Reporting a complaint for materials and activities subject to the Assisted Human Reproduction Act
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Health Canada is committed to verifying complaints from Canadians (e.g., donors, surrogates, intended parents, children born of assisted human reproduction (AHR), healthcare professionals, and clinics) and industry regarding materials or activities which are subject to the Assisted Human Reproduction Act (the AHR Act) or its Regulations.
Materials subject to the AHR Act or Regulations include, but are not limited to:
- donor sperm and ova (eggs) used for the purpose of AHR
- in vitro embryos
Activities subject to the AHR Act or Regulations include:
- providing consent for the use of donated human reproductive material for the purpose of creating an embryo
- processing, distributing, making use of and importing donor sperm or ova (eggs) for the purpose of AHR
- reimbursing surrogate mothers for expenditures incurred by her in relation to her surrogacy and loss of work-related income incurred during her pregnancy
- reimbursing sperm and ova (egg) donors for expenditures incurred in the course of donating
- reimbursing persons for expenditures related to the maintenance or transport of an in vitro embryo
Why and what to report
- Your contact information including your name, address (e.g. street number, street name, city, province, country, postal code), telephone number and email address.
Who is involved
- Names, contact information and registration numbers of other parties involved in the complaint such as primary establishments, establishments that import or distribute, clinics, surrogacy agencies.
Material or activity involved
- Any relevant information that will help identify the material in question such as a donation code or donor identification number.
- Any relevant information pertaining to an activity subject to the AHR Act or its Regulations.
- You may submit supporting documentation such as pictures or scanned documents.
- Provide a brief description of the incident or circumstances, or suspected violation of the AHR Act or its Regulations, including the date(s) when the incident(s) occurred.
- Errors or accidents must be reported separately via the Sperm and Ova Error or Accident Preliminary Investigation Report Form (FRM-0447).
- Indicate your consent for Health Canada to provide the contents of your complaint to primary establishments, importers or distributors, if necessary to facilitate follow up on your complaint.
- Indicate your consent for Health Canada to release contents of your complaint to another organization outside of Health Canada such as provincial, territorial or federal regulatory agencies or associations, if necessary, to facilitate follow-up on your complaint.
Please note that Health Canada may share the contents received in the complaint, including contact information, to the processor, importer, distributor, or other party implicated if necessary, to facilitate follow-up on the complaint by Health Canada and/or the processor, importer, distributor, or other party implicated.
The personal information you provide to Health Canada is governed in accordance with the Privacy Act. We only collect the information we need to administer national compliance and enforcement activities for materials and activities under Health Canada's mandate authorized under the AHRA Act and its Regulations.
Purpose of collection: To contact you for additional information regarding your complaint and/or, with your consent, follow up with or refer your complaint to another organization outside Health Canada.
Other uses or disclosures: In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8(2) of the Privacy Act.
For more information: This personal information collection is described in Info Source, available online at infosource.gc.ca. A Personal Information Bank is under development and will be included on Info Source.
Your rights under the Privacy Act: In addition to protecting your personal information, the Privacy Act gives you the right to request access to and correction of your personal information. For more information about these rights, or about our privacy practices, please contact Health Canada's Privacy Coordinator at 613-954-9165 or firstname.lastname@example.org. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.
How to submit reports
Please submit your complaint and documentation by email at email@example.com, or by mail to:
Biological Product Compliance Program
Regulatory Operations and Enforcement Branch
200 Eglantine Driveway
All complaints are prioritized according to the health and safety risk with high-risk complaints receiving priority attention. Actions taken are consistent with ROEB's Compliance and Enforcement Policy for the Assisted Human Reproduction Act (POL-0100) with the objective of achieving compliance using the most appropriate level of intervention. Not all complaints will lead to further action from Health Canada.
When Health Canada receives a complaint, the information is reviewed to determine if the report falls within its mandate. If it does, you will be contacted or sent an acknowledgement letter that the complaint was received.
If a complaint does not fall within our mandate, it will be directed to the appropriate authority and you will be informed of the referral or you will be provided with the appropriate authority to contact.
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