Canadian law affords Health Canada, as a federal regulatory agency, to recall unsafe toys, tools, cleaning supplies, clothing, and food; however, the agency does not have the power to recall dangerous medications. In Canada, decisions to withdraw and recall unsafe medications from the market are decided by drug manufacturers (drug companies) and distributors. The Food and Drugs Act does not provide Health Canada the authority to compel a company to recall any unsafe medications. Nothing has been done to amend this Act to empower Health Canada to make these decisions.
As in the Toronto Star article, There has been limited public pressure to change the Food and Drugs Act because Canadians tend to be separated from and unaware of how Health Canada actually works. I have provided you with a simplistic image (to the right) of how Health Canada and its branches are situated in the government.
Some of Canada's leading experts for pharmaceutical policy and regulation, Dr. Joel Lexchin and Trudo Lemmens, were interviewed for this Toronto Star article.
Trudo Lemmens, Chair in Health Law and Policy at the University of Toronto, says that "[p]eople overestimate what the drug regulatory agency is doing." Medical professionals and the public generally believe that Health Canada acts not only as the country's regulator, but also acts in the interests of patients and consumers. This, however, is not always the case as is evidenced by Health Canada's engagement in negotiations with drug companies to recall dangerous medications.
These negotiations can last several months or years. The proceedings of these negotiations are confidential - the neither physicians nor the public are privy to any information about these negotiations - which drugs are being negotiated, how long negotiations have been underway, why these negotiations are taking place. Health Canada may release a safety warning or request that a company changes its product label (product monograph) for a medication.
Dr. Joel Lexchin, professor of health policy at York University, says in the Toronto Star article that the regulation of drug safety "...should be a public responsibility, not the responsibility of a private, for-profit company." In his recent study, Dr. Lexchin found that between 3.5% and 4.5% of drugs approved by Health Canada are later withdrawn. These figures are similar to those in the US, where the US Food and Drug Administration (FDA) also lacks the authority to compel companies to recall unsafe medications.
The data submitted to Health Canada by drug companies in new drug approvals (NDAs), seeking drug approval, is proprietary to the sponsoring and submitting companies. Without this and other information about how Health Canada makes decisions about withdrawing drugs from the Canadian market, it is virtually impossible for either physicians or patients/consumers to know the true safety of many new or controversial medications.
Risky acne drug Diane-35 underscores Health Canada's limitations
Drug withdrawals from the Canadian market for safety reasons, 1963–2004Keeping An Eye On Prescription Drugs, Keeping Canadians Safe
Secrecy surrounds over 150 Health Canada drug safety reviews: Diane-35 is only oneHealth Canada drug approval system may be harmful to patients
Diane-35: Reconsidering the risksHealth Canada Branches and Agencies: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/index-eng.php#list