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Ramesh Shankar
Wednesday, May 26, 2021, 08:00 Hrs  [IST]

Of late, there has been an outcry from different quarters urging the Indian government to use the options of compulsory licensing and government authorization by invoking powers under Sections 92 and 100 of the Indian Patents Act 2005 to shore up availability of Covid drugs and vaccines in the country. Section 92 of the Patents Act is a special provision empowering the government to issue compulsory licenses for the manufacture of patented drugs in a public health emergency. And Section 100 of the Patents Act empowers the government to use patented inventions for government purposes. There can be no two opinions about the fact that the country, for that matter the entire world, is witnessing once-in-a-lifetime kind of healthcare emergency. So, the government can justifiably invoke these provisions which are WTO-compliant. It is not that the country so far did not invoke these provisions in the Patents Act. Earlier in the year 2012, the provision was used for allowing Indian drug maker Natco to locally manufacture Nexavar, a patented product of the German pharmaceutical firm Bayer, for treating kidney cancer patients. By any criterion, the situation now is more compelling as the humanity is facing the worst ever medical crisis these days due to the second wave of Covid-19 pandemic. To deal with the situation, the country needs a sufficient supply of vaccines, medicines and different types of medical equipment. There are widespread complaints of shortage of vaccines, medicines and medical equipment across the country. And no doubt, patent protection is a major barrier to the generic production of these medicines.

All said and done, there is no denying that the pharmaceutical companies need to earn sufficient revenues for recovering their costs of R&D and sustaining the research on drug discovery and new therapeutic applications. A section of the industry argues that the provision of compulsory licensing must be used cautiously and with utmost discretion. If not used judiciously, it may discourage innovator companies, which have heavily invested in R&D, and will turn out to be counterproductive to the present situation. These kinds of arguments hold water in normal circumstances. The world is presently witnessing an extremely scary situation where this kind of perspective needs to be revisited. Patent rights, and commercial returns on proprietary knowledge, cannot be the primary objective at this stage. The fastest and most cost-effective ways of obtaining vaccines and Covid-19 drugs are most imperative at this stage. The Central government’s plea in Supreme Court that availability of raw materials and essential inputs is main constraint in the current scenario and therefore any additional licenses may not result in increased production of Covid drugs looks like a very specious plea. The fact is that a large number of Indian pharmaceutical companies have the wherewithal to produce essential medicines and vaccines, provided intellectual property rights hurdles are removed with technology transfer and trade secret issues are resolved. It can be noted that many Indian companies are already manufacturing the Covid-19 drug Remdesivir under voluntary licence. But the quantity is not sufficient to meet the demand, and the price is also high from the point of view of affordability. Whatever be the arguments of the pharmaceutical companies and the Indian government, the fact remains that Covid-19 is a public health emergency, and the arising situation is apt for invoking the emergency powers under Sections 92 and 100 of the Indian Patents Act to increase the affordability and accessibility of the Covid-19 medicines and vaccines. If patents continue to determine global access to medicines and vaccines, then fighting Covid-19 will remain a distant dream.


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