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2004-2005-2006

The Parliament of the
Commonwealth of Australia

THE SENATE

Somatic Cell Nuclear Transfer (SCNT)
and Related Research Amendment Bill
2006

No.   , 2006

A Bill for an Act to amend the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, to provide for the further development of responsible research through the use of stem cells, and to provide for improvements in assisted reproductive technology, and for related purposes

Contents

1. Short title
2. Commencement
3. Object of the Act
4. Schedule(s)

Schedule 1—Amendment of the Prohibition of Human Cloning Act 2002

Schedule 2—Amendment of the Research Involving Human Embryos Act 2002

A Bill for an Act to amend the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, to provide for the further development of responsible research through the use of stem cells, and to provide for improvements in assisted reproductive technology, and for related purposes

The Parliament of Australia enacts:

1  Short title

This Act may be cited as the Somatic Cell Nuclear Transfer (SCNT) and Related Research Amendment Act 2006.

2  Commencement

This Act commences on the day on which it receives the Royal Assent.

3  Object of the Act

The object of this Act is to:

1. provide for the continuing national development of responsible medical research through the use of stem cells including innovative techniques such as somatic cell nuclear transfer; and
2. support the national interests of scientific and medical progress; and
3. provide for the responsible development of techniques for:
   1. efficient training in clinical practices; and
   2. research and improvements in clinical practice
   in assisted reproductive technology.

4  Schedule(s)

Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1—Amendment of the Prohibition of Human Cloning Act 2002

1  Section 8 (definition of human embryo)

Repeal the definition, substitute:

human embryo means a discrete entity that has arisen from either:

1. the first mitotic division when fertilisation of a human egg by a human sperm is complete; or
2. 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, the stage at which the primitive streak appears;

and has not yet reached 8 weeks of development since the first mitotic division.

2  Subsection 8(1) (at the end of the definition of excess ART embryo)

Add:

; or (c)  is:

3. diagnosed by pre-implantation genetic diagnosis according to such NHMRC guidelines on the use of assisted reproductive technology in clinical practice and research as may be prescribed; or
4. determined under such NHMRC objective criteria as may be prescribed;

as being unsuitable for implantation.

3  Section 8 (after the definition of hybrid embryo)

Insert:

licence means a licence issued under section 21 of the Research Involving Human Embryos Act 2002.

NHMRC Licensing Committee means the committee established under section 13 of the Research Involving Human Embryos Act 2002.

4  Before Division 1 of Part 2

Insert:

Division 1A—Purpose of Part

8A  Purpose of Part

1. The purpose of this Part is to specify practices which are:
   1. prohibited; or
   2. prohibited unless they are authorised by a licence.
2. Where a specified practice is authorised by a licence, the licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

5  Division 1 of Part 2

Repeal the Division, substitute:

Division 1—Prohibited practices

9  Offence—placing a human embryo clone in the human body or the body of an animal

A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an animal.

Maximum penalty:    Imprisonment for 15 years.

10  Offence—developing a human embryo outside the body of a woman for more than 14 days

A person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended.

Maximum penalty:    Imprisonment for 15 years.

11  Offence—creating or developing a human embryo containing nuclear genetic material provided by more than 2 persons

A person commits an offence if the person intentionally creates or develops a human embryo containing nuclear genetic material provided by more than 2 persons.

Maximum penalty:    Imprisonment for 15 years.

12  Offence—heritable alterations to genome

1. A person commits an offence if:
   1. the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and
   2. in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.

Maximum penalty:    Imprisonment for 15 years.

2. In this section:
   
   human cell includes a human embryonal cell, a human fetal cell, human sperm or a human egg.

13  Offence—collecting a viable human embryo from the body of a woman

A person commits an offence if the person removes a human embryo from the body of a woman, intending to collect a viable human embryo.

Maximum penalty:    Imprisonment for 15 years.

14  Offence—placing of an embryo

1. A person commits an offence if the person intentionally places a human embryo in an animal.
   
   Maximum penalty:    Imprisonment for 15 years.
   
   
2. A person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman’s reproductive tract.
   
   Maximum penalty:    Imprisonment for 15 years.
   
   
3. A person commits an offence if the person intentionally places an animal embryo in the body of a human for any period of gestation.
   
   Maximum penalty:    Imprisonment for 15 years.
   
   
4. A person commits an offence if the person intentionally places a non-ART embryo in the body of a woman for any purpose other than achieving pregnancy.
   
   Maximum penalty:    Imprisonment for 15 years.

