The COVID-19 pandemic has exposed profound inequalities in people's access to healthcare and medicines across countries; the distribution of the COVID-19 vaccine is a glaring example.
As of 7 April 2021, over 704 million doses of COVID-19 vaccines have been administered in 153 countries. 62 percent (approximately 401 million) went to the United States, the European Union, the United Kingdom, and China. In 2021, 70 percent of total available vaccine doses have been secured by 16 percent of the world population. Most high-income countries will complete their inoculation drive by the end of 2021. But, nearly a quarter of the world's population will have access to vaccines only by 2022, and in low-income countries, not until 2024. 86 percent of the total COVID-19 vaccine doses have been administered in high-and upper-middle-income countries. Only 0.1 percent have reached people in low-income countries.
86 percent of the total COVID-19 vaccine doses have been administered in high-and upper-middle-income countries.
While discussing the international legal framework on the right to health viz-a-viz access to essential medicines and protection of Intellectual Property Rights (IPRs), this piece argues that equitable access to COVID-19 vaccine is a human right and should be upheld. Pharmaceutical companies should adopt the rights-based approach and facilitate swift universal vaccination by relaxing patent rights and cooperating in technology transfer. Failure to provide equitable and speedy access to COVID-19 vaccines will prolong the pandemic and intensify social and economic catastrophes in middle-and low-income countries.
At WTO In October 2020, India and South Africa requested the World Trade Organisation (WTO) to temporarily waive some provisions of the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement, to ensure all countries have equitable and quick access to COVID-19 vaccines, drugs, and medical products during the pandemic.
The proposal was supported by 140 members, but despite several rounds of meetings, it remained blocked at the 164-member WTO. Opponents to the proposal — Australia, Brazil, Canada, Ecuador, El Salvador, Japan, the European Union, the United Kingdom, and the United States — argued that waiving IPRs would hamper scientific innovation and discourage drug makers.
The treaty provisions relating to human rights and IPRs do not impose mutually exclusive obligation.
Is there a conflict between the human right to access to medicines and the protections on intellectual property? There is no inconsistency. The treaty provisions relating to human rights and IPRs do not impose mutually exclusive obligation. However, there is some borderline tension among the two rights in practice, which has been discussed in the legal theory.
Deliberating on law
The 1966 International Covenant on Economic, Social and Cultural Rights (ICESCR), ratified by 171 states, recognises and protects the right to healthcare and rights on intellectual property. As per Article 12 of the ICESCR, everyone has a right to enjoy the "highest attainable standard of physical and mental health." Article 15 (1)(b) of the ICESCR recognises the right "to share in scientific advancement and its benefits." Article 15(1)(c) provides the right "to the protection of the moral and material interests resulting from any scientific, literary or artistic production." In other words, Article 12 provides for human right to health and a derivative right to adequate access to essential medicines when read with Article 15(1)(b), which provides a sick person with a right to benefit from scientific progress and Article 15(1)(c), which encourages scientific innovation and artistic creativity and allows people to profit from these.
It seems that there is some apparent contradiction between human rights to health and the rights of entities over their intellectual property. But human rights enjoy a superior moral and legal claim over the IPRs — distinguished as temporary monopoly and legally protected interest of lower claim. In its 2000/7 resolution, the UN Sub-Commission for the Promotion and Protection of Human Rights, asserts that human rights should enjoy precedence over patents or other economic policies. In the context of the HIV/AIDS epidemic, the UN Commission on Human Rights, in its 2005/23 resolution, advocates practical action to combat pandemic diseases and "affirms the importance of public health interests in both pharmaceutical and health policies."
Human rights enjoy a superior moral and legal claim over the IPRs — distinguished as temporary monopoly and legally protected interest of lower claim.
