Why is India calling for a global vaccine patent waiver, but objecting to discussing it at home?


Globally, India is one of the co-authors – along with South Africa – of a World Trade Organization agreement requiring a waiver of intellectual property rights on vaccines for the duration of the pandemic. India’s proposal has recently gained momentum, after US President Joe Biden announced his support, in the hopes it will make it easier for many other countries to access Covid-19 vaccines.

At home, however, the Indian government is not only taking a different position, it has even asked the Supreme Court not to even discuss or mention the use of state power to override intellectual property rights in medicines. essential or vaccines, claiming that these could have “Serious, serious and unintended adverse consequences for countries’ efforts on the global platform.”

Experts believe that the Centre’s position against compulsory licensing – which the Supreme Court had touted as a tool it could use as part of its pandemic response – is not only contradictory to its position in international forums, but it could end up jeopardizing India’s efforts to ensure vaccination. global equity.

Compulsory licenses

The weakness of India’s vaccination program has come to the fore over the past month, as the brutal second wave of Covid-19 has exploded across the country. Vaccination centers across the country have faced shortages and the current pace would not allow India to achieve herd immunity by the end of the year.

Some, like Delhi Chief Minister Arvind Kejriwal, have demanded that the Center invoke its powers to issue compulsory licenses so that vaccine production can be ramped up, with the aim of helping states immunize more people on a shorter period.

Simply put, when a government invokes a compulsory license, it grants a person permission to make or sell an invention or product without seeking permission from the patent holder. The issue of compulsory licenses in India involves two important provisions of the Patents Act 1970.

India’s vaccination campaign slows down. Photo: Sajjad Hussain / AFP

The first is section 92. Under this provision, the government can declare a license compulsory for any patented invention in a national emergency or extreme emergency. Once the declaration is made, the Comptroller General of Patents can grant licenses to any applicant. The patent holder will receive a fee set by the Comptroller General.

Section 100 of the Act, on the other hand, allows the Center or others to use the invention for government purposes, if deemed necessary. This would allow Indian companies to start manufacturing while the royalty is negotiated. If negotiations fail, it is up to the relevant High Court to set a reasonable fee.

Center stand

The Supreme Court has raised the issue in its vast case that covers everything from oxygen allowances – for which it has set up a national task force – to vaccine policy. However, the Center said it was against compulsory licensing in its affidavit in court. To communicate this position, the Center used convoluted language in its affidavit, making no clear distinction between essential drugs and vaccines.

While the section of the affidavit titled “Issuance of Compulsory License for Vaccines and Essential Medicines (Remdesivir, Tocilizumab)” deals primarily with essential medicines, she concludes by saying:

“It is strongly recommended that any discussion or mention of the exercise of statutory powers, whether for essential drugs or vaccines with patent issues, would have serious, serious and unintended adverse consequences in the efforts of countries to the global platform using all its resources, goodwill and good offices through diplomatic and other channels. ”

The Center asked the court not to discuss the exercise of statutory powers for both vaccines and essential drugs. But that line appears in a section on compulsory licensing focused on drugs. Experts believe the government’s position should apply to both essential drugs and vaccines.

This includes a statement in the affidavit that in the event that a manufacturer applies for a compulsory license under Section 92 of the Patent Act, this may be duly taken into account by the government.

Inherent contradictions

According to Shantanu Mukherjee, a qualified lawyer in New York and India and founder of Ronin Legal, a healthcare law firm, there appears to be a contradiction between India’s position at the World Trade Organization. on Covid-19 vaccines. and its position on compulsory licenses before the Supreme Court.

Mukherjee said that in October 2020, India and South Africa presented a joint proposal to the WTO to obtain a waiver on the application of four types of intellectual property rights under the agreement. on trade-related aspects of intellectual property rights. These are patents, industrial designs, copyrights and trade secrets or undisclosed information.

While at the WTO level India is seeking an intellectual property rights waiver, in the Supreme Court, the Center has essentially said that it is not currently in favor of discussing statutory provisions for compulsory licensing, although he added a caveat that if requests are made for such licenses, they may be considered.

“Only four days ago, the United States voted in favor of the Indian proposal,” Mukherjee said. The waiver proposal has therefore gained tremendous momentum. “Meanwhile, you have this affidavit that says compulsory licensing can only be counterproductive at this point, which undermines India’s argument at the WTO. Now is not the right time for India, as the architect of this waiver proposal, to lose credibility on the world stage. “

Mukherjee added that he actually sympathized with the larger idea expressed in the affidavit itself. Right now, with around 4,000 people dying every day in India, due to Covid-19, the need is to get vaccines to India quickly, and imports, he said, are the way the fastest. “And import negotiations – already hampered by disagreements with companies like Pfizer over compensation and a lack of interest from a moderna with limited capacity – could become strained or even fail if there is any question. compulsory licensing, which is probably the fear expressed by the affidavit. “

In addition, the lawyer said that there were other complications in the path of compulsory licensing such as the transfer of proprietary technology and technical know-how, which he had addressed in this article in News18.

Covaxin, a vaccine developed jointly with the Indian government. Photo: Tauseef Mustafa / AFP

Murali Neelakantan, senior counsel at Amicus and former global general counsel at Cipla, said the Centre’s position that it will review compulsory license applications is surprising. “You are not waiting for a candidacy,” he said. “The government should notify patents under sections 92 and 100 of the patent law. Subsequently, these patents are open for use. ”

Neelakantan said the Centre’s affidavit does not disclose on what basis it took its position on compulsory licensing. “Which experts did you rely on?” He asked. “You are jeopardizing the diplomatic effort at the WTO by taking a position at the national level that you are not in favor of compulsory licenses.”

Position on Covaxin

In particular, the Centre’s position on Covaxin, the locally developed vaccine in which it has joint ownership with Bharat Biotech, has not been explained in clear terms.

In the affidavit, the Center said efforts were being made to increase production of Covaxin. “… support to a private industry and three public sector manufacturing facilities is being explored to prepare them with improved capacities to support increased vaccine production over the next 6-8 months,” the report said. document.

These facilities include Bharat Biotech, Hyderabad, Indian Immunologicals, Hyderabad, Haffkine Biopharmaceuticals, Mumbai and Bharat Immunologicals and Biologicals, Bulandshahr. In total, Rs 200 crore has been allocated for this support.

Neelakantan noted that while there is the Centre’s position on compulsory licensing of other vaccines on the one hand, what was inexplicable was the reluctance to grant licenses for Covaxin which it co-owns. “There are several facilities in India that could produce Covaxin if the Center grants licenses. They did not answer the question as to why the licenses are not granted. ”

The lawyer had already argued in Scroll.in that India should offer free licenses and technology transfer for Covaxin to countries in the South and export the vaccine at an affordable price.

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