15  Offence—commercial trading in human eggs, human sperm or human embryos

1. A person commits an offence if the person intentionally gives or offers valuable consideration to another person for the supply of a human egg, human sperm or a human embryo.
   
   Maximum penalty:    Imprisonment for 15 years.
   
   
2. A person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo.
   
   Maximum penalty:    Imprisonment for 15 years.
   
   
3. In this section:
   
   reasonable expenses:
   1. in relation to the supply of a human egg or human sperm—includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and
   2. in relation to the supply of a human embryo:
      1. does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo; and
      2. includes, but is not limited to, expenses relating to the storage or transport of the embryo.
   valuable consideration, in relation to the supply of a human egg, human sperm or a human embryo by a person, includes any inducement, discount or priority in the provision of a service to the person, but does not include the payment of reasonable expenses incurred by the person in connection with the supply.

16  No defence that human embryo could not survive

It is not a defence to an offence under section 9, 10, 11, 12 or 14 that the human embryo did not survive or could not have survived.

6  Division 2 of Part 2

Repeal the Division, substitute:

Division 2—Practices prohibited unless authorised by licence

17  Offence—creating a human embryo clone

A person commits an offence if:

1. the person intentionally creates a human embryo clone; and
2. the creation of the human embryo clone by the person is not authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 15 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

18  Offence—importing or exporting a human embryo clone

1. A person commits an offence if:
   1. the person intentionally imports a human embryo clone into Australia; and
   2. the importation is not authorised by a licence and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

2. A person commits an offence if:
   1. the person intentionally exports a human embryo clone from Australia; and
   2. the export is not authorised by a licence and the person knows or is reckless as to that fact.
   
   
   Maximum penalty:    Imprisonment for 10 years.
   
   Note: The licensing system is set out in Division 4 of the Research Involving                               Human Embryos Act 2002.

18A  Offence—importing or exporting a human embryo

1. A person commits an offence if:
   1. the person intentionally imports a human embryo into Australia where:
      1. the creation of the embryo was not pursuant to a licence issued under section 21 of the Research Involving Human Embryos Act 2002; or
      2. if the human embryo was created overseas it was created by a process which could not have been authorised by a licence issued under section 21 of the Research Involving Human Embryos Act 2002; and
   2. the importation by the person is not authorised by a licence, and the person knows or is reckless as to that fact.

   Maximum penalty:    Imprisonment for 10 years.
   
   Note:          The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

2. A person commits an offence if:
   1. the person intentionally exports a human embryo from Australia; and
   2. the creation is not authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

3. The Minister for Customs must make regulations under the Customs Act 1901 permitting and prescribing the manner and means of import or export where that import or export is licensed in accordance with Division 4 of the Research Involving Human Embryos Act 2002.

19  Offence—creating a human embryo other than by fertilisation

A person commits an offence if:

1. the person intentionally creates a human embryo by a process other than by fertilisation of a human egg by a human sperm; and
2. the creation of the human embryo by the person is not authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

19A  Offence—developing a human embryo created other than by fertilisation

A person commits an offence if:

1. the person intentionally develops a human embryo; and
2. the human embryo was created by a process other than the fertilisation of a human egg by a human sperm, and the person knows or is reckless as to that fact; and
3. the development of the human embryo by the person is not authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

20  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:
   1. the person’s intention in creating the embryo is to achieve pregnancy in a particular woman; or
   2. the creation of the embryo by the person is authorised by a licence.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

2. In this section, the scope of the licence is not to extend beyond permitting research involving fertilisation of human eggs by human sperm up to, but not including the first cell division.
   
   
3. Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) of this section.

21  Offence—creating or developing a human embryo containing mitochondrial genetic material provided by more than 2 persons

A person commits an offence if:

1. the person intentionally creates or develops a human embryo containing mitochondrial genetic material provided by more than 2 persons; and
2. the creation or development of the type of human embryo mentioned in paragraph (a) is not authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

22  Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo

A person commits an offence if:

1. the person uses precursor cells taken from a human embryo or a human fetus, intending to create a human embryo, or intentionally develops an embryo so created; and
2. the person engages in activities mentioned in paragraph (a) without being authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

23  Offence—creating a chimeric embryo or a hybrid embryo

1. A person commits an offence if:
   1. the person intentionally creates a chimeric embryo; and
   2. the creation of the chimeric embryo by the person is not authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

2. A person commits an offence if:
   1. the person intentionally creates a hybrid embryo; and
   2. the creation of the hybrid embryo by the person is not authorised by a licence, and the person knows or is reckless as to that fact.

