Assisted Human Reproduction Act

This Act may be cited as the Assisted Human Reproduction Act.

The Parliament of Canada recognizes and declares that

the health and well-being of children born through the application of assisted human reproductive technologies must be given priority in all decisions respecting their use;

the benefits of assisted human reproductive technologies and related research for individuals, for families and for society in general can be most effectively secured by taking appropriate measures for the protection and promotion of human health, safety, dignity and rights in the use of these technologies and in related research;

while all persons are affected by these technologies, women more than men are directly and significantly affected by their application and the health and well-being of women must be protected in the application of these technologies;

the principle of free and informed consent must be promoted and applied as a fundamental condition of the use of human reproductive technologies;

persons who seek to undergo assisted reproduction procedures must not be discriminated against, including on the basis of their sexual orientation or marital status;

trade in the reproductive capabilities of women and men and the exploitation of children, women and men for commercial ends raise health and ethical concerns that justify their prohibition; and

human individuality and diversity, and the integrity of the human genome, must be preserved and protected.

The following definitions apply in this Act.

Agency[Repealed, 2012, c. 19, s. 713]

assisted reproduction procedure[Repealed, 2012, c. 19, s. 713]

chimera means

an embryo into which a cell of any non-human life form has been introduced; or

an embryo that consists of cells of more than one embryo, foetus or human being. (chimère)

consent[Repealed, 2012, c. 19, s. 713]

controlled activity[Repealed, 2012, c. 19, s. 713]

donor means

in relation to human reproductive material, the individual from whose body it was obtained, whether for consideration or not; and

in relation to an in vitro embryo, a donor as defined in the regulations. (donneur)

embryo means a human organism during the first 56 days of its development following fertilization or creation, excluding any time during which its development has been suspended, and includes any cell derived from such an organism that is used for the purpose of creating a human being. (embryon)

foetus means a human organism during the period of its development beginning on the fifty-seventh day following fertilization or creation, excluding any time during which its development has been suspended, and ending at birth. (foetus)

gene includes a nucleotide sequence, and an artificially created gene or nucleotide sequence. (gène)

genome means the totality of the deoxyribonucleic acid sequence of a particular cell. (génome)

health reporting information[Repealed, 2012, c. 19, s. 713]

human clone means an embryo that, as a result of the manipulation of human reproductive material or an in vitro embryo, contains a diploid set of chromosomes obtained from a single — living or deceased — human being, foetus or embryo. (clone humain)

human reproductive material means a sperm, ovum or other human cell or a human gene, and includes a part of any of them. (matériel reproductif humain)

hybrid means

a human ovum that has been fertilized by a sperm of a non-human life form;

an ovum of a non-human life form that has been fertilized by a human sperm;

a human ovum into which the nucleus of a cell of a non-human life form has been introduced;

an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or

a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form. (hybride)

in vitro embryo means an embryo that exists outside the body of a human being. (embryon in vitro)

licence[Repealed, 2012, c. 19, s. 713]

Minister means the Minister of Health. (ministre)

ovum means a human ovum, whether mature or not. (ovule)

sperm means a human sperm, whether mature or not. (spermatozoïde)

surrogate mother means a female person who — with the intention of surrendering the child at birth to a donor or another person — carries an embryo or foetus that was conceived by means of an assisted reproduction procedure and derived from the genes of a donor or donors. (mère porteuse)

This Act is binding on Her Majesty in right of Canada or a province.

The Human Pathogens and Toxins Act does not apply in respect of sperm, ova and in vitro embryos to be used for the purpose of assisted human reproduction.

The Food and Drugs Act does not apply in respect of sperm and ova to be used for the purpose of assisted human reproduction.

