Tasmania act

Human Tissue Act 1985

In ForceTAS

Jurisdiction

Tasmania

Act Number

118 of 1985

Collection

act

Plain English Summary

7/10 complexity

This Act governs removal and use of human tissue from living donors and the deceased, setting who may authorise procedures, how consent can be given or revoked, and when coroners or designated hospital officers must intervene. It bans commercial sale with narrow exceptions, protects donor privacy, and creates offences and duties. It affects donors, families, hospitals and clinicians — enabling medical use of tissue while imposing legal, administrative and ethical safeguards.

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What it does

Mechanically, the Act sets a statutory architecture for the removal, use, and disposal of human tissue in three contexts, and it prescribes who may give consent, who may authorise removal, the evidentiary form those consents must take, confidentiality obligations, criminal offences for unauthorised activity or false certification, and limited exceptions. The Act separates living-donor donations (Part II), post-mortem donations and authorisations (Part III and Part IIIA), a prohibition on commercial trading in tissue (Part IV), and ancillary matters including the statutory definition of death for the jurisdiction (Part IVA), penalties for non-compliance, and delegated procedural powers (Part V). Key procedural mechanics include: written consents by donors or next of kin as the primary authority for removals (ss 7, 8, 12, 23, 24), medical practitioner certification to validate consents (ss 9, 13, 25A), appointment and limits on the role of designated officers in hospitals (s 4), and coroner consent where a death is reportable under the Coroners Act (ss 3 definition, 28A). The statute also creates discrete rules for blood donations and transfusions (ss 17A, 18-21), special rules for children (variously defined and limited across Part II and s 17A), and an approvals-based pathway for child tissue donation for approved research (ss 22A-22B).

The Act also creates affirmative regulatory and administrative levers. The hospital manager appoints designated officers by instrument in writing, who make inquiries and may authorise removals or non-coronial autopsies (s 4, ss 23, 26B, 26C). The Secretary of the relevant Department may approve or issue guidelines that hospitals must prepare or follow for non-coronial autopsies and examinations of stillborn children (s 26F). The Governor may make regulations for record-keeping, information reporting, and disposal of tissue, and regulations may create further offences and fines (s 32). The Minister may, in special circumstances, permit contracts otherwise void under the prohibition on trading in tissue (s 27(4)).

Current sections

Direct links to the current provisions in Human Tissue Act 1985.

Part I

Preliminary

Part I Preliminary

Short title

1 Short title

This Act may be cited as the Human Tissue Act 1985 .

Commencement

2 Commencement

(1) This section and section 1 shall commence on the day on which this Act receives the Royal Assent.

(2) Except as provided in subsection (1) , this Act shall commence on such day as may be fixed by proclamation.

Interpretation

3 Interpretation

[Section 3 Subsection (1) amended by No. 74 of 1995, s. 3 and Sched. 1 ]**[Section 3 Subsection (1) amended by No. 100 of 1995, s. 97 and Sched. 7 ]

(1) *[Section 3 Subsection (1) amended by No. 68 of 1994, s. 3 and Sched. 1 ]*In this Act, unless the contrary intention appears –

[Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] affected deceased person means a deceased person whose death is a reportable death within the meaning of the Coroners Act 1995 ;

[Section 3 Subsection (1) amended by No. 11 of 2024, s. 4, Applied:05 Sep 2024]

[Section 3 Subsection (1) amended by No. 11 of 2024, s. 4, Applied:05 Sep 2024] child means a person who has not attained the age of 18 years;

coroner means a coroner within the meaning of the Coroners Act 1995 ;

designated officer, in relation to a hospital, means a person appointed under section 4 to be a designated officer for that hospital;

[Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] diagnostic purposes means the purposes of determining –

(a) the cause of a deceased person's death; or

(b) other medical issues, or the extent of other medical issues, relating to the health of a deceased person;

[Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] hospital manager means the person that has the day-to-day administrative control of the hospital;

[Section 3 Subsection (1) amended by No. 3 of 2010, Sched. 1, Applied:01 Jul 2010]

next of kin means –

(a) [Section 3 Subsection (1) amended by No. 11 of 2024, s. 4, Applied:05 Sep 2024] in relation to a deceased child who was not married – a person referred to in paragraph (a)(i) , (ii) , or (iii) of the definition of senior available next of kin ; and

(b) in relation to any other deceased person – a person referred to in paragraph (b) (i) , (ii) , (iii) , or (iv) of that definition;

[Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] non-coronial autopsy means an autopsy that is authorised under Part IIIA ;

non-regenerative tissue means tissue other than regenerative tissue;

regenerative tissue means tissue that, after injury or removal, is replaced in the body of a living person by natural processes of growth or repair;

[Section 3 Subsection (1) amended by No. 3 of 2010, Sched. 1, Applied:01 Jul 2010]

senior available next of kin means –

(a) [Section 3 Subsection (1) amended by No. 11 of 2024, s. 4, Applied:05 Sep 2024] in relation to a deceased child who was not married –

(i) where a parent of the child is available – a parent of the child;

(ii) where a parent of the child is not available – a brother or sister of the child who has attained the age of 18 years and is available; or

(iii) where no person referred to in subparagraph (i) or (ii) is available – a person who was the guardian of the child immediately before the death of the child and is available; and

(b) in relation to any other deceased person –

(i) [Section 3 Subsection (1) amended by No. 45 of 2003, Sched. 1, Applied:01 Jan 2004] [Section 3 Subsection (1) amended by No. 45 of 2003, Sched. 1, Applied:01 Jan 2004] [Section 3 Subsection (1) amended by No. 45 of 2003, Sched. 1, Applied:01 Jan 2004] where the person, immediately before his death, was married or in a significant relationship, within the meaning of the Relationships Act 2003 , and the person who was then his spouse or partner in the significant relationship is available – the person who was his spouse or partner;

(ii) [Section 3 Subsection (1) amended by No. 45 of 2003, Sched. 1, Applied:01 Jan 2004] where no person referred to in subparagraph (i) is available – a son or daughter of the person who has attained the age of 18 years and is available;

(iii) where no person referred to in subparagraph (i) or (ii) is available but a parent of the person is available – that parent; or

(iv) [Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] where no person referred to in subparagraph (i) , (ii) , or (iii) is available – a brother or sister of the person who has attained the age of 18 years and is available; or

(v) [Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] where no person referred to in subparagraph (i) , (ii) , (iii) or (iv) is available and the deceased person is an Aboriginal person within the meaning of the Aboriginal and Torres Strait Islander Commission Act 1989 of the Commonwealth – a person who is an appropriate person according to the customs and the tradition of the community or group that the deceased person belonged to;

[Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] therapeutic, medical or scientific purpose includes –

(a) the teaching of therapeutic techniques, medicine or science; and

(b) medical or scientific research; and

(c) any other purpose prescribed in the regulations for this definition;

tissue includes an organ, or part, of a human body or a substance extracted from, or from a part of, the human body.

(2) A reference in this Act to the transplantation of tissue shall be read as including a reference to the transplantation of any part of the tissue and to the transplantation of a substance obtained from the tissue.

