Ever since US President Joe Biden announced his support for an intellectual property waiver for COVID vaccines, pharma innovators have voiced concerns that it would not increase access to jabs and could set a dangerous precedent the next time there is a global health emergency.
Despite fierce opposition from the pharma industry, on May 5 the US trade representative Katherine Tai announced that the Biden administration would support an IP waiver only for COVID-19 vaccines. Her announcement was quickly followed by a tweet from US congresswoman Alexandria Ocasio-Cortez declaring: “Let’s do insulin next.”
Delegates from India and South Africa initially introduced the waiver to the World Trade Organization’s (WTO) TRIPS council in October. It included not just vaccines but all COVID-19-related technologies.
Sources from five pharma companies, including innovators of COVID vaccines and therapies, tell Managing IP that if the waiver is passed it could lead to a “slippery slope” to waivers for other diseases including diabetes, and could even be extended to technologies outside of healthcare such as climate change.
“I think the waiver is definitely a concern and I think the problem with the waiver is the precedent that it is going to set,” says the corporate vice president for an international pharma company.
“You can pretty much define many chronic diseases that are highly prevalent as diseases of epidemic proportions. I think diabetes is one such example.”
Rather than resort to a waiver that would remove IP barriers to COVID-19 vaccines, sources say countries should rely on the compulsory licensing measures included in the TRIPS Agreement.
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Not just COVID
US politicians are specifically targeting diabetes as a hot-button political issue because of the high prevalence of the disease and escalating costs of insulin.
The Centers for Disease Control and Prevention reported in 2020 that one out of 10 Americans had diabetes. At the same time, one in four patients in the US has reported rationing insulin because the rising cost has made it unaffordable.
And diabetes and other lifestyle-related diseases are not limited to the US. The World Health Organization reported that in 2019 heart disease was the leading cause of global deaths, and that in 2014 8.5% of all adults in the world had diabetes.
Sources say that given the rising numbers of lifestyle-related illnesses, activists could use a COVID-19 waiver as a precedent to push for lifting IP restrictions for other indications.
The manager for global IP litigation for a pharma innovator company says the waiver would make it easier for IP rights to be lifted not only for emergencies but also for diseases with a high number of patients.
“The waiver is an affront to the innovation system. You can come up with brilliant ideas, but the waiver introduces the risk they can be taken away from you if they are too good. It means you can’t rely on the legal system.
“Also, this does not resolve the problem we have. There are not enough vaccines, but taking away patents will not produce a single extra dose. This could, for example, set the precedent that in a couple of years it’s imaginable that there is demand to waive IP for climate change technologies,” he says.
Beyond COVID
“Lawyers are all about semantics, and the wording can be fuzzy around the edges. What if COVID mutates? Could other technologies besides vaccines be included in the meaning of the waiver? You could have a situation where the actual use of the IP might not be specifically for COVID-19 and then the waiver could still apply.”
An executive for an international pharma company says the initial waiver proposed by India and South Africa was not limited to vaccines, which means that there is the potential for companies in other countries to take the IP for COVID and use it to manufacture products for other illnesses.
“I do not think it is alarmist to say that the waiver could set a precedent for other illnesses. If you have a technology platform for COVID that could be used for something else, such as cancer, there is no limitation to how it can be used. The technology could have dual or even triple uses.”
The senior IP lawyer at the pharma company adds that one fear he has about the waiver is that technologies could be exploited by companies around the world and vaccines be used for political purposes.
“One of the fears US innovators have if the waiver is passed is that companies in places like Russia and China could take all their trade secrets that were funded by the US public. The intention of the waiver is to increase vaccine access, but you could end up with a situation where China has a new vaccine that they use as a political bargaining chip.”
Henry Hadad, deputy general counsel at BMS in New Jersey, says that the pharma industry wants to keep innovating and investing in new medicines for unmet medical needs, but that the waiver could create business uncertainty that undermines investment.
“Historically, the public sector has not had the patience or risk tolerance to do this without private industry expertise and financial support. If governments decide to appropriate private sector technology beyond true health emergencies, this will significantly decrease innovative new therapies for the entire world.
“I am concerned about the slippery slope to other technologies and the expansion of compulsory licensing beyond narrowly defined health emergencies,” he says.
Hadad adds that he wants to make sure the pharma industry is ready and willing to lead efforts the next time there is a pandemic and not be worried that its participation will lead to the appropriation of cutting-edge technologies or medicines.
Favouring the waiver
Ellen ‘t Hoen, director of think tank Medicines Law & Policy in the Netherlands, says pharma companies faced less risk in investing in COVID vaccines because they were largely funded by public money.
“Whenever I hear industry say they are afraid of the government intervening I think that they are in the best place to prevent that from happening,” she says.
“Frankly I don’t understand the concern that the waiver could be used for other indications. If you look at how the waiver is framed it is a narrow and modest proposal. A much bigger question we should be asking is whether we have the right framework in place to deal with a global crisis.”
For the moment there is no immediate likelihood of the WTO general council passing a vote on the waiver. In June the European Commission submitted a counter-measure to include compulsory licensing as an alternative to the waiver, and sources say a vote is not likely until the end of the year.
Rightly or wrongly, that’s a long time to keep the pharma industry and activists waiting for a decision.
