Human Tissue and Organ Donation Act

HUMAN TISSUE AND ORGAN DONATION ACT Chapter H‑14.5 Table of Contents 1 Definitions 2 Scope of Act 3 Transplantation, medical education, etc. 4 Deceased donor 4.1 Online registry 4.2 Consent to donate 4.3 Collection of information by additional registries 5 Living donor 6 Determination of death 7 Mandatory referral 8 Effect of donation 9 Consent requirements 10 Fatality Inquiries Act 11 Liability 12 Confidentiality of information 12.1 Alberta Organ and Tissue Donation Agency 12.2 Purpose of Agency 12.3 Duties of Agency 12.4 Powers of Agency 12.5 Reporting 12.6 Board of directors 12.7 Staff 13 Offences 14 Regulations 14.1 Lieutenant Governor in Council regulations 15 Consequential amendments 16 Repeals 17 Coming into force HER MAJESTY, by and with the advice and consent of the Legislative Assembly of Alberta, enacts as follows: Definitions 1 In this Act, (a) “Agency” means the Alberta Organ and Tissue Donation Agency continued under section 12.1; (a.01) “board” means the board appointed under section 12.6(1); (a.1) “body” means a human body; (b) “by‑product” means tissue or an organ that is a waste product of a medical procedure; (b.1) “capacity” means the ability to understand information that is relevant to a decision to be made and the ability to understand and appreciate the reasonably foreseeable consequences of a decision or lack of a decision; (c) “consent” means a consent given for a donation that meets the requirements of section 9; (d) “consenter” means a person who gives a consent; (e) “donation” means a donation of tissue, an organ or a body under section 4 or 5; (f) “donation organization” means an organization designated in the regulations that co-ordinates and supports donations for transplantation; (g) “donor” means a person whose tissue, organs or body is being considered for donation or in respect of whom a consent has been given; (h) “estranged” means living separate and apart for a year or more; (i) “immediate family” means the spouse or adult interdependent partner, parent, sibling and child of a person; (j) “independent assessment committee” means an independent assessment committee established in accordance with the regulations; (k) “Minister” means the Minister determined under section 16 of the Government Organization Act as the Minister responsible for this Act; (k.1) “online registry” means the online registry established under section 4.1; (l) “organ” means a human organ whether whole or in sections, lobes or parts; (l.1) “Registrar of Motor Vehicle Services” means Registrar as defined in the Traffic Safety Act ; (m) “tissue” means human tissue excluding organs; (n) “transplantation” means the operation of transferring tissue or an organ from a human donor to a human recipient. 2006 cH‑14.5 s1;2013 c12 s2;2022 c10 s2 Scope of Act 2 This Act does not apply to the following: (a) by‑products that are used for a purpose other than transplantation; (b) blood or blood constituents; (c) zygotes, oocytes, embryos, sperm, semen and ova. Transplantation, medical education, etc. 3 (1) A person’s tissue, organs or body may be donated for transplantation, medical education or scientific research only in accordance with this Act. (2) No person shall offer, give or receive any reward or benefit for any tissue, organ or body for use in transplantation, medical education or scientific research. (3) No person shall use any tissue, organ or body donated under this Act except for the purpose for which it was donated. (4) Only a university with a medical, dental or related health program may use a body donated under this Act for medical education or scientific research. (5) No person shall use, procure, transfer or process any tissue, organ or body for transplantation except in accordance with the regulations. (6) Repealed 2013 cS‑19.3 s3. 2006 cH‑14.5 s3;2013 cS‑19.5 s3 Deceased donor 4 (1) For the purpose of transplantation, medical education or scientific research, an adult with capacity may decide to consent to donate their tissues, organs or body for use on their death by indicating their consent in accordance with section 9. (2) A person’s tissue, organs and body must only be used on that person’s death in accordance with a consent given under subsection (1). (3) Subject to subsection (5), a person who is in one of the classes described in subsection (4) may consent to donate under subsection (1) on behalf of another person if any of the following applies: (a) the other person had not consented under subsection (1) at the time of their death; (b) the other person’s death is imminent and (i) in the opinion of a medical practitioner, they are incapable of consenting due to injury or disease, and (ii) they have not consented under subsection (1); (c) the other person is a minor at the time of their death. (4) For the purpose of subsection (3), the classes of persons, in order of priority, are as follows: (a) if they are not estranged at the time of consenting to donate, the spouse or adult interdependent partner of that person; (b) an adult child of that person; (c) a parent or guardian of that person; (d) an adult sibling of that person; (e) any other adult that is the next of kin of that person. (5) A person may not consent to donate under subsection (3) on behalf of another person if they have personal knowledge of any of the following: (a) a person in a higher priority class as described in subsection (4) is reasonably available to consent; (b) another person who is in the same priority class or a higher priority class described in subsection (4) would refuse to consent to donate; (c) the person on whose behalf they are consenting would have made a different decision. 