OTTAWA--Drug regulation in Canada is carried out in a very secretive manner because of the cozy relationship between the brand-name pharmaceutical industry and the Therapeutic Products Directorate (TPD), the arm of Health Canada in charge of testing and approving new drugs.
This is the central finding of a new CCPA study by Dr. Joel Lexchin, Associate Professor in the School of Health Policy and Management at York University. Titled "Transparency in Drug Regulation: Mirage or Oasis?", the study criticizes the TPD's dependence on funding from the pharmaceutical industry, which now contributes about half the agency's $70 million annual operating budget to cover its drug tests. The directorate turned to this "cost recovery" method of raising money after its budget was deeply slashed by the federal government in the 1990s.
Dr. Lexchin found that the directorate's close ties with the pharmaceutical firms has led to the concealment of scientific or technical information about the safety and efficacy of new drugs.
"There are valid reasons to protect manufacturing secrets," he admitted, "but not when it comes to data relating to health and safety. There is no evidence that the interests of the companies would be harmed by such disclosure, nor is such confidentiality necessary to foster research and innovation."
The study points to the drug approval process in the United States, where the Food and Drug Administration (FDA) routinely posts an approval package that contains a detailed summary of the information submitted by the company, along with the FDA's analysis of this information.
"There is no justification," says Dr. Lexchin, "for Canada's failure to match the U.S. standard."
Transparency in Drug Regulation: Mirage or Oasis? is available on the CCPA web site at http://www.policyalternatives.ca
For more information contact Kerri-Anne Finn, CCPA Communications officer, 613-563-1341 x 306.