Many presume that vaccines produced by the Serum Institute of India (SII) are “Indian vaccines” by default. Covishield, the mainstay of India’s vaccination programme used in
more than 85% of India’s inoculations, is the result of a mutually beneficial international collaboration. At least half of the doses SII produces are paid for by other countries and global platforms, but manufactured in India. The deadly second wave created an unforeseen emergency and disrupted India’s role as a global supplier of vaccines.
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recent analysis of company filings by the top four global vaccine manufacturers found that 90% all the vaccines produced in 2021 Q1 in the United States (US) and Europe were administered on populations within North America and Europe. Even
in Q2, the situation is going to be the same. This brings to the front the importance of creating and expanding vaccine production capacity in the developing world.
India’s restriction of vaccine exports was not the first; countries such as the United Kingdom (UK) and the US had
virtual bans on vaccine exports, and by invoking the Defense Production Act, the latter has also been hoarding vaccine components and raw materials. Such supply chain disruptions across the world have both created vaccine shortages as well as impacted the ability of other countries to produce vaccines.
The joint proposal for global patent waivers introduced in October 2020 before the World Trade Organisation (WTO) by South Africa and India is
getting a pushback from the European Union (EU), despite a conditional support from the US. A delay in reaching a consensus seems inevitable, and in parallel, there is demand from civil society to invoke
Compulsory Licenses (CLs) to allow Indian companies to produce Covid-19 vaccines.
A limited global supply of vaccines is mopped up by richer countries, forcing the global health leadership
to warn that the world is on the brink of a “catastrophic moral failure”, which needs to be addressed fast. However, given the urgent need, decisions to not enforce intellectual property (IP) rights, CLs at the country level, or a global patent waiver on vaccines may have only a limited success. In the current situation, a looming threat of waivers or CLs in key markets may be
more useful than actual waivers and CLs per se, to force the hand of innovator companies to get into voluntary licensing agreements with developing country manufacturers and actively share technology and know-how.
A limited global supply of vaccines is mopped up by richer countries, forcing the global health leadership to warn that the world is on the brink of a “catastrophic moral failure”, which needs to be addressed fast
As opposed to drugs, whose reverse engineering has been successfully done by many Indian generic manufacturers for decades, vaccines are much
more complex biological products, where process information and technology transfer are key. Yet another roadblock linked to technology transfer will be that of a complex supply chain. Reportedly, Pfizer’s Covid-19 vaccine alone is made out of
280 components, sourced from 86 suppliers across 19 countries. A CL of a vaccine would mean potentially a mapping of all the patents involved with these components and licensing them, which creates a mighty barrier.
For example, Moderna had announced in
October 2020 that it will not sue any company across the world that manufactures its vaccine. Seven months have passed but no company has tried manufacturing the sought after vaccine. This means that in the case of vaccines, any promise of legal protection of manufacturers may have limited meaning unless active collaborations, voluntary technology transfer and knowledge sharing are involved. In view of the complex interdependencies, the immediate answer may not really be in adversarial actions which may not change the ground situation, but in ensuring — by strong acts of persuasion — voluntary action by the companies that goes beyond “not suing”.
Vaccines from Oxford-AstraZeneca, Johnson & Johnson (J&J), Novavax and Gamaleya Research Institute (Sputnik-V) have voluntary arrangements already in place with Indian companies, involving licenses and technology transfer. However, even with an active collaboration and sharing of know-how, this is a
time consuming process. Sputnik-V production is to start in India only by August 2021. The Indian made J&J may take even longer. Even after the technology transfer is initiated, it is reported that the Indian company Biological E will take up to five months to start production.
The limitations of CLs in the short and medium run, despite its being a somewhat popular solution among commentators for the Covid-19 vaccine problem, can be further examined through the case of Bharat Biotech (BB) voluntarily allowing three public sector companies (PSUs) — Indian Immunologicals Ltd (IIL), Bharat Immunologicals & Biologicals Corporation (BIBCOL) and Haffkine Biopharmaceutical Corporation (HPC) — to manufacture Covaxin. Despite active technology transfer and knowledge sharing, IIL and BIBCOL will start production only by August-September, and HPC has sought a year to start production.
To manufacture a range of vaccines in the coming months, Indian companies will need hundreds of components from dozens of companies spread across the world. This complex network of manufacturing partnerships cannot be wished away. Restoring India’s role as a global supplier of vaccines is key in ensuring functioning supply chains. One major reason why the rate of daily vaccinations have fallen by half from the peak in early April is reported to be an acute
raw material shortage. Interestingly, India’s leadership has been harshly criticised during the second wave for exporting 'too many vaccine doses’, but also for ‘not producing enough vaccines’; a line of attack oblivious to the possible linkages between the two. Autarky or one-sided, heavy-handed action may not yield results immediately to defeat a pandemic. India’s international cooperation has not been a one way street — the country has
given to the world and also gained from it.
Restoring India’s role as a global supplier of vaccines is key in ensuring functioning supply chains. One major reason why the rate of daily vaccinations have fallen by half from the peak in early April is reported to be an acute raw material shortage
An emerging India should not aspire for a minimalist ‘
Atmnirbharta’ (self reliance), an aim of a very limited self sufficiency, where it produces vaccines for its citizens. Its ‘
Atmnirbharta’ should stem from its strong belief in ‘
Vasudhaiva Kutumbakam’ whereby the country provides for people within its borders and is also strong enough to share with those outside. It is also a practical issue: as one of the world’s biggest vaccine producers who many countries depend on, availability of vaccine components will be contingent upon the country fulfilling its central role.
While the world works towards a waiver that brings in predictability and security to manufacturers in the developing world, voluntary licenses will have to be granted, supported by active technology transfer as well as capacity expansion, multiplying the global output of Covid-19 vaccines many times over in the quickest possible time. It is a positive sign that starting with the three PSUs, idle capacity existing in the pharmaceutical sector is being actively identified and enhanced so that vaccine production can be expanded considerably.
A shorter version of this essay appeared in Hindustan Times.
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