|
Navigation: Previous Page | Contents | Next Page
Chapter 2 - The Lockhart Review Recommendations
2.1
The Legislation Review Committee, chaired by the late the Hon John Lockhart
AO QC, was appointed in June 2005 and reported on 19 December 2005.[1]
The recommendations made by the Review Committee are listed in this chapter
followed by a brief profile of each of the Review Committee members.
Recommendations
National
legislation
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.
Reproductive
cloning
2 Reproductive cloning should continue to be
prohibited.
Prohibitions
on developing and implanting embryos
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.
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.
5 Implantation
into the reproductive tract of a woman of a human–animal hybrid or chimeric embryo
should continue be prohibited.
6 Development
of a human–animal hybrid or chimeric embryo should continue to be prohibited, except
as indicated in Recommendation 17.
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.
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.
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.
10 Implantation
into the reproductive tract of a woman of an embryo carrying heritable
alterations to the genome should continue to prohibited.
11 Collection
of a viable human embryo from the body of a woman should continue to be prohibited.
Creation
of human embryos by fertilisation
12 Creation
of human embryos by fertilisation of human eggs by human sperm should remain restricted
to ART treatment for the purposes of reproduction.
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.
Use of
excess ART embryos in research
14 Use
of excess ART embryos in research should continue to be permitted, under
licence, as under current legislation.
ART
clinical practice and ART research
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.
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.
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.
18 The
Licensing Committee should develop a simple proforma application for licences
to undertake training and quality assurance activities for ART clinics.
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.
Use of
fresh ART embryos
20 An
expert body should formulate objective criteria to define those embryos that
are unsuitable for implantation.
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.
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.
Use of
human embryos created by somatic cell nuclear transfer
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.
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.
Use of
human embryos created by activation methods not involving fertilisation of a
human egg by a human sperm or somatic cell nuclear transfer
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.
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.
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.
Definition
of a human embryo
28 The
definition of a ‘human embryo’ in both Acts should be changed to:
‘A human embryo is a discrete
living entity that has a human genome or an altered human genome and that has
arisen from either:
- the first mitotic cell division when fertilisation of a human oocyte by
a human sperm is complete; or
- any other process that initiates organised development of a biological
entity with a human nuclear genome or altered human nuclear genome that has the
potential to develop up to, or beyond, 14 days and has not yet reached eight
weeks of development.’
Consent
arrangements for the donation of embryos
29 The
National Health and Medical Research Council (NHMRC) should review its
guidelines in relation to consent to research on excess ART embryos, in order
to clarify the consent process in relation to the following issues:
- the circumstances, if any, where those who choose to donate
excess ART embryos to research may be able to choose not to be contacted at
some later stage to give consent to a particular research proposal
- the circumstances, if any, where a human research ethics
committee can determine that the researcher need not ask for further consent to
use embryos already declared ‘excess’
- the development of an appropriate form of consent that could be
completed by the responsible persons for excess ART embryos shortly after the
declaration that the embryos are excess
- the manner in which those who donate embryos or gametes for the
creation of ART embryos may express any preference for the type of research for
which the tissue will be used, once the embryo is declared excess.
30 The
NHMRC should develop ethical guidelines for the use of embryos that are
unsuitable for implantation for research, training and improvements in clinical
practice (see Recommendations 20–22).
Egg
donation
31 The
current principles of consent for participation in medical research must apply
to sperm, egg and embryo donors, so as to ensure that decisions are freely
made.
32 The NHMRC should develop guidelines for egg
donation.
33 The
present prohibition of the sale of sperm, eggs and embryos should continue, but
the reimbursement of reasonable expenses should continue to be permitted.
Licensing
arrangements
34 The
Embryo Research Licensing Committee of the NHMRC (the Licensing Committee) should
continue to be the regulatory body responsible for assessing licence
applications, issuing licences and monitoring compliance, as under current
arrangements.
35 The
role of the Licensing Committee should be extended to include assessment of
licensing applications and issuing licences for any additional activities
permitted, under licence (see Recommendations 14–27).
36 The
Australian Parliament and the Council of Australian Governments should give
urgent attention to the problem of delays in the filling of vacancies on the
Licensing Committee.
37 There
should be no attempt to recover the cost of administration, licensing,
monitoring and inspection activities associated with the legislation from
researchers at this point in time.
Monitoring
powers
38 The
Licensing Committee should continue to perform its functions in relation to
licences and databases for research permitted by licences under the Research Involving
Human Embryos Act.
39 Licensing
Committee inspectors should be given powers, under the Prohibition of Human Cloning
Act and the Research Involving Human Embryos Act, of entry, inspection and enforcement
in relation to non-licensed facilities in the same manner and by the observance
of the same procedures as applicable to search warrants under Commonwealth
legislation, if such powers do not clearly exist.
Oversight
of ART clinical practice and research
40 There
should be a continuation of the role of the Reproductive Technology
Accreditation Committee in the regulation of ART.
Import
and export of human reproductive materials for personal use
41 The
import or export of a patient’s reproductive material, including ART embryos,
for the purpose of that person’s ongoing ART treatment should not require any
regulation other than that required under existing quarantine regulation.
