Senate debates

Thursday, 19 October 2006

Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006

Second Reading

10:19 am

Photo of Kay PattersonKay Patterson (Victoria, Liberal Party) Share this | | Hansard source

I move:

That this bill be now read a second time.

I seek leave to have the second reading speech incorporated in Hansard and to table an explanatory memorandum relating to the bill.

Leave granted.

The speech read as follows—

The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006 amends the Prohibition of Human Cloning Act 2002 (PHC Act) and the Research Involving Human Embryos Act 2002 (RIHE Act).

The RIHE and the PHC Acts required that both Acts be reviewed by an independent committee by December 2005.

Sub-clause 25(1) of the PHC Act provided that the Minister was required to cause an independent review of the Act to be undertaken commencing two years after it received Royal Assent. A similar provision was included in the RIHE Act. Provisions in the RIHE Act ensured the reviews of both Acts were undertaken concurrently and by the same people.

The terms of reference for the Committee was set out in both Acts and the intention in 2002 was that the Acts be reviewed together and the full terms of reference provided to the Committee by the Minister for Ageing are:

(1)
The Legislation Review Committee —Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 —is required to consider and report on the scope and operation of each of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 taking into account:
(i)
the following statutory requirements:
(a)
developments in technology in relation to assisted reproductive technology;
(b)
developments in medical research and scientific research and the potential therapeutic applications of such research;
(c)
community standards;
(d)
the applicability of establishing a National Stem Cell Bank; and
(ii)
the following additional matters in relation to the national legislative scheme:
(a)
consideration of relevant aspects of State and Territory legislation corresponding to the Research Involving Human Embryos Act 2002;
(b)
the role played by State and Territory statutory bodies that regulate assisted reproductive technology (ART) treatment as well as the role of national organisations including, but not necessarily limited to, the Fertility Society of Australia and its Reproductive Technology Accreditation Committee (RTAC);
(c)
the effectiveness of monitoring and compliance under the Research Involving Human Embryos Act 2002 in particular, but also in relation to the Prohibition of Human Cloning Act 2002 to the extent that issues may arise in relation to the latter Act;
(d)
the ongoing appropriateness and effectiveness of changes to the Customs regulations to regulate the export of human embryos derived through ART and the import of viable materials derived from human embryo clones;
(e)
options for regulation of the import and export of human embryonic stem cells;
(f)
the implications of cost recovery; and
(g)
implications for Australian science and economic activity.
(2)
The Legislation Review Committee is required to consult the Commonwealth, the States, the Australian Capital Territory and the Northern Territory and a broad range of persons with expertise in or experience of relevant disciplines.
(3)
The reports must, to the extent that it is reasonably practicable, set out the views of the Commonwealth, the States and Territories and those other persons consulted.
(4)
Each report must contain recommendations about amendments, if any, that should be made to the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, whichever is applicable.
(5)
The Legislation Review Committee is required to give a written report to the Council of Australian Governments and both Houses of the Parliament on the independent review of the operation of the Prohibition of Human Cloning Act 2002 no later than Monday 19 December 2005. The Legislation Review Committee is required to give a written report to the Council of Australian Governments and both Houses of the Parliament on the independent review of the operation of the Research Involving Human Embryos Act 2002 as an accompanying report to the report on the review of the operation of the Prohibition of Human Cloning Act 2002.

In June 2005 the Hon Julie Bishop MP (the then Minister for Ageing with portfolio responsibility for human cloning and stem cell research) appointed a six-member Legislative Review Committee. All the appointments to the Committee were agreed by each State and Territory as the Acts required.

The Legislative Review Committee was chaired by the late John S Lockhart AO QC, a former Justice of the Federal Court of Australia. The other members were Associate Professor Ian Kerridge (New South Wales) a clinical ethicist; Professor Barry Marshall (Western Australia), a specialist gastroenterologist and community advocate; Associate Professor Pamela McCombe (Queensland), a clinical neurologist; Professor Peter Schofield (New South Wales), a neuroscientist; and Professor Loane Skene (Victoria), a lawyer and ethicist.

