Copyright © Government of South Australia 2002
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RESEARCH INVOLVING HUMAN EMBRYOS BILL
The Hon. L. STEVENS (Minister for Health) obtained leave and introduced a bill for an act to regulate certain activities involving the use of human embryos and other related activities; to amend the Reproductive Technology Act 1988; and for other purposes. Read a first time.
The Hon. L. STEVENS: I move:
That this bill be now read a second time.
I seek leave to have the second reading explanation inserted in Hansard without my reading it.
The Research Involving Human Embryos Bill reflects the provisions and definitions of the equivalent Commonwealth Act.
It complements the Prohibition of Human Cloning Bill to form South Australia's part of the national scheme for regulating the use of embryos. It reflects provisions in the Commonwealth Research Involving Human Embryos Act.
This Bill proposes to amend the Reproductive Technology Act 1988 to remove the section relating
to embryo research.
It establishes a separate Act to regulate the use of embryos more broadly and to bring South Australia into the national embryo licensing scheme.
This Bill takes a very conservative approach.
It places the same strict limitations on embryo research as the Commonwealth scheme. It allows only certain embryos to be used for approved applications under specified conditions.
It empowers the couples for whom the embryos were created to determine to what use their excess embryos may be put.
The Bill is drafted to regulate all embryo use other than for the treatment of patientsclinical treatment (eg for infertile couples) will remain wholly under the Reproductive Technology Act 1988.
It requires a licence from the NHMRC for the use of human embryos that are determined to be excess to treatment to conduct research, teaching and training, audit, quality control and commercial enterprise.
The Bill has been drafted to require a licence under the State legislation equivalent to that under the Commonwealth Act.
The Bill covers all embryo research, rather than just embryonic stem cell research. Embryos can be used for other types of research related to infertility as well as for creating embryonic stem cell lines for treating diseases and injuries. The Bill regulates the creation of embryonic stem cells from embryos but not what is done with the stem cells once they are created. The Legislative scheme prohibits the creation of embryos for research which means that embryonic stem cell lines can only be created from embryos that are excess to reproductive technology treatment.
It describes certain uses of embryos associated with clinical treatment that do not require a licence.
It allows diagnostic testing of embryos to help determine for a couple why their treatment has been unsuccessful and what different options can be offered to increase the likelihood of a pregnancy.
Although other states have been able to offer such support to infertile couples, this has not been available for South Australian couples under existing legislation.
A sunset provision is included to reflect the fact that the restriction on use of embryos after 5 April 2002 will be lifted in 3 years or maybe earlier if COAG so recommends.
This was endorsed as part of the COAG Agreement to address concerns that a ban on the creation of embryos for research might result in more embryos being created for treatment of infertile couples, with the intent of producing a greater pool of excess embryos that could be accessed for research.
The NHMRC has been asked to investigate this and to assess the number of embryos actually available for research in Australia (which has been misquoted as 70 000 but is likely to be less than one tenth of that number).
THE NHMRC LICENSING SCHEME
A licence from the NHMRC will be a dual licence to use excess embryos under both Commonwealth and State legislation. This is similar to the scheme in the Gene Technology Act 2001.
The Commonwealth Research Involving Human Embryos Act 2003 contains a 6 month delayed commencement period before the NHMRC licensing scheme becomes operational.
The Act received Royal Assent on 19 December 2002, so the NHMRC licensing scheme will operate from 19 June 2003.
The NHMRC Embryo Licensing Committee will only issue a licence if it is satisfied
×that it was donated with proper consent;
×that there is compliance with any restrictions on such consent; and
×that the embryo was created before 5 April 2002.
The proposed activity or project must have been assessed and approved by a local Human Ethics Research Committee in accordance with NHMRC guidelines.
The NHMRC Licensing Committee will also take into account:
×the local Human Ethics Research Committee assessment of the project;
×the requirement to restrict the number of excess embryos to that likely to be necessary for the project; and
×the likelihood of significant advance in knowledge, treatment technologies or other applications from the proposed project.
