Oxfam report showed that a handful of high-income governmentsthe United Kingdom, United States, Australia, Hong Kong & Macau, Japan, Switzerland, and Israel, as well as the European Union – prebooked over 50 percent of the doses of the total volumes of vaccines of five vaccine candidates. These populations covered 13 percent of the world.[5] Global Justice Now reported that about 82 percent of the total volumes of Pfizer and BioNTech’s vaccine was already prebooked by the US, UK, European Commission, and Japan.[6]

Vaccine roll-out figures have underscored concerns around inequitable access. On February 8, 2021, Bloomberg’s Covid-19 Vaccine Tracker reported that of the more than 131 million doses that had been administered in 73 countries, 78 percent (more than 102.48 million doses) were given in the US, China, the EU, and the UK.[7] On February 5, the WHO reported that 130 countries were yet to administer a single vaccine dose.[8]

A shortage of supply of Covid-19 medical products will continue to impair people’s enjoyment of their rights to life, health, and a decent standard of living. Health workers at the forefront of helping countries respond to the pandemic have repeatedly raised concerns about shortages of medical supplies and their impacts on patients and working conditions.[9] In many countries, health workers who have complained about occupational health and safety concerns during the pandemic have found themselves silenced rather than having their grievances redressed.[10] Labor rights advocates have repeatedly underscored the importance of personal protective equipment and other protections for workers, especially those providing essential services.[11]

Shoring up the supply of affordable medical products, including safe and effective Covid-19 vaccines, is critical to protecting people’s lives and heath, and enabling economies to recover as quickly as possible.

Against this backdrop, this Q and A discusses some key questions about the human rights responsibilities of companies researching, developing, and manufacturing Covid-19 medical products.[12] While the questions and answers, particularly around supply and intellectual property (IP), equitable access, and pricing, are relevant for all Covid-19 medical products, including testing and drugs, Human Rights Watch has focused on Covid-19 vaccines. The issues raised are limited to universal and equitable access. Companies involved in researching, developing, and manufacturing Covid-19 medical products have a host of responsibilities covering a broad range of rights issues, including freedom of association and collective bargaining, occupational health and safety, and overall working conditions of their employees and workers in their global supply chains. But a full discussion of those issues is beyond the scope of this analysis.

1. Do companies have human rights responsibilities?

2. What are some of the key human rights risks that companies should look out for?

3. Do stakeholders have a role in companies’ human rights risk assessments?

4. How can companies help maximize the supply and affordability of medical products?

            A. Conducting Technology Transfers

            B. Addressing Actual and Potential Intellectual Property Barriers

5. What can companies do to develop an affordable pricing strategy?

6. How can companies advance equitable access principles?

7. Are there any practices that companies should avoid as part of their operations?

8. What are the risks of non-transparency?

9. What should companies do to support the Sustainable Development Goals?

  1. Do companies have human rights responsibilities?

Governments have an obligation to ensure that companies respect human rights. To fulfill that obligation, governments should structure their public investments and contractual agreements with companies in a way that aligns with key human rights principles.[13] All companies have human rights responsibilities, as articulated in the 2011 UN Guiding Principles on Business and Human Rights (UNGPs), the 2011 OECD Guidelines for Multinational Enterprises (OECD MNE Guidelines), and the 2018 OECD Due Diligence Guidance for Responsible Business Conduct (OECD RBC Guidance).[14] These should be read alongside the 2008 Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines issued by the UN Special Rapporteur on the right to health.[15] While human rights responsibilities apply at all times, they assume urgent significance in responses to a public health crisis. The Covid-19 pandemic is an extraordinary global public health crisis. In November 2020, UN human rights experts issued a statement calling on all pharmaceutical companies to take steps to “identify and address adverse impacts on the rights to life and health as set out in the [UN] Guiding Principles on Business and Human Rights.”[16]

All companies, including those involved in researching, developing, and manufacturing personal protective equipment, Covid-19 testing kits, treatments, and vaccines, should conduct robust human rights due diligence. Effective human rights due diligence consists of a series of processes. These include: assessing actual and potential human rights impacts; integrating and acting upon the findings; tracking responses; and communicating how impacts are addressed.[17] Assessments should be conducted in relation to the company’s own operations as well as its business relationships. To “act on findings” from such assessments, companies should take steps to prevent, mitigate, and remediate adverse impacts, and integrate corrective actions across all the company’s functions.[18]

Human rights due diligence processes are dynamic and not stagnant in time. Companies have the responsibility to conduct human rights risk assessments regularly, adapting to changes in the “operating context;” while developing new products; and while entering markets.[19] Human rights risk assessments should be an ongoing process without any end-date.

