CONTROLLED ACTIVITIES

Use of human reproductive material

10. (1) No person shall, except in accordance with the regulations and a licence, alter, manipulate or treat any human reproductive material for the purpose of creating an embryo.

Use of in vitro embryo

(2) No person shall, except in accordance with the regulations and a licence, alter, manipulate, treat or make any use of an in vitro embryo.

Keeping and handling gametes and embryos

(3) No person shall, except in accordance with the regulations and a licence, obtain, store, transfer, destroy, import or export

    (a) a sperm or ovum, or any part of one, for the purpose of creating an embryo; or

    (b) an in vitro embryo, for any purpose.

Transgenics

11. (1) No person shall, except in accordance with the regulations and a licence, combine any part or any proportion of the human genome specified in the regulations with any part of the genome of a species specified in the regulations.

Definitions

(2) The following definitions apply in this section.

``human genome''
« génome humain »

``human genome'' means the totality of the deoxyribonucleic acid sequence of the human species.

``species''
« espèce »

``species'' means any taxonomic classification of non-human life.

Reimburseme nt of expenditures

12. (1) No person shall, except in accordance with the regulations and a licence,

    (a) reimburse a donor for an expenditure incurred in the course of donating sperm or an ovum;

    (b) reimburse any person for an expenditure incurred in the maintenance or transport of an in vitro embryo; or

    (c) reimburse a surrogate mother for an expenditure incurred by her in relation to her surrogacy.

Receipts

(2) No person shall reimburse an expenditure referred to in subsection (1) unless a receipt is provided to that person for the expenditure.

No reimbursemen t

(3) No person shall reimburse a surrogate mother for a loss of work-related income incurred during her pregnancy, unless

    (a) a qualified medical practitioner certifies, in writing, that continuing to work may pose a risk to her health or that of the embryo or foetus; and

    (b) the reimbursement is made in accordance with the regulations and a licence.

Use of premises

13. No person who is licensed to undertake a controlled activity shall undertake it in any premises except in accordance with a licence permitting the use of the premises for that controlled activity.

PRIVACY AND ACCESS TO INFORMATION

Information to be collected by licensees

14. (1) A licensee shall not accept the donation of human reproductive material or an in vitro embryo from any person for the purpose of a controlled activity, and shall not perform a controlled activity on any person, unless the licensee has obtained from that person the health reporting information required to be collected under the regulations.

Requirements of this Act to be conveyed

(2) Before accepting a donation of human reproductive material or of an in vitro embryo from a person or accepting health reporting information respecting a person, a licensee shall

    (a) inform the person in writing of the requirements of this Act respecting, as the case may be,

      (i) the retention, use, provision to other persons and destruction of the human reproductive material or in vitro embryo, or

      (ii) the retention, use, disclosure and destruction of the health reporting information;

    (b) to the extent required by the regulations, make counselling services available to the person and ensure that the person receives them;

    (c) obtain the written consent of the person to the application of the requirements referred to in paragraph (a); and

    (d) in accordance with the regulations, provide the person with the information that the Agency makes available to the public under paragraph 19(i).

Disclosure of information restricted

15. (1) No licensee shall disclose health reporting information for any purpose except

    (a) with the written consent of the person to whom the information relates allowing its disclosure for that purpose; or

    (b) in accordance with subsections (2) to (5).

Disclosure required

(2) A licensee shall disclose health reporting information

    (a) to the Agency, to the extent required by the regulations;

    (b) to the extent required for the administration of a health care insurance plan within the meaning of the Canada Health Act;

    (c) for the purpose of complying with a subpoena or warrant issued or order made by a court, body or person with jurisdiction to compel the production of information or for the purpose of complying with rules of court relating to the production of information; and

    (d) to the extent required by the provisions of any federal or provincial law respecting health and safety that are specified in the regulations.

Transfers between licensees

(3) A licensee that transfers human reproductive material or an in vitro embryo to another licensee shall disclose to the other licensee the health reporting information in its possession respecting the material or embryo, and respecting the person or persons to whom the material or embryo relates, but the identity of any person - or information that can reasonably be expected to be used in the identification of a person - shall not be disclosed except in the circumstances and to the extent provided by the regulations.

Agency to be notified

(3.1) A licensee who transfers an in vitro embryo to another licensee shall notify the Agency of the transfer in accordance with the regulations.

Information to persons undergoing procedures

(4) Before performing an assisted reproduction procedure that makes use of human reproductive material or an in vitro embryo, a licensee shall disclose to the person undergoing the procedure the health reporting information in its possession respecting the donor, but the identity of the donor - or information that can reasonably be expected to be used in the identification of the donor - shall not be disclosed without the donor's written consent.

Research and statistics

(5) A licensee may disclose health reporting information to an individual or organization for scientific research or statistical purposes, other than the identity of any person - or information that can reasonably be expected to be used in the identification of any person.

Access to health reporting information

16. (1) A person shall be given, on request, access to any health reporting information about the person that is under the control of a licensee or other person who has obtained the information. The person is entitled to

    (a) request the correction of the information if they believe there is an error or omission in that information;

    (b) require that a notation be attached to that information reflecting any correction that was requested but was not made; and

    (c) require that such a correction or notation be communicated to any person or body to whom that information was disclosed during the two years preceding the request for a correction.

