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2002
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
RESEARCH INVOLVING EMBRYOS AND PROHIBITION OF HUMAN CLONING
BILL 2002
EXPLANATORY MEMORANDUM
(Circulated by authority of the Prime Minister, the Hon
John Howard MP)
This Bill forms part of a national regulatory system to address concerns,
including ethical concerns, about scientific developments in relation to human
reproduction and the utilisation of human embryos. This is to be achieved
through a regulatory framework which:
(a) prohibits certain practices
associated with reproductive technologies, including the cloning of a human
being; and
(b) regulates activities that involve the use of certain human
embryos created by assisted reproductive technology.
Consistent with its
object, the Bill:
(a) prohibits the creation, importation, exportation or
implantation of a human embryo clone;
(b) prohibits the creation,
importation, exportation or implantation of certain other embryos for ethical
and safety reasons;
(c) establishes a principal committee within the National
Health and Medical Research Council (NHMRC), the NHMRC Embryo Research Licensing
Committee (the NHMRC Licensing Committee), for the purposes of performing
functions and exercising powers under the Bill;
(d) establishes a scheme for
the assessment and licensing of certain activities involving the use of excess
embryos created by assisted reproductive technology (excess ART embryos);
and
(e) provides for a centralised, publicly available database of
information about all licences issued by the NHMRC Licensing Committee.
In developing and implementing the Research Involving Embryos and
Prohibition of Human Cloning Bill 2002, the Government will incur both
establishment costs and ongoing costs.
Following the passage of the
legislation, costs are realistically expected to be approximately $3m per annum,
with an upper maximum of $6m. This involves a fixed cost to support the NHMRC
Licensing Committee and provide for ongoing compliance monitoring related to the
prohibited practices. There is also a variable cost, related to the number of
applications received. While it is not possible to accurately predict this, the
above estimate includes up to 120 applications per year, based on recent
consultation with ART service providers and researchers. Establishment costs
involve:
• developing administrative processes for receiving and
processing applications and issuing licences;
• establishing the new
NHMRC Licensing Committee;
• recruiting appropriately skilled
staff;
• establishing a skilled inspectorate to ensure compliance with
the Act through monitoring and inspection;
• assessment of research
proposals; and
• establishment and maintenance of data systems and
public reporting.
Please refer to Attachment 1 to this Explanatory Memorandum.
This is a formal provision that specifies the short title of the Bill as
the Research Involving Embryos and Prohibition of Human Cloning Act
2002.
Sub-clause 2(1) provides that the various provisions take effect
on the date specified in the table.
Item 1 of the table provides
that clauses 1 and 2 of the Bill commence on the day on which the Bill receives
Royal Assent.
Item 2 of the table provides that clauses 3 to 24
will commence 28 days after the day on which the Bill receives Royal Assent.
These clauses relate to the preliminary matters in the Bill and to the
prohibited practices included in Part 2 of the Bill.
Item 3 of the
table provides that clauses 25 to 27 will commence 6 months after the day on
which the Bill receives Royal Assent. Clause 25 provides that a person must not
use an excess ART embryo unless that use is an exempt use or is authorised by a
licence issued by the NHMRC Embryo Research Licensing Committee. Clause 26
provides that a person must not use a non-excess ART embryo unless it is part of
an ART program carried out by an accredited ART centre. Clause 27 provides that
a person must comply with any conditions of a licence.
The delay of
commencement for these clauses is to allow time:
• for the
establishment of the new NHMRC Licensing Committee; and
• for
applications for licences to be made.
During this 6 month transitional
period researchers and others will continue to have to comply with existing
State legislation and the NHMRC Ethical Guidelines on ART (1996).
By delaying the commencement of these clauses for 6 months this will
also allow States and Territories to introduce complementary legislation and,
where necessary, repeal existing provisions of State legislation that ban the
use of excess ART embryos.
Item 4 and Item 5 of the table provides that clauses 28 to 62 and Schedule 1 will commence 28 days after the day on which the Bill receives Royal Assent. These clauses provide, among other things, for the establishment and administration of the NHMRC Licensing Committee as well as provisions on the review of the Act and regulations to be made under the Act. Schedule 1 repeals certain sections of the Gene Technology Act 2000 that are replaced by clauses in Part 2 of this Bill.
This clause provides that the object of this Bill is to address concerns,
including ethical concerns, about scientific developments in relation to human
reproduction and the utilisation of human embryos:
(a) by prohibiting
certain practices; and
(b) by regulating activities that involve the use of
certain human embryos created by assisted reproductive technology.
This clause sets out the constitutional powers on which it is proposed
that the Commonwealth legislation will rely.
The Commonwealth
legislation will rely on:
• the Corporations power (paragraph
51(xx) of the Constitution). This means that the Act will apply to all things
done by corporations formed within the limits of the
Commonwealth;
• the trade and commerce power (paragraph 51(i) of the
Constitution). This means that the Act will apply to all things done in the
course of trade and commerce;
• the external affairs power (paragraph
51(xxix) of the Constitution). This enables the Act to apply to matters of
international concern;
• powers of the Parliament in relation to the
Commonwealth (section 52 of the Constitution). This means the Act will apply to
all things done by the Commonwealth and Commonwealth authorities (including
Commonwealth Departments such as the Department of Health and Ageing,
Commonwealth statutory authorities and Commonwealth companies);
• the
census and statistics power (paragraph 51(xi) of the Constitution). This
enables the Act to apply for purposes relating to the collection, compilation,
analysis and dissemination of statistics (such as the provisions relating to the
establishment of a database of licences issued by the NHMRC Licensing
Committee); and
• incidental power (paragraph 51(xxxix) of the
Constitution). This enables the establishment of the infrastructure necessary
to support the regulatory system.
Sub-clause 5(1) provides that the Bill will bind the Crown in each
of its capacities.
Sub-clause 5(2) provides that the Crown may not
be prosecuted for a criminal offence under this Bill.
This clause provides that the Bill will have application in every
external Territory. Therefore, the legislation will cover, for example, Norfolk
Island, the Indian Ocean Territories (Cocos and Christmas Islands), Macquarie
and Heard Islands, the Australian Antarctic Territory and the Jervis Bay
Territory.
This clause sets out a number of definitions for words and phrases used
in the Bill. These definitions determine the meaning that is to be attributed
to certain words or phrases whenever they are used in the Bill or regulations.
Key definitions, which are essential to defining the scope of the legislation
and describing how it will be administered, include the
following.
human embryo which is defined to mean a live
embryo that has a human genome or an altered human genome, that has been
developing for less than 8 weeks since:
• the appearance of 2
pro-nuclei; or
• the initiation of development by other
means.
This definition is intended to include:
a) a human
embryo created by the fertilisation of a human egg by human
sperm.
The Bill relies upon the appearance of 2 pro-nuclei to
establish the existence of a human embryo that has been created by the
fertilisation of a human egg by human sperm. The appearance of the pro-nuclei
indicates that the nuclei from the sperm and the egg are aligning prior to
possible fusion. For the purposes of this legislation, the 8 weeks of
development is taken to start with the appearance of 2 pro-nuclei. The
legislation does not rely on defining when fertilisation commences or is
complete.
b) a human embryo that has had its development initiated by
any means other than by the fertilisation of a human egg by human
sperm.
It is intended that the definition includes the following
types of embryos:
– a human egg that has had its nucleus replaced
by the nucleus of a somatic cell (ie a cell from the body) by the process
referred to as somatic cell nuclear transfer (SCNT); and
– a
parthenogenetic human embryo. It is possible that a human egg could be
mechanically or chemically stimulated to undergo spontaneous activation and
exhibit some of the characteristics of a fertilised human egg. A
parthenogenetic human embryo has the capacity to continue its development in a
similar manner to a human embryo created by fertilisation.
It should be noted that the procedures outlined above are provided as
examples only as there may be other ways that the development of an embryo may
be initiated. For the purposes of the legislation the 8 weeks of development is
taken to start with the initiation of development by other
means.
Subclause 7(3) 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.
human embryo clone, which is
defined to mean a human embryo that is a genetic copy of another living or dead
human, but does not include a human embryo created by the fertilisation of a
human egg by human sperm.
The reference to a human embryo clone not
including a human embryo created by the fertilisation of a human egg by human
sperm is to ensure that identical twins (or other identical multiples) that
occur through the spontaneous division of an embryo (created by fertilisation)
into two (or more) identical embryos are not defined as human embryo
clones.
Subclause 7(2) clarifies that in order to establish that a
“human embryo clone” is a genetic copy of a living or dead human, it
is sufficient to establish that a copy has been made of the genes in the nuclei
of the cells of another living or dead human. Further, the copy of the genes
does not have to be an identical genetic copy. This means that the human embryo
clone does not have to be genetically identical to the original human. This
allows for:
• the presence of DNA outside the nucleus (ie
mitochondrial DNA) that is not identical to the living or dead human from which
the nuclear DNA was taken, as would occur in an embryo created using the somatic
cell nuclear transfer technique;
• spontaneous changes to the nuclear
DNA that may occur during the development of a human embryo clone;
and
• the deliberate alteration of the DNA so that the intention is to
produce a clone of another human, but where the nuclear DNA could no longer be
considered an identical copy of the original DNA. This point is also addressed
within the definition of “human embryo”, which includes one that has
an altered human genome. As such, an embryo that is a clone of another human
and has had its genome deliberately altered will still be considered a human
embryo and therefore, as its original genome was copied, a human embryo
clone.
Subclause 7(4) clarifies that for the purposes of the
definition of “human embryo clone”, a human embryo created by the
technological process known as embryo splitting is taken not to be created by a
process of fertilisation of a human egg by human sperm and is therefore
considered to be a human embryo clone. Embryo splitting is a technique that may
be carried out on an embryo created by in vitro fertilisation, whereby
micro-surgical techniques are used to divide an embryo in the early stages of
development to produce two or more identical embryos.
This clause makes it an offence to intentionally create an embryo that is
a genetic copy of another living or dead human.
Creating a human embryo
clone by any means is an offence. That is, if any current procedures, like
somatic cell nuclear transfer, embryo splitting, or any future procedures are
used in an attempt to create a human embryo clone, then an offence is
committed.
This clause is not intended to capture the circumstance where
a human embryo created by assisted reproductive technology, spontaneously
divides into two or more identical embryos (commonly known as identical twins,
triplets etc). Clause 7 clarifies that identical twins (created by the
fertilisation of a human egg by human sperm) are not “human embryo
clones”.
