Victorian Bills Explanatory Memoranda Victorian Bills Explanatory Memoranda[Index] [Search] [Download] [Bill] [Help]
Research Involving Human Embryos
Bill 2008
Introduction Print
EXPLANATORY MEMORANDUM
General
This Bill re-enacts Part 2A of the Infertility Treatment Act 1995 in a
separate Bill, consistent with the Research Involving Human Embryos Act
2002 of the Commonwealth. The Research Involving Human Embryos Bill
2008 continues to regulate certain activities involving the use of human
embryos.
Background
In June 2005, the Commonwealth Minister for Ageing, the Hon.
Julie Bishop MP (who then had portfolio responsibility for human cloning
and stem cell research), appointed a six-member Legislative Review
Committee to independently review the Commonwealth Prohibition of
Human Cloning Act 2002 and the Research Involving Human Embryos Act
2002. This was in accordance with a requirement in both Acts that they be
reviewed by an independent committee by December 2005.
The Legislative Review Committee was chaired by the late John S Lockhart
AO QC, a former Justice of the Federal Court of Australia. The Lockhart
Committee made 54 recommendations resulting in the amendment of the
Commonwealth legislation. On 12 December 2006 the Prohibition of Human
Cloning for Reproduction and the Regulation of Human Embryo Research
Amendment Act 2006 was enacted, with the Amendment Act taking effect on
12 June 2007.
At the Council of Australian Governments meeting on 13 April 2007, all
States and the ACT gave an undertaking to use their best endeavours to
introduce into their respective Parliaments a Bill that would have the effect of
achieving national consistency with the Commonwealth Research Involving
Human Embryos Act 2002 and Prohibition of Human Cloning Act 2002.
In Victoria, the provisions related to this legislation were found in Parts 2A
and 4A of the Infertility Treatment Act 1995.
561273 1 BILL LA INTRODUCTION 9/9/2008
In 2007, amendments were made to these Parts to mirror the amended
Commonwealth legislation. An undertaking was also given by the then
Victorian Minister for Health to remove Parts 2A and 4A from the Infertility
Treatment Act 1995 and to reproduce the material in two separate pieces of
legislation, in the same way as the Commonwealth. The timing of this
removal was contingent on the completion of the review of the Infertility
Treatment Act 1995 by the Victorian Law Reform Commission.
The Victorian Law Reform Commission submitted its recommendations to
Government in March 2007 in the Assisted Reproductive Technology and
Adoption Final Report. The Infertility Treatment Act 1995 is to be
repealed by the Assisted Reproductive Treatment Bill 2008. Accordingly,
Part 2A will be reproduced in stand alone legislation at the same time that the
Infertility Treatment Act 1995 is repealed.
Clause Notes
Clause 1 sets out the purpose of the Act.
Clause 2 provides that the Bill is to commence on a day to be fixed by
proclamation but no later than 1 January 2010.
Clause 3 is the definition section. Key definitions, which are essential to
defining the scope of the legislation and describing how it is to be
administered, include the following--
accredited ART centre is defined to mean a person or body
accredited to carry out assisted reproductive technology by--
· the Reproductive Technology Accreditation Committee
of the Fertility Society of Australia; or
· if the regulations prescribe another body or other bodies
in addition to, or instead of, the body mentioned in
paragraph (a)--that other body or any other bodies as
the case requires.
The Reproductive Technology Accreditation Committee (RTAC)
of the Fertility Society of Australia oversees a system of industry
based regulation for centres using ART or carrying out associated
research and sets professional and laboratory standards for
centreal practice. ART centres are usually accredited by the
RTAC for three years. Accredited ART centres are expected to
comply with the RTAC Code of Practice for Centres using
Assisted Reproductive Technology and any relevant Guidelines
issued by the RTAC.
2
human embryo which is defined to mean a discrete entity that
has arisen from either--
· the first mitotic division when fertilisation of a human
oocyte by a human sperm is complete; or
· any other process that initiates organised development
of a biological entity with a human nuclear genome that
has the potential to develop up to , or beyond, the stage
at which the primitive streak appears--
and has not yet reached 8 weeks of development since the first
mitotic divison.
This definition was developed by the National Health and
Medical Research Committee (NHMRC) and inserted in 2007.
