Review of Human Cloning and Human Embryo Research Legislation (2005)

This page summarises the 2005 review of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, and the resulting changes made by NHMRC.

Reviews of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002

The reviews of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 were a statutory requirement of the Acts.

The Hon Julie Bishop MP, the former Minister with portfolio responsibility for human cloning and stem cell research, appointed the Legislation Review Committee on 16 June 2005 with the unanimous agreement of each State and Territory.

The Committee was chaired by the late retired Federal Court Judge, Justice John Lockhart AO QC. Other members were Associate Professor Ian Kerridge, a clinical ethicist; Professor Barry Marshall, a specialist gastroenterologist and community advocate; Professor Loane Skene, a lawyer and ethicist; Professor Peter Schofield, a neuroscientist; and Associate Professor Pamela McCombe, a clinical neurologist.

The Committee's reports were tabled in both Houses of Parliament and presentated to the Council of Australian Governments on 19 December 2005.

The Review Committee made 54 recommendations, many of which are interlinked. These recommendations are explained briefly below (the groupings are not related to any perceived merits or otherwise of the recommendations):

(a) Maintaining the existing legislative framework, including the ban on reproductive cloning

These recommendations provided strong support for the current regulatory framework, including the use of excess assisted reproductive technology (ART) embryos in research. Recommendations 1 to 14; 31; 33, 34; 37; 38; 40; 43, 44; 46.

(b) Development of advice, guidance and infrastructure within the existing regulatory framework:

These recommendations are of an administrative nature and are directed at the NHMRC, government and other parties. For example, recommendation 18 recommends the NHMRC develop a pro-forma licence application. Other recommendations relate to advice and criteria for licensing the use of fresh ART embryos that are unsuitable for implantation into a woman. There are also recommendations that a national Australian stem cell bank and a national register of donated excess ART embryos be established.

Recommendations 18, 20, 21, 22, 29, 30, 32, 36, 45, 46, 47, 48, 49, 54.

(c) Allowing ‘therapeutic cloning’ and other currently prohibited techniques:

Recommends that so-called ‘therapeutic cloning’ be permitted using a technique known as somatic cell nuclear transfer (SCNT). Recommends allowing creation of other types of embryos whose creation is currently prohibited by the Prohibition of Human Cloning Act 2002, including through SCNT using animal eggs (to reduce the demand for human eggs), and cytoplasmic transfer (creation of human embryos using the genetic material from more than two people).Recommends extending the role of the NHMRC Embryo Research Licensing Committee to include licensing these additional activities.

Recommendations 23, 24, 25, 26, 27, 35, 42.

(d) Amending the definition of human embryo:

Recommendation that the definition of human embryo be amended. The proposed definition starts at the point of the first cell division after fertilisation of a human egg by a human sperm.

Recommendation 28.

(e) Allowing research on fertilisation up to the point of the first cell division:

These recommendations are linked to the recommended change to the definition of a human embryo and are aimed at facilitating research into fertilisation, testing of eggs for maturity, and cytoplasmic transfer up to, but not beyond, the point of the first cell division.

Recommendations 15, 16, 17, 19.

(f) Provide additional powers to NHMRC inspectors:

Recommendation that inspectors be given additional powers to enter premises, including non-licensed facilities, for the purpose of finding out if the legislation is complied with.

Recommendation 39.

(g) Removing restrictions on the import and export of human embryos:

Recommendation for streamlining provisions relating to a patient’s reproductive material (including ART embryos), for that person’s ongoing ART treatment.

Recommendation 41.

(h) NHMRC Embryo Research Licensing Committee rulings:

Recommendation that the legislation be amended to give the Licensing Committee the power to make binding rulings in relation to interpretation of the legislation, in order to provide greater regulatory flexibility in this fast-moving field.

Recommendations 50 to 52.

(i) Provide for further review of national legislation:

In view of the fast-moving developments in the field the two Acts should be subject to a further review either six years after Royal Assent to the current Acts or three years after Royal Assent to any amended legislation.

Recommendation 53

What changed for NHMRC?

There were changes to:

  1. The National Statement on Ethical Conduct in Human Research, 2007.
    The National Statement was tabled in Parliament on 28 March 2007. The new National Statement includes more extensive guidance on consent, and chapters on human tissue samples, human stem cells, and research involving foetal tissue.

With the passage of the Prohibition of Human Cloning for Reproduction and Regulation of Human Embryo Research Amendment Act 2006, and consideration of related recommendations arising out of the Lockhart Review, the NHMRC made changes to the following guidelines and related administrative processes:

  1. The NHMRC’s Ethical Guidelines on the use of Assisted Reproductive Technology (ART) in Clinical Practice and Research (updated in 2007).
    The document incorporates guidelines for egg donation and makes reference to guidelines on when embryos are unsuitable for implantation. The guidelines on embryos that are unsuitable for implantation are only to be used following a couple’s decision that particular embryos will not be used for ART treatment (this is a declaration that the embryos are excess to the reproductive needs of the couple). The guidelines are then used in making decisions on which of these excess embryos may be used for research.
  2. The Objective criteria on embryos that are unsuitable for implantation (the Objective Criteria) and accompanying contextual information were issued as guidelines by the CEO of the NHMRC on 6 December 2007. The Objective Criteria provide guidance on the criteria to be used before embryos are considered unsuitable for implantation into the body of a woman.
  3. Licence application forms
    • New draft licence application forms were developed to cater for the broadened scope of permitted embryo research activities.
    • For more information please email embryo.research@nhmrc.gov.au
  4. Compliance with Legislation

New arrangements were developed to monitor compliance with the increased scope of the legislation.

Reports

Reports on the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002

Contents: Preliminary pages (including summary and recommendations)

Part A: Background information

Part B: Information considered in the reviews

Part C: Committee's view and recommendations

Appendixes, Glossary, References

Media Release

Further information about the independent reviews and the Legislation Review Committee can be found at http://www.nla.gov.au/nla.arc-63190.

The Legislation Review Committee website is maintained as an historical record of the main documentation for the independent reviews.