Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
Short Title Changed
This Act may be cited as the Assisted Human Reproduction Act.
Principles Changed
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.
Interpretation and Application Changed
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Agency[Repealed, 2012, c. 19, s. 713]
assisted reproduction procedure[Repealed, 2012, c. 19, s. 713]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consent[Repealed, 2012, c. 19, s. 713]
controlled activity[Repealed, 2012, c. 19, s. 713]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]
the custody of donated human reproductive materials and in vitro embryos and the uses that are made of them.
the identity, personal characteristics, genetic information and medical history of donors of human reproductive material and in vitro embryos, persons who have undergone assisted reproduction procedures and persons who were conceived by means of those procedures; and
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.
Prohibited Activities Changed
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]
species means any taxonomic classification of non-human life.
human genome means the totality of the deoxyribonucleic acid sequence of the human species.
The following definitions apply in this section.
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.
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]
in accordance with the regulations, provide the person with the information that the Agency makes available to the public under paragraph 19(i).
obtain the written consent of the person to the application of the requirements referred to in paragraph (a); and
to the extent required by the regulations, make counselling services available to the person and ensure that the person receives them;
the retention, use, disclosure and destruction of the health reporting information;
the retention, use, provision to other persons and destruction of the human reproductive material or in vitro embryo, or
inform the person in writing of the requirements of this Act respecting, as the case may be,
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 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.
[Repealed before coming into force, 2012, c. 19, s. 720]
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.
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.
A licensee who transfers an in vitro embryo to another licensee shall notify the Agency of the transfer in accordance with the regulations.
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.
to the extent required by the provisions of any federal or provincial law respecting health and safety that are specified in the regulations.
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
to the extent required for the administration of a health care insurance plan within the meaning of the Canada Health Act;
to the Agency, to the extent required by the regulations;
A licensee shall disclose health reporting information
in accordance with subsections (2) to (5).
with the written consent of the person to whom the information relates allowing its disclosure for that purpose; or
No licensee shall disclose health reporting information for any purpose except
[Repealed before coming into force, 2012, c. 19, s. 720]
a court, body or person referred to in paragraph 15(2)(c).
government institutions subject to the Privacy Act or the National Archives of Canada Act; or
This section does not apply to
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.
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.
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.
require that a notation be attached to that information reflecting any correction that was requested but was not made; and
request the correction of the information if they believe there is an error or omission in that information;
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
[Repealed before coming into force, 2012, c. 19, s. 720]
[Repealed before coming into force, 2012, c. 19, s. 720]
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.
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.
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.
to the extent required for the administration of a health care insurance plan within the meaning of the Canada Health Act; and
for the purposes of the enforcement of this Act;
The Agency may disclose health reporting information
to the extent required by provisions of any federal or provincial law respecting health and safety that are specified in the regulations.
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
The Agency shall disclose health reporting information
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.
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.
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.
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.
[Repealed before coming into force, 2012, c. 19, s. 720]
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.
agreements entered into under section 68; and
agreements entered into under section 58;
the enforcement of this Act;
measures taken under section 44;
aggregated outcomes of assisted reproduction procedures performed by licensees;
the names and addresses of licensees;
decisions of the Agency arising from any proceedings respecting licences;
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;
notices of proceedings in respect of the issuance, amendment, renewal, suspension, restoration or revocation of licences;
applications for, and amendments or renewals of, licences;
licences issued by the Agency;
the by-laws of the Agency;
this Act, the regulations under this Act and policy directions under section 25;
Responsibility of Minister Changed
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]
The Official Languages Act applies to the Agency.
The head office of the Agency shall be at a place in Canada designated by the Governor in Council.
The Assisted Human Reproduction Agency of Canada is hereby established as a body corporate that may exercise powers and perform duties only as an agent of Her Majesty in right of Canada.
