Human Tissue and Anatomy
Legislation Amendment Bill 2003

Explanatory note
This explanatory note relates to this Bill as introduced into Parliament.

Overview of Bill

The objects of this Bill are as follows:

(a) to allow tissue lawfully removed from the body of a living person for the
purposes of medical, dental or surgical treatment to be used for other
therapeutic, medical or scientific purposes only with the consent of the
person from whom the tissue was removed or, if the person has died, a
senior available next of kin,

(b) to allow tissue to be removed from the body of a deceased person and used
for therapeutic, medical or scientific purposes only with the written
consent of the deceased person (given during his or her lifetime) or the
consent of a senior available next of kin (so that a lack of objection by
those persons will no longer be sufficient to authorise the procedure),

(c) to allow a post-mortem examination of a deceased person to be conducted,
in non-coronial cases, only with the written consent of the deceased person
(given during his or her lifetime) or a senior available next of kin (so that
a lack of objection by those persons will no longer be sufficient to
authorise the procedure),

(d) to allow tissue removed from the body of a deceased person for the
purposes of a post-mortem examination to be used for other therapeutic,
medical or scientific purposes only with the written consent of the
deceased person (given during his or her lifetime) or a senior available
next of kin,

(e) to make further provision with respect to the prohibition against entering
into certain contracts or arrangements relating to the sale or supply of
human tissue,

(f) to make it clear that anatomical examination includes any use of any
human body for scientific or medical purposes, or educational purposes
connected with medicine or science, and to require any such anatomical
examination to be conducted only by a licence holder under the Anatomy
Act 1977,

(g) to allow the anatomical examination of the body of a deceased person to
be conducted only with the written consent of the person (given during his
or her lifetime) or of a senior available next of kin (so that a lack of
objection by those persons will no longer be sufficient to authorise the
procedure),

(h) to make it an offence to conduct an anatomical examination of a human
body except with the appropriate authority under the Anatomy Act 1977,
        (i) to prohibit a person consenting to or authorising the removal of tissue from
the body of a deceased child who was in the care of the State, or the postmortem
examination or anatomical examination of such a deceased child,

(j) to require regard to be had to the dignity of a deceased person in the
conduct of all post-mortem examinations and anatomical examinations,

(k) to make further provision with respect to transfer and disposal of bodies
that are retained for anatomical examination,

(l) to authorise the retention or use of human tissue removed from the body
of a deceased person, without explicit authority from the deceased person
or a next of kin, in certain specific circumstances (such as where a small
sample of tissue is retained in the form of a tissue block or tissue slide),

(m) to confer more substantial enforcement powers in connection with the
provisions of the Human Tissue Act 1983,

(n) to confer additional regulation-making powers under the Human Tissue
Act 1983 and the Anatomy Act 1977,

(o) to make other miscellaneous and consequential amendments and
amendments of an ancillary nature.

Outline of provisions

Clause 1 sets out the name (also called the short title) of the proposed Act.

Clause 2 provides for the commencement of the proposed Act.

Clause 3 is a formal provision giving effect to the amendments to the Anatomy
Act 1977 set out in Schedule 1.

Clause 4 is a formal provision giving effect to the amendments to the Human
Tissue Act 1983 set out in Schedule 2.

Clause 5 is a formal provision giving effect to the amendments to the Acts
referred to in Schedule 3.

Schedule 1 Amendment of Anatomy Act 1977
Meaning of “anatomical examination”—extension of activities for
which a licence is required
The amendments make it clear that the expression anatomical examination of a
dead human body extends to the use of a body for medical or scientific purposes,
including carrying out any procedure on the body, or subjecting the body to any
experiment, process or research for medical or scientific purposes (or
educational purposes associated with medicine or science). Accordingly, anyone
who proposes to use dead human bodies for such purposes will require a licence
under the Anatomy Act 1977. See Schedule 1 [1], [2], [5]–[8], [12], [16], [17]
and [24]. Schedule 1 [23] includes a savings provision.