Sadly John S. Lockhart AO QC died very shortly after the Legislative Review Committee (more commonly known as the Lockhart Review Committee) provided the Minister with its report. I was not privileged to know John Lockhart but I think it would be remiss of me not to relay a comment made to me by one of the other members of the Lockhart Committee—“he was an extraordinary fellow who imbued the entire process and report with a deep respect for all parties and a deep tolerance of divergent viewpoints”.

The Committee “consulted the community extensively through a review website, written submissions, face-to-face meetings with key stakeholders, public hearings and some private meetings (at stakeholders’ requests), facilitated stakeholder discussion forums, and selected site visits. In addition, the Committee reviewed the latest results of focus group and telephone survey research by the Public Awareness Program of Biotechnology Australia, and a literature review (commissioned by the NHMRC on behalf of the Minister for Ageing) of recent scientific and technological advances in human cloning, human embryo research and related matters, including stem cell technologies.” (page xiii)

“Throughout the consultation, the Committee heard from a broad range of people about the implications of legislation for assisted reproductive technology (ART), including in vitro fertilisation (IVF), and for human embryo research. The purpose of this public consultation was to seek the views, values and ‘standards’ of the community regarding the reviews of the Prohibition of Human Cloning Act 2002 (PHC Act) and the Research Involving Human Embryos Act 2002 (RIHE Act). In doing so, the Committee came to the view that Australian society should not be characterised as being a single, homogeneous community, but instead is composed of many different ‘communities’, each of which may have its own perspectives, interests and values, and that any one individual may be a member of many different communities at the same time. Thus, a person may be a committed Christian, a scientist, a shareholder, and the relative of a person with a serious illness —’communities’ that may have very different perspectives or ‘standards’ regarding the development and use of embryos for research.

“The Committee also observed that the ‘standards’ evidenced by these communities varied enormously both between and within communities in terms of the extent to which they were clearly developed or articulated; the degree to which they were felt to bind members of the community; and the degree to which they changed over time or with developments in science and medicine. Consequently, the Committee considers that the social and moral concerns raised by ART and embryo research cannot be explained simply by reference to a single ‘standard’ or a single set of values, beliefs or interests held by a single community.

“In looking for common ground, the Committee noted that there are certain moral values that are held in common by all communities, such as a commitment to social justice and equity, and to the care of vulnerable members of society. This is reflected in broad support for medical research aimed at understanding, preventing or treating disease. The Committee also noted widespread support for medical research to assist people to have children (including a general acceptance that this process may involve the ‘wastage’ of some embryos). Hence, the Committee came to the view that considerations regarding the use of embryos for research needed to take account of both the value that different communities attach to the embryo, and the social and moral value that communities attach to the treatment of disease and the amelioration of infertility.

“It is clear that there are wide-ranging views on embryo research and human cloning, with the exception of human reproductive cloning, which appears to be widely condemned. Some people consider that human embryos have the moral status of an adult and so should not be subject to destructive research in any circumstances, regardless of medical benefit. Others hold a view that human embryos deserve some special consideration by virtue of their moral or social/relational status, but should not be accorded the same status as humans after birth. People who hold this view consider that embryos may be subject to research in certain circumstances, such as when they are judged to be excess, nonviable or unsuitable for implantation. A third group supported research on human embryos before implantation into the body of a woman and urged an extension of what is currently permitted because of the potential medical or scientific benefits that may result from such research. Each of these views is sincerely held and it was apparent to the Committee that all those who made submissions were motivated by a desire to do what is best for our society. However, it was also clear to the Committee that these views could not always be reconciled. Therefore, the challenge for the Committee has been to make recommendations that are consistent with shared values and take into account the needs, beliefs and concerns of the whole community.” (page 161)

“In framing the recommendations, the Committee considered that the higher the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where there is evident or possible harm, or where there is widespread and deeply held community objection, a total prohibition through the legal system may be justified. The Committee’s view is that it does not necessarily follow that even though some people think that an activity is unethical, it is necessary to make that activity illegal. Furthermore, the wider the range of ethical views on a particular activity, the weaker the case becomes for declaring that activity to be illegal, with all the attendant consequences of criminal conduct.” (page 162)

The Committee noted that “despite the divergent views received by the Committee during the reviews, both proponents and opponents of embryo research agreed that the current system of legislation is valuable. Therefore, it recommended a continuation of national legislation imposing prohibitions on human reproductive cloning and some other ART practices, as well as strict control and monitoring, under licence, of human embryo research”. (page xiv)

The Minister for Ageing received the Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002 in December 2005.

