Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 19 May 2017 | By Zachary Brennan
Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds.
"MSF objects to the granting of an exclusive patent license on a U.S. government-funded invention to a single pharmaceutical company as well as to the lack of conditions to ensure the vaccine will be appropriately developed and made available and affordable to all patients and medical providers who administer vaccines in the U.S. and globally," the group said in its appeal.
On Wednesday, Sanofi rejected a request from the US Army to set the Zika vaccine at a reasonable price in the US.
The deal has also previously angered lawmakers. Sen. Bernie Sanders (D-VT) in March penned an op-ed in the New York Times, "If Mr. Trump allows this deal, Sanofi will be able to charge whatever astronomical price it wants for its vaccine. Millions of people in the United States and around the world will not be able to afford it even though American taxpayers have already spent more than $1 billion on Zika research and prevention efforts, including millions to develop this vaccine."
According to MSF, the vaccine was initially developed by government scientists at the Walter Reed Army Institute of Research and has received significant funding and resources from the US government, including more than $40 million in BARDA grant funding that was given to Sanofi.
"A vaccine that is not appropriately developed or that is not sufficiently affordable and available to patients in need is a missed opportunity and a poor use of limited government resources," MSF concluded.
Also on Friday, the NGO Knowledge Ecology International submitted an appeal.
Appeal to the Department of Defense Decision to Grant an Exclusive License for U.S. GovernmentOwned Patents on Zika Vaccine Candidate
Article Updated 5/22 with KEI appeal.
Tags: Doctors Without Borders, MSF, Zika vaccine, Sanofi