Over the past year, the Covid pandemic has substantially altered everyone’s lives. The pervasive condition across the globe has created a situation of incessant panic and distress. With the advent of the second wave, a new set of issues have arisen which are being discussed and debated upon regularly. One of the cardinal discourses is the protection of Intellectual property in the Covid-19 vaccines.
Patents on manufacturing drugs offer pharmaceutical companies a monopoly over their inventions in the market for at least 20 years.But considering the current situation, multiple countries have made a proposal to temporarily waive the patent protection on the Covid-19 vaccines in public interest. The need to ensure equitable access to the vaccine is the primary motivator behind this proposal. The simple explanation behind such a waiver is the urgent need to maximize production and ensure efficient accessibility.
Regulation for protection of Vaccines
With the development of the vaccine, the first step taken by the manufacturers in various countries was to file for patent registration to secure the monopoly in their respective markets. This monopoly is the drug maker’s way to cover their enormous expenses made for the development of the drug. The patent monopoly thus acts as an incentive for the manufacturers to undergo a process which drains a substantial amount of money with no outright profit.
The 1995 Agreement on Trade-related aspects of Intellectual Property Rights (The agreement on TRIPS) is one of the major instruments which binds its member states to ensure that there is at least a minimum level of IP rights protection. TRIPS is, therefore, the main regulatory authority that imposes an obligation to grant patent protection to the vaccine manufacturers in the member states. This has always been a controversial topic where the proponents argue in favor of protection to incentivize development and innovation. While the critics emphasize the people’s right to health and state how a drug patent hinders the availability of affordable vaccines in developing countries.
The Marrakesh Agreement, which established the WTO and the Agreement on TRIPS, also provides a clause for “exceptional agreement” under Article IX (3) which allows the Ministerial Conference to waive any obligation imposed on any of the member states by a WTO Agreement. Such a waiver is required to be supported by three-quarters of the members. This clause was introduced to ensure that in case of extreme hardships, the member states have an alternative in case compliance with the WTO norms is not feasible.
A previous incident of a waiver granted by the WTO in a medical-related issue was in 2003 while dealing with the accessibility of medicines in the developing countries that lacked the ability to manufacture certain drugs. Obligations under Article 31 of TRIPS were waived which required grant of a compulsory license for supply of a patented drug. The obligation to compensate the patent holder was also waived for the eligible importing member states.
Prevailing situation across the globe
With the rise in Covid-19 cases, there has also been considerable progress on the part of the pharmaceutical companies and research organizations in developing vaccines and other drugs to combat the virus. Considering the health crises, it is essential that all the people across the countries are vaccinated. This has established an unprecedented demand for the vaccine. This is a direct coefficient to the requirement of its increase in production, supply and distribution on a global level. This has brought the pre-existing debate on vaccine patents to the forefront. Since the developers have the exclusive right to manufacture, sell and use the vaccines for the term of patent protection (20 years), the issues of wider accessibility have been raised. Due to this, a joint proposal was presented by India and South Africa in October 2020 to the WTO, requesting a temporary waiver of the IP rights on the vaccine because it hinders the supply of drugs at an affordable rate. This proposal was supported by the WTO Director-General and taken up by the WTO TRIPS Council as a recommendation to the General Council to ensure containment of the coronavirus. Granting of this waiver would release the member states from the obligation of enforcing the patents and other IP rights of the manufacturers and may also require the IPR holders to reveal their trade secrets in public interest. Since then, multiple countries such as Kenya, Pakistan, Bolivia, Venezuela, Egypt, etc. constituting a group of 60 countries, have backed the proposal and are in favor of such waiver. It is argued that a global pandemic which is the most severe health crisis in the past century is undoubtedly an “exceptional circumstance” which warrants a waiver. By May, the United States was also one of the supporters of the proposed waiver which was deemed monumental, considering the States’ history of encouraging strong IPR protection enforcement.
IP waiver during the Pandemic
Considering the burgeoning statistics of Covid cases, the supporters of the waiver proposal have emphatically stated the need for access to treatments for Covid-19. Issues such as the cost of raw material, lack of a specific skill set as well as improper infrastructure have been cited in their demand for a waiver.
It is essential to note that a much-required boost in manufacturing will not happen by itself. Steps must be taken to ensure that all countries are well equipped to rise to the challenge. The WTO had put out a notice quoting the need for a sustainable vaccine production across the globe and commended companies like AstraZeneca, which had shared their license, to ensure manufacturing at multiple sites.
But counter arguments have been raised that a patent waiver amid a global pandemic would merely be considered as a psychological respite and would not be a practical solution. The requirement of a large investment and current insufficiency of raw materials would hinder the production and distribution of the vaccine. Further, a lack of expertise in development of the said vaccine might do more harm than good. The critics have consistently cited the IP waiver granted by Moderna, a pioneer in development of messenger RNA vaccines, who had explicitly stated their intentions of not enforcing Covid-19 related IP to ensure a quick end to this pandemic. This waiver was granted in 2020, yet there have been no instances of exploitation of this opportunity to ensure an increased supply.
Additionally, considering the main objective of the patent law, it must be understood that exclusivity, in the long run, is merely a trade-off which induces development and innovation. Removal of this protection would lead to the cost of development outweighing the benefits, with the manufacturers having no guarantee of recuperation of their investments. While the pandemic is a secluded event in a long time, it is definitely not a singular one. The cost of setting a precedent of a vaccine patent waiver would, in the long run, be counter-productive to the purpose fulfilled by IP protection.
The undemanding logic behind the proposal for a waiver is to end the global pandemic as soon as possible. The only solution carved out over the past two years is the vaccine in contention.While there may be considerable complications with the grant of a TRIPS waiver, it also appears to be the only feasible step in scaling up the supply to meet the availability requirements. Therefore, heeding to the words of the World Health Organization, “with a fast-moving pandemic, no one is safe, unless everyone is safe,” it is essential that all possible solutions are explored. While the waiver may cause a long-term hitch, the priority must be to ensure that the people’s right to health is not neglected. To improve access to innovation and ensure that the population across the globe develops an immunity to the virus, a temporary ban on monopoly presents itself as an exigency instead of a possibility.
But it is pertinent that while the slow process of access to the vaccines is afoot, efforts must also be spared in encouraging multilateral actions and endeavors outside the WTO. The WTO has the obligation to establish a balance between protection of IP and access to the work protected by the IP, thus, a patent waiver, while beneficial, might not be the most efficient method to curb a global pandemic.
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James Bacchus, An Unnecessary Proposal A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines, https://www.jstor.org/stable/resrep27669 (July 25, 2021 15:03 UTC).
Marrakesh Agreement establishing the World Trade Organization, No. 31874, 15 April 1994.
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Statement by Moderna on Intellectual Property Matters during the COVID-19 Pandemic,https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19, (October 8, 2020 at 6:39 AM EDT)
World health Organisation, Waive Covid vaccine patents to put world on war footing, https://www.who.int/news-room/commentaries/detail/waive-covid-vaccine-patents-to-put-world-on-war-footing (March 7, 2021).