OTTAWA, Oct. 17, 2017 /CNW/ -
Issue
Following recent complaints, Health Canada initiated a review to verify whether the Cord Blood Bank of Canada, a private cord blood bank, was in compliance with the acts and regulations that apply to cord blood in Canada.
Health Canada's review revealed that the Client Service Agreement published on the company's website suggested that cord blood banked on behalf of clients could be donated to another individual upon termination of the agreement. This is known as allogeneic use. The document also contained statements that could lead clients to believe that the company is a registered establishment and therefore subject to Health Canada oversight under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations).
As of January 1, 2016, the Cord Blood Bank of Canada is no longer a registered establishment under the CTO Regulations and as such, cannot bank cord blood for allogeneic use. It can bank cord blood for use only by the donor; known as autologous use.
At Health Canada's request, the company has clarified on its website that only autologous use is permitted. Health Canada also requested that the Cord Blood Bank of Canada notify its clients that only autologous use is permitted. Through its correspondence with the company, Health Canada has not been able to verify that clients have been adequately informed. Therefore, Health Canada is advising Canadians that the Cord Blood Bank of Canada can store cord blood for use only by the donor.
What you should do
- If you are a client of the Cord Blood Bank of Canada and have questions on the specific use of your banked cord blood, contact the company to review your agreement.
- Be aware that, upon termination of your agreement with the Cord Blood Bank of Canada, the cord blood may only be disposed of or used for research purposes and may not be used by an individual, including the donor, at a later time.
- When deciding whether or not to bank cord blood, you should seek detailed information about the cord blood bank you are considering. Facilities that store cord blood for autologous use only are not regulated under the CTO Regulations. These facilities can attain accreditation from reputable organizations such as the Foundation for Accreditation of Cell Therapies and the American Association of Blood Banks.
- If a Canadian cord blood bank stores cord blood for allogeneic use, it must be registered with Health Canada. If you would like to find out whether an establishment is registered, contact Health Canada by emailing CTO_Registration@hc-sc.gc.ca.
- If you have concerns or complaints about cord blood or any health product, file a report with Health Canada by calling toll-free at 1‑800‑267‑9675, or complete an online complaint form.
Background
The primary aim of the CTO Regulations is to minimize the potential health risks transmitted from donors to recipients (allogeneic donations) of human cells, tissues or organs. Establishments that process, bank or distribute cord blood for allogeneic purposes are required to hold a Registration and to demonstrate that the products they handle have been processed according to health and safety standards. In autologous donations, the recipient is also the donor. As such, there is no risk of transmission of an infectious disease from the donor to the recipient, which is why autologous donations are excluded from the CTO Regulations.
Health Canada inspected the Cord Blood Bank of Canada in 2015 to assess compliance with the CTO Regulations. At that time, the Cord Blood Bank of Canada was registered under the CTO Regulations for processing and banking cord blood for both autologous and allogeneic use. The Department made several observations and the company received a non-compliant rating. As a result of the lack of satisfactory responses to address these observations, Health Canada did not renew the company's Registration, which meant that allogeneic use was no longer permitted. The company provided written confirmation that it was operating for autologous use only, to which the CTO Regulations do not apply.
In 2016, Health Canada requested that the Cord Blood Bank of Canada modify its website to remove reference to allogeneic use, and requested further actions again in August 2017.
In the future, if the Cord Blood Bank of Canada would like to release banked cord blood for allogeneic use, it would need to apply for a new Registration and demonstrate that the cord blood is processed in accordance with the CTO Regulations. In the meantime, the Cord Blood Bank of Canada, like all banks that store cord blood (whether for allogeneic or autologous use), must meet requirements under the Food and Drugs Act.
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SOURCE Health Canada
For further information: Media Inquiries: Health Canada, (613) 957-2983; Public Inquiries: (613) 957-2991, 1-866 225-0709
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