Law Commons^™

From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial …

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

Unlocking Health Canada’S Cache Of Trade Secrets: Mandatory Disclosure Of Clinical Trial Results, Matthew Herder

Articles, Book Chapters, & Popular Press

Health Canada should publicly disclose information about the safety and efficacy of pharmaceuticals, biologics and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust, address weaknesses in the evidence base, and protect Canadians from harm.

A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada …

Asking For Money Back - Chilling Commercialization Or Recouping Public Trust In The Context Of Stem Cell Research?, Matthew Herder

Articles, Book Chapters, & Popular Press

As publicly funded institutions have increasingly embraced the goal of commercializing scientific research, concerns about private appropriation have become familiar refrain. One commonly suggested remedy is to create some kind of 'recoupment' provision whereby the State, on behalf of the public, receives a certain percentage of profits realized. The Bayh-Dole Act originally included a recoupment provision but it was deleted by a legislative committee. Countries around the globe attempting to emulate Bayh-Dole have, whether by design or default, reinforced the underlying logic against recoupment, which is essentially as follows: obligations to provide direct financial returns undermine the commercialization process and …