2006 cH-14.5 s4;2022 c10 s3 Online registry 4.1 (1) The Minister must establish an online registry to facilitate the submission and registration of each consent that is made in accordance with section 4(1) with respect to the donation of a person’s tissues and organs. (2) A consent to donate submitted to the online registry must meet the requirements set out in section 9 and the regulations, if any. 2013 c12 s3;2019 c22 s7;2022 c10 s3 Consent to donate 4.2 (1) An authority referred to in subsection (1.1) must do the following in respect of an adult making an application to that authority: (a) provide the adult with written information from the Minister regarding the importance of tissue and organ donation and the process by which consent may be given in Alberta; (b) ask the adult whether they wish to consent with respect to the donation of their tissue or organs in accordance with section 4(l). (1.1) For the purpose of subsection (1), an authority is (a) in the case of the issuance or renewal of an operator’s licence under the Traffic Safety Act , the Registrar of Motor Vehicle Services, or (b) in the case of an identification card, the Minister responsible for section 17 of Schedule 12 of the Government Organization Act . (2) If, on being informed in accordance with subsection (1), an adult consents to donate in accordance with section 4(1), the Registrar of Motor Vehicle Services or the Minister responsible for section 17 of Schedule 12 to the Government Organization Act , as the case may be, shall (a) transmit that consent to the online registry, and (b) print a code or symbol on the operator’s licence or identification card indicating whether the adult has consented to donate. 2013 c12 s3;2019 c22 s7;2022 c10 s4 Collection of information by additional registries 4.3 The Lieutenant Governor in Council may, in accordance with the regulations, require a registry operated or maintained by the Government to collect and transmit information respecting an adult’s consent under section 4(1) to the online registry. 2013 c12 s3;2022 c10 s5 Living donor 5 (1) An adult’s by-products, tissue or organs from the adult’s living body may be donated for transplantation (a) if the adult gives a consent, or (b) where the adult lacks capacity to give a consent, if (i) an agent designated in a personal directive under the Personal Directives Act gives a consent and the personal directive under which the agent is authorized to act states that such a consent may be given, or (ii) a guardian appointed under the Adult Guardianship and Trusteeship Act gives a consent and the court order under which the guardian is authorized to act states that such a consent may be given. (2) Subject to subsection (3), a minor’s tissues or organs may be donated from the minor’s living body for transplantation if the donation is approved by an independent assessment committee and a guardian gives a consent. (3) A guardian shall not give a consent under subsection (2) if the guardian (a) has personal knowledge that another guardian would refuse to give a consent, or (b) lacks the authority to make medical decisions in respect of the minor. (4) A minor’s by-products may be donated from his or her living body for transplantation if a consent is given by the minor, if the minor is 16 years of age or over or lives independently of a guardian, or by a guardian. (5) Before approving a donation under this section, the independent assessment committee must ensure that (a) the minor, to the extent possible considering his or her age, agrees to the donation without coercion or inducement and understands the nature and consequences of the donation, (b) if the minor is under 16 years of age, only regenerative tissue or organs are to be donated, (c) the donation poses minimal risk to the minor, and (d) all adult members of the immediate family of the recipient have been eliminated, for medical or other reasons, as donors. (6) An independent assessment committee shall not approve a donation if all the members of the committee are not in agreement. (7) The independent assessment committee shall provide to the minor and the guardian who gave a consent for the donation written notice, with reasons, of a decision to approve or disapprove a donation. 