No person shall knowingly

create a human clone by using any technique, or transplant a human clone into a human being or into any non-human life form or artificial device;

create an in vitro embryo for any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures;

for the purpose of creating a human being, create an embryo from a cell or part of a cell taken from an embryo or foetus or transplant an embryo so created into a human being;

maintain an embryo outside the body of a female person after the fourteenth day of its development following fertilization or creation, excluding any time during which its development has been suspended;

for the purpose of creating a human being, perform any procedure or provide, prescribe or administer any thing that would ensure or increase the probability that an embryo will be of a particular sex, or that would identify the sex of an in vitro embryo, except to prevent, diagnose or treat a sex-linked disorder or disease;

alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants;

transplant a sperm, ovum, embryo or foetus of a non-human life form into a human being;

for the purpose of creating a human being, make use of any human reproductive material or an in vitro embryo that is or was transplanted into a non-human life form;

create a chimera, or transplant a chimera into either a human being or a non-human life form; or

create a hybrid for the purpose of reproduction, or transplant a hybrid into either a human being or a non-human life form.

No person shall offer to do, or advertise the doing of, anything prohibited by this section.

No person shall pay or offer to pay consideration to any person for doing anything prohibited by this section.

No person shall pay consideration to a female person to be a surrogate mother, offer to pay such consideration or advertise that it will be paid.

No person shall accept consideration for arranging for the services of a surrogate mother, offer to make such an arrangement for consideration or advertise the arranging of such services.

No person shall pay consideration to another person to arrange for the services of a surrogate mother, offer to pay such consideration or advertise the payment of it.

No person shall counsel or induce a female person to become a surrogate mother, or perform any medical procedure to assist a female person to become a surrogate mother, knowing or having reason to believe that the female person is under 21 years of age.

This section does not affect the validity under provincial law of any agreement under which a person agrees to be a surrogate mother.

No person shall purchase, offer to purchase or advertise for the purchase of sperm or ova from a donor or a person acting on behalf of a donor.

No person shall

purchase, offer to purchase or advertise for the purchase of an in vitro embryo; or

sell, offer for sale or advertise for sale an in vitro embryo.

No person shall purchase, offer to purchase or advertise for the purchase of a human cell or gene from a donor or a person acting on behalf of a donor, with the intention of using the gene or cell to create a human being or of making it available for that purpose.

In this section, “purchase” or “sell” includes to acquire or dispose of in exchange for property or services.

No person shall make use of human reproductive material for the purpose of creating an embryo unless the donor of the material has given written consent, in accordance with the regulations, to its use for that purpose.

No person shall remove human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo unless the donor of the material has given written consent, in accordance with the regulations, to its removal for that purpose.

No person shall make use of an in vitro embryo for any purpose unless the donor has given written consent, in accordance with the regulations, to its use for that purpose.

No person shall obtain any sperm or ovum from a donor under 18 years of age, or use any sperm or ovum so obtained, except for the purpose of preserving the sperm or ovum or for the purpose of creating a human being that the person reasonably believes will be raised by the donor.

The purpose of this section is to reduce the risks to human health and safety arising from the use of sperm or ova for the purpose of assisted human reproduction, including the risk of the transmission of disease.

Subject to subsection (3), no person shall distribute, make use of or import any of the following for the purpose of assisted human reproduction:

sperm that has been obtained from a donor and that is meant for the use of a female person other than a spouse, common-law partner or sexual partner of the donor;

an ovum that has been obtained from a donor and that is meant for the use of a female person other than the donor or the spouse, common-law partner or sexual partner of the donor; or

an ovum that has been obtained from a donor and that is meant for the donor’s use as a surrogate mother.

Subsection (2) does not apply if

tests have been conducted in respect of the sperm or ovum in accordance with the regulations, and the sperm or ovum has been obtained, prepared, preserved, quarantined, identified, labelled and stored and its quality assessed in accordance with the regulations; and

the donor of the sperm or ovum has been screened and tested, and the donor’s suitability has been assessed, in accordance with the regulations.

No person shall, except in accordance with the regulations, engage in any activity described in paragraph (3)(a) or (b) in respect of any of the following with the intention of distributing or making use of it for the purpose of assisted human reproduction:

sperm described in paragraph (2)(a);

an ovum described in paragraph (2)(b); or

an ovum described in paragraph (2)(c).

In this section, common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship at the relevant time, having so cohabited for a period of at least one year.

