STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE CONTROLLED SUBSTANCES AND CANNABIS BRANCH OF THE DEPARTMENT OF HEALTH OF CANADANOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHAREDBY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Controlled Substances and Cannabis Branch (CSCB) of the Department of Health of Canada regarding FDA-quality standards, supporting methodologies, and clinical research safety standards for regulated cannabis products, health products containing cannabis and drugs containing cannabis.
Recognizing the differing legal status of the possession, production and distribution of certain cannabis related products at the federal level in Canada and the United States, CSCB understands that information exchanged under this Statement of Authority and Confidentiality Commitment is exclusively for the purposes of supporting cooperative regulatory activities, and where appropriate, cooperative law enforcement activities.
I. UNDERSTANDINGS WITH RESPECT TO SHARED INFORMATION
CSCB understands that some of the information it receives from FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. CSCB understands that this non-public information is shared in confidence and that FDA considers it critical that CSCB maintain the confidentiality of the information. Public disclosure of this information by CSCB could seriously jeopardize any further scientific and regulatory interactions between FDA and CSCB. FDA will advise CSCB of the non-public status of the information at the time that the information is shared.
Therefore, CSCB certifies the following:
- CSCB has the authority to protect from public disclosure such non-public information provided to CSCB in confidence by FDA;
- CSCB will not publicly disclose or share with other government entities or third parties such FDA-provided non-public information without the written authorization of the owner or subject of the information, or a written statement from FDA that the information no longer has non-public status;
- CSCB will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from CSCB. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, CSCB will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
- CSCB will promptly inform FDA of any changes to Canada’s laws, or to any relevant policies or procedures, that would affect CSCB’s ability to honor the commitments in this Statement of Authority and Confidentiality Commitment.
This Statement of Authority and Confidentiality Commitment does not compromise the regulatory authority of CSCB to carry out its responsibilities.
This Statement of Authority and Confidentiality Commitment is not legally binding. CSCB understands that FDA may choose to refuse to share information.
Signed on behalf of the Controlled Substances and Cannabis Branch of Health Canada:
Assistant Deputy Minister
Controlled Substances and Cannabis Branch
150 Tunney’s Pasture Driveway
Ottawa, Ontario K1A0K9