[Repealed, 2012, c. 19, s. 722]
to foster the application of ethical principles,
to protect and promote the health and safety, and the human dignity and human rights, of Canadians, and
[Repealed, 2012, c. 19, s. 722]
[Repealed, 2012, c. 19, s. 722]
information concerning the general administration and management of the Agency's affairs.
health reporting information, other than the identity of any person — or information that can reasonably be expected to be used in the identification of any person; and
advice on issues pertaining to assisted human reproduction and other matters that the Minister considers appropriate;
On request by the Minister, the Agency shall provide
do anything that is reasonably necessary or incidental to achieving the Agency's objectives.
designate inspectors and analysts for the enforcement of this Act; and
provide information to the public and to the professions respecting assisted human reproduction and other matters to which this Act applies, and their regulation under this Act, and respecting risk factors associated with infertility;
collect, analyse and manage health reporting information relating to controlled activities;
consult persons and organizations within Canada and internationally;
monitor and evaluate developments within Canada and internationally in assisted human reproduction and other matters to which this Act applies;
provide advice to the Minister on assisted human reproduction and other matters to which this Act applies;
exercise the powers in relation to licences under this Act;
The Agency may
[Repealed, 2012, c. 19, s. 722]
Policy directions issued by the Minister are not a statutory instrument for the purposes of the Statutory Instruments Act.
Policy directions issued by the Minister may not affect a matter that is before the Agency at the time they are issued and that relates to a particular person.
The Minister may issue policy directions to the Agency concerning the exercise of any of its powers, and the Agency shall give effect to directions so issued.
[Repealed, 2012, c. 19, s. 722]
A person is not eligible to be a member of the board of directors if they hold a licence or are an applicant for a licence or a director, officer, shareholder or partner of a licensee or applicant for a licence.
Subsections (3) to (6) do not apply to the Chairperson or the President.
If no successor is appointed to take office on the expiry of a member's term of appointment, the member continues in office until a successor is appointed.
A member of the board shall be appointed to hold office during pleasure, and is eligible for reappointment.
A member of the board shall be appointed by the Governor in Council for a term not exceeding three years. Each initial member of the board shall be appointed to hold office for a term that will ensure, so far as possible, the expiry in any one year of the terms of office of not more than one third of the members.
The members of the board of directors shall perform their duties and functions on a part-time basis.
The membership of the board of directors must reflect a range of backgrounds and disciplines relevant to the Agency's objectives.
There shall be a board of directors of the Agency consisting of not more than 12 members, including a Chairperson and the President of the Agency.
[Repealed, 2012, c. 19, s. 722]
[Repealed, 2012, c. 19, s. 722]
[Repealed, 2012, c. 19, s. 722]
is entitled to be reimbursed for reasonable travel and living expenses incurred by the member in the course of performing their duties while absent from their ordinary place of residence.
is deemed to be employed in the public service of Canada for the purposes of the Government Employees Compensation Act and the regulations made under section 9 of the Aeronautics Act; and
shall be paid the remuneration fixed by the Governor in Council for attendance at meetings of the board of directors or any of its committees or for the performance of other duties;
[Repealed, 2012, c. 19, s. 722]
the evaluation of the Agency's performance.
the approval of the Agency's budget; and
the approval of the Agency's goals and operational policies;
the provision of advice to the Minister on assisted human reproduction and other matters to which this Act applies, or on any matter referred to the Agency by the Minister;
[Repealed, 2012, c. 19, s. 722]
[Repealed, 2012, c. 19, s. 722]
The board of directors may not delegate its powers under section 40, 41 or 42 or any of its powers or duties with respect to the provision of advice to the Minister, the approval of the Agency's goals and operational policies, the approval of its budget and the making of by-laws.
Subject to subsection (2), the board of directors may, by by-law, delegate any of the Agency's powers and duties to a committee of the board or the President, including powers and duties under sections 44, 46, 52, 54, 55, 58, 59 and 64.
[Repealed, 2012, c. 19, s. 722]
Members of an advisory panel who are not members of the board may be paid remuneration for their services as fixed by the Agency's by-laws.
A by-law establishing an advisory panel may provide for the inclusion of persons who are not members of the board.
The board of directors may, by by-law, establish advisory panels to examine, report on and make recommendations with respect to any issue referred to the panels by the board.
[Repealed, 2012, c. 19, s. 722]
The Chairperson shall preside at meetings of the board of directors, and may exercise the powers and shall perform the duties assigned by the Agency's by-laws.
The Chairperson of the board of directors shall be appointed by the Governor in Council to hold office during pleasure for a term of not more than three years, and is eligible for reappointment.
