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Contact: Donor Semen Special Access Programme
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Guidance on Donor Semen Special Access Programme: Alternative Test Requirements (PDF Version, 122 Kb)
October 4, 2001
To: All Establishments and Physicians that Process, Distribute and/or Import Donor Semen for Assisted Conception
Subject: Guidance on Donor Semen Special Access Programme: Alternative Test Requirements
Health Canada is pleased to inform you of the release of the Document entitled "Guidance on Donor Semen Special Access Programme: Alternative Test Requirements." This Guidance Document was developed in response to queries from physicians and patients regarding the alternative testing provisions outlined in subparagraph 20(1)(b)(ii) of the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations), which were promulgated on December 1, 2000. It provides guidance on alternative tests that will be considered acceptable by Health Canada within the context of the Donor Semen Special Access Programme.
A copy of the Guidance Document is included with this letter and is also available on the Therapeutic Products Directorate website at:
If you have any questions regarding this document, please do not hesitate to contact:DSSAP
Original signed by
Associate Director General
Document entitled "Guidance on Donor Semen Special Access Programme: Alternative Test Requirements."
Guidance on Donor Semen Special Access Programme: Alternative Test Requirements
Biologics and Genetic Therapies Directorate - Health Canada
The following definitions apply in this Guidance Document:
The Donor Semen Special Access Programme (DSSAP) is intended to provide access, in exceptional circumstances, to semen that has not been processed in accordance with the requirements specified in paragraphs 4(1)(b), 9(1)(a) and section 10 of the Semen Regulations. Pursuant to paragraph 20(1)(b) of the Semen Regulations, the Minister shall issue a special access authorization for the release of such semen to the processor, distributor or importer referred to in a DSSAP application if tests for human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2), hepatitis B virus (HBV) and hepatitis C virus (HCV) were performed collectively using one of the following tests, and the result of each test was negative:
Issues have arisen concerning DSSAP applications submitted to Health Canada in which the tests performed on the donor do not comply with the requirements specified in items (i) and (iii) above. Specifically, these donors were:
Further, some donors cannot be located for testing according to the requirements specified under subparagraph 20(1)(b)(i) of the Semen Regulations. Consequently, Health Canada has been asked to provide guidance on alternative tests that will be considered acceptable under subparagraph 20(1)(b)(ii) of the Semen Regulations.
The alternative testing provisions in subparagraph 20(1)(b)(ii) were included in the Semen Regulations to allow the use of other tests that are as effective as those specified in subparagraph 20(1)(b)(i) in detecting the relevant infectious agents. For example, in cases where donors cannot be located, and the only specimens available for testing are their cryopreserved semen donations, testing laboratories could proceed with testing these donations as soon as they are able to validate a method for the detection of the relevant infectious agents in semen specimens.
Many of the patients requesting special access authorization have already had a child(ren) using semen from the donors of the requested semen, and wish to have another child using semen from the same donor to ensure their children will be genetic siblings. These patients and their physicians have indicated that they do not believe the requested semen is contaminated because the patients, and in some cases their spouses/sexual partners, have been tested and found negative for all the relevant infectious agents. Thus, in lieu of a validated method for testing cryopreserved semen specimens for these infectious agents, Health Canada has been asked to consider serological tests performed on previously exposed patients as an acceptable alternative to tests performed on the semen donor.
Health Canada recognizes that the likelihood of a semen donor being infected with HIV, HBV and HCV is relatively low if the patient has already been exposed to his donations in the past without any adverse consequences. However, it is important to note that the various donations from a single donor may have been made on different days and over an extended period of time. Thus, the safety of the individual donations from the same donor will depend on the time of exposure to an infectious agent. For example, if a donor was tested and found negative for an infectious disease marker on January 1, 2000 and subsequently became infected on March 15, 2000, the donations he made before March 15, 2000 will not be contaminated with the infectious agent. However, the probability of the donations he made on or after March 15, 2000 being contaminated with the infectious agent is relatively high. Consequently, there is no assurance that all of the semen donations from a single donor are equivalent with respect to infectious disease risk.
For the reasons stated above, infectious disease tests performed on previously exposed patients were not generally accepted as effective alternative tests by Health Canada. However, some physicians have indicated they can provide additional information to assist with evaluating the effectiveness of the serological tests performed on previously exposed patients.
The acceptability of infectious disease tests performed on previously exposed patients as a substitute for donor testing will be considered on a case by case basis. A test performed on the patient may be deemed acceptable if all of the following conditions are satisfied:
Note: Relevant infectious disease markers are the markers for the infectious disease agents the donor was not tested for.
In order to determine the validity of accepting infectious disease tests performed on the patient as a substitute for tests performed on the donor, Health Canada is requesting that physicians provide all of the following information in addition to the information requested in the DSSAP application form:
Information regarding infectious disease tests must include the specific infectious disease markers detected by the tests performed. The specific markers include:
In the case of HBV, the patients and, where applicable, her spouse/sexual partner must be tested for both HBsAg and antibody to HBc (IgG or total).
For additional information please contact:DSSAP