Commonwealth Numbered Regulations - Explanatory Statements

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CUSTOMS (PROHIBITED EXPORTS) AMENDMENT REGULATIONS 2003 (NO. 2) 2003 NO. 44

EXPLANATORY STATEMENT

STATUTORY RULES 2003 No. 44

Issued by the Authority of the Minister for Justice and Customs

Customs Act 1901

Customs (Prohibited Exports) Amendment Regulations 2003 (No. 2)

Section 270 of the Customs Act 1901 (the Act) provides in part that the Governor-General may make regulations not inconsistent with the Act prescribing all matters which by the Act are required or permitted to be prescribed for giving effect to the Act.

Section 112 of the Act provides in part that the Governor-General may, by regulation, prohibit the exportation of goods from Australia and that the power may be exercised by prohibiting the exportation of goods absolutely or by prohibiting the exportation of goods unless specified conditions or restrictions are complied with.

The Customs (Prohibited Exports) Regulations 1958 (the PE Regulations) control the exportation of the goods specified in the various regulations and the Schedules to the Regulations, by prohibiting exportation absolutely, or by making exportation subject to a permission or licence.

On 27 February 2003, the Customs (Prohibited Exports) Amendment Regulations 2003 (No. 1) inserted an absolute prohibition for 12 months on the exportation of human embryos from Australia into the PE Regulations (regulation 7 refers). Consequential amendments were also made to the export controls on certain human body fluids, organs and other tissue and Schedule 1AA of the Customs Regulations 1926.

This prohibition was inserted into the PE Regulations as a result of an undertaking made by the Prime Minister in response to the debate that occurred in respect of the Prohibition of Human Cloning Act 2002 (the Prohibition of Human Cloning Act). That Act prohibits the importation and exportation of human embryo clones and prohibited embryos. The 12 month prohibition on the exportation of human embryos expanded on the controls that are in the Prohibition of Human Cloning Act and was enacted in order to allow a review of whether it is practical to allow the export of human embryos in a manner that is consistent with the Research Involving Human Embryos Act 2002 (the Research Involving Human Embryos Act).

From a number of cases that have been brought to the Government's attention, the absolute prohibition on the exportation of human embryos has negatively impacted on people who could lawfully use the embryos in Australia but due to particular circumstances need to do so overseas.

The purpose of the amending Regulations is to repeal the absolute prohibition and replace it with a prohibition which will allow human embryos to be exported from Australia in certain cases if such exportation is permitted by the Minister for Justice and Customs (the Minister).

The Minister will only be able to give the permission if he or she is satisfied that:

       the embryo that is going to be exported will, if necessary to achieve her pregnancy, be implanted in the woman for whom it was created or for a woman who has been donated the embryo in Australia (the prospective mother); or

       the embryo is going to be exported for the purpose of being implanted in another woman in accordance with an agreement, but that agreement can only be a commercial agreement if negotiations for the agreement were commenced before 27 March 2003.

In the second circumstance, if the prospective mother has died, the application for permission to export the embryo and the agreement must be consistent with an advance directive given by the prospective mother. An advance directive is made prior to any embryo being created and states what is to happen to the embryo in various circumstances (eg. death of the prospective parents).

The new permission regime will cease to have effect 12 months after it commences.

Details of the amending Regulations are set out in the Attachment A.

The amending Regulations commence on gazettal.

0303169A

ATTACHMENT A

Customs (Prohibited Exports) Amendment Regulations 2003 (No. 2)

Regulation 1 - Name of Regulations

Regulation 1 provides for the regulations to be named the Customs (Prohibited Exports) Amendment Regulations 2003 (No. 2)

Regulation 2 - Commencement

Regulation 2 provides for the regulations to commence on gazettal.

Regulation 3 - Amendment of Customs (Prohibited Exports) Regulations 1958

Regulation 3 provides for the PE Regulations to be amended as set out in Schedule 1.

Schedule 1       Amendments

Item 1 - Regulation 7

Regulation 7 of the PE Regulations currently prohibits absolutely the exportation of human embryos. Regulation 2 of the PE Regulations provides that `human embryo' has the meaning given by section 8 of the Prohibition of Human Cloning Act.

New prohibition

Item 1 will substitute the current absolute prohibition and replace it with a prohibition which would allow the exportation of human embryos with the permission of the Minister. That permission must be produced to the Collector before the goods can be exported (subregulation 7(4) refers).