Maximum penalty:    Imprisonment for 10 years.

Note: The licensing system is set out in Division 4 of the Research Involving Human Embryos Act 2002.

3. A person commits an offence if the person intentionally develops a chimeric or hybrid embryo for a period of more than 14 days, excluding any period where development is suspended.
   
   Maximum penalty:    Imprisonment for 15 years.

Schedule 2—Amendment of the Research Involving Human Embryos Act 2002

1  Section 7 (definition of human embryo)

Repeal the definition, substitute:

human embryo means a discrete entity that has arisen from either:

1. the first mitotic division when fertilisation of a human egg by a human sperm is complete; or
2. 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, the stage at which the primitive streak appears;

and has not yet reached 8 weeks of development since the first mitotic division.

2  Part 2 (at the end of the heading)

Add “or licensed embryos”.

3  Section 8 (after the definition of licence)

Insert:

licensed embryo means an embryo or human egg that is the subject of a licence issued under section 21.

4  Section 8 (definition of proper consent)

After “excess ART embryo”, insert “or a licensed embryo”.

5  Subsection 9(1) (at the end of the definition of excess ART embryo)

Add:

; or (c)  is:

3. diagnosed by pre-implantation genetic diagnosis according to such NHMRC guidelines on the use of assisted reproductive technology in clinical practice and research as may be prescribed; or
4. determined under such NHMRC objective criteria as may be prescribed;

as being unsuitable for implantation”.
                                   

6  Section 10 (at the end of the heading)

Add “or use of or creation of a licensed embryo”.

7  Subsection 10(1)

After “embryo”, insert “or uses or creates a licensed embryo”.

8  Paragraph 10(1)(a)

After “use”, insert “or creation”.

9  Section 11 (at the end of the heading)

Add “or a licensed embryo”.

10  Paragraphs 11(a) and (b)

Repeal the paragraphs, substitute:

1. the person intentionally uses, outside the body of a woman, a human embryo that is not an excess ART embryo or a licensed embryo; and
2. the use is not for a purpose:
   1. relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact; or
   2. for which use has been licensed.

11  At the end of section 16

Add:

7. It is the intention of the Parliament that any vacancy on the NHMRC Licensing Committee be filled as soon as possible.
8. If there is a vacancy in the membership of the NHMRC Licensing Committee for a period of two months the Minister must, within three sitting days of the expiration of that two months, table in each House of the Parliament a written statement of reasons for the failure to fill the vacancy.

12  Before section 20

Insert:

19A  Purpose of Division

The purpose of this Division is to licence practices specified in Division 2 of Part 2 of the Prohibition of Human Cloning Act 2002.

13 Subsection 20(1)

Omit “authorising use of excess ART embryos”.

14  Paragraph 21(3)(a)

Repeal the paragraph, substitute:

1. that appropriate protocols pursuant to NHMRC guidelines are in place:
   1. to enable proper consent to be obtained before an excess ART embryo or a licensed embryo is used under the licence; and
   2. to enable compliance with any restrictions on such consent;

15  Paragraph 21(4)(a)

After “excess ART embryos”, insert “or licensed embryos”.

16  Paragraph 21(4)(b)

After “excess ART embryos”, insert “or licensed embryos”.

17  Subsection 24(1)

Repeal the subsection, substitute:

1. A licence is subject to the condition that before an excess ART embryo or a licensed embryo is used as authorised by the licence:
   1. if an excess ART embryo is to be used—that each responsible person in relation to the excess ART embryo must have given proper consent to that use; or
   2. the egg donor must have given proper consent to the use; or
   3. the somatic cell donor must have given proper consent to the use; and
   4. the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent under paragraph (a), (b) or (c) has been obtained, and any restrictions to which the consent is subject.

18  Subsection 24(2)

After “excess ART embryo”, insert “or a licensed embryo”.

19  Subsection 24(5)

After “excess ART embryos” (wherever occurring), insert “or licensed embryos”.

20  Subsection 24(6)

After “excess ART embryos”, insert “or licensed embryos”.

21  Paragraph 24(7)(b)

After “excess ART embryos”, insert “or licensed embryos”.

22  After section 28

Insert:

28A  Action taken under a licence valid

1. An irregularity in the issuing of a licence in accordance with this Division does not affect the validity of any action taken by a person who has relied in good faith on the licence for that action.
2. Subsection (1) does not apply where a licence has been issued on the basis of false or fraudulent information supplied by the licence holder and the person relying on the licence knows or ought to have known that the information supplied was false or fraudulent.

