EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 68 OF 2011
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 98C(1)(b) made by legislative instrument number PB 119 of 2008 which came into effect on
1 December 2008. The amendments provide for changes to the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The amendments are set out in the items of Schedule 1 to the instrument.
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument constitutes a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This instrument commences on 1 October 2011.
Consultations
The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme. The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 October 2011.
Paragraph 2: provides that Schedule 1 amends PB 119 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Amendment of Form
Degarelix | From: Powder for injection 120 mg (as acetate) with solvent, syringe and needles, 2 To: Powder for injection 120 mg (as acetate), 2, injection set |
Overview
The National Health Act 1953, enacted by the Australian Parliament, establishes the legislative basis for the Pharmaceutical Benefits Scheme (PBS). This scheme aims to provide Australians with reliable, timely, and affordable access to a wide range of medicines. The Act, through its various sections, outlines the process for determining which drugs and medicinal preparations are eligible for benefits and the conditions under which these benefits are provided. Specifically, section 98C(1)(b) empowers the Minister to determine the conditions for payments related to the supply of pharmaceutical benefits by approved pharmacists and medical practitioners. This legislative instrument, F2011L01986, amends the determination made under section 98C(1)(b) to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent body comprising experts from various health-related fields, evaluates applications and advises the Minister on which medicines should be subsidised under the PBS. The amendments aim to update the conditions for payments, ensuring the scheme remains effective and responsive to contemporary healthcare needs. This instrument commences on 1 October 2011, following consultation with the PBAC and relevant stakeholders.
Scope and Application
The instrument, F2011L01986, pertains to amendments of the National Health Act 1953, specifically concerning the Pharmaceutical Benefits Scheme (PBS). It applies to all entities and individuals involved in the supply of pharmaceutical benefits, including approved pharmacists and approved medical practitioners, and it pertains to the conditions under which the Commonwealth will make payments for such supplies. The Act applies nationally, as it is a Commonwealth Act, and its amendments are effective across all states and territories of Australia. The amendments in this instrument are primarily focused on the technical details of certain pharmaceutical products, such as the form and administration of drugs, and they are subject to the broader legislative framework of the National Health Act 1953. The instrument does not exclude any specific entities or transactions but rather adjusts the conditions for payments made under the PBS, ensuring that the scheme remains effective and responsive to recommendations from the Pharmaceutical Benefits Advisory Committee. The instrument itself comes into effect on 1 October 2011, with the changes being applicable from this date.
Key Provisions
The main operative sections of this legislative instrument pertain to the amendment of the conditions under which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. These amendments are outlined in Schedule 1 of the instrument and came into effect on 1 October 2011. Specifically, the amendments alter the conditions under which pharmaceutical benefits are supplied, focusing on the form and details of certain medications, such as Degarelix, which is now specified as a powder for injection without the inclusion of syringes and needles. This change reflects the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and is detailed in the explanatory statement accompanying the instrument.
The Act imposes several obligations on parties involved in the Pharmaceutical Benefits Scheme (PBS). Approved pharmacists and approved medical practitioners must comply with the conditions set out in the determination for them to be eligible for Commonwealth payments. These conditions govern the supply of pharmaceutical benefits, including the specific forms and manners of administration for listed drugs. The Minister, as per section 84AF of the Act, is responsible for determining the responsible person for a brand of a pharmaceutical item, ensuring accountability and adherence to the provisions of the Act.
Failure to comply with the conditions set out in the Act may result in civil or criminal consequences. While the instrument does not specify exact penalties, breaches of the Pharmaceutical Benefits Scheme can typically result in substantial fines and, in severe cases, imprisonment. The specific penalties are usually detailed in the main Act or in related regulations, which might impose varying fines and penalties depending on the nature and severity of the breach. For instance, under the National Health Act 1953, there are provisions for both civil penalties and criminal offences that could apply to significant non-compliance, reflecting the serious nature of ensuring the integrity and effectiveness of the PBS.