Panelists Say TRIPS Waiver at WTO Less Important Than Countries' Decisions on Medicines

Many advocates for developing countries say a TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) waiver is needed to accelerate access to vaccines, treatments and COVID-19 tests, but most speakers at an American Bar Association-convened panel said that countries already have the power to curtail pharmaceutical patents for a pandemic, and that technical knowledge and input shortages are a bigger barrier than patents.

Archana Shanker, a New Delhi-based patent attorney, said during the April 2 panel that even though India is one of the two lead requesters for a TRIPS waiver in Geneva, India already has the ability to invoke compulsory licenses for pharmaceuticals, as well as having two vaccines it developed with its own scientists.

Shanker said developed nations that oppose a TRIPS waiver have suggested it would undermine efforts to tackle new variants with vaccine boosters, and that allowing producers outside those authorized by Pfizer, Moderna, Johnson & Johnson and AstraZeneca could undermine public confidence in vaccine safety.

“I think IP is a very, very small part of this entire issue of sharing access and equitable distribution,” she said. “The issue is not just IP, it’s about reinforcing supply chains, and assisting countries to distribute and administer vaccines.”

Shanker said that even in India, which has a more developed medical sector than many developing countries, the extreme cold storage requirements for Pfizer make it not a good candidate for use in the country.

Florida State University law professor Frederick Abbott said that while he personally would support a TRIPS waiver at the World Trade Organization, he thinks the focus by advocates on the policy change is a bit off-base because countries already have all the authority they need, either through domestic compulsory licensing, eminent domain or language in the original TRIPS agreement that allows countries to curtail intellectual property rights for the purpose of public health and in national emergencies. “They already have the authority to do it, they don’t need the WTO’s permission to do it,” Abbott said. “They shouldn't be awaiting the outcome of these negotiations.”

However, he said, the waiver isn't useless, because it sends a signal that countries could take these actions without facing as much political pressure from foreign governments or multinational pharmaceutical companies. “I do not disagree about the barriers that are created by sets of intellectual property norms,” he said. “The point is that the WTO doesn’t make those national laws and at the end of the day these all become national issues.”

Peter Maybarduk, director of the Public Citizen's global access to medicines program, argued that the TRIPS waiver is in the interest of justice. “We are in the throes of medical apartheid,” he said. “Millions more may die before we’re through this. Many may not be vaccinated til 2024 or ever.” He added that “commercial secrecy has fragmented and limited our ability to respond to the pandemic.”

Maybarduk said he has helped countries use the exceptions in the original TRIPS agreement to get access to cheaper drugs before the pandemic. “It is harder and more time-consuming than it should be to do so, to issue licenses, technology by technology. Industry uses all its connections to block each use, governments often act through an internal consensus that's hard to get over pharma opposition, and it can take time,” he said. “Requiring countries to go through the flexibilities during a pandemic, instead of just suspending the WTO's always bizarre role in regulating medical technology, is … not very practical. Extremely inefficient and time-wasting, compared to the waiver. Personally, I think it's cruel.”

“Advocates like myself are not saying, necessarily, to take the technology without compensation,” he said, though he is critical of new WTO Director-General Ngozi Okonjo-Iweala's proposal for a “third way,” to negotiate with pharma companies for more global manufacturing that is cost-accessible. Other panelists said that although there are no details of what this third way might be, Okonjo-Iweala's experience as the head of the most prominent global vaccine nonprofit positions her well to find a negotiated solution.

Brazil is one of the largest developing countries that does not support the TRIPS waiver, and patent lawyer Gustavo de Freitas Morais, who works in Brazil, said, “Any sort of debate related to this issue would be easier if someone could point out what patents are blocking local manufacturing, distribution, access to medicines.” He said many patents are not filed in least developed countries, so the barrier to production is lack of know-how, not a patent. “Such a blanket IP waiver may facilitate the entry of products of lower quality and maybe even counterfeited products,” he said.