Bill 52 - Human Organ and Tissue Donation Act

BILL 52

Human Organ and Tissue Donation Act

His Majesty, by and with the advice and consent of the Legislative Assembly of New Brunswick, enacts as follows:

Definitions

1 The following definitions apply in this Act.

“best interests” includes consideration of the physical, psychological, emotional and social well-being of the living potential donor. (intérêt supérieur)

“capacity” means the ability to understand the information that is relevant to a decision to be made and the ability to appreciate the reasonably foreseeable consequences of a decision or lack of a decision. (capacité)

“Chief Coroner” means the Chief Coroner appointed under the Coroners Act. (coroner en chef)

“continuing-care home” means any facility licensed under the Nursing Homes Act or the Family Services Act, any facility for which a resident may be approved for admission by the Department of Health or the Department of Social Development and any facility prescribed by the regulations. (foyer de soins de longue durée)

“court” means The Court of King’s Bench of New Brunswick. (court)

“critical functions” means (fonctions vitales)

(a) respiration,

(b) circulation, and

“death” means the irreversible cessation of the functioning of the organism as a whole as determined by (décès)

(a) the irreversible loss of the brain’s ability to control and co-ordinate the organism’s critical functions, or

(b) the irreversible cessation of cardiorespiratory function.

“donation after death” means a donation of any human organ, tissue or body after death in accordance with this Act. (don après décès)

“donor” means an individual who has consented, is deemed to have consented or in respect of whom a consent has been given to donate the individual’s organs, tissue or body for transplantation, scientific research or education. (donneur)

“guardian” means a guardian as defined in the Family Services Act. (tuteur)

“irreversible” means not physically possible to reverse without violating consent law. (irréversible)

“living donation” means a donation of organs or tissues in accordance with this Act while the donor is living. (don de vif à vif)

“medicare number” means medicare number as defined in the Medical Services Payment Act. (numéro d’assurance-maladie)

“Minister” means the Minister of Health and includes a person designated by the Minister to act on the Minister’s behalf. (ministre)

“organ” means an organ, whether whole or in sections, lobes or parts. (organe)

“organ-donation program” means an organ-donation program operated by a regional health authority or another prescribed entity. (programme de don d’organes)

“physician” means a duly qualified medical practitioner. (médecin)

“pre-death transplantation optimizing interventions” means interventions that are performed on a person before the person’s death for the purpose of optimizing the chances of a successful transplantation. (intervention préalable au décès)

“regional health authority” means a regional health authority as defined in the Regional Health Authorities Act. (régie régionale de la santé)

“Registry” means the Registry established or designated under section 6. (registre)

“spouse” of an individual means (conjoint)

(a) another individual who is cohabiting with that individual in a conjugal relationship as a married spouse, or

(b) an individual who is cohabiting with the individual in a conjugal relationship for a period of at least one year as common-law partners.

“substitute decision-maker” means a substitute decision-maker as determined under section 5. (mandataire spécial)

“tissue” means a functional group of human cells, excluding organs. (tissu)

“tissue bank” means a tissue bank operated by a regional health authority or another prescribed entity. (banque de tissus)

“transplantation” means the operation of transferring organs or tissues from a donor, whether living or dead, to a living human recipient. (transplantation)

“transplantation activities” means (activité de transplantation)

(a) the storage or transportation of the body of a deceased person for use in transplantation,

(b) the removal from the body of a deceased person, for use for the purpose of transplantation, of organs and tissues of which the body consists or that it contains,

(c) the storage or transportation, for the purpose of transplantation, of organs and tissues that have come from a human body, or

(d) the use, for the purpose of transplantation, of organs and tissues that have come from a human body.

Application of Act

2( 1) This Act does not apply to

(a) blood or blood constituents, or

(b) zygotes, oocytes, embryos, sperm, semen or ova.

2( 2) This Act applies only to a donation made on or after the date this Act comes into force.

Donation only in accordance with Act

3 A donation after death or a living donation may be done only in accordance with this Act.

Consent

4 Only individuals with the capacity to do so may consent or refuse consent.

Substitute decision-maker

5( 1) A substitute decision-maker is, with respect to an individual, a person determined in the following order of priority:

(a) an attorney for personal care appointed in an enduring power of attorney made under the Enduring Powers of Attorney Act;

(b) a guardian, a person authorized under paragraph 39(3)(a) of the Infirm Persons Act or a committee of the person appointed under that Act with the appropriate authority to deal with organ donation decisions;

(c) a relative of that individual listed in the following subparagraphs who, except in the case of a minor spouse, has attained the age of 19 years:

( i) a child;

( ii) a parent;

( iii) a person standing in the place of a parent;

( iv) a sibling;

( v) a grandparent;

( vi) a grandchild;

( vii) an aunt or uncle;

( viii) a niece or nephew; or

( ix) another relative; or

(d) the person lawfully in possession of the individual’s body.