23  After paragraph 35(2)(a)

Insert:

27. the entry is made under a warrant under section 36A; or

24  At the end of section 35

Add:

3. For the purposes of paragraph (1)(a), any premises includes premises where the occupier of the premises is carrying out activities without a licence issued under section 21 and an inspector has reasonable grounds for suspecting that the activities being carried out on the premises may be in breach of this Act or the Prohibition of Human Cloning Act 2002.

25  After section 36

Insert:

36A  Monitoring warrants

1. An inspector may apply to a federal magistrate acting in a personal capacity for a warrant under this section in relation to premises.
2. Subject to subsection (3), the magistrate may issue the warrant if the magistrate is satisfied by information on oath that it is reasonably necessary that one or more inspectors should have access to the premises for the purposes of finding out whether this Act or the regulations have been complied with.
3. The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.
4. The warrant must:
   1. authorise one or more inspectors (whether or not named in the warrant), with such assistance and by such force as is necessary and reasonable:
      1. to enter the premises; and
      2. to exercise the powers set out in section 36 in relation to the premises; and
   2. state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and
   3. specify the day (not more than 15 days after the issue of the warrant) on which the warrant ceases to have effect; and
   4. state the purpose for which the warrant is issued; and
   5. where the occupier of the premises is present, be shown to the occupier prior to its execution.

26  After section 47

Insert:

47A  Further review of operation of Act

1. The Minister and the CEO of the NHMRC must cause an independent joint review of the operation of this Act and the Prohibition of Human Cloning Act 2002 as amended by the Somatic Cell Nuclear Transfer (SCNT) and Related Research Amendment Act 2006 (the amending Act) to be undertaken as soon as possible after the third anniversary of the day on which the amending Act received the Royal Assent.
2. The review is to be undertaken by persons chosen by the Minister with the agreement of each State.
3. The persons undertaking the joint review must give to the Council of Australian Governments and both Houses of the Parliament a written report of the review before the fourth anniversary of the day on which the amending Act received the Royal Assent.
4. The persons undertaking the joint review must consider and report on the scope and operation of this Act and the Prohibition of Human Cloning Act 2002 taking into account the following:
   1. developments in technology in relation to assisted reproductive technology;
   2. developments in medical research and scientific research and the potential therapeutic applications of such research;
   3. community standards;
   4. an analysis of the extent of therapeutic research and scientific techniques which have not been able to be undertaken because of legislative restrictions;
   5. the results or outcomes arising from licenses granted under this Act;
   6. the impact of the Acts on ART, particularly in the areas of service delivery, quality control, access to and quality of care;
   7. the requirement for and effectiveness of consent provisions for egg and embryo donation for non-ART research;
   8. the effectiveness of the licensing regime;
   9. the extent of Commonwealth-State cooperation in the area of somatic cell nuclear transfer research and the requirement for further Commonwealth or State legislation on the matter;
   10. the need (if any) to increase or decrease the range of matters for which the NHMRC Licensing Committee may issue an authorising licence.
5. The report must contain recommendations about amendments (if any) that should be made to this Act or the Prohibition of Human Cloning Act 2002, having regard to the matters mentioned in subsection (4).
6. The persons undertaking the joint review must consult:
   1. the Commonwealth and the States; and
   2. a broad range of persons with expertise in or experience of relevant disciplines.
7. The views of the Commonwealth, the States and the persons mentioned in paragraph (6)(b) must be set out in the report to the extent that it is reasonably practicable to do so.

47B  Development of framework for national stem cell bank

1. There must be established by March 2007 an interdepartmental working group, comprising officers of the Department of Health and the Attorney General’s Department to develop a framework for a national stem cell bank.
2. The interdepartmental working group must report to the Minister by 23 November 2007.
3. The report of the interdepartmental working group must include recommendations for:
   1. such draft legislative provisions (if any) as may be required;
   2. the structure of management, control and governance required for a national stem cell bank;
   3. a code of practice for the operation of the national stem cell bank including:
      1. access to the bank, including controls on deposits of and access to stem cell lines;
      2. control of quality, risk management, safety with reference to State, national and international legal requirements;
      3. methods of donor selection, ethical issues, accreditation and authorisation;
      4. information and consent, intellectual property, ownership, fees and charges.
4. The Minister must cause a copy of the report of the working group to be tabled in both Houses of the Parliament within 3 sitting days of each House after its receipt by the Minister, or by 30 November 2007, whichever occurs first.

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