By Aditi Sangal, CNN Business
For the past year, member nations of the World Trade Organization have been deadlocked over a proposal made by India and South Africa to temporarily suspend intellectual property rights to boost production of Covid-19 vaccines and therapeutics for low-income nations.
The proposal is backed by more than 100 countries, including the United States. A temporary ban would allow multiple actors to start production sooner, instead of having manufacturing concentrated in the hands of a small number of patent holders, the Lancet reported.
Opponents of the waiver want to protect intellectual property to encourage research and innovation. Some rich regions, which are home to big pharmaceutical industries, including the United Kingdom, Switzerland, and the EU, have opposed the waiver, arguing that suspending the IP would not result in a sudden surge of vaccine supply.
“The logic of patents can be harder to defend in the face of a public health crisis, especially when there are few efficacious drugs and these remain within the patent term, that can lead to calls for the breaking or easing of patents,” WTO Director General Ngozi Okonjo-Iweala told delegates on May 5. “The issue of equitable access to vaccines, diagnostics, and therapeutics is both the moral and economic issue of our time.”
The next ministerial conference was scheduled to take place in Geneva, Switzerland, this week and debate on this again. But it was postponed after Switzerland shut its borders following the discovery of the new Omicron variant, first identified by South Africa. Talks still continue behind the scenes.
What is the TRIPS agreement?
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is about 26 years old. It is an international legal agreement between all the WTO member nations and ensures a minimum standard of IP protection that a country must provide.
How does WTO voting work?
As of 2016, WTO has 164 members. Decisions here are normally reached through consensus and have to be unanimous. So having a majority of support does not help until every member says yes or abstains. Even one member’s ‘no’ is enough to veto any proposal.
Why do the opponents want to keep the waiver in place?
European countries make up the majority of opponents of the measure, coming out in support of IP protection to encourage business, research and innovation. They dismiss the claim that IP impedes access, and argue that vaccine equity can be achieved through voluntary licensing and countries’ donations to the Covax initiative.
“We are concerned about the pandemic. Lesser-developed and developing countries aren’t getting vaccinated fast enough. But the approach of blaming the lack of vaccine availability on the IP system, and proposing that the IP protections be set aside, is intellectually dishonest,” said David Kappos, an Obama administration official who dealt with IP matters. “Vaccine inequity is a social justice issue. Not an IP issue. Countries need to lead in the fight against Covid with pills and vaccine diplomacy.”
Experts also point out that sharing and transfer of technology and establishing the infrastructure in many of the countries to manufacture these products locally would take months, if not years. The waiver would not make any immediate impact, they argue.
“Retrofitting or building new plants takes a long time. Running test batches, quality checks, audits and regulatory approval of manufacturing sites also takes a long time,” according to Andrea Taylor of Duke Global Health Innovation Center.
What do the supporters of the waiver argue?
The donation supply of Covid-19 drugs does not match demand. World Bank estimates indicate that vaccinating just 40% of Africa by end of 2021 would need 800 million doses. Yet, it has only received about 102 million doses so far, according to the Duke Global Health Innovation Center. The need of the entire world is far greater.
“We are up against the limit of manufacturing capacity. We cannot donate our way out of this. It’s not enough supply,” said said Dr. Benjamin Meier, global health policy professor at University of North Carolina at Chapel Hill. “The idea that vaccine diplomacy can alone solve this without expanding manufacturing capacity does not work.”
“It’s a debate about the world we want to live in,” he added.
Lower-income countries and developing countries find themselves short on vaccine supply, with no authority to manufacture locally and isolated from the world through travel bans when they are hit with a severe wave of Covid-19 cases.
Switzerland has enough vaccine doses to vaccinate its residents four times over and has donated less than 500,000 doses so far. The UK could vaccinate the whole country six times and has donated about 9.5 million doses, according to Duke University’s Global Health Innovation Center.
Meanwhile, under 2% of people living in Africa’s low-income countries have been fully vaccinated, according to the World Bank, and billions of doses are needed to vaccinate the world.
Yuanqiong Hu, Senior Legal and Policy Adviser at Doctors Without Borders (MSF), dismissed the argument that establishing manufacturing capacity after technology transfer would take time, saying countries like India are in a good shape to manufacture sooner rather than later.
What the waiver would do is reduce legal risk of being sued in Geneva over IP and allow governments to comprehensively respond to the pandemic instead of taking a piecemeal approach, she argued.
“If we use the traditional way of access, countries’ reaction to pandemic is delayed,” Hu told CNN. “Waiver will open up production of raw materials. Currently, some of it is under monopoly. In order to open up the entire value chain, we need the waiver.”
As an example, Moderna announced in October 2020 that it will not enforce its Covid-19-related patents against those making vaccines intended to combat the pandemic. However, there have not been many who have used the intelligence anyway.
It’s because the Moderna vaccine is based on a network of patents that are owned by many different people. The company’s announcement does not reduce the legal risk for anyone wishing to use it.
“The waiver would override all these complexities and allow countries to navigate production and pandemic response,” Hu added.
Has this ever happened before?
In 2001, at the height of the HIV/AIDS epidemic, WTO members signed the ‘Doha Declaration on TRIPS and Public Health.’ It was an IP waiver that facilitated technology transfer and empowered governments to take all steps necessary to fight the HIV/AIDS. It resulted in better access to treatment drugs and drastically lowered their prices. South Africa and India are aiming for similar results in advocating for this waiver.
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