5( 2) For the purpose of subsection (1), “person lawfully in possession of the body” does not include

(a) the Chief Coroner for the purpose of the Coroners Act,

(b) if the person died in hospital, the administrative head of the hospital,

(d) the Public Trustee in possession of the body for the purpose of its burial under the Public Trustee Act,

(e) an embalmer or funeral director in possession of the body for the purpose of its burial, cremation or other disposition, or

(f) the superintendent of a crematorium in possession of the body for the purpose of its cremation.

5( 3) For greater certainty, if two or more persons who are not described in the same paragraph or subparagraph of subsection (1) claim the authority to give or refuse consent under that subsection, the one under the paragraph or subparagraph occurring first in that subsection prevails.

5( 4) A person referred to in subsection (1) may not act as a substitute decision-maker unless the person

(a) excepting a spouse, has been in personal contact with the person over the preceding 12-month period or has been granted a court order to shorten or waive the 12-month period,

(b) is willing to assume the responsibility for making the decision,

(d) makes a statement in writing certifying the relationship to the person and the facts and beliefs set out in paragraphs (a) to (c).

DONATION AFTER DEATH

Registry

6 The Minister shall establish or designate a Registry to record consents and refusals respecting donation after death for transplantation made under this Act.

Consent to donate

7( 1) An individual who has attained the age of 19 years may consent to or refuse donation after death for transplantation by providing information respecting the consent or refusal to the Registry in the manner specified by the Minister.

7( 2) A consent to donation after death under subsection (1) may be restricted to the donation of specified organs and tissues.

Effect of consent or refusal

8( 1) Subject to section 14, a consent under section 7 is full authority for transplantation activities to the extent of the consent.

8( 2) Subject to section 14, if an individual has refused donation after death for transplantation under section 7, the individual’s organs and tissues may not be used for transplantation activities.

Physician to check Registry

9 A physician or the Chief Coroner shall, before undertaking transplantation activities, check the Registry to determine whether a decision made under section 7 is on record in the Registry.

Deemed consent

10( 1) Subject to sections 11 to 14, if an individual has not made a consent or refusal under section 7, the individual is deemed to consent to the individual’s organs and tissues being used for transplantation activities.

10( 2) A deemed consent under subsection (1) is full authority for transplantation activities.

Consent not deemed if individual lacked capacity

11( 1) An individual is not deemed to consent under section 10 if the individual has died and for a significant period before dying lacked the capacity to make a decision respecting donation after death.

11( 2) For the purpose of subsection (1), a significant period means a sufficiently long period as would lead a reasonable person to conclude that it would be inappropriate for consent to be deemed to have been given.

11( 3) Nothing in this section affects the ability of a substitute decision-maker to give consent on behalf of the individual.

Consent not deemed if individual not ordinarily resident

12( 1) An individual is not deemed to consent under section 10 if the individual has died and the individual was not ordinarily resident in the Province for a period of at least 12 months immediately before dying.

12( 2) Nothing in this section affects the ability of a substitute decision-maker to give consent on behalf of the individual.

Consent not deemed if individual under age of 19 years

13( 1) An individual is not deemed to consent under section 10 if the individual was under the age of 19 years at the time of death.

13( 2) Nothing in this section affects the ability of a substitute decision-maker to give consent on behalf of the individual.

Consent or refusal by substitute decision-maker

14( 1) If a substitute decision-maker provides information that would lead a reasonable person to conclude that an individual would have made a different decision respecting donation after death than the decision recorded in the Registry or deemed under section 10, the substitute decision-maker may consent or refuse on behalf of the individual in accordance with that information.

14( 2) A consent under subsection (1) is full authority for transplantation activities to the extent of the consent.

Tests for determination of death

15 The medical tests to demonstrate that death has occurred are those established by the medical profession from time to time.

Physicians to determine death

16( 1) For the purpose of organ donation after death for transplantation, death must be determined by at least two physicians who have skill and knowledge in conducting the specific medical tests established by the medical profession for determining death.

16( 2) A physician who has had an association with a proposed organ recipient that might influence the physician’s judgement may not take part in the determination of the death of an organ donor.

16( 3) No physician who took any part in the determination of death of the organ donor may participate in the organ transplant procedures.

