Library Subscription: Guest
Begell Digital Portal Begell Digital Library eBooks Journals References & Proceedings Research Collections
Ethics in Biology, Engineering and Medicine: An International Journal
SJR: 0.123

ISSN Print: 2151-805X
ISSN Online: 2151-8068

Ethics in Biology, Engineering and Medicine: An International Journal

DOI: 10.1615/EthicsBiologyEngMed.2014010771
pages 231-239

Faster Access to New Drugs: Fault Lines Between Health Canada's Regulatory Intent and Industry Innovation Practices

Janice E. Graham
Technoscience and Regulation Research Unit, Department of Pediatrics (Infectious Diseases), Faculty of Medicine, Dalhousie University, Halifax, NS, Canada B3H 4R2
Robert K. Nuttall
Technoscience and Regulation Research Unit, Department of Pediatrics (Infectious Diseases), Faculty of Medicine, Dalhousie University, Halifax, NS, Canada B3H 4R2

ABSTRACT

Since 2003, Health Canada has been undergoing regulatory modernization to "ensure that Canadians have faster access to the safe drugs they need", and national health agencies have developed policies to modernize the regulation of new drugs. We examined a decade of drug approval data from the Canadian setting to determine whether these policies promote innovation while maintaining safety. The drug approval data in Health Canada's Annual Drug Submission reports between 2000 and 2010 were analyzed to determine the proportion of new active substances qualifying as innovative new drugs. We also examined the proportion of successful submissions granted priority review that subsequently received safety warnings. We show that despite an increase in supplementary product submissions, there was no sustained increase in new active pharmaceutical or biologic products. Furthermore, priority reviews are intended to expedite new drug submissions that promise significant clinical benefits. While the proportion of submissions indicated for new active substances declined, there was a significantly higher rate of safety warnings for their priority reviews. Our results challenge the assumption that the new regulatory policies that were intended to spur industry innovation of new and safer drugs work.