In summary, the proposed amendments to the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002:

  • retain existing prohibitions on activities such as:
  • placing a human embryo clone in the human body or the body of an animal;
  • importing or exporting a human embryo clone;
  • creating a human embryo by fertilisation of a human egg by human sperm, for a purpose other than achieving pregnancy in a woman;
  • creating or developing a human embryo by fertilisation of human egg by human sperm which contains genetic material provided by more than 2 persons;
  • developing a human embryo outside the body of a woman for more than 14 days;
  • making heritable alterations to a human genome;
  • collecting a viable human embryo from the body of a woman;
  • creating or developing a chimeric embryo;
  • developing a hybrid embryo beyond 14 days;
  • placing a human embryo in an animal, a human embryo into the body of a human other than into the female reproductive tract or an animal embryo in a human; and
  • importing, exporting or placing in the body of a woman, a prohibited embryo.
  • enable certain types of research involving embryos to be permitted provided that the research is approved by the NHMRC Licensing Committee (in accordance with legislated criteria) and that the activity is undertaken in accordance with a licence issued by the NHMRC Licensing Committee. In summary, a person may apply for a licence to:
  • use excess ART embryos;
  • create human embryos other than by fertilisation of a human egg by a human sperm, and use such embryos;
  • create human embryos (by a process other than fertilisation of human egg by human sperm) containing genetic material provided by more than 2 persons, and use such embryos;
  • create human embryos using precursor cells from a human embryo or a human fetus, and use such embryos;
  • undertake research and training involving the fertilisation of a human egg, up to but not including the first mitotic division, outside the body of a woman for the purposes of research or training;
  • create hybrid embryos by the fertilisation of an animal egg by human sperm, and develop such embryos up to, but not including, the first mitotic division provided that the creation or use is for the purposes of testing sperm quality and will occur in an accredited ART centre; and
  • create hybrid embryos by introducing the nucleus of a human cell into an animal egg, and use of such embryos.

Unless a shorter time is specified, the uses of embryos that may be authorised by a licence may only be authorised for development up to 14 days (excluding any period during which development is suspended). In no circumstances can any embryo be developed, outside the body of a woman, beyond 14 days.

The amendments in this bill are based on the recommendations of the Lockart Review (Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002, Reports, December 2005, Legislation Review Committee (www.lockhartreview.com.au)

In 2002, when I was the Minister for Health and Ageing, I had the responsibility of taking the Prohibition of Human Cloning Bill and the Research Involving Human Embryo Bill through the Senate on behalf of the Government.

As I have said, the Acts required that they be reviewed, and one of the terms of reference required that the “reports must contain recommendations about amendments, if any, that should be made to the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos 2002, whichever is applicable”.

In 2002 I said in the debate on the bills, “If the review gives rise to possible amendments to the legislation, any such amendments must come before parliament, and at that time, whoever is here will have the opportunity to consider in detail any proposed changes to the legislation”.

This bill provides that opportunity. It is not an easy issue and people hold diametrically opposed views. It is important that the public and parliamentary debate on this bill is considered and considerate—everybody, whatever their view, has a right to express that view without being subjected to ridicule or personal abuse.

Incorporated at the end of this speech are the Lockhart recommendations and a response to each recommendation indicating if legislative changes are required and how they are dealt with in the bill.

This bill, Senator Stott Despoja’s Exposure Draft Bill and the Lockhart Review have been referred by the Senate, on my motion, to the Community Affairs Committee for inquiry and consideration. After the examination of the bill by the Community Affairs Committee and at the end of the second reading speeches I will have an opportunity to comment on matters raised in the hearings and on honourable senators’ contributions to the debate. In addition, I am sure that the various issues and points of view will be comprehensively covered in the debate and the consideration of the committee of the whole.

