India and South Africa Urge WTO to Waive TRIPS Protections for COVID-19 Technologies

On 2 October 2020, India and South Africa jointly communicated to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council of the World Trade Organization (WTO), requesting a waiver of major intellectual property provisions of the TRIPS agreement specifically for technologies related to the prevention, containment, and treatment of COVID-19. This proposal was submitted amid the global race to develop vaccines and medicines against the coronavirus.

The communication emphasized the necessity for WTO members to collaborate in ensuring that intellectual property rights—including patents, industrial designs, copyrights, and protection of undisclosed information—do not obstruct timely access to affordable medical products or impede the scaling up of research, development, manufacturing, and supply of essential COVID-19 medical products.

Central to the debate on access to COVID-19 vaccines, diagnostics, and treatments are the contentious provisions of the TRIPS agreement. The WTO operates on the premise that free trade promotes national wealth and poverty reduction. However, intellectual property rights under TRIPS grant monopoly protections to innovator companies, which can delay the entry of generic competitors and restrict accessibility and affordability of health-related products.

A notable example illustrating the impact of patents on drug pricing is Gilead Sciences’ hepatitis C drug sofosbuvir. Approved in the United States in 2013 and patented until 2024, the drug’s full course cost $84,000 in the US, whereas generic versions in countries without patents, such as Egypt, are priced around $1,900. While patents are intended to incentivize innovation, they often serve as commercial monopolies that can undermine patient welfare. Moreover, much foundational research is publicly funded, as in the case of sofosbuvir, which received support from the US National Institutes of Health.

Even prior to the COVID-19 pandemic, half of the global population lacked access to essential health technologies. Recognizing the public health challenges posed by intellectual property rights, WTO members adopted the Doha Declaration in 2001, affirming that TRIPS provisions should be interpreted to protect public health. The declaration endorsed mechanisms such as compulsory licensing, allowing governments to override patent monopolies during emergencies.

India and South Africa’s recent proposal echoes the principles of the Doha Declaration. It has garnered support from a broad coalition of developing and least developed countries, including Egypt, Indonesia, Bangladesh, Honduras, Tanzania (representing the 43-member African Group), Chad (representing the 36-member Least Developed Countries group), Sri Lanka, Pakistan, Venezuela, Nepal, Nicaragua, Argentina, Tunisia, Mali, Mauritius, and Mozambique.

The World Health Organization (WHO) declared COVID-19 a pandemic on 11 March 2020. By 1 October 2020, over 330 million cases and more than one million deaths had been reported globally. Existing repurposed medicines such as remdesivir, heparin, dexamethasone, and favipiravir have shown limited effectiveness, and no COVID-19 specific drug or vaccine had been developed at that time.

Early in the pandemic, there were signs of global solidarity. China shared the coronavirus genome sequence with the WHO by early January 2020, and countries contributed to the WHO’s pandemic response fund. However, as the pandemic progressed, commercial interests reasserted themselves, with pharmaceutical companies prioritizing profit over equitable access to vaccines, diagnostics, treatments, and related equipment.

The WHO has initiated several efforts to promote fair and equitable access to COVID-19 technologies. In May 2020, the World Health Assembly passed a resolution calling for the removal of unjustified obstacles to equitable access. The WHO also launched the COVID-19 Technology Access Pool (C-TAP) to facilitate open sharing of scientific and technical information. However, major pharmaceutical companies criticized these initiatives; for instance, Pfizer’s CEO Albert Bourla dismissed C-TAP as “nonsense” and “dangerous.”

Given the global population nearing eight billion, vaccine manufacturing capacity is a critical concern. The WHO developed an allocation framework prioritizing approximately 20% of the global population—frontline health workers, essential workers, the elderly, and those with comorbidities—for initial vaccine doses, estimated at around two billion doses. The remaining doses needed to protect the broader population require mechanisms for manufacturing, procurement, and equitable distribution.

The Access to COVID-19 Technologies Accelerator (ACT-A) is a global collaboration involving the WHO, World Bank, Bill & Melinda Gates Foundation (BMGF), Gavi, The Global Fund, Unitaid, and Wellcome. One of its pillars, COVAX, is a pooled procurement system aiming to distribute vaccines to eligible low- and middle-income countries (LMICs) and least developed countries (LDCs) at subsidized prices, covering only priority populations. Countries must negotiate bilateral agreements for doses beyond this group, often at prices set by manufacturers.

Concerns have been raised about the BMGF’s influence within ACT-A and COVAX, given its financial power and role in facilitating the transfer of Oxford University’s vaccine technology to AstraZeneca, a private company. The UN General Assembly has reaffirmed equitable access to COVID-19 technologies as a global priority, and NGOs like Oxfam have called for a “people’s vaccine” available free to all.

Despite these efforts, several high-income countries have entered into bilateral Advance Purchase Agreements (APAs) with vaccine manufacturers, securing large quantities of doses outside COVAX. For example, the United States secured 800 million doses at $10 billion, and the United Kingdom procured 340 million doses. This “vaccine nationalism” threatens to exacerbate inequities, leaving LMICs and LDCs reliant on donations or delayed access.

Pharmaceutical companies have engaged with COVAX to protect their intellectual property rights and profit margins. They have proposed differential pricing, charging higher prices to high-income countries and lower prices to LMICs, a form of cross-subsidization. However, reliance on voluntary corporate commitments is insufficient to guarantee equitable access. For instance, Gilead Sciences’ voluntary licensing of remdesivir restricted supply to select countries, excluding many in Latin America.

The India-South Africa proposal to the TRIPS Council aims to open access to COVID-19-related technical and scientific information by waiving IP protections on patents, copyrights, industrial designs, and undisclosed information without fear of WTO sanctions. This approach prioritizes global solidarity and public health over profits during a health emergency.

Support from the WHO and UNAIDS underscores the proposal’s significance. At TRIPS Council meetings on 15 and 16 October 2020, member states expressed divergent views: two countries fully supported the waiver, several offered conditional support pending negotiations, while nine—including the United States, Switzerland, Japan, Norway, the United Kingdom, Canada, Australia, Brazil, and the European Union—opposed it outright.