Commonwealth Numbered Regulations - Explanatory Statements

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CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT) 1991 NO. 23

EXPLANATORY STATEMENT

STATUTORY RULES 1991 No. 23

CUSTOMS ACT 1901

CUSTOMS (PROHIBITED IMPORTS) REGULATIONS (AMENDMENT)

ISSUED BY THE AUTHORITY OF THE MINISTER OF STATE FOR SMALL-BUSINESS AND CUSTOMS

Section 50 of the Customs Act 1901 provides in part that:

"1)       The Governor-General may, by regulation, prohibit the importation of goods into Australia.

2)       The power conferred by the last preceding sub-section may be exercised - (c) by prohibiting the importation of goods unless specified conditions or restrictions are complied with.

3)       Without limiting the generality of paragraph (2)(c), the Regulations - ...(a) may provide that the importation of the goods is prohibited unless a licence, permission, consent or approval to import the goods or a class of goods in which the goods are included has been granted as prescribed by the regulations; and ..."

The Customs (Prohibited Imports) Regulations (the Regulations) control the importation of the goods specified in the various Regulations or the Schedules to the Regulations, by prohibiting importation absolutely, or making importation subject to the permission of a specified person or Minister of State.

Background

The Statutory Rules contain several amendments to the Regulations which:

i)       introduce a review of decisions mechanism for decisions made under that part of the Regulations which the Australian Customs Service (ACS) administers on behalf of the Department of Community Services and Health (new regulations 4 and 13 refer). The review mechanism will provide a right to both Ministerial review and merits review by the Administrative Appeals Tribunal (AAT). Under the former, persons whose interests are affected by certain decisions of the Secretary of the Department of Community Services and Health (or a person authorised by him or her) will be able to request the Minister for Community Services and Health to reconsider the decision. The minister may then:

a)       confirm the decision of the Secretary;

b)       revoke the decision of the Secretary; or

c)       revoke the decision of the Secretary and substitute another decision.

The Minister's decision is then subject to review by the independent AAT; the former review mechanism is not intended as a substitute for the latter, but rather as an addition to it.

       These amendments commence on 15 February 1991, the date of commencement of the new control regime over imported therapeutic substances under the Therapeutic Goods legislation (see discussed in (ii) following). As the new regime introduces a review mechanism which provides a right to both Ministerial review and merits review by the AAT, a similar review regime was desired in the Customs legislation over the goods which the ACS administers on behalf of the same Department.

       The retrospective commencement of these amendments does not offend subsection 48(2) of the Acts Interpretation Act 1901, as the amendments confer a benefit on persons whose interests are affected by certain decisions of the Secretary of the Department of Community Services and Health, by providing those persons with a more extensive review of decisions mechanism;

ii)       provide for amendments to the Regulations consequential upon the commencement of the Therapeutic Goods Act 1989 new regulations 5, 6, 7, 8, 9, 10 and 11 refer). The amendments remove most of the controls provided for in regulations 5A to 5G, as the present Customs barrier control function over the importation of therapeutic substances will be replaced by a point of supply or sale control which will be administered by the Therapeutic Goods Administration via the Therapeutic Goods legislation.

       Section 2 of the Therapeutic Goods Act 1989 provides that that Act commences on the day after which the Therapeutic Goods Regulations have been approved by both Houses of Parliament. The Senate approved the Therapeutic Goods Regulations on 20 December 1990 and the House of Representatives approved the same Regulations on Thursday 14 February 1991, thereby providing a commencement for the new control regime over therapeutic substances of Friday 15 February 1991 (SR 394 of 1990 refers). The "consequential" amendments contained in these Regulations commence on the day the Therapeutic Goods Act 1989 commences (ie 15 February 1991), to ensure there is no gap or overlap in the import control of therapeutic substances.

       The retrospective repeal of these "consequential" regulations does not offend subsection 48(2) of the Acts Interpretation Act 1901, as the repeal effectively removes current obligations on importers under these Regulations, as opposed to imposing new obligations or liabilities on them; and

iii)       delete a number of items from Schedule 8 (these items will be controlled under the Therapeutic Goods legislation) and add several items to Schedule 8

       These amendments (with the exception of one noted hereunder), commence on 15 February 1991, the date of commencement of the new control regime over imported.. therapeutic substances under the Therapeutic Goods legislation (see discussed in (ii) above). These amendments commence on that day to ensure there is no overlap in the import control over these therapeutic substances.

