Australian Health Ethics Committee

National Health and Medical Research Council:

Position on Cloning and Related Technologies

15 December 2000

1 Clarification

The NHRMC's position on the use of cloning and stem cell technologies was inadvertently mis-stated in Appendix 1 (Background Information) of the invitation from the NHMRC to the Head of each State and Territory Health Authority, dated 1 November 2000, to the 15 December 2000 meeting to be held in Melbourne. That appendix incorrectly stated that, in its report entitled Scientific, Ethical and Regulatory Considerations Relevant to Cloning of Human Beings (1998) (Cloning Report), AHEC had identified a number of key issues which included the need to draw a basic distinction between the cloning of whole human beings and therapeutic cloning. In fact, in the Cloning Report AHEC specifically rejected the distinction between so-called `therapeutic' and so-called `reproductive' cloning.

At 3.3 of the Cloning Report, AHEC pointed out that, although the objective for the sake of which cloning is conducted is ethically-significant, other things (including whether or not cloning technologies would involve destructive research on human embryos) are also ethically-significant. At 3.22 - 3.27 these points are elaborated. AHEC's Cloning Paper restated its position on experimentation on human embryos as set out in the NHMRC Ethical Guidelines on Assisted Reproductive Technology (1996) (Ethical Guidelines). In so doing it rejected the position subsequently advanced by the Australian Academy of Science in its Position Statement of February 1999 (which employed the distinction between so-called therapeutic and so-called reproductive cloning).

2 Re-statement

The NHMRC policy on cloning and related technologies is summarized in the following extracts from the Ethical Guidelines:

Section 6 Research on embryos

6.1 Research on human embryos must take place within the limits prescribed by the law. In those States and Territories where there is no relevant legislation such research may only take place according to these Guidelines (see also Guideline 1.2).

6.2 Embryo experimentation should normally be limited to therapeutic procedures which leave the embryo, or embryos, with an expectation of implantation and development.

6.3 Non-therapeutic research which does not harm the embryo may be approved by an IEC.

6.4 Non-therapeutic research which involves the destruction of the embryo, or which may otherwise not leave it in an implantable condition, should only be approved by an IEC in exceptional circumstances. Approval requires:

• a likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the proposed research;

• that the research involves a restricted number of embryos; and

• the gamete providers, and their spouses or partners, to have consented to the specific form of research (see Guideline 3.2.5).

6.5 Protocols for ART in any clinic should take account of the success rates of fertilization typically achieved in that clinic and, on that basis, seek to avoid the likelihood of production of embryos in excess of the needs of the couple. Techniques and procedures which create embryos surplus to the needs of the infertility treatment should be discouraged.

Section 11 Prohibited/unacceptable practices:

11. 1 Developing embryos for purposes other than for their use in an approved ART treatment program.

11.2 Culturing of an embryo in vitro for more than 14 days.

11.3 Experimentation with the intent to produce two or more genetically identical individuals, including development of human embryonal stem cell lines with the aim of producing a clone of individuals.

11.4 Using fetal games for fertilisation.

11.5 Mixing of human and animal gametes to produce hybrid embryos.

11.6 Mixing of gametes or embryos of different parental origin so as to confuse the biological parentage of the conceptus.

11.6 Placing an embryo in a body cavity other than in the human female reproductive tract.

11.8 Embryo flushing.

11.9 Commercial trading in gametes or embryos.

11. 10 Paying donors of gametes or embryos beyond reasonable expenses.

11. 11 The use in ART treatment programs of gametes or embryos harvested from cadavers.

3 Explanation

In Appendix 1 to the invitation from the NHMRC to State and Territory Health Authorities, the term "therapeutic cloning" was used mistakenly in summarising AHEC's policy.

The origin of this mis-statement follows: In the Ethical Guidelines, AHEC reaffirmed and applied the well-accepted distinction between (a) therapeutic research and (b) non-therapeutic research. Therapeutic interventions are interventions directed towards the wellbeing of the individual embryo involved and non-therapeutic interventions are interventions that are not directed towards the benefit of the individual embryo but rather towards improving scientific knowledge or technical application. Non-therapeutic experimentation includes both non-destructive procedures (which include observation) and destructive procedures.

The Ethical Guidelines, and in particular the section on research on embryos (section 6) and the list of prohibited/unacceptable practices (section 11), rely upon and apply this distinction between therapeutic and non-therapeutic research. The more-recently-coined term `therapeutic cloning' collapses both (a) the distinction between therapeutic and non-therapeutic research on embryos and (b) the distinction between destructive and non-destructive experimentation on embryos. The creation of embryos specifically for research purposes, experimentation on those embryos and their subsequent destruction, etc. all fall under this term. It was because of the lack of transparency of the term `therapeutic cloning', because the term concealed rather than revealed these ethically-significant differences, that AHEC rejected its use. AHEC said that, in the matter of cloning and related technologies, the fundamental distinction was between the production by cloning of whole human entities (such as human embryos) and the production by cloning of the component parts of those entities (such as cells, DNA, etc). AHEC held that, whereas the latter has been an accepted part of medical and scientific research for over fifty years, the former should take place only in exceptional circumstances .

