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Bill C-13

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REGULATIONS

Regulations of Governor in Council

65. (1) The Governor in Council may make regulations for carrying into effect the purposes and provisions of this Act and, in particular, may make regulations

    (a) defining ``donor'', in relation to an in vitro embryo;

    (b) for the purposes of section 8, respecting the giving of consent for the use of human reproductive material or an in vitro embryo or for the removal of human reproductive material;

    (c) for the purposes of sections 10 and 11, designating controlled activities or classes of controlled activities that may be authorized by a licence;

    (d) for the purposes of section 11, specifying parts or proportions of the human genome, and parts of the genome of any species;

    (e) for the purposes of subsection 12(1), respecting the reasonable expenditures that may be reimbursed under a licence;

    (e.1) for the purposes of subsection 12(3), respecting the reimbursement of a loss of income;

    (f) respecting the conduct of controlled activities or any class of controlled activities and the use of facilities and equipment in controlled activities;

    (g) respecting the number of children that may be created from the gametes of one donor through the application of assisted reproduction procedures;

    (h) respecting the terms and conditions of licences;

    (i) respecting the issuance of licences for clinical trials referred to in subsection 40(3) and the conduct of clinical trials, including the giving of consent by donors of human reproductive material or in vitro embryos and persons undergoing assisted reproduction procedures;

    (j) respecting the qualifications for licences for controlled activities or any class of controlled activities;

    (k) respecting the issuance, amendment, renewal, suspension, restoration and revocation of licences;

    (l) respecting the information to be provided in respect of applications for a licence or for the renewal or amendment of a licence;

    (m) respecting the identification and labelling of human reproductive materials and in vitro embryos used in controlled activities;

    (n) respecting the creation and maintenance of records by a licensee, and access to them by the Agency;

    (o) respecting the collection, use and disclosure of health reporting information, including the health reporting information collected under subsection 14(1) and disclosed under section 15;

    (p) respecting the counselling services referred to in paragraph 14(2)(b);

    (q) respecting the providing of information under paragraph 14(2)(d);

    (r) respecting the reporting to the Agency of information obtained by a licensee under this Act;

    (s) for the purposes of paragraph 15(2)(d) or 18(5)(b), specifying the provisions of any federal or provincial law;

    (s.1) respecting the notification of the Agency under subsection 15(3.1);

    (t) for the purposes of subsection 16(2) or (3), respecting the destruction of health reporting information, human reproductive material or in vitro embryos;

    (u) for the purposes of paragraph 18(6)(c), identifying professional licensing and disciplinary bodies;

    (v) prescribing the information to be made available under section 19 and the manner of its availability for inspection by the public;

    (w) for the purposes of subsection 46(1), specifying the qualifications of inspectors;

    (x) respecting the treatment and disposition of material or information seized under this Act or the Criminal Code;

    (y) for the purposes of subsection 51(1), prescribing the information and the time and manner of sending it;

    (z) for the purposes of subsection 54(2) or (3), defining ``responsible person'' and prescribing the manner of disposing of human reproductive material, an in vitro embryo, a foetus or any part of an in vitro embryo or foetus;

    (z.1) for the purposes of section 71, fixing a day; and

    (z.2) exempting controlled activities or classes of controlled activities, generally or in circumstances prescribed by the regulations, from the provisions of this Act, subject to any terms and conditions prescribed in the regulations.

Incorporation by reference

(2) The regulations may incorporate any document by reference, regardless of its source, either as it reads on a particular date or as it is amended from time to time.

Documents in one language

(3) Where a document that is available in both official languages has been incorporated by reference as amended from time to time, an amendment to one language version of that document is not incorporated until the corresponding amendment is made to the other language version.

Statutory Instruments Act

(4) A document does not become a regulation within the meaning of the Statutory Instruments Act merely because it is incorporated by reference.

Proposed regulations to be laid before Parliament

66. (1) Before a regulation is made under section 65, the Minister shall lay the proposed regulation before each House of Parliament.

Report by committee

(2) A proposed regulation that is laid before Parliament shall be referred to the appropriate committee of each House, as determined by the rules of that House, and the committee may review the proposed regulation and report its findings to the House.

Standing Committee on Health

(2.1) The committee of the House of Commons referred to in subsection (2) shall be the Standing Committee on Health or, in the event that there is not a Standing Committee on Health, the appropriate committee of the House.

