On April 26, in an article in Scroll.in, we had raised the question of who owns the intellectual property rights over Covaxin – one of the two Covid-19 vaccines being used on a large scale in India.
The article cited evidence of involvement of the government of India in the research and development of the vaccine. The involvement was through the Indian Council of Medical Research and its subsidiary, the National Institute of Virology, Pune.
Thankfully, with the intervention of the Supreme Court of India through its suo moto writ petition registered to check on pan-India challenges arising out of the Covid-19 pandemic, the government has been forced to clarify matters.
Over the last two weeks, the government has released bits and pieces of information that has surely enhanced our understanding of the matter. However, a few important questions remain and must be asked.
The Scroll article had raised three questions:
1. What is the exact nature of the agreement between the ICMR and Bharat Biotech International Ltd that is manufacturing the vaccine?
2. Who owns the intellectual property rights over Covaxin?
3. If the government of India owns the rights, how did it leverage these rights to benefit Indian citizens amid the pandemic?
On the first two questions, we now have some answers from the government and ICMR. These have come through a report in The Hindu on May 3, which featured an interview with Balaram Bhargava, the director general of the ICMR, and through the government’s affidavit in the Supreme Court of India.
In the report in The Hindu, Bhargava stated the following:
“The Public-Private Partnership was executed under a formal Memorandum of Understanding between the ICMR and the BBIL [Bharat Biotech] which includes a royalty clause for the ICMR on net sales and other clauses like prioritisation of in-country supplies. The product IP is shared. It is also agreed that the name of ICMR-National Institute of Virology will be printed on the vaccine boxes.”
This news report did not provide information on the amount spent by the ICMR. However, the affidavit expands on this clarification and provides figures on expenditure.
According to the affidavit, the development of Covaxin was the outcome of a “public-private partnership”. As per the memorandum of understanding between the ICMR and Bharat Biotech, a royalty of 5% must be paid to the council and in-country supplies should be prioritised by Bharat Biotech. No direct funding was given by the ICMR to Bharat Biotech. However, several activities related to vaccine development were undertaken by ICMR for which Rs 35 crore was spent.
These activities were:
(a) Isolating virus, bulk production of virus and characterisation of the vaccine strain at the National Institute of Virology.
(b) Preclinical studies of the vaccine strain in hamsters and monkeys/
(c) Quality control samples of small animal studies and phase 1 and phase 2 serum samples.
(d) Phase 3 clinical trial (full funding).
(e) Assessing the effectiveness of Covaxin against variant strains of SARS-CoV-2 (UK variant, Brazil variant, South African variant, and Indian double mutant strain).
The report in The Hindu, on the other hand, presented matters slightly differently. It noted that there were 12 activities in the clinical and pre-clinical stage, of which five activities were fully funded by Bharat Biotech. The remaining seven activities were funded by the ICMR.
The report cited them as following:
(a) Isolating the SARS-CoV-2 virus from a “huge number” of clinical samples, passage testing and confirmation.
(b) Biosafety level-3 facility validation of Bharat Biotech for Covaxin production.
(c) Vaccine strain characterisation by ELISA tests, electron microscopy, next-generation sequencing.
(d) Testing serum samples from preclinical studies in small animals;
(e) Preclinical safety and efficacy in golden Syrian hamsters and preclinical safety and efficacy studies in rhesus macaques (monkeys).
(f) Testing sera of Covaxin vaccinated individuals for UK strain, Brazil strain, South African strain and double mutant strain of SARS-CoV-2.
(g) UK variant virus isolation and characterisation, titration, sequencing from clinical specimens and funding the site for the phase 3 clinical trial.
This much has come to the public domain after April 26. Do these answer all questions raised over the debate? Unfortunately, not. There are at least four questions that remain.
First, globally, attempts to estimate public sector contributions to vaccine development adopt a detailed methodology. It includes not just explicit working capital expenditures, but also past investments made towards basic research that may have directly or indirectly contributed to vaccine development.
For instance, when scholars tried to estimate the share of public finding in the development of the Oxford-AstraZeneca vaccine, they reviewed 100 peer-reviewed articles on the ChAdOx technology published between January 2002 and October 2020. This helped them extract 577 mentions of funding institutions from the statements that acknowledged funding.
It was thus that they reached the conclusion that about 97% of the funding behind Oxford-AstraZeneca vaccine came from public sources.
Typically, such methods of estimation should also include payments of salary and remuneration paid to scientists, and the incidental expenses. It is unclear if the method adopted by the ICMR includes such components of expenditure. If not, the figure of Rs 35 crore is an underestimate. The ICMR should make public the method used to estimate its contribution.
Secondly, it was not just the ICMR/National Institute of Virology that contributed to vaccine research. The Indian Institute of Chemical Technology in Hyderabad, a subsidiary of the Council of Scientific and Industrial Research, also played a major role. An official press release on February 25 tells us that the Indian Institute of Chemical Technology developed a synthetic route to produce the “agonist molecule” using indigenous chemicals “at an affordable price and with highest purity”.
The development of this agonist molecule helped Bharat Biotech to scale up the production of the adjuvant, which helps in the vaccine generating better immune responses. Such expenditures by other public sector institutions should be added to the expenditure by ICMR.
Thirdly, a perusal of the contributions by ICMR/National Institute of Virology and Council of Scientific and Industrial Research/ Indian Institute of Chemical Technology show the stellar contributions made by Indian public sector scientists in the development of Covaxin. The quantum of expenditure become socially inconsequential when the real scientific value of these contributions is considered. Further, the quibble over whether the government’s expenditure was large or small became irrelevant the moment the government admitted that it shared the intellectual property rights.
The question, then, is this: despite sharing the intellectual property rights with Bharat Biotech, why did the government not initiate steps to mass produce Covaxin in India over the past several months? Why were exclusive licences to produce Covaxin given to Bharat Biotech for a considerable period?
When permission was eventually given to others, why was it limited to three public sector units viz., Indian Immunologicals, Hyderabad; Haffkine Biopharmaceuticals, Mumbai; and Bharat Immunologicals and Biologicals, Bulandshar? Surely, if adequate investments were made in time over more units, by now India would have had a large quantity of Covaxin ready to use. Given the unpardonable delay, units like Haffkine can be ready for production only after six months to 12 months.
The question of the ICMR sharing the know-how to develop Covaxin was put to an “official involved with the developments” by The Hindu Business Line. The official’s response is quoted thus: “The contract with Bharat Biotech is not close-ended, it is open-ended in terms of sharing of technology. So, we are free to share the know-how with other companies.” Why then is the government wasting time?
Fourthly, as legal scholars have pointed out, there is an obvious contradiction between the Indian government’s position in the World Trade Organisation to waive all intellectual property rights on vaccines and its domestic stance on not making available open licences for the production of Covaxin. Why is the Indian government adopting fundamentally opposing positions abroad and in India?
If the government was serious about waiving intellectual property rights on vaccines, why does it not leverage its ownership over the rights for Covaxin and allow its mass production in India (and may be, even abroad)? Would this not be the ideal policy position for a vishwaguru, a teacher to the world?
One hopes that the Supreme Court will ask these when it considers the writ petition.
R Ramakumar is Professor, Tata Institute of Social Sciences, Mumbai.