The NHMRC arrived at this definition by forming the Biological
Definition of Embryo Working Party, comprising three NHMRC
Embryo Research Licensing Committee members and three other
Australian experts. Their Draft Report of the Biological
Definition of Embryo Working Party was peer reviewed by
Australian and international experts.
partner is defined as a person's spouse, or another person who
lives with the first person as a couple on a genuine domestic
basis, irrespective of gender.
proper consent, in relation to the use of an excess ART embryo
or a human egg, or the creation or use of any other embryo,
means consent obtained in accordance with guidelines issued by
the CEO of the NHMRC under the National Health and Medical
Research Council Act 1992 of the Commonwealth and prescribed
by regulations under Commonwealth legislation for the purposes
of this definition.
responsible person means--
(a) in relation to an excess ART embryo--
(i) each person who provided the egg or sperm from
which the embryo was created; and
(ii) the woman for whom the embryo was created, for
the purpose of achieving her pregnancy; and
(iii) any person who was the partner of a person
mentioned in subparagraph (i) at the time the egg
or sperm mentioned in that paragraph was
provided; and
3
(iv) any person who was the partner of the woman
mentioned in subparagraph (ii) at the time the
embryo was created; or
(b) in relation to an embryo other than an excess ART
embryo--each person whose reproductive material,
genetic material or cell was used, or is proposed to be
used, in the creation or use of the embryo; or
(c) in relation to a human egg--the woman who was the
biological donor of the egg.
Paragraphs (b) and (c) ensure that all appropriate people provide
consent in relation to the use of a human egg for research or the
creation and use of an embryo created by means other than
fertilisation of human egg by human sperm.
unsuitable for implantation in relation to a human embryo
means one that--
· is diagnosed by preimplantation genetic diagnosis as
unsuitable for Clause implantation, in accordance with
the Ethical Guidelines on the Use of Assisted
Reproductive Technology in Centreal Practice and
Research (2007); or
· is determined to be unsuitable for implantation in
accordance with objective criteria to be specified in
guidelines developed by the NHMRC and prescribed in
regulations made under the Commonwealth legislation.
use includes develop, or development, as the case requires.
This has been included for convenience only so that when the Act
refers to use of an embryo (for example, as authorised by the Act)
this includes development of an embryo.
Subsection 3(2) of the Act clarifies that for the purposes of the
definition of human embryo, in working out the length of period
of development of a human embryo, any period when
development of the embryo is suspended (for example, while it is
frozen) is not included. For example, if an embryo is placed in
storage 2 days after fertilisation and is held in storage for
10 weeks, it is still considered to be a 2 day embryo in terms of
its development.
4
Subsection 3(3) clarifies that reference to an embryo is a
reference to a human embryo unless the contrary intention
appears. Section 3(4) clarifies that a reference to a human
embryo refers to a living embryo only. Section 3(6) clarifies that
a reference to a human embryo does not include a human
embryonic stem cell line or a hybrid embryo.
Subsection 3(5) clarifies that a reference to a human oocyte is the
same as a reference to a human egg. This provision recognises
that the NHMRC definition of a human embryo refers to a
human oocyte whereas the existing prohibitions in the
Prohibition of Human Cloning for Reproduction Act 2008
(formerly Part 4A of the Infertility Treatment Act 1995) refer
to a human egg. Rather than changing all of the existing
references from human egg to human oocyte, subsection 3(5) has
been included to make it clear that both expressions are intended
to have exactly the same meaning.
Clause 4 sets out the meaning of the phrase excess ART embryo, requiring
that--
· the embryo was created by assisted reproductive
technology for use in the assisted reproductive treatment
of a woman; and
· the embryo is excess to the needs of the woman for
whom it was created and her partner (if any) at the time
the embryo was created.
This section also provides that a human embryo is an excess ART
embryo, if--
· there is a determination in writing from the woman for
whom the embryo was created and her partner (if any)
that the embryo is excess to their needs; or
· the woman for whom the embryo was created and her
partner (if any) have provided authority, in writing, for
the embryo to be used for a purpose other than
achieving pregnancy (for example, research or training
purposes). In such a case it is assumed that, by
determining that the embryo may be used for another
purpose, the woman and her partner (if any) consider
that it is excess to their needs. It should be noted that a
determination that an embryo is excess is distinct from a
consideration of whether there is proper consent from
all responsible persons for use of the embryo.
