Vaccines: Why CLS are not a quick-fix solution
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.
A 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 fore the importance of creating and expanding vaccine production capacity in the developing world.
India’s restriction on 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 Organization (WTO) by South Africa and India is getting a pushback from the European Union (EU), despite 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 Licences (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 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.
As opposed to drugs, whose reverse engineering has successfully been 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 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 knowledgesharing 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 in place with Indian companies, involving licences 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. 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 upto 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 — 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 to ensuring functioning supply chains. 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.
While the world works towards a waiver that brings in predictability and security to manufacturers in the developing world, voluntary licences 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.