The precarious second wave of COVID-19 infections has hit India with greater ferocity than the first. Despite a year to prepare, we have been caught woefully off guard again. Multiple reports of the scarcity of COVID-19 vaccines and drugs have surfaced from different parts of the country. According to the Observer Research Foundation, till the end of March, India had produced 316 million doses of Covishield and Covaxin — the two COVID-19 vaccines in use in India. Of this, 64.5 million doses have been exported. This suggests that the issue isn’t vaccine production. Perhaps, the problem has more to do with centralised procurement, distribution, and coordination with different State governments and local authorities. Nonetheless, as India aims to inoculate more and more people it is imperative to ramp up vaccine production. Serum Institute of India (SII), which manufactures Covishield, has said that it can produce 100 million doses a month, up from the 50 million doses, provided it can scale up its manufacturing capacity.
We discuss some of the legal means that the government could have employed last year and should employ now to scale up the production of COVID-19 vaccines. We divide these legal means into the non-intellectual property-(IP)-based and IP-based options.
Section 2 of the Epidemic Diseases Act of 1897 empowers the government, during the outbreak of an epidemic, to take measures that it may deem necessary to prevent the outbreak or its spread. Likewise, Section 26B of the Drugs and Cosmetics Act, 1940, empowers the Central government to regulate the sale, manufacture, and distribution of a drug that is essential to meet the requirements of an emergency arising due to an epidemic.
Since ramping up the production of vaccines would be a necessary step in that direction, the government can direct pharmaceutical companies to loan their manufacturing capacity to the existing COVID-19 manufacturers like the SII and Bharat Biotech to boost their manufacturing capability so that more COVID-19 vaccine vials can be produced. This can be done without affecting the ability of these companies to develop and test their own vaccine candidates.
Under Section 100 of the Patents Act, 1970, the Central government has the power to authorise anyone (such as specific pharmaceutical companies) to use any patents or patent applications for the “purposes of government”. Under this provision, the Central government can licence specific companies to manufacture the COVID-19 vaccines. The other option is to make use of Section 92 of the Patents Act, which allows the Central government to issue a compulsory licence (a licence issued to manufacture the patented product without the consent of the patent holder) in circumstances of national emergency or extreme urgency or in case of public non-commercial use. The pandemic is a circumstance of national emergency. Thus, the Central government, under Section 92, can issue a notification in this regard. Subsequently, any company willing or directed by the government to manufacture the COVID-19 vaccine can be issued a licence.
Another option available to the government, as some commentators have pointed out, is that all COVID-19 vaccine projects that are funded by the taxpayer’s money should not claim IP rights in the first place or if patents are granted, they should not be enforced. This would make the wider dissemination of research outcomes possible facilitating easy replication by other manufacturers. This can be done in the context of Covaxin that has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
The government needs to explore the production capabilities of the pharmaceutical companies in the public sector to build India’s manufacturing competence. For instance, Haffkine Biopharmaceutical Corporation, a State government public sector undertaking, can manufacture Covaxin immediately. A licence could have been issued to this entity by the government last year and we would have had higher supplies of COVID-19 vaccines this year. These legal options have been available to the government all along. The government should have used these options to build India’s manufacturing capacity, which would have placed us in a better position to fight the second wave. There is still hope and a chance to respond to this lament. Will the government listen?
Murali Neelakantan is Principal Lawyer at Amicus, Mumbai, and Prabhash Ranjan is with South Asian University, New Delhi. Views are personal