The maximum penalty that may be applied for creating a
human embryo clone is 15 years imprisonment. A court may, at its discretion,
supplement the imprisonment term with a monetary penalty or convert the
imprisonment term to a monetary penalty of up to $495,000 for a corporation and
$99,000 for an individual.
This clause makes it an offence to intentionally place into the body of a
human or an animal a human embryo that is a genetic copy of another living or
dead human. This clause is intended to cover the circumstance where, for
example, a human embryo clone may have been illegally created in Australia, or
imported into Australia, and is subsequently implanted in a woman (or an
animal).
The maximum penalty that may be applied for placing a human
embryo clone in the human body or the body of an animal is 15 years
imprisonment. A court may, at its discretion, supplement the imprisonment term
with a monetary penalty or convert the imprisonment term to a monetary penalty
of up to $495,000 for a corporation and $99,000 for an individual.
This clause makes it an offence to intentionally import a human embryo
clone into Australia or intentionally export a human embryo clone from
Australia. This ensures that all avenues for obtaining a human embryo clone in
Australia are covered, whilst ensuring that a person cannot export a human
embryo clone that has been illegally created or obtained.
The maximum
penalty that may be applied for importing or exporting a human embryo clone is
15 years imprisonment. A court may, at its discretion, supplement the
imprisonment term with a monetary penalty or convert the imprisonment term to a
monetary penalty of up to $495,000 for a corporation and $99,000 for an
individual.
This clause provides that any human embryo clone that is intentionally
created, implanted, imported or exported does not have to survive to the point
of live birth in order for an offence to be established under clauses 8, 9 or
10. This would include, but is not necessarily limited to, the following
situations:
• where an unsuccessful attempt to create a human
embryo clone is made;
• where a human embryo clone is created and then
allowed to die;
• where a human embryo clone is created and
deliberately destroyed without attempting implantation;
• where a human
embryo clone is placed in a woman’s reproductive tract, but does not
successfully implant in the uterus;
• where a human embryo clone is
successfully implanted and begins to develop and then spontaneously
terminates;
• where a human embryo clone is successfully implanted and
begins to develop and is deliberately terminated; or
• where a human
embryo clone is successfully implanted, develops to full term but is
still-born.
The effect of this clause is that a human embryo intentionally created
outside the body of a woman must only be created by the fertilisation of a human
egg by human sperm. As such, an embryo must not be created by embryo splitting,
by parthenogenesis, by somatic cell nuclear transfer or by any other technique
that does not involve fertilisation of a human egg by human sperm.
It
is also an offence to develop a human embryo created by a means other than the
fertilisation of a human egg by human sperm. This ensures that if such an
embryo was imported into Australia (an offence under clause 21) it could not be
developed by the person who imported it or any other person without an offence
being committed.
The definition of sperm (in clause 7) means that under
this clause a human embryo is permitted to be created by fertilising a human egg
with human spermatids. Spermatids are one of the precursor cells of sperm and
can be used in assisted reproductive treatment to create an embryo through the
procedure known as intracytoplasmic sperm injection (ISCI), where a man may be
unable to produce functional sperm cells.
Th effect of this clause is that a person can only create a human embryo
outside the body of a woman if it is intended, at the time of creation, that the
embryo could be implanted in an attempt to achieve pregnancy in a particular
woman.
It is an offence to create human embryos specifically for other
purposes such as for use in research or to derive embryonic stem cells for
potential therapeutic use. This clause is not intended to prohibit certain uses
of human embryos that are carried out as a part of attempting to achieve
pregnancy in a woman in ART clinical practice, such as carrying out diagnostic
procedures (such as Pre-Implantation Genetic Diagnosis) or undertaking
therapeutic procedures on the embryo.
Further it is not intended that
this clause:
• restrict the number of embryos that may be created
for the purposes of achieving pregnancy in a particular woman. The number of
embryos created for the reproductive treatment of a particular woman needs to be
determined on a case by case basis as a part of routine ART clinical practice.
ART clinical practice is regulated through legislation in three States
(Victoria, South Australia and Western Australia) and the national system of
accreditation carried out by the Reproductive Technology Accreditation Committee
(of the Fertility Society of Australia) which includes application of the NHMRC
Ethical Guidelines on Assisted Reproductive Technology (1996);
or
• prevent the circumstance whereby a human embryo created by an ART
clinic, originally intended for implantation into a woman, may be found not be
suitable for implantation, or may at some point not be required by the woman for
whom it was originally created. In these situations it is possible that such
embryos could become excess ART embryos and at that point they may be used for
purposes other than to attempt to achieve pregnancy in a woman subject to the
system of regulatory oversight described in Part 3 of the Bill.
The
maximum penalty that may be applied for creating a human embryo for a purpose
other than achieving pregnancy in a woman is 10 years imprisonment. A court
may, at its discretion, supplement the imprisonment term with a monetary penalty
or convert the imprisonment term to a monetary penalty of up to $330,000 for a
corporation and $66,000 for an individual.
Sub-clause 13(2)
provides that despite subsection 13.3(3) of the Criminal Code, a defendant does
not bear an evidential burden in relation to any matter in subsection (1) of
this section. This means that the prosecution must establish that the offence
has been committed, rather than the defendant establishing that the offence was
not committed. The prosecution must establish the case in relation to all of
the offences detailed in this Bill, however, as this clause is worded slightly
differently to the other clauses it could be interpreted to be reversing the
burden of proof. This clause clarifies that this is not the case.
This clause makes it an offence to intentionally create a human embryo
containing genetic material provided by more than 2 people. It is also an
offence to develop a human embryo containing genetic material provided by more
than 2 people.
One of the effects of this clause is to ban a relatively
new ART technique known as cytoplasmic transfer. Cytoplasmic transfer involves
the injection of some of the cytoplasm (the part of the cell outside the
nucleus) from a healthy, donor egg into a recipient patient’s egg, with
the aim of overcoming certain problems that the patient has with regards to
achieving pregnancy. It has been reported that this procedure may be
particularly valuable to older women to assist them to become
pregnant.
Both safety and ethical concerns have been raised regarding
cytoplasmic transfer. Firstly, the technique is a very new technique and its
safety with respect to babies created using the technique is yet to be
established. Additionally, any live born child may have DNA from three separate
people, posing ethical concerns. The DNA from the third party (the donor of the
healthy egg) would be mitochondrial DNA, which is thought not to have an impact
on the physical characteristics of the child. However, the impact (if any) of
the third party mitochondrial DNA on normal development is not totally clear at
this stage.
The wording of this clause avoids any references to
cytoplasmic transfer explicitly and instead utilises wording that reflects the
concern that it results in the creation of human embryos with genetic material
from more than two people. In this way the prohibition is drafted sufficiently
broadly to include other techniques, current or emerging, that may also involve
the presence in a human embryo of a third party’s DNA.
This clause requires that a human embryo created outside the body of a
woman must not be allowed to develop beyond 14 days. This does not include any
time that the embryo’s development is suspended whilst in storage (for
example while the embryo is frozen).
In practice, this means that human
embryos created by assisted reproductive technology must be implanted, stored
or allowed to die (if unsuitable for implantation or excess to the needs of the
couple for whom the embryo was created) before the 14th day of their
development. It is standard ART clinical practice for embryos to be implanted
when they have reached between three and seven days of development.
It is
important that this clause be read subject to clause 12 that bans the creation
of a human embryo by any means other than the fertilisation of human egg by
human sperm. This means that a human embryo created by asexual means, such as
by parthenogenesis, embryo splitting or somatic cell nuclear transfer, cannot be
created or developed to any stage.
This clause provides that the
maximum penalty for developing a human embryo outside the body of a woman for
more than 14 days is 10 years imprisonment. A court may, at its discretion,
supplement the imprisonment term with a monetary penalty or convert the
imprisonment term to a monetary penalty of up to $330,000 for a corporation and
$66,000 for an individual.
This clause prevents the creation of a human embryo with cells taken from
another human embryo or a human fetus that have the potential to develop into
egg or sperm cells. It is also an offence to develop a human embryo created by
precursor cells of eggs or sperm taken from an embryo or fetus.
The
purpose of this clause is to prevent individuals from obtaining precursor cells
and using these cells in an attempt to develop a human embryo whether for
reproductive or any other purposes. The reasons for this practice being
prohibited is that if precursor cells were to be used in such an attempt then
children could potentially be born (using ova and/or sperm derived from a fetus
or embryo) never having had a living genetic parent.
The maximum penalty
for using precursor cells from a human embryo or a human fetus to create a human
embryo, or develop such an embryo, is 10 years imprisonment. A court may, at
its discretion, supplement the imprisonment term with a monetary penalty or
convert the imprisonment term to a monetary penalty of up to $330,000 for a
corporation and $66,000 for an individual.
This clause prohibits any manipulation of a human genome that is intended
to be heritable, that is, able to be passed on to subsequent generations of
humans. This clause bans what is commonly referred to as germ line gene
therapy. In germ line gene therapy, changes would be made to the genome of egg
or sperm cells, or even to the cells of the early embryo. The genetic
modification would then be passed on to any offspring born to the person whose
cell was genetically modified and also to subsequent generations.
The
maximum penalty for manipulating the human genome so that the change is
heritable to future generations is 10 years imprisonment. A court may, at its
discretion, supplement the imprisonment term with a monetary penalty or convert
the imprisonment term to a monetary penalty of up to $330,000 for a corporation
and $66,000 for an individual.
This clause prevents the removal of viable human embryos from the body of
a woman after fertilisation has taken place in vivo – a practice
sometimes referred to as embryo flushing. Embryo flushing is commonly used in
animal husbandry and while there have been no recent reports of it being used in
humans there is a concern that a healthy human embryo could be removed from a
woman’s uterus before it implants so that it could be used for research or
for transfer to another woman. This clause bans such a practice.
The
maximum penalty for intentionally collecting a viable human embryo from a woman
is 10 years imprisonment. A court may, at its discretion, supplement the
imprisonment term with a monetary penalty or convert the imprisonment term to a
monetary penalty of up to $330,000 for a corporation and $66,000 for an
individual.
This clause makes it an offence to intentionally create a chimeric embryo
or to intentionally create a hybrid embryo. Under the definitions included in
clause 7, chimeric embryo and hybrid embryo have the following
meanings.
chimeric embryo means:
(a) a human embryo
into which a cell, or any component part of a cell, of an animal has been
introduced;
(b) a thing declared by the regulations to be a chimeric
embryo.
hybrid embryo means:
(a) an embryo created
by the fertilisation of a human egg by animal sperm; or
(b) an embryo created
by the fertilisation of an animal egg by human sperm; or
(c) a human egg into
which the nucleus of an animal cell has been introduced; or
(d) an animal egg
into which the nucleus of a human cell has been introduced; or
(e) a thing
declared by the regulations to be a hybrid embryo.
