National Health Act 1953 - Amendment determination under section 85B - price determinations and special patient contributions (No. PB 127 of 2008)

Overview

The National Health Act 1953 Amendment Determination (No. 1) 2008 (F2008L04638) was enacted to address the problem of reaching price agreements between the Minister for Health and responsible persons for certain pharmaceutical brands listed under the Pharmaceutical Benefits Scheme (PBS). The PBS is a fundamental part of the Act, ensuring Australians have reliable and affordable access to medicines. The determination allows the Minister to set the appropriate maximum price and the price claimed by the responsible person for sales of certain pharmaceutical brands to approved pharmacists when a price agreement cannot be reached. The objective of this legislative instrument is to give effect to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The instrument, which commenced on 1 January 2009, amends the earlier determination made under section 85B, specifying changes to the listed drugs and forms of certain medications, such as the deletion of Piperazine Oestrone and Tamoxifen 10 mg (as citrate) (Nolvadex) from the list. This determination was made by the Parliament of Australia to ensure the continued effective operation of the PBS in light of pricing disagreements.

Scope and Application

The National Health Act 1953 Amendment Determination under Section 85B, implemented by the legislative instrument number PB 127 of 2008, pertains to the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have reliable, timely, and affordable access to a broad range of medicines. This Act applies to all persons and entities involved in the manufacture, distribution, and sale of pharmaceutical items listed on the PBS, including drug companies and pharmacists. It has a national jurisdictional reach as it is a Commonwealth Act. The Act allows the Minister to determine the form, administration, and brand of a listed drug, thereby governing the pharmaceutical benefits provided under Part VII. The Act also allows the Minister to determine the maximum price for sales of a pharmaceutical brand to pharmacists and the special patient contribution when a price agreement cannot be reached. The amendments to the determination under section 85B, as detailed in Schedule 1, involve the deletion of certain listed drugs and forms, reflecting the ongoing evaluation and adjustments within the PBS framework.

Key Provisions

The key operative sections of this legislation, specifically the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953, require the Minister to declare by legislative instrument which drugs and medicinal preparations are subject to the PBS. These are listed drugs, as defined in subsection 84(1), with the exception of some medicinal preparations with additives. The Minister can determine the form of these listed drugs, the manner of administration, and the brands under subsections 85(2), 85(3), 85(5), and 85(6) respectively. These declarations and determinations are essential in defining what constitutes the pharmaceutical benefit under Part VII of the Act. The Act imposes specific obligations on the Minister and the responsible persons for pharmaceutical brands. The Minister must engage in consultations with responsible persons if an agreement on the price of a pharmaceutical item cannot be reached. This is outlined in section 85B(1) where it states that if the Minister and the responsible person cannot reach an agreement on the appropriate maximum price for sales of the brand of pharmaceutical item to approved pharmacists, the Minister can make a determination by legislative instrument. Additionally, under subsection 85B(3), the Minister can determine the amount that is to be taken as the price claimed by the responsible person for sales of the brand of the pharmaceutical item to approved pharmacists. The responsible person, on the other hand, must provide the necessary information and cooperate in the determination process to ensure the smooth functioning of the PBS. Breaching the obligations imposed by the Act can lead to significant consequences. While the explanatory statement does not explicitly detail the penalties for non-compliance, it is reasonable to infer that any failure to adhere to the Minister's determinations or obligations could result in legal ramifications. Such breaches may be subject to penalties as outlined in other sections of the National Health Act 1953 or related legislation, although the specific penalties are not mentioned here. These penalties could include fines, administrative sanctions, or other enforcement actions depending on the severity and nature of the breach. Furthermore, non-compliance could also have implications for the availability and affordability of medicines under the PBS, potentially affecting patient access to necessary treatments.