Destruction of information

(2) A licensee or any other person that has control of the health reporting information provided by a donor of human reproductive material or an in vitro embryo, by a person who has undergone an assisted reproduction procedure or by a person who was conceived by means of such a procedure shall, at the request of the donor or that person, as the case may be, destroy that information in the circumstances and to the extent provided by the regulations, and shall inform the donor or that person that the destruction has occurred.

Destruction of reproductive material

(3) A licensee and any other person that has control of human reproductive material or an in vitro embryo shall destroy that material or embryo at the request of its donor in the circumstances and to the extent provided by the regulations, and shall inform the donor that the destruction has occurred.

Exception

(4) This section does not apply to

    (a) government institutions subject to the Privacy Act or the National Archives of Canada Act; or

    (b) a court, body or person referred to in paragraph 15(2)(c).

Personal health information registry

17. The Agency shall maintain a personal health information registry containing health reporting information about donors of human reproductive material and in vitro embryos, persons who undergo assisted reproduction procedures and persons conceived by means of those procedures.

Use of information by Agency

18. (1) The Agency may use health reporting information, and information otherwise relating to the controlled activities undertaken by an applicant or licensee, for the purposes of the administration and enforcement of this Act or the identification of health and safety risks, potential and actual abuses of human rights, or ethical issues associated with assisted human reproduction technologies and the other matters to which this Act applies.

Consent to disclosure

(2) Notwithstanding section 8 of the Privacy Act but subject to subsections (3) to (8), health reporting information under the control of the Agency relating to a donor of human reproductive material or an in vitro embryo, a person who has undergone an assisted reproduction procedure or a person who was conceived by means of such a procedure is confidential and shall be disclosed only with the written consent of the donor or that person, as the case may be.

Disclosure to recipients of reproductive material

(3) The Agency shall, on request, disclose health reporting information relating to a donor of human reproductive material or of an in vitro embryo to a person undergoing an assisted reproduction procedure using that human reproductive material or embryo, to a person conceived by means of such a procedure and to descendants of a person so conceived, but the identity of the donor - or information that can reasonably be expected to be used in the identification of the donor - shall not be disclosed without the donor's written consent.

Relationship of individuals

(4) On application in writing by any two individuals who have reason to believe that one or both were conceived by means of an assisted reproduction procedure using human reproductive material or an in vitro embryo from a donor, the Agency shall disclose to both of them whether it has information that they are genetically related and, if so, the nature of the relationship.

Obligation to disclose

(5) The Agency shall disclose health reporting information

    (a) for the purpose of complying with a subpoena or warrant issued or order made by a court, body or person with jurisdiction to compel the production of information, or for the purpose of complying with rules of court relating to the production of information; and

    (b) to the extent required by provisions of any federal or provincial law respecting health and safety that are specified in the regulations.

Discretion to disclose

(6) The Agency may disclose health reporting information

    (a) for the purposes of the enforcement of this Act;

    (b) to the extent required for the administration of a health care insurance plan within the meaning of the Canada Health Act; and

    (c) for the purposes of disciplinary proceedings undertaken by any professional licensing or disciplinary body established under the laws of Canada or a province and specified in the regulations.

Disclosure to address health or safety risk

(7) The Agency may disclose the identity of a donor to a physician if, in the Agency's opinion, the disclosure is necessary to address a risk to the health or safety of a person who has undergone an assisted reproduction procedure, was conceived by means of such a procedure or is a descendant of a person so conceived. The physician may not disclose that identity.

Research and statistics

(8) The Agency may disclose health reporting information to an individual or organization for scientific research or statistical purposes, other than the identity of any person - or information that can reasonably be expected to be used in the identification of any person.

Information available from Agency

19. The Agency shall make available for inspection by the public in accordance with the regulations any information that is prescribed by the regulations relating to

    (a) this Act, the regulations under this Act and policy directions under section 25;

    (b) the by-laws of the Agency;

    (c) licences issued by the Agency;

    (d) applications for, and amendments or renewals of, licences;

    (e) notices of proceedings in respect of the issuance, amendment, renewal, suspension, restoration or revocation of licences;

    (f) information and observations provided to the Agency in respect of any proceedings respecting licences, other than the identity of - or information that can reasonably be expected to be used in the identification of - any donor of human reproductive material or an in vitro embryo, any person who has undergone an assisted reproduction procedure or any person who was conceived by means of such a procedure;

    (g) decisions of the Agency arising from any proceedings respecting licences;

    (h) the names and addresses of licensees;

    (i) aggregated outcomes of assisted reproduction procedures performed by licensees;

    (j) measures taken under section 44;

    (k) the enforcement of this Act;

    (l) agreements entered into under section 58;

    (m) agreements entered into under section 68; and

    (n) reports and other documentation provided to or by the Agency pursuant to the Agency's power to monitor and evaluate developments in assisted human reproduction and other matters to which this Act applies.