The Trade related Aspects of Intellectual Property Rights Agreement or the TRIPS as it is popularly called came into existence in 1995. It lays down certain minimum standards for the protection and enforcement of intellectual property rights worldwide. Owing to the divide between the global north and the global south, the IP protection standards as mentioned under the TRIPS are tilted in the favour of international corporations and developed countries. Developing countries due to their meagre resources are not able to engage in sophisticated R&D activities and often rely on the developed countries when it comes to innovation.
The past two years have witnessed the unleashing of an unprecedented pandemic, whose spread can only be prevented through large-scale vaccination. Most of the vaccines, except, India's Covaxin have been developed by the global north and the IP rights in these vaccines reside with the global pharmaceutical corporations who developed them. In the face of a life-threatening pandemic, restricting the availability and affordability of life-saving vaccines is gross erosion of human rights. Basing their argument on humanism over nationalism, India along with South Africa in October, 2020, requested the WTO to suspend some IP protections related to vaccines and other products which are material in the fight against COVID. By May, 2021, around 100 countries echoed the stand of India and South Africa. However, a few developed countries such as EU, Switzerland, Norway etc. have opposed the requested waiver. The USA, recently showed its support to the request for waiver and further strengthened the cause.
Denying access to life-saving pharmaceutical products trumps the basic human rights available to all. Through this article, we aim to examine the IP waiver request in the larger context of an intellectual property vs. human rights debate.
The Two Sides of IP Waiver
Article IX.3 of the WTO Agreement allows temporary waivers of obligations imposed on the member countries under `exceptional circumstances'. The term `exceptional circumstances', however has not been defined anywhere. Those supporting the waiver argue that the pandemic is unprecedented. Its ability to mutate and spread at a fast pace has endangered the entire human race and hence, speedy development and dissemination of vaccines is the only way, the world can win the fight against covid. Moreover, with only a few countries having the resources to develop life-saving vaccines, it is imperative that these countries freely share their technology with other nations so as to accelerate the production of the vaccines and enhance its accessibility. Restricting access to vaccines, either directly or indirectly would result in the violation of right to life of people, which is a basic human right of all. Profiteering at the cost of human lives should not be allowed to be practiced with impunity.
On the other hand, those against the IP waiver argue that the TRIPS permits certain flexibilities which would allow unimpeded production of vaccines, without invoking a temporary waiver. Some of these flexibilities are:
- Compulsory Licensing
Compulsory licensing involves a government authorising a party other than the patentee to make, use and sell the patented product without the consent of the patentee. An application for compulsory license can be made at any time after three years of grant of a patent.
- Voluntary Licenses
The patent holder can voluntarily license the right to manufacture the drug/vaccine to a generic pharmaceutical manufacturer as is the case between AstraZeneca and Serum Institute.
- Government Use
Governments can use the intellectual property without permission of the patent holder upon paying adequate remuneration.
n Let us now examine, whether a waiver is necessary to make the vaccines affordable and accessible or the TRIPS flexibilities would suffice in meeting the global needs.
Is An IP Waiver Necessary?
The flexibilities provided under the TRIPS may be used in limited circumstances, but in unprecedented situations such as the current pandemic, they may not be practically viable. Compulsory licensing works only in countries which have a large-scale manufacturing capacity. Hence, it may not be feasible to use compulsory licensing in a situation as dire as the present one. Moreover, compulsory licensing is required to be prima facie proved by proving the three grounds mentioned under Section 84 of the Patents Act, 1970. In the recent decision of Lee Pharma v. AstraZeneca AB, the court rejected the request to compulsorily license AstraZeneca's diabetes management drug as the generic manufacturer could not prove the public requirement, nor could he demonstrate the comparative requirement of the drug. The current affordability of the product is also assessed before granting a compulsory license. Judicial trends from the past, show that it is not easy to obtain compulsory licenses and more often than not, such requests get rejected. One of the successful precedents of compulsory licensing is the Natco v. Bayer decision, where compulsory license was granted for the first time after the TRIPS Agreement. Hence, opting for compulsory licensing is not the best way forward, as it would be time-consuming.
Similarly, voluntary licenses are a good way of promoting vaccine production, but this would make millions of global denizens dependant upon the whims of multinational pharmaceutical companies and may also lead to one-sided agreements, between such pharmaceutical giants and generic manufacturers.
TRIPS IP waiver, would enable free-sharing of vaccine technologies and other related products, across borders and would help in ramping up their production and distribution. It would help in making life-saving vaccines and drugs more accessible and affordable to all humans irrespective of their nationality. The waiver enforces the thought process that all lives matter and hence would act as a precedent in balancing the conflict between human rights and IPR. Irrespective of the number of alternatives that may or may not be available, the situation calls for an IP waiver and the request should be acceded to by the WTO.
Conclusion
There is a need to harmoniously balance human rights and intellectual property rights, especially now than ever before. The current situation has compelled the world to fight the virus as one single entity and it is imperative that human rights not be sacrificed at the altar of profiteering.
The author is Managing Partner & CEO,Surana & Surana International Attorneys. Views are personal.