Human Rights Watch recommends that companies conduct ongoing Covid-19 specific risk assessments until everyone, everywhere has access to a vaccine and Covid-19 is eradicated.

  1. What are some of the key human rights risks that companies should look out for?

The UNGPs state that companies should examine how they might cause or contribute to “actual and potential human rights impacts”[20] through action and inaction, either in their business operations or through the operations of their business partners.

Human Rights Watch recommends that, at a minimum, companies respond to the risks outlined below.

  1. Exacerbating supply scarcity or delays in medical products needed for an effective health response to combat Covid-19, including through enforcement of intellectual property rights;
  2. Exacerbating a lack of affordability, including by not developing affordable pricing strategies;
  3. Omitting principles of equitable access from overall business decisions;
  4. A lack of transparency.

These aspects are discussed in greater detail in other questions below.

  1. Do stakeholders have a role in companies’ human rights risks assessments?

Companies should “meaningfully consult” with “potentially affected groups” and “other relevant stakeholders” at all stages of human rights due diligence.[21] It is not enough for companies to consult with these groups at the time of identifying human rights risks and it is equally important that companies involve them while evaluating their prevention, mitigation, and remediation measures.[22]

Human Rights Watch believes that meaningful consultation on the part of companies entails good faith efforts to reach out to organizations to incorporate diverse perspectives, including from low- and middle-income countries. Human Rights Watch recommends that companies include within the umbrella of “potentially affected groups,” organizations representing essential workers, including health workers providing different types of care and in various contexts; older people’s organizations; patient organizations and advocates; organizations representing Covid-19 survivors or relatives of those who died; and humanitarian organizations providing medical assistance. “Other relevant stakeholders” should include experts on public health, intellectual property rights, pricing, and human rights, and representatives of civil society organizations that are not remunerated or funded by pharmaceutical companies.

  1. How can companies help maximize the supply and affordability of medical products?

Companies should identify factors that can exacerbate the scarcity of medical products needed for the Covid-19 health response and prevent, mitigate, and rectify them. Human Rights Watch considers that there are at least two well-known risks that exacerbate scarcity and delays, which are particularly relevant for Covid-19 vaccines’ availability:

  1. Insufficient diffusion and sharing of technological know-how that may be required to scale up manufacturing;[23]
  2. Intellectual property barriers that curb a scale-up in manufacturing.[24]

A company should “know and show,”[25] that is, demonstrate, that it is prioritizing equitable access when assessing and responding to the overall technological transfer needs surrounding the specific product it is developing or manufacturing for Covid-19 prevention, testing, or treatment and other actual and potential adverse impacts posed by the intellectual property rights during a public health crisis.

A. Conducting Technology Transfers

In the context of Covid-19 vaccines, global expertise and capacity to manufacture vaccines is limited and skewed toward rich countries, limiting low- and middle-income countries’ access to vaccines and further harming their public health and economies.[26] Companies researching, developing, and manufacturing Covid-19 vaccines should assess and respond to the unmet demand and need for transferring technological know-how to scale up vaccine manufacturing and supply. Technology transfers are especially relevant where companies are deploying new technologies that have not been widely used before. For example, Policy Cures Research, an Australia-based biomedical think tank, states that vaccines that use DNA and RNA technology have not previously been licensed and “approved for human use,” and did not already have “real-world experience” before Covid-19.[27]

Human Rights Watch recommends that a company producing Covid-19 vaccines adopt and implement appropriate technology transfer plans to equip qualified manufacturers to scale up manufacturing, track progress, and evaluate the effectiveness of its measures. While reporting on its due diligence related to the technological landscape, at a minimum, a company should:

  • Publicly report on the measures the company has taken to endorse and collaborate with voluntary pooling efforts like the Covid-19 Technology Access Pool (C-TAP), a global, WHO-led initiative that seeks to develop a shared pool of data, know-how, and technology;
  • Publicly report on the measures the company has taken to prioritize technological transfers, including those aimed at bolstering internal capacity to conduct technology transfers and disclosing agreements the company has signed committing to technology transfers;
  • Publish the names, addresses, and other information of manufacturers the company has contracted with, indicating whether it is conducting technology transfers to these manufacturers, and the relevant agreements.

