By Michael Hirsh
One critical issue is how many people around the world will die before negotiations—which can take months—are finished and the necessary technology and production capacity is transferred to those in need. India, which has been worst hit by a new surge of the coronavirus, has again broken the record for the highest daily number of new cases, with 412,262 new infections reported in the past 24 hours.
The U.S. announcement was narrowly focused on intellectual property rights for vaccines without reference to patent waivers on other medical tools, including treatments, personal protective equipment, and testing kits, as called for in the original proposal made by India and South Africa last October at the World Trade Organization (WTO).
“On the ground in India, there’s an urgent need not only for vaccines but for treatment and testing, even oxygen,” said Priti Krishtel, co-founder of I-MAK, a major advocacy group supporting wider access to medicines. “There are still IP barriers in all these areas. Manufacturers want to be freed from worry about being sued for infringement on patents, trade secrets, and clinical trial data, and governments want to feel they are not being threatened with trade sanctions. They are not yet assured of this.”
Krishtel believes a broader waiver of intellectual property rights would allow manufacturers in countries like India to accelerate mass production within two to three months—instead of a year. That difference of nine or ten months could end up translating into tens of thousands of deaths around the world or the proliferation of more virulent mutations of COVID-19. Still, Krishtel and other global health advocates said Biden’s decision Wednesday was a bold repudiation of the powerful U.S. pharmaceutical industry, whose representatives had long argued against the waiver. Under the proposal, WTO member nations would have the right to bypass intellectual property licenses on vaccines in cases of national emergency.
In a tweet, World Health Organization Director-General Tedros Adhanom Ghebreyesus called Biden’s announcement a “monumental moment in the fight against #COVID19” and said it reflected “the wisdom and moral leadership” of the United States.
Matthew Kavanagh of Georgetown University’s Global Health Policy and Politics Initiative called the move “a major and important shift in the geopolitics of access. I think it is likely the U.S. shift will bring along key U.S. allies like Japan and push the Europeans into supporting it as well.”
But on Thursday, German Chancellor Angela Merkel reportedly said she would oppose the waiver, in what could amount to the biggest dispute between the United States and Germany since Biden took office. According to a spokesperson, Merkel believes the plan would create “severe complications” for the production of vaccines. BioNTech, a major vaccine manufacturer, is based in Germany.
After months of delay, Biden’s decision appears to fulfill a promise he made last July when the then-Democratic candidate said he would “absolutely positively” not let patents stand in the way of getting vaccines to the world.
But in making the waiver announcement at a meeting of the World Trade Organization, U.S. Trade Representative Katherine Tai indicated the waiver was narrowly focused on vaccine rights. She also warned that “negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.” That raises the issue of how much and how quickly technology will really be transferred and whether nations’ most in need—like India—will gain the capacity to manufacture and distribute vaccines quickly.
“The devil will be in the details,” Kavanagh said. “Will the U.S. ensure the waiver stays broad and really provides the legal security needed to get more producers in the game for vaccines as well as diagnostics and treatments, or will they try to push through a very narrow waiver that does not meet the pandemic moment?”
A spokesperson for Tai did not immediately respond to a request for comment.
Some health advocates suggested that, in keeping with his focus on U.S. national security, Biden is mainly interested in preventing blowback in the United States from the new strains of COVID-19 emerging in India and other developing nations. Last month, the World Health Organization said of 700 million vaccines globally administered, only 0.2 percent have been in low-income countries.
“One reason why the U.S. will back a waiver on vaccines but not therapeutics or diagnostics is that vaccines in foreign markets protect us. Therapeutics, diagnostics in foreign markets, don’t,” said James Love of Knowledge Ecology International, a nongovernmental organization focused on promoting social justice in the world’s most vulnerable populations.
The waiver proposal was based on the Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The TRIPS pact grew out of the HIV/AIDS crisis, during which patents held up necessary medicine for years, and Tai suggested last month that Biden didn’t want to repeat the same mistakes the U.S. government made during the HIV/AIDS epidemic, “where various policies and actions constrained access to medicines, contributing to unnecessary deaths and suffering.”
Serious questions also remain about how transparent the Biden administration’s approach will be. The major pharmaceutical companies will seek to chip away at it, especially since the stock prices of some major drugmakers involved in the production of COVID-19 vaccines, including Pfizer and Moderna, began to drop after Wednesday’s announcement. Although billions of U.S. taxpayer dollars went into developing these vaccines quickly, the industry trade group, the Pharmaceutical Research and Manufacturers of America, condemned the move, saying it “will sow confusion between public and private partners, further weaken already strained supply chains, and foster the proliferation of counterfeit vaccines.”
Some experts note the money for building out vaccine manufacturing is already available through $16 billion set aside in Biden’s $1.9 trillion American Rescue Plan to fund vaccine distribution and supply chains. “Next up? We need the writing of the text of this waiver to be transparent and public, but as we have always said, we need tech transfer now and the U.S. to use the $16 billion already appropriated to lay the groundwork for international and domestic scale up of manufacturing,” said Gregg Gonsalves, an epidemiologist at the Yale School of Public Health.
It’s still not clear where most of the manufacturing will take place—or how quickly it could take off. Last week, White House spokesperson Jen Psaki said U.S. officials were also studying whether to boost existing U.S. vaccine manufacturing with an eye to exporting them rather than transferring know-how abroad.
Ultimately, the issue could rest on what Biden does now. “In the past, some of these WTO negotiations have taken eight months or so,” Krishtel said. “We don’t have that kind of time.
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