National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No. 2) (No. PB 66 of 2013)

Overview

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No. 2) was enacted to amend the existing National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, as established under the National Health Act 1953. The primary objective of this legislative instrument is to update the responsible party for the supply of the drug Macrogol 3350, branded as LaxaCon, from Ascent Pharma Pty Ltd to Actavis Pty Ltd. This change was made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that decisions regarding pharmaceutical benefits are evidence-based and take into account clinical effectiveness, safety, and cost-effectiveness. The amendments reflect the changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency across related arrangements and policies. The instrument was created under the authority provided by the National Health Act 1953, which enables the Minister to make special arrangements for the supply of pharmaceutical benefits and to vary or revoke such arrangements. The amendments made by this instrument align with the policy objectives of the Pharmaceutical Benefits Scheme (PBS), which aims to provide subsidised access to medicines, thereby supporting the right to the highest attainable standard of physical and mental health as recognised by the International Covenant on Economic, Social and Cultural Rights. This legislative instrument is compatible with human rights, as it facilitates the progressive realisation of these rights by ensuring that access to essential medications is maintained and updated through a rigorous and consultative process.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No. 2) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, modifying the special arrangement that provides for the supply of pharmaceutical benefits to eligible persons with paraplegia or quadriplegia. The Act applies to 'eligible persons', defined as individuals who are eligible to receive Medicare benefits under the Health Insurance Act 1973, have paraplegia or quadriplegia, and are members of an 'authorised association'. This special arrangement is limited to pharmaceutical benefits supplied under the arrangement and does not extend to other areas of health or pharmaceutical benefits outside of this specific program. The changes to the responsible person for the listed drug Macrogol 3350, with the brand name LaxaCon, from Ascent Pharma Pty Ltd to Actavis Pty Ltd, reflect updates made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment is part of a broader legislative framework under the National Health Act 1953, which allows the Minister to make and vary special arrangements for the supply of pharmaceutical benefits. The legislative instrument is compatible with human rights, specifically engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by supporting the highest attainable standard of physical and mental health through the provision of subsidised access to medicines.

Key Provisions

The main operative sections of the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No.2) are sections that establish the authority to make amendments to the Special Arrangement under subsections 100(1) and (2) of the National Health Act 1953 (the Act) (paragraphs 1 and 2). The Act allows the Minister to make special arrangements for the supply of pharmaceutical benefits, and the Instrument amends the existing Special Arrangement to make changes to the Paraplegic and Quadriplegic Program. The Instrument specifically modifies the 'Responsible Person' for the listed drug Macrogol 3350 with the brand name LaxaCon, replacing Ascent Pharma Pty Ltd with Actavis Pty Ltd, and makes corresponding changes to Schedule 1 and Schedule 2 of the Special Arrangement (paragraph 3). The obligations and requirements imposed by the Act on the parties or entities it governs include ensuring that 'authorised associations' supply pharmaceutical benefits under the Special Arrangement to 'eligible persons' (paragraph 4). 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' (paragraph 4). The Instrument mandates that the amended Special Arrangement reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) (paragraphs 5 and 6). The PBAC, an independent expert body established under the Act, recommends which drugs and medicinal preparations should be available as pharmaceutical benefits based on clinical effectiveness, safety, and cost-effectiveness (paragraph 6). Pharmaceutical companies are also required to be consulted throughout the process of changes to the listings on the Pharmaceutical Benefits Scheme (PBS) (paragraph 7). The Act imposes penalties and civil or criminal consequences for breaches of its provisions. While the Instrument itself does not explicitly state specific penalties, the overarching Act under which the Instrument operates may include provisions for penalties. For example, under section 100D of the Act, any person who contravenes a special arrangement made under subsection 100(1) may be liable for a penalty of up to 50 penalty units (currently AUD 5,350) (paragraph 8). Additionally, the Minister may take enforcement actions such as varying or revoking the special arrangement if a breach is identified (paragraph 9). It is important to note that specific penalties for breaches of the Special Arrangement would be governed by the broader legislative framework of the National Health Act 1953.