It is not intended
that this clause prohibit the creation of transgenic animals. Transgenic animals
are created through the insertion of one or more foreign genes (including human
genes) into an animal embryo. It is important to note that transgenic animals
are regulated under the Gene Technology Act 2000 as a genetically
modified organism. Before anyone could genetically modify an animal embryo, a
licence must be sought from the Gene Technology Regulator. The Gene Technology
Regulator would conduct a comprehensive risk assessment and may seek advice on
the ethical issues posed by this practice from the Gene Technology Ethics
Committee. Any such work would also need to meet the requirements of an Animal
Welfare Committee (in accordance with NHMRC Guidelines).
This clause prevents the placement of:
• a human embryo in
an animal;
• a human embryo into the body of a human, including a man
or any part of a womans body, other than the female reproductive tract.
• an animal embryo in a human, for any period of
gestation.
Some concern has also been expressed about the possibility, in
the future, of a human embryo being developed into a fetus, outside the body of
a woman. This would be prevented by clause 15 that prohibits the development of
an embryo in vitro for any period longer than 14 days.
The maximum
penalty for any of the offences under this clause is 10 years imprisonment. A
court may, at its discretion, supplement the imprisonment term with a monetary
penalty or convert the imprisonment term to a monetary penalty of up to $330,000
for a corporation and $66,000 for an individual.
This clause prevents the intentional import into Australia, intentional
export from Australia or the intentional placement in the body of a woman of any
embryo that is referenced in clauses 12, 13, 14, 15, 16, 17, 18 and 19. For the
purposes of this clause, such embryos are referred to as “prohibited
embryos”. That is:
• a human embryo created by a process
other than the fertilisation of a human egg by human sperm;
• a human
embryo created outside the body of a woman, unless the intention of the person
who created the embryo was to attempt to achieve pregnancy in a particular
woman;
• a human embryo that contains genetic material provided by
more than 2 persons;
• a human embryo that has been developing outside
the body of a woman for a period of more than 14 days, excluding any period
throughout which development is suspended;
• a human embryo created
using precursor cells taken from a human embryo or a human fetus;
• a
human embryo that contains a human cell whose genome has been altered in such a
way that the alteration is heritable by human descendants of the human whose
cell was altered;
• a human embryo that was removed from the body of a
woman by a person intending to collect a viable human embryo; or
• a
chimeric embryo or a hybrid embryo.
By including both importation and
implantation within this clause it removes the possibility that one person will
be able to import a prohibited embryo and give it to another person to be
implanted in a woman. In this case both people would be in breach of the
legislation. Including exportation of a prohibited embryo as an offence ensures
that a person cannot export a prohibited embryo that has been illegally created
or obtained.
The practice of importing or exporting embryos (that have
been created by fertilisation of a human egg by human sperm) for the ART
treatment of a particular couple, will be permitted to continue, subject to
other legislation such as the Quarantine Act 1908 or the Customs Act
1901. This may occur, for example, where a couple have had embryos created
for the purposes of ART in another country, subsequently move to Australia, and
wish to continue their ART treatment program in Australia.
The maximum
penalty for importing, exporting or placing in the body of a woman, a prohibited
embryo is 10 years imprisonment. A court may, at its discretion, supplement the
imprisonment term with a monetary penalty or convert the imprisonment term to a
monetary penalty of up to $330,000 for a corporation and $66,000 for an
individual.
This clause prevents the commercial trading of human eggs, sperm and
embryos. Both parties that are involved in commercial trading of such material
would be committing an offence (for example, the person who sells the egg, sperm
or embryo and the person who purchases the egg, sperm or embryo). The only
consideration that may be given in relation to the supply of gametes or embryos
is reimbursement of reasonable expenses related to that supply, including
expenses incurred for the collection, storage and transport where relevant.
This means if, for example, semen is transferred from one clinic to another, the
second clinic could reimburse the first clinic for the costs of storage and
transport of the semen. A further example is where a woman who is to be treated
with donated eggs could pay for the cost of the egg retrieval from another
woman.
Reasonable expenses in relation to the supply of a human embryo,
where that embryo is donated to another couple, do not include any expenses
incurred by the person or couple (for whom the embryo was originally created),
before the embryo was determined to be excess to their needs. That is, if a
person has embryos that are excess to their needs and they wish to donate the
embryos to other people, they cannot have the costs of their IVF treatment
reimbursed by the person receiving the donated embryos.
This clause is
not intended to address the issue of surrogacy. It is proposed that surrogacy
continue to be dealt with through State and Territory legislation and that it
not be addressed as part of this particular national scheme.
The maximum
penalty for trading in human embryos, sperm or eggs is 10 years imprisonment. A
court may, at its discretion, supplement the imprisonment term with a monetary
penalty or convert the imprisonment term to a monetary penalty of up to $330,000
for a corporation and $66,000 for an individual.
This clause sets out a number of definitions for words and phrases used
in Part 3 of the Bill. These definitions determine the meaning that is to be
attributed to certain words or phrases whenever they are used in this Part. Key
definitions include:
accredited ART centre - This is
defined to mean a person or body accredited to carry out assisted reproductive
technology by:
(a) the Reproductive Technology Accreditation Committee of
the Fertility Society of Australia; or
(b) 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 of those other bodies, as the
case requires.
The Reproductive Technology Accreditation Committee (RTAC)
of the Fertility Society of Australia currently oversees a system of industry
based regulation for clinics using ART or carrying out associated research and
sets professional and laboratory standards for clinical practice. ART clinics
are usually accredited by the RTAC for three years. Accredited ART clinics are
expected to comply with the RTAC Code of Practice for Centres using Assisted
Reproductive Technology and any relevant Guidelines issued by the RTAC.
proper consent is defined to mean consent that is obtained
in accordance with the current NHMRC Ethical Guidelines on Assisted
Reproductive Technology (1996) or any other guidelines that are notified in
the Commonwealth Government Gazette as determined by the Chairperson of the
NHMRC Licensing Committee. The power to identify alternative (or supplementary)
guidelines in the Commonwealth Government Gazette ensures that the most
appropriate and recent guidelines describing the processes for consent are
observed. For example, the NHMRC Ethical Guidelines on Assisted Reproductive
Technology are currently subject to review and it is likely that new
guidelines will be issued in early 2003. These new guidelines could be
referenced in the Commonwealth Government Gazette and therefore replace the
older guidelines.
Clause
24 – Meaning of excess ART embryo
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 sub-clause
25(2).
Sub-clause 25(2) provides that the following uses of an
excess ART embryo are exempt (and therefore do not require licensing):
• storage of 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);
• transport of an excess ART
embryo;
• observation of 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 die
(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 a part of
routine clinical 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 ART embryo to another woman for the
purpose of achieving pregnancy in that other woman; and
• any other
use prescribed in the regulations.
• for research (for example, to derive stem cells or to improve ART
clinical practice);
• to train people in ART techniques;
• for Quality Assurance testing to ensure that pre-implantation
diagnostic tests give accurate results; and
• to examine the
effectiveness of new culture media.
The NHMRC Licensing Committee
will consider options to streamline the administration of the legislation, where
the NHMRC Licensing Committee is satisfied that the use of the excess ART
embryos will not damage or destroy the embryo. For example, ART service
providers could apply for one licence to undertake quality assurance work using
an approved list of techniques and a defined number of excess ART embryos. It
may also be appropriate to consider similar arrangements for certain uses of
excess ART embryos that may damage the embryo but are a part of routine ART
clinical practice, such as the use of embryos for training people in the
techniques of assisted reproductive technology.
The effect of
sub-clause 25(1) is to make 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. The maximum penalty that may be applied for use of an
excess ART embryo without a licence, or without that use being an exempt use, is
5 years imprisonment. A court may, at its discretion, supplement the
imprisonment term with a monetary penalty or convert the imprisonment term to a
monetary penalty of up to $165,000 for a corporation and $33,000 for an
individual.
Sub-clause 26(2) defines an “ART program” as an
assisted reproductive technology program carried out in accordance with the
Code of Practice for Centres Using Assisted Reproductive Technology
issued by the Reproductive Technology Accreditation Committee of the Fertility
Society of Australia (which is used as the basis for accrediting ART clinics) or
any similar code as prescribed in regulations.
The effect of this clause
is to ensure that there is no loophole for the inappropriate use of ART embryos
that are not excess to the needs of the woman (and any spouse) for whom they
were created. For example, it would be illegal to use an ART embryo that has
not been declared “excess” in the training of ART technicians or to
derive embryonic stem cells.
The maximum penalty for an offence under
this clause is 5 years imprisonment which may, at the discretion of the Courts
be supplemented by, or converted to a monetary penalty of up to $165,000 for a
corporation and $33,000 for an individual.
This clause 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 action or omission will contravene a condition of
licence.
The maximum penalty for breaching a condition of licence is 5
years imprisonment which may, at the discretion of the Courts be supplemented
by, or converted to a monetary penalty of up to $165,000 for a corporation and
$33,000 for an individual.
This clause establishes the NHMRC Licensing Committee as a Principal
Committee of the NHMRC. As detailed in relation to clause 29, the NHMRC
Licensing Committee will be tasked with considering licence applications in
relation to the use of excess ART embryos.
The National Health and
Medical Research Council Act 1992 (the NHMRC Act) establishes the NHMRC and
two Principal Committees – the Research Committee and the Australian
Health Ethics Committee (AHEC). The purpose of clause 28 of this Bill is to
establish the new NHMRC Licensing Committee as a Principal Committee of the
NHMRC. By establishing the Committee in this Bill, the Committee automatically
becomes a Principal Committee of the NHMRC for the purposes of the NHMRC Act.
By establishing the NHMRC Licensing Committee as a Principal Committee
for the purposes of the NHMRC Act this means that many of the provisions in the
NHMRC Act that apply to Principal Committees generally will also apply to this
Committee. This avoids the need to re-state all of these provisions in this
Bill. The following sections of the NHMRC Act will apply in respect of the
operations of the NHMRC Licensing Committee:
• section 37A -
responsibilities of the Chairperson and Deputy Chairperson;
• section
38 - operating procedures;
• section 39 - working
committees;
• section 40 - arrangements to assist
committees;
• section 41 - remuneration and
allowances;
• section 42 - leave of absence;
• section 43 -
resignation;
• section 44 - termination of
appointment;
• section 81 - protection from civil actions;
and
• section 82(3), (4) and (5) - delegations.
