Law:Assisted Human Reproduction Act

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S.c. 2004, c. 2

Assented to 2004-03-29

An Act respecting assisted human reproduction and related research

Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:


Contents

Short Title

Short title

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


Principles

Declaration

2. The Parliament of Canada recognizes and declares that

(a) 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;

(b) 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;

(c) 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;

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

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

(f) 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

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


Interpretation And Application

Definitions

3. The following definitions apply in this Act.

“Agency”

« Agence »

“Agency” means the Assisted Human Reproduction Agency of Canada established by subsection 21(1).

“assisted reproduction procedure”

« technique de procréation assistée »

“assisted reproduction procedure” means any controlled activity referred to in section 10 that is performed for the purpose of creating a human being.

“chimera”

« chimère »

“chimera” means

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

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

“consent”

« consentement »

“consent” means fully informed and freely given consent that is given in accordance with the applicable law governing consent and that conforms to the provisions of the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002, as detailed in the Regulations.

“controlled activity”

« activité réglementée »

“controlled activity” means an activity that may not be undertaken except in accordance with sections 10 to 12.

“donor”

« donneur »

“donor” means

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

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

“embryo”

« embryon »

“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.

“foetus”

« foetus »

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

“gene”

« gène »

“gene” includes a nucleotide sequence, and an artificially created gene or nucleotide sequence.

“genome”

« génome »

“genome” means the totality of the deoxyribonucleic acid sequence of a particular cell.

“health reporting information”

« renseignement médical »

“health reporting information” means information provided under this Act respecting

(a) 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

(b) the custody of donated human reproductive materials and in vitro embryos and the uses that are made of them.

“human clone”

« clone humain »

“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.

“human reproductive material”

« matériel reproductif humain »

“human reproductive material” means a sperm, ovum or other human cell or a human gene, and includes a part of any of them.

“hybrid”

« hybride »

“hybrid”means

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

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

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

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

(e) 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.

“in vitro embryo”

« embryon in vitro »

“in vitro embryo” means an embryo that exists outside the body of a human being.

“licence”

pan class="DefinedTermLink" lang="f« autorisation »

“licence” means a licence issued in respect of a controlled activity or premises under section 40.

“Minister”

« ministre »

“Minister” means the Minister of Health.

“ovum”

« ovule »

“ovum” means a human ovum, whether mature or not.

“sperm”

« spermatozoïde »

“sperm” means a human sperm, whether mature or not.

“surrogate mother”

« mère porteuse »

“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.

Her Majesty bound

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


Prohibited Activities

Prohibited procedures

5. (1) No person shall knowingly

(a) 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;

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

(c) 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;

(d) 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;

(e) 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;

(f) 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;

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

(h) 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;

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

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

Offers

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

Payment for prohibited act

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

Payment for surrogacy

6. (1) 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.

Acting as intermediary

(2) 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.

Payment to intermediaries

(3) 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.

Surrogate mother — minimum age

(4) 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.

Validity of agreement

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

Purchase of gametes

7. (1) 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.

Purchase or sale of embryos

(2) No person shall

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

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

Purchase of other reproductive material

(3) 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.

Exchanges included

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

Use of reproductive material without consent

8. (1) 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.

Posthumous use without consent

(2) 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.

Use of in vitro embryo without consent

(3) 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.

Gametes obtained from minor

9. 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.


Controlled Activities

Use of human reproductive material

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

Use of in vitro embryo

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

Keeping and handling gametes and embryos

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

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

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

Transgenics

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

Definitions

(2) The following definitions apply in this section.

“human genome”

« génome humain »

“human genome” means the totality of the deoxyribonucleic acid sequence of the human species.

“species”

« espèce »

“species” means any taxonomic classification of non-human life.

