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Last October, India and South Africa proposed in the World Trade Organization that intellectual property rights of Covid-related drugs and vaccines be suspended. This proposal was supported by 60 countries. However, the United States, still under the Trump administration and the EU were opposed to the proposal. Then presidential candidate Joe Biden in early July itself had said that he supported such a proposal. So, there was expectation, but the pressure from the pharma lobby was intense too. Besides abruptly curtailing patent rights is against the basic sanctity of contracts.
You can’t renege on a sovereign promise, which is what patent rights are. Then in April last month more than 100 Nobel Prize winners, and several prominent world leaders, including former heads of State, urged the United States to support a waiver of the TRIPS (Trade Related aspects of Intellectual Property Rights) clause in the WTO. Such a waiver they said, would vastly increase inoculation rates, and would legally allow developing countries to make their own vaccines, which were currently developed and produced by global pharma companies.
Under compulsory licensing, a company can be forced to disclose and license its patents to others, for the sake of national emergencies. But developing countries have been reluctant to use this clause for fear of displeasing the United States, which could counter the move with some other diplomatic or economic punitive measures.
The signed letter also said that vaccine knowhow and technology should be shared openly, and industry monopolies should not be allowed to create artificial supply shortages. This is seen as essential to winning the war against the pandemic. Winning over US support for a patent waiver is crucial because it entails taking on the might of major pharma companies like Pfizer, Moderna, Novavax, Johnson and Johnson and AstraZeneca.
Of course, there is the argument, which has been examined by India as well, that the current TRIPS regime of the WTO has an escape clause in case of emergencies. This is called compulsory licensing wherein a company can be forced to disclose and license its patents to others, for the sake of national emergencies. But developing countries have been reluctant to use this clause for fear of displeasing the United States, which could counter the move with some other diplomatic or economic punitive measures. It must be remembered that during the anthrax scare of 2001, the Canadian government had threatened to break the patent protection of Bayer, and use compulsory licensing to produce ciprofloxacin on a mass scale through a small company.
Winning over US support is crucial because it entails taking on the might of major firms like Pfizer, Moderna, Novavax, J&J and AstraZeneca.
Bayer however settled the matter with the Canadian government by donating large amounts of ciprofloxacin and offering more in case of an emergency. This led the Canadian government to agree to acquire cipro exclusively from Bayer for the duration of the patent agreement. So, there is a precedent, but many developing countries of Africa have been reluctant to use this route, even for genuine national emergencies like AIDS. An interesting success story without breaking any patent rules was that of CIPLA, an Indian pharma company which in 1993 developed and sold a drug at one tenth the then prevailing price. By 2001, CIPLA had developed an anti-AIDS drug cocktail and sold it at a very low cost, upending the hitherto monopolies, and vastly contributed to the effort to combat and control AIDS.
So, in the present context of Covid, the compulsory licensing avenue is only of academic interest. Besides the US has been increasingly under diplomatic pressure to relax the restrictions on export of vaccines which lie unutilised.
This week President Biden announced that he would support a TRIPS waiver at the WTO. This is a historic decision. It comes after surmounting the challenges and pressures mounted by the pharma lobby, including the scare that the Russians and Chinese would get the American pharma technology, and that if there was an indiscriminately large production of vaccines all around the world, it would create a big stress on supply chains. As of this writing 120 out of 164 member countries in the WTO are supporting the TRIPS waiver for vaccine patents. Added to this is the statistical evidence that 60 percent of the world’s supplies have been cornered by the rich countries, or only about 16 percent of the world’s population. There is excess stock sitting around in the US which will remain unutilised.
India needs to rapidly ramp up vaccine production and imports, and immediately go for universal and free vaccinations.
Sure enough the US decision was opposed by many pharma companies and leaders like Chancellor Angela Merkel. She said that patents were not the limiting factor responsible for the vaccine shortage. It was production capacities and highquality standards. But she surely misses the point, that patent waiver allows production to happen on a massive scale, so that the current capacities are no longer the bottleneck, since newer capacities will come up, without fear of infringing on patents.
A German company BioNTech also echoed similar sentiments, saying that replicating the manufacturing process and mastering that technology can take years. It also added that it was committed to selling the mRNA vaccine to developing countries on a no-profit basis. But that no-profit price surely has the value of the patent, which itself makes it prohibitive. Strangely even Brazil has opposed the patent waiver proposed by Biden, and so has Bill Gates. Of course, if Covid vaccine patents are going to be breached now, the world has to find a way to compensate the pharma companies for the breach of contract.
The issue of TRIPS waiver for Covid vaccines is also the right time to examine excessive patent protection, and overall exorbitant monopoly drug prices. There is now abundant research which shows that the maxim “no patents, no drugs” is false.
How this waiver proposal will travel through the WTO’s voting process remains to be seen. Crucial time may be lost, so India cannot count on this proposal to help its cause. It needs to rapidly ramp up vaccine production and imports, and immediately go for universal and free vaccinations. It should not only depend on “app” based booking, because given the great digital divide, it puts the poor and underprivileged at a great disadvantage. Imagine the areas where telecom connectivity is poor, digital literacy is low (can you do a captcha in 20 seconds), and when the Cowin website open slot is as elusive as a passing comet in the sky.
The issue of the TRIPS waiver for Covid vaccines is also the right time to examine excessive patent protection, and overall exorbitant monopoly drug prices. There is now abundant research which shows that the maxim “no patents, no drugs” is false. And the billions in dollars needed to develop a new drug is mostly due to costs incurred on stage 2 and stage 3 clinical trials, which are actually in the nature of “public goods”. That’s because once the safety and reliability of the new drug is established in those trials, it deserves to be public knowledge. Hence that cost should simply be reimbursed, and patent-induced monopoly rights should be drastically reduced. This is a longer-term plan. Right now the Covid vaccines are on the agenda.
(Dr.Ajit Ranade is an economist and Senior Fellow, Takshashila Institution)