National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 7) (PB 58 of 2015)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 7)

PB 58 of 2015

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

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

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the Act, is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the highly specialised drugs program.

The amendments provide for community access to specified pharmaceutical benefits used in the treatment of hepatitis B, HIV antiretroviral therapy and schizophrenia.  Community access means harmonised community prescribing and dispensing of these medicines.  These changes reflect the move in clinical practice treat these patients in the community, instead of services provided through hospital.

The amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). 

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the 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), 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.

Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS and for this Instrument.  This includes consultation through the PBAC process, and agreement to final listing details.

Details of the instrument are set out in the Attachment.

This Instrument commences on 1 July 2015.

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

ATTACHMENT

Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015

Section 1 Name of Instrument
This section provides that the name of this instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015.  It can also be citied as PB 58 of 2015.

Section 2 Commencement
This section provides that this instrument commences on 1 July 2015.

Section 3 Amendment
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1 Amendments

Item 1 Section 1

Item 1 amends section 1 to the Special Arrangement.  The effect is to amend the title to the Special Arrangement to remove the words ‘for hospitals’.  Given this Special Arrangement will now apply in the community setting as well as the hospital setting the removal of these words from the title of the instrument is appropriate.

Items 2 to 9 Section 4

Items 2 to 9 amend section 4 (Definitions) of the Special Arrangement by inserting definitions for the following terms - accredited prescriber of medication for the treatment of Hepatitis B, accredited prescriber of medication for the treatment of schizophrenia, medication for the treatment of Hepatitis B, medication for the treatment of schizophrenia and residential care service. 

The following definitions are amended by these items – eligible medical practitioner, medication for the treatment of HIV or AIDS, and under co-payment data.

A note to the definitions section is also amended.

Items 10 and 11 Section 18 and new section 18A
Items 6 and 7 introduce the community access arrangements into the Special Arrangement. 

From 1 July 2015, HSD pharmaceutical benefits as specified in subsection 18A(1) can be supplied by approved pharmacists or approved medical practitioners (as well as by approved hospital authorities).  This means for example, that a patient can take their script for an HSD pharmaceutical benefit to their local pharmacy to have it filled.

Item 12 Section 19
Item 12 repeals section 19 and replaces it with a new section 19 which harmonises the application of regulation 25 to public hospital settings, private hospital setting and community settings. 

In summary, regulation 25 Repeat supplies of pharmaceutical benefits will not apply in any of these settings for HSD pharmaceutical benefits.

Items 13 Part 4, Division 3 heading
Item 13 amends the heading to Part 4, Division 3 of the Special Arrangement making it clear this division applies to approved medical practitioners as well as other suppliers.

Items 14 and 15 Subsections 36(2) and (3)
Items 14 and 15 allows approved medical practitioners to be included in these sections, effectively extending the operation of the Special Arrangement to the community setting.

Items 16 Part 5, Division 2 heading
Item 16 amends the heading to Part 5, Division 2 of the Special Arrangement making it clear this division applies to approved medical practitioners as well as other suppliers.

Items 17 and 19 Section 39 and section 47 headings
Items 17 and 19 amends the headings to section 39 and section 47 of the Special Arrangement making it clear these sections apply to approved medical practitioners as well as other suppliers.

Items 18, 20 and 21 Subsections 39(1), 47(1) and 47(2)
Items 18, 20 and 21 allow approved medical practitioners to be included in these provisions, effectively extending the operation of the Special Arrangement to the community setting.

Item 22 Section 49
Item 22 repeals section 49 and substitutes a new section applying to the compliance and auditing arrangements for HSD pharmaceutical benefits.  These arrangements apply to approved suppliers, being approved hospital authorities, approved pharmacists and approved medical practitioners.   

Items 23 and 24 Subsection 50(3) and paragraph 51(f)
Items 23 and 24 allow approved medical practitioners to be included in these provisions, effectively extending the operation of the Special Arrangement to the community setting.

Item 25

Item 25 inserts new transitional provisions section 56.

This provision allows for repeat prescriptions issued prior to 1 July 2015 to be supplied according to the number of repeats provided for, but that supply can only occur by public or private hospital suppliers.

Items 26 to Item 113

Provide for alteration of responsible person code, alteration to the circumstances for prescribing various pharmaceutical benefits to allow for community access (including authority requirements).

These changes are summarised below.

Summary of Changes