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 29 of 2010)

Overview

The National Health Act 1953 was enacted to provide a legislative framework for the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have reliable, timely, and affordable access to a wide range of medicines. This Act addresses the gap in ensuring that all listed drugs under the PBS are correctly identified in terms of their pharmaceutical form to avoid any administrative errors that could affect the provision of pharmaceutical benefits. The Australian Parliament enacted this legislation to establish the PBS and ensure the correct administration of pharmaceutical benefits. The policy objective is to provide accurate information regarding the form of pharmaceutical benefits, ensuring that patients receive the correct medication. The explanatory statement relates to an amendment declaration made under subsections 85(2) and 85(2AA) and an amendment determination under subsection 85(2A) of the Act. The amendment corrects an administrative oversight concerning the form of the drug dabigatran etexilate, which was incorrectly described as a tablet rather than a capsule in a previous instrument. The amendment aims to ensure the correct administration and billing of pharmaceutical benefits related to this drug.

Scope and Application

The National Health Act 1953, as amended, provides the legislative framework for the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth ensures Australians have access to reliable, timely, and affordable medicines. The Act applies to the Minister for Health who, by legislative instrument, declares drugs and medicinal preparations available as pharmaceutical benefits and specifies the circumstances and conditions for prescribing these benefits. This includes determining the form of the drug, the manner of administration, and the brand. The Act applies nationally across Australia, and its provisions extend to both listed drugs and certain extemporaneously-prepared medicinal preparations. While the Act provides broad coverage, there are exclusions and exemptions, particularly for drugs not listed under the PBS or those prepared extemporaneously outside the scope defined by the Minister. The application of the Act can be further refined or extended through subordinate instruments made by the Minister. This particular amendment corrects an oversight in the description of the form of a listed drug, dabigatran etexilate, ensuring it is accurately described as capsules rather than tablets.

Key Provisions

The main operative sections of this instrument are subsections 85(1), 85(2), 85(2AA), and 85(3) of the National Health Act 1953. Subsection 85(1) outlines that pharmaceutical benefits are to be provided by the Commonwealth in accordance with Part VII of the Act. Subsection 85(2) states that the Minister declares listed drugs and medicinal preparations by legislative instrument. Subsection 85(2AA) allows the Minister to revoke or vary a declaration made under subsection 85(2) by legislative instrument. Subsection 85(3) empowers the Minister to determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise. The instrument amends the principal instrument before it commences by correcting the description of the type of unit for the listed drug dabigatran etexilate from “tablet” or “tablets” to “capsule” or “capsules”. The Minister, by this amending instrument, is correcting an oversight in the previous legislative instrument, PB 14 of 2010. The amendment is effective before the commencement of PB 14 of 2010, which is 1 April 2010. The Act imposes obligations and requirements on the Minister for Health and Aged Care to ensure that the Pharmaceutical Benefits Scheme operates effectively. The Minister is responsible for declaring listed drugs and medicinal preparations and determining the form or forms of a listed drug. The Minister must also ensure that the correct type of unit is described for each listed drug. The responsible person that supplies the listed drug must ensure that they are supplying the correct form of the drug. Medicare Australia must also ensure that payments for the supply of these pharmaceutical benefits are administered correctly. There are no specific offences, penalties, or civil/criminal consequences for breach stated in the instrument. However, the Minister may face scrutiny or criticism for the administrative oversight that led to the incorrect description of the type of unit for dabigatran etexilate in the principal instrument. The responsible person that supplies the drug and Medicare Australia may also face administrative or financial consequences if they fail to comply with the correct description of the type of unit. The Minister's power to revoke or vary a declaration under subsection 85(2AA) may also be used as a consequence for non-compliance with the correct description of the type of unit. In summary, this amending instrument corrects an administrative oversight in the principal instrument, PB 14 of 2010, by changing the description of the type of unit for the listed drug dabigatran etexilate from “tablet” or “tablets” to “capsule” or “capsules”. The Minister for Health and Aged Care is responsible for ensuring that the Pharmaceutical Benefits Scheme operates effectively, including ensuring that the correct type of unit is described for each listed drug. There are no specific offences, penalties, or civil/criminal consequences for breach stated in the instrument, but there may be administrative or financial consequences for the responsible person that supplies the drug and Medicare Australia if they fail to comply with the correct description of the type of unit.