Assisted Human Reproduction Act (S.C. 2004, c. 2)
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Assented to 2004-03-29
ASSISTED HUMAN REPRODUCTION AGENCY OF CANADA
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note:Outside members
(2) A by-law establishing an advisory panel may provide for the inclusion of persons who are not members of the board.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note:Election of Vice-Chairperson
35. (1) The board of directors shall elect one of its members to be Vice-Chairperson.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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
Marginal note: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.
Marginal note: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.
Marginal note:Clinical trials
(3) The number of licences that the Agency considers sufficient may be issued in respect of clinical trials of a controlled activity.
Marginal note: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.
Marginal note: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.
Marginal note: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).
Marginal note: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.
Marginal note:Cost recovery prohibited
(7) The Agency may not apply a policy of cost recovery to the issuance of licences.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note:Immunity
(4) No civil or criminal proceedings may be brought against any person for offering information and observations in good faith under subsection (1).
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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).
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
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