Viable material derived from human embryo clones
- Document symbol
- G/LIC/N/3/AUS/16
- Original language
- English
- Published on
- 27/11/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Section 23C of the Prohibition of Human Cloning for Reproduction Act 2002 (Prohibition of Human Cloning for Reproduction Act) required the Minister who administers the Customs Act 1901 (Customs Act) 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 (PI Regulations). The PI Regulations prohibit the import of viable material derived from human embryo clones unless the Minister administering the Prohibition of Human Cloning for Reproduction Act, 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.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
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 and the related Research Involving Human Embryos Act 2002. Viable material means living tissues and cells.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to any viable material derived from human embryo clones originating in Australia or coming from other countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The Prohibition of Human Cloning for Reproduction Act 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.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
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. This is not subject to administrative discretion. The system cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
An application for a licence should be made well in advance of the proposed import or export. 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.
Q7.b. 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.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
No.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
The NHMRC will have responsibility for administering the permit system and will provide advice to the Department of Home Affairs on any permits issued.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
An application that meets the criteria will be granted a permit. Where an application is refused, reasons are provided, and applicants have a right of appeal to the Administrative Appeals Tribunal. In addition, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
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.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
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. Information and application forms will be available from the NHMRC website (http://www.nhmrc.gov.au).
Q11. What documents are required upon actual importation?
An approval under the legislation, such as a permit, must be obtained prior to import or export and is required to be produced at the time of import or export.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There is no licensing fee or administrative charge.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
There is no deposit or advance payment requirement associated with the issue of permits.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The period of validity of a permit will be the period set out in the permit. Details are not yet available
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Given the requirements for obtaining the permit, it is unlikely that the system will allow for transfer of permits between importers or exporters.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
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.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Customs and quarantine controls may be relevant.