Whose intellectual property is Bharat Biotech’s publicly funded Covaxin? India deserves an answer

On Saturday, the pharmaceutical company Bharat Biotech officially announced the sale prices for its Covid-19 vaccine, Covaxin. State governments will have to pay Rs 600 per dose while private hospitals will have to pay Rs 1,200 per dose. These prices, fixed far above the corresponding rates announced by the Serum Institute of India for its vaccine, Covishield, has surprised observers for many reasons.

The Serum Institute could cite royalty payments to the Swedish-British firm AstraZeneca from which it has licensed its vaccine as a potential reason for higher prices. But Bharat Biotech does not have to pay any royalty for Covaxin. Covaxin is, in large measure, a product of publicly funded research in India.

It is based on the SARS-CoV-2 strain, which was isolated in the National Institute of Virology in Pune. This institute functions under the Indian Council for Medical Research. The ICMR had transferred this strain to Bharat Biotech for development and manufacture.

A statement from the ICMR on May 10, 2020, had explained the collaboration in the following words:

“Work on vaccine development has been initiated between two partners. ICMR-NIV will provide continuous support to BBIL [Bharat Biotech] for vaccine development. ICMR and BBIL will seek fast-track approvals to expedite vaccine development, subsequent animal studies and clinical evaluation of the candidate vaccine, which will be fully indigenous to India.”

An ICMR official told the media, “ICMR and BBIL are jointly working for the pre-clinical as well as clinical development of this vaccine.” The ICMR also announced that it had selected 12 institutes to conduct clinical trials of the vaccine.

These are the only details available in the public domain on the collaboration between the ICMR and Bharati Biotech, but they demonstrated that Covaxin is the product of a close collaboration between the two entities.

However, we do not know anything yet about the extent of public investment in basic research, isolating the SARS-CoV-2 strain and other related interventions. As such, one is unable to gauge the share of public investment in the total amount spent to design, develop and manufacture the vaccine.

But there are a few other indicators that tell us that the ICMR’s involvement and control in developing the vaccine was indeed considerable. First, on July 3, the contents of a letter written by ICMR Director General Balaram Bhargava to the institutions managing the clinical trials, with a copy marked to Bharat Biotech, was reported in the press.

The letter said:

“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL [Bharat Biotech International Limited] is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project.”

The letter warned:

“Kindly note the non-compliance will be viewed very seriously. Therefore, you are advised to treat the project on highest priority and meet the given timelines without any lapse.”

Clearly, the government of India was interested in hastily releasing Covaxin on Independence Day 2020 even before it completed even the basic clinical tests. It was applying pressure on the partner institutions, including Bharat Biotech, to complete their tasks before a fixed date.

Many questions

On what authority did the ICMR director general write such a letter? Surely, the ICMR must have had some control over the processes leading up to the development of the vaccine. What was the exact nature of that control? Unfortunately, we do not know.

Secondly, on April 17 this year, the government of India allowed three new firms to produce Covaxin, including the Haffkine Institute in Mumbai. On what authority did the government of India provide licences to produce Bharat Biotech’s Covaxin to these entities? Was it a simple administrative approval from the government or was it a letter of permission from the owner of the vaccine’s intellectual property rights?

Surely, the government of India had some authority to give such an approval, especially when it had not invoked any provisions of compulsory licensing. What was that authority? Unfortunately, we do not know.

In sum, opacity marks the contracts and agreements surrounding the ICMR’s relationship with Bharat Biotech. There is no information in the public domain on who owns the intellectual property rights for Covaxin. In an important article on the subject, Anupriya Dhonchak and Anik Bhaduri ask this precise question.

They cite the provisions of the Union government’s General Financial Rules, 2017, for funding sponsored projects or schemes. The rules state that on the completion of the projects “…a stipulation should be made in such cases that the ownership in the physical and intellectual assets created or acquired out of such funds shall vest in the sponsor”. What was the stipulation in the contract between the ICMR and Bharat Biotech? Unfortunately, we do not know.

There is an indirect method we can use to judge if public money was involved in the research leading to the development of the vaccine. We could review the declarations of financial support in the research papers published on the vaccine till now. According to Bharat Biotech, there have been six international peer-reviewed journal publications on Covaxin till now. A summary of these six publications and the financial acknowledgements listed are given in the table below.

On reviewing these papers, we find that in four out of the six papers, financial support from either the Ministry of Health and Family Welfare or the National Institute of Virology, Pune, or the ICMR is clearly acknowledged. All the six papers were co-authored by scholars from Bharat Biotech and the ICMR/National Institute of Virology. In five of the six papers, the ICMR Director General Balaram Bhargava was himself a co-author.

These six papers did not provide any information on the amounts involved in the financial supports. However, they do provide unequivocal evidence that public money was indeed spent towards the research that resulted in the successful development of the vaccine.

Given that taxpayer’s money was involved in the agreement, it is only appropriate that the Union government makes all the related documents public. If indeed the government or the ICMR holds the intellectual property rights for Covaxin, yet another question would arise. Despite the intellectual property rights being in public ownership, why was one company – Bharat Biotech – provided an exclusive licence for manufacture? Why was not non-exclusive licences provided to multiple manufacturers to produce the vaccine?

It is also important to note that Bharat Biotech later signed its own exclusive agreements with firms like Ocugen for the supply of 100 million doses of Covaxin in the United States. Does the ICMR get a share of Bharat Biotech’s profits from such arrangements if it has a stake in the intellectual property rights? Unfortunately, we do not know.

Indeed, the experience with the ICMR and Bharat Biotech reminds one of the ways in which the Oxford-AstraZeneca vaccine went from being a public vaccine to a private vaccine in the United Kingdom. Reports show that 97% of the funding for the Oxford-AstraZeneca vaccine came from public sources, such as the government departments of United Kingdom, scientific institutes in the United Kingdom and United States, the European Commission and various charities. Yet, Oxford University backed out of its pledge to maintain an open licence for the vaccine and signed an exclusive licence agreement with AstraZeneca.

As is well known, AstraZeneca went on to sign another exclusive agreement with the Serum Institute of India for the same vaccine to be distributed in India under the name Covishield. Thus, the Oxford-AstraZeneca vaccine became a tool for private profiteering out of public investments

India should not allow the same fate to befall Covaxin.

The immediate step in India should be a transparent publication of all agreements and intellectual property-related information on Covaxin. The ICMR and the Ministry of Health and Family Welfare should take a lead in this matter. If it turns out that the ICMR or the government of India owns the intellectual property rights over Covaxin, the Indian public has the right to know how these intellectual property rights were leveraged for public welfare amid the pandemic.

R Ramakumar is Professor, Tata Institute of Social Sciences, Mumbai.