National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 2) (PB 13 of 2016)

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 2) amends the National Health (Highly specialised drugs program) Special Arrangement 2010 to update the supply and prescription of highly specialised drugs. Enacted by the Parliament of Australia under subsection 100(1) and 100(2) of the National Health Act 1953, the amendment addresses changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include modifications to the prescribing, supply, and responsible persons for various pharmaceutical benefits. This legislative instrument seeks to ensure that the highly specialised drugs program remains aligned with current medical practices and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established to advise on the listing of pharmaceutical benefits on the Pharmaceutical Benefits Scheme (PBS). The changes reflect an ongoing consultation process involving pharmaceutical companies and the PBAC, which considers factors such as clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 2) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, providing changes to the highly specialised drugs program under the National Health Act 1953. The instrument applies to pharmaceutical benefits, specifically to those listed under the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and pertains to the supply and prescribing of certain drugs within the highly specialised drugs program. The amendments reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the Act, which provides advice on which drugs and medicinal preparations should be available as pharmaceutical benefits. The changes include the addition, removal, and modification of pharmaceutical items, responsible persons, and prescribing circumstances, as summarised in the attachment to the instrument. These amendments are applicable nationwide as they relate to the Commonwealth-managed Pharmaceutical Benefits Scheme (PBS). The instrument commenced on 1 March 2016 and is subject to further modification or revocation by the Minister under the authority of the Act.

Key Provisions

The main operative sections of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 2) (PB 13 of 2016) are concerned with amending the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010). Section 3 of the Instrument amends the Special Arrangement by inserting definitions for terms such as "eligible medical practitioner for the treatment of hepatitis C" and "General statement for drugs for the treatment of hepatitis C" (Items 1 to 2). Additionally, the Instrument removes the highly specialised drug (HSD) hospital-only supply, allowing supply of certain HSD pharmaceutical benefits to an eligible patient by an approved pharmacist, approved medical practitioner, or approved hospital authority (Item 3). It also makes additions, remodels restrictions, and changes responsible persons for pharmaceutical items, including the addition of new pharmaceutical items and changes to the circumstances for prescribing (Items 4 to 18). Finally, Item 19 inserts a new part, Schedule 3 Part 1—General statement for drugs for the treatment of hepatitis C. The obligations and requirements imposed by the Act on the parties or entities it governs include 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 that makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The 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. The 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 also consulted throughout the process of changes to the listings on the PBS and for this Instrument, including consultation through the PBAC process and agreement to final listing details. The Instrument outlines several offences, penalties, or civil/criminal consequences for breach. However, the specific penalties are not stated within the Instrument itself. Under section 100(2) of the National Health Act 1953 (the Act), the Minister may vary or revoke a special arrangement made under subsection 100(1). Additionally, 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). The consequences of non-compliance with these provisions may include the variation or revocation of the special arrangement, which could result in the affected pharmaceutical benefits no longer being available or supplied under the highly specialised drugs program. Furthermore, any breach of the terms and conditions outlined in the amended Special Arrangement may lead to enforcement actions, penalties, or other consequences as determined by the relevant authorities, such as the Therapeutic Goods Administration (TGA) or the Department of Health.