Both the current and new prohibitions cover human embryos that are being exported from Australia in some type of container. Neither of the regulations prohibit the export of human embryos that are inside a pregnant woman (as these embryos are not goods for the purposes of the Act).

Definitions

Subregulation 7(1) defines a number of terms for the purposes of regulation 7:

accredited ART centre has the meaning given by section 8 of the Research Involving Human Embryos Act. This is a person or body accredited to carry out assisted reproductive technology by:

       the Reproductive Technology Accreditation Committee of the Fertility Society of Australia; or

       if the regulations under the Research Involving Human Embryos Act prescribe another body or other bodies in addition to, or instead of, the body mentioned in the dot point above--that other body or any of those other bodies, as the case requires.

The accredited ART centre at which an embryo is stored has to provide certain statements with all applications for permission to export a human embryo.

prospective mother has the meaning given by subregulation 7(2). Subregulation 7(2) would provide that a woman is the prospective mother in relation to a human embryo in three circumstances.

The first is if she is the woman for whom the embryo was created. This applies even if the egg from which the embryo was created was not hers. For example, a woman's sister may donate an egg to the woman in order to allow an embryo be created for the woman.

The second is if she is a woman to whom an embryo has been donated in Australia. For example, a woman may have embryos created for her and she becomes pregnant but has some embryos that were not used. She and her spouse may donate those embryos to another woman.

The third is the woman who has been donated an embryo from a woman who has died where the donation is consistent with an advance directive signed by the woman who died.

relevant agreement and relevant woman have the meaning given by subregulation 7(3). A relevant agreement may be between a number of people and a woman (the relevant woman) to the effect that the embryo will, if necessary to achieve pregnancy in the relevant woman, be implanted in the relevant woman and that a child resulting from the pregnancy will be adopted and brought up by the prospective mother and her spouse, if any or if the prospective mother dies before making the agreement - her spouse.

The people who could enter such agreements with the relevant woman are:

       if the prospective mother has a spouse - the prospective mother and her spouse;

       if the prospective mother has no spouse - the prospective mother; and

       if the prospective mother died before the making of the agreement - the person who was the spouse of the prospective mother at the time that the embryo was created.

spouse is defined to have the meaning in section 7 of the Research Involving Human Embryos Act and it includes a person who, although not legally married to the prospective mother, is living with the prospective mother as the prospective mother's spouse on a bona fide domestic basis.

storage centre, in relation to a human embryo, means the accredited ART centre at which the embryo is being stored. Accredited ART centres are defined above.

valuable consideration, in relation to a relevant agreement, includes any inducement, discount or priority in the provision of a service to the relevant woman or any other person, but does not include the payment of reasonable expenses incurred by the relevant woman in connection with fulfilling the agreement. Where it is proposed to implant an embryo into a woman (the relevant woman) other than the woman for whom the embryo has been created, the Minister may only allow the exportation for that purpose, if amongst other things, the agreement with the relevant woman does not include valuable consideration. Valuable consideration would not include reasonable expenses incurred in connection with fulfilling that agreement, such as medical expenses.

When may the Minister grant a permission

The Minister may grant a permission in two circumstances. These are as follows.

Implantation in the woman for whom it was created or the woman who has been donated the embryo

The Minister may grant a permission if he or she is satisfied that the human embryo that is being exported will, if necessary to achieve her pregnancy, be implanted into the prospective mother (subregulation 7(10) refers).

This would cover the circumstance where a woman in Australia is subject to ART treatment in Australia and then part way through that treatment decides to move overseas and wishes to take the embryos in Australia with her for the purposes of continuing that treatment.

This would not only cover circumstances where it is known that all of the embryos will be implanted, it would also cover a proposed exportation of a number of embryos where it is possible that the embryos may not all be implanted at once, and pregnancy may be achieved without implanting all of the embryos so, it is not possible to know with certainty if a particular embryo would be required to achieve pregnancy.

Implantation in a woman other than the woman for whom the embryos were created

The Minister may also grant a permission if he or she is satisfied that the embryo will, if necessary to achieve the pregnancy of a relevant woman under a relevant agreement, be implanted in the relevant woman. In respect of agreements (made or negotiations for which commenced before 27 March 2003), the agreement can be either a commercial or non-commercial agreement (ie a commercial agreement is one for which valuable consideration is given). For other agreements, the Minister cannot grant the permission if the agreement provides for valuable consideration.

