National Health (Pharmaceutical Benefits) Amendment Regulations 2000 (No. 1) 2000 No. 369
EXPLANATORY STATEMENT
STATUTORY RULES 2000 No. 369
Issued by Authority of the Minister for Health and Aged Care
National Health Act 1953
National Health (Pharmaceutical Benefits) Amendment Regulations 2000 (No. 1)
Section 140 of the National Health Act 1953 ("the Act") provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Subsection 100B(1A) of the Act provides that a person appointed under subsection 100A(3) of the Act as a member of the Pharmaceutical Benefits Advisory Committee ("the Committee") must be appointed from nominations made by bodies prescribed by the regulations for the purposes of the subsection. Eight of the twelve members of the Committee are to be appointed under subsection 100A(3).
Subsection 100B(1B) of the Act provides that the regulations may prescribe matters relating to nominations, including (but not limited to) the number of nominations to be considered by the Minister before making an appointment.
The National Health (Pharmaceutical Benefits) Regulations 1960 have been amended to prescribe the bodies that may nominate persons for selection for appointment as members of the Committee, to prescribe matters relating to nominations, and to make some other amendments as a consequence of the passage of the National Health Amendment (Improved Monitoring of Entitlements to Pharmaceutical Benefits) Act 2000.
The Regulations prescribe a number of consumer organisations and professional associations, to facilitate the nomination of a broad spectrum of persons of appropriate experience and expertise. The Regulations also provide that each of these bodies must be asked to nominate, at least three persons.
Details of the Regulations are in the Attachment.
The Regulations commenced on the date of commencement of Schedule 2 to the National Health Amendment (Improved Monitoring of Entitlements to Pharmaceutical Benefits) Act 2000, namely 1 January 2001.
ATTACHMENT
Regulation 1 of the amending regulations provides that the name of the amending regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 2000 (No. 1).
Regulation 2 of the amending regulations provides that the amending regulations will commence on the commencement of Schedule 2 to the National Health Amendment (Improved Monitoring of Entitlements to Pharmaceutical Benefits) Act 2000.
Regulation 3 of the amending regulations provides that the National Health (Pharmaceutical Benefits) Regulations 1960 will be amended as set out in Schedule 1.
Item 1 of the Schedule amends the definition of "Committee" as a consequence of an amendment to the Act whereby it is now established under section 100A of the Act.
Item 2 of the Schedule inserts new regulations 38A and 38B. Regulation 38A prescribes the bodies that may make nominations from which the Minister will select members of the Committee under subsection 100A(3) of the Act. It sets out the names of the bodies relating to each of the groups specified in paragraphs 100A(3)(a) to (f) of the Act. Regulation 38B provides that each of the bodies prescribed in regulation 38A is to be asked to nominate at least 3 persons for selection.
Item 3 of the Schedule omits the previous regulation 40 and substitutes a new regulation 40 providing that the Chairperson of the Committee may resign as Chairperson, and that members of the Committee may resign, by notice in writing given to the Minister. The amendment takes account of the fact that all members of the Committee are now appointed by the Minister.
Item 4 of the Schedule omits regulation 48 as a consequence of amendments to the Act. Provisions governing the remuneration of members of the Committee are now included in section 100D of the Act.
Overview
The National Health (Pharmaceutical Benefits) Amendment Regulations 2000 (No. 1) were introduced to address the need for enhanced governance and expertise within the Pharmaceutical Benefits Advisory Committee (PBAC) under the National Health Act 1953. Enacted by authority of the Minister for Health and Aged Care, these regulations were intended to refine the process by which members of the PBAC are nominated and appointed, ensuring a broader representation of experienced and expert individuals. The regulations amended the National Health (Pharmaceutical Benefits) Regulations 1960 to prescribe the bodies eligible to nominate candidates for PBAC membership and to require these bodies to nominate at least three individuals each. The primary objective of these amendments was to improve the monitoring of entitlements to pharmaceutical benefits by enhancing the diversity and expertise of the PBAC, thereby better serving the interests of the National Health Act.
Scope and Application
The National Health (Pharmaceutical Benefits) Amendment Regulations 2000 (No. 1) pertains to the regulation of appointments to the Pharmaceutical Benefits Advisory Committee, established under the National Health Act 1953. The Regulations apply to the entities and individuals involved in the nomination process for the Committee's members, including various consumer organisations and professional associations. These regulations are necessary to facilitate the nomination of individuals with suitable experience and expertise for Committee membership. The scope of the Regulations is confined to the specific requirements for nominations, including the number of nominees each body must provide. The Regulations have a national reach, as they are part of the broader legislative framework under the Commonwealth of Australia. There are no stated exclusions or exemptions within the Regulations themselves, but the overarching Act and any subsequent amendments or subordinate legislation may impose additional conditions or restrictions. The Regulations came into effect on 1 January 2001, aligning with the commencement of Schedule 2 of the National Health Amendment (Improved Monitoring of Entitlements to Pharmaceutical Benefits) Act 2000.
Key Provisions
The National Health (Pharmaceutical Benefits) Amendment Regulations 2000 (No. 1) (the "Regulations") were made under the authority of the National Health Act 1953 ("the Act") to amend the National Health (Pharmaceutical Benefits) Regulations 1960. These Regulations were designed to ensure the Pharmaceutical Benefits Advisory Committee (the "Committee") is comprised of suitably qualified individuals, selected through a prescribed process. Regulation 38A (item 2 of Schedule 1) prescribes the bodies that can make nominations for members of the Committee, ensuring a broad representation from consumer organisations and professional associations. These bodies are expected to nominate at least three individuals, as outlined in Regulation 38B. The Regulations also address the process for resignations, allowing both the Chairperson and Committee members to resign by providing written notice to the Minister, as specified in Regulation 40 (item 3 of Schedule 1).
Under the Regulations, various obligations are imposed on the prescribed bodies and the Minister for Health and Aged Care. The prescribed bodies must ensure that they nominate at least three individuals for each group specified in the Regulations, fostering diversity and expertise within the Committee. The Minister, on the other hand, is required to consider the nominations received from these bodies and make appointments from them, as mandated by subsection 100B(1A) of the Act. Additionally, Regulation 40 allows for the orderly resignation process of the Chairperson and Committee members, providing a mechanism for changes within the Committee.
Failure to comply with the Regulations could lead to various consequences. While the Regulations do not explicitly detail offences or penalties for non-compliance, breaches of the Act or its subsidiary legislation could result in legal actions. The Minister may face scrutiny if they fail to adhere to the prescribed nomination process or if they do not consider the required number of nominees. Similarly, prescribed bodies may face reputational damage or legal consequences if they do not fulfill their obligations under the Regulations. Although specific penalties are not outlined in the Regulations, any breaches could potentially result in civil or criminal penalties under the broader framework of the Act.