[Repealed, 2012, c. 19, s. 718]

No person shall, except in accordance with the regulations,

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

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

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

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

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

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

the reimbursement is made in accordance with the regulations.

[Repealed, 2012, c. 19, s. 720]

[Repealed before coming into force, 2012, c. 19, s. 720]

[Repealed before coming into force, 2012, c. 19, s. 720]

[Repealed before coming into force, 2012, c. 19, s. 720]

[Repealed before coming into force, 2012, c. 19, s. 720]

[Repealed before coming into force, 2012, c. 19, s. 720]

[Repealed before coming into force, 2012, c. 19, s. 720]

The Minister is responsible for the policy of the Government of Canada respecting assisted human reproduction and any other matter that, in the opinion of the Minister, relates to the subject-matter of this Act.

[Repealed, 2012, c. 19, s. 721]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed, 2012, c. 19, s. 722]

[Repealed before coming into force, 2012, c. 19, s. 724]

[Repealed before coming into force, 2012, c. 19, s. 724]

[Repealed before coming into force, 2012, c. 19, s. 724]

[Repealed before coming into force, 2012, c. 19, s. 724]

If the Minister has reasonable grounds to believe that this Act has been, or is likely to be, contravened, the Minister may take, or order any person to take, all reasonable measures that the Minister considers necessary to mitigate the effects of the contravention or to prevent the contravention.

[Repealed, 2012, c. 19, s. 725]

No person who takes measures under this section, or who takes measures specified in an order made under this section, is personally liable either civilly or criminally in respect of any act or omission in the course of taking those measures unless it is established that the person acted in bad faith.

Subsection (4) does not apply to a person who has committed a contravention of this Act.

For greater certainty, orders made under this section are not statutory instruments within the meaning of the Statutory Instruments Act.

The following definitions apply in sections 47 to 62 and 65.

information means information that is recorded in any form. (document)

material means an embryo or part of one, a foetus or part of one or any human reproductive material outside the body of a human being, or any other thing. (matériel)

The Minister may designate persons or classes of persons employed by the government of Canada or of a province as inspectors for the purposes of the administration and enforcement of this Act.

An inspector shall be given a certificate in a form established by the Minister attesting to the inspector’s designation and, on entering any place or conveyance under subsection 47(1), the inspector shall, if so required, produce the certificate to the person in charge of that place or conveyance.

Subject to section 48, an inspector may, for a purpose related to verifying compliance or preventing non-compliance with any of sections 8, 10 and 12, enter any place or conveyance in which the inspector has reasonable grounds to believe that there is any activity, material or information in respect of which any of those sections applies.

An inspector entering a place or conveyance may, for a purpose set out in subsection (1),

examine any material or information that is relevant to that purpose;

require any person in the place or conveyance to produce, in the manner and form requested by the inspector, any such material or information;

open and examine any receptacle or package that the inspector believes on reasonable grounds contains such material or information;

take, or require any person in the place or conveyance to produce, a sample of such material; and

conduct any test or analysis or take any measurement of such material.

In carrying out an inspection, an inspector may, for a purpose set out in subsection (1),

examine and make copies of or extracts from any books, documents or other records that the inspector believes on reasonable grounds contain information that is relevant to that purpose;

require any person to produce such books, documents or other records for examination or copying;

use or cause to be used any computer system to examine information relevant to that purpose that is contained in or available to the computer system;

reproduce such information in the form of a printout or other intelligible output for examination or copying; and

use or cause to be used any copying equipment.

The owner or person in charge of a place entered by an inspector under subsection (1) and every person found in that place shall give the inspector all reasonable assistance and furnish them with any information that they may reasonably require.

Where a place referred to in subsection 47(1) is a dwelling-house, an inspector may not enter it without the consent of the occupant, except under the authority of a warrant issued under subsection (2).

