Processing and Distribution of Semen for Assisted Conception

Act: Food and Drugs Act, R.S.C. 1985, c. F-27
Regulation: Processing and Distribution of Semen for Assisted Conception Regulations, SOR/96-254

To Whom Does This Apply?

All semen establishments, processors, importers, distributors of semen used for assisted conception and physicians performing assisted conception.

Summary

The Food and Drugs Act (the Act) governs the sale of drugs and medical devices, among other therapeutic products. The Act provides Health Canada with powers for inspection and enforcement, and those found to be non compliant with the Act can be faced with fines and imprisonment.

The Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations) establish national requirements for those involved with the processing and distribution of semen for assisted conception. The objective of these regulations is to minimize the risk of transmission of infectious diseases (including AIDS) and disease agents through semen used in assisted conception, including in vitro fertilization, among other reproductive techniques.

Assisted conception is defined in the Semen Regulations as "a reproductive technique performed on a woman for the purpose of conception, using semen from a donor who is not her spouse or sexual partner". Therefore, semen belonging to a spouse or a sexual partner of the recipient is not subject to any of the requirements outlined in the Semen Regulations.

The Semen Regulations outline specific obligations that must be met in Canada by all semen establishments in which assisted conception is performed, processors, importers and distributors of semen used for assisted conception and physicians who perform assisted conception:

• Screen donors by performing medical and social history and test for sexually transmitted diseases, and then re-evaluate and retest the donor after the semen has been frozen in quarantine for a minimum of six months;
• Mark each container of semen with an identification code so it can be linked back to the donor and to the date of donation;
• Keep records of the distribution of the semen; and/or
• Stop distribution and perform a thorough investigation concerning all semen suspected of being infected with a disease.

Users should also note that every person who processes or imports, or intends to process or import, semen for assisted conception must give notice to Health Canada before beginning any activity.

Additional Information

You may also consult the following document Guidance on the Processing and Distribution of Semen for Assisted Conception Regulations prepared by Health Canada.

DISCLAIMER
Information contained in this section is of a general nature only and is not intended to constitute advice for any specific fact situation. For particular questions, the users are invited to contact their lawyer. For additional information, see contact(s) listed below.

Quebec Contact(s):
Quebec Operational Centre (Quebec)
BTOX Specialist
Health Canada
A. L. 0900C2
1001 St-Laurent Ouest
Longueuil, Quebec  J4K 1C7
Telephone: 450-646-1353
Fax: 450-928-4455
Web site: http://www.hc-sc.gc.ca/index_e.html

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National Contact(s):
National
BTOX Manager - National
Health Canada
3rd Floor
Graham Spry Building
250 Lanark Avenue
Address Locator: 2003D
Ottawa, Ontario  K1A 0K9
Telephone: 613-954-5011
Fax: 613-946-5636
E-mail: BTOX_STOX@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html