B. Addressing Actual & Potential Intellectual Property Barriers

Intellectual property barriers can delay or altogether thwart timely access to medical products required to respond to Covid-19. The patent landscape surrounding Covid-19 vaccines is complex.[28] As a law firm specializing in intellectual property practice warned, unless there is access to all of the underlying patents governing a vaccine candidate, manufacturing the vaccine widely will be difficult.[29] Companies have already sued others they claim infringed their intellectual property rights underlying Covid-19 vaccine candidates.[30]

As discussed above, vaccines do not have “identical” generics. A vaccine manufactured by a non-originator has to undergo lengthy and rigorous preclinical and clinical trials. Where companies claim and exercise data exclusivity over clinical trial data, these may delay manufacturing scale-up and regulatory approvals.

In November 2020, UN human rights experts called on pharmaceutical companies to “refrain from causing or contributing to adverse impacts on the rights to life and health by invoking their intellectual property rights and prioritizing economic gains.”[31]

Against this backdrop, Human Rights Watch recommends that a company adopt due diligence measures that demonstrate its commitment to prioritizing public health over enforcing its intellectual property claims, and include the following measures:

  • Publicly disclose all its efforts to sign global, open, and non-exclusive licenses to prevent and mitigate the risk of lawsuits and delays in seeking approvals for the use of patented technology.
  • Publicly disclose whether it has enabled global, open, and non-exclusive licenses through its participation in one or more voluntary efforts. For example, a number of companies, including small companies manufacturing medical products, have signed the Open COVID Pledge, that is modeled on global, open, and non-exclusive licensing.[32] Companies should endorse and participate in such efforts, including C-TAP and take measures to drive up access to its technologies through global, non-exclusive, and open licenses.
  • Publicly disclose information about all relevant patents and patent filings (including in which countries such patents have been filed and/or issued) for different technologies used to develop the vaccine, including pre-existing patents that the company owns or licenses.
  • Create and publicize the contact information for rapid response teams that can receive requests from third parties to license the company’s patented technology and respond in a time-bound manner.
  • Publicly disclose the names, addresses, and other information about licensees and disclose the terms of the licensing agreements.[33]
  • Disclose publicly, and in any new patent filings by the company, information about the total funding the company received to develop the vaccine from government and non-government sources, including amounts received before the Covid-19 outbreak, as well as any funder’s claims to the intellectual property.
  • Commit to not interfere with or litigate against governments that make use of existing public health safeguards and flexibilities included in the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) in order to expand supply, ensure affordability, or address other IP-related barriers to access.
  • Publicly share clinical trial data and information, so others beginning clinical trials elsewhere can learn and build on previous trials and so the public remains informed.

Companies should publicly and privately support the proposal by India and South Africa to waive some aspects of the TRIPS Agreement until “widespread vaccination is in place globally” and pave the way for strengthening the vaccine manufacturing capacity of and the rapid supply of vaccines to low- and middle-income countries.

  1. What can companies do to develop an affordable pricing strategy?

While the ultimate responsibility to ensure the affordability of medicines and vaccines vests with governments, companies have a role to play and should not exploit regulatory gaps. Especially during a public health crisis, companies should make good faith efforts to demonstrate that they are supporting all governments – whether low-, middle- or high-income – to achieve their public health goals and are catering to the diverse needs of vulnerable or historically marginalized populations, especially those living in poverty.