5
Clause 5 provides that Act will bind the Crown in right of the State of
Victoria and, so far as the legislative power of Parliament
permits, in all other capacities. This section also provides that
nothing in this Act renders the Crown liable to be prosecuted for
an offence.
Clause 6 This clause essentially describes the scope of the regulatory
scheme for excess ART embryos by describing the uses of excess
ART embryos that require a licence and those that do not.
In summary, all uses of an excess ART embryo are required to be
licensed by the NHMRC Licensing Committee unless such uses
are exempt uses in accordance with subsection (3).
Clause 6(3) provides that the following uses of an excess ART
embryo are exempt (and therefore do not require licensing)--
· storing an excess ART embryo;
· removing an excess ART embryo from storage
(provided that no subsequent use of the embryo is
proposed that would otherwise require a licence);
· transporting an excess ART embryo;
· observing an excess ART embryo (including taking a
photograph of the embryo or taking a recording of the
embryo from which a visual image can be produced);
· allowing the excess ART embryo to succumb;
· diagnostic investigations using excess ART embryos
that are unsuitable for implantation (for example,
chromosomally abnormal embryos) provided that the
investigations are specifically related to achieving
pregnancy in the woman for whom the embryo was
created. In some cases, as part of routine centreal
practice, it may be beneficial to the woman for whom
the embryo was created for diagnostic tests to be
undertaken on ART embryos that are unsuitable for
implantation to determine the reason why they are not
suitable for implantation so as to improve the likelihood
of successful pregnancy in the next attempt;
· donating the excess AT embryo to another woman for
the purpose of achieving pregnancy in that other
woman;
· any other use prescribed in the regulations.
6
All other uses of an excess ART embryo are required to be
licensed by the NHMRC Licensing Committee. This includes,
for example, using excess ART embryos--
· for research (for example, to derive stem cells or to
improve ART centreal practice);
· to train people in ART techniques;
· for Quality Assurance testing to ensure that
pre-implantation diagnostic tests give accurate results;
· to examine the effectiveness of new culture media.
The NHMRC Licensing Committee will consider options to
streamline the administration of the legislation, if the NHMRC
Licensing Committee is satisfied that the use of the excess ART
embryos will not damage or destroy the embryo. For example,
ART centres could apply for one licence to undertake quality
assurance work using a defined number of excess ART embryos
and an approved list of techniques that may damage the embryo
but are part of routine ART centreal practice, such as the use of
embryos for training people in the techniques of assisted
reproductive technology.
Clause 6(1) specifically makes it an offence to intentionally use
an excess ART embryo unless the use is authorised by a licence
or is one of the exempt uses detailed above.
Clause 6(2) provides that an offence against section 6 is
punishable by imprisonment for a term not exceeding 5 years.
Clause 7 provides that a person commits an offence if a person
intentionally uses the following types of embryos without a
licence issued by the NHMRC Licensing Committee--
· a human embryo created by a process other than the
fertilisation of a human egg by a human sperm; or
· a human embryo that contains genetic material provided
by more than 2 persons; or
· a human embryo created using precursor cells from a
human embryo or a human foetus; or
· a hybrid embryo.
7
This provision is needed because the Prohibition of Human
Cloning for Reproduction Act 2008 (formerly Part 4A of the
Infertility Treatment Act 1995) relates specifically to creation
and development of embryos and the requirement for licensing in
these circumstances. This provision relates to use of embryos
that have been created or developed under licence.
This provision makes it clear that not only must the creation or
development of these types of embryos be authorised by a licence
but the use of such embryos must also be authorised by a licence.
The maximum penalty for non-compliance with this provision is
imprisonment for 5 years.
Clause 8 establishes an offence if someone undertakes research or training
involving the fertilisation of a human egg by human sperm, up to
but not including the first mitotic division, outside the body of a
woman for the purposes of ART research or training without a
licence issued by the NHMRC Licensing Committee.
The offence attracts a maximum penalty of imprisonment for up
to 5 years. This is consistent with similar existing offences in the
Bill.
