Viable material derived from human embryo clones

Member:

Legislations

Product Category

Basic information

Outline of the system

The Prohibition of Human Cloning for Reproduction Act 2002 (section 23C) required the Minister who administers the Customs Act 1901 to make regulations "permitting, subject to appropriate conditions or restrictions, the import and export of human embryonic stem cell lines which have been derived from human embryo clones using practices consistent with Australian legislation".

The relevant regulation is regulation 5L of the Customs (Prohibited Imports) Regulations 1956. The regulations prohibit the import of viable material derived from human embryo clones unless the Minister administering the Prohibition of Human Cloning for Reproduction Act 2002, or an authorised person has granted permission in writing and the permission is produced at or before the time of import.

Although the first embryonic stem cell lines from human embryo clones were reported in May 2013, a request for permission to import such material has not yet been made. Details of the permit system will be developed as required and prospective importers can contact the National Health and Medical Research Council (NHMRC) for information.

Product coverage

The permit system relates to the import or export of viable material derived from human embryo clones and is necessary to give effect to the legislative requirements of the Prohibition of Human Cloning for Reproduction Act 2002 and the related Research Involving Human Embryos Act 2002. Viable material means living tissues and cells.

Nature of licensing

Automatic

If Automatic, administrative purpose

Non-Automatic

If Non-Automatic, description of the notified Non-Automatic Licensing regime

Products under restriction as to the quantity or value of imports

The Prohibition of Human Cloning for Reproduction Act 2002 is intended to prohibit the import or export of viable material derived from human embryo clones unless the Minister or an authorised person has granted permission.

Questions for products under restriction as to the quantity or value of imports

Not applicable

The system applies to products originating from which country?

The system applies to any viable material derived from human embryo clones originating in Australia or coming from other countries.

Expected duration of licensing procedure

Legal requirements

Is the licensing statutorily required?

The relevant legislation is cited above at question 1.

Obtaining a permit under the legislation is a statutory requirement in all circumstances. All materials covered by the definition of "viable material" derived from a "human embryo clone" will require a permit.

Does the legislation leave designation of products to be subject to licensing to administrative discretion?

This is not subject to administrative discretion.

Eligibility of applicants

Is there a system of registration of persons or firms permitted to engage in importation?

What persons or firms are eligible to apply for a licence?

Yes. However, a person or organisation seeking an import permit must satisfy the Authorised Person specified in the regulations that they are capable of complying with any conditions attaching to the permit.

In relation to persons or organisations applying for an export permit it is expected that only the person or organisation that derived the viable material in Australia would be eligible to apply. Such persons or organisations would need to hold a licence issued under the Research Involving Human Embryos Act 2002 authorising the creation of the human embryo clone and derivation of viable material from it.

Is there a registration fee?

Is there a published list of authorized importers?

Contact point for information on eligibility

Ministry/Authority

Address

Telephone

Fax

E-mail address

Website

Contact officer

Submission of an application

Administrative body(ies) for submission of an application

Documentation requirements

What information is required in applications?

As noted above the details of the permit system have not been finalised. However, the importer or exporter will be required to demonstrate that the viable material has been obtained using practices consistent with Australian legislation. This will include providing evidence that the viable material has been derived or obtained legally and ethically.

What documents is the importer required to supply with the application?

Information and application forms will be available from the NHMRC website (http://www.nhmrc.gov.au) .

Window of submission of an application

How far in advance of importation must application for a licence be made?

An application for a licence should be made well in advance of the proposed import or export.

Are there any limitations as to the period of the year during which application for licence can be made? If so, explain

No.

Issuing the license

Can a licence be granted immediately on request?

It is unlikely that immediate granting of a permit will be possible given the information required and the time needed to assess it.

Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence

As the details of the system have not been finalised it is not possible to provide specific information. However, the time taken to consider an application for a licence will vary depending on the circumstances of the import or export and the completeness of information provided.

Which administrative body is responsible for approving application of licences?

The NHMRC will have responsibility for administering the permit system and will provide advice to Home Affairs on any permits issued.

Must the applications be passed on to other organs for visa, note or approval?

Are there any other conditions attached to the issue of a licence?

The regulations allow for conditions to be attached to permits. The details of such conditions have not yet been finalised. Failure to comply with the conditions can lead to revocation of the permit.

Fees and other administrative charges

Is there any licensing fee or administrative charge?

There is no licensing fee or administrative charge.

What is the amount of the fee or charge?

Is there any deposit or advance payment required associated with the issue of licences?

There is no deposit or advance payment requirement associated with the issue of permits.

Amount or rate?

Is it refundable?

What is the period of retention?

What is the purpose of this requirement?

Refusal of an application

Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?

An application that meets the criteria will be granted a permit

Are the reasons for any refusal given to applicants?

Where an application is refused, reasons are provided, and applicants have a right of appeal to the Administrative Appeals Tribunal.

Have applicants a right of appeal in the event of refusal to issue a licence?

In addition, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.

If so, to what bodies and under what procedures?