       The retrospective commencement of the amendments which delete items from Schedule 8 (ie. proposed new subregulations 14.2, 14.4 and 14.5) not offend subsection 48(2) of the Acts Interpretation Act 1901, as the amendments remove the existing import controls which attach to those goods and therefore remove certain liabilities which are imposed on importers. The retrospective commencement of the amendment which places "anabolic or androgenic substances or natural or synthetic growth hormones" in Schedule 8 of the Regulations (ie. new subregulation 14.1) also does not offend subsection 48(2) of the Acts Interpretation Act 1901, as it does not impose any liabilities on any person; this existing control has simply been transferred from regulation 5A to Schedule 8 (regulation 5H) of the Regulations.

       The commencement of the import control on "laetrile and preparations containing laetrile" (ie. subregulation 14.3) is the more usual "date of Gazettal," as this amendment provides for a new import control which is not covered anywhere else in the. Regulations.

The above changes are explained in greater detail in the attachment hereto.

Regulation 1 - Commencement:

provides that the Regulations commence of the day of commencement of the Therapeutic Goods Act 1989 (ie. 15 February 1991), with the exception of the new import control on the therapeutic substance laetrile (subregulation 14.3) which commences on the date of Gazettal of these Regulations.

The retrospective commencement of the bulk of these regulations reflects the. fact that they are consequential on the commencement of the new import control regime for therapeutic substances, which has effectively been removed from Customs legislation and transferred to the Therapeutic Goods legislation. The repeal of the Customs control regime effective from the 15 February 1991 date of commencement of the new Therapeutic Goods legislation ensures there is no overlap between control regimes, and thus no unnecessary imposition of additional requirements on importers. As discussed in the Outline hereto, the retrospective commencement does not offend the prohibition against retrospectivity in subsection 48(2) of the Acts Interpretation Act 1901.

Regulation 2 - Amendment:

provides that the Customs (Prohibited Imports) Regulations are amended as set out in these Regulations.

Regulation 3 - Regulation 2 (Interpretation):

effects a technical drafting change to the Interpretation provision of the Regulations, consequential on the repeal of Regulations 5B, C, D, E and G relating to the transfer of therapeutic goods import controls from these Regulations to the Therapeutic Goods legislation.

Regulation 4 - Regulation 5 (Importation of drugs):

Subregulation 4.1 substitutes subregulation 5(18A), dealing with AAT review rights for decisions made under Regulation 5, with a new subregulation 5(18A), as part of the new review of decisions amendments in these Regulations. The substantive Regulation dealing with the new Ministerial layer of review, and the expanded AAT merits review of decisions relating to the importation of drugs for which the Minister for Community Services and Health is responsible is dealt with in regulation 13 -new regulation 5HA.

A corollary to such review is the obligation on the decision maker to provide notice of his or her decision, which is to include a statement to the effect that a person whose interests are affected by the decision may seek to have the decision reconsidered by the Minister, or ultimately, the AAT.

The obligation to include a statement that the particular decision may be independently reviewed is dealt with in regulation 13 - new subregulation 5HA(6). The notice of the decision obligation is dealt with in this subregulation as follows:

       new subregulation 5(18A) provides that where the Secretary of the Department of Community Services and Health or an authorised officer makes a "reviewable" decision under Regulation 5, the decision maker must give to the relevant affected person notice in writing setting out the decision as soon as practicable after making the decision.

       The particular decisions under Regulation 5 subject to this notice obligation (which then grounds the review rights by either the Minister or the AAT under regulation 13 - new regulation 5HA) have been expanded to include 3 additional decisions not previously subject to review. In addition to decisions under subregulations 5(5) and 5(17) not to grant a licence to import drugs or the revocation of same, decisions not to grant a permission to import drugs or to revoke same are now reviewable, as well as decisions relating to the imposition of conditions or requirements on such permissions.

Subregulation 4.2: inserts a definition of "authorised person" into subregulation 5(20). This definition is consequential on regulation 15 which effectively is a delegation provision to enable a number of decisions by the Secretary of the Department of Community Services and Health in Regulation 5 to be made by a person authorised by the Secretary to do so.

Regulation 5 - Regulation 5A (Importation of therapeutic substances):

amends regulation 5A as a consequence of the Therapeutic Goods Act 1989, as follows:

Subregulation 5.1 provides that the Customs import controls in subregulation 5A(1) are to remain in respect of antibiotic substances only. Those goods are to be subject to an import prohibition (with exceptions similar to those presently in existence for personal use not exceeding 3 months supply at the maximum recommended dose) unless a permission for the importation from the Department of Community Services and Health has been obtained.