If a licence is issued, the NHMRC Licensing Committee will notify the applicant, the Human Ethics Research Committee that assessed and approved the project and the relevant State body, which in South Australia will be the SA Council on Reproductive Technology through its Secretariat in the Department of Human Services.
The period of the licence will be determined on a case-by-case basis.
The NHMRC Licensing Committee will be able to vary a licence if it believes on reasonable grounds that this is necessary or desirable.
Once the Commonwealth licensing scheme becomes operational, South Australian scientists will be able to apply for a licence to conduct research on embryos, or use embryos for training or quality audits.
Some of the activities for which a licence may be approved could be detrimental to the embryos.
Because State laws that are inconsistent with Commonwealth laws are invalid to the extent of the inconsistency, in South Australia in July 2003, a laboratory or clinic will be able to apply for a licence from the NHMRC to use human embryos for purposes that are currently prohibited under the South Australian Reproductive Technology Act.
NHMRC LICENSING COMMITTEE
The Commonwealth provisions that deal with the establishment of the NHMRC Licensing Committee do not need to be reflected in the state legislation, but provisions related to the Committee's operation have been incorporated.
The Committee is currently being established with input from the States.
It is expected to be in place in time to approve research licences in June 2003.
The Committee members will be appointed by the Commonwealth Minister for Health and will include a member of Australian Health Ethics Committee of the NHMRC and members with expertise in the following specific areas:
×relevant area of research;
×assisted reproductive technology;
×a relevant area of law;
×consumer health issues relating to disability and disease;
×consumer issues relating to assisted reproductive technology;
×the regulation of assisted reproductive technology;
THE ROLE OF HUMAN RESEARCH ETHICS COMMITTEES
Few Human Research Ethics Committees (HRECs) in Australia deal with proposals for research involving human embryos or other ART related research.
HRECs assess research proposals against legislative requirements and guidelines prepared by the NHMRC.
The NHMRC Australian Health Ethics Committee has suggested that HRECs dealing with research proposals involving human embryos are provided with access to independent technical advice and detailed guidelines about matters that must be taken into account when considering a proposal involving human embryos.
Reporting requirements of HRECs are being strengthened to improve accountability and transparency.
The Australian Health Ethics Committee has also recommended that:
×membership of a HREC should include relevant expertise to allow a thorough determination of the value of the proposed research;
×the HREC must be satisfied that the research proponents have the competence to complete the proposed research;
×the HREC must be satisfied that the embryos in question are no longer needed for implantation.
There are very strict criteria to be met before a research licence will be issued by the NHMRC Licensing Committee including evidence of proper informed consent by those donating the embryos and their partners.
These "embryo parents" can determine whether to donate their excess embryos to research (or to other infertile couples or to discard them); and can determine the type of research to which they are prepared to donate them and under what conditions.
The researchers are required to account for every embryo so licensed and to abide by conditions set by donors.
In South Australia at present most embryos donated to research are donated for research into infertility problems and treatments.
It is likely that most embryos in Australia will be used for infertility research, rather than stem cell research. Infertility research usually requires more embryos to be used to achieve valid results whereas many stem cells can be created from a single embryo.
INSPECTORS AND MONITORING
The Bill enables inspectors appointed under the Commonwealth Act to inspect premises covered by the State or Commonwealth legislation.
Reporting requirements mirror those in the Commonwealth legislation.
Most non-infertility research using embryos, such as embryonic stem cell research, is expected to be conducted as part of national collaborations. Therefore, tabling of regular national reports provided by the NHMRC is considered most useful.
The Parliament will also continue to receive the annual report of the SA Council on Reproductive Technology which will report broadly on embryo research and other reproductive technology research conducted in South Australia.