Designated officers

4 Designated officers

[Section 4 Substituted by No. 19 of 2006, s. 5, Applied:10 Nov 2006]

(1) For the purposes of this Act, the hospital manager, by instrument in writing, may appoint such medical practitioners as are necessary to be designated officers for the hospital.

(2) A designated officer must not act in that capacity under Part IIIA in respect of a deceased person if the designated officer –

(a) before the deceased person's death, was involved in the provision of medical care to the person; or

(b) is likely to be involved in –

(i) the performance of a non-coronial autopsy on the deceased person; or

(ii) the removal of tissue at such an autopsy.

Part II

Donations of Tissue by Living Persons

Part II Donations of Tissue by Living Persons

Division 1

Exclusion of certain tissue

Division 1 Exclusion of certain tissue

Interpretation

5 Interpretation

[Section 5 Amended by No. 11 of 2024, s. 5, Applied:05 Sep 2024] In this Part, a reference to tissue shall not be read as including a reference to breastmilk, foetal tissue, spermatozoa, or ova.

Division 2

Donations by adults

Division 2 Donations by adults

Blood transfusions not subject to this Division

6 Blood transfusions not subject to this Division

Nothing in this Division prevents the removal in accordance with Division 5 of blood from the body of a person.

Consent by adult living donor to removal of regenerative tissue

7 Consent by adult living donor to removal of regenerative tissue

A person, other than a child, may give his consent in writing to the removal from his body of specified regenerative tissue (other than blood) –

(a) for the purpose of the transplantation of the tissue to the body of another living person; or

(b) [Section 7 Amended by No. 19 of 2006, s. 6, Applied:10 Nov 2006] for use for other therapeutic, medical or scientific purposes.

Consent by adult living donor to removal of non-regenerative tissue for transplantation

8 Consent by adult living donor to removal of non-regenerative tissue for transplantation

(1) A person, other than a child, may give his consent in writing to the removal from his body, at any time after the expiration of 24 hours from the time at which the consent is given, of specified non-regenerative tissue for the purpose of the transplantation of the tissue to the body of another living person.

(2) A consent given under subsection (1) shall specify the time at which the consent is given.

Medical practitioner may give certificate in relation to consent

9 Medical practitioner may give certificate in relation to consent

A medical practitioner may certify in writing in relation to a consent given under section 7 or 8 by a person, being a consent the terms of which are set out in the certificate, that –

(a) [Section 9 Amended by No. 11 of 2024, s. 6, Applied:05 Sep 2024] the consent was given in the medical practitioner’s presence;

(b) [Section 9 Amended by No. 11 of 2024, s. 6, Applied:05 Sep 2024] the medical practitioner explained to the person before the consent was given the nature, consequences and risks of the removal from the body of the person of the tissue specified in the consent; and

(c) [Section 9 Amended by No. 11 of 2024, s. 6, Applied:05 Sep 2024] the medical practitioner is satisfied that –

(i) [Section 9 Amended by No. 11 of 2024, s. 6, Applied:05 Sep 2024] at the time the consent was given, the person had attained the age of 18 years;

(ii) at that time, the person was of sound mind; and

(iii) the consent was freely given.

Division 3

Donations by children

Division 3 Donations by children

Blood transfusions not subject to this Division

10 Blood transfusions not subject to this Division

Nothing in this Division prevents the removal in accordance with Division 5 of blood from the body of a child.

References to parent not to include guardian, &c.

11 References to parent not to include guardian, &c.

In this Division, a reference to a parent of a child shall not be read as including a reference to a guardian of a child or to another person standing in loco parentis to the child.

Removal for transplantation of regenerative tissue from body of child

12 Removal for transplantation of regenerative tissue from body of child

(1) A child, and a parent of that child, may jointly give their consent in writing to the removal from the body of the child of specified regenerative tissue for the purpose of the transplantation of the tissue to the body of another member of the family of the child or to the body of a relative of the child.

(2) [Section 12 Subsection (2) inserted by No. 11 of 2024, s. 7, Applied:05 Sep 2024] Despite subsection (1) , a child who is, in the opinion of a medical practitioner giving a certificate under section 13 in relation to the consent of that child, capable of –

(a) understanding the nature, consequences and risks of the tissue removal specified in subsection (1) ; and

(b) making a decision regarding the tissue removal that is informed and free from coercion –

may give consent in writing to the tissue removal specified in subsection (1) independently of any parent.

Medical practitioner may give certificate in relation to consent

13 Medical practitioner may give certificate in relation to consent

[Section 13 Amended by No. 11 of 2024, s. 8, Applied:05 Sep 2024] A medical practitioner may certify in writing in relation to a consent given under section 12 , being a consent the terms of which are set out in the certificate, that –

(a) [Section 13 Amended by No. 11 of 2024, s. 8, Applied:05 Sep 2024] the consent was given in the medical practitioner’s presence;

(b) [Section 13 Amended by No. 11 of 2024, s. 8, Applied:05 Sep 2024] the medical practitioner explained to the child and to any parent of the child before the consent was given the nature, consequences and risks of the removal from the body of the child of the tissue specified in the consent and the nature of the transplantation of that tissue; and

(c) [Section 13 Amended by No. 11 of 2024, s. 8, Applied:05 Sep 2024] the medical practitioner is satisfied that –

(i) [Section 13 Amended by No. 11 of 2024, s. 8, Applied:05 Sep 2024] at the time the consent was given, the person or persons consenting understood the nature, consequences and risks of the removal of the tissue and the nature of the transplantation; and

(ii) [Section 13 Amended by No. 11 of 2024, s. 8, Applied:05 Sep 2024] the consent was freely given by the person or persons consenting.

Division 4

Effect of consents

Division 4 Effect of consents

Effect of consent under section 7

14 Effect of consent under section 7

Subject to section 17 , a document that purports to be a consent given in accordance with section 7 is, where a certificate has been given in accordance with section 9 in relation to that consent, sufficient authority for a medical practitioner, other than the medical practitioner who gave the certificate, to remove the regenerative tissue specified in the consent for the purpose or the use, as the case may be, specified in the consent.

Effect of consent under section 8

15 Effect of consent under section 8

Subject to section 17 , a document that purports to be a consent given in accordance with section 8 is, where a certificate has been given in accordance with section 9 in relation to that consent, sufficient authority for a medical practitioner, other than the medical practitioner who gave the certificate, to remove, at any time after the expiration of 24 hours from the time specified in the consent to be the time at which the consent was given, the non-regenerative tissue specified in the consent for the purpose of the transplantation of the tissue to the body of another living person.

Effect of consent under section 12

16 Effect of consent under section 12

Subject to section 17 , a document that purports to be a consent given in accordance with section 12 is, where a certificate has been given in accordance with section 13 in relation to that consent, sufficient authority for a medical practitioner, other than the medical practitioner who gave the certificate, to remove the regenerative tissue specified in the consent for the purpose specified in the consent.

Written consent not to be sufficient authority in certain circumstances

17 Written consent not to be sufficient authority in certain circumstances

A document that purports to be a consent given in accordance with section 7 , 8 , or 12 is not sufficient authority for a medical practitioner to remove tissue if –

(a) the medical practitioner has been informed that the consent has been revoked; or

(b) the medical practitioner knows or has reasonable grounds for suspecting that a certificate given for the purpose of section 9 or 13 , as the case may be, in relation to that document contains a false statement.

