COVID-19: The world needs to back India and South Africa’s call to remove TRIPS hurdles

A research scientist works inside a laboratory of India's Serum Institute, the world's largest maker of vaccines, which is working on vaccines against COVID-19 in Pune on 18 May 2020. Euan Rocha/REUTERS

On 2 October, India and South Africa sent a joint communication to the Trade Related Aspects of Intellectual Property Rights Council of the World Trade Organisation, the multilateral institution formed to promote free trade between countries. The communication asked the body to recommend a waiver of major intellectual-property provisions of the TRIPS agreement for technologies to prevent, contain and treat COVID-19. The proposal was made in the middle of the global race to develop medicines and vaccines against the coronavirus. 

The communication said, “It is important for WTO members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.”

At the heart of the debate about access to COVID-19 related vaccines, diagnostics and medicines are the contentious provisions of the TRIPS agreement. The WTO largely functions on the assumption that free trade helps increase the wealth of the nations and is thereby one of the pathways for poverty reduction. Intellectual-property rights or IPR recognised under the TRIPS agreement include patents, trademarks, and copyrights. These provisions provide monopoly rights to “innovator” companies, thereby preventing competition. Such monopolies, when applied to health-related products such as medicines, diagnostics, medical valves or even masks hinder accessibility and affordability by denying the early entry of generic products into the market. 

For example, in 2013 the United States approved a drug from Gilead Sciences called sofosbuvir meant to treat hepatitis C. The company got a patent in several countries including the US, granting it market monopoly up to 2024. As a result, a complete course of sofosbuvir cost $84,000 in the US. The same course is available as a generic in Egypt, where there was no patent, for just $1,900. The ostensible reason for granting patents to innovators is to encourage research and development and reward path-breaking innovations. However, patents have been used more as blanket commercial incentives resulting in the erosion of patient welfare. Moreover, most basic molecular research is not done by pharmaceutical companies themselves but in public universities funded by taxpayer money. Gilead Sciences got funding through the government-run National Institutes of Health in the US to develop sofosbuvir and still applied for a patent. 

Even before the COVID-19 pandemic, 50 percent of the world population lacked access to health technologies. Members of the WTO recognised public health barriers that intellectual property rights and TRIPS created at the organisation’s Doha ministerial summit in 2001. They agreed to allow TRIPS provisions to be interpreted in such a manner as to protect public health. The Doha Declaration that emerged from the summit allowed use of provisions like compulsory licensing, which allowed governments to suspend or revoke patent monopolies and allow generic manufacturing during emergencies like the current pandemic. 

India and South Africa’s recent communication to the TRIPS council echoes the Doha Declaration. It found support from most countries that identify themselves at the WTO as least developed and developing—Egypt, Indonesia, Bangladesh, Honduras, Tanzania on behalf of 43-member African Group, Chad on behalf of the 36-member Least Developed Countries group, Sri Lanka, Pakistan, Venezuela, Nepal, Nicaragua, Argentina, Tunisia, Mali, Mauritius and Mozambique. 

The WHO declared COVID-19 a pandemic on 11 March 2020. As of 1 October, there were more than 330 million confirmed cases globally and had more than one million deaths. Existing medicines that have been repurposed to treat COVID-19 such as remdesivir, heparin, dexamethasone and favipiravir have shown limited effectiveness. Ten months into the pandemic, there has been no COVID-19 specific drug or vaccine developed. 

The initial stages of the outbreak of disease saw attempts at global solidarity. China, the country where the pandemic originated, shared the coronavirus genome sequence with the WHO by early January 2020. Countries contributed to the WHO’s fund for a pandemic response. However, as the year progressed, things slipped to business-as-usual mode with international business resorting to its profiteering approach to COVID-19 technology development be it vaccines, diagnostics, medicines for treatment or related equipment such as personal protection equipment or machines for support. 

The World Health Organisation has deployed many tools to ensure fair and equitable access to biomedical technology that can combat the disease. In May 2020, the World Health Assembly, the decision-making body of the WHO, passeda resolution calling for the “removal of unjustified obstacles” to “Equitable Access to Covid19 Technologies”, known by its abbreviation EACT. The WHO set up the COVID-19 Technology Access Pool or C-TAP initiative to gather COVID-19-related technical and scientific information in an open-source environment for faster deployment of vaccines, medicines and other technologies. However, big pharmaceutical companies ridiculed this step. Albert Bourla, the chief executive of Pfizer, called the step “nonsense” and “dangerous”. 

The world will need vaccines for the global population of nearly eight billion. Such a large number of doses cannot be manufactured immediately. Anticipating unequal access to COVID-19 resources, the WHO created an allocation framework for fair, ethical and equitable access to COVID-19 health products. The framework defined a ‘priority group’ that covered around twenty percent of the global population comprising frontline workers such as doctors, nurses, community health workers, sanitation and other essential workers, as well as the elderly and people with co-morbidities. This priority population will require about two billion vaccine doses. The world will still need a mechanism to manufacture, procure and equitably distribute the rest of the six billion vaccine doses—maybe more depending on whether more than one dose is required—to protect the global population.