Summary of Lockhart recommendations and how these are addressed in the bill

Lockhart Review recommendation

How the issue is addressed in the bill

1

Clinical practice and scientific research involving assisted reproductive technologies (ART) and the creation and use of human embryos for research purposes should continue to be subject to specific national legislation.

The national legislative scheme will continue to exist.

2

Reproductive cloning should continue to be prohibited.

Proposed clauses 9 and 14 continue to ban the development of a human embryo clone for longer than 14 days and the implantation of such a clone in a human or animal. Amended section 20 also bans the development and implantation of any embryo that does not result from the fertilisation of a human egg by human sperm.

3

Implantation into the reproductive tract of a woman of a human embryo created by any means other than fertilisation of an egg by a sperm should continue to be prohibited.

This is banned in proposed clause 20 of the PHC Act.

4

Development of a human embryo created by any means beyond 14 days gestation in any external culture or device should continue to be prohibited.

This is banned in proposed clause 14 of the PHC Act.

5

Implantation into the reproductive tract of a woman of a human–animal hybrid or chimeric embryo should continue be prohibited.

This is banned in proposed clause 20 of the PHC Act.

6

Development of a human–animal hybrid or chimeric embryo should continue to be prohibited, except as indicated in Recommendation 17.

Creation of chimeric embryos is banned in proposed clause 17 of the PHC Act. The creation and development of hybrid embryos is banned by proposed clause 23B, unless authorised by licence. The only licences that may be issued are ones giving effect to recommendations 17 and 24. Development of hybrid embryos beyond 14 days is banned in all cases by proposed clause 18.

7

Placing a human embryo into an animal or into the body of a human apart from into a woman’s reproductive tract, or placing an animal embryo into the body of a human, for any period of gestation, should all remain prohibited.

This is banned in proposed clause 19 of the PHC Act.

8

Implantation into the reproductive tract of a woman of an embryo created with genetic material provided by more than two people should continue to be prohibited.

This is banned in proposed clause 20 of the PHC Act.

9

Implantation into the reproductive tract of a woman of an embryo created using precursor cells from a human embryo or a human fetus should continue to prohibited.

This is banned in proposed clause 20 of the PHC Act.

10

Implantation into the reproductive tract of a woman of an embryo carrying heritable alterations to the genome should continue to prohibited.

This is banned in proposed clause 20 of the PHC Act.

11

Collection of a viable human embryo from the body of a woman should continue to be prohibited.

This is banned in proposed clause 16 of the PHC Act.

12

Creation of human embryos by fertilisation of human eggs by human sperm should remain restricted to ART treatment for the purposes of reproduction.

This will continue to be the case (proposed clause 12 of the PHC Act).

13

Creation of human embryos by fertilisation of human eggs by human sperm to create embryos for the purposes of research should continue to be prohibited except in the situation described in Recommendation 15.

This is banned in proposed clause 12 of the PHC Act, which makes it an offence to create a human embryo by fertilisation of human egg with human sperm for any purpose other than achieving pregnancy.

14

Use of excess ART embryos in research should continue to be permitted, under licence, as under current legislation.

Use of excess ART embryos in research will continue to be permitted, under licence (proposed amended section 20 of the RIHE Act).

15

Research involving fertilisation of human eggs by human sperm up to, but not including, the first cell division should be permitted for research, training and improvements in clinical practice of ART.

The proposed amendments to section 20 of the RIHE Act allow a person to apply to the Licensing Committee to undertake research involving fertilisation of human eggs by human sperm up to, but not including, the first cell division. Such activity not authorised by a licence is banned under proposed clause 10B of the RIHE Act.

16

Testing of human oocytes for maturity by fertilisation up to, but not including, the first cell division or by parthenogenetic activation should be permitted for research, training and improvements in clinical practice of ART.

