Health Canada Details New Confidential Info Disclosures in Draft Guidance
Posted 14 March 2016 | By
Health Canada is proposing to disclose more confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public, according to new draft guidance.
The disclosure of such CBI, approved under the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa's Law) of 2014, stipulates that the Minister of Health may disclose CBI “about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to a government; a person from whom the Minister seeks advice; or a person who carries out functions relating to the protection or promotion of human health or the safety of the public.”
The disclosure of such CBI can be for prescription and non-prescription drugs, vaccines, blood and blood products, radiopharmaceuticals, donor semen for assisted conception, gene and cell therapies, tissues and organs and medical devices. But the disclosures do not apply to CBI related to natural health products.
The review process what will be disclosed is overseen by a committee of senior Health Canada officials mandated to recommend a decision based on relevant technical and scientific expertise. The committee’s recommendation is also considered by a senior Health Canada official not involved in the review process who has been designated to exercise the Minister's authority.
Requesters of such CBI disclosures are required to confirm that the project for which they request disclosure of CBI is for a non-commercial purpose.
Health Canada also requires requesters to complete a Conflict of Interest declaration, which will helpt to determine whether or not to disclose CBI to a requester whose financial interests, employment and other affiliations could conflict with their commitment to use the CBI exclusively for non-commercial purposes that supports the protection or promotion of human health or the safety of the public.
The nine-step process for requesting the release of such CBI is as follows:
- Screening: Requests are reviewed to ensure that they are complete, including proof of qualifications, corporate mandate and a project description that includes a specific purpose for seeking access to CBI. Incomplete requests will be returned to the requester.
- Assessment: Complete requests are referred to the review committee for assessment. The committee will assess whether or not the request meets the requirements of the Act, taking into account the requester's qualifications, corporate mandate (where relevant) and the proposed project.
- Record search: For requests that meet the requirements of the Act, Health Canada will conduct a search of its records. The search will identify records that include information described in the request and that are directly related to the project described in the request. If the records do not contain CBI, the requester will be notified and provided an opportunity to obtain the information from the appropriate Health Canada office or Access to Information and Privacy division.
- Communication with requester: “If CBI is included in records relating to an assessed request, the requester will be notified and, where large volumes of records have been identified, may be consulted to refine their request. At this stage the requester will be asked to complete a Conflict of Interest Declaration and to sign a Confidentiality Agreement. The signing of a Confidentiality Agreement by the requester at this point in the process does not mean that information will be disclosed. Further information may also be required in order to complete Health Canada's review of the request.”
- Recommendation: Once the requester has provided a completed Conflict of Interest Declaration, signed Confidentiality Agreement and any other required info, the committee will prepare a recommendation on whether to disclose records containing CBI identified in the record search. The recommendation will include an assessment that a request meets the requirements of the Act and an assessment of whether or not the designated decision maker should exercise the Minister’s authority to disclose CBI, as well as other factors relevant to the particular request.
- Decision: The committee recommendation is considered by a senior Health Canada official designated to exercise the Minister's authority to disclose CBI under the Act.
- Notification to requester: Health Canada will notify the requester of its decision. When the decision is to disclose CBI, arrangements will be made to ensure secure transmission of the information to the recipient. When the decision is to refuse to disclose CBI, the requester will be notified with an explanation.
- Notification to originator: Health Canada does not notify the originator of the CBI when it is considering a request for disclosure. As a voluntary practice, Health Canada may notify the originator following disclosure of CBI.
- Notification of the public: Information regarding the request, including a description of the 408 project and the terms and conditions of the Confidentiality Agreement, may be made public.
Comments on the draft guidance should be provided to Health Canada within 75 days from the date of this notice.