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Vaccine Trials and the Law

Oxford University is launching a human trial of a potential coronavirus vaccine, with the daunting aim of making a successful jab available to the public later this year. Of the more than 100 research projects around the world to find a vaccine described by the United Nations as the only route back to “normality” - seven are currently in clinical trials, according to the London School of Hygiene and Tropical Medicine. Such trials are already underway in China and the United States and are due to begin at the end of this month in Germany, where the federal vaccine authority gave the green light on Wednesday.


LEGAL ASPECTS OF COVID-19 VACCINE:


COMPULSORY LICENSES UNDER PATENTS ACT,1970:


Compulsory licenses are authorizations given to a third-party by the Controller General to make, use or sell a particular product or use a particular process that has been patented, without the need of the permission of the patent owner. This concept is recognized at both national as well as international levels, with an express mention in both (Indian) Patent Act, 1970, and TRIPS Agreement. There are certain pre-requisite conditions, given under sections 84-92, which need to be fulfilled if a compulsory license is to be granted in favor of someone.


As per Section 84, any person, regardless of whether he is the holder of the license of that Patent, can make a request to the Controller for grant of a compulsory license on expiry of three years, when any of the following conditions is fulfilled –

  1. the reasonable requirements of the public with respect to the patented invention have not been satisfied.

  2. the patented invention is not available to the public at a reasonably affordable price.

  3. the patented invention is not worked in the territory of India.


Further, compulsory licenses can also be issued suo motu by the Controller under section 92, pursuant to a notification issued by the Central Government if there is either a "national emergency" or "extreme urgency" or in cases of "public non-commercial use".


ANALYSIS:


Under the assumption that such the COVID-19 vaccine is successful after human testing by the United Kingdom, the vaccine will be patented by the respective Government, and the same will be sold at a price determined by the government responsible for such vaccine. This results in a monopoly of the availability of the vaccine at the time of such pandemic across the world. Countries like India would be put in a situation wherein they can access such vaccine only through the provision of “ Compulsory License “ under Section 84 or Section 92 under the Patents Act,1970 considering Covid-19 either a "national emergency" or "extreme urgency".


As researchers around the world rush to develop new diagnostics and treatments for COVID-19, we must not forget that such cooperation is an exception to the rule. In the absence of public intervention, we will remain reliant on life-saving drugs and vaccines on a monopoly-driven system that favors profits over people.


In responding to the pandemic, the global scientific community has shown a remarkable willingness to share knowledge of potential treatments, coordinate clinical trials, develop new models transparently, and publish findings immediately. In this new climate of cooperation, it is easy to forget that commercial pharmaceutical companies have for decades been privatizing and locking up the knowledge commons by extending control over life-saving drugs through unwarranted, frivolous, or secondary patents, and by lobbying against the approval and production of generics.


With the arrival of COVID-19, it is now painfully obvious that such monopolization comes at the cost of human lives. Worse, multiple patents are in force in most of the world for three of the most promising treatments for COVID-19 – remdesivir, favipiravir, and lopinavir/ritonavir. Already, these patents are preventing competition and threatening both the affordability and the supply of new drugs.


We now have a choice between two futures:


1. In the first scenario, we continue, as usual, relying on the big pharmaceutical companies, hoping that some potential treatment for COVID-19 will make it through clinical trials, and those other technologies for detection, testing, and protection will emerge. In this future, patents will give monopoly suppliers control over most of these innovations. The suppliers will set the price high, forcing downstream rationing of care. In the absence of strong public intervention, lives will be lost, particularly in developing countries.


2. In the second possible future, we would acknowledge that the current system – in which private monopolies profit from the knowledge that is largely produced by public institutions – is not fit for purpose. As public-health advocates and scholars have long argued, monopolies kill, by denying access to life-saving medicines that otherwise would have been available under an alternative system – like the one facilitating the yearly production of the flu vaccine.


There is already some movement in favor of alternative approaches. For example, Costa Rica’s government recently called on the WHO to establish a voluntary pool of IP rights for COVID-19 treatments, which would allow multiple manufacturers to supply new drugs and diagnostics at more affordable prices.


Conclusion:


To be sure, some will argue that the COVID-19 crisis is sui generis, or that the threat of compulsory licenses offers sufficient means for pressuring drug companies to behave well. But, beyond front-line researchers who are not motivated solely by short-term profits, it is not clear that the big pharmaceutical companies understand their responsibilities.


It’s time for a new approach. Academics and policymakers have already come forward with many promising proposals for generating socially useful – rather than merely profitable – pharmaceutical innovation. There has never been a better time to start putting these ideas into practice.


Indian Research in the field of Covid-19 Vaccine:

Serum Institute of India(SII) on Patenting such Covid-19 Vaccine:


With respect to patenting the vaccine, Serum Institute of India on Thursday said it is not going to patent the vaccine it is developing for COVID-19, which is expected by 2021.


When the vaccine is developed, whosoever does it will need to partner with multiple firms to manufacture it so that it is available across the world, Serum Institute India (SII) CEO Adar Poonawalla said. "I can speak for my company, SII. We are not going to patent this product and we will make it available to as many people as we can to manufacture this drug because we don't want to make money from and commercialize something beyond a sustainable level in such a public health epidemic.... "...we are able to do this because we are a private limited company and that is part of why we didn't list because we are not accountable to shareholders. "


"Whosoever makes and develops the vaccine will need multiple partners to manufacture the vaccine. I hope that whichever company develops the vaccine will not hide behind patents and makes it available even on royalties or some commercial understanding to as many manufacturers across the world to make billions of dosages very quickly.”


At the moment the company is conducting animal trials with mice and primates. It is hoping to start clinical trials with humans in around a month in India.

ABOUT THE AUTHOR

Suresh Khannan is currently a 3rd year Law student at Symbiosis Law School, Pune,

You can contact them at https://www.linkedin.com/in/suresh-khannan-k-t-5b41661aa

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