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Bill C-13

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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

    (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;

    (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;

    (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-Chairper son

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

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

(3.2) 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.

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.

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.

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).

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.

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