The following provision is not in force.Reimbursement of expenditures

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

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

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

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

Receipts

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

No reimbursement

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

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

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

Use of premises

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


Privacy And Access To Information

The following provision is not in force.Information to be collected by licensees

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

Requirements of this Act to be conveyed

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

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

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

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

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

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

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

The following provision is not in force.Disclosure of information restricted

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

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

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

Disclosure required

(2) A licensee shall disclose health reporting information

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

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

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

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

Transfers between licensees

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

Agency to be notified

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

Information to persons undergoing procedures

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

Research and statistics

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

The following provision is not in force.Access to health reporting information

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

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

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

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

Destruction of information

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

Destruction of reproductive material

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

Exception

(4) This section does not apply to

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

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

The following provision is not in force.Personal health information registry

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

The following provision is not in force.Use of information by Agency

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

Consent to disclosure

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

Disclosure to recipients of reproductive material

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

Relationship of individuals

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

Obligation to disclose

(5) The Agency shall disclose health reporting information

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

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

Discretion to disclose

(6) The Agency may disclose health reporting information

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

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

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

Disclosure to address health or safety risk

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

Research and statistics

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

The following provision is not in force.Information available from Agency

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

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

(b) the by-laws of the Agency;

(c) licences issued by the Agency;

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

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

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

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

(h) the names and addresses of licensees;

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

(j) measures taken under section 44;

(k) the enforcement of this Act;

(l) agreements entered into under section 58;

(m) agreements entered into under section 68; and

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


Responsibility Of Minister

Assisted human reproduction policy

20. (1) 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.

Agency

(2) The Minister is responsible for the Agency.


Assisted Human Reproduction Agency Of Canada

Agency established

21. (1) 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.

Head office

(2) The head office of the Agency shall be at a place in Canada designated by the Governor in Council.

Application of Official Languages Act

(3) The Official Languages Act applies to the Agency.

Objectives

22. The objectives of the Agency are

(a) to protect and promote the health and safety, and the human dignity and human rights, of Canadians, and

(b) to foster the application of ethical principles,

in relation to assisted human reproduction and other matters to which this Act applies.

Principles

23. The Agency shall exercise its powers in a manner consistent with the principles set out in section 2.

Powers of Agency

24. (1) The Agency may

The following provision is not in force.(a) exercise the powers in relation to licences under this Act;

(b) provide advice to the Minister on assisted human reproduction and other matters to which this Act applies;

(c) monitor and evaluate developments within Canada and internationally in assisted human reproduction and other matters to which this Act applies;

(d) consult persons and organizations within Canada and internationally;

The following provision is not in force.(e) collect, analyse and manage health reporting information relating to controlled activities;

(f) 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;

The following provision is not in force.(g) designate inspectors and analysts for the enforcement of this Act; and

(h) do anything that is reasonably necessary or incidental to achieving the Agency's objectives.

Advice to Minister

(2) On request by the Minister, the Agency shall provide

(a) advice on issues pertaining to assisted human reproduction and other matters that the Minister considers appropriate;

(b) 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

(c) information concerning the general administration and management of the Agency's affairs.

Policy directions

25. (1) 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.

Exception

(2) 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.

Statutory Instruments Act

(3) Policy directions issued by the Minister are not a statutory instrument for the purposes of the Statutory Instruments Act.

Board of directors

26. (1) There shall be a board of directors of the Agency consisting of not more than 13 members, including a Chairperson and the President of the Agency.

Appointment criteria

(2) The membership of the board of directors must reflect a range of backgrounds and disciplines relevant to the Agency's objectives.

Part-time service

(3) The members of the board of directors shall perform their duties and functions on a part-time basis.

Term of office

(4) 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.

Removal and reappointment

(5) A member of the board shall be appointed to hold office during pleasure, and is eligible for reappointment.

Continuation in office

(6) 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.

Provisions not applicable

(7) Subsections (3) to (6) do not apply to the Chairperson or the President.

Persons not eligible to be directors

(8) 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.

Meetings

27. The board of directors may determine the times and the places in Canada of its meetings, but it shall meet at least twice a year.

