Voluntary licensing of Covaxin will boost vaccine production
India is known globally for the vigour of its pharmaceutical sector built over several decades. It would be extremely tragic if the government fails to channelise this prowess to save precious Indian lives.
The second wave of the Covid-19 pandemic continues unabated in India, with people scrambling for vaccines, medicines, and oxygen. The Supreme Court, hearing a suo motu case on the pandemic, asked the Centre why it wasn’t issuing compulsory licences (CLs) under the Indian Patent Act to boost the production of Covid-19 vaccines and related drugs.
CL refers to granting a licence by the government to a third party to use the patent, without the consent of the patent holder, after paying a government-determined royalty to the patent owner. It is an important flexibility in patent law to address public health needs. As the pandemic set in last year, countries such as Canada and Chile introduced measures to accelerate the process of issuing CLs. However, the Indian government, inexplicably, has remained tight-lipped about making use of CLs in the pandemic.
Notwithstanding the usefulness of CLs to produce medicines through reverse engineering and other products important for tackling Covid-19, it will not be prudent to put all eggs in CL basket. CLs may not be useful in the case of technologically advanced Covid-19 products such as vaccines. While a CL will enable overcoming the restrictions imposed by patent law, it will not solve the problem of lack of access to the know-how related to the manufacturing of vaccines. Issuing a CL does not impose a legal requirement on the vaccine inventors to transfer or share the know-how with anyone.
Thus, especially for vaccines, India needs to explore other options such as voluntary licensing (VL) — the patent holder authorising a third party to manufacture and sell the patented product on mutually beneficial terms. The most obvious vaccine candidate for VL is Covaxin — India’s indigenously developed vaccine.
Bharat Biotech and the Indian Council of Medical Research have jointly developed Covaxin. Given the involvement of public money, the intellectual property rights over Covaxin ought to be with the government. The government needs to urgently license the production of Covaxin to as many pharmaceutical companies as possible, not just in India but also abroad, by actively sharing the know-how. This will augment the production and supply of vaccines.
Additionally, on the global stage, this will demonstrate India’s strong political will to increase the accessibility of Covid-19 vaccines. India has been proactive at the World Trade Organization (WTO) pushing for a temporary waiver of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement for Covid-19 vaccines, therapeutics, and related technologies. The central idea behind the temporary TRIPS waiver is to ensure that intellectual property does not become a barrier to expeditious access to Covid-19 vaccines, drugs, and other therapeutics.
Recently, India has taken some steps in this direction by giving permission to Haffkine Institute, a public sector company, and nudging Bharat Biotech to negotiate with Panacea Biotech, a private firm, to manufacture Covaxin. However, this is too little too late. India should have started the process of licensing and sharing the know-how of Covaxin months ago.
Private manufacturers wouldn’t have come forward to ramp up facilities and manufacture Covaxin till its phase-three trial data established the vaccine’s efficacy. The government, like several developed countries, should have underwritten the risks faced by these companies by promising to buy the doses produced. This would have been a calculated gamble given the certainty of the second wave, even if its ferocity was unknown. Covaxin’s supply would have increased manifold. India should also persuade firms such as AstraZeneca, Pfizer and others to issue licences and transfer technology to more Indian pharmaceutical firms. If need be, the government should offer financial incentives to these firms enabling speedier production.
India is known globally for the vigour of its pharmaceutical sector built over several decades. It would be extremely tragic if the government fails to channelise this prowess to save precious Indian lives.
Prabhash Ranjan is a senior assistant professor at South Asian University’s faculty of legal studies
The views expressed are personal