The Customs (Prohibited Import) Regulations 1956 (section 5L) and Customs (Prohibited Export) Regulations 1958 (section 8A) regulate the import and export of embryonic stem cell lines derived from human embryo clones. People wishing to import or export such cell lines must apply to the Minister administering the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act) for written permission. The permit must be produced when required by the Department of Immigration and Border Protection.
NHMRC has responsibility for administering the permit scheme and anyone wishing to import or export embryonic stem cell lines derived from human embryo clones should contact email@example.com for more information.
Importation or exportation will only be allowed if the cell lines have been derived using practices consistent with Australian legislation (s23C, PHCR Act).
Research to create human embryo clones can only be conducted in Australia under a licence issued by the NHMRC Embryo Research Licensing Committee. Therefore derivation of any embryonic stem cell lines from human embryo clones in Australia must have been conducted under licence and thus will have been derived using practices consistent with Australian legislation.
See the NHMRC website to apply for a licence to conduct embryo research.
An export permit will be necessary if you wish to distribute the cell lines outside Australia. Please contact firstname.lastname@example.org for more information.
To obtain permission to import cell lines derived from human embryo clones outside Australia it will be necessary to provide information to demonstrate that derivation of the cell lines was consistent with Australian legislation. This includes:
- Evidence that derivation of embryonic stem cell lines from human embryo clones is legal in the jurisdiction where the cell lines were derived (compare with s22, PHCR Act, s20(1)(b) Research Involving Human Embryos Act 2002 (RIHE Act)) and that derivation of the specific cell line was conducted in accordance with any regulatory requirements imposed by the jurisdiction.
- Evidence that the woman who donated the egg and the person whose genetic material was used had each given specific consent to derivation of the cell line and its possible distribution outside the jurisdiction where it was derived (s24(1), s8 RIHE Act , Chapter 17.21 Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research). Consent to donate eggs or genetic material to “research” is not sufficient.
- Evidence that any payment given to the woman was reimbursement of verifiable reasonable expenses associated with the donation of the eggs (s21, PHCR Act ). This does not include compensation for time or discomfort (Chapter 17.21 Ethical Guidelines on the use of assisted reproductive technology in clinical practice and research ).
Please contact email@example.com for more information.
Importing or exporting certain human embryos
Section 20 of the PHCR Act prohibits importing or exporting embryos defined as “prohibited embryos”.
“Prohibited embryos” include (but are not limited to):
- Embryos created by processes other than fertilisation of a human egg by a human sperm. This includes embryos created by somatic cell nuclear transfer.
- Embryos that contain genetic material provided by more than 2 people.
- Other embryos as defined in the legislation.