The Committee on the Economic, Social and Cultural Rights has dealt in detail with the provisions related to access to medicines and IPRs, under the General Comments. On the obligation of the state parties under ICESCR, General Comment 3 affirms that the states must realise the rights protected by the Covenant, which include the right to health and access to medicine and vaccination. The states should achieve these goals either independently or through international assistance and cooperation. General Comment 14 spells out the developed states' obligation to provide economic, scientific, and technical assistance to developing countries in immunisation programs and other strategies of prevention, treatment, and control of infectious diseases. General Comment 17 says, "Ultimately, intellectual property is a social product and has a social function" and counsels the states to strike an adequate balance between obligations under Article 15(1)(c) and 'other rights' as enshrined under various provisions of the ICESCR, including the right to food, health, and shelter. General Comment 25 states that every person is entitled, without any discrimination, to the "best available applications of scientific progress necessary to enjoy the highest attainable standards of health."
The mandate to provide affordable and widespread access to essential medicines and pressure from developing countries forced the World Trade Organisation (WTO) to restructure and link IPRs to trade policies. This led to the adoption of the ambitious TRIPS Agreement in 1994, which allowed WTO's least-developed members to evade certain patent restrictions and secure public health. Over the past years, many countries have been demanding flexible implementation of the TRIPS Agreement, but this has been blocked by pharmaceutical giants. Even in the production and distribution of COVID-19 vaccines, the TRIPS Agreement is at the heart of the process of universal COVID-19 vaccination.
Is TRIPS effective?
Experts argue that the TRIPS Agreement's current flexibilities — parallel imports and compulsory licenses — can address the challenge for the production and distribution of COVID-19 vaccines. However, these flexibilities are never fully realised in their spirit due to complex and burdensome in-built mechanisms. Thus, countries have to fight on many fronts to procure life-saving drugs. It took Rwanda three years to process the import of generic HIV/AIDS drugs from Canada due to conditions imposed under Canada's TRIPS national regime. The governments that decided to manufacture generic drugs at home were sued by the pharmaceutical companies challenging national laws. 39 pharmaceuticals sued the Government of South Africa in 1998, when it attempted to break the monopolies of foreign firms on anti-retroviral drugs. Some of these legal battles lasted for over a decade. In 1998, Swiss pharmaceutical giant Novartis filed a lawsuit against India's government to secure monopoly control over its treatment for leukaemia. The Supreme Court of India finally decided this case in 2013. To avoid legal challenges, the developing countries, instead of opting for TRIPS waiver benefits, are now entering into bilateral agreements with industrial countries to receive essential drugs. This was approved by the WTO in 2016, after a decade-long negotiation. Due to these ambiguities, the WTO, in 2002, adopted the Doha Declaration on TRIPS Agreement which affirms that "the TRIPS Agreement does not and should not prevent members from taking measures to protect public health." However, obstacles continue to persist for developing countries.
Not surprisingly, none of the drug makers has signed the WHO's technology access pool for COVID-19 vaccine technology transfer. Despite multiple reforms, pharmaceutical companies continue to enjoy monopoly, which directly impacts people's health. The COVID-19 pandemic has allowed us to reflect on how we operate and benefit under the current IPR regime, in the essential pharmaceuticals and drugs segment.
While governments have the primary responsibility to respect, protect, and fulfil human rights, corporations also have an obligation to respect human rights. The 2008 UN Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines and the 2011 UN Guiding Principles of Business and Human Rights draw a duty on the pharmaceutical companies to respect human rights. In the fight to eradicate COVID-19, they are bound to ensure everyone has affordable and equitable access to COVID-19 vaccines without any impediment in supply due to enforcement of IPRs.
The World Health Organisation (WHO) Constitution states that every person is entitled to the "highest attainable standard of health." However, in practice, what is attainable under the current legal framework remains ambiguous, as access to medicines, vaccines, and medical technologies remain under the control of a few selected countries and pharmaceutical giants.
The world needs the vaccine today — not tomorrow — to stop the disease and end the pandemic. We need to embrace the access to medicine movement — a movement against patent monopoly in life-saving drugs. A TRIPS waiver, which India and South Africa requested at WTO, will allow drug manufacturers in multiple countries to produce COVID-19 vaccines without taking individual legal measures. While this alone will not help vaccinate the world, it will be a step towards solving the global imbalance in equitable access and distribution of the vaccine.
This article was first published on ORF.