Rupa Subramanya is an independent researcher and commentator based between India and Canada.
As countries around the world gear up to vaccinate millions of people against COVID-19, can developing countries like India and South Africa really become the "pharmacy to the world," as they claim?
A simmering dispute at the World Trade Organization, pitting rich against poor countries on the contentious issue of intellectual property protection, or IPP, puts this claim to the test.
On Oct. 2, India and South Africa placed a proposal before the WTO's Council on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, to waive IPP in the pharmaceutical sector, in light of the current pandemic. On Dec. 10, noting the lack of consensus among members despite pushback from some rich countries against the proposal, the matter was deferred into 2021.
Advocates for the proposal have portrayed this as a battle between rich country pharmaceutical companies that earn fat profits from their patents against the urgent need to ensure, if not universal, then at least widespread, access to vaccines. For their part, defenders of existing IPP rules have argued that such a waiver, which would rob pharmaceutical companies of legitimately earned profits, would create a serious disincentive for future, potentially lifesaving research, the vast bulk of which occurs in rich countries.
In reality, India and South Africa are cleverly pandering to a false dichotomy between intellectual property and saving lives in the context of this dispute. The claim made by the two countries, that a blanket waiver on IPP rules is necessary to ensure an adequate, global public health response to COVID-19, fails to address the fact that existing WTO provisions offer considerable leeway already. In particular, the TRIPS agreement specifically lays out exceptions that permit governments to refuse granting patents under specific circumstances.
What is more, the November 2001 Doha Declaration of the WTO reiterates that "the TRIPS Agreement does not and should not prevent members from taking measures to protect public health." In other words, developing countries already have the legal tools necessary to invoke a regulation known as compulsory licensing, which would, in effect, override patents and ensure the manufacture of vaccines in their countries, all by using the existing safeguards.
So what are India and South Africa really up to with this proposal? They tip their hand in the letter to the WTO, by claiming that the response to COVID-19 requires "rapid access to affordable medical products including diagnostic kits, medical masks, other personal protective equipment, and ventilators, as well as vaccines and medicines." Notice that vaccines come toward the end of this long list, almost as an afterthought.
The notion that either of these two countries could effectively manufacture a sufficient quantity of vaccine doses to meet global demand was never credible. For example, India, the world's largest manufacturer of generic pharmaceuticals, simply does not have the necessary infrastructure, distribution and logistical capacity, most critically extreme cold storage -- which is indispensable to the efficacy of the Moderna and Pfizer-BioNTech vaccines -- to manufacture vaccines for itself, leave aside becoming the world's savior.
Indeed, at the time of writing, the Indian government had not even signed off on contracts with vaccine suppliers, leaving cold storage manufacturers unaware of what specifications they need to prepare for, as each vaccine has unique requirements. Despite the "pharmacy of the world" hype, India appears to be flying blind.
This is not to deny that India will be a part of the global vaccine solution. British pharmaceutical giant AstraZeneca and Oxford University, whose vaccine is less temperature-sensitive, but also less effective than either Moderna or Pfizer-BioNTech, has contracted with the Serum Institute of India, the world's largest vaccine maker, who have already stockpiled 50 million doses and claim to be able to make 400 million by July 2021. By contrast, Pfizer-BioNTech has committed to producing more than a billion doses by the end of 2021, none of which are expected to be made in the developing world.
Vials of AstraZeneca's vaccine inside a visual inspection machine at a laboratory of the Serum Institute of India in Pune, pictured on Nov. 30. © Reuters Clearly, it appears the real motivation behind the proposal is to allow both India, and South Africa, also an important generic pharmaceutical manufacturer, to grab a larger share of the lucrative market in the paraphernalia such as masks, diagnostic kits, and generic drugs used to treat the symptoms of COVID-19, and has little if anything to do with vaccines.
Critics of rich country pharmaceutical companies who profess to speak for the developing world assert that, because public money was used to fund COVID-19 vaccines, regulatory hurdles were eased, and, in the case of Moderna, the U.S. government committed to purchase the vaccine in advance, these companies no longer have a moral claim on their patents and the profits that would flow from them.
There is a legitimate debate to be had on whether the unique circumstances surrounding COVID-19 vaccines justify an abrogation of intellectual property in this case. But this misses the fact that the public money spent on all of the currently viable vaccines were by rich country governments. If anything, it is taxpayers in the rich countries, not India or South Africa, who ought to have a say. The matter before the WTO is, in other words, a sideshow.
The author would like to acknowledge valuable inputs from professor Pravin Krishna of Johns Hopkins University.
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December 25, 2020 at 03:00PM
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