EXPLANATORY STATEMENT
STATUTORY RULES 1987 No 262
ISSUED BY AUTHORITY OF THE MINISTER FOR COMMUNITY SERVICES AND HEALTH
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT)
Section 140 of the National Health Act 1953 (“the National Health Act”) provides that the Governor-General may make regulations, not inconsistent with that Act, prescribing all matters which by that Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to that Act.
Subsection 4(1) of the Acts Interpretation Act 1901 provides that where an Act is expressed to amend another Act in such a manner that the other Act, as amended, will confer power to make regulations, then, unless the contrary intention appears, the power may be exercised before the Act concerned comes into operation. Subsection 4(2) of the Acts Interpretation Act 1901 provides that such regulations take effect on the day on which the Act concerned comes into operation.
Section 84E of the National Health Act will be amended when sub-section 5(1) of the National Health Amendment Act 1987 (Act No 22 of 1987, assented to on 26 May 1987) is proclaimed so as to require the lodgement of certain documents at “prescribed
offices”. The National Health Regulations (Amendment) prescribe the offices at which the documents are to be lodged. The Regulations will come into operation on the date of proclamation of the National Health Amendment Act 1987.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1987 No 262, issued by authority of the Minister for Community Services and Health, amends the National Health Act 1953 to address a gap in the pharmaceutical benefits scheme by requiring the lodgement of certain documents at prescribed offices. The regulations were enacted to ensure compliance with the National Health Amendment Act 1987, which was assented to on 26 May 1987. The policy objective of these amendments is to facilitate the administration of the pharmaceutical benefits scheme by specifying the offices where relevant documents must be lodged, thereby enhancing the efficiency and effectiveness of the scheme.
In line with the provisions of the Acts Interpretation Act 1901, these regulations take effect on the day the National Health Amendment Act 1987 is proclaimed, thereby ensuring that the amended National Health Act can confer the necessary regulatory powers immediately upon the Act's operation. This legislative update aims to streamline the procedural aspects of the pharmaceutical benefits scheme, ensuring that all stakeholders are clearly informed of where and how to submit required documentation.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) issued under the authority of the Minister for Community Services and Health, modify the National Health Act 1953 by specifying additional requirements for the lodgement of certain documents at prescribed offices. This regulatory amendment applies to all entities and individuals who are involved in activities regulated by the National Health Act, including pharmaceutical companies, healthcare providers, and consumers who seek to access pharmaceutical benefits. The regulations are designed to streamline and formalise the process of document lodgement, ensuring compliance with the updated provisions of the National Health Act. The geographic scope of these regulations is national, applying across all jurisdictions within Australia. There are no specific exclusions or exemptions stated within the regulations themselves, but the detailed application of these requirements may be further defined through subordinate instruments, which can extend or restrict the application of the regulations to specific entities or circumstances as necessary. The regulations will take effect on the date the National Health Amendment Act 1987 is proclaimed.
Key Provisions
The key operative sections of the National Health (Pharmaceutical Benefits) Regulations (Amendment) focus on the amendments made to the National Health Act 1953. Specifically, section 84E will be modified to include a requirement for the lodgement of certain documents at offices prescribed by the new regulations (National Health Act 1953, s 140). This amendment is made to ensure that the provisions of the Act are effectively carried out and that necessary documentation is managed in a prescribed manner. The amendment aligns with the legislative intent to maintain the efficacy and integrity of the Pharmaceutical Benefits Scheme under the National Health Act.
The obligations imposed by these regulations on parties or entities governed by the Act include the requirement to lodge specific documents at the prescribed offices. This mandate ensures that all relevant parties are aware of where and how to submit necessary documentation. Such compliance is crucial for maintaining the smooth operation of the Pharmaceutical Benefits Scheme, ensuring that all stakeholders are aware of their obligations and the process for fulfilling them. The regulations also provide clarity and guidance to those involved, facilitating adherence to the legislative framework established by the National Health Act.
Failure to comply with these regulations can result in both civil and criminal consequences. While the specific penalties are not detailed in the explanatory statement, it is implied that non-compliance could lead to enforcement actions under the National Health Act. This may include fines, legal proceedings, or other penalties as prescribed by the Act or relevant subsidiary legislation. The severity of the penalties would depend on the nature and extent of the breach, as well as any mitigating or aggravating factors present in the case. The overarching goal of these penalties is to ensure that the legislative framework is upheld and that the Pharmaceutical Benefits Scheme operates efficiently and effectively.