The import control of anabolic or androgenic substances or natural or synthetic growth hormones will be continued, but will be provided by transferring these goods to Schedule 8, Regulation 5H. The remaining therapeutic substances will be controlled via the Therapeutic Goods legislation.

Subregulations 5.2 and 5.3 omit existing subregulations 5A(2) and (3) as the import control regime provided therein has been superseded by Sections 14 and 20 of the Therapeutic Goods Act 1989.

Subregulation 5.4 amends subregulation 5A(4) so it only refers to a permission granted under the modified 5A(1).

Subregulation 5.5 effects a technical drafting change to subregulation 5A(5) by replacing "authorized" with "authorised".

Subregulation 5.6 omits subregulation 5A(6) and substitutes a remade subregulation 5A(6) to provide a power to revoke a permission granted under subregulation 5A(1) if the conditions imposed pursuant to 5A(4) are not complied with, irrespective of whether the person is charged with an offence under subsection 50(4) of the Act.

       In the absence of such an express revocation power, no such power would exist.

Subregulation 5.7 effects another technical drafting change by omitting subregulation 5A(7), as that subregulation applies to regulation 5D which is repealed by regulation 8.

Subregulation 5.8 inserts a standard definition of "authorised officer" for the purposes of Regulation 5.

Regulation 6 - Regulation 5B (Licensed importers):

omits regulation 5B. This regulation deals with issues concerning the granting of licences for the importation of therapeutic substances. As the issuing of licences to approved importers of therapeutic substances will no longer be controlled under Customs legislation (as a consequence of the transfer of such matters to the Therapeutic Goods legislation), it is therefore removed from these regulations.

Regulation 7 - Regulation 5C (Designated therapeutic substances):

omits regulation 5C. This regulation deals with the power of the Secretary of the Department of Community Services and Health to declare certain substances as designated therapeutic substances in relation to licensed importers. Similar to regulation 5B, it is omitted as a consequence of the transfer of therapeutic goods administration to the Therapeutic Goods legislation.

Regulation 8 - Regulation 5D (Conditions of licences under Regulation 5B):

omits regulation 5D. This regulation deals with conditions of licences under regulation 5B. As a consequence of omitting regulation 5B (regulation 6 refers), regulation 5D is also omitted.

Regulation 9 - Regulation 5E (Disposal of therapeutic substances):

omits regulation 5E. This regulation deals with the disposal of regulation 5C designated therapeutic substances. As a consequence of omitting regulation SC (regulation 7 refers), regulation SE is also omitted.

Regulation 10 - Regulation 5F (Reasons for refusal to be given):

effects a number of technical drafting changes to Regulation 5F as a result of the various repeals in Regulations 6 to 9. (Regulation 5F ensures that if a permission, licence or approval is refused or revoked, then the person affected shall be given reasons in writing as to why it was refused or revoked).

Subregulation 10.1 omits paragraph 5F(1)(b) as it refers to reasons to be given for a refusal under subregulation 5A(3), which is omitted by subregulation 5.3, and includes a decision to revoke a permission under subregulation 5A(6) as a decision where, if such permission is revoked, the person affected shall be given reasons in writing as to why it was so revoked.

Subregulation 10.2 omits paragraphs 5F(1)(c),(d),(e) and (f) as they refer to reasons to be given for refusals or revocations under paragraphs which are omitted.

Subregulation 10.3 omits subregulation 5F(2) as it refers to licensed importers who have applied to dispose p of designated therapeutic substances under regulation SC which is omitted (regulation 7 refers).

Subregulation 10.4 amends subregulation 5F(3) to omit any references to subregulation 5A(3), which is omitted (subregulation 5.3 refers).

Subregulation 10.5 omits subregulation 5F(4), which defines "authorised person", due to the inclusion of a definition for that phrase in subregulation 5A(8) (subregulation 5.8 refers).

Regulation 11 - Regulation 5G (Appeals):

omits regulation 5G. This regulation provides certain avenues of appeal for persons aggrieved by certain decisions of the Secretary of the Department of Community Services and Health or an authorised person. The new review of decisions mechanism is provided for in regulation 13, making this provision superfluous.

Regulation 12 - Regulation 5H (Importation of certain goods):

amends regulation 5H by adding a new subregulation 5H(4) which provides the Secretary of the Department of Community Services and Health with the power to revoke a permission granted under subregulation 5H(2) if the conditions imposed are not complied with. irrespective of whether or not the person is charged with an offence under subsection 50(4) of the Act. Similar to subregulation 5.6, in the absence of such an express revocation power, no such power exists.

