Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006.
15 Subsection 20(1)
Repeal the subsection, substitute:
1. A person may apply to the NHMRC Licensing Committee for a licence authorising one or more of the following:
- use of excess ART embryos;
- creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;
- creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;
- creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos; Schedule 2 Research Involving Human Embryos Act 2002 20 Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 No. 172, 2006
- research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART;
- creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if:
- the creation or use is for the purposes of testing sperm quality; and
- the creation or use will occur in an accredited ART centre.
1A. To avoid doubt, paragraphs (1)(a), (b), (c) and (d) do not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended.
Prohibition of Human Cloning Act (2002), Act No. 144.
- Part 1 (Preliminary); Section 8 (Definitions):
- Human Embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means.
- Human Embryo Clone means a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.
- Part 2 (Prohibited Practices); Division 1 (Human Cloning); Section 9 (Offence – creating a human embryo clone): A person commits an offence if the person intentionally creates a human embryo clone… Section 11 (offence – importing or exporting a human embryo clone): (1) a person commits an offence if the person intentionally imports a human embryo clone into Australia…
- Part 2 (Prohibited Practices); Division 2 (Other prohibited practices); Section 14 (Offence – creating a human embryo for a purpose other than achieving pregnancy in a woman): (1) A person commits an offence if the person intentionally creates a human embryo outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman.
Research Involving Human Embryos Act (2002). Act No. 145
- Part 2 (Regulation of certain uses involving excess ART embryos); Division 1 (Interpretation); Section 9 (Meaning of excess ART embryo): excess ART embryo mean a human embryo that:
(a) Was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and
(b) Is excess to the needs of:
- The woman for whom it was created; and
- Her spouse (if any) at the time the embryo was created.
For the purposes of paragraph (b) of the definition of excess ART embryo, a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular time if:
- Each such person has given written authority for the use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or
- Each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.
- Part 2 (Regulation of certain uses involving excess ART embryos); Division 2 (Offences); Section 10 (Offence – use of excess ART embryo): A person commits an offence if the person intentionally uses an excess ART embryo unless:
(a)The use of the person is authorised by a licence…
- Part 2 (Regulation of certain uses involving excess ART embryos); Division 4 (Licensing System); Section 21 (Determination of application by Committee):
(3) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following…
(b) if the use of an excess ART embryo proposed in the application may damage or destroy the embryo – that appropriate protocols are in place to enable compliance with the condition that such use is authorised only in respect of an embryo created before 5 April 2002…
China (Hong Kong)
Human Reproductive Technology Ordinance – Section 15
(1) No person shall-
(a) for the purposes of embryo research-
(i) bring about the creation of an embryo; …
(e) replace the nucleus of a cell of an embryo with a nucleus taken from any other cell; or
(f) clone any embryo
China (People’s Republic)
Guidelines on Human Assisted Reproductive Technologies (Ministry of Health July 2003)
Part III. Guidelines for Practitioners
-Prohibit the human egg plasma and nucleus transfer technology for the purpose of reproduction.
-Prohibit human reproductive cloning.
Ethical Guidelines for Research on Human Embryonic Stem Cells (2003)
Part 2: The human embryonic stem cells described in the Guidelines include stem cells derived from donated human embryos, those originated from germ cells and those obtained from somatic cell nuclear transfer.
Part 4: Any research aiming at human reproductive cloning shall be prohibited.
Part 5: Human embryonic stem cells used for research purposes can only be derived from the following means:
1) Spared gamete or blastocyst after in vitro fertilization;
3) Blastocyst obtained either by parthenogenetic split or by somatic cell nuclear transfer technology
Draft Guidelines for Stem Cell Research/Regulation (currently being reviewed by Parliament) Introduction-Sources of stem cells;
II. Cord Blood Cells: TERMINATION OF PREGNANCY FOR OBTAINING FOETUS FOR STEM CELLS, research of for transplantation will not be permitted.
III. Embryonal Stem Cells; The main source of embryonic stem cells will be from the ART/IVF clinics dealing with the Infertility treatment where SPARE OR SUPERNUMERARY embryos will be available for these purposes. However no embryo can be CREATED for the sole purpose of obtaining stem cells.