Participation of deputy ministers

28. The Deputy Minister of Health, or an alternate designated by the Deputy Minister of Health, and a person nominated by the deputy ministers of the departments responsible for health in the provinces from among their number, or an alternate so nominated, are entitled to attend meetings of the board of directors and speak to any matter under consideration at the meeting.

Members of the board

29. Each member of the board of directors, except the President of the Agency,

(a) 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;

(b) 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

(c) 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.

Management of Agency

30. The board of directors is responsible for the overall management of the Agency, including

(a) 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;

(b) the approval of the Agency's goals and operational policies;

(c) the approval of the Agency's budget; and

(d) the evaluation of the Agency's performance.

By-laws

31. The board of directors may, with the approval of the Governor in Council, make by-laws for the regulation of its proceedings and generally for the conduct of its activities.

Delegation

32. (1) 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.

Exceptions

(2) 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.

Advisory panels

33. (1) 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.

Outside members

(2) A by-law establishing an advisory panel may provide for the inclusion of persons who are not members of the board.

Fees

(3) 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.

Appointment of Chairperson

34. (1) 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.

Functions of Chairperson

(2) 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.

Election of Vice-Chairperson

35. (1) The board of directors shall elect one of its members to be Vice-Chairperson.

Replacing Chairperson

(2) 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.

Appointment of President

36. (1) 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.

Chief executive officer

(2) 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.

Delegation

(3) 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.

Acting President

(4) 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.

President's pay and benefits

37. The President

(a) shall be paid the remuneration fixed by the Governor in Council; and

(b) 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.

Exercise of powers by officers and employees

38. An officer or employee of the Agency may exercise any power and perform any duty of the Agency if the officer or employee is appointed to serve in a capacity appropriate to the exercise of the power or performance of the duty.

Contracts and arrangements

39. (1) 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.

Title to property

(2) 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.

Legal proceedings

(3) 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.


Administration

The following provision is not in force.Issuance of licence for controlled activity

40. (1) 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.

Use of in vitro embryo

(2) 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.

Clinical trials

(3) The number of licences that the Agency considers sufficient may be issued in respect of clinical trials of a controlled activity.

Written consent required

(3.1) 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.

Responsible individual

(4) 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.

Issuance of facility licences

(5) 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).

Terms and conditions

(6) 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.

Cost recovery prohibited

(7) The Agency may not apply a policy of cost recovery to the issuance of licences.

The following provision is not in force.Amendment and renewal of licences

41. The Agency may, in accordance with the regulations, amend a licence or renew an expiring licence, with or without amendment.

The following provision is not in force.Amendment, suspension or revocation for cause

42. The Agency may, in accordance with the regulations, amend, suspend or revoke the licence of a licensee who contravenes this Act or the regulations or the terms and conditions of the licence or who fails to comply with any measures ordered to be taken under this Act, and may prescribe conditions for the restoration of a suspended licence.

The following provision is not in force.Matters to be considered

43. (1) 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.

Disclosure

(2) 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.

Identifying information

(3) 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.

Immunity

(4) No civil or criminal proceedings may be brought against any person for offering information and observations in good faith under subsection (1).

The following provision is not in force.Threats to health or safety

44. (1) The Agency may take, or order any person to take, all reasonable measures that the Agency considers necessary to prevent, reduce or mitigate any threat to human health or safety that results, or may reasonably be expected to result, from a controlled activity.

Entry and management

(2) 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.

Recovery of costs

(3) 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.

Personal liability

(4) No person acting under this section is personally liable for so acting, either civilly or criminally, unless it is established that the person acted in bad faith.


Inspection And Enforcement

The following provision is not in force.Definitions

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

“information”

« document »

“information” means information that is recorded in any form.

“material”

« matériel »

“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.

The following provision is not in force.Designation of inspectors

46. (1) The Agency may designate any person employed by the government of Canada or of a province, or having the qualifications specified in the regulations, as an inspector for the purpose of the enforcement of this Act.

Certificates to be produced

(2) An inspector shall be given a certificate in a form established by the Agency 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.