Pre-death approval by Chief Coroner

17 The Chief Coroner may allow the removal of organs or tissue after the death of a person notwithstanding that death has not yet occurred if

(a) in the opinion of a physician the death of the person is imminent by reason of injury or disease,

(b) the physician has reason to believe that section 4, 6 or 6.1 of the Coroners Act may apply when death does occur, and

Mandatory referral

18( 1) If an individual dies, or in the opinion of a physician death is imminent, in a hospital or in circumstances set out in section 4, 6 or 6.1 of the Coroners Act, the hospital or the Chief Coroner shall, as soon as possible, provide to the organ-donation program and the tissue bank

(a) the age of the individual,

(b) the cause, or expected cause, of the death of the individual,

(d) any available past and current personal information, including medical and social history, that is relevant to organ or tissue transplantation.

18( 2) The organ-donation program and the tissue bank shall make a determination as to whether the organs and tissue of the individual may be medically suitable for use in another person by assessing the information provided under subsection (1).

18( 3) If the organ-donation program or the tissue bank determines that the organs or tissue of the individual may be medically suitable for use in another person, the hospital or the Chief Coroner shall, as soon as possible, provide the individual’s name and medicare number to the organ-donation program and the tissue bank for the purpose of determining whether the individual has provided a consent or refusal in the Registry and whether deemed consent applies.

18( 4) Despite subsection (1), the hospital or the Chief Coroner shall not provide the information referred to in subsection (1) to the tissue bank and the organ-donation program if the individual clearly meets criteria established by the tissue bank and the organ-donation program that set out circumstances in which an individual’s organs or tissues would not be medically suitable for use in another person.

18( 5) If the hospital or Chief Coroner does not provide the information referred to in subsection (1), the reasons for the decision must be placed in the record of the individual.

18( 6) If the organ-donation program or the tissue bank determines that a medical or other condition exists that may make the organs or tissue of the individual medically unsuitable for use in another person, the reason for the determination must be placed in the record of the individual.

Annual reports

19( 1) The chief executive officer of a regional health authority and the Chief Coroner shall submit a report annually to the Minister.

19( 2) The report referred to in subsection (1) must include

(a) the number of deceased persons who were medically suitable to be a donor, based upon criteria established by the tissue bank and the organ-donation program, but were not referred to the tissue bank and the organ-donation program,

(b) any actions undertaken or proposed to address issues related to missed referrals and their effectiveness, and

Consent to donation for scientific research or education purposes

20( 1) A person may consent to donation after death for scientific research or education purposes by express personal consent or by consent given by a substitute decision-maker.

20( 2) For greater certainty, a deemed consent under section 10 does not include consent to donation after death for scientific research or educational purposes.

Pre-death transplantation optimizing interventions

21( 1) Consent to donate organs does not imply consent to pre-death transplantation optimizing interventions.

21( 2) An individual with the capacity to give voluntary and informed consent may consent to the use of pre-death transplantation optimizing interventions on the individual’s body

(a) in writing signed by the individual, or

(b) orally in the presence of at least two witnesses with documentation of the consent signed by the witnesses at the time the consent was made.

21( 3) If an individual has not provided consent, the individual lacks capacity to consent and in the opinion of a physician the individual’s death is imminent, a substitute decision-maker shall

(a) follow any instructions in a power of attorney for personal care or health care directive made under the Enduring Powers of Attorney Act, unless

( i) there are expressions of a contrary wish made subsequently by the individual while the individual had the capacity to do so,

( ii) technological changes or medical advances make the instruction inappropriate in a way that is contrary to the intentions of the individual, or

( iii) circumstances exist that would have caused the individual to set out different instructions had the circumstances been known based on what is known of the values and beliefs of the individual and from any other written or oral instructions, or

(b) in the absence of instructions, act according to what the substitute decision-maker believes the wishes of the individual would be based on what the substitute decision-maker knows of the values and beliefs of the individual and from any other written or oral instructions.

21( 4) The consent of a substitute decision-maker must be given

(a) in writing, signed by the substitute decision-maker,

(b) orally, in person or otherwise, by the substitute decision-maker in the presence of at least two witnesses with documentation of the consent signed by the witnesses at the time the consent was made, or

21( 5) Consent to pre-death transplantation optimizing interventions given under this Act is full authority for a physician or hospital to perform such interventions

(a) when it is made, or

(b) if it is contained in a health care directive made under the Enduring Powers of Attorney Act or other lawful advance directive, when the health care directive or advance directive is activated.

