Parl panel calls for compulsory license for covid drugs, jabs

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The bipartisan parliamentary standing committee on trade has recommended invoking compulsory licenses for the production of drugs and vaccines for the treatment of covid, as the pandemic has led to a national health emergency.

“Producing generics in large quantities without any patent obligations would help remove supply constraints in the availability of affordable medicines, drugs and vaccines during times of high workload and mortality from covid-19. The committee recommends that the government consider the possibility of temporarily waiving patent rights and issuing compulsory licenses to address the insufficient availability and accessibility of vaccines and covid-19 drugs during a situation. emergency induced by the pandemic ”, the committee stated in its report entitled“ Review of Intellectual Property Rights Regime in India ”.

Article 92 of the Patent Act, 1970, provides for a special provision for the issuance of a compulsory license (CL) by the central government to a third party to use the patent without the consent of the patent owner, after paying a royalty determined by the government on the proprietary patent. The government can invoke the CL in circumstances of “national emergency or in circumstances of extreme urgency or in cases of public non-commercial use”. India has issued an LC only once, to Natco Pharma Ltd for the production of the generic version of Bayer Corp. ‘ s patented drug Nexavar, which is a life-prolonging drug used in the treatment of liver and kidney cancer.

At the World Trade Organization, India and South Africa have requested a temporary patent waiver to facilitate equitable, affordable and universal access to vaccines and medicines for all countries.

While praising the government’s efforts, the panel observed that immediate action should be taken at the national level, such as issuing compulsory licenses and encouraging the voluntary licensing mechanism to share technology with other companies.

“This will help scale up production and manufacturing of covid vaccines and drugs in the country in the event of a national health emergency. Proactive measures should be taken for technology transfers to manufacturing companies after drug or vaccine trials are completed to avoid any delay in their availability, which would be detrimental to the country’s interests, ”the report said.

When hearing a suo motu pandemic case on April 30, the Supreme Court asked the Center why it was not issuing compulsory licenses under patent law to boost vaccine and drug production against covid. The court observed that several drugs that were central to the covid treatment protocol are under patent in India, including remdesivir, tociluzumab and favipiravir. However, he left the final decision to invoke the CL to the government.

“We have only sketched the legal framework within which the central government may possibly consider compulsory licenses,” the SC said.

A joint letter from the main opposition parties to Prime Minister Narendra Modi on May 12 also urged him to “invoke compulsory licenses to develop national vaccine production”.

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