Commonwealth Numbered Regulations - Explanatory Statements

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CUSTOMS (PROHIBITED IMPORTS) AMENDMENT REGULATIONS 2003 (NO. 1) 2003 NO. 18

STATUTORY RULES 2003 No. 18

Issued by the Authority of the Minister for Justice and Customs

Customs Act 1901

Customs (Prohibited Imports) Amendment Regulations 2003 (No. 1)

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

The Customs (Prohibited Imports) Regulations 1956 (the PI Regulations) control the importation of the goods specified in the various regulations and the Schedules to the Regulations, by prohibiting importation absolutely, or by making importation subject to a permission or licence.

The Prohibition of Human Cloning Act 2002 (the Prohibition of Human Cloning Act) prohibits the importation and exportation of human embryo clones and prohibited embryos.

The purpose of the amending Regulations is to prohibit the importation of viable material derived from human embryo clones.

The amendments expand the prohibitions contained in the Prohibition of Human Cloning Act by introducing a new import prohibition on viable material derived from human embryo clones (the importation of which is not prohibited by the Prohibition of Human Cloning Act).

Details of the amending Regulations are set out in the Attachment A. A Regulation Impact Statement is set out in Attachment B.

The amending Regulations commence on gazettal.

ATTACHMENT A

Customs (Prohibited Imports) Amendment Regulations 2003 (No. 1)

Regulation 1 - Name of Regulations

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

Regulation 2 - Commencement

Regulation 2 provides for the regulations to commence on gazettal.

Regulation 3 - Amendment of Customs (Prohibited Imports) Regulations 1956

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

Schedule 1 Amendments

Item 1 - Regulation 2, after definition of flash point

Item 1 inserts a definition of 'human embryo clone' into the PI Regulations. The definition is the same as in section 8 of the Prohibition of Human Cloning Act. This ensures that any amendments to the definition of human embryo in the Prohibition of Human Cloning Act follow through to the PI Regulations.

Item 2 - Regulation 2, after definition of therapeutic use

Item 2 inserts a definition of 'viable material' into the PI Regulations. Viable material means living tissue and cells. This includes stem cells and other living products derived from human embryo clones.

Item 3 - Schedule 1, after item 26

The importation of the goods listed in Schedule 1 to the PI Regulations is prohibited absolutely. Item 3 inserts new item 27 into Schedule 1 to absolutely prohibit the importation of viable material derived from human embryo clones.

This prohibition is in addition to the prohibitions on the importation of human embryo clones and prohibited embryos contained in Prohibition of Human Cloning Act.

ATTACHMENT B

1. Background

On 27 June 2002 the Federal Government introduced into Federal Parliament, the Research Involving Embryos and Prohibition of Human Cloning Bill 2002. During the course of debate on the Bill, the Bill was split into two Bills - the Research Involving Embryos Bill 2002 and the Prohibition of Human Cloning Bill 2002.

The Prohibition of Human Cloning Act 2002 bans the creation, import and export of human embryo clones. The legislation does not, however, regulate the import of products derived from human embryo clones (or from any embryos) such as stem cells.

2. Problem

During the course of debate on the Bills, concern was expressed by some Senators that the legislation did not ban the import of viable products of human embryo clones (such as stem cells) but did ban human embryo clones themselves. It was argued that it was ethically unacceptable that Australian scientists should be able to freely import embryonic stem cell lines derived from an embryo that was created via a process that would be banned in Australia (such as somatic cell nuclear transfer (SCNT)) and attract an imprisonment term of up to 15 years.

It was noted that the creation of human embryo clones via the process of SCNT is permitted in a number of countries including the United Kingdom (subject to oversight by the relevant regulatory authority).

However, it could also be argued that to deny Australian scientists access to any viable products (such as stem cells) derived from the legal creation of embryos via SCNT overseas may deny them of valuable research opportunities that may give rise to treatments for disease.

3. Objective

To address the ethical concerns associated with the import and use in Australia of viable products derived from human embryo clones created overseas.

