List of Details
|
Subject matter
|
Detail
|
|
Health
|
Mrs. Cindy Gates-Dee, and the Dee family, seeks to lobby public office holders regarding Canadian Blood Services’ 1998, and
any subsequent, memorandum of understanding between the
federal, provincial and territorial governments, Donor health
assessment questionnaire (DHAQ) and Good manufacturing
practices (GMP).
|
|
Health
|
Mrs. Cindy Gates-Dee, and the Dee family, seeks to lobby public office holders regarding Health Canada’s Guidance Document for Cell, Tissue, and Organ Establishments, Food and Drugs Act (R.S.C., 1985, c. F-27), and pp. 30-99, men who have sex with men (MSM), “exceptional distribution,” and the donor being flagged as “high risk,” Safety of Human Cells and Tissues and Organs for Transplantation Regulations (SOR/2007-118) and CSA Standards (e.g. Z900 CSA Standards).
|
|
Health
|
Mrs. Cindy Gates-Dee, and the Dee family, seeks to lobby public office holders regarding Health Canada’s latest Guidance on the Safety of Human Cells, Tissues and Organs for Transplantation Regulations; Health Canada’s previous Guidance Document (i.e. the 2018 version in effect at the time) indicated that for deceased donors, the following evidence should be assessed in a physical examination: “for a male donor, physical evidence of anal intercourse including perianal condyloma”; After Mrs. Cindy Gates-Dee, and the Dee family, sought to lobby public office holders to have this removed from the Guidance the statement was subsequently removed by Health Canada. The statement does not exist in the updated version of the Guidance Document (updated 2024).
|
|
Health
|
Mrs. Cindy Gates-Dee, and the Dee family, seek to lobby public office holders to eliminate the use of ‘men who have sex with men’ and other criterion on the basis of gender or sexual orientation for donor risk assessments. Health Canada has indicated their intention to eliminate the ‘men who have sex with men’ criterion for donor risk assessments and are proposing moving toward gender neutral behavioral screening. A press release regarding this recent policy change was not found online; Public review period for comment was launched for the proposed amendments of CSA Z900.1 (General standard) and Z900.2.3 (Perfusable organs). The comment period will close on May 10th 2025.
|
|
Health
|
Mrs. Cindy Gates-Dee, and the Dee family, sought to lobby public office holders regarding Health Canada issuance of a Notice to industry requiring the use of universal Nucleic Acid Testing (NAT) for all donations to reduce the risk of HIV, HBV, and HCV. A Notice was subsequently issued by Health Canada requiring the use of NAT to reduce the risk of HIV, HBV, and HCV on February 25, 2025; In 2013, Health Canada made it mandatory to use HIV-1 NAT and HCV NAT assays to test cord blood donors and deceased tissue donors. At the time, this requirement was not extended to other types of donations, such as organs and fresh lymphohematopoietic cells, due to concerns about the accessibility of NAT assays licensed by Health Canada, as well as concerns about the rates of false positive test results. Over the past decade, the accessibility of licensed donor screening NAT assays for HIV-1, HBV, and HCV has increased substantially and the false positivity rate of the current generation of these tests has dropped considerably.
|
|
