October 22, 2018
Yael commented on Federal Court Justice Sebastien Grammond’s decision that Peter Doshi, an assistant professor at the University of Maryland, should receive complete copies of clinical study reports and raw datasets related to several vaccines.
This decision was the first official word on a drug safety legislation by the name of Vanessa’s Law. Grammond ruled Health Canada’s initial conditions attached to the data release, including a confidentiality agreement preventing Doshi from publishing or disseminating his findings, to be overly restrictive. Further, Grammond stated these conditions were contradictory to both the purpose of Vanessa’s Law, which is to improve clinical trial transparency, as well as Doshi’s freedom of expression, guaranteed by the Canadian Charter of Rights and Freedoms.
“The court insisted on Health Canada really looking at what is at play and exercising its discretion, as opposed to imposing a blanket policy,” Yael told Law Times.
Yael and the team wrote about the case in the bulletin “Federal Court Addresses the Intention and Application of Vanessa's Law.”