EMBRYO RESEARCH NOT COVERED BY THE NHMRC LICENSING SCHEME
The Commonwealth scheme does not cover use of human sperm or ova in research, nor clinical research (eg clinical trials) which do not use excess human embryos as the embryos are destined to be implanted.
In other States, particularly where there is not an equivalent body to the SA Council on Reproductive Technology, such research requires only local Human Ethics Research Committee approval.
It is proposed that clinical research that leaves the embryo in an implantable condition and research using gametes do not need to be subject to a separate state licensing scheme.
However, it is considered essential that the Council continues to monitor research using embryos and gametes conducted in South Australia, including clinical trials, and so it is intended that regulations will require HRECs to report to the Council on all the research proposals that they consider, approve or refer to the NHMRC Licensing Committee for a licence.
It is envisaged that this information would be included in the Council's annual report to Parliament.
Medical research into causes and effects of infertility that does not use embryos and social research into the impact of assisted reproductive technology on families are not impacted by the amendment to the Reproductive Technology Act 1988.
Such research is not currently licensed but is and will continue to be monitored by the Council.
Explanation of Clauses
Clause 1: Short title
This clause is formal.
Clause 2: Commencement
The measure will be brought into operation by proclamation.
Clause 3: Interpretation
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:
"accredited ART centre" 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 prescribed 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.
"excess ART embryo" means a human embryo where
(a)the embryo was created by assisted reproductive technology for use in the treatment of a woman; and
(b)the embryo is excess to the needs of the woman for whom it was created and any spouse (at the time the embryo was created) of that woman.
The determination with respect to being excess to the needs of the woman and any spouse of the woman (at the time the relevant embryo was created) is provided for under clause 3(5).
"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 other means.
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 (i.e. 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.
Clause 3(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.
Clause 4: Nationally consistent scheme
This clause specifically states that it is intended that the principal objects of the measure be achieved through a regulatory framework and a range of offences that operate in conjunction with, and in a manner that is consistent with, corresponding Commonwealth and State laws.
Clause 5: Offenceuse 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 subclause (2).
Subclause (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;
×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 carried out at an appropriate facility in limited circumstances using excess ART embryos that are unsuitable for implantation;
×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.
Clause 6: Offenceuse of embryo that is not an excess ART embryo
This clause provides that it is an offence to intentionally use, outside the body of a woman, a non-excess ART embryo unless the use is for a purpose related to the assisted reproductive technology treatment of a woman carried out by an accredited ART clinic under a South Australian clinical practice licence.
Clause 7: Offencebreaching a licence condition
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.
Clause 8: Conferral of functions on Committee
This clause confers functions on 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 licence application including the applicant, the relevant Human Research Ethics Committee (HREC) and other appropriate bodies;
×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;
×providing information about the Committee's functions for inclusion in the NHMRC annual report; and
×providing advice to applicants on the licensing requirements and the preparation of applications.
Clause 9: Powers of Committee
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.
Clause 10: 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. The application must also be accompanied by an application fee if such an application fee is prescribed in the regulations.
Clause 11: Determination of application by Committee
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.
Subclause (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
×if the proposed use of the excess ART embryo may damage or destroy the embryo, 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.
Subclause (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; and
×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; and
×any relevant guidelines, or parts of guidelines, issued by the NHMRC and prescribed under the corresponding Commonwealth Act; and
×the HREC assessment of the application; and
×such additional matters (if any) as are prescribed by the regulations.
Clause 12: Notification of decision
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 other prescribed persons or bodies.
Clause 13: Period of licence
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.
Subclause (2) clarifies that a licence is not in force throughout any period of suspension.
Clause 14: Licence is subject to conditions
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.
Clause 15: Variation of licence
This clause enables the NHMRC Licensing Committee to vary a licence. A variation may be made where the NHMRC Licensing Committee believes on reasonable grounds that it is necessary or desirable to do so.
Clause 16: Suspension or revocation of licence
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.
Clause 17: Surrender of licence
A licence holder may surrender a licence.