The other global initiative around COVID-19 vaccines is the Access to COVID-19 Technologies accelerator. ACT-A is a collaboration of the WHO, the World Bank, the Bill & Melinda Gates Foundation which is a private philanthropic organisation, Gavi which is the vaccine-focussed global alliance, and global health organisations such as The Global Fund, Unitaid and Wellcome. One of the pillars of ACT-A is its vaccine mechanism called COVAX, which is a pooled procurement system for COVID-19 vaccines. It has identified certain eligible countries to which it will distribute vaccines at heavily subsidised prices. COVAX guarantees access to vaccines only to priority populations—around 20 percent of total population—in the groups of low and middle income countries called LMICs and least developed countries called LDCs. Countries will have to negotiate bilateral agreements with manufacturers for vaccine doses meant for people outside this target population at prices fixed by the company. Organisations like the BMGF command considerable power given their financial strength, relegating WHO to the margins in the COVAX partnership. This raises concerns of unequal access to the eventual vaccine. Public health experts around the world have raised questions about the BMGF’s accountability during the pandemic. The foundation played a role in Oxford University, which is a public university, handing over its vaccine technology to AstraZeneca, a private pharmaceutical company.

The UN general assembly has reiterated that EACT is a global priority. Oxfam, the international NGO, has called for a “people’s vaccine,” which should be available to all people in all countries free of charge. However, several high-income countries have entered into bilateral Advance Purchase Agreement or APAs with vaccine manufacturers after anticipating the need to look beyond COVAX for vaccine supply. This has given rise to a COVID-19 version of  vaccine nationalism. A case in point is the United States’ APA deals with seven vaccine manufacturers to secure 800 million doses at $10 billion and the United Kingdom’s deals for 340 million doses. Countries that have the capacity and companies working on COVID-19 tools are moving away from global solidarity, threatening huge inequity in access to COVID-19 treatment related tools, leaving LMICs and LDCs in the lurch.

High income countries will be able to buy vaccines for most of their populations beyond the designated priority populations. However, LMICs and LDCs that lack the same financial resources may not be able to afford so many vaccine doses by entering into APAs within a short period of time. For example, during the 2008 H1N1 crisis countries like France bought out a majority of H1N1 vaccines in the market. Meanwhile, LDCs had to wait for vaccine donations.This time too, LDCs may have to wait for the IPR of COVID-19 technologies to expire for competition to bring down prices of the vaccine or wait for donations. 

Not surprisingly, pharmaceutical conglomerates have enthusiastically participated in COVAX to safeguard their IPR and profit margins. The global pharmaceutical industry has also been hinting at differential pricing by which HICs will have to pay more and LMICs can pay less for medicines—a form of cross subsidisation. The global health system cannot rely only on the voluntary intent of pharmaceutical companies for COVID-19 drugs in LMICs to ensure equitable access. Even during this global health emergency, Gilead Sciences, which holds the patents for the drug remdesivir, entered into unfair voluntary licenses with generic companies. That restricted the number of countries the medicine can be supplied to and excluded Latin American countries.

The communication by India and South Africa to the TRIPS Council can trigger opening up access to COVID-19 related technical and scientific information. It can spur action that will allow countries to waive intellectual property protection on copyright, industrial design, patents and undisclosed information without the fear of sanctions for violation of international trade rules. It is a call for solidarity and cooperation, putting people before profits, during a health emergency that requires a global effort. Without relying solely on voluntary mechanisms of pharmaceutical corporations, LDCs and LMICs need to support the communication for the waiver to ensure that they can use COVID-19 related technology without fear or control by pharmaceutical corporations and thereby protect the health of their people. It will also allow countries like India and Brazil, which have production capacities, to quickly ramp up manufacturing and distribution of vaccines and medicines. This could potentially help supply other LMICs and LDCs. 

The WHO and the Joint United Nations Programme on HIV and AIDs, known as UNAIDS, have expressed their support for the waiver proposal. The TRIPS council received differing opinions from member states at their meetings on 15 and 16 October. Two countries fully supported the move, some provided general support seeking further negotiation on the proposal, and nine members—the United States, Switzerland, Japan, Norway, the United Kingdom, Canada, Australia, Brazil and the European Union—completely opposed the move. If other WTO member countries support the proposal, they will be effectuating the principles of EACT. They will also help speed up the response to the pandemic by removing barriers to technical and scientific information. The last two months of this year will be crucial as the WTO rules require the member countries to further consider this proposal within 90 days of receiving the application for waiver. The waiver proposal will expire on 31 December. 

Countries need to be proactive to break monopolies, move towards a people’s vaccine and allow open access to COVID-related tools. This is a better strategy than depending on voluntary commitments and appealing to the goodness of the pharmaceutical industry. The waiver proposal serves as a step towards building precedence within the WTO for pandemic situations and provide legal clarity for member states to develop policies that do away with the intellectual property protections for COVID-19 tools in these times of crisis. 

Prasanna S Saligram and Priyam Lizmary Cherian are associated with Equitable Access to Covid Technologies Project of the People’s Health Movement.