US President Joe Biden has thrown his support behind efforts by India, South Africa and dozens of other countries to temporarily suspend intellectual property (IP) protections for coronavirus vaccines, offering hope for countries struggling for doses and leaving vaccine makers exasperated.
The reversal of the previous US position comes as a deadly second wave of the coronavirus sweeps through India, leaving tens of thousands dead and many more infected over the past few weeks. The virus has overwhelmed the country's already dilapidated health care system with patients struggling for hospital beds and medical oxygen.
Public health activists say the easing of patent protections on COVID-19 vaccines will allow drugmakers in poor countries to start production of effective vaccines sooner and speed up the end of the pandemic, which if allowed to rage could see the emergence of vaccine-resistant COVID variants.
"This [the US move] is very significant. The US government has a long tradition of punishing countries that import or produce drugs without the pharmaceutical companies' permission even during times of crisis," said Sapna Kumar, a professor of Intellectual Property Law at the University of Houston.
"There is a growing realization that pharmaceutical companies have really been calling all the shots and that perhaps they haven't been acting in the public interest and maybe it's time for the government to take a more aggressive approach," she told DW.
"It's worth saying that governments such as Germany and the United States have paid a lot of the money for this research and that only a small sliver of pharma companies' profits come from lower-income countries."
Protracted WTO negotiations
India and South Africa approached the World Trade Organization (WTO) in October, calling on it to waive parts of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The suspension of rights such as patents, industrial designs, copyright and protection of undisclosed information would ensure "timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19," they said.
The proposal was vehemently opposed by the previous US administration and other wealthy nations like Britain as well as the European Union, who said that a ban would stifle innovation at pharmaceutical companies by robbing them of the incentive to make huge investments in research and development.
This, they argue, would be especially counterproductive during the current pandemic, which needed drugmakers to remain on their toes to deal with a mutating virus.
A change of heart by the US — normally a vocal supporter of IP rights — does not guarantee a patent waiver by the WTO, whose decisions require a consensus of all 164 members. Biden's top trade negotiator, Katherine Tai, has cautioned deliberations would take time, possibly even months as member states negotiate a specific waiver plan.
European Commission President Ursula von der Leyen said Thursday that Brussels was ready to discuss the US-backed proposal. The German government, however, on Thursday insisted that intellectual property must be protected so as not to stifle innovation.
India and South Africa have agreed to revise their initial proposal to address some of the concerns of the wealthy nations. The next formal TRIPS Council meeting is scheduled for early June.
Pharmaceutical companies dismayed
The pharmaceutical industry reacted angrily to Biden's announcement amid sharp drops in shares of COVID-19 vaccine makers such as Moderna, Novavax and Germany's BioNtech as investors weighed the eventual loss in royalty revenues for the companies.
The pharmaceutical industry's global lobby group, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), warned that a waiver would rather undermine the global response against the virus instead of boosting vaccine supplies.
"Demands for a release of patent information relating to vaccines would not increase supply by a single dose in the short term because they overlook the complexity of vaccine manufacture and ignore the extent to which vaccine manufacturers and pharmaceutical companies and developing nations already cooperate in order to ramp up vaccination capacities," Thomas Cueni, the director-general of IFPMA, told DW in an earlier interview.
"The euphoria over the development of highly effective vaccines has somehow created the impression that once a vaccine has been developed, a billion doses can roll out of the factories at the push of a button. I think we need to be aware of just how complex and difficult vaccine manufacturing is," he said.
The problems at AstraZeneca show just how complicated vaccine-making is. The British-Swedish company has struggled to meet its contractual vaccine delivery obligations, partly due to supply chain issues, and has now been sued by the EU. The company's licensed partner in India, the Serum Institute of India — the world's largest vaccine maker — has also had to contend with a US embargo on the supply of critical raw materials which has hurt its vaccine deliveries.
Patent waiver is not enough
The WTO talks are taking place as some wealthy countries face criticism for cornering billions of COVID shots — many times the size of their populations — while leaving poor countries struggling for supplies. Experts say the global scramble for vaccines, or vaccine nationalism, risks prolonging the pandemic.
"We have to recognize that this virus knows no boundaries, it travels around the globe and the response to it should also be global. It should be based on international solidarity," said Ellen 't Hoen, the director of Medicines Law & Policy — a nonprofit campaigning for greater access to medicines.
"Many of the large-scale vaccine manufacturers are based in developing countries. All the production capacity that exists should be exploited…and that does require the sharing of know-how and the technology by those who have it in their hands," she told DW.
Health organizations and activists welcomed Biden's support for the waiver but said much more was needed to be done to boost global vaccine production, including the sharing of know-how and personnel.
"If the US truly wants to end this pandemic, it must also share its surplus vaccines doses with COVAX [COVID vaccine dose-sharing program led by the WHO and the GAVI vaccine alliance] now and fill the access gap until additional manufactures are able to scale up production," Avril Benoit, executive director of the US chapter of Doctors Without Borders, said in a statement.
"The US must also demand that pharma companies that received significant amounts of US taxpayer funding to create these vaccines share the technology and know-how with other capable manufacturers to protect more people worldwide."