Clause 18: Notification of variation, suspension or revocation of licence
This clause provides that if the NHMRC Licensing Committee varies, suspends or revokes a licence the Committee must notify the licence holder and other relevant bodies.
Clause 19: NHMRC 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.
Subclause (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;
(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 has been 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;
(f)the period of the licence.
Clause 20: Confidential commercial information may only be disclosed in certain circumstances
This clause is intended to protect, from public disclosure, certain information that is legitimately confidential commercial information.
Clause 21: Interpretation
This clause sets out definitions that are relevant to the scheme for the review of licensing decisions under the measure.
An "eligible person" in relation to a decision of the NHMRC Licensing Committee means
×a licence applicantin relation to a decision by the NHMRC Licensing Committee not to issue a licence; and
×the licence holder in relation to
×a decision by the NHMRC Licensing Committee relating to the period of a licence; or
×a condition of licence imposed by the NHMRC Licensing Committee; or
×a decision by the NHMRC Licensing Committee to vary, refuse to vary, suspend or revoke a licence.
A "reviewable decision" is any of the following decisions of the NHMRC Licensing Committee:
×a decision not to issue a licence; or
×a decision in respect of the period throughout which the licence is to be in force; or
×a decision to specify a licence condition; or
×a decision to vary or refuse to vary a licence; or
×a decision to suspend or revoke a licence.
Clause 22: Review of decisions
An eligible person will be able to apply to the Administrative and Disciplinary Division of the District Court for review of a reviewable decision. An application to the District Court will need to be made within 28 days after the making of the relevant decision and the proceedings may be heard by a Judge sitting with assessors if assessors have been appointed and the Judge considers that the Court should be so constituted.
Clause 23: Powers of inspectors
The inspectors under this measure are to be inspectors who have been appointed under a related Commonwealth law.
This clause sets out the powers of an inspector to enter and search premises. An inspector will not be able to enter premises under this clause unless
(a)the occupier of the premises has consented to the entry; or
(b)activities being carried out on the premises are covered by a licence and the entry is at a reasonable time; or
(c)the entry is under the authority of a warrant; or
(d)the inspector considers on reasonable grounds that the circumstances require immediate entry.
Clause 24: Announcement before entry
An inspector must give the occupier of premises a reasonable opportunity to consent to entry to the premises before exercising a statutory power to gain entry.
Clause 25: Inspector must produce identity card on request
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.
Clause 26: Compensation for damage
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 under the terms of the provision.
Clause 27: Return of seized things
This clause sets out a scheme for dealing with any item that has been seized by an inspector under this Part.
Clause 28: Related matters
It will be an offence to hinder or obstruct an inspector in the exercise of statutory powers under this Part. A person will not be required to answer a question if to do so might tend to incriminate the person or make the person liable to a penalty.
Clause 29: Commonwealth/State arrangements
This clause is intended to facilitate the interaction between this measure and related Commonwealth Acts.
Clause 30: Delegations
This provision will allow the Minister and the NHMRC Licensing Committee to delegate functions and powers under the measure.
Clause 31: Annual reports
Reports of the NHMRC Committee that are relevant to this measure will be provided to the Minister and tabled in Parliament.
Clause 32: False or misleading information
It will be a specific offence to provide false or misleading material in any information under the measure.
Clause 33: Liability of directors
This clause relates to the responsibility of directors of corporations for breaches of the Act.
Clause 34: Evidential burden in relation to exceptions etc
This clause is intended to ensure consistency between this measure and Commonwealth law with respect to certain evidential burdens.
Clause 35: Regulations
The Governor will be able to make regulations for the purposes of the measure.
Clause 36: Sunset provision
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.
Related amendments must be made to the Reproductive Technology Act 1988. It is also necessary to ensure the immediate operation of the first set of regulations under the new measure to ensure that there is no `hiatus' in the regulatory scheme.
The Hon. W.A. MATTHEW secured the adjournment of the debate.