LIVING DONATION

Consent to living donation

22( 1) Any individual with the capacity to do so may, in writing signed by the individual, consent to donate specific organs or tissues from the individual’s living body.

22( 2) The consent must be

(a) voluntary and informed, and

(b) given by a person with the legal authority to give, refuse or withdraw consent.

If individual lacks capacity

23( 1) If an individual lacks the capacity to give a valid consent and the individual has a valid health care directive or power of attorney for personal care setting out clear instructions or expressions of wishes that the individual would want to consent to a living donation, a substitute decision-maker who gives voluntary and informed consent may, in writing signed by that person, consent to the living donation of organs for transplantation on behalf of the individual.

23( 2) When a person authorized pursuant to subsection (1) is making a decision about a living donation by an individual, the person shall follow any instructions of the individual in a health care directive or power of attorney for personal care made under the Enduring Powers of Attorney Act, unless

(a) there are expressions of a contrary wish made subsequently by the individual while the individual had the capacity,

(b) technological changes or medical advances make the instruction inappropriate in a way that is contrary to the intentions of the individual, or

(c) circumstances exist that would have caused the individual to set out different instructions had the circumstances been known based on what is known of the values and beliefs of the individual and from any other written or oral instructions.

Court authorization

24( 1) If an individual lacks the capacity to give a valid consent and the criteria set out in section 23 are not met, the individual’s organs may not be donated from the individual’s living body for transplantation without court authorization.

24( 2) When the court is deciding whether to authorize a donation for transplantation pursuant to subsection (1), the court shall consider

(a) whether the proposed recipient has a close personal relationship with the individual,

(b) a written report by a physician stating that the donation by the individual who lacks capacity is the best option for a successful transplant for the recipient,

(c) a written report by the ethics program associated with the hospital where the transplant will be performed that has reviewed the case,

(d) a written psychosocial report about the donor by an independent psychologist or psychiatrist who has experience working with

( i) adults without capacity if the donor is an adult, or

( ii) minors without capacity if the donor is a minor,

(e) a written statement by the substitute decision-maker who has the authority to make health-care decisions in respect of the individual consenting to the donation,

(f) whether the donation

( i) if the individual is an adult, is consistent with the known prior wishes of the individual while the individual had the capacity or, if such wishes are not known, is in the best interests of the individual, or

( ii) if the individual is a minor, is in the best interests of the individual, and

(g) the current wishes of the individual.

24( 3) When a substitute decision-maker referred to in paragraph (2)(e) is making a decision about a living donation by an individual, the substitute decision-maker shall

(a) if the individual is an adult,

( i) act according to what the substitute decision-maker believes the wishes of the individual would be based on what the substitute decision-maker knows of the values and beliefs of the individual and from any other written or oral instructions, or

( ii) if the substitute decision-maker does not know the wishes, values and beliefs of the individual, make a decision that the substitute decision-maker believes would be in the best interests of the individual, or

(b) if the individual is a minor, make a decision that the substitute decision-maker believes would be in the best interests of the individual.

24( 4) If there is more than one substitute decision-maker who has equal authorization to make health-care decisions, the court may authorize the donation if there is consent from one of those persons.

24( 5) Upon application of a party or on its own motion, the court may order that a litigation guardian be appointed for an individual who lacks capacity.

Consent or court authorization full authority

25( 1) A consent given in accordance with sections 22 and 23 or a court authorization under section 24 is full authority for any physician to

(a) make any examination of the donor that is necessary to assure medical suitability of the organ specified therein, and

(b) remove the specified organ from the body of the donor.

25( 2) If for any reason the organ specified in the consent is not removed in the circumstances to which the consent relates, the consent is void.

GENERAL

Dealing in tissue or body parts for valuable consideration prohibited

26( 1) Subject to subsection (3), no person shall buy, sell or otherwise deal in, directly or indirectly, for valuable consideration, any human organ, tissue or body for use in transplantation, education or scientific research.

26( 2) For the purpose of subsection (1), valuable consideration does not include

(a) reimbursement for reasonable expenses associated with the removal, transplantation, implantation, processing, preservation and quality control and storage of organs or tissue,

(b) remuneration received for participating in or performing a service necessarily incidental to the process whereby a transplant of human tissue is effected or a human body or part of the body is prepared for use for therapeutic purposes or for the purpose of education or scientific research, or

26( 3) Parties who conduct, fund or participate in research involving human organs or tissues donated under this Act may receive payments for products or processes developed for therapeutic purposes as a result of such research.