Division 5

Donations of blood

Division 5 Donations of blood

[Division 5 of Part II Heading amended by No. 3 of 2008, s. 4, Applied:17 Apr 2008]

17A

Interpretation

17A Interpretation

[Section 17A Inserted by No. 3 of 2008, s. 5, Applied:17 Apr 2008] In this Division –[Section 17A Amended by No. 11 of 2024, s. 9, Applied:05 Sep 2024]

[Section 17A Amended by No. 11 of 2024, s. 9, Applied:05 Sep 2024] child means a person who has not attained the age of 16 years.

Consents by adults to removal of blood

18 Consents by adults to removal of blood

A person, other than a child, who is of sound mind may consent to the removal of blood from his body –

(a) for transfusion to another person; or

(b) [Section 18 Amended by No. 19 of 2006, s. 7, Applied:10 Nov 2006] for the purpose of the use of the blood or of any of its constituents for other therapeutic, medical or scientific purposes.

Consents to removal of blood from children

19 Consents to removal of blood from children

[Section 19 Amended by No. 11 of 2024, s. 10, Applied:05 Sep 2024] Subject to the requirements of Division 7 of Part II , a parent of a child may consent to the removal of blood from the body of the child for a purpose referred to in section 18 if –

(a) a medical practitioner advises that the removal is not likely to be prejudicial to the health of the child; and

(b) the child agrees to the removal.

Consent to be sufficient authority for removal of blood at certain places

20 Consent to be sufficient authority for removal of blood at certain places

A consent duly given under section 18 or 19 is sufficient authority for the removal of blood from the body of the person who has given the consent, or from the body of the child in relation to whom the person has given the consent, as the case requires –

(a) at a hospital; or

(b) at premises, or in a vehicle, used by the Australian Red Cross Society, or by another body approved by the Minister for the purpose of this Division, for the removal of blood from the bodies of persons.

Division 5A

[Division 5A of Part II Heading inserted by No. 3 of 2008, s. 6, Applied:17 Apr 2008] Blood transfusions

Division 5A [Division 5A of Part II Heading inserted by No. 3 of 2008, s. 6, Applied:17 Apr 2008] Blood transfusions

Administration of blood transfusions to children without parental consent

21 Administration of blood transfusions to children without parental consent

(1) In this section –

blood transfusion means the transfusion of human blood or any of the constituents of human blood;

child means a person who has not attained the age of 18 years.

(2) The operation of removing all or part of the blood of a person and replacing it with blood taken from another person shall, for the purposes of this section, be deemed to be a blood transfusion.

(3) [Section 21 Subsection (3) amended by No. 11 of 2024, s. 11, Applied:05 Sep 2024] Subject to subsection (4) , a medical practitioner may administer a blood transfusion to a child who is otherwise unable to give consent without the consent of a parent of the child or a person having authority to consent to the administration of the transfusion if –

(a) [Section 21 Subsection (3) amended by No. 11 of 2024, s. 11, Applied:05 Sep 2024] that medical practitioner and at least one other medical practitioner, or if another medical practitioner is not available, a paramedic, are of the opinion that the child is in danger of dying and that the administration of a blood transfusion to the child is the best means of preventing the death of the child; and

(b) [Section 21 Subsection (3) amended by No. 11 of 2024, s. 11, Applied:05 Sep 2024] the first-mentioned medical practitioner is satisfied that the blood to be transfused is compatible with the blood of the child.

(4) A medical practitioner is not entitled to administer a blood transfusion to a child in pursuance of subsection (3) unless –

(a) [Section 21 Subsection (4) amended by No. 11 of 2024, s. 11, Applied:05 Sep 2024] a parent of the child, or a person having authority to consent to the administration of the transfusion, upon being asked to consent to the administration of the transfusion, has failed to give consent; or

(b) the medical practitioner is of the opinion that, in the circumstances, it is not practicable to delay the administration of the transfusion until the consent of a parent of the child or a person having authority to consent to the administration of the transfusion can be obtained.

(5) Where a blood transfusion is administered to a child in accordance with this section, the transfusion shall, for all purposes, be deemed to have been administered with the consent of a parent of the child or a person having authority to consent to the administration of the transfusion.

(6) [Section 21 Subsection (6) amended by No. 11 of 2024, s. 11, Applied:05 Sep 2024] Nothing in this section relieves a medical practitioner from liability in respect of the administration of a blood transfusion to a child, being a liability to which the practitioner would have been subject if the transfusion had been administered with the consent of a parent of the child or a person having authority to consent to the administration of the transfusion.

(7) [Section 21 Subsection (7) inserted by No. 11 of 2024, s. 11, Applied:05 Sep 2024] Nothing in this section prevents a child who, in the opinion of a medical practitioner proposing to administer a blood transfusion to the child, is capable of –

(a) understanding the nature, consequences and risks of the administration of a blood transfusion to the child; and

(b) making a decision regarding the administration of a blood transfusion to the child that is informed and free from coercion –

from giving, refusing to give, or revoking consent to such a blood transfusion independently of any other person.

Division 6

Revocation of consent

Division 6 Revocation of consent

Revocation of consent

22 Revocation of consent

(1) A reference in this section, in relation to a consent given for the purposes of this Act, to the donor shall be read –

(a) in a case in which the consent is given in respect of a child – as a reference to the child;

(b) in any other case – as a reference to the person who gave the consent.

(2) A person who gives, or either or both of the persons who jointly give, a consent for the purposes of this Act may at any time thereafter revoke that consent by indicating, either orally or in writing –

(a) where the donor, in relation to that consent, is a patient in a hospital –

(i) [Section 22 Subsection (2) amended by No. 11 of 2024, s. 12, Applied:05 Sep 2024] to any employee of that hospital;

(ii) to a medical practitioner who is attending the donor in a professional capacity; or

(iii) to a registered nurse employed at that hospital;

(b) where the donor is not a patient in a hospital – to a medical practitioner who is attending the donor in a professional capacity –

that the consent is revoked.

(3) Where –

(a) the donor is a patient in a hospital; and

(b) [Section 22 Subsection (3) amended by No. 11 of 2024, s. 12, Applied:05 Sep 2024] a person, being the person who gave, or one of the persons who jointly gave, the consent for the purposes of this Act, indicates to a person referred to in subsection (2)(a) that the consent is revoked –

the last-mentioned person shall inform a designated officer for that hospital forthwith of the revocation of the consent.

(4) [Section 22 Subsection (4) substituted by No. 11 of 2024, s. 12, Applied:05 Sep 2024] Where a person revokes a consent in accordance with subsection (2) –

(a) if the donor is a patient in a hospital at the time of the revocation – the person to whom the revocation is communicated in accordance with subsection (2) or (3) ; or

(b) if the donor is not a patient in a hospital at that time – any medical practitioner who becomes aware that the consent has been revoked –

must, if it appears to the person specified in paragraph (a) or (b) , after making such inquiries (if any) as are reasonable in the circumstances, that a medical practitioner is proposing to rely on the consent in connection with the removal of tissue from the body of the donor, inform that medical practitioner as soon as possible that the consent has been revoked.

