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Why compulsory licencing seems to be the only viable option to tackle COVID in India?

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The ferocity with which the second wave arrived remains unimaginable even a fortnight back. It came at such a time when the economy was starting to revive, and people were managing to get back to normal routines. The government failed to learn from their mistake, without thinking of any adversities allowed massive gatherings like Kumbha Mela and Election Rallies. Though there are various reports which talk about the oxygen export doubled in FY21, but the government has denied such reports as misleading with the sole objective to create panic. What’s perplexing is that the sole reason, as it stands now, for the oxygen crisis is a mere logistical issue, causing numerous death.

Lockdown is not a feasible option, as the economy in such a fragile state cannot withstand another blow. There is still no concrete evidence to show that night curfew or the partial lockdown can help. Moreover, India’s population is primarily dominated by middle class and upper-middle-class income group which is already acutely affected in terms of income, and another complete lockdown will aggravate their stressed economic situation. Despite mandates, half of India isn’t wearing masks, and many unwilling to follow SOPs. Also, the virus is still mutating resulting in the formation of new variants. In recent times, deadly fungal infections have also been seen gripping people suffering from coronavirus. WHO has already stated that the pandemic won’t be over unless and until 70% of the population is vaccinated, considering India is the second-largest populated country in India, at least 95.6 crore people need to be vaccinated. The only feasible solution in light of these scenarios is a mandated vaccination drive.

India has been a powerhouse of vaccines, producing 60% of the world’s vaccines. However, most of the doses are exported, citizens being left with insufficient stock. Adar Poonawalla, CEO, Serum Institute of India, has cleared that there isn’t enough vaccine for everyone. When vaccination seems to be the only possible way to win this fight against COID-19, the scenario remains confusing and complicated. India needs at least 7 million to 10 million doses per day, whereas it can currently produce only 65 million doses every month. Indian Government (Indian Council of Medical Research) has developed the vaccine jointly with Bharat Biotech. If voluntary licensing is invoked by the Government, then the patent rights of Bharat Biotech automatically gets are affected and. Such transfer of patent rights through voluntary licensing can only be done with the prior permission of co-owners of the patent holder. Also, voluntary licensing may end with trade retaliation and no future collaboration with the Government. To make enough vaccine doses available for the country’s citizens, compulsory licensing remains the only viable way to be done under various provisions of the Patent Act, 1970.

Section 92 of The Patent Act, 1907, can play a major role in tackling this catastrophic situation by solving the crisis of life-saving drugs and vaccines. Section 92 provides a powerful weapon of compulsory licensing in the hand of the governments in “circumstances of national emergency or in circumstances of extreme emergency or the case of public non-commercial use.” This section allows, in exceptional cases, a compulsory license granted by the Controller General of Patents, Designs, and Trademarks to those who are willing and can manufacture the generic version of patented drugs for the benefit of the public at large. Recently, Israel issued a compulsory license to allow the government to import generic versions of Kaletra for the medical treatment of COVID 19 patients. 

Section 100 of the Patent Act further allows the Central Government or any other person authorized to use such invention “for the purpose of the government.” While Section 47 (4) and Section 92 empowers the government and its undertakings for import of medicine, Section 92 and 100 allow the third party to use the inventions through a license, assignment, or agreement with the patentee in cases of national emergency and for the benefit of public-at-large. “This is an exact case where we should go for compulsory licensing. This is a situation of Public Health Emergency“, Justice Ravindra Bhat observed while hearing the Suo Moto on COVID-19 issues (In Re-Distribution of Essential Supplies and Services During Pandemic) along with Justice DY Chandrachud and Justice L Nageswara Rao.

However, these provisions are neither novel nor radical, but looking at the current scenario, invoking these sections seems to be the only prudent decision. Compulsory licensing is a powerful tool in the public health regime. Along with South Africa, India moved to WTO in October 2020 for the waiver of vaccine patents. However, this was resisted by the developed countries and the proposal couldn’t pass. Thus, the only way remains is by invoking compulsory licensing provisions to enable vigorous production of vaccines. India in the past has invoked compulsory licensing of ‘Nexavar’ a life-saving drug for the treatment of liver cancer, and there lies no reason why it shouldn’t be invoked now.

Compulsory licensing is an extreme measure, which comes with many consequences. To tackle an extremely severe disease, an extreme step is quintessential, for which Government should be preparing nonetheless. In India, the onus of producing millions of vaccines is on only two companies, making it a grueling task to cater to. There also arises an immediate need for strict intervention on the part of the Government to disseminate vaccines to the masses at a faster rate. For compulsory licensing to be successful, there should be a complete ban on the private selling of vaccines, and Government should be declared as the sole purchaser. It undeniable that compulsory licensing might create a barrier for Big Pharma companies to reap mega-profits from their Research & Development, but looking at the bigger picture, it can save millions of lives.

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