Regulation 13 - New Regulation 5HA (Review of Decisions):

inserts a new regulation 5HA which introduces the new review of decisions mechanism for decisions relating to the importation of goods for which the Minister for Community Services and Health has administrative responsibility. The new review mechanism will provide an expanded right to merits review by the Administrative Appeals Tribunal (AAT) (eg. more decisions are made reviewable), as well as providing a completely new layer of Ministerial review prior to the AAT stage. This "intermediate" review process has been Inserted to mirror the similar review facility of decisions under the new

Therapeutic Goods legislation, so that persons importing goods for which the Minister for Community Services and Health has administrative responsibility might receive similar review treatment under both sets of legislation.

The new "intermediate" review mechanism provides that a person whose interests are affected by certain decisions of the Secretary of the Department of Community Services and Health, or an authorised person, may request the Minister to reconsider the decision. The Minister may:

a)       confirm the decision of the Secretary or authorised person;

b)       revoke the decision of the Secretary or authorised person; or

c)       revoke the decision of the Secretary or authorised person and substitute another decision.

The decision of the Minister may then be reviewed by the AAT.

The new regulation provides for this twotiered review facility as follows:

Subregulation 13.1 inserts new regulation 5HA, which introduces the regime as follows;

New subregulation 5HA(1) defines "decision", "initial decision" and "Minister" for the purposes of the new regulation 5HA. "Decision" is defined as having the same meaning as in subsection 3(3) of the Administrative Appeals Tribunal Act 1975, and "Minister" is defined as being the Minister for Community Services and Health.

The "initial decisions" are those decisions of the Secretary of the Department of Community Services and Health or an authorised person which are subject to the new two stage review process. These decisions are:

1)       a decision under subregulation 5(5) to refuse an application for a licence or permission to import drugs referred to in regulation 5;

2)       a decision under subregulation

5(13) to include in the permission to import drugs referred to in regulation 5, conditions or requirements to be complied with by the holder of the permission. This decision is open to review to ensure that a permission cannot, in effect, be "denied" by the decisionmaker granting a permission but attaching conditions or requirements so onerous or unfair that they cannot, in practical terms, be complied with;

3)       a decision under subregulation 5(15) to refuse to specify a further period for importation where, for reasons outside the control of the holder of a permission to import a drug referred to in regulation 5, the quantity, or part of the quantity, of the drug cannot be imported;

4)       a decision under subregulation 5(17) to revoke a licence for failure to comply with a condition or a requirement set out in subregulation 5(9);

5)       a decision under subregulation 5(18) to revoke a permission for failure to comply with a condition or a requirement as specified;

6)       a decision under subregulation 5A(1) to refuse a permission to import the substance referred to in that subregulation (ie. antibiotics);

7)       a decision under subregulation 5A(4) to impose conditions or requirements on a permission granted under subregulation 5A(l). Similar to decisions under subregulation 5(13), this decision is open to review to ensure that permissions cannot, in effect, be "denied" by the decisionmaker granting a permission but attaching conditions or requirements so onerous or unfair that they cannot, in practical terms, be complied with; and

8)       a decision under subregulation 5A(6) to revoke a permission for failure to comply with a condition as specified.

In addition, the following decisions by the Secretary of the Department of Community Services and Health or an authorised officer are also defined as "initial decisions" (and thus reviewable) for the purposes of new subregulation 5HA(1):

1)       a decision under new subregulation 5H(2) to refuse a permission to import goods specified in Schedule 8; and

2)       a decision under new subregulation 5H(4) to revoke a permission granted under subregulation 5H(2) for failure to comply with a condition as specified.

       Schedule 8 contains a range of goods whose importation is prohibited unless the permission of the Minister for Community Services and Health is first obtained. In respect of these goods, it was considered a Customs barrier control was still desirable.

New subregulation 5HA(2) provides that a person affected by an "initial decision" has 90 days from the date the person was given notice of the decision (subregulation 4.1 discussed previously refers) to request that the Minister reconsider the decision.

New subregulation 5HA(3) provides that the Minister, upon receiving a request to reconsider the decision, must as soon as practicable reconsider it, and may:

a)       confirm the initial decision;

b)       revoke the initial decision; or

c)       revoke the initial decision and substitute another decision.'

New subregulation 5HA(4) provides that the initial decision is taken to be confirmed by the Minister if no notice of the Minister's reconsideration Is given within 60 days.