In the context of Covid-19 vaccines, a company’s affordable pricing strategy should be aligned with the 2008 UN Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines[34] and, at a minimum, take into consideration the following factors:

  • The amount of public and philanthropic money the company received to research, develop, or manufacture the vaccine.
  • The risk of adding to the medical debt of families, especially for those uninsured, underinsured, or in countries where there is no sufficient insurance or public provisioning of vaccines.
  • The risk of undermining low- and middle-income governments’ ability to make vaccines widely available, free of cost to vulnerable populations.

A company should, at a minimum, include the following aspects while reporting on the effectiveness of its affordable pricing strategy:

  • Provide information about the company’s financial investments in Covid-19 vaccine R&D and costs of manufacturing as well as information about public and philanthropic money received.
  • Publish third party audit reports of the company’s account of its own investments into innovations – past and present – that form the basis of the vaccine.
  • Publish the prices paid in the public and private markets in all countries with an explanation as to the differences in prices paid and disclose net prices for such products in public and private markets.
  1. How can companies advance equitable access principles?

A key and ongoing challenge for public health responses to Covid-19 is the skewed global supply of medical products. While companies alone cannot check the dangers of governments prebooking scarce vaccine doses, they can take steps to drive universal and equitable access.

In the context of Covid-19 vaccines, for instance, companies can develop mechanisms to ensure that the overall volumes of vaccines they are able to produce are distributed across low-, middle-, and high-income countries. In order to demonstrate its commitments to the overarching goals of universal and equitable access, a company that is developing vaccines should publicly report on the following:

  • The company’s equitable access policy and date of last update;[35]
  • The total volumes the company plans to produce of the vaccine and breakdown of volume commitments through advance purchase commitments across different categories – high-income, upper middle-income, lower middle-income, and low-income governments; COVAX Facility; humanitarian organizations; and others.
  • Steps taken to prevent the risk of diverting vaccine doses to private groups or entities in ways that undermine the WHO's Equitable Allocation Framework.
  • Any company guidance for the distribution of vaccines for its employees and any essential workers in the company’s supply chain.
  1. Are there any practices that companies should avoid as part of their operations?

At a minimum, companies involved in researching, developing, and manufacturing Covid-19 medical prodcutrs, including vaccines, should avoid the practices described below.[36]

  • Artificial end-dates to the public health crisis: Companies should not undermine the authority of the WHO and national-level health authorities by signing agreements with clauses that allow companies to assume overriding powers or mutually agree with contracting parties to put an artificial end-date to the pandemic or epidemic that is not supported by credible and scientific public health data provided by diverse sources, including relevant authorities in a particular geographic context.
  • Exclusive licensing: Exclusive licensing allows companies to limit and control the number of manufacturers who can produce a particular product. Especially during a public health crisis, where the demand far outstrips the supply, exclusive licensing exacerbates scarcity, and delays the ability of governments to make medical products widely available.
  • Domestic-use-only clauses: Companies should not exacerbate the scarcity of a medical product by putting contractual limits on the benefits of technology transfers during a public health crisis. Companies that agree to transfer technology to scale up manufacturing, but simultaneously restrict the ability of manufacturers to produce for domestic consumption only, significantly hamper timely access to other import-dependent countries.
  • Thwarting government use of TRIPS flexibilities: According to the WTO TRIPS Agreement, reaffirmed by the WTO Doha Declaration on TRIPS and Public Health, governments have the flexibility to apply public health safeguards and “protect public health,” which includes responding to a “public health crisis.” Companies should take steps to stop, prevent, and mitigate any corporate actions that impede governments’ ability to exercise TRIPS flexibilities in their Covid-19 health responses.[37]
  • Overbroad use of “commercial sensitivity” to thwart transparency: Companies involved in the research, development, and manufacture of Covid-19 health products should publish the contracts they sign. They should restrict the scope and use of “commercial confidentiality” and adopt an approach that is pro-transparency, that serves public health and right-to-information goals.[38] Companies should not prevent governments from publicly disclosing procurement prices.
  1. What are the risks of non-transparency?

