National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2014 (No. 5) (No. PB 35 of 2014)

Overview

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2014 (No. 5) was enacted to amend the existing special arrangement established under the National Health Act 1953 to better support individuals with paraplegia or quadriplegia. This legislative instrument is designed to ensure that the Paraplegic and Quadriplegic Program can effectively meet the evolving needs of eligible persons by making necessary adjustments to the Pharmaceutical Benefits Scheme. The instrument, made under the authority of the Act, allows the Minister for Health to make special arrangements for the supply of pharmaceutical benefits, ensuring that individuals with specific medical conditions receive appropriate and timely access to necessary medications. The changes introduced by this instrument were made in consultation with the Pharmaceutical Benefits Advisory Committee, which advises the Minister on matters related to the Pharmaceutical Benefits Scheme. These amendments align with recommendations from the Committee and aim to improve the accessibility and effectiveness of the Scheme for those with paraplegia or quadriplegia, ensuring that they have access to a broader range of pharmaceutical benefits. This legislative update is intended to progressively realise the human right to the highest attainable standard of physical and mental health, as outlined in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2014 (No.5) is a legislative instrument under the National Health Act 1953, specifically tailored to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010. This instrument applies to eligible persons who are members of authorised associations and have paraplegia or quadriplegia. These individuals are entitled to pharmaceutical benefits under the special arrangement, which is aimed at providing them with necessary medications and treatments. The geographic scope of this Act is national, as it pertains to the overall pharmaceutical benefits scheme managed under Commonwealth legislation. The Act does not specify any exclusions or thresholds beyond those defined in the Health Insurance Act 1973 and the National Health Act 1953. The instrument facilitates the inclusion of a new listed brand of the drug Macrogol 3350, Molaxole, which has been added to Schedule 1 of the Special Arrangement, thereby extending the pharmaceutical options available to eligible persons. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring alignment with current pharmaceutical practices and recommendations.

Key Provisions

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2014 (No.5) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (subsection 100(1) of the National Health Act 1953). The primary amendment is the inclusion of a new listed brand of the drug Macrogol 3350, Molaxole, in Schedule 1 of the Special Arrangement (section 2). This change reflects the updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (section 3). These legislative amendments aim to enhance the availability and accessibility of pharmaceutical benefits under the Paraplegic and Quadriplegic Program, ensuring that eligible persons, defined as those with paraplegia or quadriplegia who are members of authorised associations and eligible for Medicare benefits, have access to essential medications. The amended Act imposes obligations on authorised associations to supply pharmaceutical benefits to eligible persons in accordance with the updated Special Arrangement (section 2). It also mandates that these associations comply with the new listing of Molaxole in Schedule 1, ensuring that this drug is available for eligible persons as part of their pharmaceutical benefits package. The Act further requires that the Pharmaceutical Benefits Advisory Committee (PBAC) continue its role in recommending changes to the Pharmaceutical Benefits Scheme (PBS) and that these recommendations align with the criteria of clinical effectiveness, safety, and cost-effectiveness. There are no specific offences or penalties outlined in this legislative instrument for non-compliance with the amended Special Arrangement. However, any breach of the National Health Act 1953 or its associated regulations could result in legal action. The penalties for such breaches may include fines and other civil or criminal consequences as stipulated in the relevant sections of the Act. The maximum penalties would depend on the specific nature and severity of the breach, as well as any applicable regulations or subsidiary legislation. The legislative instrument ensures that the amendments are consistent with the human rights and freedoms recognised or declared in the International Covenant on Economic, Social and Cultural Rights (ICESCR) (section 6). By advancing the right to the highest attainable standard of physical and mental health through the provision of subsidised access to medicines via the PBS, the instrument supports the progressive realisation of these rights. The involvement of the PBAC in decision-making ensures that these recommendations are evidence-based, thereby reinforcing the protection of human rights within the healthcare framework.