2006 cH‑14.5 s5;2008 cA‑4.2 s134 Determination of death 6 (1) A physician shall not participate in the determination of a donor’s death for the purposes of a donation under section 4 for transplantation if the physician (a) has had any association with the proposed recipient that might influence his or her judgment, or (b) will remove the tissue or organ or perform the transplantation. (2) Subsection (1) does not apply to a physician who will remove a donor’s eyes for corneal transplantation. Mandatory referral 7 (1) Subject to subsection (2) and the regulations, if any, when a person dies or their death is imminent, a medical practitioner making the determination of the person’s death must provide a donation organization with the following information: (a) the age of the person; (b) the cause, or expected cause, of the person’s death; (c) if death has occurred, the time of death of the person; (d) any available past and current health information of the person that is relevant to their medical suitability for tissue or organ transplantation. (2) A medical practitioner is not required to provide the information referred to in subsection (1) to a donation organization if (a) in the opinion of the medical practitioner, the person’s tissue or organs are not medically suitable for transplantation based on the criteria prescribed by the regulations, if any, and the medical practitioner has made a written note of the reasons for that determination in the person’s medical record, or (b) the medical practitioner has personal knowledge that the deceased person would have refused to consent to donate. (3) A donation organization must consider the suitability of a person’s tissue or organs for transplantation by assessing the information provided to it in accordance with subsection (1). (4) If a donation organization determines that a person’s tissue or organs may be suitable for transplantation, it must (a) confirm whether a consent has been made in accordance with section 4 to donate that person’s tissue or organs for transplantation, and (b) if no consent has been made, request consent to donate that person’s tissue or organs for transplantation in accordance with section 4 and document its efforts. 2006 cH‑14.5 s7;2013 c12 s4;2022 c10 s6 Effect of donation 8 (1) Subject to section 10, a consent given in accordance with this Act is binding and authorizes (a) any medical practitioner to make any examination necessary to assure medical acceptability of the donation, and (b) the use of the body or the removal and use of the specified tissue or organ for the specified purpose. (2) If a person has custody or control of a consent given under section 4(1) that has not been revoked pursuant to section 9(8), that person must provide that consent for the purposes of subsection (1). (3) Despite subsection (1), a person must not act on a consent to donate if (a) the person has personal knowledge that the person to whom the donation relates revoked their consent to donate or otherwise objected to the donation proceeding, or (b) in the case of a consent to donate made in accordance with section 4(3), the person has personal knowledge that a person in the same priority class or a higher priority class, as described in section 4(4), other than the person who consented to donate, would object to that consent. (4) If for any reason a donation cannot be used in the circumstances to which the consent relates, the consent is void and, if necessary, the donated tissue, organ or body must be dealt with and disposed of as if the donation had not been made. 2006 cH-14.5 s8;2022 c10 s7 Consent requirements 9 (1) A consent to donate under this Act must be (a) in writing or electronic form, (b) dated, and (c) signed (i) by the person consenting to donate and a witness, or (ii) subject to subsections (6) and (7), if the person consenting to donate is unable to sign for any reason, by 2 adults who witnessed that person’s oral instructions that they consented to donate, as applicable, and that they asked to have those instructions documented. (2) For greater certainty, subsection (1)(c)(i) includes a person referred to in section 4(1) or (3). (3) A consent to donate signed in accordance with subsection (1)(c)(ii) must (a) indicate that each adult directly witnessed the person’s oral instructions to consent to donate referred to in that subsection, (b) identify the manner in which the oral instructions of the person were received by each witness, and (c) if a consent to donate is given in accordance with section 4(3), indicate that 1 witness was knowledgeable about the donation process and advised the person consenting to donate of the nature and consequences of providing that consent. (4) For the purpose of section 4(1), a consent to donate must specify each of the following: (a) whether the consent applies to the donor’s whole body or to specific tissues, or groups of tissues and organs and, if so, the specific tissues, organs, or groups of tissues and organs to be donated; (b) any of the following purposes for which the donor’s whole body, or specified tissues, organs or groups of tissues and organs, as applicable, may be used: (i) medical education; (ii) scientific research; (iii) transplantation. (5) A consent to donate on the form provided on a certificate of registration issued under the Health Insurance Premiums Act is valid despite it not being dated. (6) Despite subsection (1)(c)(ii) and (8), (a) a consent or revocation of a consent to donate provided through