Transparency is key to effective human rights due diligence, as well as engendering trust between companies, governments, and the public. Companies should regularly publish information about how they monitor key human rights risks, as well as the specific risks they have identified, the measures they are taking to prevent, mitigate, and rectify them, and their effectiveness.[39]

Companies should also be transparent about key pieces of information related to equitable access, such as the amount of public funding received; contracts signed; production volumes and percentage committed and to whom; and clinical trial data. Particularly for companies that have benefitted from public or philanthropic funding, such transparency is vital to engendering public trust, combatting vaccine hesitancy, and encouraging best practices across the industry.

For the same reason, companies should take steps to avoid any perception of conflicts of interest, including by disclosing information about their beneficial ownership (people or entities that own or control the company), as well as that of all other companies to which they award major contracts.

As recommended by UN Special Rapporteur on the right to health, companies should establish an independent body to consider disputes that may arise regarding disclosure of information.[40]

  1. What should companies do to support the Sustainable Development Goals?

The primary responsibility for achieving the Sustainable Development Goals (SDGs) and related targets vests with governments. But companies can play an important role.[41] Companies should incorporate relevant SDGs and targets into their policies and practices and demonstrate how they are contributing to the achievement of these targets.

The third SDG obligates governments to ensure healthy lives and promote well-being for all at all ages. One of the targets of this goal is to “[a]chieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”[42] Another target is to: “[s]upport the research and development of vaccines and medicines for the communicable and noncommunicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health…. and, in particular, provide access to medicines for all.”[43]

Similarly, SDG 9 seeks to “[b]uild resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation,” including by investing in and enhancing scientific research and technological capabilities, particularly of developing countries.[44]

Companies should develop policies and practices that are aligned with the overarching goal of developing the capacity of low- and middle-income countries to improve their manufacturing capacity. This would equip these countries to become self-sufficient even when global supply chains are disrupted by public health crises.

 

[1] UNCTAD, “Global Trade Update,” October 2020, https://unctad.org/system/files/official-document/ditcinf2020d4_en.pdf (accessed November 2, 2020).

[2] Anthony D. So and Joshua Woo, “Reserving coronavirus disease 2019 vaccines for global access: cross sectional analysis,” British Medical Journal 2020; 371, https://www.bmj.com/content/371/bmj.m4750 (accessed December 23, 2020).

[3] Policy Cures Research, “COVID-19 Vaccine Clinical Trial Results Table,” and “Table 1, Vaccine Platform Attributes,” https://www.policycuresresearch.org/vaccines-clinical-trial-results-summary (accessed December 2, 2020). The organization notes that medical regulators across different countries may vary in how they interpret the information submitted by companies as part of their applications seeking approvals to produce vaccines, “leading to some vaccines or medicines being approved in one country but not another.”

[4] World Health Organization (WHO) and International Centre for Trade and Sustainable Development, “Increasing Access to Vaccines through Technology Transfer and Local Production,” https://www.who.int/phi/publications/Increasing_Access_to_Vaccines_Through_Technology_Transfer.pdf (accessed on December 2, 2020), p. 5.

[5] “Small Group of Rich Nations Have Bought Up More Than Half the Future Supply of Leading COVID-19 Vaccine Contenders,” Oxfam news release, September 17, 2020, https://www.oxfam.org/en/press-releases/small-group-rich-nations-have-bought-more-half-future-supply-leading-covid-19 (accessed February 9, 2021).

[6] Global Justice Now, “Most of Pfizer’s vaccine already promised to richest, campaigners warn,” November 11, 2020, https://www.globaljustice.org.uk/news/2020/nov/11/most-pfizers-vaccine-already-promised-richest-campaigners-warn (accessed December 3, 2020).

[7] Bloomberg, “Covid-19 Vaccine Tracker,” https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/ (accessed February 8, 2021).

[8] World Health Organization, “WHO Director-General's opening remarks at the media briefing on COVID-19 – 5 February 2021,” February 5, 2021, https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19-5-february-2021 (accessed February 8, 2021).

[9] Human Rights Watch, Whoever Finds the Vaccine Must Share It: Strengthening Human Rights and Transparency Around Covid-19 Vaccines (New York: Human Rights Watch, 2020), https://www.hrw.org/report/2020/10/29/whoever-finds-vaccine-must-share-it/strengthening-human-rights-and-transparency#9410, pp. 26-28; Amnesty International, Exposed, Silenced, Attacked: Failures to Protect Health and Essential Workers During the Covid-19 Pandemic, (London: Amnesty International, 2020), https://www.amnesty.org/download/Documents/POL4025722020ENGLISH.PDF (accessed December 3, 2020).

