EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 1)
PB 3 of 2012
Authority
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).
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87 of 2011) (the Special Arrangement), to make changes to the special arrangement relating to the chemotherapy pharmaceuticals access program.
The Special Arrangement deals with the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients and patients on discharge.
Changes to the Special Arrangement made by this Instrument
This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the chemotherapy pharmaceuticals access program. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commence on the same day.
This Instrument:
- Adds 8 pharmaceutical benefits with the listed drugs ‘Epirubicin’ and ‘Gemcitabine’;
- Removes circumstances for pharmaceutical benefits with the listed drug ‘Gemcitabine’.
A provision by provision description of this Instrument is contained in the Attachment.
Consultations
An ongoing and formal process of consultation in relation to matters relevant to this instrument includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.
PBAC members are appointed following nomination by prescribed organisations and associations 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), 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.
Statement of Compatibility
This instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
General
This Instrument commences on 1 March 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 1)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2012 (No. 1) and that it may also be cited as PB 3 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 March 2012.
Section 3 Amendments to PB 87 of 2011
This section provides that Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87 of 2011) (the Principal Instrument).
Schedule 1
Item 1 amends the entry in Schedule 1 of the Principal Instrument for ‘Epirubicin’ by adding a new pharmaceutical benefit, which is the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL’ with manner of administration ‘Injection/intravesical’ and brand ‘Epirubicin Actavis 10’.
Item 2 amends the entry in Schedule 1 of the Principal Instrument for ‘Epirubicin’ by adding a new pharmaceutical benefit, which is the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL’ with manner of administration ‘Injection/intravesical’ and brand ‘Epirubicin Actavis 20’.
Item 3 amends the entry in Schedule 1 of the Principal Instrument for ‘Epirubicin’ by adding a new pharmaceutical benefit, which is the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ with manner of administration ‘Injection/intravesical’ and brand ‘Epirubicin Actavis 50’.
Item 4 amends the entry in Schedule 1 of the Principal Instrument for ‘Epirubicin’ by adding a new pharmaceutical benefit, which is the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL’ with manner of administration ‘Injection/intravesical’ and brand ‘Epirubicin Actavis 100’.
Item 5 amends the entry in Schedule 1 of the Principal Instrument for ‘Epirubicin’ by adding a new pharmaceutical benefit, which is the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ with manner of administration ‘Injection/intravesical’ and brand ‘Epirubicin Actavis 200’.
Item 6 amends the entry in Schedule 1 of the Principal Instrument for ‘Gemcitabine’ by removing all circumstance codes.
Item 7 amends the entry in Schedule 1 of the Principal Instrument for ‘Gemcitabine’ by adding a new pharmaceutical benefit, which is the listed drug ‘Gemcitabine’ in the form ‘Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL’ with manner of administration ‘Injection’ and brand ‘Gemcitabine Ebewe’.
Item 8 amends the entry in Schedule 1 of the Principal Instrument for ‘Gemcitabine’ by adding a new pharmaceutical benefit, which is the listed drug ‘Gemcitabine’ in the form ‘Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL’ with manner of administration ‘Injection’ and brand ‘Gemcitabine Ebewe’.
Item 9 amends the entry in Schedule 1 of the Principal Instrument for ‘Gemcitabine’ by adding a new pharmaceutical benefit, which is the listed drug ‘Gemcitabine’ in the form ‘Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL’ with manner of administration ‘Injection’ and brand ‘Gemcitabine Ebewe’.
Item 10 amends Schedule 3 of the Principal Instrument by removing the entry for ‘Gemcitabine’.