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CUSTOMS (PROHIBITED EXPORTS) AMENDMENT REGULATIONS 2003 (NO. 1) 2003 NO. 17
EXPLANATORY STATEMENTSTATUTORY RULES 2003 No. 17
Issued by the Authority of the Minister for Justice and Customs
Customs Act 1901
Customs (Prohibited Exports) 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 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.
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 exportation of human embryos for 12 months from the date of gazettal.
The amendments expand the prohibitions contained in the Prohibition of Human Cloning Act so that the exportation of all human embryos (which may include human embryo clones and prohibited embryos) is prohibited for 12 months.
In accordance with the Government's announcement during the debate of the Prohibition of Human Cloning Act, the prohibition on exporting human embryos ceases 12 months after the amending Regulations commence.
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 Exports) Amendment Regulations 2003 (No. 1)
Regulation 1 - Name of Regulations
Regulation 1 provides for the regulations to be named the Customs (Prohibited Exports) Amendment Regulations 2003 (No. 1)
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 2, after definition of Foreign Minister
Item 1 inserts a definition of 'human embryo' into the PE 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 PE Regulations.
Item 2 - After regulation 6
Item 2 inserts new regulation 7 into the PE Regulations to prohibit absolutely the exportation of human embryos. Regulation 7 ceases to have effect at the end of the day 12 months after it commences, that is 12 months after gazettal.
Item 3 - Schedule 6, item 1
Item 1 of Schedule 6 to the PE Regulations prohibits the exportation of certain human body fluids, organs and other tissue. These can be exported with the permission of the Minister for Health and Ageing. Item 3 replaces item 1 of Schedule 6 to exclude from that prohibition human embryos as the exportation of human embryos is prohibited absolutely by regulation 7. Human embryos are excluded from the operation of item 1 for the period in which regulation 7 is in effect, that is for 12 months after gazettal.
ATTACHMENT B
1. Background
The effect of the Customs (Prohibited Exports) Regulations 1958 (Schedule 6, item 1) is that anyone who wishes to export embryos, sperm or gametes where the internal volume of the immediate container in which the material is packed exceeds 50ml, must seek a permit from the Commonwealth Department of Health and Ageing. This assists the Department to monitor any potential trade in human tissue (including in human embryos).
The regulation of the export of human embryos was recently supplemented by the Prohibition of Human Cloning Act 2002 which bans the export of all "prohibited embryos" such as human embryo clones and embryos created with the genetic material of more than two people.
2. Problem
During debate on the Prohibition of Human Cloning Bill 2002, concern was expressed by various Senators that neither the Prohibition of Human Cloning Bill 2002 or the Customs (Prohibited Exports) Regulations 1958, prohibit absolutely the export of human embryos overseas. The rationale for doing so was that if Australian embryos were exported overseas then once they were overseas Australian law would not apply to their use and they could be used for
research that would not be permitted in Australia because it is ethically unacceptable.
3. Objective
To adequately address concerns that embryos created in Australia not be used overseas in a way that is currently considered unethical (and is now prohibited) in Australia.
4. Options and Impact analysis
Groups likely to experience the benefits and costs
The groups likely to be affected by any further regulation of the export of human embryos are: government (predominantly the Commonwealth government); researchers (who may wish to export embryos overseas for use as part of a collaborative research project); ART service providers and consumers of ART services (in 2000 there were 34 IVF clinics in Australia); and the community.
Option 1: Ban the export of all embryos (both excess ART embryos and other ART embryos) subject to a 12 month sunset clause
Impact on government: There would likely be some minor costs incurred by the Commonwealth government to monitor compliance with the prohibition for a 12 month period. Costs would also be incurred to government to review the operation of the prohibition and identify any changes that may be necessary in 12 months time.
Impact on researchers: This is unlikely to impact on researchers in Australia. There is currently no evidence of researchers exporting excess ART embryos for the purposes of research overseas. It is important that this be distinguished from the export of established embryonic stem cells which is currently permitted and is likely to continue to occur in the future. This proposal would not ban the export of embryonic stem cell lines derived in Australia.