Further, if the prospective mother has died at the time of the application, the Minister may give the permission if the application and the agreement are consistent with an advance directive of the prospective mother. For example, if the prospective mother directed that the embryos not be used if she dies, and the spouse applies to export the embryos so they can be implanted in another woman, the Minister could not permit that exportation (subregulation 7(11) refers).

Application for permission to export

An application for permission to export a human embryo must be made in writing and must be lodged with the Minister (paragraphs 7(5)(a) and (b) and 7(6)(a) and (b) refer).

If the prospective mother is alive, the application can only be made by the prospective mother (paragraph 7(5)(c) refers).

If the prospective mother has died, the application can only be made by the spouse of the prospective mother at the time that the embryo was created or donated (paragraph 7(6)(c) refers).

Statements to accompany an application

The application must be accompanied by statements from a number of people and in certain circumstances, documents (paragraphs 7(5)(d) and (e) and 7(6)(d) and (e) refer).

In the case where the prospective mother is alive, each of the following people must state that the embryo is being exported for the purpose of being implanted in the prospective mother, if necessary to achieve her pregnancy:

       the prospective mother;

       the spouse of the prospective mother. If the prospective mother does not have a spouse, for example because they have died, no statement is required;

       the director of the storage centre; and

       the medical practitioner in the country to which the embryo is being exported who will be responsible for the storage of the embryo.

These statements are needed so that the Minister can decide whether the embryo is being exported for the relevant purpose.

The application must also be accompanied by the relevant agreement if there is one.

In the case where the prospective mother has died, the application must be accompanied by:

       a statement from the director of the storage centre that the prospective mother signed an advance directive as to what should happen to the embryo in the event of her death, and that the proposed exportation is consistent with the directive;

       a copy of the advance directive; and

       a statement from the director of the storage centre that the embryo was created at an accredited ART centre for implantation in the prospective mother or was donated to the prospective mother.

Further there must be a statement from the following people that the embryo is being exported for the purpose of being implanted in the relevant woman, if necessary to achieve her pregnancy:

       the spouse of the prospective mother who made the application;

       the director of the storage centre; and

       the medical practitioner in the country to which the embryo is being exported who will be responsible for the storage of the embryo.

If an embryo was created for another woman who has died and it has been donated to a woman (the prospective mother), the application must be accompanied by a statement from the director of the storage centre that the woman for whom the embryo was created signed an advance directive as to what should happen to the embryo in the event of her death, and that the embryo was donated to the prospected mother consistently with the directive. Further a copy of the advance directive must be attached to the application.

The Minister may require these statements to be in the form of a statutory declaration, or another document with similar effect under the law of the country in which it is made (subregulation 7(9) refers).

If the Minister requires a statement to be made in a statutory declaration, the declaration would be subject to Statutory Declarations Act 1959. Under that Act, if a person intentionally makes a false statement in a statutory declaration they commit an offence punishable by imprisonment of up to 4 years.

The statements from the medical practitioner who is going to store the embryo overseas after exportation will be made outside Australia. Hence, the Minister may require the statement to be made in accordance with a law of the country in which it was made.

Notification of decision

If a permission is granted, a notice must be given in writing and it may specify conditions or requirements that have to be complied with by the person to whom the permission is granted (subregulation 7(12) refers).

If the Minister refuses to grant a permission, he or she must notify the applicant in writing (subregulation 7(13) refers).

Revoking a permission

Further, the Minister may revoke a permission if the holder fails to comply with a condition or requirement specified in the permission, whether or not the holder is charged with an offence under subsection 112(2B) of the Act with failure to comply with a condition or requirement. The permission may also be revoked if the person is convicted of that offence (subregulation 7(14) refers).

A decision to not grant a permission, to grant a permission subject to a condition or requirement or to revoke a permission will be able to be reviewed in accordance with the Administrative Decisions (Judicial Review) Act 1977. Those decisions will not be able to be reviewed by the Administrative Appeals Tribunal as they involve policy decisions of a high political content.

Reporting to Parliament

The Minister would also be required to twice a year lay before each House of the Parliament a report setting out information about permissions granted in the previous 6 months. That information must be of a statistical character and must not identify individuals (subregulation 7(15) refers). For example, he or she could report the number of permissions given in the previous 6 months.

Regulations cease to have effect

As with the current regulations, the amending regulations will cease to have effect 12 months after they commence (subregulation 7(16) refers).


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