Trade
and international exchange of human reproductive materials and stem cells
42 The
import or export of ethically derived viable materials from human embryo clones
should be permitted after approval by the appropriate authority.
43 The
existing requirements for the import and export of human biological materials
are satisfactory and, for ethically derived human embryonic stem cells, no
further restrictions are necessary.
Biotechnology
and commercialisation
44 Trade
in human gametes or embryos, or any commodification of these items, should
continue to be prohibited.
45 Donors
of tissue that is going to result in an immortal stem cell line should be
informed by means of processes monitored by human research ethics committees
about the potential use of that stem cell line, including the potential for
commercial gain and the fact that they may not have any rights in potential
stem cell developments.
46 The
development of biotechnology and pharmaceutical products arising from stem cell
research should be supported.
National
stem cell bank
47 A national stem cell bank should be established.
48 Consideration
should be given to the feasibility of the Australian Stem Cell Centre operating
the stem cell bank.
49 A national register of donated excess ART embryos
should be established.
Regulatory
approach to legislation
50 The
Licensing Committee should be authorised under the Prohibition of Human Cloning
Act to give binding rulings on the interpretation of that Act, or the
regulations made under that Act, on condition that it reports immediately and
in detail to the NHMRC and to parliament on such rulings.
51 The
Licensing Committee should be authorised by the Research Involving Human
Embryos Act to give binding rulings and to grant licences on the basis of those
rulings for research that is not within the literal wording of the Act, or the
regulations made under the Act, but is within their tenor, on condition that
the Committee reports immediately and in detail to the NHMRC and to parliament
on any rulings it gives, or any licences it grants, in that way.
52 A
researcher who conducts research on the basis of a ruling or a licence should
be protected from liability under the legislation, provided that they act in
accordance with the relevant ruling or licence.
53 In
view of the fast-moving developments in the field, and the range of amendments
proposed herein, the two Acts should be subject to a further review either six
years after royal assent of the current Acts or three years after royal assent
to any amended legislation.
Public
education
54 There should be ongoing public education and
consultation programs in the areas of science that are relevant to the Acts.
Committee members
2.2
A brief profile of the members of the Legislative Review Committee
follows.[2]
The Hon John Lockhart passed away in January 2006, shortly after the
presentation of the Review Committee's report.
The Hon
John S Lockhart
AO QC (Chair)
The Honourable John Lockhart is a highly regarded member of
the international legal community. He was a Justice of the Federal Court of
Australia from 1978 until 1999. He has been a member of the Appellate Body of
the World Trade Organization, Geneva, Switzerland since 2002 and was appointed as
the Deputy Chair of the International Legal Services Advisory Council in 2004. Mr
Lockhart has highly relevant experience in chairing high level committees that
deliberate on contentious issues.
Associate
Professor Ian Kerridge
(New South Wales)
Associate Professor Kerridge is a highly regarded clinical
ethicist and specialist haematologist. He is Associate Professor in Bioethics
and Director of the Centre for Values, Ethics and Law in Medicine at the University
of Sydney and Staff Haematologist/Bone Marrow Transplant Physician at Westmead
Hospital, Sydney. Associate Professor Kerridge has highly relevant skills and
expertise demonstrated through his work and publications in the fields of
health ethics.
Professor
Barry Marshall (Western
Australia)
Professor Marshall is Research Professor of Microbiology at
the University of Western Australia and also brings generalist scientific
expertise in addition to his abilities in community representation. He is a highly
awarded scientist of international renown who is also a successful community
advocate both in Australia and overseas. He is a specialist gastroenterologist
who is noted for his discovery of the link between the bacteria Helicobacter
pylori and gastric ulcers. Professor Marshall and a colleague won the 2005
Nobel Prize in Physiology or Medicine for this discovery.
Associate
Professor Pamela McCombe
(Queensland)
Associate Professor McCombe is a Consultant Neurologist and
a Visiting Medical Officer at the Royal Brisbane Hospital and holds the
position of Associate Professor, Department of Medicine at the University of Queensland.
She is Chair of the Wesley Research Institute Research Committee and Chair of
the Scientific Program Committee of the Australian Association of Neurologists.
Professor
Peter Schofield (New
South Wales)
Professor Schofield is a renowned neuroscientist. He is
Executive Director and Chief Executive Officer of the Prince of Wales Medical
Research Institute, Senior Principal Research Fellow at the Garvan Institute of
Medical Research and Conjoint Professor at the Faculty of Science and Faculty
of Medicine at the University of New South Wales. Professor Schofield’s skills
and expertise are in a highly relevant scientific discipline to the review
subject matter.
Professor
Loane Skene (Victoria)
Professor Skene is a renowned lawyer, ethicist and academic.
She is Pro Vice-Chancellor, Professor of Law in the Law Faculty and an Adjunct
Professor of Law in the Faculty of Medicine, Dentistry and Health Sciences at
the University of Melbourne. Professor Skene has highly relevant skills and expertise
demonstrated through her work and publications in the fields of health law and
ethics.
Navigation: Previous Page | Contents | Next Page
Website feedback: web.senate@aph.gov.au
Last reviewed 31 October 2006 by the Senate Web Administrator
© Commonwealth of Australia
Parliament of Australia Web Site Privacy Statement
Images courtesy of AUSPIC
|