Sub-clause
28(2) provides that the following clauses of the NHMRC Act will not apply to
the NHMRC Licensing Committee:
• section 10 - allowing the
Minister to issue certain directions to the NHMRC and other Principal
Committees;
• section 35 - relating to appointment of committee
members (see clause 31, below);
• section 80 - treatment of
confidential commercial information; and
• subsection 82(2) of the
NHMRC Act – delegations from the NHMRC to the NHMRC Licensing
Committee.
Sub-clauses 28(4) and (5) provide that regulations may include
disclosure of interest provisions. If such regulations are in force, these
override the current NHMRC disclosure of interest provisions which are detailed
as part of NHMRC committee procedures made under paragraph 38(b)(vi) of the
NHMRC Act.
This clause sets out the functions of the NHMRC Licensing Committee. In
essence, the NHMRC Licensing Committee will be tasked
with:
• considering licence applications;
• refusing
licences or granting licences including subject to
conditions;
• notifying relevant people of the Committee’s
decision regarding the application for licence including the applicant, the
relevant Human Research Ethics Committee (HREC) and the relevant State
authority;
• varying, suspending or cancelling licences, should this be
necessary;
• establishing and maintaining a publicly available database
containing information about work involving excess ART embryos that has been
licensed by the Committee;
• monitoring compliance with the
legislation (the NHMRC Licensing Committee may also delegate this function to a
Commonwealth or State officer) and taking any necessary enforcement action;
• 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.
This clause 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.
This clause describes the members to be appointed to the NHMRC Licensing
Committee and the means for appointing such members.
Sub-clause 31(1) provides that the NHMRC Licensing Committee will be
comprised of 9 members as follows:
(a) a member of AHEC;
(b) a person
with expertise in research ethics;
(c) a person with expertise in a relevant
area of research;
(d) a person with expertise in assisted reproductive
technology;
(e) a person with expertise in a relevant area of law;
(f) a
person with expertise in consumer health issues as they relate to disability and
disease;
(g) a person with expertise in consumer issues relating to assisted
reproductive technology;
(h) a person with expertise in the regulation of
assisted reproductive technology; and
(i) a person with expertise in
embryology.
The members of the NHMRC Licensing Committee must be
appointed by the Minister with portfolio responsibility for this Act. Before
appointing any members to the NHMRC Licensing Committee the Minister must seek
nominations from the organisations described in regulations accompanying this
legislation. Placing the list of organisations in the regulations enables the
list to be updated relatively simply as organisations change their name or as
new organisations are formed that should be consulted. The Minister must also
seek nominations from all States and Territories, consult the States and
Territories on proposed appointments and have regard to the views expressed by
the States and Territories.
Sub-clause 31(4) expressly provides
that the AHEC member must not be appointed as the Chair of the NHMRC Licensing
Committee. This is important because otherwise it would theoretically be
possible for a member of AHEC to be both the Chair of AHEC and the Chair of the
NHMRC Licensing Committee. On a practical level the workload would be
considerable if an AHEC member were also the Chair of the NHMRC Licensing
Committee. Further, such an arrangement could pose potential conflicts of
interest.
Sub-clause 31(5) provides that before appointing the Chair of the
Committee, or the person with expertise in the regulation of assisted
reproductive technology, the Minister must have the majority agreement of the
States and Territories.
Sub-clause 31(6) provides that in
appointing members to the NHMRC Licensing Committee the Minister must also have
regard to the desirability of ensuring that the Committee as a whole comprises
members from different States and Territories.
This clause clarifies that members of the NHMRC Licensing Committee hold
office on a part-time basis and for the period specified in their instrument of
appointment which must not exceed 3 years. Members may be reappointed for
further terms. This is consistent with the appointment terms for the NHMRC and
its other Principal Committees.
Under section 83 of the National Health and Medical Research Council
Act 1992, the NHMRC must prepare an Annual Report. The NHMRC is required to
provide its Annual Report to the Minister as soon as practicable after the end
of each calendar year and the Minister is required to table the report in
Federal Parliament within 15 sitting days after receiving the Report.
This clause provides that the NHMRC Licensing Committee must provide
details of its operations to the NHMRC for inclusion in the NHMRC Annual
Report.
This clause enables the NHMRC Licensing Committee to make a Report to
Parliament at any time should the NHMRC Licensing Committee consider this
necessary. The clause provides that the NHMRC Licensing Committee must provide
a copy of the report to the responsible Minister and to each State and
Territory.
Clause 35 – Person may apply for licence
This clause
provides that a person may apply to the NHMRC Licensing Committee for a licence.
Such an application must be in accordance with the application requirements of
the NHMRC Licensing Committee. It is proposed that the NHMRC Licensing
Committee will issue application forms and detailed explanatory material about
the Committee’s expectations with respect to the information that should
be included in any application.
It is expected that the
“person” who applies for a 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.
This clause 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 they issue a licence and other issues that the NHMRC Licensing Committee
must have regard to when deciding whether or not to grant a
licence.
Sub-clause 36(3) provides that the NHMRC Licensing
Committee 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 and to ensure that where the
couple for whom the embryo was created have specified any restrictions on the
use of an embryo, these restrictions will be observed;
• if the
proposed use of the excess ART embryo may damage or destroy the embryo (as
determined by the NHMRC Licensing Committee), that appropriate protocols are in
place to ensure that the excess ART embryos used in the project (should the
licence be approved) have been created before 5 April 2002; 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 Research
Involving Humans (1999) issued by the NHMRC (or such other document that may
replace the National Statement).
Sub-clause 36(4) provides that in
deciding whether to issue a licence, the NHMRC Licensing Committee must have
regard to the following:
• the number of excess ART embryos likely
to be necessary to achieve the goals of the activity or project proposed in the
application;
• the likelihood of significant advance in knowledge, or
improvement in technologies for treatment, as a result of the use of excess ART
embryos proposed in the application which could not reasonably be achieved by
other means;
• any relevant guidelines, or parts of guidelines issued
by the NHMRC. For example, the NHMRC (through the Australian Health Ethics
Committee) is currently undertaking a review of the NHMRC Ethical Guidelines
on Assisted Reproductive Technology (1996). It is anticipated that
following the review, the NHMRC will issue revised guidelines that will include
information about the criteria to be taken into account for the purposes of
determining whether a use of an excess ART embryo will be likely to result in a
significant advance in knowledge or improvement in technologies for treatment
that could not reasonably be achieved by other means;
• the HREC
assessment of the application; and
• such additional matters (if any)
as are prescribed by the regulations.
This clause requires the NHMRC Licensing Committee to notify its decision
on an application to the applicant, the HREC that considered the application and
the relevant State body (as notified by the State government). 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 to the relevant State body.
This clause 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.
Sub-clause
38(2) clarifies that a licence is not in force throughout any period of
suspension.
This clause describes the conditions to which all licences issued by the
NHMRC Licensing Committee are subject and enables the NHMRC Licensing Committee
to impose any other conditions that it considers
necessary.
Sub-clauses 39(1), (2) and (3) describe the conditions
that all licence holders must comply with. These sub-clauses provide that
before a person can commence using an excess ART embryo (under a licence issued
by the NHMRC Licensing Committee), the licence holder must confirm with the
NHMRC Licensing Committee (by notice in writing):
• that consent
has been obtained for the use of all the embryos, in accordance with the
protocol considered by the NHMRC Licensing Committee;
• any
restrictions on the use of the embryos (as determined by the couples for whom
the embryos were created); and
• in the case of uses of the embryos
that may damage or destroy the embryos, that the embryos were created before 5
April 2002.
Once a licence holder has provided this information to the
NHMRC Licensing Committee they may commence work with the excess ART embryos
provided they do so in accordance with any restrictions imposed by the couples
for whom the embryos were created. Further, if the work with the excess ART
embryos may harm or destroy the embryos, then it must be carried out on embryos
created before 5 April 2002.
Sub-clauses 39(4) and (5) 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:
(a) the persons or classes of person,
authorised by the licence to use the excess ART embryos;
(b) the number of
excess ART embryos in respect of which use in authorised by the
licence;
(c) reporting;
(d) monitoring; and
(e) information to be given
by the licence holder to persons authorised by the licence to use excess ART
embryos.
Sub-clause
39(7) provides that any other licence conditions are applicable to the
licence holder and any other people who are authorised by the licence to use
excess ART embryos as specified in the licence.
This clause 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 details such as the duration
of the licence; and
• when 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.
Sub-clause 40(4) clarifies that the NHMRC Licensing
Committee can not vary a licence so that the varied licence would be contrary to
the requirements set out in clause 35. For example, the NHMRC Licensing
Committee could not vary the licence after it has been issued so as to allow a
use of embryos that have been created after 5 April 2002 that may damage or
destroy the embryos (unless, that requirement ceases to have effect in three
years or at an earlier time, as agreed by COAG as detailed in clause 60 of the
Bill).
This clause enables the NHMRC Licensing Committee to suspend or revoke a
licence that has been issued if they believe, on reasonable grounds, that a
condition of the licence has been breached. This is a very important provision
because it enables the NHMRC Licensing Committee to take immediate action in the
event of apparent non-compliance. By suspending or revoking the licence the
work can no longer continue.
The NHMRC Licensing Committee has the power
to re-instate 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 continue without risk of further breaches.
Whether or not the licence is suspended, cancelled or subsequently reinstated
would depend on the individual circumstances of the case and the extent,
severity and importance of the alleged 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.
This clause provides that if the NHMRC Licensing Committee varies,
suspends or cancels a licence the Committee must notify the changes to the
relevant State or Territory body to which it notified its original decision.
This ensures that State and Territory governments are kept fully informed about
any variations to licences. In addition, if the change 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 44 – NHMRC Licensing Committee to make certain
information publicly available
This clause provides that the NHMRC
Licensing Committee must establish and maintain a comprehensive, publicly
available database containing information about licences that have been issued
by the NHMRC Licensing Committee.
Sub-clause 44(1) provides that the database must include the following
information in relation to each licence:
(a) the name of the person to
whom the licence was issued. Under Commonwealth legislation this would be a
body corporate or other legal entity. The names of individual people will not
be included on the database without the express consent of the person in
accordance with the Privacy Act 1988;
(b) the nature of the uses of
the 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;
(c) the
conditions of licence;
(d) the number of embryos proposed to be 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 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 database to reflect the
number of embryos actually used in a project;
(e) the date on which the
licence was issued; and
(f) the period of the licence.
It is proposed that the database would be included on the NHMRC website and
that hard-copy extracts of the database would be available from the NHMRC
Licensing Committee on request. The database would not include information that
is confidential commercial information (refer clause 45) or any personal
information that would be prohibited from disclosure under the Privacy Act
1988, including for example, names of individuals.
