EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 41 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)
AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)
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 in relation to which Part VII applies are declared by the Minister by legislative instrument as such under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
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 (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Subsection 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation.
Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee (PBAC). Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA). Subsection 101(4) further provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared.
This legislative instrument in giving effect to recommendations of the PBAC amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 88 of 2007 which came into effect on 1 December 2007. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 May 2008, was made on 2 April 2008.
Consultations
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 May 2008.
Paragraph 2: provides that Schedule 1 amends PB 88 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drugs
Lapatinib
Lercanidipine with enalapril
Risedronic acid and calcium with colecalciferol
Alteration of Circumstances
Flucloxacillin [addition of powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL]
Macrogol 3350
SCHEDULE 2
Alteration of Circumstances
Flucloxacillin [addition of powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL]
SCHEDULE 3
Addition of Allowable Compounds
Calcium with colecalciferol
Lercanidipine with enalapril
Overview
The National Health Act 1953, as amended by the legislation F2008L01027, aims to provide reliable, timely, and affordable access to a wide range of medicines for all Australians through the Pharmaceutical Benefits Scheme (PBS). This Act is overseen by the Australian Parliament and establishes the legal framework for the Commonwealth to provide pharmaceutical benefits as outlined in Part VII. The 2008 amendment, effective from 1 May 2008, introduces changes to the listed drugs, allowable compounds, and specific circumstances under which certain drugs can be administered, based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). These amendments were designed to address gaps in the availability of certain medications on the PBS and ensure the scheme remains responsive to the medical needs and safety standards of the population.
The PBAC, an independent expert body, plays a crucial role in this legislative process by recommending to the Minister which drugs and medicinal preparations should be added to or removed from the PBS. This recommendation process involves extensive consultation with various stakeholders and takes into account factors such as the clinical effectiveness, safety, and cost-effectiveness of the medications. The 2008 amendment, incorporating the PBAC's advice, adds new drugs like Lapatinib, Lercanidipine with enalapril, and Risedronic acid with calcium and colecalciferol to the PBS, and modifies the administration conditions for certain drugs like Flucloxacillin. These changes are aimed at enhancing the accessibility and effectiveness of the PBS, ensuring that Australians have access to necessary medications that meet high standards of safety and efficacy.
Scope and Application
The National Health Act 1953, as amended, pertains to the Pharmaceutical Benefits Scheme (PBS) which facilitates affordable access to a wide range of medicines for Australians. Under this Act, the Commonwealth provides pharmaceutical benefits in accordance with Part VII, which applies to drugs and medicinal preparations declared by the Minister as listed drugs, as well as to certain extemporaneously-prepared medicinal preparations. The Minister has the authority to determine the form, manner of administration, and brand of listed drugs through legislative instruments. Any revocation or variation of these declarations must be preceded by advice from the Pharmaceutical Benefits Advisory Committee (PBAC), which must be tabled in Parliament. The amendments to the PBS, as set out in Schedules 1 to 3, include the addition of new listed drugs and allowable compounds, as well as alterations to the circumstances under which certain drugs can be listed.
The amendments to the PBS apply nationally across Australia and extend to the specified drugs and compounds listed in the schedules of the instrument. The changes to the PBS are intended to ensure that the scheme continues to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. This legislative instrument, which came into effect on 1 May 2008, reflects the recommendations of the PBAC, which is composed of experts from various fields relevant to the functions of the committee.
Key Provisions
The National Health Act 1953 (the Act) sets out the legislative basis for the Pharmaceutical Benefits Scheme (PBS), as detailed in Part VII. Section 85(1) outlines the primary provision for the Commonwealth to supply pharmaceutical benefits to Australians, ensuring reliable, timely, and affordable access to medicines. The Act allows the Minister to declare drugs and medicinal preparations under subsection 85(2), listing them as pharmaceutical benefits, which are then subject to the provisions of Part VII. These declarations include specified drugs as defined in subsection 84(1). Furthermore, certain extemporaneously-prepared medicinal preparations are covered under paragraph 85(2)(b). The Minister can also determine the form, administration, and brand of a listed drug through legislative instruments, as specified in subsections 85(3), 85(5), and 85(6). These determinations are crucial for defining what constitutes a pharmaceutical benefit under the Act.
The obligations imposed by the Act require the Minister to follow a formal process for declaring and determining the form of listed drugs. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a vital role in this process, providing recommendations to the Minister on which drugs should be listed as pharmaceutical benefits. The Minister must consider these recommendations, as stipulated in subsection 101(4), and obtain written advice from the PBAC before revoking or varying a declaration under subsection 85(2AA). This advice must be tabled in Parliament, as outlined in subsection 85(2AC). The PBAC, composed of experts from various fields, ensures that decisions are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness.
Non-compliance with the provisions of the National Health Act 1953 can result in significant legal consequences. While the Act does not explicitly detail penalties for breaches, any failure to adhere to the declared provisions or the recommendations of the PBAC could lead to civil or criminal consequences. This may include legal action for non-compliance with the legislative instrument, leading to fines or other penalties as prescribed by the relevant legislation. Additionally, any actions that undermine the integrity of the PBS could be subject to scrutiny and enforcement actions by the relevant authorities.
This legislative instrument, effective from 1 May 2008, amends previous declarations and determinations made under PB 88 of 2007. The amendments, detailed in Schedule 1, include the addition of new listed drugs such as Lapatinib, Lercanidipine with enalapril, and Risedronic acid with calcium and colecalciferol. Schedule 2 and Schedule 3 further detail alterations to the circumstances of existing drugs and the addition of allowable compounds, ensuring the PBS remains comprehensive and up-to-date with the latest medical and pharmaceutical developments.