Human Tissue Gift Regulations, H-15.1 Reg 1

1 HUMAN TISSUE GIFT H-15.1 REG 1 The Human Tissue Gift Regulations being Chapter H-15.1 Reg 1 (effective July 16, 2018). NOTE: This consolidation is not official. Amendments have been incorporated for convenience of reference and the original statutes and regulations should be consulted for all purposes of interpretation and application of the law. In order to preserve the integrity of the original statutes and regulations, errors that may have appeared are reproduced in this consolidation. 2 H-15.1 REG 1 HUMAN TISSUE GIFT Table of Contents 1 Title 6 Exemptions re prohibition in section 17 of the Act - medical education 2 Definitions and interpretation 7 Standards adopted re medical education 3 Exception re prohibition in section 17 of the Act - reimbursement of expenses 8 Power to require information or material 4 Exemptions re prohibition in section 17 9 Disclosure of information of the Act - corneas 10 Coming into force 5 Standards adopted re corneas 3 HUMAN TISSUE GIFT H-15.1 REG 1 CHAPTER H-15.1 REG 1 The Human Tissue Gift Act, 2015 Title 1 These regulations may be cited as The Human Tissue Gift Regulations. Definitions and interpretation 2(1) In these regulations: “accredited eye bank” means a not-for-profit organization: (a) that obtains, medically evaluates and distributes eyes donated by individuals for use in corneal transplantation; and (b) that holds accreditation with the Eye Bank Association of America; “Act” means The Human Tissue Gift Act, 2015; “provincial health authority” means the provincial health authority within the meaning of The Provincial Health Authority Act. (2) In sections 7, 9 and 16 and clause 22(b) of the Act and in these regulations, “medical education” includes public health education and public awareness for the purpose of informing the public with respect to matters related to public health. 20 Jly 2018 c H-15.1 Reg 1 s2. Exception re prohibition in section 17 of the Act - reimbursement of expenses 3(1) No person contravenes section 17 of the Act if the person receives reimbursement for reasonable expenses incurred in connection with participating in or performing a service necessarily incidental to the process whereby: (a) a transplant of human tissue is effected; or (b) a human body or part or parts of a human body are prepared for use for therapeutic purposes or for purposes of medical education or scientific research. (2) Nothing in this section prohibits reimbursement to the donor or recipient of a body, a part of a body or tissue from a body, or to the family or survivors of that donor or recipient, or to any government or private medical or hospital plan, as the case may be, of expenses incurred in connection with carrying out a direction or complying with a consent in accordance with the Act. 20 Jly 2018 c H-15.1 Reg 1 s3. 4 H-15.1 REG 1 HUMAN TISSUE GIFT Exemptions re prohibition in section 17 of the Act - corneas 4(1) Subject to subsections (2) to (5), the following are exempt from section 17 of the Act with respect to the procurement of corneas for the purpose of transplant: (a) the provincial health authority; (b) the Eye Bank of Saskatchewan. (2) Persons or classes of persons exempted pursuant to this section may only procure corneas from an accredited eye bank. (3) The Eye Bank of Saskatchewan may procure corneas for the purpose of transplant only after being directed to do so by the provincial health authority. (4) An exemption pursuant to clause (1)(b) is conditional on approval by the provincial health authority. (5) Any exemption pursuant to this section is conditional on the exempted person or class of persons complying with: (a) the Act and these regulations; (b) any other Act, any regulation made pursuant to any other Act, any Act of the Parliament of Canada or any regulation made pursuant to any Act of the Parliament of Canada; and (c) any other requirements or conditions that are required or permitted by law. 20 Jly 2018 c H-15.1 Reg 1 s4. Standards adopted re corneas 5(1) For the purposes of section 4, the Medical Standards published by the Eye Bank Association of America, dated June 16, 2017 are adopted, as amended from time to time. (2) The procurement, handling and distribution of corneas for transplant must be done in accordance with the Medical Standards adopted pursuant to subsection (1). 