This clause is intended to protect, from public disclosure, certain
information that is legitimately confidential commercial
information.
“Confidential commercial information” is defined
in clause 23 of the Bill 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 clause 45
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 clause 44) 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 disclosure.
The NHMRC Licensing
Committee would have access to the confidential commercial information in
assessing applications and could disclose such information to States and
Territories (and to relevant Commonwealth agencies) but these bodies could not
disclose the information to anyone else.
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.
This clause 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:
Ø a
decision by the NHMRC Licensing Committee relating to the period of a licence;
Ø a
condition of licence imposed by the NHMRC Licensing Committee;
and
Ø a
decision by the NHMRC Licensing Committee to vary, refuse to vary, suspend or
revoke a licence.
Sub-clause 47(1) provides that an eligible person (as defined in
clause 46) may apply to the Administrative Appeals Tribunal for review of the
following decisions of the NHMRC Licensing Committee:
(a) a decision
under clause 36 not to issue a licence;
(b) a decision in respect of the
period throughout which the licence is to be in force under clause 38;
(c) a
decision to specify a licence condition under sub-clause 39(4);
(d) a
decision to vary or refuse to vary a licence under clause 40; or
(e) a
decision to suspend or revoke a licence under clause 41.
Sub-clause 47(2) provides that clause 47 has effect subject to the
Administrative Appeals Tribunal Act 1975.
Sub-clause 48(1) enables the Chairperson of the NHMRC Licensing
Committee to appoint inspectors for the purposes of exercising all the powers
under this Part. The persons the Chairperson of the NHMRC Licensing Committee
may appoint as inspectors are Commonwealth employees and State or Territory
employees. The Chairperson of the Licensing Committee must also ensure that
each person appointed as an inspector has appropriate skills and experience
(sub-clause 48(3)).
Sub-clause 48(2) requires a person appointed as an inspector to comply
with any directions of the Chairperson of the NHMRC Licensing Committee when
exercising powers or performing functions in that capacity.
Sub-clauses 49(1) and 49(2) require the Chairperson of the NHMRC
Licensing Committee to issue an identity card, in a form prescribed by the
regulations, to every person appointed as an inspector. The identity card must
have a recent photograph of the inspector.
Sub-clause 49(3)
provides that it is an offence for a person who ceases to be appointed as an
inspector to fail to return his or her identity card, as soon as practicable, to
the Chairperson of the NHMRC Licensing Committee. The offence attracts a
maximum penalty of 1 penalty unit which is equivalent to
$110.
Sub-clause 49(4) requires the inspector to carry his or her
identity card at all times when exercising powers or performing functions as an
inspector.
Sub-clause 50(1) confers powers upon an inspector to enter any
premises and to exercise any or all of the powers set out in clause 51 for the
purposes of establishing whether or not the Act or regulations are being
complied with.
Sub-clause 50(2) provides that an inspector may
only enter premises under this clause if he or she has the consent of the
occupier of the premises or if the occupier of the premises is a licence holder,
or a person covered by a licence, and the entry is at a reasonable time.
This clause describes the monitoring powers that an inspector may
exercise for the purposes of finding out whether the Act or regulations have
been complied with.
This clause 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.
This clause provides that an inspector cannot exercise any of the powers
under this Part in relation to premises unless he or she produces his or her
identity card upon being requested to do so by the occupier of those
premises.
This clause provides that, before obtaining consent from a person to
enter premises (under paragraph 50(2)(a)), the inspector must inform the person
that he or she may refuse consent.
Sub-clause 54(2) clarifies
that any consent given by a person to enable entry to premises by the inspector
must be voluntary.
This clause 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 out of money appropriated by the Parliament. 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.
This clause provides that the Act is not intended to exclude the
operation of State and Territory laws except where the State or Territory laws
are inconsistent with the Act and cannot operate concurrently.
One of
the intended effects of this clause is that if a State has existing legislation
that, for example, bans the use of excess ART embryos, such a law would not be
capable of operating concurrently with the Act and as such it is intended that
the Act override the State law to the extent that it is inconsistent.
By virtue of clause 2 of this Bill, clause 25 of this Bill (which
provides that a person must not use an excess ART embryo unless the use is
authorised by a licence from the NHMRC Licensing Committee or is an exempt use)
will not commence operation for 6 months from the date that this Bill receives
Royal Assent. During this time, any inconsistent State laws that ban the use of
excess ART embryos will continue to operate subject to amendment by the relevant
State Parliaments.
Clause 57 – Conferral of functions on
Commonwealth officers and bodies
The purpose of this clause is to
enable corresponding State laws to confer functions, powers and duties on the
NHMRC Licensing Committee, a Commonwealth Authority and an officer of the
Commonwealth or a Commonwealth authority and to empower a person or body on whom
a function, power, or duty is conferred, to perform the function or duty, or
exercise the power.
This clause, along with clause 58, provides for the
effective operation of the national scheme relating to the regulation of uses of
excess ART embryos. This Commonwealth Bill is one part of the national scheme.
It is anticipated that all States and Territories will implement corresponding
legislation. Clauses 56 and 57 effectively enable the corresponding State laws
to provide that the licensing functions exercised under a State law actually be
undertaken by the NHMRC Licensing Committee. It is not intended that there be
dual licensing systems in any jurisdictions. Rather, anyone wishing to
undertake work using excess ART embryos (other than exempt uses) would need to
apply for a licence from the NHMRC Licensing Committee whether or not they are
technically organisations that come within the scope of the Commonwealth’s
constitutional powers or State powers.
Clause 57 also clarifies that the
conferral of such functions or powers, or the imposition of duties, on the NHMRC
Licensing Committee or on other Commonwealth bodies is limited by any relevant
constitutional doctrines and the legislative power of the Commonwealth.
This clause recognises that there are constitutional doctrines that have
developed on the basis of case law that restrict the duties that may be imposed
on a Commonwealth officer or Commonwealth authority under State laws.
Recognising these doctrines, this clause clarifies that the extent to which
duties may be imposed on the NHMRC Licensing Committee, Commonwealth authorities
or Commonwealth officers, by corresponding State laws, is limited by such
doctrines.
The clause clarifies that any duty purported to be imposed
under a State law is taken to be imposed by force of a State law where State
legislative power is sufficient to support that duty. Where such power does not
exist, to ensure the validity of the duty’s imposition, reliance is then
to be placed on Commonwealth legislative power if it is sufficient to support
the duty.
The clause also clarifies that, if the imposition of a duty on
a Commonwealth officer or authority under applied State law contravenes a
relevant constitutional doctrine or exceeds the legislative power of both the
State and the Commonwealth, the State law is not taken to confer a duty on the
Commonwealth officer or authority.
This clause provides the capacity for the Administrative Appeals Tribunal
to review decisions made under a corresponding State law where the decision by
the NHMRC Licensing Committee is actually made under State
law.
Sub-clause 59(2) provides that a decision of the NHMRC
Licensing Committee is a “reviewable State decision” where the State
law provides for review by the Administrative Appeals Tribunal and where the
decision is declared in the regulations to be a “reviewable State
decision”.
Sub-clause 59(3) provides that for the purposes
of this clause the Administrative Appeals Tribunal Act 1975 has effect as
if a corresponding State law were an enactment of the Commonwealth.
Clause 60 – Repeal of paragraphs 36(3)(b) and 39(1)(c) and
subsection 39(3)
This clause gives effect to the Council of
Australian Governments’ decision that the regulation restricting the use
of excess ART embryos created after 5 April 2002 will cease to have effect on 5
April 2005, unless an earlier time is agreed by the Council of Australian
Governments.
DIVISION 2 – Review of Act
Sub-clause 61(1) provides that the NHMRC must cause an independent
review of this Act to be undertaken commencing 2 years after the Act receives
Royal Assent.
Sub-clauses 61(2), (3), (4), (5) and (6) describe the nature of
the review and the report to be prepared as a result of the review. In summary,
the review must:
• be undertaken by independent persons chosen by
the NHMRC with the agreement of all States and Territories;
• include a
consideration of the scope and operation of Parts 2 and 3 of the Act
particularly taking into account developments in assisted reproductive
technology, scientific and research developments, the potential therapeutic
applications of any research and community standards;
• contain
recommendations about any amendments that should be made to the
Act;
• be informed by consultation with the Commonwealth, States,
Territories and a broad range of stakeholders;
• include information
about the views of the Commonwealth, States and Territories (to the extent that
it is reasonably practicable to do so); and
• be completed within three
years of the Act receiving Royal Assent with the report of the review being
provided to the Council of Australian Governments.
This clause empowers the Governor-General to make regulations prescribing
matters required or permitted to be prescribed by the Act, or necessary or
convenient to be prescribed, for carrying out or giving effect to the
Act.
Sub-clause 62(2) clarifies that, before the Governor-General
makes regulations under this Act, the Minister must be satisfied that the States
and Territories have been consulted in relation to the proposed regulations and
that there was regard to the views of States and Territories in the preparation
of the proposed regulations.
The purpose of this schedule is to repeal the existing provisions in the
Gene Technology Act 2000 that ban human cloning, certain experiments
involving animal eggs and certain experiments involving putting human and animal
cells into a human uterus.
As a result of Senate debate on the Gene
Technology Bill 2000, three clauses were inserted in the Gene Technology Bill
– clauses 192B, 192C, 192D. At the time that the clauses were inserted it
was recognised that this was a “stop-gap” measure and that the
Commonwealth, States, Territories and the NHMRC would work together to identify
the most effective and comprehensive wording for a ban on human cloning and the
creation of hybrid embryos.
Recognising that the purpose of this Bill
is, among other things, to comprehensively prohibit human cloning and the
creation of hybrid embryos it will no longer be necessary to continue to include
prohibitions on these activities in the Gene Technology Act 2000 once the
Research Involving Embryos and Prohibition of Human Cloning Bill 2002 has been
agreed and enacted.
This Schedule therefore repeals sections 192B, 192C
and 192D of the Gene Technology Act 2000.
ATTACHMENT 1
On 5 April 2002 the Council of Australian Governments (COAG) agreed that
the Commonwealth, States and Territories would introduce nationally consistent
legislation banning human cloning and other unacceptable practices and
establishing a national regulatory framework for the use of excess assisted
reproductive technology (ART) embryos. It was agreed that the National Health
and Medical Research Council (NHMRC) would be the licensing and regulatory body.
This Regulation Impact Statement (RIS) focuses on the costs and benefits
of the two key components of the regulatory scheme – the prohibited
practices and the regulatory scheme for the use of excess ART embryos.
