In Canada, the information included within a New Drug Submission is considered to be commercially confidential information (CCI) and, therefore, is confidential under Canada's federal Access to Information Act. Health Canada will not release this information without the drug manufacturer's approval. Consequently,the safety and efficacy information in unpublished trials, which are submitted to Health Canada, is usually unavailable to researchers, physicians, and patients. The lack of transparency in the drug approval process may reasonably lead to inappropriate prescribing and use of medications. Nondisclosure of the information contained within New Drug Submissions has led to serious disadvantages for Health Canada, health professionals, Canadians. When scientific data is considered to be CCI and is never permitted to enter normal peer-review channels, neither the data, nor evaluations of the data by Health Canada reviewers, can undergo scrutiny by independent scientists. Physicians, researchers, and the public are forced to blindly accept Health Canada's judgement about the safety and effectiveness of the drugs approved for the Canadian market. Health Canada possesses information that is potentially vital to the proper use of a medication, but commonly cannot make this information public.
The typical argument for the legal protection of the data contained within New Drug Submissions in Canada is that the disclosure of such data would compromise the economic interests of the drug manufacturers. However, the US Food and Drug Administration (FDA) discloses research information from preclinical and clinical trials, which is considered to be CCI and proprietary to companies, in Canada. Arguably, the disclosure of this information in the United States has not thwarted companies' profitability or willingness to operate in the US market.
A 2004 study by Dr. Joel Lexchin and Dr. Barbara Mintzes evaluated the adequacy of information in SBDs in 3 cases (celecoxib, efficacy of antidepressants, and cardiovascular risks of hormone replacement therapy) in which unpublished data submitted to drug regulators contained important clinical information that was unavailable or misrepresented in the published literature. This study found that in all three cases, the information that was available in the published literature failed to reflect the full body of scientific knowledge about that drug's effects and these problems were not evident in Health Canada's SBDs, which lacked detailed and necessary information on clinical trial design, methods, and outcomes. This study also found that Health Canada's SBDs for rosuvastatin and agalsidase also failed to include study protocol, information about baseline characteristics about trial participants, number of participants who withdrew from the trial, and reasons for their withdrawal. Furthermore, SBDs for these drugs failed to provide data about primary and secondary efficacy outcomes or fatal and non-fatal serious adverse events (SAEs) by treatment arm.
More recently, a 2014 study by Roojin Habibi and Dr. Joel Lexchin evaluated the ability of Health Canada's SBDs to inform clinician decision-making. 161 documents, which contained information on 456 clinical trials, were analyzed. The study focused on answering three questions that prescribers may have prior to prescribing a new drug:
- Do the characteristics of patients enrolled in trials match those of patients in their practice?
- What are the details concerning the drug's risks and benefits?
- What are the basic characteristics of clinical trials?
4. Trial inclusion criteria
5. Treatment length
7. Statistical significance of results
8. Comparator therapy
9. Withdrawal rate
10. Statistical significance of withdrawal rate
11. Pivotal trial status
12. Number of patients enrolled
13. Single- or multi-site
14. Study ID
- Overall, clinical trial information provided within Health Canada's SBDs was presented haphazardly and without an apparent method to its presentation,
- The majority of SBDs, 126/161, contain only two-thirds of the information that could potentially be included, leaving one-third of the potential information about patient-trial characteristics and benefits and risks of tested treatments to be missing,
- Basic details of clinical trials were often described, any ambiguities in this category were especially troubling, given the straightforward nature of the information that needs to be conveyed to physicians and patients, who need all of the information on drug safety and efficacy when attempting to make educated prescribing decisions,
"[Summary Basis of Decision documents] do not present crucial clinical trial information in a predictable, clearly organized manner. Not having a clear idea of what kinds of information can be found in these documents, and where they can be found, makes it very unlikely that clinicians would refer to them in their day-to-day practice [...] The level of detail contained in these documents varies from document to document. One SBD would provide statistical significance of results, while the other mentioned results only in passing, and only in relative terms. Quantitatively, results were found to be incompletely discussed nearly more than 80% of the time. A recent evaluation of Phase I SBDs undertaken by Health Canada itself has brought to light the fact that other stakeholders have also noticed the lack of detailed about clinical trials contained in SBDs. Whether Health Canada plans on taking these criticisms seriously remains to be seen. One thing is certain, however: Calls for more transparency are only multiplying in number and amplifying in volume. Health Canada would do well to heed this trend."
How Drugs Are Reviewed in Canada
How Drugs Are Approved in Canada
Government of Canada: Access to Information Act
Adverse Events Considered to be Commercially Confidential Information (CCI)
Transparency in Drug Regulation: Mirage or Oasis?
Transparency in Drug Regulation: Mirage or Oasis?Opening the Medicine Cabinet: First Report on Health Aspects of Prescription Drugs
Quality and Quantity of Information in Summary Basis of Decision Documents Issued by Health Canada
Unlocking Health Canada's Cache of Trade Secrets: Mandatory Disclosure of Clinical Trials Results
Health Canada Drug Approval System May Be Harmful to Patients
New Drugs and SafetyWhat Happened to New Active Substances Approved in Canada Between 1995 and 2010?Transparency in drug regulation: Mirage or oasis?
Provision of information on regulatory authorities’ websites
Who Needs Faster Drug Approval Times in Canada: The Public or the Industry?
Secrecy and the Health Protection Branch
Hear No Secrets, See No Secrets, Speak No Secrets: Secrecy in the Canadian Drug Approval System
Legislative regulation and ethical governance of medical research in different European Union countries
When it Comes to Drug Safety, Health Canada's Abilities are Limited