Completed requests for disclosure of confidential business information under s21.1(3)(c) of the Food and Drugs Act

The list below summarizes completed requests for Health Canada to use its authority to disclose confidential business information (CBI). This information can be disclosed to eligible persons to protect or promote public health and safety. Health Canada reviews all requests that provide the required information. We complete the process by either:

disclosing information in response to the request
denying the request
closing the request

For each completed request, the list below outlines:

the information requested
the purpose of the request
Health Canada’s decision
the reason we denied or closed a request

Links to related information are also provided. Additional information is available by request.

This list is updated quarterly.
Updated: 21 December 2017

2015

Request number: 01
Requester: Individual, health professional
Information requested: Information related to the efficacy and safety of Diclectin (doxylamine-pyridoxine) in the treatment of nausea and vomiting of pregnancy.
Purpose: A comprehensive review of the efficacy and safety evidence, including a summary of the unpublished data and discussion of this data in the context of previously published findings.
Date received: 2015-03-09
Completion date: 2015-09-16
Decision: Disclosed.
Revision date: 2019-05-02
Decision: Agreement with requester revised to align with amendments made to the Food and Drug Regulations (C.R.C., c.870).
Additional related information:
Summary Safety Review - DICLECTIN (doxylamine and pyridoxine combination) - Assessing Safety in pregnancy (July 2016)
Scientific Advisory Panel on Diclectin (SAP-Diclectin) (June 2016)

Request number: 02
Requester: Individual, health professional
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of lorazepam, haloperidol and risperidone.
Purpose: To inform administration of medication to patients.
Date received: 2015-12-24
Completion date: 2016-03-01
Decision: Denied, purpose of request does not meet requirements of the Act.

Request number: 03
Requester: Individual, health professional
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of fluorine/fluoride additives.
Purpose: For education and to incorporate into requester’s clinical practice and daily life.
Date received: 2015-12-24
Completion date: 2016-03-01
Decision: Closed, information provided is insufficient for Health Canada review.

Request number: 04
Requester: Individual, health professional
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of venlafaxine.
Purpose: For use in capacity as convenor of a patient support group located outside Canada.
Date received: 2015-12-29
Completion date: 2016-03-01
Decision: Denied, purpose of request does not meet requirements of the Act.

Request number: 05
Requester: Individual, health professional
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of clozapine.
Purpose: For use in capacity as convenor of a patient support group located outside Canada.
Date received: 2015-12-29
Completion date: 2016-03-01
Decision: Denied, purpose of request does not meet requirements of the Act.

2016

Request number: 06
Requester: Individual
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of Apo-fluvoxamine.
Purpose: For use in a high school science class.
Date received: 2016-01-14
Completion date: 2016-03-21
Decision: Denied, requester and purpose of request do not meet requirements of the Act.

Request number: 07
Requester: Individual
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of surgical mesh products (ProteGen, Ob Tape, Avaulta Plus, Gynecare Prolift, Gynecare Prolift + M, Gynecare TVT Secure System, Gynecare Prosima Pelvic Floor Repair System, Advantage Sling System, Avaulta Plus Biosynthetic Support System, Elevate Anterior and Apical Prolapse Repair System, Gynemesh, Pelvitex Polypropylene Mesh, Pelvicol Tissue).
Purpose: For use in an online educational resource for mesh harmed women.
Date received: 2016-01-25
Completion date: 2016-03-21
Decision: Denied, requester and purpose of request do not meet requirements of the Act.

Request number: 08
Requester: Individual, health professional
Information requested: Information submitted to Health Canada by the manufacturer/distributer along with the evaluation by Health Canada that led to the approval of Dukoral as an "Oral, Inactivated Travellers’ Diarrhea and Cholera Vaccine" (2003) and its relabeling as an “Oral, Inactivated Cholera and ETEC Diarrhea Vaccine” (2015).
Purpose: To conduct an independent analysis of all third party and Health Canada reports regarding the approval of this vaccine product in Canada.
Date received: 2016-05-19
Completion date: 2016-11-01
Decision: Disclosed.
Revision date: 2019-05-03
Decision: Agreement with requester revised to align with amendments made to the Food and Drug Regulations (C.R.C., c.870).

Request number: 09
Requester: Individual, health professional and researcher
Information requested: Correspondence pertaining to Health Canada’s decision not to include the analgesic tramadol in the Controlled Drugs and Substances Act.
Purpose: To inform clinical education regarding the treatment of chronic pain, and the role of tramadol in particular, and to inform a scholarly publication on the appropriate use of tramadol by Canadian physicians.
Date received: 2016-06-06
Completion date: 2016-12-09
Decision: Closed, information provided is insufficient for Health Canada review.

Request number: 10
Requester: Individuals, health professionals
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of pregabalin.
Purpose: To inform clinical education and to incorporate into requesters’ clinical practice.
Date received: 2016-07-13
Completion date: 2016-12-09
Decision: Closed, information provided is insufficient for Health Canada review.

Request number: 11
Requester: Individual, researcher
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of the neuraminidase inhibitors Tamiflu and Relenza.
Purpose: To conduct a systematic review of the regulatory data and improve the methodology of evidence synthesis and appraisal of regulatory documents.
Date received: 2016-01-08
Completion date: 2017-02-07
Decision: Denied, request does not warrant exercise of discretion to disclose CBI.

Request number: 12
Requester: Individual, researcher
Information requested: Unpublished information, including clinical trials and other investigational studies, pertaining to the safety and effectiveness of three HPV vaccines: Gardasil, Gardasil 9, and Cervarix.
Purpose: To conduct a systematic review of the regulatory data and improve the methodology of evidence synthesis and appraisal of regulatory documents.
Date received: 2016-01-16
Completion date: 2017-02-07
Decision: Denied, request does not warrant exercise of discretion to disclose CBI.

2017

No reports received

2018