Impact on ART clinics and consumers of ART services: This is likely to have an impact on those couples who wish to export their embryos for the purposes of their own ART treatment or to donate to another couple. For example, a couple receiving ART treatment may move overseas and wish for their embryos to be transferred to an ART clinic overseas so that their treatment can be continued. A couple may also wish to donate excess ART embryos to a relative or friend overseas, for use in the ART treatment of that person. While the export of ART embryos for such purposes is currently permitted in all jurisdictions this does not appear to be a common practice. As such, the impact of a ban on the export of embryos is unlikely to have a significant impact on ART clinics or consumers of ART services.
Impact on the community: This option would be likely to address concerns expressed by some (as reflected during Senate debate on the Prohibition of Human Cloning Bill 2002 and the Research Involving Embryos Bill 2002) that embryos created in Australia could be used overseas for unethical purposes.
Option 2: Ban the export of excess ART embryos only and allow the export of embryos for the purposes of the ART treatment of a couple
Impact on Government: It is likely that there would be costs incurred to government to monitor compliance with the prohibition. The costs would likely be higher than the costs associated with an absolute ban on the export of all embryos (excess and non-excess ART embryos) because it would be necessary for Customs to determine the proposed "end use" of the embryos (for ART treatment or for research or some other purpose).
Impact on researchers: As for Option 1.
Impact on ART clinics and consumers of ART services: This would allow couples to export embryos overseas for the continuation of their own treatment but would prevent the export of excess ART embryos either for donation to another woman (for the purposes of ART) or for research. This would be likely to alleviate the impact of Option 1 to a significant degree.
Impact on the Community: No impact.
Option 3: Retain the status quo - allow the export of all embryos subject to a permit being granted (if necessary) under the Customs (Prohibited Exports) Regulations 1958
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. While there is currently no evidence of embryos being exported for research purposes overseas, this could occur. If the internal volume of the immediate container in which the embryos are packed exceeds 50m1, a permit would continue to be required from the Department of Health and Ageing.
Impact on ART clinics and consumers of ART services: No impact. Couples would continue to be able to export their ART embryos for any purpose (to continue their own treatment, to donate to another woman overseas or for research purposes).
Impact on the Community: This would be unlikely to address the concerns raised by some regarding the unethical use of embryos created in Australia, overseas.
Conclusion and recommended option
It is recommended that Option 1 be adopted. This Option would:
• result in the lowest compliance costs for government whilst meeting the undertaking made by government during Senate debate on the Research Involving Embryos Bill 2002;
• be unlikely to have an impact on researchers (as there is no evidence that embryos are currently being exported for research purposes);
• have some impact on consumers of ART services who may wish to export their embryos overseas to continue their ART treatment although it is anticipated that this impact is likely to be minimal (given the very small number, if any, of couples wishing to export their embryos over the next 12 months). However, reconsideration of the ban within 12 months will enable detailed consideration of the impact on consumers of ART services; and
• address concerns that embryos could be exported from Australia to a country with weaker legislation (or no legislation at all) and used for purposes that are currently considered to be ethically unacceptable and therefore prohibited in Australia.
5. Consultation
Extensive consultation was undertaken to inform the development of the Prohibition of Human Cloning Act 2002. This consultation included consultation on a Regulation Impact Statement for that legislation. The particular proposal detailed in this RIS arose as the result of Senate debate and a commitment during that debate, to amend the Customs (Prohibited Exports) Regulations 1958 in accordance with Option 1.
6. Implementation and Review
Should Option 1 be adopted, the ban on the export of human embryos would commence on gazettal of the Customs (Prohibited Exports) Regulations 1958 and cease 12 months from the date of gazettal. During the 12 month period in which the ban is in force, an analysis will be undertaken of the ongoing need for the ban in the context of the operation of the Research Involving Human Embryos Act 2002 (which allows the use of excess ART embryos for research in Australia, subject to a licence being granted by the NHMRC Licensing Committee). Recommendations with respect to any changes that may need to be made to the regulation of the export of embryos (including the impact on consumers of ART services) will be considered by government in 12 months.