EXPLANATORY STATEMENT
Statutory Rules 1990 No
Issued by the authority of the Minister of State for Aged, Family and Health Services.
Subject - National Health Act 1953
National Health (Pharmaceutical Benefits) Regulations (Amendment)
These Regulations amend a number of Regulations as they relate to the Safety Net provisions of the Pharmaceutical Benefits Scheme. The amendments enhance financial control of the Scheme.
Paragraph 84D(7)(c) of the National Health Act 1953 (the Act) provides for the prescribing of particulars to be included on a prescription record form where a pharmaceutical benefit has been supplied to the holder of the form. The amendment to regulation 9A adds the amount of the charge made for the supply of the pharmaceutical benefit to the particulars already prescribed. This allows for ease of checking to ensure that the supply of a particular benefit is at no more than the agreed price.
Subsections 84H(1) and (3) of the Act provide for the making of Regulations for the issue of additional or replacement entitlement cards. The amendment to regulation 9C provides that only the Secretary to the Department, and not the approved supplier of the original card (as was previously allowed under the Regulations), can issue additional entitlement cards for cards which have been lost, stolen, damaged or destroyed and thereby improves control over the issue of these cards.
The remaining amendments to the Regulations are consequential upon the above amendments.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1990 were introduced to refine the financial controls within the Pharmaceutical Benefits Scheme (PBS) and address certain administrative shortcomings identified in the existing regulations. Enacted by the Minister of State for Aged, Family and Health Services, these amendments aim to enhance the efficiency and oversight of the PBS, particularly concerning the Safety Net provisions which are designed to protect consumers from excessive out-of-pocket expenses for pharmaceuticals. The primary objective is to ensure that the PBS remains a financially sustainable and equitable system, while also improving the accuracy and control over the issuance of entitlement cards, which are vital for accessing the scheme's benefits.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1990 No. 2939, issued under the authority of the Minister of State for Aged, Family and Health Services, primarily focus on refining the Safety Net provisions within the Pharmaceutical Benefits Scheme (PBS). These amendments apply to all entities and individuals who supply pharmaceutical benefits under the National Health Act 1953, particularly those involved in the PBS. This legislation impacts the pharmaceutical industry and healthcare providers, ensuring that the financial control mechanisms within the PBS are enhanced. The geographic reach of these regulations is nationwide, applying across all states and territories in Australia. There are no stated exclusions or exemptions in these regulations, but they do introduce thresholds and controls that must be adhered to by all parties involved in the PBS. The Regulations also allow for the possibility of further extensions or restrictions through subordinate instruments, which may be prescribed to implement the broader objectives of the PBS and to maintain financial integrity within the scheme.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) focus on enhancing the financial control of the Pharmaceutical Benefits Scheme (PBS), particularly under the Safety Net provisions. Section 84D(7)(c) of the National Health Act 1953 mandates that specific details must be included on a prescription record form when a pharmaceutical benefit is supplied. This includes the addition of the amount charged for the supply of the pharmaceutical benefit, as outlined in the amendment to regulation 9A. This requirement ensures that the cost of the pharmaceutical benefit supplied does not exceed the agreed price, providing a clear and verifiable record for compliance and audit purposes.
These regulations impose certain obligations on parties involved in the PBS. Under the amended regulation 9C, the responsibility for issuing additional or replacement entitlement cards is now vested solely with the Secretary to the Department. This change replaces the previous provision that allowed approved suppliers of the original cards to issue replacements. This centralisation of card issuance aims to improve control over the distribution of entitlement cards, reducing the risk of fraudulent or unauthorised issuance.
Breaching the provisions of these regulations can lead to significant consequences. While specific offences and penalties are not detailed within the explanatory statement, it is known that the Act includes provisions for both civil and criminal penalties for non-compliance with pharmaceutical regulations. Typically, breaches of the National Health Act 1953 can result in substantial fines and, in severe cases, imprisonment. The exact penalties would depend on the specific nature and severity of the breach, as outlined in the relevant sections of the Act. Compliance with these regulations is therefore crucial to avoid potential legal repercussions.