20 Jly 2018 c H-15.1 Reg 1 s5. Exemptions re prohibition in section 17 of the Act - medical education 6(1) Subject to subsections (5) to (7), the provincial health authority is exempt from section 17 of the Act with respect to the display of human tissue, for valuable consideration or otherwise, for the purposes of medical education. (2) Subject to subsections (3) to (7), a person carrying on the display of human tissue for the purposes of medical education is exempt from section 17 of the Act with respect to the display of human tissue for those purposes. (3) An exemption pursuant to subsection (2) is conditional on approval by the provincial health authority. 5 HUMAN TISSUE GIFT H-15.1 REG 1 (4) Persons or classes of persons exempted pursuant to this section must not obtain human tissue for the purposes of medical education without first receiving approval from the provincial health authority. (5) Subject to subsection (3) and section 7, a person exempted pursuant to this section shall not use, transport, handle or otherwise deal with human tissue obtained for the purposes of medical education for any other purpose. (6) Any exemption pursuant to this section is conditional on the exempted person or class of persons complying with: (a) the Act and these regulations; (b) any other Act, any regulation made pursuant to any other Act, any Act of the Parliament of Canada or any regulation made pursuant to any Act of the Parliament of Canada; and (c) any other requirements or conditions that are required or permitted by law. (7) A person who is exempt from section 17 of the Act with respect to displaying human tissue for the purpose of medical education in accordance with this section is not exempt from that section of the Act as it otherwise applies to the prohibition against the purchase, sale or any other dealings with respect to human tissue. 20 Jly 2018 c H-15.1 Reg 1 s6. Standards adopted re medical education 7(1) For the purposes of section 6, the Saskatchewan Biomedical Waste Management Guidelines, published by the Ministry of Health, the Ministry of Environment and the Ministry of Advanced Education, Employment and Labour, dated February 2008 are adopted, as amended from time to time. (2) The disposal of human tissue obtained for the purposes of medical education must be done in accordance with the Saskatchewan Biomedical Waste Management Guidelines adopted pursuant to subsection (1). (3) A person exempted from section 17 of the Act pursuant to section 6 of these regulations shall ensure that he or she stores, transports and handles the human tissue being displayed in accordance with generally accepted standards for the storage, transportation and handling of human tissue. 20 Jly 2018 c H-15.1 Reg 1 s7. Power to require information or material 8(1) At any time, the minister may direct the provincial health authority or an organ procurement organization to provide the minister with any information or material the minister reasonably requires for the purposes of the Act and these regulations, or for program planning purposes. (2) The provincial health authority or the organ procurement organization, as the case may be, shall comply with the direction of the minister within the period and in the manner that the minister may require as set out in the direction. 20 Jly 2018 c H-15.1 Reg 1 s8. 6 H-15.1 REG 1 HUMAN TISSUE GIFT Disclosure of information 9(1) If a person of any age who has not given a consent pursuant to section 7 of the Act is, in the opinion of a physician, incapable of giving a consent by reason of injury or disease and the person’s death is imminent, information about the person, including personal information and personal health information, may be disclosed in the manner set out in subsection (2). (2) In the circumstances described in subsection (1), information about the person mentioned in that subsection may be disclosed to a person whose responsibilities include determining whether that person would be a suitable candidate for donation of the person’s tissue and body or parts of the body, if disclosure of that information is reasonably necessary to facilitate that determination. 20 Jly 2018 c H-15.1 Reg 1 s9. Coming into force 10(1) Subject to subsection (2), these regulations come into force on the day on which section 1 of The Human Tissue Gift Act, 2015 comes into force. (2) If section 1 of The Human Tissue Gift Act, 2015 comes into force before the day on which these regulations are filed with the Registrar of Regulations, these regulations come into force on the day on which they are filed with the Registrar of Regulations. 20 Jly 2018 c H-15.1 Reg 1 s10. REGINA, SASKATCHEWAN Printed by the authority of THE QUEEN’S PRINTER Copyright©2018