18. Every processor who conducts an investigation under paragraph 15(1)(e) shall, on completion of the investigation,

• (a) provide the Minister with a detailed report setting out the results of the investigation, including, where the semen is required to be collected, destroyed or reserved for special access distribution, the disposition of all containers of that semen; and

• (b) notify in writing the donors of the semen of the results of the investigation.

• 19. (1) If a physician wishes to obtain access to semen that has not been processed in accordance with the requirements of paragraphs 4(1)(b) and 9(1)(a) and section 10 or that has been reserved for special access distribution for use in performing assisted conception on a patient whose needs can not be met using semen that has been processed in accordance with those requirements, the physician shall apply in writing to the Minister for a special access authorization that permits the processor, distributor or importer of the semen or several of those persons to distribute or import for distribution the semen for that purpose.

• (2) The application shall contain the following:

  • (a) the name, business address and business telephone number of the physician;

  • (b) the name and business address of the processor of the requested semen;

  • (c) the name and business address of the distributor from whom the physician obtained or will obtain the semen;

  • (d) the name and business address of the person who is in possession of the semen;

  • (e) in the case of semen that is to be imported, the name and business address of the importer of the semen;

  • (f) the name and address of the health care facility to which the semen is to be shipped;

  • (g) the initials and date of birth of the patient;

  • (h) the number of containers of semen requested and the identification code of each requested container;

  • (i) a declaration signed by the processor or an authorized agent of the processor

    • (i) certifying that the requested semen has been processed in accordance with section 11,

    • (ii) certifying that the tests referred to in paragraph 20(1)(b) have been performed in respect of the donor of the requested semen and that the results of the tests were negative, and

    • (iii) 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;

  • (j) the date that the requested semen was donated and 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;

  • (k) a statement by the physician that he or she has obtained information from the processor as to whether the requested semen was processed in accordance with section 10;

  • (l) a statement by the physician indicating that he or she does not have reasonable grounds to believe that an infectious agent may have been transmitted to a woman as a result of assisted conception having been performed on the woman using semen from the same donor as that of the requested semen;

  • (m) a rationale by the physician that outlines

    • (i) the reasons that justify the use of the requested semen, having regard to the available information on the safety of the semen and the needs of the patient, and

    • (ii) 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) and 9(1)(a) and section 10;

  • (n) a statement by the physician that, in his or her opinion, the use of the requested semen would not pose

    • (i) a serious risk to the health of the patient, having regard to the available information on the safety of the semen and the health of the patient, or

    • (ii) a serious risk of transmitting an infectious agent to a child to be conceived from the semen, having regard to the available information on the safety of the semen; and

  • (o) a statement by the physician that he or she has informed the patient of the risks that the use of the requested semen could pose to the patient and to a child to be conceived from the use of the semen and has obtained the patient’s written consent to its use.

• (3) The application shall be signed and dated by the physician.