IP waiver won’t solve vaccine problems, warn experts

A landmark proposal to suspend provisions of TRIPS for COVID-19 vaccines and treatments was first raised in October 2020. But, nearly a year and a half later, in January 2022, it seems there is no end in sight, with members of the World Trade Organization (WTO) failing to reach consensus.

Progress has stalled for a variety of reasons. While the pandemic itself has caused issues—in November, the new Omicron variant forced the WTO to postpone its ministerial conference—a divide between the more developed nations and developing nations has driven the waiver’s stagnation.

To discuss the IP waiver and its wider implications, Jim Pooley, independent attorney at James Pooley PLC, and Sven Bostyn, associate professor of biomedical innovation law at the University of Copenhagen, sat down with LSPN Connect last week.

Pooley said: “As usually happens, they have locked themselves up to try to see if they can come up with a document that will achieve consensus among the member states that are part of the relevant committee. This is just the beginning of a process that will ultimately take whatever it is that they come up with to the member states.

“But along the way, all of the negotiation is happening in the hallways and behind closed doors as they attempt to find a way that they can agree on something. I think we should not be expecting too much.”

Why the waiver won’t work

Poole believes that rather than being an effective way of improving global vaccine distribution, an IP waiver is “more of a distraction”. He emphasised the distinction between patent rights and trade secrets.

“Waiving TRIPS is not going to do anything to change [pharmaceutical company’s] rights to hold on to the data that they have. Honestly, the biggest danger is that it will diminish the incentive for investment in future medicines for the next pandemic. It’s very problematic in a lot of ways,” he said.

Providing balance to the argument over the waiver, Bostyn explained that other options aimed at improving distribution, such as compulsory licensing or voluntary licensing, have their own problems. While voluntary licensing is dependent on goodwill, compulsory licensing can be incredibly inefficient, with each patent needing to be licensed individually.

“The idea is that with one stroke, we can give access to technology,” said Bostyn, on the waiver. “It would be a great idea if it could work. The problem is, will it ever work? There are more complications than just trade secrets, including data and market exclusivity. Data exclusivity is covered [within TRIPS], but market exclusivity does not fall within waiver, and would have to be separately legislated.”

Bostyn also expressed concern about liability where trade secrets have to be shared.

He said: “Let’s say some company gets access to trade secrets, produces a vaccine and people die. Who is liable? The company producing under some kind of IP waiver will say I received bad trade secrets, it’s not my fault. If there’s one thing a pharmaceutical company is terrified of, it’s medical liability.

“If you’re a big company, you might survive it. But some of our producers are medium-sized companies, medical liability issues could be the end of a company. If that's what’s waiting for you, you might start thinking twice about entering that space.”

In agreement, Poole warned that if the waiver were to take away a company’s right to control its information and instead distribute the information around the world, we will be facing a “very difficult problem with the next generation of pandemics and the medicines we need”.

He concluded: “It takes billions and billions of risk capital to develop these drugs. Asking private industry to do that once you’ve taken away those rights is going to be extremely difficult. Where’s the investment income going to come from when it can’t be reliably recovered in some way?”

Watch:  The WTO TRIPS Waiver-Status and Implications

LSPN Connect is the membership programme for the Life Sciences—for more information on joining, visit  www.lspnconnect.com

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