Principal investigator:	Dr. Janice E. Graham
Granting Agency:	CIHR
Grant Status:	Completed (2004-2009)
Related Links:	Post-Doctoral Researchers   Grant Productivity

  

The Health Products and Food Branch, the regulatory arm of Health Canada is responsible for the protection and management of risks for the entire range of drugs and therapeutic devices.  The determination of regulatory policy, the reach of regulatory activity, and the scientific and ethical competencies of regulators are central to the debate about the nature of a just society and the relative importance of public health issues.  But, for many Canadians, regulatory processes are obscure, unclear, unfathomable.  This project allowed the TRRU team to describe a set of regulatory actors and their tasks, map the regulatory territory of scientific evidence and policy decisions, and illustrate how a regulatory system adapts in response to external factors, rapidly emerging scientific and policy changes, and contingency.  Graham's primary field site was the Biologics & Genetic Therapies Directorate of the Health Products and Food Branch, where she sought to dispel the prevalent image of "the black box" of regulation.

This study followed the step-by step process of product submission and regulatory review as teams of research scientists, biologists, medical officers, and technicians, equipped with state-of-the-art technologies and instrumentation, tweak basic science in response to regulatory needs. Scientists, clinical evaluators and policy advisors review submissions, sample consistency, conduct extensive chemistry and manufacture confirmatory tests, reanalyze data and check back with the sponsors for missing data or for any queries they might have about the submitted evidence. Decision-making frameworks have been established by the various parties, but decisions to submit, re-submit or finally withdraw the application are almost completely in the hands of the sponsor.  Inevitably the actors on both sides must balance legislated deadlines with partial data, and weigh individual and public health safety against public and industry desires.  The oft-heard expressions that "biologicals are illogical" and "biologics are different" underlie the special status these categories of therapies and diagnostics hold. Biologics are heterogeneous products involving inherently process-related events unlike the purity/impurity profile of a chemical drug product. Unlike synthetic pharmaceuticals, complex biologics require stringent containment conditions to prevent adventitious agents and impurities during cell culture based production. Antibody response to a protein presents immunogenicity issues. Protein products from molecular pharming present emerging issues, as do combination products which represent hybrid chemistry/biologic/medical device crossovers challenging existing classifications. Unlike a pill that can be stored on a shelf for five years, many biologicals last only days, perhaps only hours in the case of radiopharmaceuticals.

The principle objectives of this five-year project (2004-2009) were:

• to follow a sample of emerging scientific technologies (biologics, radiopharmaceuticals and new genetic therapies) through the stages of regulatory approval in order to describe, analyze and portray the structure and practices of regulatory scientists, clinicians, policy analysts and industry sponsors;

• to explore the dynamics of scientific, social and moral encounter among these actors; and

• to document and examine the relations between science and policy within the regulatory framework at BGTD and to locate policies and local decisions within an expanded international context of economic and technological innovation and harmonization.
  

   

   

Post-Doctoral Researchers:

• Mavis Jones has conducted ethnographic research within the Office of Consumer and Public Involvement in the Canadian Health Products and Food Branch. Her work focused on the implementation of the Branch's Review of Regulated Products: Policy on Public Input. Mavis' work is funded by a CIHR Postdoctoral Fellowship (Institute of Genetics - Ethics, Law and Society).

• Rob Nuttall has examined the approval and post-market surveillance of biological therapies in Canada. While the pharmaceutical industry touts these products as being the future of health care, Rob's research questioned their innovation and examined their safety, revealing fault lines between Health Canada's regulatory intent and industry practice.
• Emma Varley joined the TRRU team in September 2008 to commence a Killam postdoctoral fellowship under the Risks & Regs project. 
• Marylène Dugas conducted ethnographic research in Burkino Faso. She addressed the relationship between global health, disease and society. Her research explored the bioethical issues of transfer of knowledge necessary to obtain the informed consent in clinical research on the African community. Her projects are located at the junction of critical anthropology and health sciences, combining basic research and empirical research, and testing models that incorporate approaches of medical anthropology in the field of global health.
• Farah Huzair investigated the evolving Subsequent Entry Biologics (SEB) regulatory pipeline and the impacts of new regulation on the innovation, development and production of SEB vaccines. The study had a qualitative methodology and involved a comparison of two vaccine cases in Canada. The overall aim of the project was to be able to discuss the implications of the evolving regulation for the Canadian SEB vaccine industry.
• Amrita Mishra's work involved an ethnographic examination of the new questions and issues for the field of cervical cancer prevention with the availability of vaccination against high risk HPV. Contending views on vaccination seem to take on a keener significance in the case of Nova Scotia, a Canadian province with one of Canada's well established and organized cervical cancer screening programs (the other is British Columbia). The QEII Health Sciences Centre is one of the actors that has been involved in clinical trials of GlaxoSmithKline's Cervarix. Amrita examined the work of the infectious disease specialists both at the laboratory end and at the clinical application end. She interviewed people who enter clinical trials and vaccination drives or admit their children to it. Her methodology also involved an ethnographic engagement with the laboratories at Dalhousie Med/Dalhousie University involved in or interested in virally induced oncogenesis, cancer biomarkers, and vaccination.