Making of regulations

(3) A regulation may not be made before the earliest of

    (a) 30 sitting days after the proposed regulation is laid before Parliament,

    (b) 160 calendar days after the proposed regulation is laid before Parliament, and

    (c) the day after the appropriate committee of each House of Parliament has reported its findings with respect to the proposed regulation.

Explanation

(4) The Minister shall take into account any report of the committee of either House. If a regulation does not incorporate a recommendation of the committee of either House, the Minister shall lay before that House a statement of the reasons for not incorporating it.

Alteration

(5) A proposed regulation that has been laid before Parliament need not again be so laid prior to the making of the regulation, whether it has been altered or not.

Exceptions

67. (1) A regulation may be made without being laid before either House of Parliament if the Minister is of the opinion that

    (a) the changes made by the regulation to an existing regulation are so immaterial or insubstantial that section 66 should not apply in the circumstances; or

    (b) the regulation must be made immediately in order to protect the health or safety of any person.

Notice of opinion

(2) If a regulation is made without being laid before Parliament, the Minister shall lay before each House of Parliament a statement of the Minister's reasons.

EQUIVALENCY AGREEMENTS

Non-applicati on of provisions in a province

68. (1) The Governor in Council may, by order, declare that any or all of sections 10 to 16, 46 to 53 and 61 and any corresponding provisions of the regulations do not apply in a province, except in respect of Her Majesty in right of Canada, if the Minister and the government of that province agree in writing that there are law of the province in force that are equivalent to those sections and the correcponding provisions of the regulations.

Term of agreement

(2) An agreement made under subsection (1) shall be for a period of five years, or any shorter period agreed to by the parties, but may be renewed.

Protection of human health and safety

(3) An order under subsection (1) does not prevent the Agency from taking measures under section 44.

Adaptation of this Act

(4) Where an order has been made under subsection (1) in respect of a province, any person carrying on an activity in the province that would be a controlled activity under this Act shall obtain health reporting information in accordance with section 14 and disclose it under paragraph 15(2)(a) as if the person were a licensee under this Act, and sections 17 and 18 apply in respect of that health reporting information.

Transitional

(5) When provisions of this Act cease to apply in a province by virtue of this section, a licence issued in respect of a person or premises in the province continues in effect in that province as if it were issued under provincial law.

Termination of agreement

69. (1) An agreement referred to in section 68 may be terminated by either party giving to the other at least six months written notice of termination.

Revocation of order

(2) The Governor in Council may, by order, on the recommendation of the Minister, repeal an order made under section 68 if an agreement referred to in that subsection is terminated.

Transitional

(3) When provisions of this Act become applicable in a province by virtue of subsection (2), a licence issued under the provincial law in respect of a person or premises in the province continues in effect in that province as if it were issued under this Act, unless otherwise provided by the provincial law.

PARLIAMENTARY REVIEW

Parliamentary review of Act

70. (1) The administration of this Act shall, within three years after the coming into force of section 21, be reviewed by any committee of the Senate, the House of Commons or both Houses of Parliament that may be designated or established for that purpose.

Report and recommendati ons

(2) The committee shall undertake a comprehensive review of the provisions and operation of this Act and shall, within a year after the review is undertaken or within such further time as the Senate, the House of Commons or both Houses of Parliament may authorize, submit its report on the review including a statement of any changes to this Act or its administration that the committee recommends.

TRANSITIONAL PROVISION

Grandfathered activities

71. Notwithstanding sections 10 to 13, a person who undertakes a controlled activity at least once during the period of one year preceding the coming into force of those sections may subsequently, without a licence, undertake the controlled activity and use any premises required for that purpose until a day fixed by the regulations.

CONSEQUENTIAL AMENDMENTS

R.S., c. A-1

Access to Information Act

72. Schedule I to the Access to Information Act is amended by adding the following in alphabetical order under the heading ``Other Government Institutions'':

Assisted Human Reproduction Agency of Canada

    Agence canadienne de contrôle de la procréation assistée

73. Schedule II to the Act is amended by adding the following in alphabetical order:

Assisted Human Reproduction Act

    Loi sur la procréation assistée

and by adding a corresponding reference to ``subsection 18(2)''.

R.S., c. F-11

Financial Administration Act

74. Schedule II to the Financial Administration Act is amended by adding the following in alphabetical order:

Assisted Human Reproduction Agency of Canada

    Agence canadienne de contrôle de la procréation assistée

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