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TASMANIA
__________
HUMAN TISSUE AMENDMENT BILL 2006
__________
CONTENTS
1. Short title
2. Commencement
3. Principal Act
4. Section 3 amended (Interpretation)
5. Section 4 substituted
4. Designated officers
6. Section 7 amended (Consent by adult living donor to removal of
regenerative tissue)
7. Section 18 amended (Consents by adults to removal of blood)
8. Section 23 amended (Authority to remove tissue where body of
deceased at a hospital)
9. Section 24 amended (Authority to remove tissue where body of
deceased not at a hospital)
10. Section 25 repealed
11. Part IIIA inserted
PART IIIA Non-coronial autopsies and medical
examinations
Division 1 General
26A. Non-coronial autopsies to be dignified
Division 2 Consent to non-coronial autopsies
26B. Authority to perform non-coronial autopsy
26C. Removal of tissue during non-coronial autopsy
26D. Effect of authorisation under this Part
Division 3 Consent to medical examination
[Bill 38]-II
26E. Medical examination of stillborn child
Division 4 Procedure
26F. Secretary to approve or issue guidelines
12. Section 28A inserted
28A. Consent by coroner
13. Section 30 amended (Offences)
14. Section 31 amended (Disclosure of information)
15. Section 32 substituted
32. Regulations
2
HUMAN TISSUE AMENDMENT BILL 2006
(Brought in by the Minister for Health and Human Services,
the Honourable Larissa Tahireh Giddings)
A BILL FOR
An Act to amend the Human Tissue Act 1985
Be it enacted by His Excellency the Governor of Tasmania, by
and with the advice and consent of the Legislative Council and
House of Assembly, in Parliament assembled, as follows:
1. Short title
This Act may be cited as the Human Tissue
Amendment Act 2006.
2. Commencement
This Act commences on the day on which this
Act receives the Royal Assent.
3. Principal Act
In this Act, the Human Tissue Act 1985* is
referred to as the Principal Act.
*No. 118 of 1985
[Bill 38] 3
Human Tissue Amendment Act 2006
Act No. of
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4. Section 3 amended (Interpretation)
Section 3(1) of the Principal Act is amended as
follows:
(a) by inserting the following definition
before the definition of "child":
"affected deceased person" means a
deceased person whose death is a
reportable death within the
meaning of the Coroners Act
1995;
(b) by inserting the following definitions
after the definition of "designated
officer":
"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 a deceased
person;
"hospital manager" means the person
that has the day-to-day
administrative control of the
hospital;
(c) by inserting the following definition after
the definition of "next of kin":
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Human Tissue Amendment Act 2006
Act No. of
s. 4
"non-coronial autopsy" means an
autopsy that is authorised under
Part IIIA;
(d) by omitting "available;" from paragraph
(b)(iv) of the definition of "senior
available next of kin" and substituting
"available; or";
(e) by inserting the following subparagraph
after subparagraph (iv) in paragraph (b)
of the definition of "senior available next
of kin":
(v) 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;
(f) by inserting the following definition after
the definition of "senior available next of
kin":
"therapeutic, medical or scientific
purpose" includes
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Human Tissue Amendment Act 2006
Act No. of
s. 5
(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;
5. Section 4 substituted
Section 4 of the Principal Act is repealed and the
following section is substituted:
4. Designated officers
(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
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Human Tissue Amendment Act 2006
Act No. of
s. 6
(i) the performance of a non-
coronial autopsy on the
deceased person; or
(ii) the removal of tissue at
such an autopsy.
6. Section 7 amended (Consent by adult living donor
to removal of regenerative tissue)
Section 7(b) of the Principal Act is amended by
omitting "therapeutic purposes or for medical or
scientific purposes" and substituting
"therapeutic, medical or scientific purposes".
7. Section 18 amended (Consents by adults to removal
of blood)
Section 18(b) of the Principal Act is amended by
omitting "therapeutic purposes or for medical or
scientific purposes" and substituting
"therapeutic, medical or scientific purposes".
8. Section 23 amended (Authority to remove tissue
where body of deceased at a hospital)
Section 23 of the Principal Act is amended as
follows:
(a) by omitting from subsection (1)(a)(ii)
"therapeutic purposes or for medical or
scientific purposes" and substituting
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Human Tissue Amendment Act 2006
Act No. of
s. 9
"therapeutic, medical or scientific
purposes";
(b) by omitting subparagraph (iv) from
subsection (2)(b) and substituting the
following subparagraph:
(iv) 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
9. Section 24 amended (Authority to remove tissue
where body of deceased not at a hospital)
Section 24(1)(b) of the Principal Act is amended
by omitting "therapeutic purposes or for medical
or scientific purposes" and substituting
"therapeutic, medical or scientific purposes".
10. Section 25 repealed
Section 25 of the Principal Act is repealed.
8
Human Tissue Amendment Act 2006
Act No. of
s. 11
11. Part IIIA inserted
After section 26 of the Principal Act, the
following Part is inserted:
PART IIIA NON-CORONIAL AUTOPSIES AND
MEDICAL EXAMINATIONS
Division 1 General
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.
Division 2 Consent to non-coronial autopsies
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
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Human Tissue Amendment Act 2006
Act No. of
s. 11
(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
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Human Tissue Amendment Act 2006
Act No. of
s. 11
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
(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
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Act No. of
s. 11
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
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Act No. of
s. 11
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.
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Act No. of
s. 11
(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
(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,
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Act No. of
s. 11
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.
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Act No. of
s. 11
Division 3 Consent to medical examination
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
16
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Act No. of
s. 11
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
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Act No. of
s. 11
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 parental
conditions of 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.
Division 4 Procedure
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.
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Act No. of
s. 11
(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.
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Act No. of
s. 11
(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.
20
Human Tissue Amendment Act 2006
Act No. of
s. 12
12. Section 28A inserted
After section 28 of the Principal Act, the
following section is inserted in Part V:
28A. Consent by coroner
(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.
21
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Act No. of
s. 13
(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).
13. Section 30 amended (Offences)
Section 30 of the Principal Act is amended as
follows:
(a) by omitting from the penalty under
subsection (1) "10 penalty units" and
substituting "50 penalty units";
(b) by inserting the following subsection
after subsection (1):
(1A) 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, sufficient authority for
22
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Act No. of
s. 14
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.
14. Section 31 amended (Disclosure of information)
Section 31(1)(a) of the Principal Act is amended
by omitting "therapeutic purposes or for medical
or scientific purposes" and substituting
"therapeutic, medical or scientific purposes".
15. Section 32 substituted
Section 32 of the Principal Act is repealed and
the following section is substituted:
32. Regulations
(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
23
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Act No. of
s. 15
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 dead); and
(ii) the use of the tissue for
any purpose; and
24
Human Tissue Amendment Act 2006
Act No. of
s. 15
(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
25
Human Tissue Amendment Act 2006
Act No. of
s. 15
published or issued before or after the
commencement of this Act.
26 Government Printer, Tasmania