Testing by fertilisation up to the first mitotic division will be permitted under licence (proposed clauses 10B and 20 of the RIHE Act). Parthenogenic activation will be also be permitted under licence in accord with recommendation 25 (amended clause 20 of the RIHE Act allows a person to apply for a licence to create an embryo by any means other than fertilisation of human egg by human sperm).

17

Certain interspecies fertilisation and development up to, but not including, the first cell division should be permitted for testing gamete viability to assist ART training and practice.

Proposed paragraph 20(1)(f) enables the granting of a licence to permit this.

18

The Licensing Committee should develop a simple proforma application for licences to undertake training and quality assurance activities for ART clinics.

No legislative change required.

19

Consideration should be given to the use of cytoplasmic transfer (including transfer of mitochondrial DNA), under licence, for research on mitochondrial disease and other uses to improve ART treatment.

Proposed amended section 20(1) of the RIHE Act will permit, under licence, certain types of research that may be useful in relation to cytoplasmic transfer. However, an embryo containing genetic material from more than two people (and created by the fertilisation of human egg and sperm) will not be able to be created for research purposes.

20

An expert body should formulate objective criteria to define those embryos that are unsuitable for implantation.

The new definition of “unsuitable for implantation” in subsection 7(1) of the RIHE Act provides for this.

21

Fresh ART embryos that are unsuitable for implantation, as defined by the objective criteria, should be permitted to be used, under licence, for research, training and improvements in clinical practice.

New subclause 24(8) in the RIHE Act enables the Licensing Committee to modify the requirements for “proper consent” in relation to use of such embryos. This will enable the current 14 day cooling-off period to be shortened, so as to allow the use of fresh embryos.

22

Fresh ART embryos that are diagnosed by preimplantation genetic diagnosis (according to the ART guidelines) as being unsuitable for implantation should be permitted to be used, under licence, for research, training and improvements in clinical practice.

New subsection 24(8) in the RIHE Act (described immediately above) will enable this.

23

Human somatic cell nuclear transfer should be permitted, under licence, to create and use human embryo clones for research, training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

Section 22 of the PC Act bans the creation or development of a human embryo by a process other than fertilisation unless this is licensed. Section 20 of the RIHE provides for the licensing of the creation and use of such embryos. This has the effect of allowing SCNT under licence. The PHC Act also bans the development of any human embryo (including a human clone) outside the body of a woman beyond 14 days (clause 14), and the implantation of a human embryo clone (or any embryo that has not been created using sperm and egg) (clauses 9 and 20(3)).

24

In order to reduce the need for human oocytes, transfer of human somatic cell nuclei into animal oocytes should be allowed, under licence, for the creation and use of human embryo clones for research, training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

Paragraph 20(1)(g) of the RIHE Act enables the granting of a licence to permit this. Section 18 of the PHC Act bans the development of such embryos for more than 14 days.

25

Creation of human embryos and human embryo clones by means other than fertilisation of an egg by a sperm (such as nuclear or pronuclear transfer and parthenogenesis) should be permitted, under licence, for research, training and clinical applications, including production of human embryonic stem cells, as long as the research satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

Proposed clause 22 of the PHC Act bans such activity, except under licence. Proposed clause 20 of the RIHE provides for the granting of licences. Clause 9 of the PHC Act bans the implantation of such embryos and proposed clause 14 of the PHC Act bans their development for longer than 14 days.

26

Creation of human embryos using the genetic material from more than two people, or including heritable genetic alterations, should be permitted, under licence, for research, training and clinical applications, including production of human embryonic stem cells, as long as the research satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

The combined effect of proposed clauses 13 and 23 of the PHC Act and clause 20(1) of the RIHE Act is that the Licensing Committee may licence the creation of embryos that include genetic material from more than two people provided that the embryo is created by means other than fertilisation of a human egg by human sperm. Fertilisation studies may also be undertaken, under licence, up to (but not including) the first mitotic division.

27

Creation of embryos using precursor cells from a human embryo or a human fetus should be permitted, under licence, for research, training and clinical applications, including production of human embryonic stem cells, as long as the research satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.