EXPLANATORY STATEMENT
STATUTORY RULES 1981 NO. 102
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
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.
The National Health Amendment Act 198 3 (the amending Act) Act No. 35 assented to on 19 June 1983 amended Part VII of the Act by abolishing the patient declaration of entitlement to free or concessional pharmaceutical benefits under the Pharmaceutical Benefits Scheme. The amending Act also introduced a simpler arrangement by which a person’s entitlement to free or concessional pharmaceutical benefits may be made known to the pharmaceutical chemist.
Section 6 of the amending Act inserted a new section 84AA into the Act which provided the new procedure
whereby a person’s entitlement to free or concessional pharmaceutical benefits is made known to the pharmaceutical chemist. New sub-section 84AA(1) provides that a prescription for a pharmaceutical benefit shall not be taken to be a prescription in respect of a concessional beneficiary, or a pensioner, or one of their dependents, unless the prescription form contains certain prescribed information as to that person’s entitlement. New sub-section 84AA(2) makes similar provision for prescriptions that are communicated to pharmaceutical chemists in urgency situations.
The Regulations amended the National Health (Pharmaceutical Benefits) Regulations to give effect to these changes by prescribing the new administrative procedures to enable an eligible person to receive a pharmaceutical benefit at the concessional rate or free of charge.
The Regulations were made in pursuance of section 4 of the Acts Interpretation Act 1901 and therefore took effect at the same time as the relevant provisions authorising the Regulations in the National Health Amendment Act 1983. Details of the Regulations are set out at Attachment A.
Authority: Section 140 of the National Health Act 1953.
Attachment A
The regulations amended existing regulation 5 by inserting the definitions of “concessional beneficiary”, and “dependant” in relation to a concessional beneficiary, and omitted the definition of “declaration”.
Regulation 3 inserted a new regulation 19A which provides that the information prescribed for the purposes of sub-sections 84AA(1) and (2) of the Act, is information in respect of the type of entitlement card issued by the Commonwealth to a person who is a concessional beneficiary or a pensioner, and the entitlement number specified on that card,
Regulation 19A also provides that the manner of communicating prescribed information for the purposes of subsection 84AA(1) of the Act, would be the writing or marking the prescribed information on a prescription form, either in accordance with a form prescribed by the regulations, or, with the consent of the Minister, by an endorsement on the prescription in the existing form.
Sub-regulation 19A(3) provides, for the purposes of sub-section 84AA(2) of the Act, for the manner in which prescribed information shall be communicated to a pharmaceutical chemist in an urgency situation.
Regulations 4 and 5 amended the existing regulations 26 and 26A to omit the reference to a “declaration”, and inserted a new sub-regulation 31(1B) to provide that the receipt of the pharmaceutical benefit, and the certification as to the validity of the prescribed information on the prescription, shall be covered by the one signature.
Regulation 7 inserted a new Schedule 7 to the Principal Regulations which provided for a form by which the manner of communicating prescribed information to the pharmaceutical chemist is exercised pursuant to sub-regulation 19A(2).
Overview
The National Health Amendment Act 1983, enacted to address inefficiencies and gaps in the administration of pharmaceutical benefits under the Pharmaceutical Benefits Scheme, introduced significant changes to the National Health Act 1953. This legislation, assented to on 19 June 1983, aimed to streamline the process by which a person's entitlement to free or concessional pharmaceutical benefits is ascertained and communicated. The Act abolished the patient declaration of entitlement and introduced a new procedure where the information regarding a person’s entitlement must be explicitly stated on the prescription form to qualify for a concessional rate or free pharmaceutical benefit. This shift was intended to facilitate smoother transactions between eligible individuals and pharmaceutical chemists. The Regulations, made under the authority of the Minister for Health pursuant to section 140 of the National Health Act 1953, detail the administrative procedures necessary to implement these changes, ensuring that the new system is effectively operationalised.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) issued under the National Health Act 1953, applies to individuals who are concessional beneficiaries or pensioners, and their dependents, as well as to pharmaceutical chemists who dispense pharmaceutical benefits. The regulations establish a new procedure for communicating a person's entitlement to free or concessional pharmaceutical benefits under the Pharmaceutical Benefits Scheme, which involves providing specific information on a prescription form or endorsing an existing prescription form with the necessary details. This amendment removes the previous requirement for a patient declaration of entitlement to free or concessional pharmaceutical benefits. The regulations extend across the Commonwealth of Australia and are designed to streamline the process of identifying eligible patients and ensuring they receive the appropriate benefits. The amendments do not specify exclusions or thresholds but focus on establishing a clearer administrative process. The scope of the regulations can be further defined or extended through subordinate instruments, allowing for adjustments in administrative procedures and forms as necessary to meet the evolving needs of the scheme.
Key Provisions
The key operative sections of the National Health (Pharmaceutical Benefits) Regulations (Amendment) revolve around the administration of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) as detailed in sub-sections 84AA(1) and (2) of the National Health Act 1953 (hereafter referred to as "the Act"). These sections introduce new procedures for communicating a person’s entitlement to free or concessional pharmaceutical benefits to the pharmaceutical chemist. Specifically, sub-section 84AA(1) mandates that a prescription for a pharmaceutical benefit will not be recognised as a prescription for a concessional beneficiary, a pensioner, or their dependent unless the prescription form contains prescribed information about that person’s entitlement. Similarly, sub-section 84AA(2) requires similar provisions for prescriptions that need to be communicated to pharmaceutical chemists in urgent situations. These provisions are aimed at streamlining the process of identifying eligible recipients of concessional pharmaceutical benefits.
The Act imposes several obligations and requirements on the parties involved, primarily the prescribing doctors and the pharmaceutical chemists. Doctors are required to ensure that prescriptions for eligible concessional beneficiaries or pensioners include specific information about the patient’s entitlement card and number. This ensures that the prescription is valid and recognised for the purpose of obtaining pharmaceutical benefits at the concessional rate or free of charge. Pharmaceutical chemists, on the other hand, must verify the information on the prescription before dispensing any medication. Both parties are also required to adhere to the new administrative procedures outlined in the regulations, which include the use of prescribed forms or endorsed existing forms with the necessary information.
Failure to comply with the requirements set out in the Act and the Regulations can result in various civil and criminal consequences. While the exact penalties are not specified in the provided excerpt, it is common for breaches of health-related regulations to carry significant penalties. Typically, these might include fines, imprisonment, or both, depending on the severity and intent of the breach. The penalties are intended to ensure adherence to the regulations and the proper administration of pharmaceutical benefits within the PBS. The specific penalties would be outlined in more detail in other sections of the Act or related legislation, but they are designed to enforce compliance and protect the integrity of the scheme.
In summary, the National Health (Pharmaceutical Benefits) Regulations (Amendment) introduce new administrative procedures for communicating the entitlement of concessional beneficiaries or pensioners for pharmaceutical benefits. These regulations impose clear obligations on prescribing doctors to include specific information on prescriptions and on pharmaceutical chemists to verify this information. Failure to comply with these regulations can result in significant penalties, underscoring the importance of adhering to the prescribed procedures to ensure the proper administration of the Pharmaceutical Benefits Scheme.