Governments and other research funders may be missing an opportunity to help speed the development of coronavirus vaccines and treatments by not insisting that drugmakers share intellectual property, research data, and other information, some watchdog groups and patient advocates say.
As billions of dollars are given for pharmaceutical companies’ research into coronavirus medicines, the World Health Organization has encouraged funders to include clauses in their contracts requiring equitable distribution of Covid-19 medicines and publication of trial data. It’s joined advocates who say a failure to be proactive on property and data rights shifts the power to the drug industry.
The U.S. government, which is supporting Covid-19 projects at pharmaceutical giants like Johnson & Johnson Inc. and Sanofi S.A., isn’t part of the WHO’s effort. President Donald Trump’s animus against the WHO led him to announce the U.S. withdrawal from the body on Friday, and the U.S. has historically been reluctant to attach too many conditions to funding it provides private companies for research and development, legal scholars said.
“If we don’t start using our public resources and authorities more smartly—and insist on technology transfer and bring capacities to scale, and insist on affordability—the world could be in a lot worse shape,” said Peter Maybarduk, director of the access to medicines program at the watchdog group Public Citizen.
Many conversations around pricing and availability of Covid-19 medicines have included compulsory licensing—when a government allows someone other than the innovator to make a patented product, without the consent of the patent owner.
Conditioning financial support on terms that companies share intellectual property, or publish research data and regulatory filings, is viewed as a less extreme measure.
WHO made calls to funders as part of its launch Friday of a voluntary pool to collect scientific knowledge, data, and other information that can be shared to accelerate development of Covid-19 products. The WHO is also encouraging companies to contribute patents for therapies to the United Nations’ Medicines Patent Pool. More than 30 countries have backed the effort, including Mexico, Brazil and the Netherlands.
The extent to which drugmakers will voluntarily contribute to the pool is unclear. During a media briefing ahead of the WHO launch, some industry leaders questioned whether it’s necessary.
“The industry is already doing all the right things,” said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations. Cueni said there has been a willingness within the industry for voluntary licensing and collaboration.
The requirements attached to financing can vary depending on the funder. The Bill & Melinda Gates Foundation, one of the leading funders of medical research, requires published research resulting from its funding to be broadly disseminated. The U.K. charity Wellcome Trust has a similar policy.
The European Commission recently led an event that drew more than $8 billion in pledges for vaccines and other products. It said for that publicly funded research there should be open access to data, knowledge and IP “to the extent needed to ensure global deployment and access.”
“In the case of private companies, they will not in principle be required to forgo their intellectual property rights, but we do expect them to commit to the goal of achieving universal and affordable access of diagnostics, treatments and vaccines,” a commission spokeswoman said.
Companies that partner with the U.S. government own the intellectual property rights and related trial data for the products they develop. The government has said it does seek considerations for pricing if the product becomes commercially viable.
Ellen ‘t Hoen, director of the legal research group Medicines Law & Policy, said countries and organizations serious about ensuring that Covid-19 products are global public goods need enforcement mechanisms, and to “attach strings to your financing.”
A U.S. government agency tried in the late 1980s to condition licenses on fair pricing but abandoned the approach after pushback from drugmakers. The government, regardless of administration, has been hesitant to demand much from companies when it’s made investments, industry experts said.
“The consistent philosophy of the United States government has been, and to my knowledge still is, ‘we need to get the private sector involved and we don’t want to place restrictions on them, we don’t want to discourage them from engaging in essential R&D activity,’” said Chan Park, general counsel at the Medicines Patent Pool.
Through the Biomedical Advanced Research and Development Authority, the U.S. has committed hundreds of millions of dollars to Johnson & Johnson and Moderna Inc. for Covid-19 vaccine development. Last month, it pledged up to $1.2 billion to AstraZeneca PLC.
“With so much money being spent right now, we have been asked as a public to sort of not worry about the access and the price of what’s going to come downstream,” said Ameet Sarpatwari, an instructor at Harvard Medical School. “But I think that we should be worried.”
Funders have wide discretion over their money, able to impose controls on how a company operates or who its CEO is, said Paul Fehlner, the former head of intellectual property at Novartis Pharma. Within that framework, he said it would be consistent that funders require companies to contribute to efforts like the WHO pool.
Funders could benefit as well. Fehlner, who is now president and CEO of reVision Therapeutics Inc., said that by utilizing the knowledge in the pool, they can ensure their money isn’t being spent on work that has already been done.
“You don’t have to recreate the wheel if the wheel is in the pool,” Fehlner said. “You just take the wheel, you put it on your cart, and now you go somewhere.”
Advocates say it may already be too late. An effective vaccine may have already been funded, or diagnostics already be in development, potentially leaving governments and others with few tools other than public or political pressure.
“This is certainly an important lesson for the world to learn in advance of the next pandemic,” Park said, suggesting funders give “some thought to what types of provisions and conditions of funding that you want to include in these types of agreements.”