Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access

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Contact: Donor Semen Special Access Programme

Date: 2002-11-27

Biologics and Genetic Therapies
Directorate
Building #6, AL 0603D
Tunney's Pasture
Ottawa, Ontario K1A 0L2

November 27, 2002
02-119916-973

To: All Establishments and Physicians that Process, Distribute and/or Import Donor Semen for Assisted Conception

Subject: Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access.

This is to inform you that Health Canada has released a Document entitled "Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access" to provide further clarification regarding semen donations that are eligible for special access authorization. Specifically, it addresses the needs of individuals who wish to build their families using semen from donors who are currently excluded from donating semen for normal distribution on the basis of the exclusion criteria specified in the Processing and Distribution of Semen for Assisted Conception Regulations and the Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination.

If you have any questions regarding this document, or need a hard copy, please do not hesitate to contact:

DSSAP
Blood, Tissues and Organs Division
Biologics and Radiopharmaceuticals Evaluation Centre
Building #6, AL 0603C3 Tunney's Pasture
Ottawa, Ontario K1A 0L2
Telephone: (613)952-8318
Facsimile: (613)941-5841
Email: DSSAP@hc-sc.gc.ca

Yours sincerely,

Original signed by

Julia Hill Acting Director General

Attachments:

Document entitled "Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access."

Biologics and Genetic Therapies Directorate - Health Canada - November 2002

1. Purpose

The purpose of this document is to provide further clarification regarding donor semen that is eligible for special access authorization.

2. Definitions

The following definitions apply in this Guidance Document:

Anonymous Donor

A donor whose identity is unknown to the recipient. This includes donors whose identity is revealed to the patient by the semen establishment.

Directive

"Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination - July 2000".

DSSAP Guidance Document

"Therapeutic Products Programme Guidance: Donor Semen Special Access Programme (December 2000)".

Donor Who is Known to the Patient

A donor whose identity is known to the patient. This includes a designated or directed donor who directs his donations for use in a particular patient (e.g., family member or friend of the patient or couple). It does not include the patient's spouse or sexual partner, or an anonymous donor whose identity is revealed to the patient by the semen establishment.

Patient

The woman on whom assisted conception will be performed using the donor semen in respect of which the special access authorization is being requested.

Physician

The physician who submits a Donor Semen Special Access Programme application to Health Canada.

Requested Semen

the donor semen in respect of which the special access authorization is being requested.

Semen From Excluded Donors

Semen collected from a donor, who at the time of donation, is known to be excluded from donating on the basis of the exclusion criteria specified in Directive.

Semen Regulations

Processing and Distribution of Semen for Assisted Conception Regulations.

3. BackGround

The Donor Semen Special Access Programme (DSSAP) provides 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. The DSSAP was primarily intended to provide access to cryopreserved semen donations that were placed under detention because they were not processed in accordance with regulatory requirements in place at the time, or because they no longer met updated regulatory requirements. As specified under the heading "Donor Semen Eligible for Special Access" in Section 4 of the "Therapeutic Products Programme Guidance: Donor Semen Special Access Programme, December 2000" (DSSAP Guidance Document), the three categories primarily targeted by the DSSAP are as follows:

1. Donor semen that was processed in accordance with regulatory requirements that have been superseded by updated requirements;
2. Donor semen that was incorrectly processed (i.e. where certain tests were inadvertently omitted or done incorrectly); or
3. Donor semen that has been the subject of an investigation under section 15 of the Semen Regulations and the results of the investigation are inconclusive as to whether the semen is contaminated with an infectious agent.

Subsection 20(1) of the Semen Regulations outlines the conditions under which a special access authorization shall be issued by the Minister. Paragraph 20(1)(e) states that "the Minister shall issue a special access authorization to the processor, distributor or importer referred to in the application made under subsection 19(1), or several of those persons, if the authorization is not being sought for the purpose of circumventing the processing requirements of Part 1" of the Regulations. Given that it is possible for all establishments to comply with the current Semen Regulations when processing semen, the interpretation provided for paragraph 20(1)(e) in Section 4 of the DSSAP Guidance Document was as follows:

It is important to note that the special access authorization cannot be used as a mechanism to circumvent the normal processing requirements of the Semen Regulations and the Directive. For example, a special access authorization will not be granted if it is determined that the processor intentionally omitted an exclusion criterion or a test for any of the infectious agents specified in the Directive. Consequently, semen processors must comply with all the requirements of the Semen Regulations, including paragraphs 4(1)(b), 9(1)(a) and section 10, when processing all semen donations.

Paragraphs 4(1)(b) and 9(1)(a) refer to the requirements specified in the "Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination - July 2000" (the Directive) under the headings "Exclusions", "Work-up", "Repeat Screening and Quarantine" and "Microbiology." Thus, as currently worded in Section 4 of the DSSAP Guidance Document, the interpretation of paragraph 20(1)(e) of the Semen Regulations implies that a special access authorization will not be issued if, at the time of donation, the processor is aware the donor is excluded from donating on the basis of the exclusion criteria specified in the Directive under the heading "Exclusions."