IV. Embryonic stem cells (ES cells): Embryo should not be generated for the sole purpose of obtaining stem cells. Only surplus or spare or supernumerary embryos can be used with the permission of the couple…at present only research [programme] relating to in vitro induction of differentiation into various cell lines will be cleared. Reproductive cloning will not be permitted on ethical grounds. At present human cloning is not permitted for the purpose of creating a new individual. However, in special situations where cloning is for therapeutic purposes with regard to cells, tissues or organs, the Committee [National Apex Committee (NAC) for cell based research & therapy] will examine them on a case to case basis.
The Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques (Law No. 146, 2000)
Article 2 (Definitions);
(1) In this Law, the terms stated in each of the following paragraphs have the meanings defined therein:
9. Human embryonic clone embryo- An embryo produced by fusion between a human enucleated egg and a human fertilized embryo or a human split embryo at the one-cell stage, or an embryonic cell with a cell nucleus of a human fertilized embryo, a human split embryo or a human-human chimeric embryo.
10. Human somatic clone embryo- An embryo produced by fusion between a human somatic cell with a cell nucleus and a human enucleated egg (including each embryo produced successively by not less than one plit of such an embryo).
Article 3 (Prohibited Acts); No person shall transfer a human somatic clone embryo, a human-animal amphimictic embryo, a human-animal hybrid embryo or a human-animal chimeric embryo into a uterus of a human or an animal.
The Guidelines for Derivation and Utilization of Human Embryonic Stem Cells
Article 1 (Definitions)
3. Human fertilized embryo: An embryo produced by fertilization between a human spermatozoon and a human unfertilized egg…
Article 4 (Gratuitous Donation of Human Embryo): A human embryo shall be donated for derivation of human ES cells gratuitously, except for necessary expenses.
Article 6 (Requirements for Human Embryos Used for Derivation of Human ES Cells): A human embryo used for derivation of human ES cells shall
1. be the human fertilized embryo which has initially been created for the purposes of fertility treatment, but is planned not to be used any longer for the purposes, and, hence, is surely intended to be discarded by its donors…
4. be used within 14 days after the fertilization, not counting any time during which it has been stored frozen.
Note – Dr. Norio Nakatsuji noted that part of the guidelines include the clause that “1. Research institute that derivates hES cell lines should distribute hES cells to other scientists free or at cost. It is an obligation of the institue and a condition to obtain approval of the derivation from the government committee.” (Personal Correspondence with Dr. Norio Nakatsuji, 28 January 2006 ).
Human Assisted Reproductive Technology Act 2004-092
1: Preliminary Provisions
-“Cloned embryo” means a human embryo that is a genetic copy (whether identical or not) of a living or dead human being, a still-born child, a human embryo, or a human foetus.
-“Embryo” includes a zygote and a cell or a group of cells that has the capacity to develop into an individual; but does not include stem cells derived from an embryo.
Schedules: FIRST – Prohibited Actions
(1) Artificially form, for reproductive purposes, a cloned embryo. For the purposes of this item, a cloned embryo is not formed by splitting, on 1 or more occasions, an embryo that has been formed by the fusion of gametes.
The Human Cloning and Other Prohibited Practices Act 2004
Part I: Preliminary
2.—(1) In this Act, unless the context otherwise requires –
… “human embryo” means any live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means; another living or dead human, but does not include a human embryo created by the fertilization of a human egg by human sperm; …
“prohibited embryo” means –
(a) any human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when the development is suspended;
(b) any human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or
(c) such other thing as may be prescribed to be a prohibited embryo for the purposes of this Act;
Part III: Prohibited Practices
Division 1 – Human cloning
5. Prohibition against placing human embryo clone in body of human or animal
Division II – Other prohibited practices
7. No person shall develop any human embryo, that is created by a process other than the fertilization of a human egg by human sperm, for a period of more than 14 days, excluding any period when the development of the embryo is suspended.
8. No person shall develop any human embryo outside the body of a woman for a period of more than 14 days, excluding any period when the development of the embryo is suspended.
