EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 7)
PB 67 of 2016
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
This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 7) (the Amending Instrument). The purpose of the Amending Instrument is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) program.
The amendment made by this Instrument reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 67 of 2016 include adding and removing various pharmaceutical benefits and adding new Responsible Persons.
These changes are summarised, by drug name, in the Attachment.
A provision by provision Description of this instrument is contained in the Attachment.
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 August 2016.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016
PART 1 PRELIMINARY
Section 1 Name of Instrument
This section provides the name of this instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 7). It can also be cited as PB 67 of 2016.
Section 2 Commencement
This section provides that this instrument commences on 1 August 2016.
Section 3 Amendment
This section provides that the Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
SCHEDULE
Item 1 Section 4
Item 1 amends section 4 (Definitions) of the Special Arrangements by removing the listed drug ‘Telbivudine’ from the definition of medication for the treatment of hepatitis B.
Items 2 to 7 Schedules 1, 2 and 3
Items 2 to 5 provide for adding and removing various pharmaceutical benefits and adding new Responsible Persons. These changes are summarised below:
Listed Drug | Type of Change |
Azacitidine; Tacrolimus. | Addition of new pharmaceutical items |
Azacitidine; Tacrolimus. | Addition of new Responsible Persons |
Telbivudine | Deletion of pharmaceutical item |
Overview
The National Health Act 1953, enacted by the Australian Parliament, governs the administration of health services, medical benefits, and pharmaceutical benefits within Australia. One of the Act's purposes is to facilitate the supply of pharmaceutical benefits, and under Section 100, the Minister for Health has the authority to establish special arrangements for such supply. The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 7) was introduced to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, addressing changes to the Highly Specialised Drugs (HSD) program. This amendment was made in response to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and aims to reflect these changes within the special arrangement. The amendments were developed in consultation with the Pharmaceutical Benefits Advisory Committee, ensuring a formal and ongoing process of consultation with relevant stakeholders, including pharmaceutical companies.
Scope and Application
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 7) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislation applies to the Highly Specialised Drugs (HSD) program and the associated pharmaceutical benefits listed under the National Health Act 1953. The amendments, which commenced on 1 August 2016, include adding and removing various pharmaceutical benefits and introducing new Responsible Persons, as detailed in the Schedule. The changes are in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which consults with a range of stakeholders including pharmaceutical companies, to ensure the clinical effectiveness, safety, and cost-effectiveness of the medicines listed on the Pharmaceutical Benefits Scheme (PBS). This Instrument is a legislative instrument under the Legislation Act 2003 and has effect subject to any special arrangement made under the National Health Act 1953.
Key Provisions
The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 7) (Amending Instrument) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (Special Arrangement). This amendment, referenced in section 3 of the Amending Instrument, involves changes to the Highly Specialised Drugs (HSD) program, including additions and removals of pharmaceutical benefits and the appointment of new Responsible Persons. These changes are detailed in the Schedule of the Amending Instrument and are intended to reflect the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Amending Instrument, which can be cited as PB 67 of 2016, commences on 1 August 2016.
The obligations imposed by the Amending Instrument on the parties or entities it governs primarily involve adherence to the updated Special Arrangement. This includes compliance with the new definitions, the addition and removal of pharmaceutical benefits, and the responsibilities of the newly appointed Responsible Persons. These amendments are made to align the HSD program with the changes in the Pharmaceutical Benefits Scheme (PBS) as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body established under the Act, plays a crucial role in advising the Minister on which drugs should be available as pharmaceutical benefits, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness.
Under the Amending Instrument, there are no specific offences, penalties, or consequences outlined for breaches of the updated Special Arrangement. However, non-compliance with the provisions of the National Health Act 1953 (Act) or the Special Arrangement could result in legal consequences. The Act provides that the Minister may vary or revoke a special arrangement made under section 100(1), and non-compliance with such arrangements could lead to enforcement actions by the Minister or other relevant authorities. Additionally, failure to adhere to the updated Special Arrangement may have implications for the provision of pharmaceutical benefits and the administration of the HSD program.
In summary, the Amending Instrument amends the Special Arrangement by updating the definitions, adding and removing pharmaceutical benefits, and appointing new Responsible Persons. The obligations on the parties governed by the Act include compliance with the amended Special Arrangement. While the Amending Instrument itself does not specify penalties for breaches, non-compliance with the Act or the Special Arrangement could lead to enforcement actions and legal consequences. The changes reflect the recommendations of the PBAC and are intended to align the HSD program with the updated PBS listings.