the online registry is valid despite not being witnessed, if it is in writing and dated, and (b) a person who revokes consent through the online registry is not required to provide that revocation to any other person who has a copy of the consent to donate. (7) The following persons are not eligible to witness a consent to donate if a witness is required: (a) the physician who will remove the tissue or organ, or perform a transplantation of the tissue or organ, to which the consent applies; (b) the recipient of the transplant referred to in clause (a) or any of their immediate family; (c) a person who is required to give consent to donate in respect of the same donation. (8) A person may, in accordance with the regulations, if any, revoke a consent to donate by providing a written revocation that meets (a) the same requirements set out in subsections (1) and (2), and (b) any additional prescribed requirements. 2006 cH‑14.5 s9;2013 c12 s5;2019 c22 s7;2022 c10 s8 Fatality Inquiries Act 10 (1) A medical examiner appointed under the Fatality Inquiries Act may, notwithstanding that death has not occurred, give any directions the medical examiner thinks proper respecting the removal of tissue or organs donated for transplantation under section 4 if the donor’s death is imminent and the attending physician has reason to believe that section 10, 11, 12 or 13 of the Fatality Inquiries Act may apply when death occurs. (2) A direction made under subsection (1) has the same force and effect as if it had been made after death. (3) Except as provided in this section, nothing in this Act affects the operation of the Fatality Inquiries Act . Liability 11 No action lies against any person in respect of anything done or omitted to be done in good faith pursuant to this Act. Confidentiality of information 12 (1) Subject to subsections (2) and (3), and section 4.2, no person may publicly disclose information that identifies any of the following: (a) a person who has consented to donate; (b) a person to whom a consent to donate has been made; (c) a person into whose body donated organs or tissue have been or may be transplanted. (2) Subsection (1) does not apply if the disclosure (a) is permitted or required by an enactment or order of the court, or (b) has been agreed to in writing (i) by the person whose identity would be disclosed or their guardian, or (ii) by a person who gave a consent to donate under section 4(3). (3) A person may collect, use or disclose a person’s health information and personal information if necessary to do any of the following: (a) assess a person’s suitability to donate under section 4; (b) use or obtain a donation under section 4 or 5; (c) assess medical suitability under section 7. 2006 cH-14.5 s12;2022 c10 s9 Alberta Organ and Tissue Donation Agency 12.1 (1) The Alberta Organ and Tissue Donation Agency is continued. (2) Subject to subsection (3), a provincial health agency, regional health authority or provincial health corporation under the Provincial Health Agencies Act may carry out activities on behalf of the Agency. (3) During any period in which a provincial health agency, regional health authority or provincial health corporation is carrying out activities on behalf of the Agency under subsection (2), (a) sections 12.2, 12.3, 12.4(1) and 12.5 apply to the provincial health agency, regional health authority or provincial health corporation with all necessary modifications, as if it were the Agency, (b) sections 12.2, 12.3, 12.4, and 12.5 do not apply to the Agency, and (c) section 12.6 does not apply. 2013 c12 s6;2022 c10 s9;2024 c10 s24;2024 c16 s12;2025 c10 s31 Purpose of Agency 12.2 The purpose of the Agency is to co‑ordinate and support the work of donation organizations in managing the organ and tissue donation system in Alberta. 2022 c10 s9 Duties of Agency 12.3 To fulfill its purpose under section 12.2, the Agency must do each of the following: (a) monitor and measure information about organ and tissue donation and related services, infrastructure and training related to organ and tissue donation in Alberta; (b) consult with donation organizations, corporations, organizations, associations, institutions and professional and employee groups in respect of the subject matter of this Act; (c) educate the public and health care community and work with health professionals and their respective organizations to increase awareness about tissue and organ donation in Alberta; (d) support and encourage the use of the online registry; (e) make recommendations to the Minister in accordance with section 12.5; (f) perform any other duty that is prescribed by the regulations. 2022 c10 s9 Powers of Agency 12.4 (1) In carrying out its duties under section 12.3, the Agency may do any of the following: (a) receive and hear submissions from individuals or groups related to the Agency’s purpose; (b) publish any submissions that are included in a report provided to the Minister under section 12.5, except in the case of a report provided under section 12.5(2), which may only be published after the report has been laid before the Assembly in accordance with section 12.5(3). (2) The Agency may make bylaws governing the calling of its meetings and the conduct of its business. 