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The U.S. Army wants to grant an exclusive license for a Zika vaccine, but there are worries that exclusivity would lead to a high price.
Sanofi Pasteur could be granted an exclusive license to manufacture and sell a Zika vaccine produced by the U.S. Army, but the arrangement is causing concern for some state officials and nonprofit organizations. Many fear that such an agreement could lead to a vaccine that is priced out of the reach of those who need it.
According to a report by National Public Radio (NPR), the U.S. Army is planning to grant an exclusive license to Sanofi Pasteur because of the high risk and high cost involved in advanced vaccine development.
Opponents, however, point out that the U.S. government's contribution to producing the vaccine has already been significant and say that offering an exclusive license could have negative consequences to the United States.
A formal appeal opposing the exclusive license was filed in May by Knowledge Ecology International; the American Federation of State, County and Municipal Employees; People of Faith for Access to Medicines, Social Security Works; Universities Allied for Essential Medicines; Public Citizen; and the economist Dean Baker.
Jamie Love, Director of Knowledge Ecology International, a nonprofit organization that advocates for the public interest in matters concerning management of knowledge resources, including patents and government-funded research and development, said that his primary concern is that prices could soar if Sanofi gets what he referred to as a "legal monopoly."
"Sanofi is very aggressive when it comes to prices," he says. "If it is illegal for anyone else to make and sell the vaccine, it will be very expensive."
In the NPR article, Rebekah Gee, MD, MPH, Louisiana's Secretary of Health, also voiced concerns about the potential cost of the vaccine and the implications it could have for that state if it has to choose between making more state funding cuts or addressing Zika-related health concerns.
In any agreement reached between the two entities, Love said that at a minimum he'd like to see a clause that would prevent Sanofi from charging United State residents higher prices than they charge other high-income industrialized countries.
The Army is currently conducting a phase I trial of the vaccine to find out if it is safe and effective. According to NPR, if the first phase of testing goes well, the Army plans to give Sanofi $43 million for a Phase II trial.
Another $130 million is being offered by HHS for a phase III trial.
Love believes the Army should hold off before reaching any agreements with outside parties.
"The Army should wait until the phase II data is in," he said. "The Army already paid for the Phase II trial."
At that point, he said, the Army would be able to find a company willing to accept the $130 million grant being offered for the phase III trial and willing to charge an affordable price or negotiate a shorter monopoly.