National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No. 3) (No. PB 87 of 2013)

Overview

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No. 3) was enacted to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, addressing a need to update the pharmaceutical benefits available under the Special Arrangement. Authorised by Subsection 100(1) and (2) of the National Health Act 1953, the Instrument allows the Minister to make special arrangements for the supply of pharmaceutical benefits and enables the variation or revocation of these arrangements. The primary objective of this amendment is to incorporate a new listed brand of the drug Macrogol 3350, lax-sachets, into Schedule 1 of the Special Arrangement, reflecting changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislative update aligns with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and ensures that eligible persons with paraplegia or quadriplegia continue to receive necessary pharmaceutical benefits under the Paraplegic and Quadriplegic Program.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No.3) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 to update the list of pharmaceutical benefits available under the Special Arrangement. This amendment is applicable to eligible persons, defined as those who are eligible to receive Medicare benefits under the Health Insurance Act 1973, have paraplegia or quadriplegia, and are members of an authorised association. The amendment specifically adds a new listed brand of the drug Macrogol 3350, lax-sachets, to Schedule 1 of the Special Arrangement, reflecting changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes are in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on the listing of pharmaceutical benefits. The Instrument is a legislative instrument under the Legislative Instruments Act 2003 and is compatible with human rights, as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health, in line with the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The main operative sections of the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No.3) (the Instrument) are those that amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (the Special Arrangement) by adding a new listed brand of the drug Macrogol 3350, lax-sachets, to Schedule 1 of the Special Arrangement (Schedule 1). This amendment allows 'authorised associations' to supply this pharmaceutical benefit to 'eligible persons' who have paraplegia or quadriplegia and are members of these associations. This change aligns with updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Instrument imposes several obligations on the parties it governs. Firstly, it requires that any pharmaceutical benefits provided under the Special Arrangement must be supplied by 'authorised associations' to 'eligible persons'. An 'eligible person' is defined as someone who is eligible to receive Medicare benefits under the Health Insurance Act 1973, has paraplegia or quadriplegia, and is a member of an 'authorised association'. Furthermore, the Instrument mandates that the Pharmaceutical Benefits Advisory Committee (PBAC) be involved in the decision-making process regarding the listing of pharmaceutical benefits. PBAC, an independent expert body, provides recommendations to the Minister based on clinical effectiveness, safety, and cost-effectiveness of the medicines. In terms of potential offences and penalties, the Instrument itself does not explicitly detail criminal or civil penalties for non-compliance. However, breaches of the National Health Act 1953, under which this Instrument is made, may result in civil or criminal penalties. For instance, unauthorised supply of pharmaceutical benefits could be subject to penalties under sections of the Act related to fraud or improper conduct. Additionally, failure to comply with the requirements of the Special Arrangement could potentially lead to revocation of an association’s authorisation to supply pharmaceutical benefits, effectively barring them from participating in the program. The amendments made by this Instrument reflect recommendations from the PBAC, which ensures that decisions about which drugs are listed on the Pharmaceutical Benefits Scheme (PBS) are evidence-based. This reflects a commitment to providing accessible and effective pharmaceutical benefits to those in need. The involvement of PBAC, with its diverse membership, underscores the importance of considering multiple perspectives in the decision-making process. By aligning with international human rights standards, particularly those under the International Covenant on Economic, Social and Cultural Rights, the Instrument supports the progressive realisation of the right to the highest attainable standard of physical and mental health.