2022 c10 s9 Reporting 12.5 (1) The Agency is responsible and reports to the Minister. (2) In addition to any report provided to the Minister under subsection (1), the Agency must provide an annual report to the Minister containing the following information: (a) a summary of the Agency’s activities during the preceding year; (b) statistical information about the number of potential donor identifications, potential donor referrals and the donation consent rate for the preceding year; (c) its recommendations, if any, for improving the efficiency and effectiveness of the tissue and organ donation system in Alberta. (3) On receipt of a report under subsection (2), the Minister must lay a copy of the report before the Assembly if it is sitting or, if the Assembly is not sitting, within 15 days after the commencement of the next sitting. 2022 c10 s9 Board of directors 12.6 (1) Subject to subsections (3) and (4), the Lieutenant Governor in Council must appoint a board of directors consisting of at least 7, but no more than 9, directors. (2) The board is responsible for managing and supervising the business and affairs of the Agency. (3) Each director of the board may serve for a term not exceeding 4 years and must be a resident of Alberta. (4) The board must include an individual appointed as a director from each of the following: (a) an Alberta non-profit organization with expertise in the area of organ and tissue donation; (b) an employee of a provincial health agency, regional health authority or provincial health corporation under the Provincial Health Agencies Act with an expertise in the area of organ and tissue donation; (c) a medical practitioner with an expertise in the area of organ and tissue donation; (d) a person with an expertise in the area of clinical ethics. (5) The Lieutenant Governor in Council must designate 1 director to serve as chair of the board. (6) The Lieutenant Governor in Council must set out each of the following in a director’s appointment: (a) the amount of remuneration to be paid to the director; (b) each type of expense for which the director may be reimbursed. 2022 c10 s9;2024 c10 s24;2024 c16 s12;2025 c10 s31 Staff 12.7 In accordance with the Public Service Act , the Minister may appoint the employees required to conduct the business of the Agency. 2013 c12 s6;2022 c10 s9 Offences 13 (1) Subject to subsections (2) and (3), a person who knowingly contravenes this Act is guilty of an offence and liable to a fine of not more than $10 000. (2) A person who contravenes section 12(1) is guilty of an offence and liable to a fine of not more than $50 000. (3) A person who contravenes section 3(2) is guilty of an offence and liable to a fine of not more than $100 000 or to imprisonment for a term of not more than 6 months or to both. 2006 cH-14.5 s13;2022 c10 s10 Regulations 14 The Minister may make regulations (a) designating donation organizations for the purposes of this Act; (b) respecting the use, procurement, transfer or processing of tissue, organs or bodies for transplantation; (c) repealed 2023 c9 s13; (d) respecting the establishment of independent assessment committees; (e) respecting any other matter that the Minister considers necessary to carry out the intent of this Act. 2006 cH‑14.5 s14;2013 c12 s7;2023 c9 s13 Lieutenant Governor in Council regulations 14.1 The Lieutenant Governor in Council may make regulations (a) respecting the establishing and operation of the online registry; (b) respecting the information that may be included in the online registry; (c) respecting the collection, use and disclosure of information in the online registry; (c.1) respecting the manner in which a person must submit a consent to donate to the online registry under section 4.1(2); (d) respecting a request regarding consent to donation under section 4.2 and the collection, use and disclosure of information obtained under that section; (e) prescribing a form for the purposes of section 4.2(2)(b); (f) prescribing registries under section 4.3 and respecting the collection, use and disclosure of information by those registries; (f.1) prescribing the circumstances in which a medical practitioner must provide a donation organization with information when a person dies or their death is imminent for the purpose of section 7(1); (f.2) prescribing the criteria to assess the medical suitability of a person’s tissue or organs for the purpose of section 7(2)(a); (f.3) describing additional duties of the Agency for the purpose of section 12.3(f). (g) respecting the membership and functions of the Agency; (h) prescribing the remuneration and expenses payable to members of the Agency. 2013 c12 s8;2022 c10 s11 15 (This section amends other Acts; the amendments have been incorporated into those Acts.) Repeals 16 The Human Tissue Donation Procedures Statutes Amendment Act , RSA 2000 c15(Supp), and the Human Tissue Gift Act , RSA 2000 cH‑15, are repealed. Coming into force 17 This Act comes into force on Proclamation. (NOTE: Proclaimed in force, except section 3(6), August 1, 2009.)