COVID-19 TREATMENTS: ACCESSIBILITY, HUMAN RIGHTS AND PATENTS
As COVID-19 treatments traverse their voyage from laboratories to people, major questions regarding their pricing in private markets have emerged. Though governments, including that of India, aim to provide the treatments at subsidized prices, the process of vaccinating billions, especially those belonging to poorer countries is unlikely to be successful if private companies continue to monopolize the rights of producing the treatment facilities.
The unavailability of treatments to a large proportion of the human population is directly in contravention of the human rights obligations of states promulgated in The Declaration of Alma-Ata, 1978 which recognized that health is a fundamental human right demanding urgent international action, and declared that attainment of greatest possible degrees of health world-wide is a primary social goal for all nations. The problem of inaccessibility of treatments also violates the international responsibilities of states laid down in Article 2.1 of The International Covenant on Economic, Social and Cultural Rights, which obligates states to ensure progressive realization of the rights protected by the Covenant, including the right to health provided in Article 12 of the covenant, both individually and through international assistance and co-operation.
The effects of the pandemic on the lives of the people and the threat it occasions on their life itself has transformed the availability of treatment facilities for COVID-19 into an essential human rights demanding urgent attention. A report by Oxfam acts exhibits the gravity of the situation, claiming that 90% of the people in poorer countries won’t be able to procure a vaccine in 2021. These reports act as reminder of the HIV crises nearly twenty years ago, when access to affordable treatment became difficult due to patenting, resulting in nearly 9000 deaths on a daily basis. Consequently, countries of the world came together under the liege of the World Trade Agreement in November, 2001 to promulgate the Doha Declaration on the TRIPS Agreement and Public Health, whereby it was clarified that global intellectual property rules permit governments to issue licenses for patents during a public health crisis. In order to ensure accessibility of treatment for the poorest, several drastic but necessary measures encouraging the suspension or overriding of intellectual property rights of patent-holding private companies have been proposed in recent times.
The India-South Africa Proposal
Today, as we face the worst heath crises in modern human history, lessons from the early days of the HIV crises when treatment was available only to the rich, seem to be forgotten by developed countries who are persistently opposing the Indian-South African proposal to push a temporary ban on COVID-19 related patents. Instead of working towards accessibility, wealthier countries have adopted prejudicial policies of “vaccine nationalism” by hoarding the vaccines by pre-ordering enough dosages to vaccinate their entire populations three times, whilst poorer countries struggle to purchase enough to vaccinate a quarter of theirs due to monopoly over production activities by few private actors.
Considering the situation, the temporary ban on patents of COVID-19 related treatments proposed by India and South-Africa in October, 2020 and supported by many middle and low income countries under the World Trade Organization’s Trade-Related Aspects of Intellectual Property (TRIPS) may be necessary to ensure accessibility of vaccines, medicines, and other new technologies needed to control the pandemic. A temporary ban would permit multiple actors to commence production of the vaccines, instead of concentrating the production with few patent holders. Although the waiver is being supported by most countries, it has not been passed, as decisions in the WTO are generally based on a consensus. Wealthier countries, many of which have already accumulated buffer stocks of treatment facilities are opposing the waiver, citing the importance of intellectual property rights as incentives for private actors with sufficient capabilities to develop additional expertise and technology required for combatting the pandemic in future.
It has been contended that mechanisms encouraging technology transfer by patent holders on a voluntary basis should be preferred over a legal waiver, but voluntary transfer cannot be an ideal solution as the results delivered by the same are limited. For instance, an agreement between the Serum Institute of India and AstraZeneca for voluntary transfer of technology has been criticized for lack of transparency. On the other hand, many companies delivering promising results such as Pfizer and BioNTech have not exhibited proclivity for technology transfer of their patented products.
Similarly, other initiatives being proposed as an alternative to the waiver, such as the COVAX initiative which aims to ensure equitable access to vaccines, suffer from limitations induced by vaccine nationalism and absence of support from geopolitically and economically important countries like the United States.
Article 73: The National Security Exception
Article 73(b) in the TRIPS agreement, which primarily governs Intellectual Property Rights in the international realm permits countries to take any actions it considers necessary for “protection of its essential security interests”. In Article 73(b)(iii), these interests include war and other emergencies in international relations.
These national security grounds have often been invoked for non-compliance with otherwise applicable norms, including contravention of patents. However, they often culminate into disputes before the World Trade Authority, the resolution of which entails its own costs. In a recent dispute between Qatar and Saudi Arabia regarding non-application of intellectual property rights under the TRIPS agreement, the dispute settlement panel noted that when a state proceeds under Article 73(b), claiming that they are undergoing an emergency in international relations, the panel may reach a decision after determining:
Whether the existence of international emergency in international relations has been established;
Whether the relevant actions were taken during the time of the emergency;
Whether the invoking state has been able to articulate a link between the “essential security interests” and the relevant actions undertaken;
Whether the relevant actions are so remote from the emergency as to make it implausible that the actions were necessary for the protection of its essential security interests arising out of the emergency.