[Repealed, 2012, c. 19, s. 722]
In the event of the absence or incapacity of the Chairperson or a vacancy in that office, the Vice-Chairperson may exercise the powers and shall perform the duties of the Chairperson.
The board of directors shall elect one of its members to be Vice-Chairperson.
[Repealed, 2012, c. 19, s. 722]
In the event of the absence or incapacity of the President or a vacancy in that office, the board of directors may authorize an officer of the Agency to act as President, but no person may act as President for a period exceeding 90 days without the approval of the Governor in Council.
The President may delegate to any officer of the Agency any power conferred or duty imposed on the President by or under this or any other Act.
The President is the chief executive officer of the Agency and has supervision over and direction of the work and staff of the Agency, and may exercise the powers and shall perform the duties assigned by the Agency's by-laws.
The President of the Agency shall be appointed by the Governor in Council to hold office during pleasure for a term of not more than five years, and is eligible for reappointment.
[Repealed, 2012, c. 19, s. 722]
is entitled to be reimbursed for reasonable travel and living expenses incurred by the President in the course of performing duties while absent from the President's ordinary place of work.
shall be paid the remuneration fixed by the Governor in Council; and
[Repealed, 2012, c. 19, s. 722]
[Repealed, 2012, c. 19, s. 722]
Actions, suits or other legal proceedings in respect of any right or obligation acquired or incurred by the Agency, whether in its own name or in the name of Her Majesty in right of Canada, may be brought or taken by or against the Agency in the name of the Agency in any court that would have jurisdiction if the Agency were not an agent of Her Majesty.
Property acquired by the Agency is property of Her Majesty in right of Canada, and title to it may be held in the Agency's name or in Her Majesty's name.
The Agency may enter into contracts, agreements, memoranda of understanding and other arrangements with a department or agency of the Government of Canada, with any other government or any of its agencies or with any person or organization, either in its own name or in the name of Her Majesty in right of Canada.
Administration and Enforcement Changed
[Repealed before coming into force, 2012, c. 19, s. 724]
The Agency may not apply a policy of cost recovery to the issuance of licences.
The Agency may, in accordance with the regulations, attach terms and conditions to a licence at the time of issuing the licence or at any time after that.
The Agency may, in accordance with the regulations, issue a licence to the owner or operator of any premises permitting the use of those premises for a controlled activity undertaken by persons to whom a licence has been issued under subsection (1).
If a person to whom a licence is issued is not an individual, the licence must designate an individual as the person responsible for compliance with this Act, but that designation does not affect the responsibility of the licensee or any other individual under this Act.
The Agency shall not issue a licence under subsection (1) for embryonic stem cell research unless it has received the written consent of the original gamete providers and the embryo provider in accordance with the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002, as specified in the regulations.
The number of licences that the Agency considers sufficient may be issued in respect of clinical trials of a controlled activity.
A licence authorizing the use of an in vitro embryo for the purpose of research may be issued only if the Agency is satisfied that the use is necessary for the purpose of the proposed research.
The Agency may, in accordance with the regulations, issue a licence to any person having the qualifications provided under the regulations, authorizing the person to undertake any controlled activity specified in the licence.
[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]
No civil or criminal proceedings may be brought against any person for offering information and observations in good faith under subsection (1).
The identity of — or information that can reasonably be expected to be used in the identification of — 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 may not be disclosed except to an applicant or licensee who, in the Agency's opinion, requires the information to support an application.
Subject to subsection (3), the Agency shall, on request, disclose the information and observations provided under subsection (1) unless the disclosure would, in the Agency's opinion, pose a risk to the health or safety of any person.
In exercising its powers under sections 40 to 42, the Agency may take into account information and observations offered by any person and may seek the advice of persons having expertise related to the application or of persons representative of any interest affected by the application.
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.
Any costs incurred by an inspector acting under this section shall be borne by the person who holds the licence in respect of the controlled activity or premises and, until paid, those costs are recoverable in any court of competent jurisdiction as a debt due to Her Majesty in right of Canada.
For the purposes of taking measures referred to in subsection (1), the Agency may authorize an inspector designated under section 46 to enter the premises where the controlled activity is being undertaken and to assume the management of those premises and that activity.
[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 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,
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.
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.
