I remember one of the (several) questions that I answered wrong in my law school entrance examination (way back in 1999) was the full form of TRIPS. At the time I was unaware what the agreement on Trade Related Intellectual Property Rights was.
It was in the news then because India, to comply with its WTO commitments, had just passed the Patents Amendment Act to set the stage for abandoning its policy on pharmaceutical patents which had revolutionised drug affordability in the global South.
TRIPS is in the news again as India and South Africa have been lobbying for months to rally support for a limited waiver of its provisions to enable suspension of patent protections on Covid vaccines and drugs.
To take a step back, India had introduced a new patent regime in 1970, which, pursuant to recommendations of the Ayyangar Committee, granted only process patents in the pharmaceutical sector and not product patents.
This meant that Indian pharma companies could manufacture an identical product to a patented drug as long as they used a different process. Despite a great deal of lobbying against it and a lot of whining from Big Pharma, this legal regime led to the burgeoning of India’s pharma industry, driven by its ability to make low-cost copies, called generics, of prohibitively expensive patented drugs.
More importantly, this also meant that poorer countries now had access to affordable life-saving drugs, and Indian generics played a major role in, among other things, the fight against the . Study after study has demonstrated that this patent regime in India had a profound impact on healthcare in the global South.
India joining the WTO and consequently signing the TRIPS agreement meant that it was compelled to undo this patent regime and eventually, in 2005, Indian patent law fell in line with the western world, granting full product patents to drugs.
Cut to 2020 and the world is reeling from the Covid pandemic, and institutions around the world are racing to develop vaccines and therapeutic formulations to combat it. In October, India and South Africa submitted a proposal to the WTO to waive certain provisions of the TRIPS agreement to enable countries to suspend patent and other IP protections, and make Covid drugs, vaccines, diagnostics, and other technologies more widely and cheaply available.
While this was met with widespread support from , a small group of developed countries, including the US, UK, Switzerland, Germany, and Australia, expressed their opposition, no doubt in order to protect the interests of the pharma multinationals whose profits they value over the lives of people saved during a pandemic. These countries and pharma majors have had a toolkit of arguments to undermine the proposal that are disingenuous and full of sophistry.
Medecins Sans Frontieres has put out rubbishing these arguments, including the age-old “IP is what drives innovation” canard. The statement also called out those that claim IP is not a barrier to the pandemic response and Bill Gates’s favourite defence that “developing countries will not be able to manufacture high-tech vaccines”.
It is especially amusing to read these arguments now because were advanced in the late 1960s in India as well, when the new patent law was being debated. Members of the right-wing Swatantra Party, mostly representing the interests of the industrialists and the capitalist class in general, were quick to argue that patents were essential for scientific innovation and progress, that Indian labs and factories were paltry and incapable of technological progress, that compulsory licensing was an adequate safeguard, and that the prospect of compulsory licensing would compel enough voluntary licensing as to make this a non-issue, and so on.
While in many ways the Patent Act of 1970 was a compromise that conceded much to the demands of the industrial lobbies, even the limited extent to which it stepped back from full-fledged patent protections enabled a sea change in access to cheap life-saving drugs all over the world. The period from 1970 to 2005 provided a striking demonstration that diluting patent protections can improve both the availability and the affordability of drugs.
Of all the arguments advanced by the pharma lobby, the one that seems to have found most traction of late is that Covid vaccines and drugs cannot be manufactured outside of a few CGMP facilities – those approved by the United States Food and Drug Administration – controlled by the patent holders, because they are simply too advanced, technologically. This argument fails at two levels.
Firstly, history has shown that Indian pharma manufacturers are capable of producing high-tech pharmaceutical products. In 1986, Merck and GSK held patents for recombinant hepatitis B vaccines which were sold at prohibitively high prices. Indian firms (much like they are today) that it “cannot afford such high technology vaccines. India does not require vaccines. And even if you can afford to buy the technology, your scientists cannot understand recombinant technology in the least”.
However, a small Indian firm called Shantha Biotech independently , in its own CGMP facility, a recombinant hepatitis B vaccine, and managed to sell it for a tiny fraction of what Merck and GSK were selling it for.
Secondly, even if it were true that the manufacturers in India and elsewhere currently lack the technology to produce the vaccines or the drugs, the correct response would be a combination of an IP waiver and proactive royalty-free technology sharing to enable these manufacturers to quickly ramp up the capabilities to produce these vaccines. To claim that an IP waiver alone would not enable these companies to manufacture the vaccines, even if accurate in a limited sense, only shows that is a necessary but not sufficient step.
The imperative of battling the pandemic worldwide is the shared interest of humankind. No one is safe until everyone is safe. In this circumstance, to resort to disingenuous logical fallacies to safeguard the profits of corporations, rather than do everything that is possible and necessary to ensure the most robust pandemic response, is a stunning lack of enlightened self-interest, not only from the pharmaceutical industry but also from their state supporters in the western world.
The latest development in this story is that the United States has, uncharacteristically, and come out in support of the TRIPS waiver. While this is no doubt a positive development, Germany has stepped in to make sure it counts for little, by sticking to its antagonistic position against the waiver. At the current rate of progress, it appears that even if the waiver does happen, it may take a substantial amount of time for it to come into effect.
But it is still a battle worth fighting, firstly because the fight against this pandemic is going to be a long drawn out war, lasting several years, and at a broader level as an example for the world that nations can come together to put lives above the profits of pharmaceutical companies.