The US has agreed to go along with Indian and South African plea for a patent waiver at the WTO discussions whereas the European Union has diplomatically but quite rightly parried the issue by saying that even if the vaccines invented in the EU become available as a generic medicine, it would be a long haul despite the legendary Indian reputation for its generic medicine prowess.
European Commission President Ursula von der Leyen rightly harped on scaling up production and fair distribution as the more pressing issue and the need of the hour. She was guarded in not using the term vaccine equity as that would most certainly offend the US, Canada, UK, and Israel which stockpiled vaccines by preordering from whatever sources possible. Small wonder the US is able to give India 60 million doses of AstraZeneca vaccine from out of its what in hindsight turned out to be a needless stockpile given its faith in its own Pfizer and Moderna vaccines. Enlightened self-interest is the subtle message emanating from the US and EU. Be that as it may.
Kiran Mazumdar Shaw the founder of the Indian biotech firm Biocon is also of the firm view that the Indian government would do well to prevail upon the US to lift the ban on the export of raw materials and consumables it had put under its Defence Act. She goes on to add that patent waiver is not as much a big deal as the US agreeing to make raw materials available.
Indeed vaccine production can require more than 200 individual components, which are often manufactured in different countries. These include glass vials, filters, and resin, tubing and disposable bags. If any critical item falls short, then it can disrupt the entire process. Therefore, it is necessary to understand that vaccine manufacturers cannot produce without the supply chain of components firing on all four cylinders which unfortunately is not happening.
Shortage of components is already holding up production in few production centers. This points to the need for not viewing the production of vaccines in isolation but holistically. And this is the point Biocon’s Shaw is making tellingly. Serum Institute which is hopeful of ramping up its production to 100 million doses a month badly needs all these 200 or so raw materials which were freely available to it when the current pandemic had not broken out thus making it the vaccine hub of the world. But the pandemic has made the manufacturers in the supply chain cringe and look inward.
The emphasis must be on quickly vaccinating as many people as possible. Israel has the envious record of vaccinating 56 percent of its population whereas only 16 crore Indians have so far got the first dose. At this rate even by the end of 2022 India would have vaccinated only 50 percent of its population. Herd immunity in the Indian context with its dense population would presumably require that at least 75 percent of the population is fully vaccinated.
Even if Pfizer’s vaccine becomes generic, Indian generic manufacturers would take a couple of years to roll out the vaccine which incidentally requires -70 degrees Celsius cold storage chain along the route to factory to the vaccination centers.
Patent waiver thus has relevance only in the long run but in the ongoing crisis what we need is stepping up of domestic production as well as imports both of the vaccine and raw materials. The former Prime Minister Manmohan Singh’s exhortation to the Modi government to invoke the compulsory licensing dispensation under the Indian Patent Act alas is a tad confrontationist for a man known for his mild manners and consensus-building efforts.
Under compulsory licensing, if a patent holder is sitting on his invention i.e. not producing vaccines in sufficient quantities he can be asked to enter into a licensing arrangement with Indian manufacturers for a royalty mandated by the Indian government. That could leave a bad taste in the mouths of the inventors.
What the Indian government must do is to replicate Sputnik-Dr Reddy’s Lab model on a wider front so that all vaccine inventors enter into collaboration agreements with Indian pharma firms on a war-footing to halt the rampaging virus in its tracks.
—S. Murlidharan is a CA by qualification and writes on economic issues, fiscal and commercial laws. The views expressed in the article are his own