Critics of the plan say a global agreement to relinquish patent protection for Covid-19 vaccines could jeopardize future pandemic responses while doing little to address current access to doses.
Last week, the World Trade Organization approved a deal to loosen the protection of intellectual property, which many policymakers say will shatter investment and innovation incentives for drug manufacturers to meet the needs of major health crises. The deal was a blow to vaccine manufacturers such as
“Anyone with an interest in preventing or responding to future crises should be concerned about the negative effects of this agreement,” said James Poole, former deputy director general of the United Nations World Intellectual Property Organization.
The abandonment of IP comes after nearly two years of debate and at a time when the initial catalysts for a plan to boost access to vaccines and production opportunities have been largely considered – leaving many in IPs and drug spaces skeptical about the agreement’s objectives beyond political convenience. .
“It gives the worst possible result: coming at a time when there is an oversupply of vaccines, this is irrelevant to the current crisis; and by reducing the reliability and predictability of patent protection, it makes it much more difficult to secure the private investment in research needed to tackle the next global health crisis, ”said Puli.
Calls for a halt to the protection of intellectual property began in 2020 in the WTO with a proposal from India and South Africa, in a bid to facilitate the growth of vaccine production and reduce inequalities in access for poorer and developing countries. The United States signaled its support for the resignation in May 2021.
The agreement overcame the battle between the United States and China over the Biden administration’s demand that China be clearly excluded from the deal for fear that it would allow China to steal American technology. The current waiver is limited to vaccines and encourages developing countries with Covid vaccine production capacity to make a binding commitment to abandon the deal.
There is a noticeable absence from the agreed plan of an explicit waiver of trade secrets – essentially recipes for how to make vaccines. This protection of intellectual property is considered critical to allow the production of vaccines from third countries, as provided for in the refusal.
“I don’t think this will lead to more vaccine production, because the agreement does not abolish trade secrets, much of vaccine production,” said Tahir Amin, co-founder of the Drugs, Access and Knowledge Initiative. “So while countries may be able to avoid patents, they may still face trade secrets.
The vaccine waiver agreement will “make access to medical supplies and components more predictable in this pandemic – and in the next,” WTO Director-General Ngozi Okonjo-Iuela said in a closing remark at a ministerial conference last week.
“This will contribute to the ongoing efforts to deconcentrate and diversify vaccine production capacity so that the crisis in one region does not leave others cut off,” she said.
Some lawyers say the waiver is a partial profit for drug manufacturers because it is narrower than originally proposed by South Africa and India and lasts for five years. The original proposal also included trade secrets and copyrights on Covid treatment outside of vaccines.
“It’s significantly diluted, but there are still enough possible pitfalls that will really depend on how it develops,” said Kevin Noonan, a lawyer at McDonnell Boehnen Hulbert & Berghoff LLP. He called the refusal a “modified victory” for patent holders.
“Under the circumstances, I don’t think there is a need for that at all,” he said. “But if this is going to be a deal we’re making, it could be a much worse deal.”
But how countries implement it can be a determining factor.
The waiver shows that patent rights include ingredients and processes necessary for the production of the vaccine. If this is interpreted to include trade secrets, it could scare off investment capital, Puli said.
Others worry that the move could give companies like Moderna and Pfizer a break in future health crises. Even if trade secrets are protected, the refusal puts a slippery slope, said Brian Nesse of Mayer Brown LLP, noting that many pharmaceutical technologies can be trade secrets.
“If we start talking about giving up those rights, talking about allowing people to go in and dive into the garbage can and misappropriate trade secrets, you can very easily imagine that this creates a whole bunch of problems,” he said. Carries.
Drug companies say there is no evidence that patents have prevented the release of vaccines. Meanwhile, demand for Covid-19 vaccines is declining as the Omicron variant appears to cause less severe disease than other variants.
“There remains a broad consensus that the problem is not the availability of a vaccine against COVID-19, but rather the implementation and assimilation of vaccines,” Pfizer said in an e-mail statement.
“Weakening intellectual property rules will not solve these real challenges. “Pfizer remains committed to helping ensure fair access for all, as it did during this pandemic,” the company said.
Earlier this year, the African Union and Covax, a World Health Organization-backed group that aims to distribute Covid vaccines in low- and middle-income countries, turned down options to buy millions of additional doses from Moderna.
WTO officials have “fallen victim to a false story that IP is an obstacle to overcoming the pandemic,” said Michelle McMurray-Heath, president and CEO of the Organization for Innovation in Biotechnology.
“Even some of the countries that have asked for IP exemption, including South Africa and India, now acknowledge that there is enough supply of affordable vaccines. In fact, hundreds of millions of doses have been refused, including in African countries, “she said.
During the pandemic, concerns about production capacity served as a major catalyst for those calling for an abandonment of IP for Covid vaccines.
As early as March 2021.
“Vaccine manufacturers have produced more than 13 billion doses of vaccine against COVID-19 and have built up the capacity to vaccinate everyone in the world,” Stephen J. said in a statement. Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America.
“Challenges in the distribution of the last mile are forcing countries around the world to destroy unused vaccines and refuse donations. Instead of resolving these issues, diplomats have spent the last year and a half arguing with the World Trade Organization over ways to undermine intellectual property rights themselves, which have allowed hundreds to work together to produce COVID-19 vaccines globally, he said.
Although the waiver agreement does not meet the aspirations of its most vocal supporters and defenders, the impetus behind it could signal a change in outlook on intellectual property rights in a crisis.
The debate over the release has prompted governments to say that because spending is not an object and access is a goal, we need to move to a model that provides generous payments in exchange for liberal access to the technologies in question, said Daniel Takas, a regulatory policy assistant. at the Niskanen Center.
“What this means for the future of the current pandemic largely depends on how the denial is used,” Takas said.