health + tech in law = mixing chalk + cheese
Regulations made under Vanessa’s law target clinical trial information transparency for Canadian drug and medical device approvals.
On March 20, 2019, new regulations relating to clinical trial information transparency were published in the Canada Gazette, part II. There are two parts to the regulations, one part amending the Food and Drug Regulations to deal with the drug approval process, and one part amending the Medical Device Regulations, to address medical device approvals.
These regulations are made under Vanessa’s law and are part of efforts to make Health Canada’s reviews for market approval of drugs and medical devices more transparent. In addition, according to the Regulatory Impact Assessment Statement (RIAS), increasing transparency with respect to clinical trial information will be putting Canada more into alignment with other jurisdictions, such as Europe and the United States. Earlier this week, Health Canada also opened up the Clinical Information Portal, although at the moment, it is pretty empty. (At the time of my visit, it also had a rather detailed “non-disclosure” click-wrap agreement before one can actually access the information.)
The cornerstone of the new regulations is that clinical trial information will cease to be considered confidential upon certain triggering events. Thus, the clinical trial information will become publicly available.
Previously, Health Canada treated any detailed clinical trial information and data used to support drug submissions and medical device applications as confidential business information (CBI) as provided for under the Food and Drugs Act. As such, Health Canada would generally not publicly disclose this type of information, or even release it to physicians or researchers without demanding that the information be kept confidential.
However, in 2017, Health Canada began holding consultations regarding the release of clinical trial information. Further, a decision in the Federal Court last year concluded that Health Canada could not withhold clinical trial data from a researcher who refused to sign a confidentiality agreement. This decision probably pretty much guaranteed that Health Canada would need to increase transparency.
For drugs, the triggering events for when clinical trial information will cease to be CBI are (see section C.08.009.2 (1)) :
Similarly, for medical devices, the triggering events are:
I’ve put the words “formal” and “final” in quotation marks above since I’m referring to the formal/final written decisions referred to in applicable regulations. In practice, there may be informal or non-final requests or communications from Health Canada that should obviously not trigger the release of information.
For both drugs and medical devices, clinical trial information will still be considered confidential during the review process. Further, Health Canada has clarified (in the RIAS) that disclosure will only occur after any applicable reconsideration processes have been completed or the time to request reconsideration has passed.
Under the transitional provisions, clinical trial information from past decisions will also cease to be CBI.
The regulations will generally apply to human clinical trial information for human drugs and medical devices. The regulations do not cover other kinds of information in a drug submission or medical device application, such as manufacturing or quality information.
For drugs, the regulations will apply to most types submissions, including New Drug Submissions (NDSs), Extraordinary Use New Drug Submissions (EUNDSs), Abbreviated New Drug Submissions (ANDSs), Abbreviated Extraordinary Use New Drug Submissions (AEUNDSs) and Supplemental submissions to the foregoing.
For medical devices, the regulations will apply to clinical studies and investigational testing contained in license applications for Class III and IV (higher risk) devices.
For both drugs and medical devices, clinical trial information that is not used to support the proposed purpose (i.e. indication) will not cease to be considered as CBI.
Further, “tests, methods or assays that are used exclusively by the manufacturer” are also exempted from disclosure. In the RIAS, Health Canada has stated that this exception is limited “to the description of the methods or assays and not the clinical information produced through their use.”
Health Canada will enable manufacturers to redact information covered by the above exceptions and to protect the privacy of the individuals involved in clinical trials. The guidance document setting out the process can be found here.
Patients, physicians and researchers will benefit release of clinical trial information. But there is a tension between the goal of transparency and manufacturers’ commercial interests in keeping this information and data confidential. Ultimately, from the approach set out in the finalized regulations and the statements in the RIAS, it’s clear that the government took great pains to decide on the appropriate balance.