(5) [Section 22 Subsection (5) amended by No. 11 of 2024, s. 12, Applied:05 Sep 2024] Where a consent is revoked, a person who has in the person’s possession the instrument of consent shall, upon being informed by a designated officer for a hospital or by the medical practitioner to whom the revocation is communicated that the consent has been revoked, surrender –

(a) that instrument; and

(b) [Section 22 Subsection (5) amended by No. 11 of 2024, s. 12, Applied:05 Sep 2024] if a certificate given in accordance with section 9 or 13 is in the person’s possession, being a certificate relating to the consent – that certificate –

to the person, or one of the persons, who revoked the consent.

Division 7

Donations for approved research

Division 7 Donations for approved research

22A

Interpretation

22A Interpretation

[Section 22A of Part II Inserted by No. 11 of 2024, s. 13, Applied:05 Sep 2024] In this Division –

approved research means research approved by a human research ethics committee in accordance with the Australian Code and the National Statement;

Australian Code means the Australian Code for the Responsible Conduct of Research, issued by the NHMRC in 2018, as amended and in force from time to time;

human research ethics committee means a committee formed in accordance with the requirements stated in the National Statement;

National Statement means the National Statement on Ethical Conduct in Human Research, issued by the NHMRC in 2007, as amended and in force from time to time;

NHMRC means the National Health and Medical Research Council established under the National Health and Medical Research Council Act 1992 of the Commonwealth.

22B

Authorised donation by child

22B Authorised donation by child

[Section 22B of Part II Inserted by No. 11 of 2024, s. 13, Applied:05 Sep 2024]

(1) The removal of tissue from a child’s body is authorised if –

(a) it is done –

(i) for the purpose of approved research; and

(ii) in accordance with the approval given in respect of that research, including any conditions of the approval; and

(b) consent is given in accordance with the National Statement; and

(c) one or more of the following applies:

(i) the approved research is for the benefit of the child;

(ii) the removal of the tissue occurs during a procedure that is for the benefit of the child and a medical practitioner is satisfied that the removal of the tissue for approved research is not likely to prejudice the health of the child;

(iii) a medical practitioner is satisfied that the removal of the tissue will involve a negligible or low risk of harm and minimal discomfort to the child.

(2) For the purposes of subsection (1)(c)(ii) and (iii) , the medical practitioner must make a record of the practitioner’s satisfaction.

(3) For the purposes of subsection (1)(c)(iii) , the medical practitioner’s satisfaction, and the record of that satisfaction, may relate to –

(a) a particular child or children; or

(b) a group of children that is or may be participating in stated approved research.

Part III

Donations of Tissue After Death

Part III Donations of Tissue After Death

Authority to remove tissue where body of deceased at a hospital

23 Authority to remove tissue where body of deceased at a hospital

(1) Subject to this Part, where it appears to a designated officer for a hospital, after making such inquiries as are reasonable in the circumstances, that a deceased person who has died in the hospital or whose dead body has been brought into the hospital –

(a) had, during his lifetime, expressed the wish for, or consented to, the removal after his death of tissue from his body –

(i) for the purpose of the transplantation of the tissue to the body of a living person; or

(ii) [Section 23 Subsection (1) amended by No. 19 of 2006, s. 8, Applied:10 Nov 2006] for the purpose of the use of the tissue for other therapeutic, medical or scientific purposes; and

(b) had not withdrawn the wish or revoked the consent –

the designated officer may, by instrument in writing, authorize the removal of tissue from the body of the deceased person for that purpose.

(2) Subject to this Part, where, in relation to a deceased person who has died in a hospital or whose dead body has been brought to a hospital –

(a) the senior available next of kin of the deceased person has consented, in writing, to the removal of tissue from the body of the deceased person for any of the purposes referred to in subsection (1)(a) ; and

(b) it appears to a designated officer for that hospital, after making such inquiries as are reasonable in the circumstances, that –

(i) the designated officer is not authorized by subsection (1) to give an authority in respect of that person;

(ii) the deceased person had not, during his lifetime, expressed an objection to the removal of tissue from his body;

(iii) the consent referred to in paragraph (a) has not been revoked; and

(iv) [Section 23 Subsection (2) amended by No. 19 of 2006, s. 8, Applied:10 Nov 2006] no objection has been made by any other next of kin (of the same or a higher order of the classes referred to in paragraphs (a) and (b) of the definition of senior available next of kin in section 3(1) ) to the removal of tissue from the body of the deceased person for any purpose including the purpose, or any of the purposes, specified in that consent –

the designated officer may, by instrument in writing, authorize the removal of tissue from the body of the deceased person for that purpose or those purposes.

Authority to remove tissue where body of deceased not at a hospital

24 Authority to remove tissue where body of deceased not at a hospital

(1) Subject to this Part, where the body of a deceased person is at a place other than a hospital, the senior available next of kin of the deceased person may, by instrument in writing, authorize the removal of tissue from the body of the deceased person –

(a) for the purpose of the transplantation of the tissue to the body of a living person; or

(b) [Section 24 Subsection (1) amended by No. 19 of 2006, s. 9, Applied:10 Nov 2006] for the purpose of the use of the tissue for other therapeutic, medical or scientific purposes.

(2) Where it appears to the senior available next of kin of the deceased person, after making such inquiries (if any) as are reasonable in the circumstances, that –

(a) the deceased person had, during his lifetime, expressed an objection to the removal of tissue from his body and had not withdrawn that objection; or

(b) another next of kin of the same or a higher order of the classes in paragraph (a) or (b) of the definition of senior available next of kin in section 3(1) has an objection to the removal of tissue from the body of the deceased person –

the senior available next of kin shall not, under subsection (1) , authorize the removal of tissue from the body of the deceased person.

(3) Subject to this Part, where, during his lifetime, a deceased person whose body is at a place other than a hospital expressed the wish for, or consented to, the removal after his death of tissue from his body for a purpose referred to in subsection (1) and the wish had not been withdrawn or the consent revoked, the removal of tissue from the body of the deceased person in accordance with the wish or consent is, by force of this subsection, hereby authorized.

25.

[Section 25 Subsection (1) amended by No. 74 of 1995, s. 3 and Sched. 1 ] [Section 25 Repealed by No. 19 of 2006, s. 10, Applied:10 Nov 2006]

25A

Certificates required in certain situations

25A Certificates required in certain situations

[Section 25A Inserted by No. 51 of 1987, s. 5 ]

(1) Where –

(a) a person has died within the meaning of section 27A ; and

(b) at the time at which he died or at any time thereafter his respiration was being maintained by artificial means –

a designated officer for a hospital shall not give an authority under this Part in respect of that deceased person unless 2 medical practitioners, each of whom has been a medical practitioner for a period of not less than 5 years, have each certified in writing –

(c) that he carried out a clinical examination of the person while the respiration of that person was being maintained by artificial means; and

(d) that, in his opinion, at the time of that examination, irreversible cessation of all function of the brain of the person had already occurred.