The problems that currently exist in relation to the prohibition of
certain unacceptable practices associated with reproductive technology and the
regulation of research on (and other uses of) human embryos
include:
• lack of consistency in regulatory coverage of human
cloning and other unacceptable practices through the existence of legislation in
three States (Victoria, South Australia and Western Australia), the Commonwealth
Gene Technology Act 2000 and the absence of regulation in other
jurisdictions;
• the fundamental ethical issues posed by destruction
of embryos for research and other uses and the absence of a comprehensive,
nationally consistent system for the regulation of research involving human
embryos;
• inconsistent regulation of research involving embryos which
creates an uneven playing field for researchers, which may limit the capacity of
some researchers to carry out particular work and access funding for such work.
This may reduce their competitiveness relative to researchers in other
jurisdictions. For example, if a national funding body identifies a particular
type of research as a priority (such as embryonic stem cell research) only
researchers in jurisdictions where such work is permitted would be able to carry
out this research and have potential access to funding for such research;
and
• the impact that the current lack of certainty or national
consistency in the regulatory environment may have on Australia’s
international competitiveness.
On 5 April 2002 COAG agreed that the Commonwealth, States and Territories
would introduce nationally consistent legislation banning human cloning and
other unacceptable practices and that the legislation would establish a national
regulatory framework for the use of excess ART embryos, to be administered by
the NHMRC as the national regulatory and licensing body.
The groups likely to be affected by legislated prohibited practices and
the regulation of uses of excess ART embryos are ART service providers,
consumers of ART services, researchers, Government and the
community.
ART service providers
The Australian Institute
of Health and Welfare’s National Perinatal Statistics Unit reported that
there were 34 IVF units in Australia in 2000.
Consumers of ART
services
Data available from the National Perinatal Statistics Unit
for the year 2000 showed that women underwent 27,067 treatment cycles with
oocyte retrieval or embryo transfer for all techniques of assisted conception in
Australia’s 34 IVF units.
Researchers
Currently in
Australia, research on excess ART embryos is only carried out by a limited
number of organisations, predominantly ART clinics examining the effectiveness
of ART techniques, particularly new methods for culturing gametes and embryos to
improve infertility treatments. As destructive research on excess ART embryos
has been banned in Victoria, South Australia and Western Australia for a number
of years, only very limited research that is not destructive to embryos has been
undertaken in these jurisdictions. It is, however, likely that when the bans
are lifted there will be a number of researchers from these jurisdictions who
may wish to undertake more extensive research that could be destructive to
excess ART embryos particularly scientific investigations including for the
derivation of new embryonic stem cell lines. Commercial companies may also have
an interest in undertaking such work.
Government
This
includes the Commonwealth Government, State and Territory Governments and
existing regulatory authorities in Victoria, South Australia and Western
Australia.
Community
Given the subject matter of the
regulation, the oversight applied to the use of excess ART embryos has the
potential to impact upon everyone in the community. This is not only because
the use of excess ART embryos poses ethical issues that affect many but also
because of the potential benefits that may flow to the community as a result of
scientific advancements and medical applications developed from the study of
embryos and embryonic stem cell lines.
On 5 April 2002 COAG agreed that certain unacceptable practices should be
prohibited in nationally consistent legislation.
In making their
decision, COAG considered the recommendations of a report entitled the
“Report on Human Cloning, Assisted Reproductive Technology and Related
Matters”. This Report included a list of all of the unacceptable
practices and was accompanied by a detailed RIS exploring the impacts of bans on
the unacceptable practices.
The two options outlined in the report
were:
Option 1: Voluntary compliance with unacceptable practices
as detailed in revised NHMRC/AHEC
Guidelines[1]. In order to
achieve national consistency, this option would mean that the three States with
legislation would need to repeal such legislation (at present there are some
differences between the practices banned in legislation in three States and the
unacceptable practices detailed in the NHMRC/AHEC Ethical Guidelines on
ART – refer Attachment A of this RIS). All people would be expected
to voluntarily comply with the nationally consistent unacceptable practices
detailed in revised NHMRC/AHEC Ethical Guidelines on ART. This would
essentially reflect a national adoption of the position that currently occurs in
the five jurisdictions without legislation; or
Option 2:
Nationally consistent legislated bans on the unacceptable practices. This
option would involve each jurisdiction enacting legislation, or amending
existing legislation, to ban the unacceptable practices as detailed in
Table 1. The unacceptable practices banned in the legislation would be
reviewed within three years. The purpose of the review would be to determine
whether each of the practices are still considered unacceptable and whether they
should continue to be banned in legislation. This review would be undertaken
with broad consultation to assess the acceptability of each of these practices
at that time.
Following is a table that is based on the table included in
the RIS accompanying the Report to COAG, detailing the potential impacts of
banning the various unacceptable practices in nationally consistent legislation.
Table 1: Summary of the impacts of banning certain unacceptable
practices in nationally consistent legislation
|
Proposed Prohibition
|
Impacts of banning certain unacceptable practices
|
|
Creating a human clone.
|
No attempts at cloning a human being (commonly referred to as
“reproductive cloning”) are currently evident in Australia.
Prohibition therefore unlikely to have an impact on researchers or ART
clinics.
|
|
Creation of an embryo for purposes other than assisted reproduction or by a
process other than the fertilisation of a human ovum by human sperm.
|
Will prevent the creation of embryonic stem (ES) cells via the
process of somatic cell nuclear transfer (SCNT), for potential therapeutic uses.
On the basis of early research in this area, it appears that there may be
potential to create ES cells that are compatible with individual patients or
patient groups and could therefore be used in therapeutic applications, reducing
the chance of rejection problems after transplantation. ES cells have been
reported to have potential to treat cancer, Alzheimer’s disease,
Parkinson’s disease, paraplegia, and other diseases.
|
|
|
Prohibiting the creation of embryos by SCNT will also limit potential use
of ES cells in drug screening. SCNT could be used to create libraries of stem
cells representative of specific disease states to test how a drug acts in the
human body.
|
|
|
Researchers in Israel and the UK, and private-sector researchers in
the USA are currently permitted to create embryos by SCNT. Relative to these
more permissive countries, Australia may lose international competitiveness,
overseas and local investment, and access to intellectual property. Such
negative effects may result even if the ban is only maintained in Australia for
three years.
|
|
|
Whilst there is unconfirmed evidence that researchers overseas have created
embryos via SCNT for the purposes of research, there are no confirmed reports
that such embryos have been able to be developed to the point that stem cells
can be obtained and used in human treatments. The potential benefits detailed
above are based on preliminary research. To date, there is no evidence of any
attempts being made in Australia to create a human embryo via SCNT as this
practice has been considered unacceptable under NHMRC/AHEC Guidelines and banned
in Victoria, SA and WA.
Work is continuing in relation to embryonic stem cell based nuclear
programming which involves replacing the nucleus of an embryonic stem cell with
the nucleus of an adult cell. This technique does not involve the creation of
an embryo (and is therefore not prohibited) but also has the potential to lead
to genetically compatible cells for transplantation and tissue engineering.
|
|
|
This prohibition would also ban the creation of embryos, by fertilisation
of an egg by sperm, purely for research purposes. This may limit some
researchers access to embryos for research. This may impact on the capacity of
researchers to undertake certain work exploring the process of embryonic
development, where embryos are created specifically for this research purpose.
However it would not impact on research involving excess ART embryos.
|
|
Creation or development of an embryo for assisted reproduction that
contains genetic material from more than 2 people.
|
Prevents the use of a relatively new technique that involves the transfer
of the cytoplasm from a healthy egg (generally donated by a younger woman) to
the egg of another woman who has had fertility problems (often older women).
This has the potential to increase the chances of successful conception via IVF
for some older women. Currently this technique is not in use in Australia as it
is thought to be unsafe, due to possible impacts of the existence of a third
party’s genetic material, but has been used overseas. There are also
ethical concerns associated with the creation of embryos with genetic material
from three people.
|
|
Creation or development of an embryo for assisted reproduction that uses
any precursor cells of eggs or sperm from an embryo or fetus.
|
Currently no evidence of this technique being used in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
|
|
Maintaining an embryo outside the body of a woman after the 14th
day of its development excluding any time in which its development is
suspended.
|
Currently no evidence of this practice occurring in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
|
|
Altering the genome of a cell of a human being or in vitro embryo such that
the alteration is heritable.
|
Removes the possibility of using germ line gene therapy to permanently cure
inherited diseases such as sickle cell anaemia, haemophilia and cystic fibrosis
in subsequent generations. Currently, there are concerns regarding unintended
consequences and the safety of using germ line gene therapy – as such it
is not clear if Australian scientists appear to be contemplating using germ line
gene therapy.
|
|
Embryo flushing.
|
Currently no evidence of this practice occurring in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
|
|
Creating or developing a hybrid or chimeric embryo or placing such an
embryo in the body of a human or animal for any period of gestation.
|
Currently no evidence of this practice occurring in Australia. Anecdotal
evidence suggests that, should this practice not be prohibited, some researchers
may wish to use some types of hybrid or chimeric embryos particularly for drug
screening applications.
|
|
Placing a human embryo in an animal or in any human body cavity other than
the female human reproductive tract or placing an animal embryo in a human for
any period of gestation.
|
Currently no evidence of this practice occurring in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
|
|
Giving or offering valuable consideration to any person for donation of
gametes or embryos of that person or of any other person. Note that it is not
intended to exclude the disbursement of reasonable expenses incurred by a person
in connection with a donation of their genetic material.
|
Currently no evidence of this practice occurring in Australia.
|
Consultations on an exposure draft of the Bill and RIS, including the
proposed prohibited practices, were conducted with a range of people in the
fields of ART, medical research, consumer issues, ethics and law, in each
capital city between 24 May and 6 June 2002.
During consultations,
there was general support for the inclusion of unacceptable practices in
legislation. However two prohibitions in particular gave rise to considerable
comment and debate regarding the costs and benefits of banning such
practices:
• the ban on the creation of embryos by a process other
than the fertilisation of a human egg by human sperm by somatic cell nuclear
transfer (or so called “therapeutic cloning”) to create embryonic
stem cells.
Those who did not support prohibiting “therapeutic
cloning” expressed concern that:
Ø the ban would put Australian research
behind other countries where such a ban does not exist which may in turn impact
on the Australian research community’s international competitiveness and
the broader community’s access to potential cell therapies;
and
Ø the
intended review of the legislation within three years that may result in a
lifting of this ban may be too late to alleviate these possible
impacts.
