On March 20, 2019, new amendments to both the Food and Drug Regulations (the Regulations) and the Medical Devices Regulations regarding the disclosure of clinical data were published in the Canada Gazette. These changes follow from the May 2017 release of Health Canada’s white paper – Public Release of Clinical Information in Drug Submissions and Medical Device Applications (which we have previously reported on here and here), and confirm Health Canada’s decision to allow certain clinical study information from regulatory submissions to be made publicly available following a final regulatory decision.
The amendments came into force on February 28, 2019.
Health Canada has justified these amendments on the basis that health professionals and researchers need access to more clinical data in order to be able to perform independent analyses of the evidence underlying published research findings and Health Canada’s regulatory reviews. Without such access, Health Canada is of the view that transparency is limited, which leads to missed opportunities “to promote greater confidence in the oversight of drugs and medical devices”, and does not align with Vanessa’s Law or Health Canada’s “key regulatory partners” such as the European Medicines Agency and the U.S. Food and Drug Administration.
The details of this rationale are provided in the Regulatory Impact Analysis Statement that was released with the new amendments, which can be found in the Canada Gazette (p. 750).
Timing and impact of the amendments on the release of clinical information
Under the Regulations, the new amendments provide that clinical trial information in a drug application “ceases to be confidential business information” upon the issuance of a Notice of Compliance (NOC). Importantly, the amendments further provide that such information also ceases to be confidential business information in circumstances where the Minister of Health (the Minister) notifies a manufacturer that its submission does not comply with the Regulations, and the manufacturer does not amend the submission within the applicable time period.
As soon as clinical trial information is no longer confidential business information under the Regulations, the Minister has the power to disclose, without notice or consent, any information in respect of the clinical trial contained within the related submission. However, these new amendments will only apply to clinical trial information that was used by the manufacturer in the submission to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended. The amendments also do not apply to clinical trial information that describes tests, methods or assays exclusively used by the manufacturer.
The new transitional provisions specify that clinical trial information contained in a drug submission ceases to be confidential business information on the day on which the amendments to the Regulations came into force, provided that:
- the Minister issued an NOC in respect of the submission on a date before the new amendments came into force;
- the Minister issued a notice to the manufacturer indicating that the submission was considered to have been withdrawn in circumstances where the manufacturer does not amend its submission to comply with the Regulations, as required on a date before the new amendments came into force; or
- the Minister notified the manufacturer that upon the filing of additional information by the manufacturer in respect of its submission, that the submission did not comply with the Regulations on a date before the new amendments came into force.
Where a regulatory submission was filed within 90 days of the day on which the amended Regulations came into force, and the Minister notified the respective manufacturer that the submission did not comply with the Regulations before the day on which the amendments came into force, clinical trial information contained in the submission ceases to be confidential business information on the expiry of whichever of the following periods apply if the manufacturer does not amend the submission within that period:
(a) 90 days after the day on which the Regulations come into force; or
(b) any longer period specified by the Minister.
Similar amendments were made to the Medical Devices Regulations, which specify that clinical trial information associated with medical device applications ceases to be confidential information upon the issuance or amendment of a license by the Minister, or in circumstances where a license or amendment is refused.
Implementation thus far
The changes will apply to all of the types of drug submissions captured by the Regulations: New Drug Submissions, Extraordinary Use New Drug Submissions, Supplemental New Drug Submissions, Supplemental Extraordinary Use New Drug Submissions, Abbreviated New Drug Submissions, Supplemental Abbreviated New Drug Submissions, Abbreviated Extraordinary Use New Drug Submissions, and Supplemental Abbreviated Extraordinary Use New Drug Submissions.
Health Canada has stated that it is establishing a process to anonymize personal information prior to its release under the new Regulations. The clinical information it intends to publicly release includes clinical summaries; clinical overviews and clinical study reports, including protocol and protocol amendments; sample case report forms; and statistical analysis plans. Medical device clinical information includes the summaries, reports, and supporting evidence of safety and effectiveness.
However, as noted above, clinical information will not be released until a final decision has been made to issue an NOC, a Notice of Non-Compliance – withdrawn, or a Notice of Deficiency – withdrawn. Disclosure will also only occur after the time to file additional information has passed and any applicable reconsideration processes have been completed.
Health Canada has also released a Guidance Document on the process for complying with these regulations. Clinical information from past drug submissions and medical device applications that received a final regulatory decision prior to the coming into force of the new amendments may be requested through Health Canada’s Clinical Information Portal, which has been available as of March 13, 2019. Information in submissions and applications that received a final decision after that date but which was not yet subject to proactive publication is also available on request.