Clause 9 bans the use, outside the body of a woman, of an embryo that is
not an excess ART embryo unless the use is for the purposes of
ART. The purpose of clause 9 is to ban the use of non-excess
ART embryos created by the fertilisation of human egg by
human sperm but making it clear that the ban does not extend to
use of embryos that have been created by means other than
fertilisation of human egg by human sperm. Use of any such
embryos is only permitted under licence by the NHMRC
Licensing Committee.
An offence against this clause is punishable by imprisonment for
a term not exceeding 5 years.
Clause 10 provides that a person is guilty of an offence if they intentionally
do something, or fail to do something, that they know will result
in a breach of a condition of licence or that they do so being
reckless as to whether or not the omission will contravene a
condition of licence.
8
Clause 11 clarifies that a person is not criminally responsible for an offence
against the Act if--
· the conduct by the person is purportedly authorised by a
provision of a licence; and
· the licence or the provision is invalid, whether because
of a technical defect or irregularity or for any other
reason; and
· the person did not know, and could not reasonably be
expected to have known, of the invalidity of the licence
or the provision.
This clause is intended to address the underlying policy objective
of Recommendations 50-52 of the Lockhart Review.
Those recommendations suggest that the NHMRC Licensing
Committee should be given the power to give legally binding
rulings on the interpretation of the legislation and that a person
who conducts research on the basis of a ruling should be
protected from liability under the legislation.
This recommendation raises significant constitutional issues
relating to the impermissible exercise of judicial power by a non-
judicial body. For example, in the Brandy case, the High Court
unanimously held that the power of Human Rights and Equal
Opportunities Commission to decide whether conduct was
unlawful and to award damages was an impermissible conferral
of judicial power, because of the binding and conclusive nature
of the Commission's determinations.
Recognising these concerns, a provision has been included in the
Bill (clause 11) which avoids these constitutional issues, but
attempts to address the potential liability of researchers where
they are acting in good faith in accordance with a licence but
where the NHMRC Licensing Committee in fact had no power to
issue the licence.
Clause 12 confers functions on the NHMRC Licensing Committee, which is
a Committee established by section 13 of the Commonwealth
Act. In essence, the NHMRC Licensing Committee will be
tasked with--
· considering licence applications; and
· refusing licences or granting licences including subject
to conditions; and
9
· notifying relevant people of the Committee's decision
regarding the licence application including the
applicant, the relevant Human Research Ethics
Committee (HREC) and the Authority; and
· varying, suspending or cancelling licences, should this
be necessary; and
· establishing and maintaining a publicly available
database containing information about work involving
excess ART embryos that has been licensed by the
Committee; and
· monitoring compliance with the legislation (the
NHMRC Licensing Committee may also delegate this
function to a Commonwealth or Victorian officer) and
taking any necessary enforcement action; and
· providing information about the Committee's functions
for inclusion in the NHMRC annual report; and
· providing advice to applicants on the licensing
requirements and the preparation of applications.
Clause 13 provides that the NHMRC Licensing Committee has power to do
all things needed to be done in connection with the performance
of the NHMRC Licensing Committee's functions.
Clause 14 provides that a person may apply to the NHMRC Licensing
Committee for a licence authorising the use of excess ART
embryos. Such an application must be in accordance with the
application requirements of the NHMRC Licensing Committee.
It is expected that the person who applies for the licence will be
the organisation in which the work with excess ART embryos is
proposed to be undertaken, rather than the individual proposing
to undertake the work.
The application must also be accompanied by an application fee
if such an application fee is prescribed in the regulations.
The purpose of clause 14(1) is to set out all of the activities for
which a person may request a licence from the NHMRC
Licensing Committee. If the activity does not fall within this list,
it is not able to be licensed by the NHMRC Licensing
Committee. (This means that it is either prohibited absolutely or
does not fall within the scope of this legislation.)
10
A person may apply to the NHMRC Licensing Committee for a
licence authorising one or more of the following--
· use of excess ART embryos;
· creation of human embryos other than by fertilisation of
a human egg by a human sperm, and use of such
embryos;
· creation of human embryos (other than by fertilisation
of a human egg by a human sperm) and containing
genetic material provided by more than 2 persons, and
use of such embryos;
· creation of human embryos using precursor cells from a
human embryo or a human foetus, and use of such
embryos;
· research and training involving the fertilisation of a
human egg, up to the first mitotic division, outside the
body of a woman for the purposes of research or
training;
· creation of hybrid embryos by the fertilisation of an
animal egg by human sperm, and use of such embryos
up to the first mitotic division, if--
(i) the creation or use is for the purposes of testing
sperm quality; and
(ii) the creation or use will occur in an accredited
ART centre.