Penalty: Fine not exceeding 50 penalty units or imprisonment for a term not exceeding 6 months, or both.

(2) For the purposes of subsection (1) , any period during which a person who is a medical practitioner practised as a medical practitioner, however described, under the law in force in a place outside Australia shall be taken into account in calculating the period of 5 years referred to in that subsection.

Effect of authority under this Part

26 Effect of authority under this Part

[Section 26 Substituted by No. 51 of 1987, s. 6 ]

(1) An authority under this Part is sufficient authority for a medical practitioner other than –

(a) a medical practitioner referred to in section 25A (1) ; and

(b) in a case to which section 23 applies, the designated officer who gave the authority –

to remove tissue from the body of the deceased person referred to in the authority for the purpose referred to in the authority.

(2) A contravention by a designated officer of section 25A (1) in relation to the giving of an authority does not affect the validity of the authority.

Part IIIA

Non-coronial autopsies and medical examinations

Part IIIA Non-coronial autopsies and medical examinations

26A

Non-coronial autopsies to be dignified

26A Non-coronial autopsies to be dignified

In the performance of a non-coronial autopsy under this Act, regard is to be had to the dignity of the deceased person.

26B

Authority to perform non-coronial autopsy

26B Authority to perform non-coronial autopsy

(1) A designated officer, by instrument in writing, may authorise a non-coronial autopsy of the body of a deceased person if, after making reasonable enquiries, the designated officer is satisfied that –

(a) the deceased person is not a deceased child; and

(b) the deceased person had, during his or her lifetime, given written consent to the non-coronial autopsy; and

(c) the consent had not been withdrawn or revoked before the deceased person's death; and

(d) if the deceased person is an affected deceased person, the coroner has consented under section 28A to the non-coronial autopsy.

(2) A designated officer, by instrument in writing, may authorise a non-coronial autopsy of the body of a deceased person if, after making reasonable enquiries, the designated officer –

(a) is not satisfied of the matters referred to in subsection (1) ; but

(b) is satisfied that –

(i) the deceased person did not, during his or her lifetime, object to a non-coronial autopsy being performed after his or her death; and

(ii) the senior available next of kin of the deceased person has given written consent to the non-coronial autopsy; and

(iii) the consent of the senior available next of kin has not been withdrawn or revoked; and

(iv) no objection to the non-coronial autopsy has been made by any other next of kin (of the same or of a higher order of the classes of next of kin specified in the definition of senior available next of kin in section 3 ); and

(v) if the deceased person is an affected deceased person, the coroner has consented under section 28A to the non-coronial autopsy.

(3) However, subsection (2)(b)(ii) , (iii) and (iv) do not apply if, after making reasonable enquiries, a designated officer is unable to locate, or ascertain the existence of, any of the deceased person's next of kin.

(4) The consent of a deceased person or senior available next of kin of a deceased person to a non-coronial autopsy of the deceased person may be given conditionally or unconditionally.

26C

Removal of tissue during non-coronial autopsy

26C Removal of tissue during non-coronial autopsy

(1) A designated officer, by instrument in writing, may authorise the removal of tissue for use for therapeutic, medical or scientific purposes during a non-coronial autopsy if, after making reasonable enquiries, the designated officer is satisfied that –

(a) the deceased person is not a deceased child; and

(b) the deceased person had, during his or her lifetime, given written consent for the removal and use of tissue for such purposes; and

(c) the consent had not been withdrawn or revoked before the deceased person's death; and

(d) if the deceased person is an affected deceased person, the coroner has consented under section 28A to the removal of tissue.

(2) A designated officer, by instrument in writing, may authorise the removal of tissue for use for therapeutic, medical or scientific purposes during a non-coronial autopsy if, after making reasonable enquiries, the designated officer –

(a) is not satisfied of the matters referred to in subsection (1) ; but

(b) is satisfied that –

(i) the deceased person did not, during his or her lifetime, object to tissue being removed for use for therapeutic, medical or scientific purposes after his or her death; and

(ii) the senior available next of kin of the deceased person has given written consent for the removal and use of tissue for such purposes; and

(iii) that consent of the senior available next of kin has not been withdrawn or revoked; and

(iv) no objection to the removal and use of the tissue has been made by any other next of kin (of the same or of a higher order of the classes of next of kin specified in the definition of senior available next of kin in section 3 ); and

(v) if the deceased person is an affected deceased person, the coroner has consented under section 28A to the removal of tissue.

(3) However, subsection (2)(b)(ii) , (iii) and (iv) do not apply if, after making reasonable enquiries, a designated officer is unable to locate, or ascertain the existence of, any of the deceased person's next of kin.

(4) The consent of a deceased person or senior available next of kin of a deceased person to the removal of tissue for use for therapeutic, medical or scientific purposes during a non-coronial autopsy may be given conditionally or unconditionally.

(5) An authorisation under this section is not required to remove tissue for diagnostic purposes during a non-coronial autopsy.

26D

Effect of authorisation under this Part

26D Effect of authorisation under this Part

(1) In this section –

conditions of consent means the conditions attached to –

(a) a consent for the performance of a non-coronial autopsy; or

(b) a consent for the removal of tissue for use for therapeutic, medical or scientific purposes during a non-coronial autopsy.

(2) An authorisation given under section 26B is authority for a medical practitioner, other than the designated officer giving the authorisation, to –

(a) perform, in accordance with the conditions of consent, a non-coronial autopsy on the body of the deceased person specified in the authorisation; and

(b) remove such tissue from the deceased person during a non-coronial autopsy as is necessary for diagnostic purposes.

(3) An authorisation given under section 26C is authority for –

(a) a medical practitioner, other than the designated officer giving the authorisation, to remove, in accordance with the conditions of consent, tissue from a deceased person during a non-coronial autopsy in accordance with the authorisation; and

(b) the removed tissue to be used, in accordance with the conditions of consent, for therapeutic, medical or scientific purposes.

(4) If the same tissue is required for diagnostic purposes and for therapeutic, medical or scientific purposes, the tissue is to be used for diagnostic purposes first.

26E

Medical examination of stillborn child

26E Medical examination of stillborn child

(1) In this section –

conditions of parental consent means the conditions attached to the consent of a parent of a stillborn child for –

(a) the performance of a medical examination of the stillborn child; or

(b) the removal of tissue for use for therapeutic, medical or scientific purposes during a medical examination of a stillborn child;

stillborn child means a child who is stillborn and –

(a) is at least 20 weeks in gestation; or

(b) if it cannot be reliably established whether the period of gestation is at least 20 weeks, has a body mass of at least 400 grams at birth.

(2) A designated officer, by instrument in writing, may authorise a medical examination of a stillborn child if a parent of the stillborn child has given consent in writing to the examination.

(3) An authorisation under subsection (2) is authority for a medical practitioner, other than the designated officer who gave the authorisation, to –

(a) perform, in accordance with the conditions of parental consent, the medical examination of the stillborn child specified in the authorisation; and

(b) remove such tissue from the stillborn child during the medical examination as is necessary for medical testing.

