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Ed Silverman, STAT
Ed Silverman, STAT
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Sanofi Pasteur has rejected a request from the US Army to set an affordable US price for a Zika virus vaccine that the company is developing with American taxpayer funds, prompting an angry response from Senator Bernie Sanders.
For months, Sanders has pushed the Army to negotiate a more favorable agreement with Sanofi, which is one of the world’s largest vaccine makers and which has already received a $43 million US research grant. But Sanofi recently refused, according to an Army timeline of events reviewed by STAT.
The rejection comes amid negotiations the Army is holding to grant Sanofi a license to make and sell a Zika vaccine. But the prospect of giving Sanofi an exclusive license to sell a potential blockbuster — depending upon how extensively the virus travels — at whatever price it wants, has upset various lawmakers and advocacy groups, who are pressing the Army to insist on affordable pricing.
As a result, the deal, which could provide the company with another $130 million in government funds, has sparked still wider debate about pricing for products that are discovered with US taxpayer dollars.
“It is unacceptable that Sanofi has rejected the Army’s request for fair pricing” in the US that is comparable to what other countries may be charged, Sanders told us in a statement. “American taxpayers have already spent more than $1 billion on Zika research and prevention efforts, including millions to develop this vaccine. Americans should not be forced to pay the highest prices in the world for a critical vaccine we paid to help develop.”
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Meanwhile, the Army said it is still weighing whether to grant the company an exclusive license, despite previous assertions. In a May 4 letter to Sanders, Acting Secretary of the US Army Robert Speer wrote that “the decision to grant an exclusive license to Sanofi Pasteur is not final” and is “still several months away.” Such a license may be issued this summer, according to the same Army timeline.
Speer was responding to concerns the company will be given a monopoly and, consequently, may charge more for any forthcoming vaccine than many Americans can afford. The Army last June signed a research agreement with Sanofi to develop a Zika vaccine, and an Army spokeswoman maintained that an exclusive license must be offered to the company.
Speer, however, appears to contradict what an official in the Army’s medical technology transfer office last month wrote to Knowledge Ecology International, an advocacy group that has criticized exclusive licensing for the vaccine. In an April 24 letter, the official maintained the military intended to proceed with plans to award Sanofi an exclusive license to a pair of government patents.
Spokespeople for both Sanofi and the Army stressed that details have not been finalized.
The shifting Army timetable, however, may reflect a bid to forestall further negative publicity.
For several months, the topic was on a low boil as Sanders and other lawmakers, as well as patient advocacy groups such as Doctors Without Borders, pressed the Army. They have tried to persuade the Army to issue a non-exclusive license or impose requirements allowing the federal government to intervene if the company sets a price that would make the vaccine inaccessible to many Americans.
But in March, Sanders drew national attention to the issue in an op-ed in The New York Times in which he scolded the Army for a “bad deal” that may subject Americans to price gouging. He noted that Sanofi was awarded a $43 million grant from the US Biomedical Advanced Research and Development Authority, and the company has previously indicated it expects to ask BARDA for more funding.
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Last week, meanwhile, Louisiana Governor John Edwards also wrote Speer to express “serious concern” about an exclusive license, since Louisiana may be “one of the Gulf states most likely to be affected” if the virus spreads. He also warned that monopoly pricing, “without constraints, could cripple state budgets and threaten public health.”
For its part, the Army has maintained that it is trying to help solve a public health problem. There was mounting alarm last year over the spread of Zika, a mosquito-borne virus that can cause birth defects. And Speer wrote to Sanders that the Army struck a deal with Sanofi because the military lacks “sufficient” research and production capabilities to develop and manufacture a Zika vaccine.
And in that April 24 letter, the other Army official wrote the military is not in a position to enforce “affordable prices.” But one advocate, Jamie Love of Knowledge Ecology International, countered that federal law requires an exclusive license to cover an invention that has a practical application, which is defined as being made “available to the public on reasonable terms” and should be “substantially” made in the US.
Moreover, Arti Rai, the co-director of the Duke University Law School Center for Innovation Policy, believes the Army has leverage for another reason. One of two provisional patent applications was filed before the Army and Sanofi signed their deal, which is known as a CRADA, or cooperative research and development agreement. And the CRADA excluded the first provisional patent application.
As a result, the Army may not be required to offer an exclusive license, at least for that particular patent application. “My reading of the (federal statute) is that if the invention was created and federally owned before a CRADA was signed, then the Army is not obligated to give a license” to Sanofi, she explained.
But the Army may not be pushing Sanofi harder over the terms of the agreement due to concerns the company will walk away. It was only after an April 14 conversation between Sanders and Speer that the Army broached the pricing issue, according to Sanders’ office. Four days later, Sanofi rejected the notion. In his May 4 letter, Speer noted Sanofi is the “only known pharmaceutical company willing to license” the patents from the Army.
Such concerns prompted the National Institutes of Health in 1995 to remove “reasonable pricing” clauses from CRADA agreements. At the time, former NIH director Dr. Harold Varmus described such clauses as a “restraint” on new product development.
As for Sanofi, Elias Zerhouni, who heads global R&D, responded to the recent Sanders op-ed that the company will make “significant milestone and royalty payments” to the Army, which will allow the US government to “recoup its investment.” Those details have not been publicly released. A Sanofi spokeswoman told us “we can’t determine the price of a vaccine that we haven’t even made yet.”
It is worth noting that, just last week, Sanofi vowed to limit price hikes to a level at or below the medical rate of inflation in the US. The move comes not only as the company faces questions over the license for the Zika vaccine, but also pressure from lawmakers, including Sanders, who want federal authorities to investigate the company and two rivals for alleged price collusion over insulin products. Separately, some consumers filed a lawsuit.
Meanwhile, another Sanofi spokeswoman wrote us that “it’s important to note that our discussions with the US Army are ongoing and any terms of a licensing agreement are still being negotiated. Further discussions are planned.”
Similarly, a US Army spokeswoman sent us a note saying “any license agreement will not be signed unless the terms of the license application and agreement satisfy relevant law and regulations, and the government determines that the terms are in the best interest of the government and the public. The government and Sanofi Pasteur are engaged in continuing negotiation of the terms of the license agreement, so a final decision has not been made.”
This article is reproduced with permission from STAT. It was first published on May 17, 2017. Find the original story here.
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