Confidential information

27( 1) Subject to subsections (2) and (3), no person shall disclose or give to any other person, other than the health-care professionals involved in the person’s care and in the transplantation process, any information or document that identifies any person, living or dead, including a substitute decision-maker,

(a) who has given or refused to give a consent to donation,

(b) with respect to whom a consent to donation has been given or refused, or

27( 2) Subsection (1) does not apply if the disclosure

(a) is permitted or required by an Act of the Legislature or of the Parliament of Canada or by an order of the court, or

(b) has been agreed to in writing by the person whose identity would be disclosed.

27( 3) Subsection (1) does not apply as between the donor and the recipient if

(a) an organ, a heart valve or a tissue of a type prescribed by the regulations was donated,

(b) both the recipient of an organ, heart valve or tissue of a type prescribed by the regulations or the recipient’s substitute decision-maker and the donor or the donor’s substitute decision-maker voluntarily agree in writing to the exchange of identifying information or to a meeting, and

(c) those agreeing under paragraph (b) have been informed of the reasonably foreseeable risks of such a meeting or identifying information exchange before they give their consent.

Immunity

28 No action or other proceeding for damages lies against any person in respect of anything done or omitted to be done in good faith and without negligence in the exercise or intended exercise of any authority under this Act.

False information

29 No person shall give false information under this Act.

Consent withdrawn or objection

30 No person shall act on a consent given or deemed to be given under this Act if the person has knowledge

(a) that the donor subsequently withdrew the consent, or

(b) of an objection by the donor.

Different decision

31 No person shall give a consent or refusal under this Act if the person has personal knowledge that the individual for whom the consent or refusal is given would have made a different decision.

Offence and penalty

32 Every person who knowingly violates or fails to comply with this Act commits an offence punishable under Part 2 of the Provincial Offences Procedure Act as a Category E offence.

Coroners Act

33 Except as provided in sections 17 and 18, nothing in this Act affects the operation of the Coroners Act.

Human Tissue Gift Act

34 Nothing in this Act invalidates an authorization made under the Human Tissue Gift Act before the coming into force of this Act.

Regulations

35 The Lieutenant-Governor in Council may make regulations

(a) prescribing a facility for the purposes of the definition “continuing-care home” in section 1;

(b) prescribing an entity or entities for the purposes of the definition “organ-donation program” in section 1;

(d) respecting the Registry, including

( i) the process for recording information in the Registry, and

( ii) who may access or edit information recorded in the Registry;

(e) respecting the manner by which individuals may provide information respecting consents or refusals to donation after death to the Registry;

(f) prescribing information that must be provided in a report from a hospital or the Chief Coroner;

(g) prescribing additional reports that hospitals, the Chief Coroner, the organ-donation program or the tissue bank must provide;

(h) excluding or including certain practices from the meaning of valuable consideration;

(i) setting rates of reimbursement that are not considered valuable consideration;

(j) respecting the products or processes for which parties who conduct, fund or participate in research are permitted to receive payments;

(k) prescribing types of tissues for the purpose of paragraph 27(3)(a);

(l) defining any word or expression used but not defined in this Act;

(m) further defining any word or expression defined in this Act;

(n) respecting any matter or thing the Lieutenant-Governor in Council considers necessary or advisable to carry out effectively the intent and purpose of this Act.

Consequential Amendment

36 Subsection 5(1) of the Coroners Act, chapter C-23 of the Revised Statutes, 1973, is amended by striking out “Human Tissue Gift Act” and substituting “Human Organ and Tissue Donation Act”.

Conditional Amendments

37( 1) If the Supported Decision-Making and Representation Act, chapter 60 of the Acts of New Brunswick, 2022, comes into force, on the commencement of this subsection, paragraph 5(1)(b) of this Act is repealed and the following is substituted:

(b) a guardian or a person authorized under the Supported Decision-Making and Representation Act with the appropriate authority to deal with organ donation decisions;

37( 2) If the Bill entitled An Act to Amend the Coroners Act, introduced in the second session of the 60th Legislature, receives Royal Assent, on the commencement of this subsection, this Act is amended

(a) in paragraph 17(b) by striking out “section 4, 6 or 6.1” and substituting “sections 4 and 5.1 to 6.1”;

(b) in subsection 18(1) by striking out “section 4, 6 or 6.1” and substituting “sections 4 and 5.1 to 6.1”.

Repeal

38 The Human Tissue Gift Act, chapter 113 of the Revised Statutes, 2014, is repealed.

Commencement

39 This Act or any provision of it comes into force on a day or days to be fixed by proclamation.