EXPLANATORY STATEMENT

Issued by the Minister for Health and Ageing

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (IVF/GIFT PROGRAM) SPECIAL ARRANGEMENT 2011

PB 93 of 2011

Purpose

This legislative instrument provides for a special arrangement under subsection 100(1) of the National Health Act 1953 (the Act) relating to the supply of pharmaceutical benefits to eligible patients who are receiving in vitro fertilisation (IVF) or gamete intrafallopian transfer (GIFT) treatment. 

This Special Arrangement revokes, under subsection 100(2) of the Act, the special arrangement titled National Health Act 1953 – Arrangements made under subparagraph 100(1)(b)(i) – IVF/GIFT Program (PB 26 of 2007) (the Previous Arrangement).

Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:

(a)  who are living in isolated areas: or

(b) who are receiving treatment in circumstances in which generally available pharmaceutical benefits are inadequate for that treatment; or

(c) if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.

Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

This section 100 special arrangement

This instrument makes changes to the pharmaceutical benefits available under the section 100 arrangement for the IVF/GIFT program. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (the main listing instrument) made under sections 84AF, 85, 85A and 101 of the Act, which commences on the same day.

Three additional pharmaceutical benefits are made available for supply under this Special Arrangement, being two pharmaceutical benefits with the listed drug ‘Corifollitropin Alfa’ and one pharmaceutical benefit with the listed drug “Nafarelin’.

This Special Arrangement also includes some minor and machinery changes of a technical nature. The minor and machinery changes include:

·         removing references to ‘special pharmaceutical product’ and replacing with ‘pharmaceutical benefit’ or ‘brand of a pharmaceutical item’ for transparency, in line with amendments made to section 100 of the Act by Schedule 6 of the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2010 (the Amending Act) and the main listing instrument, both of which commenced on 1 December 2010;

·         referring to the ‘general medical services table’ made under the Health Insurance Act 1973 as the reference is more ambulatory. The current general medical services table is the Health Insurance (General Medical Services Table) Regulations 2011;

·         updating references from ‘Chief Executive Officer of Medicare Australia’ and ‘Medicare Australia’ to ‘Chief Executive Medicare’ and ‘Human Services Department’ for transparency, in line with the Human Services Legislation Amendment Act 2011;

·         moving the reference to ‘accredited IVF/GIFT clinic’ from the note of the Previous Arrangement into the body of this Special Arrangement;

·         removing the reference to luteal phase support as it is not needed. Luteal phase support is included in all the medicare items referred to in the Previous Arrangement and in this Special Arrangement;

·         including responsible person and section 100 only status references for transparency; and

·         including transitional provisions to ensure patient access is maintained with the revocation and replacement of the Previous Arrangement.   

Consultations

The Special Arrangement was made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC. When making recommendations, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.

Apart from making three new pharmaceutical benefits available for supply under this Special Arrangement, the changes made are minor and machinery in nature.

General

This legislative instrument commences on 1 December 2011.

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

A provision by provision description of this Instrument is contained in the Attachment.

ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (IVF/GIFT PROGRAM) SPECIAL ARRANGEMENT 2011

Section 1    Name of Instrument

This section provides that this Instrument is the National Health (IVF/GIFT Program) Special Arrangement 2011 and that it may also be cited as PB 93 of 2011.

Section 2    Commencement

This section provides that this Instrument commences on 1 December 2011.

Section 3    Revocation

This section provides that this Special Arrangement revokes the National Health Act 1953 – Arrangements made under subparagraph 100(1)(b)(i) – IVF/GIFT Program (PB 26 of 2007) (the Previous Arrangement).

Section 4    Definitions

A number of expressions used in this Special Arrangement are defined in section 4.

Consistent with the Previous Arrangement, ‘accredited IVF/GIFT clinic’ is defined by reference to the definition of ‘accredited ART centre’ in section 8 of the Research into Human Embryos Act 2002 and approval by the Human Services Department for supply under this Special Arrangement. ‘ART’ means Assisted Reproductive Technology.  

Sections 5  Eligible for pharmaceutical benefits

Subsection 5(1) provides that an eligible patient is entitled to receive the pharmaceutical benefits listed in Schedule 1, free of charge, from an accredited IVF/GIFT clinic. ‘Eligible patient’ and ‘accredited IVF/GIFT clinic’ are both defined in section 4.

Subsection 5(2) provides that payment of medicare benefits for items 13200, 13201, 13202 and 13203 in the general medical services table is evidence of a person’s eligibility under this Special Arrangement. ‘General medical services table’ is defined in section 4.

Subsection 5(3) provides that for supply under this Special Arrangement the accredited IVF/GIFT clinic is required to notify the Chief Executive Medicare of the eligible patient’s Medicare number.

Section 6    Responsible Person

This section provides for the responsible person for each brand of pharmaceutical item covered by this Special Arrangement. A responsible person has been determined by the Minister to be the responsible person under section 84AF of the Act in another legislative instrument and the references to responsible person are included in this Special Arrangement for transparency.

Section 7    Section 100 only supply

This section provides for matters relating to section 100 only supply of the pharmaceutical benefits covered by this Arrangement.  These matters have been determined by the Minister under relevant provisions of the Act in another legislative instrument and are included in this Arrangement for transparency.  The matters concern:

·         Section 100 only drugs declared under subsection 85(2A) of the Act; and

·         Section 100 only pharmaceutical benefits determined under paragraph 85(8)(a) of the Act.

The letter ‘D’ in the ‘Section 100 only’ column in Schedule 1 indicates that the drug is a section 100 only drug and that all pharmaceutical benefits that have that drug may only be supplied under this or another special arrangement under section 100.  They are not available for general supply on the PBS.

The letters ‘PB’ in the ‘Section 100 only’ column in Schedule 1 indicates that the pharmaceutical benefit is a section 100 only pharmaceutical benefit and that pharmaceutical benefit may only be supplied under this or another special arrangement under section 100.  It is not available for general supply on the PBS.

Section 8             Transitional Arrangements

Subsection 8(1) provides that an accredited IVF/GIFT clinic under the Previous Arrangement will continue to be an accredited IVF/GIFT clinic under this Special Arrangement.

Subsection 8(2) provides that a Medicare number that has been notified under the Previous Arrangement is taken to have been notified under section 5 of this Special Arrangement.

Subsection 8(3) provides a definition for ‘old Arrangement’ for the purposes of this section of this Special Arrangement.

A supply under the Previous Arrangement that took place prior to the commencement of this Special Arrangement may be claimed and processed under the Previous Arrangement: section 15 of the Legislative Instruments Act 2003.

Schedule 1      Pharmaceutical benefits covered by this Arrangement

This Schedule sets out the pharmaceutical benefits covered by this Arrangement and a number of related matters.  Some of the matters have been declared or determined in other legislative instruments and are included in this Arrangement for reasons of transparency.   The pharmaceutical benefits covered by this Arrangement have been determined in this Special Arrangement (section 5) even though the declarations and determinations which define those medicines as pharmaceutical benefits have been made in another instrument.

The matters dealt with in the various columns of the Schedule, the corresponding provisions of the Act are set out in the table below.

Schedule 2      Responsible person codes

This Schedule relates to section 6 of this Arrangement.  The responsible person for each brand of a pharmaceutical item is identified in the column headed ‘Responsible Person’ in Schedule 1 by a two letter code.  Schedule 2 sets out the name of the responsible person and their ABN, if any, for each code.