Subclause 14(2) makes it clear that section 14(1) does not permit
the NHMRC Licensing Committee to authorise any use of an
excess ART embryo or other embryo that would result in the
development of the embryo for a period of more than 14 days,
excluding any period when development is suspended.
Clause 15 describes the matters that must be considered by the NHMRC
Licensing Committee when deciding whether or not to issue a
licence. The clause sets out certain things that the NHMRC
Licensing Committee must be satisfied of before it issues a
licence and other issues that the NHMRC Licensing Committee
must have regard to when deciding whether or not to grant a
licence.
11
Clause 15(3) provides that the NHMRC must not issue the
licence unless it is satisfied that--
· appropriate protocols are in place to enable proper
consent to be obtained before an excess ART embryo is
used , or other embryo is created or used under the
licence, and to ensure that if restrictions on the use of an
embryo have been specified, these restrictions will be
observed; and
· the proposed project has been considered and assessed
by a Human Research Ethics Committee (HREC) that is
constituted in accordance with, and acting in
compliance with, the National Statement on Ethical
Conduct in Human Research (2007), issued by the
NHMRC, (or other such document that may replace
National Statement).
Clause 15(4) provides that in deciding whether to issue a licence,
the NHMRC Licensing Committee must have regard to the
following--
· restricting the number of embryos necessary to achieve
the goals of the project;
· whether there are likely to be any significant advances
in knowledge or improvements in technologies for
treatment as the result of the use of the excess ART
embryos;
· any relevant guidelines or parts of guidelines, issued by
the NHMRC;
· the HREC assessment of the application;
· such additional matters as are prescribed by the
regulations.
Clause 16 requires the NHMRC Licensing Committee to notify its decision
on an Clause application to the applicant, the HREC that
considered the application and the Authority. In addition, if the
NHMRC Licensing Committee issues a licence to the applicant, a
copy of the licence must also be provided to the HREC and the
Authority.
12
Clause 17 provides that a licence comes into force on the day specified in
the licence or, if no such date is specified, the day that the licence
is issued. The licence ceases operation on the day specified in
the licence unless it is suspended, revoked or surrendered before
that day.
Clause 17(2) clarifies that a licence is not in force throughout any
period of suspension.
Clause 18 describes the conditions to which all licences issues by the
NHMRC Licensing Committee are subject and enables the
NHMRC Licensing Committee to impose any other conditions it
considers necessary.
Clause 18(1) and (2) describe the conditions that all licence
holders must comply with. These subclauses provide that before
a person can use an excess ART embryo, or human egg, or create
or use any other embryo (under a licence issued by the NHMRC
Licensing Committee)--
· proper consent must have been obtained for the creation
or use in accordance from each responsible person; and
· the licence holder must have reported in writing to the
NHMRC Licensing Committee that such consent has
been obtained, and any restrictions to which the consent
is subject.
Once a licence holder has provided this information to the
NHMRC Licensing Committee, the licence holder may
commence work with the excess ART embryo, human egg and
other embryos provide they do so in accordance with any
restrictions imposed.
Clause 18(3) and (4) provide that the NHMRC Licensing
Committee may impose any other conditions that are necessary
and provides some examples of the types of conditions the
NHMRC Licensing Committee may impose. For example, the
NHMRC Licensing Committee may impose conditions relating
to the following--
· the persons authorised by the licence to use excess ART
embryos, human eggs or create or use other embryos;
· the number of excess ART embryos or human eggs in
respect of which use is authorised by the licence, or the
number of other embryos authorised to be created or
used under the licence;
· reporting;
13
· monitoring;
· information to be given by the licence holder to persons
authorised by the licence to use excess ART embryos or
human eggs, or to create or use other embryos.
Clause 18(5) provides that the conditions included in section
18(1), (2) and (3) are applicable to all people who are authorised
by the licence to use excess ART embryos or human eggs, or to
create or use other embryos.
