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Call for compulsory licence to address supply shortages

PT Jyothi Datta Mumbai | Updated on April 30, 2021

FILE PHOTO: Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech's COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. REUTERS/Adnan Abidi//File Photo/File Photo   -  REUTERS

Chennai: A medic prepares to administer a dose of COVID-19 vaccine at the Government Omandurar Medical College and Hospital, in Chennai, Wednesday, April 28, 2021. (PTI Photo/R Senthil Kumar)(PTI04_28_2021_000095B)   -  PTI

A compulsory licence allows a third party to make an innovative drug in public interest

As the country grapples with a shortage of Covid-19 vaccines and medicines, public health voices have urged the Centre to explore all regulatory avenues, including a compulsory licence, to increase the availability of vaccines in the country.

In an intervention filed by the Jan Swasthya Abhiyan (Mumbai) in a case the Supreme Court has taken up suo motu, the civil society organisation sought a direction to the government to increase the production of Covid-19 vaccines.

Health emergency

“Covid-19 is a public health emergency and the government is obligated to issue an order of government authorisation under Section 100 or a compulsory licence for non-commercial public use under Section 92(1) of the Patents Act to respond and ensure continued access to the vaccines,” the applicant said. The Government is the respondent.

A compulsory licence allows a third party to make an innovative drug in public interest. India’s first compulsory licence under the amended Patents Act (1970) was issued in 2012 when Natco was allowed to make Bayer’s advanced kidney cancer drug Nexavar, with a royalty payment to the latter.

On Covid-19 vaccines, the petition said that one of the reasons for the supply shortfall was manufacturing limited to two companies (Serum Institute of India and Bharat Biotech). And while the Centre had roped in three public sector units for this purpose, “there is no clarity when the products from these facilities will be available in the market and the projected number of doses,” it pointed out.

Intellectual Property expert Rajeshwari Hariharan told BusinessLine that the Centre should use the tools available under the amended Patents Act to issue a CL on anti-viral drug Remdesivir, Tocilizumab and the Covid-19 vaccines that are presently in short supply. Even if it takes a few months for third party companies to supply the product, it would help States that are set to see a peak in Covid-19 cases in the coming months, and in case of another surge in the country, she explained.

IP waiver sought

India and South Africa have been calling for an IP waiver on Covid-related diagnostics, therapeutics and vaccines at the World Trade Organization. The Centre is “expected to be consistent at the domestic and international level in its response,” the applicant pointed out.

Further, it said, “Unlike the compulsory licence provisions in the Patents Act, there is no legal mechanism in India to disclose the trade secret to protect public health.”

Pointing to the differential pricing of vaccines, the petition said, “For the first time in the history of India, there is a differentiation between the States and the Government of India to procure diagnostics, therapeutics or vaccines. The money for purchasing the vaccines and medicines comes from direct and indirect taxes and from international assistance and does not brook any difference between the States and the Centre.”

Published on April 29, 2021

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