The US on Wednesday announced its support for the waiver of intellectual property protections on Covid-19 vaccines. This was the result of months of advocacy by India, South Africa and civil society. Several scientists and Nobel Laureates have been campaigning for this and have found widespread public support.
The announcement itself wasn’t unexpected given the 2021 Special 301 Report of the US Trade Representative released on April 30 which specifically recognised:
“The United States respects the right of its trading partners to exercise the full range of existing flexibilities in the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health in order to scale up the production and distribution necessary to overcome the challenges of the ongoing Covid-19 pandemic.”
India led the world in ensuring that the World Trade Organisation’s Trade Related Intellectual Property Rights ( or “TRIPS”) Agreement, which established a uniform set of rules granting extensive intellectual property rights protections, contained “flexibilities” so that nations could restrict the monopolies that patents grant in certain cases – specifically, during health emergencies like pandemics.
India was a key player in the Doha Declaration that reaffirmed the TRIPS flexibilities and acknowledged that patients trumped patents.
In the ongoing World Trade Organisation negotiations to consider proposals reaffirming these flexibilities, India should insist on the text of the India-South Africa draft and must not allow dilution that the pharma lobbies are actively seeking.
The US Trade Representative announcement mentions “waiver” of intellectual property protection only for vaccines. This is insufficient. What is needed is free availability of all intellectual property including know-how and technology for the patents to be effectively used.
The intellectual property waiver should not be limited to just the patents on vaccines but should include IP attaching to all consumables, raw materials and equipment, essential drugs, medical devices and other hospital equipment needed for the treatment of Covid-19 that are in the India-South Africa waiver proposal.
India needs to walk the talk
1. India hasn’t implemented the TRIPS flexibilities and Doha Declaration, despite having intellectual property rights laws that empower it. Section 92 (compulsory licensing) and Section 100 (using patented inventions for government purposes) in the Patents Act, provide these flexibilities that the Union government seems too meek to utilise even during a pandemic. This was specifically noticed by the Supreme Court in its recent order in the suo motu matter on the Covid-19 situation in the country, as well as the Delhi High Court.
2. Patents have had a chilling effect on innovation and particularly, access to healthcare. The Union government must issue a notification under sections 92 and 100 of the Patents Act to freely license all patents necessary for vaccine and drug production, including for equipment and all raw materials for vaccines, hospital equipment and drugs to treat Covid-19. Industry will seize this opportunity – vaccines and other products necessary to deal with the pandemic will be produced more easily and more quickly if it was not necessary to craft a passage through a maze of patents. Running the patent gauntlet is just not worth it for most entrepreneurs.
3. Incentivise technology transfer and penalise those who refuse by revoking their patents under Section 102 of the Patents Act. This is the threat recently issued by Brazil, and India should do the same. We have seen how issuing one compulsory license opened up so many voluntary licenses for a number of new drugs. Patent holders would rather license their intellectual property than risk compulsory licences or revocation of their patents.
4. Indian industry has a well-respected expertise and capability to use the freed intellectual property and know-how to rapidly manufacture raw materials, consumables and equipment necessary to produce drugs, vaccines, medical devices and equipment. There are many more pharma powerhouses in the making eagerly waiting for support from the Union government.
5. Offer free licensing and technology transfer of the government funded Covaxin to the Global South, and export Covaxin at an affordable price. It is morally abhorrent to charge high prices for Covaxin so that the Indian Council for Medical Research can earn royalties, and Bharat Biotech can profiteer. The Indian government has to lead with putting patients before profits.
India has, once again, an opportunity to lead the Global South, advocating access to healthcare for all. This was how India built its reputation as the pharmacy of the world. It is time to remind the global community that India has been a global leader in producing vaccines not only for India, but also the world. Intellectual property waivers and free technology transfers will enable India to vaccinate the world.
Murali Neelakantan is the principal lawyer at Amicus. He was formerly global general counsel at Cipla and global general counsel and executive director at Glenmark.
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