An anatomical examination will not include a post mortem examination that is
required or directed by a competent legal authority or authorised under the
Human Tissue Act 1983. A licence will not be required in order to conduct such
an examination. See Schedule 1 [4].

Authority to conduct anatomical examination
At present, a designated officer for a hospital may authorise the anatomical
examination of the body of a deceased person if it appears that the deceased
person had (during his or her lifetime) consented to that action or it appears that
the deceased person had not (during his or her lifetime) expressed an objection
to that action and a senior available next of kin has not objected to that action.

Under the amendments, a designated officer will be permitted to give such an
authority only if the deceased person (during his or her lifetime), or a senior
available next of kin, consents in writing to the anatomical examination.

The amendments will also allow a designated officer for a forensic institution to
give such an authority in the same circumstances.

Any anatomical examination must be conducted in accordance with the relevant
authority.

See Schedule 1 [9]–[11]. Schedule 1 [1] includes consequential amendments.

Conduct of anatomical examinations
The offences in the Act are revised so as to make it clear that:

(a) anatomical examinations must be conducted at licensed premises, and

(b) anatomical examinations must be conducted by licence holders or persons
authorised by licensed holders, and

(c) anatomical examinations must be conducted in accordance with an
authority that, under the Act, is sufficient to authorise the conduct of the
anatomical examination.

Anything authorised by or under the Coroners Act 1980, the Human Tissue Act
1983 or any other law is excluded from the above offences. See Schedule 1 [17]
and [18].

In addition, it will be an offence to give an authority under the Act without
having made the inquiries that the person is required by the Act to have made.

See Schedule 1 [17].

The amendments also make it clear that anatomical examinations are to be
conducted having regard to the dignity of the deceased person. See Schedule 1
[20].

Transfer of human tissue
The amendments allow a licence holder to transfer human tissue (that is, an
organ or other part of a dead human body) to another licence holder, an
authorised officer for a hospital or interstate hospital or any other person
approved by the Director-General of the Department of Health. Details of the
transfer must be registered, and arrangements must be made for the return and
disposal of the human tissue. See Schedule 1 [13].

Disposal of bodies
At present, the Anatomy Act 1977 requires a body of a deceased person that is
retained for anatomical examination to be disposed of within 4 years after the
death of the person. However, an inspector may authorise the retention of a body
for a longer period.

The amendments will limit the discretion of an inspector to grant such an
authorisation. In particular, an inspector will not be able to authorise the
retention of a human body, or a part of the body, for more than 8 years after the
death of the person.

The amendments also extend the disposal requirements to any human tissue that
is removed from the body, unless an authority has been given for the permanent
retention of the tissue. Small samples of tissue retained in the form of tissue
blocks or tissue slides are excluded from the disposal requirements.

See Schedule 1 [14] and [15]. Schedule 1 [23] includes a transitional provision.

Children in the care of the State
It will be an offence for a person to authorise the anatomical examination of a
child who was, immediately before his or her death, in the care of the State. See
Schedule 1 [19].

Regulation-making powers
The amendments provide for more extensive regulation-making powers.

Regulations may be made with respect to the standards to be complied with in
connection with any actions that are authorised under the Act. See Schedule 1
[21].

Schedule 1 [22] and [23] allow savings and transitional regulations to be made.

Miscellaneous
Schedule 1 [3] provides that notes in the Act do not form part of the Act. It also
allows a next of kin to delegate his or her functions under the Act to another
person. A consequential amendment in Schedule 1 [1] makes it clear that a
function includes an authority or duty.

Schedule 2 Amendment of Human Tissue Act 1983
Authority to use tissue removed from living person during medical,
dental or surgical treatment
The amendments will regulate the use of tissue lawfully removed from the body
of a living person during medical, dental or surgical treatment performed in the
interests of the health of the person. This includes tissue expelled from the body
in the course of such treatment (for example, blood).

