A misadventure and a compromise in Geneva by the government
Last fortnight, the long-running negotiations on the TRIPS waiver – Trade-Related Aspects of Intellectual Property Rights – finally concluded at the Ministerial Conference of the World Trade Organization. The final text of the ministerial decision indicates that the Indian government has very pragmatically reconsidered its request for a “total waiver”.
Simply put, India’s initial hope was that developing countries would not be required to recognize patents or patent rights – Articles 27 and 28 of the TRIPS Agreement – or the protection of trade secrets, in under Article 39, or to enforce these rights, under Articles 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 only, not therapeutics and diagnostics, does not waive patent rights or trade secret protection. At most, it makes it possible to facilitate the export of patented vaccines produced under compulsory license without having to follow a cumbersome procedure under article 31bis of TRIPs.
The likely reason for the government’s decision to walk away from its full waiver request was the realization that it had administered 1.95 billion Made in India doses to its own population and exported an additional 229 million doses, according to figures from the Ministry of Foreign Affairs as of May 30, without TRIPs derogation. An additional 200 million doses made by Pune-based vaccine company Serum Institute of India sit unused and are at risk of expiring.
This was largely possible because several foreign vaccine developers were more than willing to voluntarily license their vaccine technology to Indian vaccine makers, a fact that was obvious to anyone following the licensing deals struck in the first year of the pandemic. pandemic. India’s vaccine, Covaxin, also helped until the World Health Organization flagged the manufacturer’s premises due to “good workmanship”.
The other likely reason the Indian government changed its mind was the realization that a waiver, in its full avatar or otherwise, would not change much on the ground. Indeed, manufacturing 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 no company has applied for a compulsory license for vaccine technology in India since the start of the pandemic.
On the remaining issue of therapeutics and diagnostics, the final text of the waiver proposes to discuss the possibility of its application to diagnostics and therapeutics of Covid-19 after a period of six months. It is unclear why India would even demand such an extension when it is crystal clear that all drugs approved for Covid-19, including some of questionable efficacy, have been willfully licensed from Indian companies.
Also, unlike vaccines, Indian pharma companies have the ability to reverse engineer these drugs but have not had to apply for compulsory licenses as most of the big corporations have quickly secured voluntary licenses from the innovators at an acceptable royalty rate.
In any event, if the government is genuinely concerned about a shortage of Covid-related therapies and diagnostics, it is free to issue a notification under Section 92 of the Indian Patents Act 1970 , declaring the Covid-19 pandemic a national health problem. emergency and inviting manufacturers to apply for compulsory licenses to increase production.
Neither the TRIPS Agreement nor Section 92 of the Indian Patents Act require procedural formalities to be followed for the issuance of compulsory licenses in cases of national emergency. Yet in the past two years of the pandemic, the government has not issued such a notification under Section 92 declaring Covid-19 a national emergency. The only reason we think it hasn’t is because there hasn’t been a real shortage of drugs or diagnostics for Covid-19.
All of this begs the question, why has the Indian government spent little diplomatic capital in Geneva on the issue of the TRIPS waiver? The answer lies partly in India’s historically skeptical approach to patents, which is driven by an ideological standpoint that views any form of patent protection as against its interests.
Except this time, instead of carving out a nuanced position for herself, as she has done in the past during TRIPS negotiations, she failed to properly assess the realities of vaccine technology or the new business model of Big Pharma which basically seduced the Indian pharmaceutical industry. through a voluntary patent licensing system. These days, even the once mighty Cipla is lining up at Big Pharma’s door for these voluntary licenses.
Although we lack conclusive answers on what exactly changed the Department of Commerce’s view of the TRIPS waiver, it is to be commended for reading the writing on the wall and changing its position. Rarely does the Indian government adopt such pragmatism in the face of populist pressure.
At the very least, by means of a post-mortem, the Indian government should hold accountable those elements of the bureaucracy that led it down the path of fighting an ill-conceived and half-prepared proposal, lest ‘he won’t repeat the mistake in the future. . Otherwise, it will face a deep credibility crisis not only among its trading partners, but also in the eyes of the Global South, which is counting on India to lead it in global negotiations.
Yogesh Pai is an associate professor at the National Law University, Delhi. Prashant Reddy T is a lawyer.