Update Nov Dec 2013 - (Page 30)

Thalidomide: The Impact of One Drug on Canadian Drug Regulation By Jill Daley and Kristin Wall T he drug thalidomide has had a unique regulatory history in Canada. The tragic circumstances surrounding thalidomide's removal from the market in the 1960s prompted a complete revision of the Food and Drugs Act and Food and Drug Regulations in order to strengthen Health Canada's regulatory oversight and data requirements for new drug submissions.2 More recently, a re-introduced thalidomide (THALOMID) was subject to price review by Canada's Patented Medicine Prices Review Board for sales made under Health Canada's Special Access Programme. This resulted in the first judicial consideration of the Board's jurisdiction over patented medicines by the Supreme Court Kristin Wall is an Intellectual Property Law Associate of Norton Rose Fulbright Canada LLP in Toronto, Ontario. 30 Update November/December 2013 of Canada. Furthermore, controversy surrounding the data protection eligibility of THALOMID prompted Canadian Courts to consider the meaning of "innovative drug" with respect to the data protection provisions of the Food and Drug Regulations. This article reviews the impact of one drug, thalidomide, on federal drug regulatory law in Canada, specifically with regards to: (1) the 1960s modernization of the Food and Drugs Act and the Food and Drug Regulations, (2) the jurisdiction of the Patented Medicine Prices Review Board and (3) the scope of market exclusivity provided under Canada's data protection regimen. Jill Daley is a Regulatory Law Associate of Norton Rose Fulbright Canada LLP in Toronto, Ontario. www.fdli.org http://www.fdli.org

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013