New subregulation 5HA(5) provides that after reconsideration of an initial decision the applicant must receive notice, in writing, of the result of the reconsideration and notice of his or her right to apply for a statement setting out the reasons for the decision, together with notice of his or her right to apply to the AAT for review of the reconsideration.

New subregulation 5HA(6) provides that the initial decision given to a person whose interests are affected by the decision, shall include advice with regard to the person's right both to intermediate review (ie., the reconsideration by the Minister) and ultimately, review by the AAT.

       See this previously discussed under subregulation 4.1.

New subregulation 5HA(7) is a standard provision to ensure that failure to comply with the notice requirements under new subregulation 5HA(5) and 5HA(6) does not affect the validity of the actual decision.

New subregulation 5HA(8) ensures that AAT review is available after the intermediate review process is completed, ie. this expressly ensures that the Ministerial layer of review is not in substitution of merits review review by the AAT.

Regulation 14 - Schedule 8:

sends Schedule 8 to the Regulations which lists goods the importation of which is prohibited except with the permission of the Secretary of the Department of Community Services and Health or of an authorised officer.

Subregulation 14.1 provides for the control on the importation of anabolic or androgenic substances or natural or synthetic growth hormones to be transferred from regulation 5A to Schedule 8.

Subregulation 14.2 omits the following substances from Schedule 8 as the controls on their importation are transferred from Customs legislation to the Therapeutic Goods legislation:

drug infusion systems (Item 8B); implantable cardiac pacemakers and accessories, implantable defibrillators and accessories, and implantable cardio convertors and accessories (Item 11AA); insulin syringes (Item 11A); intra-ocular lenses (Item 11B); and intra-uterine contraceptive devices (Item 11C).

Subregulation 14.3 adds - "laetrile and preparations containing laetrile" to Schedule 8.

       The Government decided in May last year to add these substances to Schedule 8 because of some extravagant and misleading claims concerning this experimental anti-cancer drug. Laetrile is consider a major risk to public health because of its undoubted toxicity. The prohibition on its importation has been supported by the Australian Drug Evaluation Committee and Subcommittees.

Subregulation 14.4 amends Item 13 of Schedule 8 by deleting "tobacco habit" from "preparations that purport to be a remedy for drunkenness, alcoholic habit, tobacco habit or drug habit", as this control is now in the Therapeutic Goods legislation.

Subregulation 14.5 omits "prosthetic heart valves" from Schedule 8 as the controls on this importation are transferred from Customs legislation to the Therapeutic Goods legislation.

Regulation 15 - Further Amendments:

provides for a number of technical drafting amendments to regulation 5 to ensure that, where appropriate, decisions made by the Secretary of the Department of Community Services and Health can be made by the Secretary or by an authorised person.

       an authorised person, as defined in subregulation 5(20), means a person authorised in writing by the Secretary of the Department of Community Services and Health.

Regulation 16 - Transitional:

ensures that certain rights granted to persons under regulations 5, 5D and 5E shall continue to exist even though the relevant regulations have been Substantially amended or repealed (Regulations 4, 8 and 9 refer).

Subregulation 16.1: provides that if a person has made application to the AAT for a review of a decision of the Secretary of the Department of Community Services and Health to not grant a licence under subregulation 5(5) or to revoke a licence to import drugs under subregulation 5(17) before subregulation 5(18A) is repealed by Regulation 4 of these Regulations, then this application can proceed as if these Regulations had not been made. This ensures that an individual's existing review rights are not altered by this amendment.

Subregulation 16.2 provides that if a licence has been granted under regulation 5B before the commencement of these Regulations, then any conditions imposed under regulation 5D shall continue to apply for a period of 6 months after the commencement of these Regulations.

Subregulation 16.3 provides that if a licensed importer has applied to dispose of a designated therapeutic substance.(designated under regulation before the commencement of these Regulations, then the permission to dispose of such substances shall continue to apply for a period of 6 months after the commencement of these Regulations.

       Subregulations 16.2 and 16.3 ensure that transitional arrangements as provided for by Item 11 of Schedule 5 to the Therapeutic Goods Regulations, (which provides that therapeutic goods in respect of which there is a licence or permission in force under regulation 5A, 5B or 5C of the Customs (Prohibited Imports)

Regulations granted before the commencement of the Therapeutic Goods Act 1989 are exempt from the necessity for registration or listing under that Act for a period of 6 months after the commencement of the Act), shall also apply to regulations 5D and 5E of the Customs (Prohibited Imports) Regulations.


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