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2002
THE PARLIAMENT OF THE
COMMONWEALTH OF
AUSTRALIA
SENATE
RESEARCH INVOLVING
EMBRYOS BILL 2002
REVISED 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 regulates activities that involve the use
of certain human embryos created by assisted reproductive
technology.
This Bill was originally introduced into Parliament as the
Research Involving Embryos and Prohibition of Human Cloning Bill 2002.
On 29 August 2002 the House of Representatives voted to amend the Bill by
dividing it into two separate pieces of legislation – the Research
Involving Embryos Bill 2002 and the Prohibition of Human Cloning Bill
2002.
Consistent with its object, the Bill:
(a) 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;
(b) 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
(c) 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 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, as included
in the Prohibition of Human Cloning Bill 2002. 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 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 9
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
definitions relevant to the regulation of excess ART embryos.
Item 3
of the table provides that clauses 10 to 12 will commence 6 months after the
day on which the Bill receives Royal Assent. Clause 10 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 11 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 12
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).
Delaying the commencement of these clauses for 6 months 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 of the table provides that clauses 13 to 48 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.
This clause provides that the object of this Bill is to address concerns,
including ethical concerns, about scientific developments in relation to the
utilisation of human embryos 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:
Ø 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
Ø 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(2) 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.
This clause sets out a number of definitions for words and phrases used
in Part 2 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
9 – 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
10(2).
Sub-clause 10(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 10(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 11(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 14, 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 13 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
13(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 16, 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 13(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 16(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 16(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 16(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 16(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 20 – 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 21(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 21(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
23(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 24(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 24(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
24(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 25(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 20. 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 46 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 29 – 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 29(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 30) 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 8 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 30 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
29) 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 32(1) provides that an eligible person (as defined in
clause 31) may apply to the Administrative Appeals Tribunal for review of the
following decisions of the NHMRC Licensing Committee:
(a) a decision
under clause 21 not to issue a licence;
(b) a decision in respect of the
period throughout which the licence is to be in force under clause 23;
(c) a
decision to specify a licence condition under sub-clause 24(4);
(d) a
decision to vary or refuse to vary a licence under clause 25; or
(e) a
decision to suspend or revoke a licence under clause 26.
Sub-clause 32(2) provides that clause 32 has effect subject to the
Administrative Appeals Tribunal Act 1975.
Sub-clause 33(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 33(3)).
Sub-clause 33(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 34(1) and 34(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 34(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 34(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 35(1) confers powers upon an inspector to enter any
premises and to exercise any or all of the powers set out in clause 36 for the
purposes of establishing whether or not the Act or regulations are being
complied with.
Sub-clause 35(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 35(2)(a)), the inspector must inform the person
that he or she may refuse consent.
Sub-clause 39(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 a reference in Part 3 to the Research Involving
Embryos Act 2002 includes a reference to the Prohibition of Human Cloning
Act 2002 and a reference in Part 3 to regulations includes a reference to
regulations made under the Prohibition of Human Cloning Act 2002. The
effect of Clause 41 is that Part 3 will apply in exactly the same way to the
Prohibition of Human Cloning Act 2002 as it does to the Research
Involving Embryos Act 2002. That is, inspectors will exercise monitoring
powers under both Acts.
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 10 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 43 – 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 44, 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 42 and 43 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 43 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 45(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 45(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 46 – Repeal of paragraphs 21(3)(b) and 24(1)(c) and
subsection 24(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 47(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
47 (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:
• include a consideration of the scope and operation of the
Research Involving Embryos Act 2002 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;
and,
• include information about the views of the Commonwealth, States
and Territories (to the extent that it is reasonably practicable to do so).
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 48(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.
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 regulatory scheme for the use of excess ART embryos.
The problems that currently exist in relation to the regulation of
research on (and other uses of) human embryos include:
• 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 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 (NPSU) reported that there were 34 IVF units in Australia in 2000.
Consumers of ART services
Data available from the NPSU 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 if 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.
Options and impact analysis
for the scope of the regulation of uses of excess ART embryos
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 consider applications and may 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 ART treatment;
• 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 couple for whom it was
created
• for observation of the embryo; or
• for use that
forms part of diagnostic investigations conducted in connection with the ART
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 for ART treatment;
• 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 couple for whom
it was created
• observation of the embryo; or
• use that
forms part of diagnostic investigations conducted in connection with the ART
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 to undertake 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 HREC 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 costs 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 over time. 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 the destruction of the embryos, 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 assurance 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. It may also be the
case, that monitoring costs are higher to ensure that researchers are not
undertaking work that requires a licence after self-assessing that the work does
not require a licence.
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 of the Research Involving Embryos and Prohibition of Human
Cloning Bill 2002 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 it a more attractive option
than 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. It 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 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 the people who undertake the review of the
Prohibition of Human Cloning Act and be undertaken concurrently with that
review;
• include a consideration of the scope and operation of parts
of the legislation, 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 legislation;
• be informed by consultation with the
Commonwealth and States and a broad range of stakeholders;
and,
• include information about the views of the Commonwealth and
States (to the extent that it is reasonably practicable to do so).
The
people who undertake the review must give COAG written report of the review.
The report must accompany the report on the Prohibition of Human Cloning
Act review.
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.