Last fortnight, the long-running negotiations over the TRIPs – Trade-Related Aspects of Intellectual Property Rights – waiver finally concluded at the World Trade Organization’s Ministerial Conference. The final text of the ministerial decision indicates that the Indian government very pragmatically walked back its demand for a “full waiver”.
Simply put, India’s initial hope was that developing countries would not be required to recognise patents or patent rights – Article 27 and 28 of the TRIPs agreement – or trade secret protection, under Article 39, or to enforce such rights, under Article 44 and 45, for all Covid-related vaccines, therapeutics and diagnostics.
In contrast, the final text of the Ministerial Decision indicates that the waiver agreement, which is now limited to vaccines alone, and not therapeutics and diagnostics, does not waive patent rights or trade secret protection. At most, it allows for easier exports of patented vaccines produced under a compulsory license without having to follow a cumbersome procedure under Article 31bis of TRIPs.
The likely reason for the government’s decision to move away from its demand for a full waiver was the realisation that it had administered 1.95 billion Made in India doses on its own population and exported another 229 million doses, according to the figures of the Ministry of External Affairs as on May 30, without a TRIPs waiver. Another 200 million doses manufactured by the Pune-based vaccine company the Serum Institute of India are lying unused and likely to expire.
This was largely possible because multiple foreign vaccine developers were more than ready to voluntarily licence their vaccine technology to Indian vaccine manufacturers, a fact that was obvious to anybody tracking the licensing deals being struck in the first year of the pandemic. India’s homegrown vaccine, Covaxin, also helped until the World Health Organization red-flagged the manufacturer’s premises due to “good manufacturing concerns”.
The other likely reason that the Indian government changed its mind was a realisation that a waiver, in its full avatar or otherwise, would not change much on the ground. This is because the manufacture of vaccines requires active technology transfer from innovators.
Vaccines, unlike conventional small molecule drugs, cannot be easily reverse engineered. This is one of the reasons why not a single company has put in a compulsory licensing application for vaccine technology in India since the beginning of the pandemic.
On the remaining issue of therapeutics and diagnostics, the final waiver text proposes to discuss the possibility of its application to Covid-19 diagnostics and therapeutics after a period of six months. It is unclear why India would even demand such an extension when it is as clear as day that all approved drugs for Covid-19, including some of questionable efficacy, have been voluntarily licensed to Indian companies.
Further unlike vaccines, Indian pharmaceutical companies have the capability to reverse engineer these drugs but did not have to seek compulsory licences because most of the big companies were promptly given voluntary licences by the innovators at an acceptable royalty rate.
In any event, if the government is really worried about a shortage of Covid-related therapeutics and diagnostics, it is at liberty to issue a notification under Section 92 of the Indian Patents Act, 1970, declaring the Covid-19 pandemic as a national health emergency and inviting manufacturers to request for compulsory licences to augment production.
Neither the TRIPs agreement nor Section 92 of the Indian Patents Act require procedural formalities to be followed for issuing compulsory licences during national emergencies. Yet, for the past two years of the pandemic, the government has not issued such a notification under Section 92 declaring Covid-19 as national emergency. The only reason we think it has not done so is because there has been no real shortage of either drugs or diagnostics for Covid-19.
All this begs the question as to why the Indian government spent scarce diplomatic capital in Geneva on the issue of the TRIPs waiver? The answer partially lies in India’s historically sceptical approach to patents which is driven by an ideological viewpoint that visualises any form of patent protection as inimical to her interest.
Except, this time, instead of carving out a nuanced position, as it has in the past during TRIPs negotiations, it did not properly assess the realities of either vaccine technology or the new business model of Big Pharma which has basically seduced the Indian pharmaceutical industry through a system of voluntary patent licences. These days, even the once mighty Cipla lines up at Big Pharma’s doorstep for these voluntary licences.
While we lack any conclusive answers to what exactly changed the mind of the commerce ministry on the TRIPs waiver, it should be commended for reading the writing on the wall and changing its stand. It is rare for the Indian government to embrace such pragmatism in the face of populist pressure.
At the very least, by way of a post-mortem, the Indian government should hold accountable those elements of the bureaucracy that led it down the path of fighting over a poorly strategised, half-baked proposal, lest it repeat the mistake in the future. Otherwise, it will face a deep credibility crisis not only amongst its trading partners but also in the eyes of the Global South, which relies on India to lead it during global negotiations.
Yogesh Pai is an Associate Professor at National Law University Delhi. Prashant Reddy T is a lawyer.