[10] See for example, “Russia: Health Workers Face Retaliation for Speaking Out,” Human Rights Watch news release, June 15, 2020, https://www.hrw.org/news/2020/06/15/russia-health-workers-face-retaliation-speaking-out; “Egypt: World Bank Funds Health but Neglects Jailed Doctors,” Human Rights Watch news release, December 8, 2020, https://www.hrw.org/news/2020/12/08/egypt-world-bank-funds-health-neglects-jailed-doctors; “Lebanon: Health Workers’ Safety Neglected During Covid-19,” Human Rights Watch news release, December 10, 2020, https://www.hrw.org/news/2020/12/10/lebanon-health-workers-safety-neglected-during-covid-19; Amnesty International, ibid.

[11] See for example, International Trade Union Confederation, “ITUC Global COVID-19 Survey: Global gaps in adequate provision of PPE and preparation of safe workplaces to protect workers from spread of Covid-19 in spotlight,” April 28, 2020, https://www.ituc-csi.org/ituc-global-covid-19-survey-20april (accessed January 5, 2021); Public Services International, “Briefing: Health Before Wealth,” January 20, 2021, https://publicservices.international/resources/news/briefing-health-before-wealth?id=11516&lang=en (accessed February 8, 2021); Public Services International, “Joint Demands of Community Health Workers in South Asia,” December 10, 2020, https://pop-umbrella.s3.amazonaws.com/uploads/0778ab85-31ae-497b-bb62-d5fa17bd49c5_PSI_Brochure_English_10Dec2020.pdf (accessed February 8, 2021), p. 4.  

[12] This paper uses the term companies to include all entities, however they are structured, involved in researching, developing, and manufacturing medical products in response to Covid-19. These include those producing vaccines, personal protective equipment, testing kits, treatments, and other medical equipment necessary for Covid-19 treatment such as ventilators.

[13] Human Rights Watch, Whoever Finds the Vaccine Must Share It.

[14] Office of the United Nations High Commissioner for Human Rights, “Guiding Principles on Business and Human Rights,” 2011, https://www.ohchr.org/documents/publications/GuidingprinciplesBusinesshr_eN.pdf (accessed June 12, 2020); OECD, “OECD Guidelines for Multinational Enterprises,” 2011, http://www.oecd.org/daf/inv/mne/48004323.pdf (accessed June 12, 2020); OECD, “OECD Due Diligence Guidance for Responsible Business Conduct,” 2018, http://mneguidelines.oecd.org/OECD-Due-Diligence-Guidance-for-ResponsibleBusiness-Conduct.pdf (accessed June 12, 2020).

[15] UN Special Rapporteur on the right to health, “Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines,” 2008, https://www.who.int/medicines/areas/human_rights/A63_263.pdf (accessed December 10, 2020).

[16] “Statement by UN Human Rights Experts: Universal access to vaccines is essential for prevention and containment of Covid-19 around the world,” November 9, 2020, https://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=26484&LangID=E (accessed November 9, 2020).

[17] UNGPs, principle 17.

[18] UNGPs, principle 19.

[19] UNGPs, principle 17(c) and related commentary.

[20] UNGPs, principle 17.

[21] UNGPs, principle 18.

[22] UNGPs, principles 18, 20.       

[23] Human Rights Watch, Whoever Finds the Vaccine Must Share It, pp. 46-57.

[24] Ibid.

[25] UNGPs, principle 15, commentary. “Business enterprises need to know and show that they respect human rights. They cannot do so unless they have certain policies and processes in place. Principles 16 to 24 elaborate further on these.”

[26] CEPI, “CEPI survey assesses potential COVID-19 vaccine manufacturing capacity,” August 5, 2020, https://cepi.net/news_cepi/cepi-survey-assesses-potential-covid-19-vaccine-manufacturing-capacity/ (accessed December 3, 2020); Third World Network, “VaxMap: An open source-based map of COVID-19 candidate vaccines and manufacturing capacity,” last updated October 7, 2020, http://vaxmap.org/ (accessed December 3, 2020).

