EXPLANATORY STATEMENT
STATUTORY RULES 1986 NO. 319
ISSUED BY AUTHORITY OF THE MINISTER FOR HEALTH
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT)
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.
Part VII of the Act which makes provision for the Pharmaceutical Benefits Scheme was amended by the Health Legislation Amendment Act (No. 2) 1986 (Act No 94 of 1986 which received Royal Assent on 13 October 1986) to provide for a revised Pharmaceutical Benefits Scheme. Those amendments which are expressed to come into operation on 1 November 1986 provide that when a person or that person’s family has received 25 pharmaceutical benefits in a year, that person may be issued with an entitlement card which entitles the person and the person’s family to free pharmaceutical benefits for the remainder of the year. The amendments also increase the cost of a general benefit prescription from $5 to a maximum of $10 and the cost of a concessional benefit prescription from $2 to $2.50. Pensioners will still be able to obtain pharmaceutical benefits free of charge.
The Regulations prescribe a number of matters which are required to be prescribed for purposes of the amendments to Part VII of the Act and make a number of necessary consequential amendments. The principal matters prescribed are:
• information to be included on pharmaceutical benefits prescription record forms
• information to be included on pharmaceutical benefits entitlement cards
• form of applications for additional and replacement entitlement cards
• provision for persons to seek a review by the Administrative Appeals Tribunal where the Secretary refuses to issue an additional or replacement entitlement card
The Regulations are made pursuant to section 4 of the Acts Interpretation Act 1901. Sub-section 4(1) provides that where an Act that is not to come into operation immediately upon its enactment confers a power to make an instrument (including regulations), then that power may be exercised before the Act concerned comes into operation. Sub-section 4(2) provides that such an instrument takes effect on the day on which the Act concerned comes into operation. By virtue of sub-sections 4(1) and 4(2), the Regulations will come into operation on 1 November 1986.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1986 No. 319, issued under the authority of the Minister for Health, was enacted to address gaps in the existing Pharmaceutical Benefits Scheme (PBS) by providing a revised framework for the PBS as outlined in the Health Legislation Amendment Act (No. 2) 1986. This amendment introduced changes such as the issuance of entitlement cards for free pharmaceutical benefits after a certain threshold of benefits has been reached, and adjustments to the costs of general and concessional benefit prescriptions. The regulations were made under the authority of the National Health Act 1953, which empowers the Governor-General to make regulations necessary for the implementation and enforcement of the Act. The policy objective of these amendments was to streamline the PBS and ensure that it remains accessible and equitable, particularly for those who are most in need.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) apply to individuals and families who receive pharmaceutical benefits under the National Health Act 1953, and they govern the administration and operation of the Pharmaceutical Benefits Scheme. The Act applies to all persons and entities within the Commonwealth of Australia, including the states and territories, ensuring a uniform approach to pharmaceutical benefits across the nation. The Regulations specify the information that must be included on prescription record forms and entitlement cards, the application process for additional or replacement entitlement cards, and the mechanism for seeking a review by the Administrative Appeals Tribunal in cases where the Secretary refuses to issue such cards. The Regulations also implement the amended thresholds and costs for general and concessional benefit prescriptions, and they provide for pensioners to continue receiving pharmaceutical benefits free of charge. These Regulations extend the provisions of the Act through subordinate legislation, ensuring that the necessary details are established for the effective implementation of the amended scheme.
Key Provisions
The main operative sections of these regulations (National Health (Pharmaceutical Benefits) Regulations (Amendment)) pertain to the requirements for the pharmaceutical benefits prescription record forms, the information to be included on pharmaceutical benefits entitlement cards, and the form of applications for additional and replacement entitlement cards. Under section 4 of the Acts Interpretation Act 1901, these regulations are to come into effect on the same date as the amendments to the National Health Act 1953, which is 1 November 1986. The regulations also provide for the review of decisions by the Secretary to refuse to issue additional or replacement entitlement cards by the Administrative Appeals Tribunal (section 140 of the Act).
These regulations impose obligations on various parties, including pharmaceutical providers and patients. Pharmaceutical providers are required to ensure that prescription record forms include all the prescribed information, and they must issue entitlement cards to eligible patients. Patients must provide accurate information when applying for entitlement cards and must use their entitlement cards appropriately to access free pharmaceutical benefits. The Secretary of the Department of Health has the responsibility to issue entitlement cards and to handle applications and reviews.
Breach of these regulations may lead to civil or criminal consequences. For example, failure to comply with the requirements for prescription record forms could result in penalties under the National Health Act 1953. Similarly, providing false information on an application for an entitlement card could be considered fraudulent and may result in criminal charges. The maximum penalties for such offences are not specified within these regulations but would be determined by the relevant provisions of the National Health Act 1953 and other applicable laws. It is important for all parties to adhere to the regulations to avoid potential penalties and to ensure the smooth operation of the Pharmaceutical Benefits Scheme.