Intellectual Property: Why is India silent, as a compromise deal on COVID-19 therapies is worked out


The fact is, Indian and South African interests have diverged; India is not in desperate need of vaccines anymore and hence does not want to rock the boat

There are unusual goings-on at the World Trade Centre, where a much-contested proposal to lift intellectual property (IP) restrictions on the manufacture of vital COVID-19 therapies and vaccines has entered what appears to be the endgame.

That proposal, made by India and South Africa (SA) in October 2020, sought a temporary waiver of the World Trade Organization (WTO)’s obstructive agreement on IP rights known as TRIPS (Trade-Related Aspects of Intellectual Property Rights) so that affordable vaccines and therapies could be made available to the global south, which has faced an acute shortage of medical items to fight the pandemic.

The negotiations went nowhere because of the opposition of developed countries to any IP waivers on the lucrative vaccines and therapies produced by their drug companies.

Early this year, an informal process was initiated by WTO Director-General Ngozi Okonjo-Iweala with the European Union — the main objectors to the waiver — along with the US, India and South Africa to break the long impasse.

The Quad negotiations, as they became known, were conducted in secrecy and many rich countries had objected to it.

In March, a leaked text of the Quad’s compromise agreement made the rounds globally and lead to an outcry, because the waiver was not only limited to vaccines but also came with a string of stricter new conditions than those embedded in TRIPS.

India remained enigmatically silent on the leaked text, refusing to own it. Ditto for South Africa. The US continued to play its careful diplomatic games, focused on its vaccines-only offer.

The leaked document was forwarded on May 3 by the WTO chief as the outcome of the Quad negotiations to the new chair of the TRIPS Council, Lansana Gberie of Sierra Leone, who promptly released it to the full membership after an informal Council meeting that was held on May 6.

The apex trade body has characterised the Quad effort as “a problem-solving approach” aimed at “streamlining and simplifying how governments can override patent rights, under certain conditions, to enable diversification of production of COVID-19 vaccines”.

In short, a solution put together by the WTO chief who went on record soon after she took charge to say that a waiver was unnecessary.

The latest statement says the director-general “supported an informal group of ministers to come together around what could be a meaningful proposal that, without prejudice to their respective positions, could provide a platform to be built upon by the membership.”

By excluding the over 100 members who backed the India-SA proposal from such discussions, Okonjo-Iweala has ensured the path ahead will remain difficult as there has been opposition to both the proposal and the process she has adopted. Only the EU has given its approval, since it has secured what it wants, while Washington is treading a careful path of supporting further meaningful talks.

For instance, the UK, which is opposed to the waiver, has pointed out that since the proposal is not endorsed by any of the 164 member-states, the dialogue cannot be taken forward.

China’s backing for the proposal — which would exclude it from the waiver — is also in doubt, although Okonjo-Iweala has claimed in a Reuters interview that Beijing is “favourably disposed” to being considered a developed country in this deal and thus agreeable to excluding itself. That would be a big concession, but there has been no confirmation from the Chinese.

Other reports quoted an unnamed official as saying “most members” had sought more time to hold consultations internally before engaging in discussions.

The draft proposal tabled on May 6 is a faithful reproduction of the leaked document, which in essence says the waiver applies to all developing countries except those that exported more than 10 per cent of the total world exports of COVID-19 vaccine doses in 2021.

Currently limited to vaccines, the draft includes a proposal to extend the waiver to therapeutics and diagnostics within six months of the decision being applied to vaccines.

The only changes are the additions of brackets around a couple of points, notably the troublesome requirement for a comprehensive patent listing by those using the waiver. This is a clear indication that such issues remain thorny.

So, 19 months after the proposal was made, what do we have? The proposal also allows eligible members to issue a single authorisation to use multiple patents, export the vaccines and supply these to regional or global initiatives such as the World Health Organization (WHO)’s COVAX facility.

Pertinently, it does not remove all IP barriers that could promote wider access to COVID-19 medicines. Barring patents, it does not address the other forms IP restrictions such as trade secrets, undisclosed data, copyright and industrial design that enclose vaccines and medicines.

As such, criticism of the limitations of the proposed waiver by humanitarian and public health organisations has become trenchant since the document was first leaked on March 15.

Public Citizen, a US-based non-profit consumer advocacy organisation, accuses WTO of using this text to show the institution’s relevance rather than to solve the real-world problems in global vaccine equity exacerbated by WTO rules.

It states WTO officials are “mischaracterising” the text as if it has been agreed by all four Quad members. In fact, only the EU has signalled its support for the text, which is not surprising since it supports “their (the EU’s) stance of using existing (insufficient) WTO rules in lieu of a meaningful waiver.”

This begs a critical question. If India and SA have not agreed to the text, as some groups have assumed, why do they continue to remain silent? Are they under pressure to accept the current proposal, which is a truncated, mangled version of what they sought? Or is it a diplomatic ploy that will pay off when the final negotiations begin?

The bigger enigma is India and the questions its stance provokes. Does New Delhi really care about a TRIPS waiver anymore, especially a truncated one? Is it still on the same page as SA? The fact is, their interests have diverged.

India is not in desperate need of vaccines. At the last count (on May 7), some 63 per cent of its people were fully vaccinated, 73 per cent had received at least one shot and another seven per cent had got booster shots. India has fallen hugely behind in meeting promised supplies to COVAX after halting exports in 2021.

As for therapies, its generic industry has negotiated a plethora of voluntary licensing agreements with drug giants such as Merck, Gilead, Pfizer and Eli Lilly.

Neither the government — remember its affidavit in the Supreme Court explaining its refusal to use the existing flexibility of the compulsory licence route —nor the generic drug industry wants to rock the boat. Why press for a TRIPS waiver when it has all it wants?

This was first published in the 16-31 May, 2022 edition of Down To Earth









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