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India seeks patent waiver on Covid vaccines

A move by 65 odd nations at the World Trade Organisation (WTO) to craft a consensus on softening patent rules that block access to Covid vaccines, drugs and equipment for large swathes of the globe, has run into a roadblock and possibilities of a “comprehensive solution“ to battle a crisis has diminished.

India on Monday at the 12th Ministerial Conference of WTO lodged a strong protest and disappointment over member countries limiting a proposal for waiver of patents on vaccines, drugs and equipment mooted by India and South Africa almost 20 months ago “only to vaccines” and further restricting the scope of flexibility to the export of only vaccines with multiple pre-conditions.

Commerce and industry minister Piyush Goyal at the thematic session in response to the pandemic and TRIPS waiver at MC 12 (ministerial conference of the World Trade Organisation) said, ”For India, our response to the pandemic would not be complete without a TRIPS waiver.“

In a session attended by all WTO members and chaired by the DG WTO, he added, ”In the course of my discussions, it has been indicated that favour was being done to the developing countries. I think it’s pretty clear that rather than concern for humanity, for the hundreds of thousands of lives lost or the millions affected, it is sad that the super-profits of a few pharmaceutical companies prevail over global good.”

The minister’s scathing attack came after texts of two drafts in response to the pandemic came up for an intervention in the WTO MC12. One was an overarching response to the pandemic and the other specifically on the TRIPS waiver.

While the proposal by India and South Africa had 100 odd countries supporting it, there are 65 odd member countries which had tagged along as co-sponsors and a lot of convergence was crafted.

The Indian waiver proposal included temporary, not in perpetuity, relaxations in IPR rules on vaccines, drugs and equipment. It also included therapeutics and diagnostics to assist poor nations in battling ongoing and future pandemics.

The text of the document on the overarching response speaks about four key elements – trade measures in the form of policies and disciplines, the role of services in economic recovery, and transparency in countries sharing domestic measures that may impact trade.

India objected to the export restriction clause in the text and stated that these cannot be accepted beyond the policy space of the current agreement and be blanket in character. However, India agreed to the need for transparency with a rider that developing and less developed countries do not have the capacity to usher in transparency like developed nations.

In his intervention during the thematic session to showcase the efforts made by India, Goyal said, ”India has made several compromises along the way to make this possible, like the TRIPS automaticity clause, which was not accepted, extensive dilution of the language on IP and tech transfer; a muted ambition on food security and economic resilience, compromises on a strong forward-looking agenda on these issues, resolution of the issue of developing countries and LDCs, acceptance of issues and language we have not been comfortable with in areas of transparency, export restriction, market openness and developing countries etc. We hope the flexibility that we have shown will pave the way for its acceptance and also be replicated in other tracks for a successful MC-12.”

He urged members not to disturb what he called a “delicately poised document” even slightly, as that would unravel the months-long complex negotiations and will run the risk of failing an outcome we are close to achieving.

In another setback for developing nations, the push to include diagnostics and therapeutics in the text has not succeeded. The idea behind the inclusion was to expand the manufacture and distribution of expensive patent-protected equipment like testing machines and ventilators which are critical in battling the current pandemic and those which may arrive in future. Backing these, several members stated that there cannot be a pandemic response which does not deliver an effective and workable document on TRIPS.

India and some other nations also lodged their protest in their interventions over the draft declaration skipping the mention of public stock holding for food security purposes. Goyal took the opportunity to underline the value of its food security programme and public stock holding which is contested by members of WTO countries.

He said, ”During almost three years of the pandemic, India distributed nearly 100 million tonnes of food grains through our public distribution system, thanks to the public stocks that we had acquired and allocated to nearly 800 million poor and vulnerable people for nearly 25 months, at a cost of over $50 billion. This almost doubled up the existing food grains being distributed to the vulnerable sections of society under our National Food Security programme. Several reports internationally suggest that this has helped bring down inequality amongst different sections of society. As I said, this was only possible because of the robust public stockholding programme which India runs.”

He added, “The text formulated after consensus-based discussions does not reflect what we as co-sponsors of the waiver proposal had envisaged.”

To underline that the draft was inadequate and dismissive of global realities, he said, “It has taken us nearly over a year and a half to reach this stage. Vaccines are no more in scarcity with sufficient and affordable stocks available across the world. In fact, vaccines are now getting wasted due to expiry dates. Yet there is opposition to some of the clauses even now. There is opposition to including therapeutics and diagnostics, which could at least pave the way in the future to tackle any crisis.”

The limitations in the text document objected by India and other nations have created serious concerns about the possibility of a consensus in the WTO MC12 on the IP waiver.

This would eventually defeat a move after an impasse of more than one year in the TRIPS Council by the WTO Director-General Ngozi Okonjo-Iweala on May 3, 2022, in form of an outcome document that emerged from the informal process conducted with the Quad (the European Union, India, South Africa and the United States) for an intellectual property response to Covid-19.

However, that exercise seems to have run into a hurdle as developed nations, especially parent countries to pharmaceutical giants, are stiffly opposing the waivers. The WTO could well be heading for a major political failure in its response to the coronavirus pandemic.

If member states are unable to agree on India and South Africa’s request to suspend intellectual property rights on vaccines, tests and anti-covid drugs it could well be because of systematic blocking by countries including host Switzerland without offering coherent solution for equitable access to means of fighting health crises. India Today

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