(4) A designated officer, by instrument in writing, may authorise the removal of tissue for use for therapeutic, medical or scientific purposes during a medical examination of a stillborn child if a parent of the stillborn child has given written consent for the tissue to be removed for use for therapeutic, medical or scientific purposes.

(5) An authorisation under subsection (4) is authority for –

(a) a medical practitioner, other than the designated officer who gave the authorisation, to remove, in accordance with the conditions of parental consent, tissue from a stillborn child during a medical examination in accordance with the authorisation; and

(b) the removed tissue to be used, in accordance with the conditions of parental consent, for therapeutic, medical or scientific purposes.

(6) The consent of a parent of a stillborn child to a medical examination of the stillborn child, or to the removal of tissue for use for therapeutic, medical or scientific purposes from the stillborn child, may be given conditionally or unconditionally.

(7) If the same tissue is required for medical testing and for therapeutic, medical or scientific purposes, the tissue is to be used for medical testing first.

26F

Secretary to approve or issue guidelines

26F Secretary to approve or issue guidelines

(1) This section applies to a hospital where non-coronial autopsies, or medical examinations of stillborn children, are performed in accordance with this Act.

(2) A hospital manager is to submit draft guidelines to the Secretary.

(3) The draft guidelines –

(a) must include guidelines on any matter specified by the Secretary; and

(b) may include guidelines on the following matters:

(i) procedures relating to obtaining consent for non-coronial autopsies or medical examinations of stillborn children;

(ii) hospital procedures and protocols for all stages of non-coronial autopsies or medical examinations of stillborn children;

(iii) the collection and recording of information relating to non-coronial autopsies or medical examinations of stillborn children; and

(c) may include other guidelines relating to the performance of non-coronial autopsies or medical examinations of stillborn children.

(4) The draft guidelines may amend, or replace, the existing guidelines for the hospital.

(5) The Secretary may –

(a) approve the draft guidelines as guidelines; or

(b) refuse to approve the draft guidelines.

(6) The Secretary may issue guidelines, without having first received a submission under subsection (2) , that –

(a) put guidelines in place for a hospital; or

(b) amend the existing guidelines of a hospital; or

(c) replace the existing guidelines of a hospital.

(7) If the Secretary issues guidelines that amend the existing guidelines, the amendment, unless it states otherwise, is incorporated into the existing guidelines.

(8) If the Secretary issues guidelines that replace the existing guidelines, the existing guidelines are rescinded unless the replacement guidelines state otherwise.

(9) The Secretary may specify in the guidelines the hospital, or hospitals, to which the guidelines apply.

Part IV

Prohibition of Trading in Tissue

Part IV Prohibition of Trading in Tissue

Certain contracts not to be entered into

27 Certain contracts not to be entered into

(1) *[Section 27 Subsection (1) amended by No. 51 of 1987, s. 8 and Sched. 1 ]*Subject to this section, a person shall not enter into a contract or arrangement under which a person agrees, for valuable consideration, whether given or to be given to himself or to another person, to the sale or supply of tissue from his body or from the body of another person, whether before or after his death or the death of the other person, as the case may be.

Penalty: Fine not exceeding 5 penalty units or imprisonment for a term not exceeding 3 months, or both.

(2) Subsection (1) does not apply to or in relation to the sale or supply of tissue other than blood or any of its constituents if the tissue has been subjected to processing or treatment and the sale or supply is made for use, in accordance with the directions of a medical practitioner, for therapeutic or scientific purposes.

(3) Subsection (1) does not apply to or in relation to a contract or arrangement providing only for the reimbursement of any expenses necessarily incurred by a person in relation to the removal of tissue in accordance with this Act.

(4) Where he considers it desirable by reasons of special circumstances so to do, the Minister may, by instrument in writing, approve the entering into of a contract or arrangement that would, but for the approval, be void by virtue of subsection (5) and nothing in subsection (1) or (5) applies to and in relation to a contract or arrangement entered into in accordance with an approval under this subsection.

(5) A contract or arrangement entered into in contravention of this section is void.

Part IVA

Definition of Death

Part IVA Definition of Death

27A

When death occurs

27A When death occurs

*[Section 27A Inserted by No. 51 of 1987, s. 7 ]*For the purposes of the law of Tasmania, a person has died when there has occurred –

(a) irreversible cessation of all function of the brain of the person; or

(b) irreversible cessation of circulation of blood in the body of the person.

Part V

Miscellaneous

Part V Miscellaneous

Act does not prevent specified removals of tissue, &c.

28 Act does not prevent specified removals of tissue, &c.

(1) Nothing in this Act applies to or in relation to –

(a) the removal of tissue from the body of a living person in the course of a procedure or operation carried out, in the interests of the health of the person, by a medical practitioner with the consent, express or implied, given by or on behalf of the person or in circumstances necessary for the preservation of the life of the person;

(b) the use of tissue so removed;

(c) [Section 28 Subsection (1) amended by No. 26 of 2006, Sched. 2, Applied:01 Mar 2007] anything done in pursuance of the Anatomical Examinations Act 2006 ;

(ca) [Section 28 Subsection (1) amended by No. 11 of 2024, s. 14, Applied:05 Sep 2024] the removal of tissue from the body of a person permitted under another Act;

(d) the embalming of the body of a deceased person; or

(e) the preparation, including the restoration of any disfigurement or mutilation, of the body of a deceased person for the purpose of interment or cremation.

(2) In subsection (1) , tissue has the same meaning as in Part II .

28A

Consent by coroner

28A Consent by coroner

[Section 28A Inserted by No. 19 of 2006, s. 12, Applied:10 Nov 2006]

(1) Before –

(a) a senior available next of kin consents to the removal of tissue from the body of an affected deceased person; or

(b) a designated officer authorises the removal of tissue from the body of an affected deceased person; or

(c) a designated officer authorises the performance of a non-coronial autopsy of an affected deceased person –

a coroner must have consented to the removal of the tissue or, as the case may be, the performance of the non-coronial autopsy.

(2) However, before or after the death of an affected deceased person, a coroner may give a direction that his or her consent is not required under this section and, in that event, the deceased person is no longer an affected deceased person for the purposes of this Act.

(3) A consent or direction by a coroner under this section –

(a) if the coroner makes the consent or direction orally, is to be confirmed in writing as soon as practicable; and

(b) may be on such conditions as are specified in the consent or direction.

(4) Sections 24(3) and 26D do not apply in relation to an affected deceased person until a coroner has given his or her consent under subsection (1) .

Exclusion of liability of person acting in pursuance of consent or authority

29 Exclusion of liability of person acting in pursuance of consent or authority

(1) Subject to subsection (2) , where –

(a) a person carries out a procedure; and

(b) a consent or authority given under this Act is sufficient authority under this Act for that person to carry out that procedure –

that person is not liable to any other person in respect of anything done or omitted to be done by that first-mentioned person in the carrying out of that procedure.

(2) Nothing in this section relieves a person from liability for negligence in respect of anything done or omitted to be done by him in the carrying out of a procedure.