[27] Policy Cures Research, “COVID-19 Vaccine Clinical Trial Results Table,” and “Table 1, Vaccine Platform Attributes,” https://www.policycuresresearch.org/vaccines-clinical-trial-results-summary (accessed December 2, 2020).

[28] Dr. Leena Contarino and Ellie Purnell, “The Patent Landscape Behind Covid-19 Vaccines,” International Pharmaceutical Industry Regulatory and Marketplace, Autumn 2020, Volume 12, Issue 3, https://www.ipimediaworld.com/wp-content/uploads/2020/10/The-Patent-Landscape-Behind-COVID-19-Vaccines-compressed.pdf (accessed December 23, 2020); Public Citizen, “mRNA-1273 Vaccine Patent Landscape (For NIH-Moderna Vaccine),” November 16, 2020, https://www.citizen.org/article/modernas-mrna-1273-vaccine-patent-landscape/ (accessed December 24, 2020) and “BioNTech and Pfizer’s BNT162 Vaccine Patent Landscape,” November 16, 2020, https://www.citizen.org/article/biontech-and-pfizers-bnt162-vaccine-patent-landscape/ (accessed December 24, 2020).

[29] Dr. Leena Contarino and Ellie Purnell, “How a platform technology patent list can expedite Covid-19 vaccine research,” IAM, July 7, 2020, https://www.iam-media.com/coronavirus/covid-19-platform-technology-patent-list (accessed October 19, 2020).

[30] Human Rights Watch, Whoever Finds the Vaccine Must Share It, p. 53; Rebecca Tapscott, “Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies,” IP Watchdog, October 7, 2020, https://www.ipwatchdog.com/2020/10/07/regeneron-pfizer-biontech-accused-infringing-allele-patent-connection-covid-19-technologies/id=126017/ (accessed November 30, 2020); Edward Hammond, “Patent dispute looms as a major complication for Moderna’s COVID-19 vaccine,” Third World Network Info Service on Health Issues, August 3, 2020, https://twn.my/title2/health.info/2020/hi200801.htm (accessed November 30, 2020).

[31] “Statement by UN Human Rights Experts: Universal access to vaccines.”

[32] UN Special Rapporteur on the right to health, “Human Rights Guidelines for Pharmaceutical Companies,” guideline 30. “As part of its access to medicines policy, the company should issue non-exclusive voluntary licences with a view to increasing access, in low-income and middle-income countries, to all medicines…They should also include any necessary transfer of technology. The terms of the licences should be disclosed.”

[33] Ibid.

[34] Ibid., guidelines 5, 33, and 38.

[35] Ibid., guidelines 1, 2, 3, and 5.

[36] This list is not meant comprehensive. Companies should be guided by stakeholder consultations while identifying what practices they should avoid and limit in their business operations to research, develop, and manufacture Covid-19 medical products.

[37] UN Special Rapporteur on the right to health, “Human Rights Guidelines for Pharmaceutical Companies,” guidelines 4, 26, 27, 28, 29.

[38] Ibid, guidelines 6, 7, and 8.

[39] UNGPs, principles 17, 20, 21.

[40] UN Special Rapporteur on the right to health, “Human Rights Guidelines for Pharmaceutical Companies,” guidelines 6, 7, and 8.

[41] See for example, UN Global Compact, “How Your Company Can Advance Each of the SDGs,” https://www.unglobalcompact.org/sdgs/17-global-goals (accessed November 2, 2020).

[42] UNDP, “Goal 3: Good Health and Well-being,” Sustainable Development Goals, https://www.undp.org/content/undp/en/home/sustainable-development-goals/goal-3-good-health-and-well-being.html (accessed November 3, 2020).

[43] Ibid.

[44] UNDP, “Goal 9: Industrial Innovation and Infrastructure,” Sustainable Development Goals, https://www.undp.org/content/undp/en/home/sustainable-development-goals/goal-9-industry-innovation-and-infrastructure.html (accessed November 2, 2020).

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