EXPLANATORY STATEMENT
Select Legislative Instrument 2006 No. 121
Minute No. 15 of 2006 – Minister for Health and Ageing
Subject: National Health Act 1953
National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 1)
Subsection 140(1) 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.
The National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) prescribe matters relating to Part VII of the Act. Part VII of the Act regulates the Pharmaceutical Benefits Scheme, which provides for the supply of drugs and medicinal preparations as pharmaceutical benefits.
The Regulations would amend the Principal Regulations to reflect amendments to be made to the Act by the Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006 (the Amendment Act). Part 1 of Schedule 2 to the Amendment Act will make amendments to the Act by providing the Minister with a discretionary power (under section 90A of the Act) to substitute a decision of the Secretary (under section 90 of the Act) not to approve a pharmacist to supply pharmaceutical benefits at or from particular premises, with a decision to approve the pharmacist. Subsection 2(1) of the Amendment Act provides that Schedule 2 to the Amendment Act will commence on 1 July 2006.
The purpose of the Regulations is to amend regulation 8A of the Principal Regulations to provide that if the Minister exercises his or her discretionary power and approves a pharmacist to supply pharmaceutical benefits, the Minister may allot a number to that approval. This would be consistent with the existing subregulations 8A(1) and (1A) which provide for the allotment of a number by the Secretary to an approval under sections 84A, 90, 91 or 92 of the Act to supply pharmaceutical benefits.
Details of the proposed Regulations are set out in the Attachment.
The Act does not specify any conditions that need to be met before the power to make the proposed Regulations may be exercised.
The Regulations would be a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulations would commence on 1 July 2006 to coincide with the commencement of Schedule 2 to the Amendment Act, which received Royal Assent on 3 May 2006.
Medicare Australia has been consulted on this matter. Medicare Australia has the delegated responsibility for allotting numbers under regulation 8A to approvals to supply pharmaceutical benefits, and would therefore be responsible for allotting numbers to approvals granted by the Minister under these new arrangements.
Authority: Subsection 140(1) of the National Health Act 1953
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) AMENDMENT REGULATIONS 2006 (No. 1).
Regulation 1 will provide that the Regulations may be referred to as the National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 1).
Regulation 2 will provide for the Regulations to commence on 1 July 2006.
Regulation 3 will provide that the National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) are amended as set out in Schedule 1.
Schedule 1 – Amendment
Item [1] – subregulation 8A(1B)
This item inserts a new subregulation 8A(1B) into the Principal Regulations. The new subregulation applies where the Minister decides to substitute for a decision of the Secretary not to approve a pharmacist under section 90 of the National Health Act 1953 (the Act), a decision to approve the pharmacist under subsection 90A(2) of the Act.
The new subregulation 8A(1B) provides that if the Minister approves a pharmacist under subsection 90A(2), the Minister may allot a number to that approval.
Overview
The National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 1) were introduced to address the need for regulatory updates in line with legislative amendments provided by the Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006. This set of regulations, enacted by the Minister for Health and Ageing, aims to ensure the smooth implementation of the new legislative framework concerning the Pharmaceutical Benefits Scheme under the National Health Act 1953. Specifically, the regulations amend the National Health (Pharmaceutical Benefits) Regulations 1960 to reflect the new discretionary power granted to the Minister to approve pharmacists for supplying pharmaceutical benefits, allowing the Minister to allot a number to such approvals. This aligns with existing provisions for allotment of numbers by the Secretary, facilitating a consistent approach to managing approvals under the scheme. The regulations are designed to commence on 1 July 2006, the same date as the commencement of the relevant amendments to the Act, ensuring cohesive operation across the legislative and regulatory frameworks.
Scope and Application
The National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 1) are an extension of the National Health Act 1953, specifically tailored to modify the National Health (Pharmaceutical Benefits) Regulations 1960. This legislation applies to pharmacists who seek to supply pharmaceutical benefits, with the Minister for Health and Ageing having the authority to approve or disapprove such supply at particular premises. This amendment is prompted by the Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006, which grants the Minister a discretionary power to substitute a decision of the Secretary not to approve a pharmacist under section 90 of the Act with a decision to approve the pharmacist under subsection 90A(2) of the Act. The Regulations come into effect on 1 July 2006, aligning with the commencement of Schedule 2 to the Amendment Act. Medicare Australia, responsible for allotting numbers under regulation 8A to approvals for supplying pharmaceutical benefits, will also handle the allotment of numbers to approvals granted by the Minister under these new arrangements.
Key Provisions
The National Health (Pharmaceutical Benefits) Amendment Regulations 2006 (No. 1) introduce specific provisions under the National Health Act 1953. These Regulations amend the National Health (Pharmaceutical Benefits) Regulations 1960 (referred to as the Principal Regulations) to align with the Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006. The main operative sections of these Regulations focus on modifying the approval process for pharmacists supplying pharmaceutical benefits. Regulation 3 of the Amendment Regulations specifies that the Principal Regulations are amended as outlined in Schedule 1 (paragraph 2). Schedule 1, in turn, details the specific changes to regulation 8A of the Principal Regulations. This amendment allows the Minister, when exercising their discretionary power under section 90A of the Act, to approve a pharmacist to supply pharmaceutical benefits and allot a number to that approval (Schedule 1, Item [1]). This is consistent with existing provisions under subregulations 8A(1) and 8A(1A), which allow for the allotment of a number by the Secretary for approvals under sections 84A, 90, 91, or 92 of the Act.
The obligations imposed by these Regulations primarily concern the Minister’s discretionary power and the allotment of numbers to approvals. When the Minister substitutes a decision of the Secretary not to approve a pharmacist, they must ensure that any approval granted includes the allotment of a number to that approval (Schedule 1, Item [1]). This process aligns with the existing framework for allotment of numbers by the Secretary, ensuring a consistent approach to the administration of approvals under the Pharmaceutical Benefits Scheme. Furthermore, Medicare Australia, which has the delegated responsibility for allotting numbers under regulation 8A, will be responsible for allotting numbers to approvals granted by the Minister under these new arrangements (Attachment).
The Regulations also outline the consequences for non-compliance. While the explanatory statement does not specify any offences, penalties, or civil or criminal consequences for breach, it is implied that adherence to the Regulations is necessary to maintain the integrity of the Pharmaceutical Benefits Scheme. The Minister’s discretionary power to approve pharmacists and allot numbers to those approvals is a significant administrative function. Non-compliance with the provisions outlined in the Regulations could potentially lead to administrative errors or inconsistencies in the operation of the Scheme. Given the critical nature of this function, any breach could have significant implications for the proper functioning of the Pharmaceutical Benefits Scheme, although specific penalties are not detailed in the explanatory statement. The Regulations, therefore, ensure that the administrative processes are followed correctly to maintain the efficiency and effectiveness of the Scheme.