This article is written by Sandeep Chauhan, a 4th year student of National Law University, Odisha.
The COVID-19 pandemic has put the human race to an excruciated test which led the entire globe to develop a vaccine to end this pandemic. When 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 a market sooner rather than later. The accessibility and affordability of vaccine is not a novel issue before the world but the same already 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, reliable availability and economically fair 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 very well recognized that intellectual property rights are important for the development of new medical products but the same has the potential of becoming thwart for public health. This leads us to the internal question of how developed vaccine gets patent rights or patented. The monopoly of the patent right holders can become a big thwart to the accessibility and affordability of the vaccine. However, 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 defined ‘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 bioequivalent vaccine or generic vaccine which is cheaper in rate. Thus, it would help in these unprecedent circumstances by providing a generic vaccine at affordable prices across the globe.
For instance, the 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, vaccine 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 license and suspends patents related to medicines, which are effective for Covid-19, are lopinavir/ritonavir. It has also allowed import of generic medicines from other countries. In the same way, countries like Canada, Germany, Ecuador, and others have also amended their laws to grant a compulsory license. 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 of the TRIPS Agreement.
Another incidental issue to the accessibility of developed vaccine lies in the fact that many countries lag behind in the availability of medical infrastructure for 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 it doesn’t make the whole mechanism invalid but WTO members should carefully examine the reasons behind the system deficiencies before implement 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 also provides accessibility of vaccine to low-middle income countries at a feasible rate.
Countries are taking preventive measures to ensure a breakthrough in the patent barriers to access the vaccine of COVID-19. Due to which they turned to compulsory licenses which is 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 Medicines Patent Pool and 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 the data, technology, medicine, and vaccine with each other. The patent pool is helpful for the countries which can approach the pool and agree to the term and start manufacturing the products. Thus, it helps hundreds of manufacturers across the world to produce the vaccine and made it quickly available.
The patent pool not only helps in the accessibility of vaccine but also to reduce the cost of the vaccine for low-middle income countries. For instance, Medical Patent Pool has established license agreement that allows the sub-licenses, in the countries which have agreed on 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, etc. Thus, the global patent would play a key role in the accessibility of 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 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 pandemic like this one. It is therefore imperative for international agencies and countries to implement the Compulsory License and Patent Pool measures properly 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 patenting of vaccine and strengthening of intellectual patent rights capabilities, wherever is necessary in order to reduce patent-related impediments