Written by Sandeep Singh Chauhan
Fourth Year, BA. LLB. National Law University, Odisha
Source: Times of India
Disclaimer: Please note that the views expressed below represent the opinions of the article's author. The following does not necessarily represent the views of Law & Order.
The COVID-19 pandemic has put the human race at an intense test which led the entire globe in a race to develop a vaccine to end the pandemic. As the global race for the vaccine escalates, there is a question that haunts everyone’s mind: When will a successful vaccine be available in the market and how will its accessibility and affordability be ensured across the globe?
The issue is genuine as many vaccines are already in the clinical trial stage, it can be expected to be in the market sooner rather than later. The accessibility and affordability of the vaccine is not a novel issue before the world but similar to one which was also witnessed during the H1N1 pandemic. During the H1N1 pandemic, developed countries have taken the advance orders of the vaccines and effectively carved out low and middle-income countries. Thus, availability and affordability of the vaccine remain a major global concern.
The present article analyses the different issues that become a barrier to the accessibility vis-à-vis affordability of the COVID-19’s vaccine after it emerges into the market and further provides a solution to overcome it with the help of intellectual property rights.
Importance of Agreement on Trade Related Aspects of Intellectual Property Rights
It is a very well recognized fact that intellectual property rights are important for the development of new medical products but the same has the potential of becoming a thwart for public health as the monopoly of the patent right holders may not allow the accessibility of the vaccine at affordable rate. This leads us to the question of how a developed vaccine can be accessible after patented. Therefore, Article 31 of the Agreement on Trade Related Aspects of Intellectual Property Rights [hereinafter ‘TRIPS’] provides a way out in the form of compulsory license. Compulsory license is defined as ‘a competent government authority to license the use of a patented invention to a third party or government agency without the consent of the patent-holder during emergency’. It helps to suspend the monopoly effect of the patent holder so that individuals other than the patent holder are allowed to produce and supply the product.
Moreover, Article 31 of the TRIPS Agreement includes the license of pharmaceutical and medical products as further augmented in the Doha declaration on the TRIPS Agreement and Public Health. Compulsory Licensing is beneficial amid the pandemic period as it furnishes the interested party a chance to develop a bio-equivalent vaccine or generic vaccine which is cheaper in rate. Thus, it would help in these unprecedented circumstances by providing a generic vaccine at affordable prices across the globe.
For instance, antiretroviral (HIV medicines) has been charged around $10,000 per patient per year in the United States by the pharmaceutical companies who withhold the patent monopolies. However, Cipla has come up with a generic version of HIV antiretroviral at less than $200 per patient per year. This makes the antiretroviral treatment within reach to many people across the globe.
In the light of COVID-19, many countries recently adopted a resolution for use of compulsory license in allowing access to technology, medicine and vaccines needed for curbing the outbreak. For example, Chile has adopted a resolution for granting of non-voluntary licenses under the Industrial Property Law. Besides, Israel has issued compulsory licenses and suspends patents related to medicines, such as lopinavir/ritonavir which are drugs developed for reducing the effects of the Coronavirus. It has also allowed importing of generic medicines from other countries. In the same way, countries like Canada, Germany, Ecuador, and others have also amended their laws to grant compulsory licenses. Further, thirty-seven members of the World Trade Organization, who were listed ineligible to import medicines manufactured under a compulsory license in 2003, are now urged to declare themselves eligible for the same under Article 31 bis of the TRIPS Agreement.
Another incidental issue to the accessibility of the developed vaccine lies in the fact that many countries lag behind in their manufacturing and pharmaceutical capacities. However, the issue can be resolved with the help of para 6 of the Doha Declaration on the TRIPS Agreement and Public Health which states that the countries, which are insufficient in the pharmaceutical sector, can import the generic medicines from countries which are developing it.
For instance, Rwanda is the only country to date which used this mechanism to import cheaper life-savings medicine from the Canadian generic company Apotex for HIV patients. However, it was not effective due to the slow and arduous process of their agreement. Despite this being the case, it doesn’t make the whole mechanism invalid. Yet, WTO members should carefully examine the reasons behind the system deficiencies before implementing it among the countries. Thus, in the post coronavirus’ vaccine period these provisions would help not only in terms of protection from misuse of a patent monopoly but will also provide accessibility of the vaccine to low-middle income countries at a feasible rate.
Countries are taking preventive measures to ensure a breakthrough in patent barriers to access the vaccine of COVID-19 because of which they turned to compulsory licenses as a sensible measure for individual countries but it does not address the requirement for preemptive global mechanism. A proposal given by Costa Rica to the WHO for the establishment of a voluntary patent pool for COVID-19 is one of the preemptive global mechanisms. It is further supported by the Medicines Patent Pool and the United Nations. Patent pool defined ‘a voluntary agreement between two or more patent owners to access patent and other intellectual property rights to each other or third party for production and advanced development of product’. The COVID-19 pool has been made for the countries, universities, and research companies to share data, technology, medicine, and vaccines with each other. The patent pool is helpful for countries that can approach the pool and agree to the terms and start manufacturing the products. Thus, it helps hundreds of manufacturers across the world to produce the vaccine and make it quickly available.
The patent pool not only helps in the accessibility of vaccines but also to reduce the cost of the vaccine for low-middle income countries. For instance, the Medical Patent Pool has established a license agreement that allows the sub-license in the countries which signed the agreement, to develop the generic version of drugs for the treatment of tuberculosis, HIV, and other essential medicines. They have developed many generic medicines under the said agreement such as tenofovir, disproxi, dolutegravir for the treatment of HIV/AIDS. Thus, the global patent would play a key role in the accessibility of the vaccine at affordable prices across the globe. However, this can only be accomplished with the collective efforts of countries, international organizations, companies, universities, and researchers.
In the current global crisis, states have the obligation to adopt measures necessary to protect public health and prevent the abuse abuse of intellectual property rights as provided under Article 8 of the TRIPS Agreement. However, many low-middle income countries have not been able to take action on these measures and due to which they remain unprotected from the COVID-19. It is therefore imperative for international agencies and countries to implement the Compulsory License and Patent Pool measures as these encourage accessibility and affordability for life-saving medication. It is suggested that these measures could help in encouraging a competitive supplier base for the quality vaccine at affordable prices across the globe. Further, they will also play a key role in improving the transparency with respect to the patenting of vaccines and strengthening of intellectual patent rights capabilities, wherever is necessary in order to reduce patent-related impediments.
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WTO Decision on the Implementation of Paragraph 6 of the Doha Declaration.
WHO and Costa Rica preview technology pooling initiative to ensure access to COVID-19 health products.
Patent Pools and Antitrust – A Comparative Analysis by World Intellectual Property Organization.
Annual Report 2018 of the Medicines Patent Pool.
Access to Medicines: Intellectual property protection: impact on public health by World Health Organization.