If, on ex parte application, a justice of the peace is satisfied by information on oath that the justice of the peace may issue a warrant authorizing the inspector named in it to enter the dwelling-house, subject to any conditions that may be specified in the warrant.

the conditions for entry described in subsection 47(1) exist in relation to a dwelling-house,

entry to the dwelling-house is necessary for a purpose related to verifying compliance or preventing non-compliance with any of sections 8, 10 and 12, and

entry to the dwelling-house has been refused or there are reasonable grounds for believing that entry will be refused,

In executing a warrant issued under subsection (2), the inspector named in it shall not use force unless the inspector is accompanied by a peace officer and the use of force has been specifically authorized in the warrant.

No person shall obstruct or hinder, or knowingly make any false or misleading statement either orally or in writing to, an inspector engaged in carrying out duties under this Act.

Except with the authority of an inspector, no person shall remove, alter or interfere in any way with material or information seized under this Act.

An inspector who enters a place or conveyance under section 47 may seize any material or information by means of which, or in relation to which, the inspector believes on reasonable grounds this Act has been contravened.

An inspector may direct that seized material or information be kept or stored in the place where it was seized or be removed to any other proper place.

A person from whom material or information is seized may, within 60 days after the date of the seizure, apply to a provincial court judge within whose jurisdiction the seizure was made for an order of restoration, if the person sends to the Minister notice of their intention to do so.

The provincial court judge may order that seized material or information be restored immediately to the applicant if, on hearing the application, the judge is satisfied that

the applicant is entitled to possession of it; and

it will not be required as evidence in any proceedings under this Act.

If, on hearing an application, a provincial court judge is satisfied that the applicant is entitled to possession of seized material or information but is not satisfied as regards paragraph (2)(b), the judge may order that the material or information be restored to the applicant

on the expiry of 180 days after the date of the seizure if no proceedings under this Act have been commenced before that time; or

on the final conclusion of proceedings under this Act.

A provincial court judge may not make an order for the restoration of material or information if it has been forfeited by consent under subsection 52(2).

If no application is made under subsection 51(1) for the restoration of seized material or information within 60 days after the date of the seizure, or an application has been made but on the hearing of the application no order of restoration is made, the material or information is forfeited to Her Majesty.

Where an inspector has seized material or information and the owner or the person in whose possession it was at the time of the seizure consents in writing to its forfeiture, the material or information is forfeited to Her Majesty.

Subject to section 54, an inspector may dispose of material or information forfeited to Her Majesty in any manner that the designated officer, as defined in the regulations, directs.

An inspector is a public officer for the purposes of the application of section 487 of the Criminal Code in respect of an offence under this Act.

An inspector may exercise without a warrant any of the powers conferred by virtue of subsection (1) if the conditions for obtaining a warrant exist but, by reason of exigent circumstances, it would not be practicable to obtain a warrant.

The designated officer, as defined in the regulations, shall make reasonable efforts to preserve any viable sperm, ovum or in vitro embryo that is seized under this Act or the Criminal Code. Any further measures shall be consistent with the consent of the donor or, if the consent cannot be obtained, shall be in accordance with the regulations.

The Minister may designate any person as an analyst for the purpose of the administration and enforcement of this Act.

An inspector may submit to an analyst, for analysis or examination, any material or information seized by the inspector.

An analyst who has made an analysis or examination may issue a certificate or report setting out the results of the analysis or examination.

Subject to subsections (2) and (3), in any prosecution for an offence under this Act, a certificate purporting to be signed by an analyst, stating that any material or information has been analysed or examined by the analyst and stating the results of the analysis or examination, is admissible in evidence and, in the absence of evidence to the contrary, is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed it.

The party against whom a certificate of an analyst is produced under subsection (1) may, with leave of the court, require the attendance of the analyst for the purpose of cross-examination.

No certificate shall be admitted in evidence under subsection (1) unless, before the trial, the party intending to produce the certificate has given reasonable notice of that intention, together with a copy of the certificate, to the party against whom it is intended to be produced.

The Minister may enter into agreements with any department or agency of the government of Canada or of a province or with any law enforcement agency with respect to the administration and enforcement of this Act.

[Repealed before coming into force, 2012, c. 19, s. 733]

A person who contravenes any of sections 5 to 7 and 9 is guilty of an offence and

is liable, on conviction on indictment, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding ten years, or to both; or