These plans are important because Health Canada does not have the authority to withdraw or recall previously approved drugs from the market: Health Canada can communicate with drug companies to encourage them to withdraw or recall unsafe drugs, but drug companies have the final say. Withdrawals and recalls are decided by companies on a voluntary basis. Furthermore, Health Canada does not make information during the approval process known to experts or the public. This has garnered further criticism of Health Canada, especially in light of the 2012 and 2013 studies, both of which found that Health Canada maintains practices that are harmful to patient health and publish misinformation, leaving doctors and patients vulnerable to unsafe prescribing.
The 2012 study, published in JAMA Internal Medicine, found that Health Canada's regular approval processes (standard review = 300 business days) have resulted in a 1/5 (20%) chance that approved drugs will have a serious safety warning after being approved for the market. Drugs approved through the priority review system (180 business days) had a 1/3 change of having a serious safety warning after being approved for prescription in Canada. In priority review cases, Health Canada does, in fact, have the authority to compel post-market studies and reassessments of safety and effectiveness, Canada's health regulator doesn't properly use this authority. The 2013 study, published in PLoS ONE, found that Health Canada's Summary Basis of Decision (SBD) documents were generally filled with inconsistency, ambiguity, and misinformation about the safety and effectiveness of drugs. In fact, over 97% of the documents did not provide complete information about patient withdrawal rates from clinical trials and over 66% of the documents failed to report significant information about the results of clinical trials.
Also in 2013, The Toronto Star obtained a list of 2012 drug reviews after 5 months of requests to Health Canada for this information. This obtained list contains 151 secret safety reviews of medications completed by Health Canada in 2012. Even after new commitments to transparency, Health Canada will release only a fraction of its drug reviews, citing costs as a setback in compiling the summaries and making them available to the public. This is why drugs reviews, which had been completed before 2014, will not be released for expert and public viewing. Arguments have been made, however, that committing resources to increased transparency will improve safe prescribing by physicians and reduce serious adverse events experienced by patients. Furthermore, although Health Canada has been collecting data on off-label drugs and their serious and fatal side-effects for 6 years, it removes the off-label details before publishing the data in its side-effects database and keeps this information secret. The FDA provides this data. [Off-label uses are those for which doctors prescribe approved medications for unapproved uses.]
In light of these and other calls for transparency, on 2 July 2014, Minister Rona Ambrose said that Health Canada will make information on serious and fatal side-effects from, which it has been keeping secret, public. A Government of Canada press release from today, 25 July 2014, states that "Health Canada will devote $3.6 million to support the development of evidence-based practices for the most commonly abused classes of prescription drugs: opioids, stimulants, sedatives, and tranquilizers. The Call for Proposals is aimed at projects that will improve prescribing practices and the educational needs of healthcare practitioners. It also focuses on projects that will develop new approaches, training and tools to improve these prescribing practices." However, there is no mention of giving Health Canada the authority it requires to make these changes, improve transparency, and require post-market surveillance of drugs in these classes once they have been approved for the Canadian market. The Call for Proposals focuses on education, guidelines, and training tools for doctors, but this is only a piece of the puzzle. Health Canada must have the authority to protect Canadians in cases in which recalling, withdrawing, or post-marketing surveillance studies on drugs are required. As of yet, Health Canada does not have this authority.
Health Canada drug approval system may be harmful to patients
Health Canada's Summary Basis of Decision (SBD) Documents are Inconsistent and of Little Help to Physicians and Patients
Public Senate report acknowledges Health Canada's lack of transparency
Canadian Government: October 2013 Throne Speech
Health Canada’s inability to recall unsafe drugs widely criticized
New Drugs and Safety: What Happened to New Active Substances Approved in Canada between 1995 and 2010?
Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
Give Health Canada power to require post-market monitoring of drug safety: Senate reportStar obtains list of red-flagged drugs
Health Canada must disclose information on off-label drug side effects: Editorial
Health Canada to release side-effect data after Star probe
Dangers of off-label drug use kept secret
Health Canada slammed over drug secrecy
Minister Ambrose Takes Steps to Address Safe Prescribing Practices for Drugs Prone to Abuse