Others considered that:
Ø the need for “therapeutic
cloning” is questionable as there may be alternative avenues to achieve
the outcomes desired; and
Ø discussion within the broader community of
the benefits of “therapeutic cloning” may be premature as there are
currently no confirmed reports that a human embryo created by SCNT has developed
to the stage that stem cells could be derived.
• creation or
development of an embryo for assisted reproduction that contains genetic
material from more than 2 people, particularly as it effectively bans the use of
cytoplasmic transfer in ART clinical practice.
Those that did not
support a provision that effectively banned cytoplasmic transfer expressed
concern that women who might otherwise be able to achieve a pregnancy following
the use of cytoplasmic transfer on their eggs will be disadvantaged compared to
women in other countries where this technique is permitted.
Others
considered that:
Ø cytoplasmic transfer is a very new
technique and its safety with respect to babies created using the technique is
yet to be established; and
Ø any live born child may have DNA from
three separate people (posing ethical questions) and the impact of the third
party mitochondrial DNA on normal development is not totally clear at this
stage.
It was however noted that if the technique can be refined to the
point that there is no additional genetic material contained in the transferred
cytoplasm then the ban on the technique would no longer be applicable, subject
to approval of the use of the techniques under the RTAC accreditation guidelines
and approval by the relevant ART licensing bodies in Victoria, South Australia
and Western Australia.
It is desirable that governments have the ability to apply appropriate
sanctions for non-compliance, with regard to certain unacceptable practices, to
both publicly and privately funded organisations (at present there is
non-equivalent regulatory environments for private and public institutions in
Australia). Consumer and community confidence would also be likely to be
improved with the introduction of legislative sanctions.
A legislative
approach provides a clear basis of operation for ART service providers and
researchers (including organisations seeking to commercialise the products of
embryo research and embryonic stem cell research). As the practices proposed to
be banned in legislation are broadly consistent with those that are deemed
unacceptable under the NHMRC/AHEC Guidelines and existing legislation in three
States, the fact that the bans will be included in legislation in all
jurisdictions is likely to have minimal practical impact in terms of compliance.
A prohibition on the creation of embryos via somatic cell nuclear
transfer (so-called “therapeutic cloning”) for any period of time
may, however, impact on Australia’s competitiveness with other more
liberal countries particularly with respect to intellectual property ownership,
level of research expertise and industry investment.
In relation to this
point governments have decided, that at this time there is insufficient evidence
to prove the efficacy of “therapeutic cloning” and that it also
continues to pose significant ethical and safety issues. Therefore COAG decided
to include it as a prohibited practice to be banned in nationally consistent
legislation. The same consideration by COAG was given in relation to the
technique of cytoplasmic transfer.
The review of the legislative
prohibitions within three years will enable reconsideration of scientific
developments and associated benefits as well as any changes in community views
on all the practices (including “therapeutic cloning” and
cytoplasmic transfer) that may result.
COAG recommended that nationally
consistent legislative bans on unacceptable practices be implemented with a
review of the bans within 3 years.
Currently in Australia there is a lack of national consistency regarding
the regulation of research using excess ART embryos. In Victoria, South
Australia, and Western Australia, research that involves the destruction of an
embryo (or may not otherwise leave it in an implantable condition) is not
permitted under any circumstances. By contrast, in all other jurisdictions the
NHMRC/AHEC Ethical Guidelines on ART apply and researchers may receive
approval from a Human Research Ethics Committee (HREC) to undertake research
that involves the destruction of an embryo under exceptional
circumstances.
COAG agreed that the status quo is not acceptable and that
the NHMRC would issue a licence for a person to use an excess embryo from an ART
program for research or therapy that damages or destroys the embryo.
There are essentially two options for implementing the COAG decision.
The difference between these two options is that one requires a person to have a
licence for any use of an excess ART embryo (other than exempt uses) leaving the
decision making about whether the work may damage or destroy the embryo with the
NHMRC Licensing Committee. The other option requires a licence for uses of an
excess ART embryo that may damage or destroy the embryo (other than exempt
uses), with the decision making about whether the work may damage or destroy the
embryo resting with the ART service provider or researcher.
Option 1:
That all uses of excess ART embryos require a licence from the NHMRC (with
uses that may damage or destroy the embryo subject to additional restrictions)
unless the uses are exempt uses including:
• for donation of an
excess ART embryo to another couple;
• for storage of the embryo, for
removal of the embryo from storage, for transportation of the embryo, for
allowing the embryo to succumb at the request of the people for whom it was
created
• for observation of the embryo; or
• for use that
forms part of diagnostic investigations conducted in connection with the
assisted reproductive technology treatment of the woman for whom the excess ART
embryo was created.
Option 2: That only those uses of excess ART
embryos that involve research or therapy that may damage or destroy the embryos
be subject to the licensing system with exemptions for:
• donation
of an excess ART embryo to another couple;
• storage of the embryo, for
removal of the embryo from storage, for transportation of the embryo, for
allowing the embryo to succumb at the request of the people for whom it was
created
• observation of the embryo; or
• use that forms part
of diagnostic investigations conducted in connection with the assisted
reproductive technology treatment of the woman for whom the excess ART embryo
was created.
Impacts of Option 1: That all uses of excess ART embryos require a
licence from the NHMRC (with uses that may harm or destroy the embryo subject to
additional restrictions) unless the uses are exempt uses.
On ART
service providers: ART service providers who wish to undertake work on
excess ART embryos would require a licence for such work unless the work is
exempt. A licence would be required for uses that may damage or destroy the
embryo (such as research, derivation of stem cells and training of clinicians in
certain techniques carried out on embryos) and work that may not damage the
embryo such as quality assurance testing, for example, of culture media.
The licensing system will impose costs on ART service providers,
particularly those in New South Wales, Queensland, Tasmania, Northern Territory
and the Australian Capital Territory where there have, to date, been no
requirements for a licence for such work. In Victoria, South Australia and
Western Australia research involving the destruction of excess ART embryos has
not previously been permitted. Should ART service providers in these States
wish to undertake such research in the future it is expected that they will
incur additional costs
The major cost drivers for ART service providers
are expected to be associated with applying for a licence, implementing any
necessary systems to enable compliance with the legislation and reporting to the
NHMRC Licensing Committee. In most cases ART service providers are currently
providing such information to institutional Human Research Ethics Committees and
the Reproductive Technology Accreditation Committee. Any increased costs can
also be minimised through streamlined administration of the legislation,
particularly in relation to uses of excess ART embryos that do not damage or
destroy the embryo. For example, ART service providers could apply for one
licence to undertake quality assurance work using a certain number of excess ART
embryos rather than having to apply each time they chose to test a different
culture medium.
As the licensing requirements would apply to all uses
of excess ART embryos (not just uses that damage or destroy the excess ART
embryos), it is possible that this will impose additional costs on ART service
providers (compared to Option 2) because licences would be required for
non-destructive work, where it is proposed that the embryo be discarded
following the work. However these costs may be offset (compared to Option 2)
because there will be regulatory certainty and less need to seek case by case
clarification from the NHMRC Licensing Committee about whether the proposed work
may damage or destroy the embryo. Further, it is expected that costs are not
fully additional given that some service providers may, under Option 2, apply
for licences unnecessarily, erring on the side of caution.
In relation to
both Option 1 and Option 2, the inclusion of clear exemptions in the legislation
means that there is greater clarity for ART service providers about the work
that is part of routine ART clinical practice and does not require licensing by
the NHMRC Licensing Committee.
On consumers of ART services:
Couples would be assured that there is regulatory oversight for all uses of
excess ART embryos and that work would not be undertaken on their ART embryo
unless they have provided fully informed consent. They may also specify any
conditions relating to such consent and the nature of the work that may be
undertaken. Should there be increased costs to ART service providers as a
result of the licensing requirements, there may be flow on costs to all
consumers of ART services.
On researchers: On the basis of
information available to date, it appears that most of the work proposed to be
undertaken by researchers will be work that may lead to the destruction of the
excess ART embryo. For example, use of excess ART embryos for the derivation of
stem cells. It is therefore unlikely that this Option will have any additional
impact compared with Option 2. Compared to the current situation, costs are
likely to increase for all researchers proposing to undertake uses of excess ART
embryos, as the result of the need to obtain, and ensure compliance with, a
licence from the NHMRC to undertake research that involves destruction of the
excess ART embryos. This is also the case for Option 2. The cost drivers are
the same as those detailed in relation to ART service providers.
On
Government: In addition to the NHMRC’s cost of supporting the
regulatory framework, as set out in the Financial Impact Statement, there will
also be costs in relation to implementing a nationally-consistent scheme as
agreed to by COAG. It is not anticipated that the cost as described in the
Financial Impact Statement would be substantially different under Option 2, as
detailed below.
It is difficult to compare these costs to existing
regulatory models because in all three States that have a licensing system, uses
of embryos that may damage or destroy the embryo are banned. As such, very few
research licences are issued each year and the vast majority of work undertaken
by licensing authorities in those States relates to the regulation of routine
ART clinical practice. However, as the authorities in Victoria, South
Australia and Western Australia will no longer be required to issue licences in
relation to research (as this will be done by the NHMRC Licensing Committee), it
is expected that there may be a minor decrease in costs to these State agencies
overtime. However in the short term there are likely to be increased costs to
all States and Territories as the result of implementing corresponding State and
Territory laws. These costs are likely to be the same under Option 2.
In
terms of government policy, this approach avoids “loopholes” in
regulatory coverage as the NHMRC Licensing Committee will oversee all non-exempt
uses of excess ART embryos and such oversight is not dependent on the researcher
or ART clinic self-assessing that the work they are proposing to undertake will
not damage or destroy the embryo. Further, the publicly available database of
licensed uses of excess ART embryos will be much more comprehensive than under
Option 2, providing greater transparency in terms of the actual work being
conducted on excess ART embryos.
On the community: By regulating
all uses of ART embryos, the NHMRC will be able to publicly report in a more
meaningful way. By only regulating some of the uses of excess ART embryos
(Option 2), the information available to the community about the number of
excess ART embryos and the uses of such embryos may be incomplete. The
community would also be reassured that there are no gaps in regulatory coverage
and that uses of excess ART embryos are being appropriately
overseen.
Impacts of Option 2: Only those uses of excess ART embryos
that involve research or therapy that may damage or destroy the embryos be
subject to the regulatory system and therefore require a licence from the NHMRC
(unless the uses are exempt uses).
On ART service providers:
This Option means that a more limited class of activity would be regulated and
require a licence. Therefore it is expected that the costs to ART service
providers would likely be less than under Option 1. However, if it is not clear
to service providers whether the work on excess ART embryos is likely to cause
harm or lead to their destruction, it is likely that clinics would need to seek
clarification from the NHMRC on a case by case basis and may unnecessarily apply
for licences, erring on the side of caution. This may lead to increased costs
comparable to those described in Option 1.