4. Options and Impact analysis

Groups likely to experience the benefits and costs

The groups likely to be affected by regulation of the import of viable material from human embryo clones are: government (predominantly the Commonwealth government); researchers (who may wish to import embryonic stem cell lines derived from embryos created via SCNT); and the community. No impact is anticipated on ART clinics or consumers of ART services.

Option 1: Ban the import of viable material derived from human embryo clones

Impact on Government: There are likely to be minor costs incurred by government to monitor compliance with the prohibition including potentially changing import declaration forms to clarify that the import of viable material derived from human embryo clones is banned.

Impact on researchers:       While there is currently no evidence that stem cells (or any other viable material) derived from a human embryo clone have been imported into Australia, some researchers may wish to import embryonic stem cell lines derived from a human embryo clone into Australia in the future in order to research the development of potential therapies. The review of the Prohibition of Human Cloning Act 2002 which will be completed by December 2005, will include analysis of the advantages and disadvantages of SCNT including community attitudes attributed to the use of such technology and extending to consideration of the desirability of retaining the ban on the creation and import of human embryo clones (and stem cells derived from such embryos) other than for reproductive purposes.

Impact on the community:       Would address ethical concerns expressed by some (as noted during the Senate debate on the Research Involving Human Embryos Bill 2002). As detailed above, the review of the Prohibition of Human Cloning Act 2002 will enable reconsideration of the issues surrounding SCNT and any potential benefits for consumers and the community in general.

Option 2:       Allow the import into Australia of viable material derived from human embryo clones

Impact on Government: The Commonwealth government would be likely to attract strong criticism for reneging on undertakings made during Senate debate to secure passage of the Prohibition of Human Cloning Bill 2002 and the Research Involving Embryos Bill 2002.

Impact on researchers:       No impact. However, researchers may benefit from being able to import embryonic stem cells lines derived from human embryo clones, for research. They would potentially be able to perform similar research to that performed overseas and would therefore minimise any competitive disadvantages of not being able to undertake SCNT in Australia.

Impact on the Community: Would not address concerns (expressed during debate on the Prohibition of Human Cloning Bill 2002 and the Research Involving Human Embryos Bill 2002) that the legislative position is inconsistent with the ethical position enacted in legislation by the Federal Parliament in December 2002. Namely, that scientists in Australia should not be able to import into Australia embryonic stem cells that it would be illegal to create in Australia.

Conclusion and recommended option

Given the ban on the creation and import of human embryo clones in the Prohibition of Human Cloning Act 2002, it is ethically consistent that the import of viable material from a human embryo clone (eg embryonic stem cell lines) also be banned. While the creation and use of human embryo clones for research is currently rare, it is likely to increase in the future (given the rapid developments in science and the conducive regulatory environment in countries like the UK). It is important that legislation is in place in Australia to ensure that embryonic stem cell lines derived from human embryo clones can not be imported into Australia. This ensures that the ethical and scientific position adopted by the Australian government and reflected in the Prohibition of Human Cloning Act 2002 is not undermined.

Any future benefits that may result from the creation of embryos via SCNT or the use of embryonic stem cells derived from such embryos can be examined as part of the review of the ban on the creation of human embryo clones in the Prohibition of Human Cloning Act 2002. In the light of this review, consideration may be given to the value of retaining the prohibition on the import of viable products derived from human embryo clones.

5. Consultation

Extensive consultation was undertaken to inform the development of the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning Act 2002. This consultation included consultation on Regulation Impact Statement's for each of those pieces of legislation. The particular proposal detailed in this RIS arose as the result of Senate debate on the legislation and the conclusion and recommended option is consistent with the results of earlier consultation on the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002.

6. Implementation and Review

The Prohibition of Human Cloning Act 2002 (and the Research Involving Human Embryos Act 2002) will be subject to a comprehensive, independent review commencing two years after the commencement of the operation of the legislation. The review will be completed by December 2005 and will be presented to COAG and to both Houses of Parliament for consideration. The review will include consideration of the desirability of retaining a ban on the creation and import of human embryo clones (and viable products of such clones) for purposes other than reproduction.