With respect to COVID-19, the Article may be invoked by individual states to justify a breach of the intellectual property rights of patent-holders within their borders, after establishing the above before the WTO panel. COVID-19, having been declared as a public health emergency by the WHO Director-General in January, 2020 itself and having caused over 2 million deaths can be deemed as an emergency concerning the international community. This, compounded with the fact of the severely uneven distribution of treatment facilities between High and Low income countries, along with other aspects arising out of the pandemic including slowdown of international trade and travel should be sufficient to justify the pandemic as an “emergency of international relations”. The second element may be satisfied as long as the pandemic lasts, and continues to represent a threat to public health. The protection of public life and health remains one of the core obligations of a state, and a pandemic that threatens public health and domestic order should be sufficient to satisfy the third element. A plausible relationship between the act of protecting public health by increasing the accessibility of COVID-19 treatments, and overriding foreign patents in order to encourage their production through a greater number of domestic manufacturerscan be established by lower income countries.
However, the national security exception is not devoid of limitations, which have been discussed in the Qatar-Saudi Arabia case and 2019 dispute between Russia and Ukraine regarding transit in goods. Firstly, the national security exception requires that a state is able to establish a plausible relationship between overriding of patents and national security. For this, the state needs to possess the capability of producing treatments and other treatments, and the same cannot be proved by a number of low-income countries. Further, the exception cannot be invoked by a state that possesses the capability to provide treatments to another state which does not possess the same, for this action will be considered remote to the security interests as per the interpretation of the section in the abovementioned decisions. Hence, middle or high income countries (with production capabilities) cannot provide assistance to lower-income countries using the security exception, and the former would be left without a recourse in the absence of adequate production capabilities.
Whilst Article 73 may act as a potential solution for some countries, the glaring reality of absence of production capabilities is likely to preclude many lower-income countries from invoking the national security exception as an efficacious remedy.
Compulsory Licensing: Article 31 of the TRIPS Agreement
One of the primary alternatives being proposed to confront the inaccessibility problem is Compulsory Licensing, the principles and procedures for which are laid down in Article 31 of the TRIPS Agreement. The provisions authorize governments to permit parties other than patent holders to use the technology without consent of patent-holder in certain circumstances. Whilst compulsory licenses in the interest of public health, which is the supposed exception to invoke for an urgency such as COVID-19 sounds like an amenable solution, a bare perusal of the TRIPS agreement exhibits the way in which the agreement subjects these licenses to a number of conditions; Article 31(c) ensures that the duration and scope of license is limited to authorized purpose, Article 31(d) mandates the grant of these licenses to be non-exclusive and non-assignable, Article 31(f) states that licenses can be granted only for maintaining supply to the domestic markets of the authorizing member, Article 31(h) mandates provision of adequate remuneration to the patent holder and Article 31(i) subjects the licenses to judicial review and other independent review. A recent amendment to the agreement appended Article 31(bis), which supersedes the domestic market restriction for health emergencies in Article 31(f), and allows third countries to export drugs at affordable rates to poorer countries without adequate capacities for production. However, these licenses are still subjected to other conditions such as judicial review and remuneration to patent holders.
The remedy, though appearing to be lucrative in theory, has been found to be too complex and slow in its application, and has not acted as an efficacious solution to the problem of accessibility. The limitations of the mechanism are compounded by a lack of lucidity in the section and presence of highly subjective terms. For instance, with respect to the provision of ‘Adequate” remuneration, the term adequate has not been defined, which makes any given license subject to judicial review. The inefficiency of the mechanism became conspicuous recently, when Israel chose to provide a compulsory license to import Lopinavir, a COVID-19 drug being tested in India without abiding by the mechanism provided in TRIPS agreement in light of the limitations of the process. However, despite its limitations, the compulsory licensing mechanism is one of the more commonly used remedies to combat such crises, and in the absence of other effective remedies, the same might be able to provide some relief against the problem of accessibility if necessary cooperation with relevant stakeholders is achieved and regulatory barriers, which have hindered its effective implementation are overcome.
The COVID-19 pandemic, having transcended the title of a mere health concern has become a human rights concern for all. Controversies regarding equitable access of treatment facilities have prompted drastic suggestions on a global level in the form of invocation of the national security exception under TRIPS and a temporary suspension of COVID-19 related patents. Whilst the former is unlikely to be an effective solution for countries without production capacities, the latter is being opposed by wealthier countries. In the absence of a consensus on effective solutions for ensuring accessibility, the lives and futures of many continue to remain uncertain despite clinical successes in battling COVID-19.
Title Image Source: Research Professional News
This article has been written by Kashish Agarwal. Kashish is a second year student of law in National Law University, Delhi.