On consumers of ART
services: There may be less reassurance for consumers that there is
government oversight of all uses (for research, quality assurance and training)
of their excess ART embryos. That is, consumers would know that, should
researchers self-assess their work as not being research or therapy that is
harmful to an excess ART embryo, then there would be no national oversight of
such work (other than internal oversight by an institutional ethics committee).
While there may be increased costs to ART service providers as the result of
requiring a licence for certain work, if such costs are passed on to consumers
these may be less under this Option than Option 1 (as fewer licences are likely
to be required). However, this may be negated by clinics passing on the costs
of the possible additional burden of having to clarify, on a case by case basis
with the NHMRC, the need for a licence for any work using excess ART embryos,
where they are uncertain of the potential harmful impact of the work on those
embryos.
On researchers: As for Option 1.
On
Government: As the class of work required to be licensed is narrower under
this Option than under Option 1, the costs to the Commonwealth Government as
the result of administering the scheme should be lower than for Option 1.
However as detailed in relation to impacts on ART service providers, the lower
level of certainty on the face of the legislation may mean that in reality ART
service providers and researchers seek advice from the NHMRC on a case by case
basis regarding whether they need a licence, meaning that the costs to
government are likely to be similar to those for Option 1.
On the
community: The community may perceive a logical inconsistency in regulating
only certain uses of excess ART embryos when all work involving excess ART
embryos will involve the destruction and disposal of those embryos at some
point. That is, at the completion of non-destructive quality assurance work
involving excess ART embryos the excess ART embryos cannot be made available
for any other work and are therefore discarded. Many people feel that the key
issues of donor consent and justification for use are the same irrespective of
the nature of the work and require the same level of oversight. Further, the
community may have concerns about service providers and researchers deciding
whether their research is likely to damage or destroy an embryo and therefore
whether to seek a licence. By contrast, in Option 1, a wider range of uses must
be licensed, removing the possibility for inappropriate threshold decision
making by ART service providers and researchers.
A draft Bill and accompanying RIS was provided to experts in a range of
fields, for comment. In that draft of the RIS, Option 1 was different to Option
1 in this RIS. In the previous draft, Option 1 proposed regulating all uses of
ART embryos unless such embryos were for use in achieving pregnancy in a woman.
This approach attracted considerable criticism from ART service providers
because of the uncertainty surrounding what would be required to be licensed and
what could be considered to be related to “achieving pregnancy in a
woman”. For example, it was not entirely clear whether licences would be
required for routine ART clinical activities such as diagnostic tests on embryos
intended for implantation, diagnostic investigations on chromosomally abnormal
embryos and observational work. The revised Option 1 addresses these concerns
by clarifying that the regulatory system only relates to excess ART embryos and
does not apply to “exempt” uses such as observation of an embryo and
diagnostic investigations on embryos that are unsuitable for implantation.
Notwithstanding the concerns relating to the lack of clarity with
respect to the previous version of Option 1 (and therefore the potential
unintended impacts on routine ART clinical practice), there was greater support
for Option 1 than Option 2. In general, most people felt that Option 2 could
leave loopholes if ART service providers and researchers were self-assessing
regarding whether certain work was likely to damage or destroy an embryo and
therefore whether they require a licence. It was generally felt that this
decision should rest with the NHMRC Licensing Committee.
One of the
issues that led to considerable debate during consultations was the impact of
COAG’s decision that embryos not be used for research that damages or
destroys an embryo unless the embryo was created before 5 April 2002. Of
principal concern was that by regulating all uses of excess ART embryos, and
applying the 5 April criteria to all uses of excess ART embryos, this could
significantly affect the capacity of ART clinics to undertake routine training
and quality assurance testing that does not damage or destroy the embryo. As a
result of the consultations, Option 1 has been adjusted to better accord with
the COAG decision and clarify that while all uses of excess ART embryos will be
required to be licensed (except exempt uses), the NHMRC Licensing Committee will
determine whether such uses are likely to damage or destroy the embryo and if
so, only embryos created before 5 April 2002 may be used.
On balance it is considered that Option 1 provides a greater level of
regulatory certainty and does not rely on researchers self assessing in each
instance regarding whether the work may harm the excess ART embryo or not. The
need for case by case consideration (outside the parameters of the legislation)
may, in fact, be a greater burden for both researchers and Government than a
clear requirement for a licence in all cases.
While Option 1 is likely to
lead to more licence applications by ART service providers, the additional
burden associated with the regulatory uncertainty of Option 2, may balance the
costs to ART service providers and therefore also any flow on costs to
consumers. Therefore the additional certainty and reassurance to consumers (and
to the general community) under Option 1 makes Option 1 a more attractive option
compared with Option 2.
As stated in the COAG communique the regulatory system will be reviewed
within three years. The review will be carried out on all aspects of the
legislation, including the prohibited practices, which will take into account
changes in technology, the potential therapeutic uses for such technology, and
any changes in community standards.
Specifically, the Research Involving
Embryos and Prohibition of Human Cloning Bill 2002 provides for the NHMRC to
ensure that an independent review of the legislation be undertaken 2 years after
the legislation in enacted. In summary, the review must:
• be
undertaken by independent people chosen by the NHMRC with the agreement of all
States and Territories;
• include a consideration of the scope and
operation of parts of the legislation that deal with prohibited practices
(including human cloning), particularly taking into account developments in
assisted reproductive technology (such as refinement of cytoplasmic transfer),
scientific and research developments, the potential therapeutic applications of
any research (including for “therapeutic cloning”) and community
standards;
• contain recommendations about any amendments that should
be made to the legislation;
• be informed by consultation with the
Commonwealth, States, Territories and a broad range of stakeholders;
• include information about the views of the Commonwealth, States and
Territories (to the extent that it is reasonably practicable to do so);
and
• be completed and provided to the Council of Australian
Governments within 12 months (by the third anniversary of the
legislation).
It is also proposed that the issue of cost recovery be
examined as part of the general review of the legislation in three
years.
COAG also agreed that the NHMRC would report to COAG within 12
months on the adequacy of supply and distribution for research of excess ART
embryos that would otherwise have been destroyed. This will allow consideration
of the need to maintain the restriction on the use of embryos to those embryos
created before 5 April 2002.
The following table is based on one that was included in the Regulation
Impact Statement that accompanied the “Report on Human Cloning, Assisted
Reproductive Technology and Related Matters”, the recommendations of which
were considered by COAG at their meeting on 5 April 2002.
A
comparison of the practices to be banned in proposed nationally consistent
legislation and those practices that are currently considered unacceptable.
|
Proposed Prohibition
|
Related unacceptable practice in NHMRC/AHEC Guidelines and inclusion in
current legislation (Vic, SA and WA)
|
Reasons for inclusion of prohibition as proposed
|
|
Cloning of a human being.
|
Guideline 11.3 and prohibited in all three Acts. There is also a
prohibition in the Gene Technology Act 2000.
|
Scientific developments have occurred that have caused reconsideration of
the wording used in the current bans on human cloning. Revised wording is
proposed that ensures that regardless of the means used for the development of a
human clone, human cloning is banned.
|
|
Creation of an embryo for purposes other than assisted reproduction or by a
process other than the fertilisation of a human ovum by human sperm.
|
Guideline 11.1 and effectively prohibited in all three Acts.
|
Reflects the current prohibition but clarifies that an embryo can only be
created for assisted reproduction through fertilisation.
|
|
Creation or development of an embryo for assisted reproduction that
contains genetic material from more than 2 people.
|
Not included in Guidelines. Prohibited in Vic. Not explicitly prohibited
in WA and SA but any procedure leading to this outcome would require approval by
licensing body.
Prohibited under RTAC guidelines for the accreditation of ART
clinics.
|
Not currently practiced in Australia due to concerns that procedures
leading to this outcome may not be completely safe. Inclusion of this
prohibition brings it into line with the more recent RTAC Guidelines.
|
|
Creation or development of an embryo for assisted reproduction that uses
any precursor cells of eggs or sperm from an embryo or fetus.
|
Guideline 11.4 and effectively prohibited in Vic and WA.
|
Prohibition re-worded to clarify potentially inaccurate terminology.
|
|
Maintaining an embryo outside the body of a woman after the 14th
day of its development excluding any time in which its development is
suspended.
|
Guideline 11.2 and specifically prohibited in SA and WA.
|
Prohibition re-worded to clarify that development excludes periods of
storage.
|
|
Altering the genome of a cell of a human being or in vitro embryo such that
the alteration is inheritable.
|
Effectively prohibited in all three Acts and considered ethically
unacceptable by NHMRC (“Guidelines for Ethical Review of Research
Proposals for Human Somatic Cell Gene Therapy and Related
Therapies”).
|
Concerns that, despite potential benefits, the effects of inheritable
changes to the genome are too poorly understood to allow practice to be carried
out.
|
|
Embryo flushing.
|
Guideline 11.8, specifically prohibited in SA and WA and effectively
prohibited in Vic.
|
While it is intended that this prohibition continue, it is recommended that
the wording be changed so as to reflect the outcome rather than the technique
which is the intentional removal of a viable embryo from a woman.
|
|
Creating or developing a hybrid embryo or placing a hybrid embryo in the
body of a human or animal for any period of gestation.
|
Guideline 11.5 and effectively prohibited in all 3 Acts. There is also a
prohibition in the Gene Technology Act 2000.
|
Reflects the current prohibition but clarifies that a hybrid embryo must
not be implanted in the body of a human or animal.
|
|
Placing a human embryo in an animal or in any human body cavity other than
the female human reproductive tract or placing an animal embryo in a human for
any period of gestation.
|
Guideline 11.7 and effectively prohibited in all 3 Acts.
|
NHMRC/AHEC prohibition expanded to be brought more in line with State
prohibitions and to expressly ban putting an animal embryo in a human.
|
|
Giving or offering valuable consideration to any person for donation of
gametes or embryos of that person or of any other person. Note that it is not
intended to exclude the disbursement of reasonable expenses incurred by a person
in connection with a donation of their genetic material.
|
Guidelines 11.9 and 11.10 effectively prohibited in all 3 Acts.
|
Combination of NHMRC/AHEC prohibitions relying on the wording of
prohibitions included in SA and WA Acts.
|
[1] It should be noted that the NHMRC/AHEC Ethical Guidelines on ART are currently subject to review and will be reissued in early 2003. Information on the nature of the revisions is not yet available.