If a donor or responsible person does not provide consent under subsection (2), the Agency may return the material to the donor or responsible person or may dispose of it in the manner prescribed by the regulations.
it is disposed of in the manner prescribed by the regulations, if the Agency is not reasonably able to identify or to contact the donor or responsible person.
the Agency has obtained the consent of the donor, in the case of human reproductive material, or the consent of the responsible person as defined in the regulations, in any other case; or
The Agency may not dispose of human reproductive material, an in vitro embryo, a foetus or any part of an in vitro embryo or foetus unless
The Agency shall make reasonable efforts to preserve any viable sperm, ovum or in vitro embryo that is seized under this Act or the Criminal Code pending its disposition.
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]
Offences Changed
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
is liable, on summary conviction, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding four years, or to both.
A person who contravenes any provision of this Act — other than any of sections 5 to 7 and 9 — or of the regulations or an order made under subsection 44(1) is guilty of an offence and
is liable, on conviction on indictment, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding five years, or to both; or
is liable, on summary conviction, to a fine not exceeding $100,000 or to imprisonment for a term not exceeding two years, or to both.
A court that imposes a fine or term of imprisonment on a person in respect of an offence under this Act may
order the forfeiture and disposition, subject to section 54, of any material or information by means of which or in relation to which the offence was committed; or
on application by the Attorney General of Canada, order the person not to engage in any activity that, in the court’s opinion, may lead to the commission of an offence under this Act.
A prosecution for an offence under this Act may not be instituted except with the consent of the Attorney General of Canada.
The Minister may notify any interested authority, such as a professional licensing or disciplinary body established under the laws of Canada or a province, of the identity of a person who is charged with an offence under this Act or who there are reasonable grounds to believe may have acted in breach of any professional code of conduct.
Regulations Changed
The Governor in Council may make regulations for carrying into effect the purposes and provisions of this Act and, in particular, may make regulations
defining donor, in relation to an in vitro embryo;
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;
respecting the tests to be conducted in respect of sperm and ova described in any of paragraphs 10(2)(a) to (c), and the obtaining, preparation, preservation, quarantining, identification, labelling and storage of, and the assessment of the quality of, the sperm and ova;
respecting the testing and screening of, and the assessment of the suitability of, donors described in paragraph 10(3)(b);
respecting the disposition of sperm and ova described in any of paragraphs 10(2)(a) to (c);
respecting the tracing of sperm and ova described in any of paragraphs 10(2)(a) to (c), including regulations that require
measures to be taken to identify persons who have distributed, made use of or imported the sperm or ova for the purpose of assisted human reproduction, or who are storing any of them for that purpose,
the communication of information to the persons referred to in subparagraph (i), to the donors of the sperm and ova and to the persons who have undergone assisted human reproduction procedures in which the sperm or ova were used,
measures to be taken to determine the nature, cause and extent of the risks to human health and safety, and
measures to be taken in respect of the sperm and ova to reduce those risks;
respecting the reporting to the Minister of information with respect to an activity described in section 10;
respecting the reimbursement of expenditures for the purposes of subsection 12(1), including providing for the expenditures that may be reimbursed;
for the purposes of subsection 12(3), respecting the reimbursement of a loss of income;
for the purposes of subsection 46(1), specifying the qualifications of inspectors;
prescribing the information to be made available under section 19 and the manner of its availability for inspection by the public;
for the purposes of paragraph 18(6)(c), identifying professional licensing and disciplinary bodies;
for the purposes of subsection 16(2) or (3), respecting the destruction of health reporting information, human reproductive material or in vitro embryos;
respecting the notification of the Agency under subsection 15(3.1);
for the purposes of paragraph 15(2)(d) or 18(5)(b), specifying the provisions of any federal or provincial law;
respecting the providing of information under paragraph 14(2)(d);
respecting the counselling services referred to in paragraph 14(2)(b);
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;
respecting the identification and labelling of human reproductive materials and in vitro embryos used in controlled activities;
respecting the information to be provided in respect of applications for a licence or for the renewal or amendment of a licence;
respecting the issuance, amendment, renewal, suspension, restoration and revocation of licences;
respecting the qualifications for licences for controlled activities or any class of controlled activities;
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;
respecting the terms and conditions of licences;