Clause 18(6) provides that licence conditions specified in the
licence are applicable to the licence holder and any other people
who are authorised by the licence to use excess ART embryos or
human eggs, or to create or use other embryos as specified in the
licence.
Clause 18(7) provides that a licence in relation to embryos that
are unsuitable for implantation (as defined) may provide that the
NHMRC guidelines referred to in the definition of proper consent
may apply in a modified form in relation to the use, under the
licence, of excess ART embryos that are unsuitable for
implantation.
The purpose of this provision is to allow fresh ART embryos that
are unsuitable for implantation, as defined by objective criteria,
to be able to be licensed for use in training and research.
Currently, the Act does not expressly prohibit this.
However, there is a statutory condition of licence that the
responsible people in relation to an excess ART embryo must
give proper consent to any research, in accordance with NHMRC
guidelines. The relevant guidelines are the Australian Health
Ethics Committee (AHEC) Ethical Guidelines on the use of
assisted reproductive technology in centreal practice and research
(June 2007). These Guidelines provide that--
· a person responsible for an embryo must be free at any
time to withdraw consent to further involvement in the
research. In view of the fact that once an embryo has
been destroyed it cannot be restored, it is recommended
that the consent of the persons responsible to a use that
will damage or destroy an embryo must not be acted
upon until a suitable fixed period of time for
reconsideration has been allowed, normally at least two
weeks after their consent to such research.
This "cooling-off" period before consent becomes
effective must be explained to the persons responsible
when consent is obtained.
14
Clause 18(7) clarifies that if the NHMRC Licensing Committee
considers it appropriate, it may approve the use of embryos that
are unsuitable for implantation and alter the cooling-off period
that would be "normally at least two weeks" as recommended by
the NHMRC. This would allow the use of excess ART embryos
that are unsuitable for implantation and would still ensure that
appropriate consent is obtained from the responsible people.
In no circumstances would the use of embryos that are not excess
be permitted.
Clause 19 enables the NHMRC Licensing Committee to vary a licence.
There are two possible circumstances in which the NHMRC
Licensing Committee may need to vary a licence--
· on request of the licence holder. For example, if the
licence holder wishes to change administrative details
on the licence such as contact details or more significant
such as the duration of the licence; and
· if the NHMRC Licensing Committee considers it
necessary or desirable to vary a condition of licence.
For example, should the NHMRC Licensing Committee
wish to add additional conditions of licence, change the
wording of existing conditions of licence or delete
existing conditions of licence.
Clause 19(4) clarifies that the NHMRC Licensing Committee
cannot vary a licence so that the varied licence would be contrary
to the requirements set out in section 14. For example, the
NHMRC Licensing Committee could not vary a licence after it
has been issued so as to allow the use of more excess ART
embryos than approved for the activity or project proposed in the
licence application.
Clause 20 enables the NHMRC Licensing Committee to suspend or revoke
a licence that has been issued if it believes, on reasonable
grounds, that a condition of the licence has been breached.
This is a very important provision as it enables the NHMRC
Licensing Committee to take immediate action in the event of
non-compliance. By suspending or revoking the licence the work
can no longer continue.
The NHMRC Licensing Committee has the power to reinstate the
licence should the suspected breach of condition fail to be
established or should the licence holder rectify the situation and
the Committee is convinced that the work can Clause continue
without further breaches. Whether or not the licence is
suspended, cancelled or subsequently reinstated would depend on
15
the individual circumstances of the case and the extent, severity
and importance of the breach.
It is important that the NHMRC Licensing Committee has a
degree of discretion in this respect given that breaches of licence
can range from fairly minor infringements (for example, late
submission of annual reports to the NHMRC Licensing
Committee) through to very serious breaches such as using more
embryos than has been authorised by the licence.
Clause 21 provides that a licence holder may surrender a licence by written
notice to the NHMRC Licensing Committee. An organisation
may wish to surrender a licence if, for example, it has completed
the work involving the excess ART embryos or human eggs, or
other embryos.
Clause 22 provides that if the NHMRC Licensing Committee varies,
suspends, or revokes a licence the Committee must notify the
changes to the Authority as well as the licence holder and the
relevant Human Research Ethics Committee. In addition, if the
changes to the licence impacts on the information that is included
on the publicly available database, the database must also be
amended to reflect the change.