4 AHEC's current plan

The Commonwealth Minister for Health referred AHEC's Cloning Report to the House of Representatives Standing Committee on Legal and Constitutional Affairs. The Standing Committee is currently conducting its enquiry into the matters raised in the Cloning Report. At its meeting of 11th and 12th September, 2000, AHEC decided to await the report of this Committee before undertaking any further work on this subject.

However, a working party of AHEC is now undertaking, on behalf of the NHMRC, the necessary follow up of the enactment of the Gene Technology Bill 2000 and the 15 December meeting to develop a national ban on the cloning of human beings.

Dr Kerry Breen

Chairperson

Australian Health Ethics Committee

15 December 2000

The NHRMC's position on the use of cloning and stem cell technologies was inadvertently mis-stated in Appendix 1 (Background Information) of the invitation from the NHMRC to the Head of each State and Territory Health Authority, dated 1 November 2000, to the 15 December 2000 meeting to be held in Melbourne. That appendix incorrectly stated that, in its report entitled Scientific, Ethical and Regulatory Considerations Relevant to Cloning of Human Beings (1998) (Cloning Report), AHEC had identified a number of key issues which included the need to draw a basic distinction between the cloning of whole human beings and therapeutic cloning. In fact, in the Cloning Report AHEC specifically rejected the distinction between so-called `therapeutic' and so-called `reproductive' cloning.

At 3.3 of the Cloning Report, AHEC pointed out that, although the objective for the sake of which cloning is conducted is ethically-significant, other things (including whether or not cloning technologies would involve destructive research on human embryos) are also ethically-significant.

The more-recently-coined term `therapeutic cloning' collapses both (a) the distinction between therapeutic and non-therapeutic research on embryos and (b) the distinction between destructive and non-destructive experimentation on embryos. The creation of embryos specifically for research purposes, experimentation on those embryos and their subsequent destruction, etc. all fall under this term. It was because of the lack of transparency of the term `therapeutic cloning', because the term concealed rather than revealed these ethically-significant differences, that AHEC rejected its use. AHEC said that, in the matter of cloning and related technologies, the fundamental distinction was between the production by cloning of whole human entities (such as human embryos) and the production by cloning of the component parts of those entities (such as cells, DNA, etc.).

... has been an accepted part of medical and scientific research for over fifty years ...

In responding to your request AHEC advises that a distinction must be drawn between the cloning of human beings, which is ethically unacceptable and legally prohibited in three states, and the cloning of such parts as DNA and cells. Cloning of DNA and cells is currently undertaken as part of routine laboratory research.

This report—

recommends that you urge remaining States and Territories ... which have not legislated in this area to introduce legislation prohibiting the application of techniques to clone a new human individual. This legislation should not, however, interfere with those cloning techniques which do not involve human embryos.

Reference is made to several points in the Senate Hansard of Monday, 4 December 2000 to a "whole human being". It appears that the intent of the Bill before the chamber is to use this term in an exclusion sense, namely that the procedure under discussion (cloning) shall not be undertaken to produce a "whole human being" but may be undertaken to produce other entities that cannot be so described.

In the absence of any definition of what is intended by a "whole human being" the reasonable, and I believe the only semantically logical construction, that can be placed on the phrase is that permissibility may extend to parts (of a human being) but that production of the whole is proscribed. This interpretation would be consistent with the terminology adopted in the AHEC report of 16 December, 1998. The distinction was drawn in the opening paragraph (1.1) of that report as follows: "There is an international consensus that a distinction should be drawn between two categories of cloning: cloning of a human being and copying (cloning) of human component parts ... such as DNA and cells" ...

When the issue before the chamber is presented as a definition of what may be permissible rather than that of what is prohibited, the answer must be procedures undertaken on parts, the semantic distinction intended by AHEC. As "whole" and "part" are antonyms, there is no scope for having entities which are in between, or neither whole nor part. It will be ridiculous, both semantically and biologically to classify an embryo, irrespective of whether it is a single cell zygote or late blastocyst of hundreds of cells, as a part.

If clarity is sought in the drafting of this legislation, it is necessary to acknowledge that the meaning of "whole human being" is in accord with the international consensus referred to by AHEC rather than having some idiosyncratic meaning peculiar to this legislation.