Health Canada has recently been made aware of individuals who wish to build their families using semen collected from excluded donors who are known to the patient. An analysis of this situation in the context of the requirements and objectives of the special access regulations indicates that a special access authorization could be issued under these circumstances, following a review of a DSSAP application as specified in Part 2 of the Semen Regulations.

4. Considerations

1. The information that must be provided in the DSSAP application, is outlined in section 19 of the Semen Regulations and includes, among others:
   1. The date that the requested semen was donated, the tests, screening and monitoring performed in respect of the donor of the semen and the dates and results of those measures, including, if necessary, an interpretation of the results [see paragraph 19(2)(j)]; and
   2. A declaration signed by the processor or an authorized agent of the processor indicating which measures required under paragraphs 4(1)(b) and 9(1)(a) have not been taken and the reasons why they have not been taken [see paragraph 19(2)( i )(iii)].
      
      Although ( i ) the information requested in section 19 of the Semen Regulations includes both the screening and testing performed in respect of the donor of the semen; and (ii) section 20 of the Semen Regulations precludes the issuance of a special access authorization if the minimum infectious disease testing requirements set out in this section are not met; none of the regulatory requirements prohibit the issuance of a special access authorization if the donor falls within a group set out in the Directive under the heading "Exclusions."
2. Pursuant to paragraph 19(2)(m) of the Semen Regulations, physicians applying for special access authorization are required to provide a rationale that outlines:
   1. The reasons that justify the use of the semen, having regard to the available information on the safety of the semen and the needs of the patient; and
   2. The reasons why the needs of the patient cannot be met using semen that has been processed in accordance with the requirements of paragraphs 4(1)(b), 9(1)(a) and section 10.

Examples of rationale provided by physicians in the past include the use of the requested semen for assisted conception by women or couples who ( i ) have already had a child through assisted conception, and wish to have another child using semen from the same donor to ensure their children will be genetic siblings; or (ii) are unable to find other donors with characteristics that meet their needs. To date, there have been no applications for special access authorization for donations processed after the promulgation of the special access regulations (i.e., after December 2000) where the information provided indicates that the request is for semen from an excluded donor. However, this does not mean that such donations are not eligible for special access authorization under exceptional circumstances.

5. Clarification: Donor semen eligible for special access

Respecting,

1. the needs of individuals who wish to build their families using semen collected from excluded donors who are known to the patient; and
2. the special access provisions that allow access to semen that has not been processed in accordance with certain regulatory requirements for use in performing assisted conception in "exceptional circumstances"

the non application of the exclusion criteria to donors of semen collected in anticipation of distribution pursuant to a special access authorization, will not automatically be interpreted as an attempt to circumvent the processing requirements of Part 1 of the Semen Regulations, regardless of when the semen is collected. All DSSAP applications will be considered on a case by case basis. As set out in the Semen Regulations, a special access authorization may not be issued unless;

1. the rationale provided by the patient's physician indicates that the semen is being requested for use under exceptional circumstances;
2. it is determined that the authorization is not being sought for the purpose of circumventing the processing requirements of Part 1 of the Semen Regulations; and
3. all the other requirements of the special access regulations are met.

As such, Section 4 of the DSSAP Guidance Document as it appears in the December 2000 version is to be replaced in its entirety with the amended version as follows:

"The DSSAP targets donor semen that cannot be distributed for general access because it does not meet the regulatory requirements that are applicable at the time of distribution. This donor semen falls into four categories:

1. Donor semen that was processed in accordance with regulatory requirements that have been superseded by updated requirements;
2. Donor semen that was incorrectly processed (i.e. where certain tests were inadvertently omitted or done incorrectly);
3. Donor semen that has been the subject of an investigation under section 15 of the Semen Regulations and the results of the investigation are inconclusive as to whether the semen is contaminated with an infectious agent; or
4. Semen collected from excluded donors in anticipation of distribution pursuant to a special access authorization.

Donor Semen that has been found to be contaminated with an infectious agent is not eligible for distribution under the DSSAP and must be destroyed.

It is important to note that the special access authorization cannot be used as a mechanism to circumvent the normal processing requirements of the Semen Regulations and the Directive. Thus, although the current Semen Regulations and the Directive make no distinction between anonymous and known donors, a rationale for not applying the exclusion criteria that may be considered acceptable for known donors, could be considered unacceptable for anonymous donors. This distinction is based on the specific needs of individuals who wish to build their families using semen donated by friends and family members, and consequently, can justify the use of such donations under "exceptional circumstances". As well, a special access authorization may not be granted if it is determined that the processor intentionally ignored a test for any of the infectious agents specified in the Directive.

6. Additional information

For additional information please contact:

DSSAP
Blood, Tissues and Organs Division
Biologics and Radiopharmaceuticals Evaluation Centre
3rd Floor, Building #6
Postal Locator 0603C3 Tunney's Pasture
Ottawa, Ontario KIA 0L2
Tel: (613) 952-8318
Fax: (613) 941-5841
E-mail: DSSAP@hc-sc.gc.ca