Clause 23 provides that the NHMRC Licensing Committee must establish
and maintain a comprehensive, publicly available data base
containing information about licences that have been issued by
the NHMRC Licensing Committee.
Clause 23(1) provides that the database must include the
following information in relation to each licence--
· the name of the person to whom the licence was issued;
· the nature of the uses of the excess ART embryos or
human eggs, or creations and uses of any other
embryos authorised by the licence. For example, the
record would state whether the embryos are proposed to
be used for the derivation of stem cells, for use for
testing culture medium, for training of technicians, etc;
· the conditions of licence;
· the number of excess ART embryos or human eggs
proposed to be used, or the number of other embryos
proposed to be created or used. At the time that a
licence is granted, one of the conditions would describe
the maximum number of embryos permitted to be used
as part of the project. Another condition of licence
16
would describe reporting requirements including in
relation to how many embryos were actually used and
when they were used. It is proposed that the NHMRC
Licensing Committee will update the data base to reflect
the number of embryos actually used in a project;
· the date on which the licence was issued;
· the period of the licence.
Clause 24 is intended to protect from public disclosure certain information
that is legitimately confidential commercial information.
A definition of confidential commercial information is in
section 3 of the Act. The term is defined to mean information
that has a commercial or other value that would be, or could
reasonably be expected to be, destroyed or diminished if the
information were disclosed.
The effect of this section is that the NHMRC Licensing
Committee can decide not to release certain information into the
public domain (for example, by inclusion on the database
established by section 23) if the NHMRC Licensing Committee
is satisfied that the information is commercial information or
other information (such as research findings) that has a value that
would be, or could reasonably be expected to be, destroyed or
diminished as the result of the disclosure.
The NHMRC Licensing Committee would have access to the
confidential commercial information in assessing applications
and could disclose such information to a State Agency (which is
defined to include the State, the Minister and the Authority), the
Commonwealth and to relevant Commonwealth agencies but
these bodies could not disclose the information to anyone else.
However, such information may only be disclosed in the course
of performing duties or functions under this Act or the
Commonwealth Act.
The information may also be disclosed by order of a court or with
the consent of the person to whom the information has a
commercial or other value.
17
Clause 25 describes those persons who are able to seek review in relation to
various types of decisions made by the NHMRC Licensing
Committee. In summary, the clause provides that an eligible
person in relation to a decision of the NHMRC Licensing
Committee means--
· a licence applicant--in relation to a decision by the
NHMRC Licensing Committee not to issue a licence;
and
· the licence holder in relation to--
· a decision by the NHMRC Licensing Committee
relating to the period of a licence; or
· a condition of licence imposed by the NHMRC
Licensing Committee; or
· a decision by the NHMRC Licensing Committee
to vary, refuse to vary, suspend or revoke a
licence; or
· a decision by the NHMRC Licensing Committee
to modify guidelines under clause 18(7) in
respect of a licence.
Clause 26 provides that an eligible person (as defined in clause 25) may
apply to the Commonwealth Administrative Appeals Tribunal for
review of the following decisions of the NHMRC Licensing
Committee--
· a decision under clause 15 not to issue a licence;
· a decision in respect of the period throughout which the
licence is to be in force under clause 17;
· a decision to specify a licence condition under
clause 18(4);
· a decision to modify guidelines under clause 18(7);
· a decision to vary or refuse to vary a licence under
clause 20;
· a decision to suspend or revoke a licence under
clause 21.
18
Clause 26 also provides that this section has effect subject to the
Administrative Appeals Tribunal Act 1975 of the
Commonwealth.
Clause 27 confers powers upon an inspector to enter any premises and to
exercise any or all of the powers set out in clause 28 for the
purposes of establishing whether or not the Act or the regulations
are being complied with.
There is a definition of inspector in section 3 which states that an
inspector is a person appointed under clause 33(1) of the
Commonwealth Act.
Clause 27(2) provides that an inspector may only enter premises
under this section if--
· they have the consent of the occupier; or
· the occupier of the premises is a licence holder, or a
person covered by a licence, and the entry is at a
reasonable time; or
· the entry is made under a warrant in accordance with
clause 30.
The monitoring powers also enable entry, inspection and
enforcement in relation to non-licensed facilities in the same
manner and by the observance of the same procedures as
applicable to search warrants under Commonwealth legislation
(Recommendation 39).