Offences

30 Offences

(1) [Section 30 Subsection (1) amended by No. 11 of 2024, s. 15, Applied:05 Sep 2024] *[Section 30 Subsection (1) amended by No. 51 of 1987, s. 8 and Sched. 1 ]*A person shall not remove tissue from the body of a person, whether living or dead, except in accordance with a consent or authority that is, under this Act or another Act, sufficient authority for the removal of the tissue by that person.

Penalty:  [Section 30 Subsection (1) amended by No. 19 of 2006, s. 13, Applied:10 Nov 2006] Fine not exceeding 50 penalty units or imprisonment for a term not exceeding 6 months, or both.

(1A) [Section 30 Subsection (1A) amended by No. 11 of 2024, s. 15, Applied:05 Sep 2024] [Section 30 Subsection (1A) inserted by No. 19 of 2006, s. 13, Applied:10 Nov 2006] A person must not perform a non-coronial autopsy on the body of a deceased person, or a medical examination of a stillborn child, except in accordance with a consent or authority that is, under this Act or another Act, sufficient authority for the performance of the non-coronial autopsy or the medical examination by that person.

Penalty:  Fine not exceeding 50 penalty units or imprisonment for a term not exceeding 6 months, or both.

(2) *[Section 30 Subsection (2) amended by No. 51 of 1987, s. 8 and Sched. 1 ]*A person shall not, in connection with a proposal to remove tissue from the body of a person, whether living or dead, for the purpose of transplantation or for use for other therapeutic, medical, or scientific purposes, knowingly furnish information that is false or misleading concerning the suitability of the body for removal of the tissue for that purpose.

Penalty:  Fine not exceeding 100 penalty units or imprisonment for a term not exceeding 2 years, or both.

(3) *[Section 30 Subsection (3) amended by No. 51 of 1987, s. 8 and Sched. 1 ]*A person who –

(a) [Section 30 Subsection (3) amended by No. 11 of 2024, s. 15, Applied:05 Sep 2024] gives an authority under this Act without having made the inquiries that the person is required by this Act to make;

(b) makes a false statement in a certificate given for the purposes of this Act; or

(c) contravenes or fails to comply with a provision of Division 6 of Part II –

is guilty of an offence and is punishable upon conviction by a fine not exceeding 10 penalty units or imprisonment for a term not exceeding 6 months, or both such fine and imprisonment.

(4) *[Section 30 Subsection (4) amended by No. 74 of 1995, s. 3 and Sched. 1 ]*Nothing in subsection (1) applies to or in relation to –

(a) anything done in pursuance of an order by a coroner under the Coroners Act 1995 ; or

(b) any other act authorized by law.

Disclosure of information

31 Disclosure of information

(1) *[Section 31 Subsection (1) amended by No. 51 of 1987, s. 8 and Sched. 1 ]*Subject to this section, a person to whom this section applies shall not disclose or give to any other person any information or document whereby the identity of a person or a deceased person –

(a) [Section 31 Subsection (1) amended by No. 19 of 2006, s. 14, Applied:10 Nov 2006] from whose body tissue other than blood has been removed for the purpose of transplantation or for the purpose of the use of the tissue for other therapeutic, medical or scientific purposes;

(b) with respect to whom or with respect to whose body a consent, other than a consent under section 18 , or authority has been given under this Act; or

(c) into whose body tissue other than blood has been, is being, or may be, transplanted –

may become publicly known.

Penalty: Fine not exceeding 5 penalty units or imprisonment for a term not exceeding 3 months, or both.

(2) *[Section 31 Subsection (2) amended by No. 51 of 1987, s. 8 and Sched. 1 ]*Subject to this section, a person to whom this section applies shall not disclose or give to any other person any information or document whereby the identity of a child from whose body blood has been removed for a purpose referred to in section 18 may become publicly known.

Penalty: Fine not exceeding 5 penalty units or imprisonment for a term not exceeding 3 months, or both.

(3) This section applies –

(a) where a consent has been given in accordance with this Act – to a medical practitioner who gave a certificate in relation to the consent;

(b) where an authority has been given in accordance with this Act by a designated officer for a hospital – to the designated officer;

(c) where tissue has been removed from the body of a person or a deceased person – to the medical practitioner who removed the tissue and, if the tissue was removed at a hospital, each person who was employed at the hospital at the time of the removal of the tissue or has since been employed at the hospital;

(d) where tissue has been transplanted into the body of a person – to the medical practitioner who performed the transplantation and, if the tissue was transplanted at a hospital, each person who was employed at the hospital at the time of the transplantation or has since been employed at the hospital; and

(e) where it is proposed that tissue will be transplanted into the body of a person – to the medical practitioner who is to perform the transplantation and, if the tissue is to be transplanted at a hospital, each person who is employed at the hospital or who becomes so employed.

(4) Subsections (1) and (2) do not apply to or in relation to information disclosed –

(a) in pursuance of an order of a court or when otherwise required by law;

(b) for the purposes of hospital administration or bona fide medical research;

(c) [Section 31 Subsection (4) amended by No. 11 of 2024, s. 16, Applied:05 Sep 2024] with the consent of the person to whom the information relates, or, if that person is deceased, the consent of that person's next of kin; or

(d) when the circumstances in which the disclosure is made are such that the disclosure is or would be privileged.

Regulations

32 Regulations

[Section 32 Amended by No. 51 of 1987, s. 8 and Sched. 1 ][Section 32 Substituted by No. 19 of 2006, s. 15, Applied:10 Nov 2006]

(1) The Governor may make regulations for the purposes of this Act.

(2) Without limiting the generality of subsection (1) , the regulations may –

(a) provide for the making and keeping of records in connection with the removal of tissue from the body of a person (whether living or deceased), including records relating to –

(i) the removal of tissue in the course of medical, dental or surgical treatment; and

(ii) the use of the tissue for any purpose; and

(b) provide for the making and keeping of records relating to –

(i) a non-coronial autopsy under this Act; and

(ii) the use of any tissue removed under this Act for therapeutic, medical or scientific purposes; and

(c) prescribe information to be provided to the Secretary, or to any other specified person concerned in the administration of this Act, relating to –

(i) the removal of tissue under this Act from the body of a person (whether living or deceased); and

(ii) the use of the tissue for any purpose; and

(d) prescribe how tissue is to be dealt with once it is no longer required for the purposes of this Act.

(3) The regulations may be made so as to apply differently according to such factors as are specified in the regulations.

(4) The regulations may –

(a) provide that a contravention of any of the regulations is an offence; and

(b) in respect of such an offence, provide for the imposition of a fine not exceeding 50 penalty units and, in the case of a continuing offence, a further fine not exceeding 10 penalty units for each day during which the offence continues.

(5) The regulations may adopt, either wholly or in part and with or without modification, and either specifically or by reference, any standards, rules, codes or specifications whether or not the standards, rules, codes or specifications are published or issued before or after the commencement of this Act.

(6) A reference in subsection (5) to standards, rules, codes or specifications includes a reference to an amendment to those standards, rules, codes or specifications, whether the amendment is published or issued before or after the commencement of this Act.

Consequential amendment, &c., of other Acts

33 Consequential amendment, &c., of other Acts

(1) The amendments effected by this subsection have been incorporated into the authorised version of the Anatomy Act 1964.