The following provision is not in force.Entry by inspectors

47. (1) Subject to section 48, an inspector may at any reasonable time enter any place or conveyance in which the inspector believes on reasonable grounds that a controlled activity is undertaken or that there is any material or information in respect of which this Act applies or any information pertaining to a controlled activity.

Inspection

(2) An inspector entering a place or conveyance may

(a) examine any material or information that is relevant to the administration or enforcement of this Act;

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

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

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

(e) conduct any test or analysis or take any measurement of such material.

Examination of information

(3) In carrying out an inspection, an inspector may

(a) examine and make copies of or extracts from any books, documents or other records that the inspector believes on reasonable grounds contain information relevant to the administration or enforcement of this Act;

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

(c) use or cause to be used any computer system to examine information relevant to the administration or enforcement of this Act that is contained in or available to the computer system;

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

(e) use or cause to be used any copying equipment.

Assistance and information to inspector

(4) 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.

The following provision is not in force.Warrant to enter dwelling-house

48. (1) 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).

Authority to issue warrant

(2) If, on ex parte application, a justice of the peace is satisfied by information on oath that

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

(b) entry to the dwelling-house is necessary for any purpose relating to the administration or enforcement of this Act, and

(c) 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.

Use of force

(3) 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.

The following provision is not in force.Obstruction and false statements

49. (1) 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.

Interference

(2) 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.

The following provision is not in force.Seizure by inspector

50. (1) 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.

Storage and removal

(2) 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.

The following provision is not in force.Application for restoration

51. (1) 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 the Agency a notice containing the information prescribed by the regulations within the time and in the manner prescribed in the regulations.

Order of restoration

(2) 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

(a) the applicant is entitled to possession of it; and

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

Order of later restoration

(3) 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

(a) 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

(b) on the final conclusion of proceedings under this Act.

Exception

(4) 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).

The following provision is not in force.Forfeiture

52. (1) 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.

Forfeiture with consent

(2) 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.

Disposal

(3) Subject to section 54, the Agency may dispose of material or information forfeited to Her Majesty in any manner that the Agency directs.

The following provision is not in force.Search and seizure under warrant

53. (1) 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.

Where warrant not necessary

(2) 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 following provision is not in force.Maintaining viable gametes and embryos

54. (1) 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.

Disposal of material

(2) 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

(a) 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

(b) 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.

Return to donor

(3) 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.

The following provision is not in force.Designation of analysts

55. The Agency may designate any person as an analyst for the purpose of the enforcement of this Act.

The following provision is not in force.Analysis and examination

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

Certificate or report

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

The following provision is not in force.Certificate of analyst

57. (1) 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.

Requiring attendance of analyst

(2) 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.

Notice of intention to produce certificate

(3) 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 following provision is not in force.Agreements for enforcement

58. The Agency 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 enforcement of this Act.

The following provision is not in force.Assistance to enforcement officers

59. The Agency may provide assistance to the Attorney General of Canada or a province, or to a peace officer or prosecutor as those terms are defined in the Criminal Code, in the investigation and prosecution of any offence under this Act.


Offences

Offence and punishment

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

(a) 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

(b) 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.

Offence and punishment

61. A person who contravenes any provision of this Act, other than sections 5 to 9, or the regulations is guilty of an offence and

(a) 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

(b) 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.

Court orders

62. A court that imposes a fine or term of imprisonment on a person in respect of an offence under this Act may

(a) 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

(b) 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.

Consent of Attorney General

63. A prosecution for an offence under this Act may not be instituted except with the consent of the Attorney General of Canada.

Notice to interested authorities

64. The Agency 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

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 dsciplinary 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-application 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 corresponding 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 recommendations

(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

Access to Information Act

72. (Amendment)

73. (Amendment)


Financial Administration Act

74. (Amendment)


Privacy Act

75. (Amendment)


Public Service Staff Relations Act

The following provision is not in force.76. (Amendment)


Public Service Superannuation Act

77. (Amendment)


Coming Into Force

Order of Governor in Council


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