On October 18, 2012, Health Canada issued a news release and subsequent Drugs and Health Products Notice announcing that it will create a web-based list of clinical trials authorized by Health Canada.1 The list will be publicly accessible and appears to be intended to enable Canadians to make better informed decisions about their healthcare. In addition to the list, Health Canada has a longer-term goal of developing mandatory requirements for the registration of clinical trials by sponsors.
The Canadian list of authorized clinical trials is proposed to include administrative information about each trial for which a "No Objection Letter" is issued under a Clinical Trial Application for the study of a drug. At present, this system appears to be less onerous than registry requirements in other jurisdictions. For example, in the United States, sponsors conducting certain clinical trials are required to register the trial with the publicly accessible databank at www.clinicaltrials.gov. In addition to the legal requirement to register, many key medical journals in the United States will not publish clinical trial data unless the trial is registered with a publicly accessible registry.
Currently, clinical trials being conducted in Canada may be announced on international publicly accessible registries that contain international clinical trial information. These registries rely on sponsors to voluntarily register their clinical trials. It appears unlikely, however, that inclusion on the Canadian list will be voluntary, because Health Canada has been moving toward the goal of greater transparency for some time. Further, in a recent push toward this goal, the Auditor General recommended that Health Canada "enhance public access to information on authorized clinical trials."
It is unclear how the commercial confidentiality and privacy of sponsors will be safeguarded when this initiative is implemented. It is also unclear whether a sponsor will have any control over the information included in the list. Health Canada has not yet published any guidance in this respect. And it also remains to be seen how this initiative interfaces with Canada’s obligations under NAFTA regarding protection of trade secrets and confidential information.
Stakeholders will be formally invited later this fall to provide feedback on the plan and the proposed information to be included in the list. Torys will provide further information once Health Canada publishes details about the plan and proposed information.
1 Plans Underway for First Canadian List of Authorized Clinical Trials; Update: Registration and Disclosure of Clinical Trial Information
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