Bioethics and Biosafety Act, effective on December 6, 2008 (Act. No. 9100)
Chapter 1 (General Provisions);
Article 2 - Definitions: -
“Embryo” refers to a fertilized oocyte (or segmented cell) from the moment of fertilization to the point of time at which all organs of the given organism have developed embryologically-
“Spare Embryo” refers to an embryo that is created through in vitro fertilization procedures and remains after fertility treatment.
-Somatic Cell Nucleus Transfer” refers to the transfer of a human somatic cell nucleus to a human oocyte from which the nucleus has been removed.
- “Somatic Cell Embryo” refers to an embryo formed by the act of somatic cell nucleus transfer.
Chapter 3 (Embryo Production and Research);
Section 1- Prohibitions on Human Cloning:
Article 11 - Prohibition on Human Cloning:
(1) No one shall implant a somatic cell embryo clone into a uterus, maintain a cloned embryo within a uterus, or give birth when the pregnancy results from the act of implanting a somatic cell embryo clone into a uterus.
Section 2- Embryos Produced through Artificial Fertilization;
Article 13 - Producing Embryos: (1) No one shall produce embryos other than for the purpose of pregnancy.
Article 17 - Research on Spare Embryos: Spare embryos that have passed the storage period outlined in Article 16 [5 years or with consent] may be utilized for the following purposes, but only until the embryological primitive streaks appear in their developmental process:
1. To conduct research aimed at developing contraception and infertility treatments;
2. To conduct research aimed at curing rare or incurable diseases, as decreed by the President.
3. To conduct other research approved by the President after being reviewed by the Committee.
Section 3-Somatic Cell Embryo Clones;
Article 22 -The Act of Somatic Cell Nucleus Transfer:
(1) No one shall conduct somatic cell nucleus transfer other than for the purpose of conducting research aimed at curing rare or currently incurable diseases, as described in article 17-(2).
(2) The type. subject and extent of allowed research on somatic cell nuclear transfer guided by the purpose stated in paragraph 1 shall be decided by the presidential decree after it has been reviewed by the National Committee.
Article 23 - Anyone wishing to produce or research somatic cell cloning embryos shall register with the Minister of Health, Welfare and Family Affairs only after satisfying the requirements concerning facilities and personnel set by the Ministry for Health, Welfare and Family Affairs.
Policy instructions on the ethics of human embryo and embryonic stem cell research
3. Embryo and their stem cell research shall not be conducted in the following ways:
(1) The use of somatic cell nuclear transfer techniques to produce an embryo and
implant that embryo into a uterus;
(2) The use of in vitro fertilization to produce embryos for research purposes;
(3) The production of hybrids;
(4) The in vitro culture of embryos with primitive streaks;
(5) The reproduction of embryos for research purposes or implantation of embryos for
research use into the uterus of humans or other species;
(6) Reproduction of chimeras containing human germ cells; and
(7) Injection of nuclei from other species into nucleus-free human eggs.
4. Embryos and their stem cells shall be obtained in a non-remunerative way from embryos
from spontaneous abortions, embryos from induced abortions in compliance with
regulations of the Genetic Health Act, embryos remaining from in vitro fertilization
procedures, or embryos or embryonic tissues produced by somatic cell nuclear transfer
without the presence of primitive streaks.
European Commission, Directorate General: Research. Survey on opinions from National Ethics Committees or similar bodies, public debate and national legislation in relation to human embryonic stem cell research and use . July 2004, Volume II, p. 21.
1. Pursuant to the Guideline for Artificially Assisted Reproduction, human reproductive cloning is forbidden.
2. Subject to the Ethical Code for Stem Cell Research,
(1) Using spare embryos left over from artificial insemination is under conditions permitted.
(2) Production of embryos for the sole purpose of research is forbidden.
(3) Due to lacking consensus, and because the issue is of great importance, it needs further discussion, whether therapeutic cloning should be perm
3. Pursuant to the draft bill of Artificially Assisted Reproduction Act submitted by the Department of Health, spare embryos left over from artificial insemination would be permitted.