respecting the number of children that may be created from the gametes of one donor through the application of assisted reproduction procedures;
respecting the conduct of controlled activities or any class of controlled activities and the use of facilities and equipment in controlled activities;
[Repealed, 2012, c. 19, s. 737]
respecting the creation and maintenance of records by any person who
engages in an activity for which written consent is required under section 8,
engages in an activity described in section 10, or
makes a reimbursement under section 12;
[Repealed, 2012, c. 19, s. 737]
authorizing the Minister, in the manner set out in the regulations, to require any person described in paragraph (n) to provide to the Minister any records that the person is required by the regulations to create or maintain, and any additional information related to the activity described in subparagraph (n)(i), (ii) or (iii), and requiring that person to provide to the Minister those records and that information within the time and in the manner set out in the regulations;
[Repealed, 2012, c. 19, s. 737]
respecting the treatment and disposition of material or information seized under this Act or the Criminal Code;
for the purposes of subsection 51(1), prescribing the information to be contained in the notice and the time and manner of sending it;
respecting the further measures referred to in section 54;
respecting the giving of consent for the purposes of section 54;
defining designated officer for the purposes of subsection 52(3) and section 54;
exempting any person from the application of section 10, conditionally or unconditionally, in the circumstances provided for in the regulations; and
exempting from the application of subsection 12(2), conditionally or unconditionally, in the circumstances provided for in the regulations, any person who reimburses expenditures referred to in the regulations.
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.
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.
A document does not become a regulation within the meaning of the Statutory Instruments Act merely because it is incorporated by reference.
Before a regulation is made under section 65, the Minister shall lay the proposed regulation before each House of Parliament.
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.
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.
A regulation may not be made before the earliest of
30 sitting days after the proposed regulation is laid before Parliament,
160 calendar days after the proposed regulation is laid before Parliament, and
the day after the appropriate committee of each House of Parliament has reported its findings with respect to the proposed regulation.
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.
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.
A regulation may be made without being laid before either House of Parliament if the Minister is of the opinion that
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
the regulation must be made immediately in order to protect the health or safety of any person.
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.
[Repealed, 2012, c. 19, s. 738]
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.
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.
An order under subsection (1) does not prevent the Agency from taking measures under section 44.
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.
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 corresponding provisions of the regulations.
[Repealed, 2012, c. 19, s. 738]
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.
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.
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.
[Repealed, 2012, c. 19, s. 738]
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.
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.
[Repealed, 2012, c. 19, s. 738]
Consequential Amendments Changed
Access to Information Act Changed
[Amendment]
[Amendment]
Financial Administration Act Changed
[Amendment]
Privacy Act Changed
[Amendment]
[Repealed before coming into force, 2012, c. 19, s. 739]
Public Service Superannuation Act Changed
[Amendment]
Coming into Force Changed
The provisions of this Act come into force on a day or days to be fixed by order of the Governor in Council.[Note: Act, other than sections 8, 12, 14 to 19, 21 to 59, 72 and 74 to 77, in force April 22, 2004, see SI/2004-49; sections 21 to 24, other than paragraphs 24(1)(a), (e) and (g), sections 25 to 39, 72, 74, 75 and 77 in force January 12, 2006, see SI/2005-42; section 8 in force December 1, 2007, see SI/2007-67; section 44 in force June 29, 2012, see 2012, c. 19, s. 740; sections 45 to 58 in force June 9, 2019, section 12 in force June 9, 2020, see SI/2019-38.]
Provisions not in the current consolidation
28 provisions mirrored on this date are not in the current consolidation; they could not be placed in document order.
Access to Information Act
Administration
Administration and Enforcement
Assisted Human Reproduction Agency of Canada
Coming into Force
Consequential Amendments
Controlled Activities
Equivalency Agreements
Financial Administration Act
Inspection and Enforcement
Interpretation and Application
Offences
Parliamentary Review
Principles
Privacy Act
Privacy and Access to Information
Prohibited Activities
Public Service Staff Relations Act
Public Service Superannuation Act
Regulations
Responsibility of Minister
Short Title
Transitional Provision
Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
in relation to assisted human reproduction and other matters to which this Act applies.
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.
RELATED PROVISIONS