(2) The amendments effected by this subsection have been incorporated into the authorised version of the Anatomy Act 1964.

(3) The amendments effected by this subsection have been incorporated into the authorised version of the Medical Act 1959.

(4) The Sale of Blood Act 1964 and the Sale of Blood Act 1978 are repealed.

Source text: opening excerpt

Sourced from Tasmanian Legislation Online (legislation.tas.gov.au), CC BY 4.0.

Part I Preliminary

1 Short title

This Act may be cited as the Human Tissue Act 1985 .

2 Commencement

(1) This section and section 1 shall commence on the day on which this Act receives the Royal Assent.

(2) Except as provided in subsection (1) , this Act shall commence on such day as may be fixed by proclamation.

3 Interpretation

[Section 3 Subsection (1) amended by No. 74 of 1995, s. 3 and Sched. 1 ]**[Section 3 Subsection (1) amended by No. 100 of 1995, s. 97 and Sched. 7 ]

(1) *[Section 3 Subsection (1) amended by No. 68 of 1994, s. 3 and Sched. 1 ]*In this Act, unless the contrary intention appears –

[Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] affected deceased person means a deceased person whose death is a reportable death within the meaning of the Coroners Act 1995 ;

[Section 3 Subsection (1) amended by No. 11 of 2024, s. 4, Applied:05 Sep 2024]

[Section 3 Subsection (1) amended by No. 11 of 2024, s. 4, Applied:05 Sep 2024] child means a person who has not attained the age of 18 years;

coroner means a coroner within the meaning of the Coroners Act 1995 ;

designated officer, in relation to a hospital, means a person appointed under section 4 to be a designated officer for that hospital;

[Section 3 Subsection (1) amended by No. 19 of 2006, s. 4, Applied:10 Nov 2006] diagnostic purposes means the purposes of determining –

Compliance requires an operational playbook that aligns clinical practice, hospital governance, research ethics, and documentation to statutory requirements. Below is a practical checklist and recommended process steps aligned to the Act’s provisions, with citation references to the relevant sections.

Governance and appointments

Appoint designated officers by written instrument. Hospital managers must make formal written appointments for the hospital’s designated officers as provided in s 4(1). Ensure those appointed are not conflicted under s 4(2); specifically, exclude practitioners who treated the patient pre-mortem or who will likely perform the autopsy or tissue removal.

Consent collection procedures

For adult living donors, obtain written consent specifying the tissue and purpose, and have a medical practitioner certify the consent in writing under s 9, confirming presence, explanation of risks, age (18+), sound mind and freedom of consent. For non-regenerative tissue for transplant, include the time consent was given and observe the 24-hour delay under s 8(1)-(2).
For child donors, follow the child-consent route under ss 12-13. Joint parental and child consent is required for regenerative tissue unless a medical practitioner certifies the child’s competence under s 12(2). Ensure the certifying practitioner documents the competency assessment in a written certificate as required by s 13 and retains records.
For blood donations and transfusions, follow Division 5 and Division 5A rules. Note the different threshold for "child" in blood contexts (s 17A). For emergency transfusions to a child without parental consent, document the criteria in s 21(3)-(4), including the opinion of a second practitioner or paramedic that the child is in danger of dying and that the transfusion is the best means to prevent death, and that the transfused blood is compatible (s 21(3)(a)-(b)).

Certification and independence

Ensure the certifying medical practitioner is not the practitioner who will carry out the removal or autopsy (see s 26(1) noting exceptions), and that certificates comply with s 9 and s 13. Keep certificates in a secure, auditable file. Implement verification checks to detect falsified certificates because false statements in certificates are penalised under s 30(3)(b).

Designated officer enquiries and documentation

Require designated officers to make and document "reasonable enquiries" prior to authorising removals, non-coronial autopsies, or tissue use (ss 23(1), 26B(1), 26C(1)-(2)). Standardise what constitutes "reasonable enquiries" as a matter of hospital procedure, including next-of-kin checks, searches for documented objections, and coroner liaison where relevant. Preserve documentation evidencing inquiries to mitigate exposure under s 30(3)(a).

Coroner coordination

For deaths that may be reportable under the Coroners Act, immediately notify the coroner and obtain coroner consent where required under s 28A(1). Keep records if the coroner directs that their consent is not required (s 28A(2)). Establish protocols with local coroner offices to expedite decision-making.

Revocation and communication pathways

Implement a revocation protocol consistent with s 22, including training for all hospital employees, attending medical practitioners and registered nurses who might receive a revocation. Ensure these staff know to inform the designated officer forthwith (s 22(3)). Create forms or electronic flags to ensure instruments of consent are surrendered and any certificates attached are collected and secured, as required by s 22(5).

Research ethics and child research donations

For research involving child tissue, obtain approval from a human research ethics committee in accordance with the Australian Code and the National Statement, as defined in s 22A. Ensure consent processes comply with the National Statement and that a medical practitioner records satisfaction with benefit or negligible risk as required by s 22B(2)-(3). Maintain the human research ethics committee’s approval documentation and record the practitioner’s satisfaction.

Confidentiality and data handling

Implement privacy and information access controls consistent with s 31. Restrict disclosure of identifying information about donors and recipients, particularly for tissue other than blood and for child blood donors. Where disclosure is necessary for research, ensure it falls under the "bona fide medical research" exemption and is supported by research ethics committee approval, or obtain informed consent from the person or next of kin under s 31(4)(c).

Trading and procurement policies

Prohibit contracts that provide valuable consideration for the sale or supply of tissue in contravention of s 27(1). Where processed non-blood tissue is sold for use under a medical practitioner’s directions, confirm that the processing and intended use fall within s 27(2). Maintain documentation of reimbursements of necessary expenses to satisfy the narrow exception in s 27(3). If a commercial arrangement may depend on Ministerial approval under s 27(4), seek that approval in writing and keep the instrument.

Record-keeping and regulatory compliance

Adopt and maintain records and reports as may be prescribed under s 32. Even absent regulations, implement internal records for removal, authorisation, certificate copies, inquiry notes, coroner communications, and disposal plans. Submit draft hospital guidelines for non-coronial autopsies and stillborn examinations to the Secretary for approval where applicable, and implement any Secretary-issued guidelines per s 26F.

Training and audit

Provide staff training on consent requirements, the 24-hour rule, revocation procedures, coroner consent processes, confidentiality obligations, and the boundaries of permitted commercial activity. Schedule regular audits of consent forms, certificates, and designated officer inquiries to detect and remedy compliance gaps. Ensure clinical governance includes review of competence certificates for child consent and documentation for research approvals.

Incident response and legal liaison

Establish immediate incident response procedures for suspected unauthorised removals, false certificates, or privacy breaches, including legal counsel notification. Because s 29 preserves liability for negligence, integrate clinical risk management and professional indemnity considerations into the incident response plan.

By translating the statutory mechanics into policies, training, and recordkeeping aligned to the specified sections , notably ss 4, 7-9, 12-13, 17A, 21, 22, 23-26, 26F, 27-28A, 30-32 , hospitals, medical practitioners, and researchers can materially reduce the risk of criminal exposure, administrative sanctions, and professional liability.