As a result of the amendments, the use of such tissue for therapeutic, medical or
scientific purposes (other than the purposes of the treatment itself) will be
permitted only if the patient or, if the patient has died, a senior available next of
kin, has given his or her consent in writing to the use of the tissue for that
purpose. In cases where the patient is a child or is under guardianship, an
authority to use the tissue may be given by the senior available next of kin or
guardian of the patient.

All tissue must be used in accordance with the relevant consent.

See Schedule 2 [12], [23], [24] and [27]. Schedule 2 [2], [4]–[6] and [15] are
consequential amendments.

Authority to remove and use of tissue from body of deceased person
At present, a designated officer for a hospitalmay authorise the removal of tissue
from the body of a deceased person, and its use for transplantation or for other
therapeutic, medical or scientific purposes, if it appears that the deceased person
had (during his or her lifetime) consented to that action or it appears that the
deceased person had not (during his or her lifetime) expressed an objection to
that action and a senior available next of kin has not objected to that action.

Under the amendments, a designated officer will be permitted to give such an
authority only if:

(a) the deceased person (during his or her lifetime) consents in writing to the
removal and use of the tissue, or

(b) a senior available next of kin consents in writing or in another manner
prescribed by the regulations to the removal and use of the tissue.

See Schedule 2 [13].

Authority to conduct post-mortem examination
At present, a designated officer for a hospital may authorise a post-mortem
examination of the body of a deceased person if it appears that the deceased
person had (during his or her lifetime) consented to a post-mortem examination
or it appears that the deceased person had not (during his or her lifetime)
expressed an objection to a post-mortem examination and a senior available next
of kin has not objected to the post-mortem examination.

Under the amendments, a designated officer will be permitted to give such an
authority only if the deceased person (during his or her lifetime), or a senior
available next of kin, consents in writing to the post-mortem examination.

The amendments do not affect the power of a coroner to order a post-mortem
examination.

See Schedule 2 [16]. Schedule 2 [15] is a consequential amendment.

Authority to use tissue removed during post-mortem examination
At present, the Human Tissue Act 1983 provides that tissue removed from the
body of a deceased person for the purposes of a post-mortem examination may
be used for any therapeutic, medical or scientific purposes.

The amendments provide that tissue may be used for therapeutic, medical or
scientific purposes only with the consent in writing of the deceased person
(given during his or her lifetime) or a senior available next of kin.

All tissue must be used in accordance with the relevant consent.

See Schedule 2 [18], [19] (proposed Division 2 of Part 5) and [28]. Schedule 2
[1], [2], [3], [8], [14] and [17] include consequential amendments.

Persons who may give authority
The amendments allow a designated officer for a forensic institution (an
institution at which post-mortem examinations are carried out) to give
authorities under the Act in appropriate circumstances. See Schedule 2 [1], [2],
[3], [8], [16] and [19].

Prohibited trading in tissue
The amendments extend the prohibition against entering into a contract or
arrangement for the sale or supply of human tissue to the act of offering to enter
into such a contract or arrangement. See Schedule 2 [20].

The amendments also exclude from that prohibition tissue that has been
subjected to processing or treatment, whether or not the tissue is to be used in
accordance with the directions of a medical practitioner. This makes it clear that,
for example, diagnostic kits used by scientists are not subject to the prohibition
against sale. See Schedule 2 [21].

Exceptions/exclusions
The amendments make clear that the following things are permitted (without
authority under the Act):

(a) the use, for therapeutic, medical or scientific purposes, of small samples
of tissue lawfully removed from the body of a person and retained in the
formof a tissue slide or tissue block,

(b) the retention of tissue lawfully removed from the body of a person in
circumstances prescribed by the regulations, for such period as the
regulations authorise, for the purpose of obtaining an authority under the
Act to use the tissue for therapeutic, medical or scientific purposes,

(c) anything authorised by or under the Coroners Act 1980, the Anatomy Act
1977 or any other law.

