National Health Act 1953 - Amendment determination under section 85B - price determinations and special patient contributions (No. PB 57 of 2010)

Overview

The National Health Act 1953, amended by legislative instrument PB 57 of 2010, addresses the gap in the Pharmaceutical Benefits Scheme (PBS) where the Minister and responsible persons for certain brands of pharmaceutical items could not reach a price agreement for the sale of these items to approved pharmacists. This legislation empowers the Minister to determine the appropriate maximum price and the responsible person's price for these items by reference to a quantity or number of units. The instrument also defines the Special Patient Contribution as the difference between the Commonwealth price and the responsible person's price, and sets out circumstances under which the Commonwealth may pay this contribution. The amendment, effective from 1 July 2010, follows recommendations from the Pharmaceutical Benefits Advisory Committee and removes certain brands from the PBS where a special patient contribution no longer applies.

Scope and Application

The National Health Act 1953, as amended by the instrument F2010L01635, applies to the Pharmaceutical Benefits Scheme (PBS) administered by the Commonwealth to ensure Australians have reliable, timely, and affordable access to a wide range of medicines. The Act, specifically under Part VII, pertains to the listing of drugs and medicinal preparations by the Minister, who declares these as pharmaceutical benefits through legislative instruments. These instruments also determine the forms of listed drugs, their administration, and the brands that meet the criteria. When the Minister and the responsible person for a brand of pharmaceutical item cannot agree on the appropriate maximum price, the Minister can determine this price under section 85B of the Act. The instrument in question amends a previous determination, made effective from 1 April 2010, to delete brands of pharmaceutical items where a special patient contribution no longer applies, reflecting the recommendations of the Pharmaceutical Benefits Advisory Committee. This legislative instrument, which commenced on 1 July 2010, involves consultation with certain responsible persons whose medicines are listed on the PBS, ensuring the PBS operates effectively within the legislative framework.

Key Provisions

The key operative sections of the National Health Act 1953 Amendment Determination (PB 57 of 2010) (the Determination) are primarily concerned with amendments to the Pharmaceutical Benefits Scheme (PBS) under section 85B. This section allows the Minister to make determinations regarding the appropriate maximum price for sales of a brand of pharmaceutical item to approved pharmacists when the Minister and the responsible person cannot agree on a price (subsection 85B(2)). Additionally, subsection 85B(3) allows the Minister to determine the amount the responsible person claims as their price for sales of the brand of pharmaceutical item to approved pharmacists. The Determination also addresses the calculation of the special patient contribution (subsection 85B(4)), which is the difference between the Commonwealth price and the price claimed by the responsible person. This instrument amends the determination under section 85B made by legislative instrument number PB 18 of 2010, which came into effect on 1 April 2010, by deleting brands of pharmaceutical items where a special patient contribution no longer applies. The Determination imposes specific obligations on the Minister and responsible persons regarding pharmaceutical items listed on the PBS. Under section 85B, the Minister is required to determine the appropriate maximum price for sales of a brand of pharmaceutical item to approved pharmacists if an agreement cannot be reached with the responsible person. Furthermore, the Minister must also determine the price claimed by the responsible person. These obligations ensure that there is a clear and transparent process for setting prices within the PBS, thereby maintaining the scheme's integrity and affordability. In terms of consequences for non-compliance, the Act does not explicitly outline offences or penalties for breaches related to the Determination. However, it is understood that failure to comply with the provisions of the Act and its regulations could potentially lead to civil or criminal liabilities, depending on the nature and severity of the breach. The National Health Act 1953 and associated regulations provide a framework within which these potential consequences would be addressed, although specific penalties are not detailed in the Determination itself. Compliance with these provisions is essential to uphold the integrity and effectiveness of the PBS, ensuring that Australians have reliable access to affordable medicines.