National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 10) (PB 94 of 2015)

Overview

The National Health Act 1953, as amended by the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015, addresses the need for a flexible framework to provide Australians access to highly specialised drugs that are not already listed on the Pharmaceutical Benefits Scheme (PBS). Enacted by the Parliament of Australia, this amendment aims to streamline and enhance the administration of the highly specialised drugs program. It responds to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the program remains aligned with clinical effectiveness, safety, and cost-effectiveness criteria. This legislative instrument updates the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the program continues to meet the evolving healthcare needs of the Australian population.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 10) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, made under the National Health Act 1953. This legislative instrument applies to the highly specialised drugs program, specifically altering the circumstances for prescribing various pharmaceutical benefits and updating responsible person codes. The changes are in response to modifications to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendment ensures that the Special Arrangement aligns with the updated listings on the Pharmaceutical Benefits Scheme, reflecting the recommendations of the Pharmaceutical Benefits Advisory Committee. This Act applies nationally and involves consultation with pharmaceutical companies, consumer groups, health economists, and healthcare professionals through the PBAC process. The instrument commenced on 1 October 2015, and its detailed provisions are outlined in the accompanying Attachment.

Key Provisions

The main operative sections of this legislation, specifically the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 10), are primarily concerned with amending the National Health (Highly specialised drugs program) Special Arrangement 2010. Section 3 of the instrument details the amendments made to the Special Arrangement, which include changes to the circumstances for prescribing various pharmaceutical benefits and adjustments to the responsible person codes. The amendments reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These changes are summarised in the Attachment and include the remodelling of restrictions for drugs such as Abtacept, Anakinra, Infliximab, Ivacaftor, Lanthanum, Rituximab, Sevelamer, Sucroferric Oxyhydroxide, and Tocilizumab. Additionally, there are changes to the responsible persons for certain drugs, such as Filgrastim and Nevirapine, and the addition of new responsible person codes. The obligations and requirements imposed by this Act on the parties or entities it governs primarily revolve around ensuring that the amendments to the Special Arrangement are implemented correctly and that the changes to the pharmaceutical benefits and responsible person codes are accurately reflected in practice. Pharmaceutical companies, healthcare providers, and other relevant entities must ensure that they are compliant with the new restrictions and coding changes as per the Special Arrangement. The changes are designed to ensure that the highly specialised drugs program remains effective and aligned with current medical and economic standards. Any offences or breaches of this Act may result in civil or criminal consequences, although specific penalties are not detailed within the text of the explanatory statement. However, given the nature of the amendments, non-compliance could potentially lead to legal action, fines, or other penalties as prescribed by the relevant health and pharmaceutical regulations. The precise penalties would be in accordance with the broader legislative framework governing the National Health Act 1953 and related instruments. The amendments reflect the recommendations made by the Pharmaceutical Benefits Advisory Committee, ensuring that the changes are thoroughly vetted and aligned with expert medical advice.