National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - Amendment determination under subsection 85(2A) - drugs and medicinal preparations (No. PB 128 of 2009)

Overview

The National Health Act 1953, amended in 2009 by the legislative instrument F2010L00099, serves to regulate the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth ensures accessible, reliable, and affordable medicines for all Australians. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in this process by recommending to the Minister which drugs and medicinal preparations should be listed as pharmaceutical benefits. This legislative instrument gives effect to these recommendations by amending declarations and determinations regarding the list of drugs available under the PBS and the conditions under which these benefits may be prescribed. The instrument was made on 21 December 2009 and commenced on 1 February 2010, amending previous legislative instruments such as PB 113 of 2008. The amendments include the deletion of certain drugs, alterations in the circumstances of drug prescription, and adjustments to the allowable compounds, all aimed at refining the scope and application of pharmaceutical benefits available under the PBS.

Scope and Application

The National Health Act 1953 Amendment Instrument, numbered PB 128 of 2009, amends the Pharmaceutical Benefits Scheme (PBS) by modifying the list of drugs and medicinal preparations eligible for pharmaceutical benefits, as well as the conditions under which these benefits can be prescribed. The amendments, which came into effect on 1 February 2010, are made pursuant to subsections 85(2) and 85(2AA) of the Act, and they follow recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This committee, consisting of experts from various relevant fields, advises the Minister on which drugs should be listed on the PBS. The amendments include the deletion of certain drugs, such as bifonazole and silver sulfadiazine with chlorhexidine, and the alteration of prescription conditions for others, like glucose indicator—blood and hydromorphone. The Act applies to all Australians who access the PBS, thereby influencing the availability and affordability of medications within the Commonwealth. The instrument also allows for the revocation or variation of previous declarations, ensuring the PBS remains responsive to changes in medical and economic conditions.

Key Provisions

The National Health Act 1953 (the Act) and its amendments, as evidenced in the Explanatory Statement, primarily govern the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and timely medicines. The Act, through sections such as 85(1), 85(2), and 85(2AA), establishes the framework for the Commonwealth to provide pharmaceutical benefits. Specifically, subsection 85(1) mandates that the Commonwealth furnish benefits in accordance with Part VII of the Act. Subsection 85(2) allows the Minister to declare drugs and medicinal preparations that are eligible for the PBS by legislative instrument, while subsection 85(2AA) empowers the Minister to revoke or vary these declarations. The form, manner of administration, and brand of the pharmaceutical items are determined under subsections 85(3), 85(5), and 85(6) respectively. The obligations imposed by the Act include the requirement for the Minister to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) before making significant changes to the PBS list. The PBAC, as outlined in section 100A, is an expert body comprising representatives from various sectors including consumers, health economists, and medical professionals. This committee recommends which drugs should be listed on the PBS based on criteria such as clinical effectiveness, safety, and cost-effectiveness. The Minister must obtain written advice from the PBAC before revoking or varying a drug listing, as stipulated in subsection 85(2AB), and table this advice in Parliament as per subsection 85(2AC). Additionally, a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) unless the PBAC has recommended it, as per subsection 101(4). Failure to comply with the requirements of the Act can result in civil or criminal consequences. For instance, if the Minister does not follow the necessary consultation process with the PBAC, or if the PBAC's recommendations are ignored, these actions could potentially lead to legal challenges or penalties under the relevant provisions of the Act. However, the specific penalties for such breaches are not detailed in the provided text, but they may include fines or other sanctions as prescribed by law. The amendments to the PBS list and the circumstances under which pharmaceutical benefits may be prescribed are detailed in Schedule 1 to the instrument, reflecting the changes made to better align the PBS with current medical needs and economic considerations.