This approach is consistent with the approach detailed in the
Gene Technology Act 2000 and with general Australian
Government law enforcement policy.
Clause 28 describes the monitoring powers that an inspector may exercise
for the purposes of finding out whether the Act or the regulations
are being complied with.
Clause 29 provides that if an inspector, during the course of inspecting
premises, finds something that may be evidence in relation to an
offence committed under the Act the inspector may secure the
thing pending the obtaining of a warrant to seize it.
Clause 30 provides that an inspector may apply to a magistrate for a warrant
and the magistrate may issue a warrant if the magistrate is
satisfied that it is reasonably necessary that one or more
inspectors should have access to the premises for the purposes of
finding out whether the Act or any regulations made under it
have been complied with.
19
The warrant enables one or more inspectors to enter premises and
exercise the powers set out in clause 28 in relation to the
premises.
Clause 31 provides that if a warrant under clause 30 is being executed and
the occupier of the premises or another person who represents the
occupier is present at the premises, then the inspector must make
a copy of the warrant available to the person and identify himself
or herself to that person.
Clause 32 provides that an inspector must, before entering premises under a
warrant, announce that he or she is authorised to enter the
premises and give any person at the premises an opportunity to
allow entry to the premises.
Clause 33 provides that if a warrant is being executed and the occupier of
the premises (or another person who represents the occupier) is
present at the premises, the person is entitled to observe the
search being conducted but must not impede the search.
Clause 34 provides that an inspector cannot exercise any of the powers
under this Part in relation to premises unless he or she produces
an identity card upon being requested to do so by the occupier of
those premises.
Clause 35 provides that, before obtaining consent from a person to enter
premises under clause 27(2)(a) the inspector must inform the
person that he or she may refuse consent.
Clause 35(2) clarifies that any consent given by a person to
enable entry to Clause premises by the inspector must be
voluntary.
Clause 36 provides that if damage is caused to equipment or other facilities
as a result of it being operated by an inspector and the damage
resulted from insufficient care being exercised by the inspector in
operating the equipment, compensation is payable to the owner.
Compensation is payable by the NHMRC Licensing Committee
from monies appropriated by the Commonwealth Parliament for
the purpose pursuant to the Commonwealth Act. In determining
the amount payable, regard is to be had to whether the occupier
(or his or her employees and agents) had provided any warning or
guidance as to the operation of the equipment or facility. This is
to minimise compensation in cases where, for example, there has
been a deliberate programming of software to destroy or cause
damage if not accessed in a particular manner, or where the
occupier failed to mitigate damage by providing warning or
guidance.
20
Clause 37 provides that the monitoring powers in Part 4 of the Bill also
apply to the Prohibition of Human Cloning for Reproduction
Act 2008.
Clause 38 enables the Governor in Council to make regulations prescribing
matters required or permitted by this Bill or necessary or
convenient to be prescribed for the carrying out or giving effect
to this Bill.
Clause 39 specifies that for the purposes of the transitional provisions, a
reference to the repealed Act means the Infertility Treatment
Act 1995.
Clause 40 provides that from commencement of the Bill, references in other
Acts and in documents to Part 2A is taken to be a reference to
this Act if the context permits.
Clause 41 provides that, if a person applied for a licence under Part 2A of
the Infertility Treatment Act 1995 and the licence had not been
granted before this Bill commenced, the application is to be
decided under this Bill.
Clause 42 provides that a licence in force under Part 2A of the Infertility
Treatment Act 1995 immediately before this Bill commenced
continues in force after the commencement of this Bill.
Clause 43 clarifies that if, before the commencement of this Bill,
proceedings for an offence under Part 2A of the Infertility
Treatment Act 1995 had started but not been completed, and
determined, the proceedings may continue under that Act.
Clause 44 provides that consent regarding research given under the IT Act
is to be considered consent given for the purposes of this Bill.
Clause 45 provides that--
· gametes or embryos donated for research procedures
under the IT Act but not used in those procedure on
commencement must be taken to have been donated for
the purpose of research under this Bill; and
· donors of gametes or embryos referred to above must be
taken to be donors for the purposes of this Bill.
Clause 46 makes a consequential amendment to the Magistrates' Court
Act 1989.
21