See Schedule 2 [25] and [29].

Conduct of post-mortem examinations
The amendments make it clear that post-mortem examinations are to be
conducted having regard to the dignity of the deceased person. See Schedule 2
[19] (proposed Division 3 of Part 5).

Enforcement powers
The amendments allow the Director-General of the Department of Health to
appoint inspectors for the purposes of enforcing the Act and the regulations. At
present, inspectors are appointed under Part 3B of the Act and have powers only
in relation to the enforcement of that Part. Inspectors appointed under the new
provisions will have enforcement powers in relation to the whole Act. These
include the powers currently exercised by inspectors under Part 3B (such as
powers of entry and inspection, and powers of seizure) and some new
enforcement powers (such as power to require information to be provided or to
obtain a search warrant). See Schedule 2 [22].

Schedule 2 [2], [10] and [11] include consequential amendments. Schedule 2
[32] includes a transitional provision.

Schedule 3.2 is a consequential amendment to the Search Warrants Act 1985.

Children in care of the State
It will be an offence in certain circumstances for a person to consent to or
authorise the removal of tissue from the body of a deceased child who was in the
care of the State, or the post-mortem examination or use of tissue removed
during a post-mortem examination of a deceased child who was in the care of the
State. See Schedule 2 [26].

Regulation-making powers
The amendments provide for more extensive regulation-making powers.

Regulations may be made with respect to the making and keeping of records, the
provision of information and the standards to be complied with, in connection
with any actions that are authorised under the Act. See Schedule 2 [30] and [31].

Schedule 2 [32] allows savings and transitional regulations to be made.

Miscellaneous
Schedule 2 [6] makes it clear that the medical or scientific purposes authorised
under the Act include educational purposes associated with medicine or science.

Schedule 2 [9] allows a next of kin to delegate his or her functions under the Act
to another person. A consequential amendment in Schedule 2 [2] makes it clear
that a function includes a power, authority or duty.

Schedule 2 [7] provides that notes in the Act do not form part of the Act.

Schedule 3 Amendment of other Acts
Retention and use of human tissue
The amendments confirm the authority of investigating police and others to
remove and use tissue from the body of a deceased person for the purposes of a
coroner’s investigation, an investigation of an offence or proceedings for an
offence, but only where a coroner has ordered a post-mortem examination or
other examination or test.

Any such order will also be taken to authorise the retention of small samples of
certain tissue and its use in connection with legal and other proceedings.

Accordingly, an authority will not be required in respect of that use under the
Human Tissue Act 1983.

See Schedule 3.1 [3].

Ordering and conduct of post-mortem examination
The amendments make it clear that a post-mortem examination or other order or
test with respect to a deceased person may be ordered by a coroner in order to
assist in the investigation of any of the following matters:

(a) the identity of the deceased person,

(b) the date and place of death of the deceased person,

(c) the manner or cause of death of the deceased person.

A senior next of kin will be able to delegate to another person his or her right to
object to the post-mortem examination.

The amendments also require all post-mortem examinations or other
examinations or tests performed under the Coroners Act 1980 to be conducted
having regard to the dignity of the deceased person.

See Schedule 3.1 [1], [2] and [4].

Search warrants
Schedule 3.4 is a consequential amendment to Schedule 2 [22]. It applies the
provisions of the Search Warrants Act 1985 to search warrants obtained under
the Human Tissue Act 1983.

The Search Warrants Act 1985 is to be repealed by the Law Enforcement
(Powers and Responsibilities) Act 2002. Schedule 3.2 and 3.3 contain
provisions that are consequential on that repeal.

Note: If this Bill is not modified, these Explanatory Notes would reflect the Bill as passed in the House. If the Bill has been amended by Committee, these Explanatory Notes may not necessarily reflect the Bill as passed.

 

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