Photo Credit: Leonhard Lenz
TRIPS waivers are another way governments can seize drug IP. As part of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), this provision is designed to address public health crises and ensure access to affordable medications, especially in developing countries. The World Trade Organization oversees TRIPS and can authorize waivers that permit member countries to produce or import generic versions of patented drugs without the consent of the patent holder. The system was developed and most successfully used during the AIDS crisis. In 2007, Rwanda became the first country to use the TRIPS waiver mechanism to import generic ARVs from Canada under a compulsory license issued by the Canadian government.
During the COVID pandemic, there were calls for TRIPS waivers to facilitate access to vaccines, treatments, and diagnostics in poorer countries. In June 2022, a targeted waiver was approved to help distribute vaccines, but by then demand had decreased to the point where no country felt the need to use the waiver.
Besides, the technology used to develop mRNA vaccines was novel and sophisticated. Simply allowing anyone to ignore Moderna’s and Pfizer/BioNtech’s mRNA vaccine patents would not have meant that they could competently build the facilities and develop the processes to produce more doses. It takes years to transfer this kind of knowhow. In the heat of the pandemic, the most efficient course of action was to contract with those companies to make more doses using their knowhow and facilities. Moderna and Pfizer weren’t holding back on making extra doses because countries weren’t willing to pay high prices for them, but they were capacity constrained. Some countries couldn’t afford to even cover the cost of making more doses; what good would having access to patents be to them? They would still need to find companies that would be willing to build those facilities and make those doses. And since those companies would have no doubt even higher costs than Moderna and Pfizer, since they would not be producing doses at nearly the same scale, those doses would be even less affordable to poor countries.
During the pandemic, there was a lot of money raised to buy doses cheaply from the established vaccine companies and make them available to poor countries. Calls for TRIPS waivers were just a facile proposal issued by those who either didn’t understand what the real constraints on making more doses available were or didn’t care and just used COVID to gin up more anti-pharma sentiment.
The fact is that the drug industry already recognizes that it can’t make money from selling drugs to poor countries and doesn’t even try. Sometimes it flat out donates medicines to poor countries and otherwise sells them at cost because no one wants to see people go without. Gilead famously licensed the right to make its HCV drug to generics companies for low cost distribution throughout the world except for wealthy countries where Gilead sold its drug itself.
One of the biggest obstacles to accessing novel medicines in poor countries is that those countries lack the healthcare delivery capabilities to make those medicines available to patients. For example, Tuberculosis has long been easily diagnosed and treated in developed countries, but the healthcare infrastructure around diagnosis and treatment of TB in poor countries has allowed it to persist as the deadliest infectious disease on Earth.