National Health (Pharmaceutical Benefits) Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02940 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953 No.

National Health (Pharmaceutical Benefits) Regulations (Amendment)

Apart from section 140 of the National Health Act 1953 (the Act), which provides that the Governor-General may make regulations for purposes of the Act, certain other provisions in the Act also specifically provide for matters to be prescribed by Regulation.

Paragraph 84D(7)(c) of the Act provides for the prescribing of particulars to be included on a prescription record form where the pharmaceutical benefit has been supplied to the holder of the form.

Subsection 84D(6) of the Act provides that where an approved pharmacist supplies a pharmaceutical benefit in accordance with subsection 84C(4) and the holder of a pharmaceutical benefits prescription record form presents it at the time of supply, the pharmacist must record the supply, including the supply at the “agreed price,” of under $11 items (for which the Commonwealth does not make any contribution), of the pharmaceutical benefit on the form. Where a person has had supplied to him or her 25 pharmaceutical benefits, he or she is entitled to be issued with an entitlement card allowing that person to be supplied with free pharmaceutical benefits for the rest of the calendar year. No compulsion is placed on the pharmacist to charge only the agreed price, but if he or she does not so charge, he or she is not able to record that supply on the prescription record form in accordance with subsection 84D(6). The “agreed price” is the price determined by the Minister after taking into account a number of factors outlined in subsection 84C(8) of the Act, and after consultation with the Pharmacy Guild of Australia.


Paragraph 9A(4)(c) of the National Health (Pharmaceutical Benefits) Regulations was made with effect from 1 August 1990 to ensure that the amount of the charge made for the supply of the pharmaceutical benefit was also recorded on a prescription record form. This would have allowed the Department of Community Services and Health (the Department) to check whether, for the purposes of filling in the record form under subsection 84D(6), the “agreed price” was in fact actually charged. The Department has since developed certain administrative measures to deal with this matter, and it is considered that these measures are more appropriate than the requirement (through paragraph 9A(4)(c)) for the pharmacist to record the charge.

Accordingly this amendment will repeal paragraph 9A(4)(c) with effect from 1 August 1990. The retrospectivity is not in breach of subsection 48(2) of the Acts Interpretation Act 1901, ie the amendment will not prejudice the rights of a person (other than the Commonwealth) existing at the date of notification of the Regulations, and liabilities will not be imposed on any person in respect of anything done or omitted to be done before the date of notification.

Overview

The National Health Act 1953 was enacted to provide for the health and hospital services in Australia, including the regulation of pharmaceutical benefits. The Act was introduced to address the need for a comprehensive framework governing the supply of pharmaceutical benefits to the public, ensuring that such benefits are accessible and affordable. The National Health (Pharmaceutical Benefits) Regulations (Amendment) were established under the authority of section 140 of the Act, with the objective of refining the regulatory framework to better align with current administrative practices and ensure compliance with legislative intent. The Parliament of Australia, through the enacting body responsible for the amendment, aims to streamline the processes for recording pharmaceutical benefit supplies and charges on prescription record forms, ensuring that administrative measures are both efficient and effective. This amendment seeks to repeal a specific regulatory requirement that has become superseded by more appropriate administrative measures developed by the Department of Community Services and Health.

Scope and Application

The National Health (Pharmaceutical Benefits) Regulations (Amendment) pertains to the National Health Act 1953 and governs the regulation of pharmaceutical benefits provided under the Act. The Regulations apply to pharmacists and other approved persons who supply pharmaceutical benefits to patients, as well as to patients who present a pharmaceutical benefits prescription record form at the time of supply. The amendment specifically concerns the recording of particulars on prescription record forms, including the agreed price for the supply of pharmaceutical benefits. The agreed price is determined by the Minister after considering various factors and consultation with the Pharmacy Guild of Australia. The amendment seeks to repeal a requirement that the charge amount be recorded on a prescription record form, as the Department of Community Services and Health has developed more appropriate administrative measures to address this matter. The amendment applies from 1 August 1990 and ensures that it does not prejudice any existing rights or impose liabilities for actions taken prior to the amendment's notification. The scope of the amendment is limited to the regulation of pharmaceutical benefits under the National Health Act 1953 and does not extend to other areas or industries. The repeal of paragraph 9A(4)(c) of the National Health (Pharmaceutical Benefits) Regulations is intended to streamline the process for recording particulars on prescription record forms and to facilitate the implementation of the Department's administrative measures. Any further application or extension of the amendment is subject to subordinate instruments made under the authority of the Act.

Key Provisions

The National Health (Pharmaceutical Benefits) Regulations (Amendment) (F1996B02940) contains provisions that amend the requirements for recording details on prescription record forms under the National Health Act 1953. Specifically, section 84D(6) of the Act mandates that pharmacists must record the supply of a pharmaceutical benefit, including the agreed price, on a prescription record form if presented by the holder at the time of supply. Moreover, an individual who receives 25 or more pharmaceutical benefits is entitled to an entitlement card that allows them to receive free pharmaceutical benefits for the remainder of the calendar year. The agreed price, as determined by the Minister in consultation with the Pharmacy Guild of Australia, is the price charged for pharmaceutical benefits for which the Commonwealth does not contribute. This agreed price must be charged to record the supply on the prescription record form. Under the current regulations, pharmacists are required to record the amount charged for the pharmaceutical benefit on the prescription record form. However, the Department of Community Services and Health has developed administrative measures that are considered more suitable than the requirement for pharmacists to record the charge. This amendment seeks to repeal paragraph 9A(4)(c) of the National Health (Pharmaceutical Benefits) Regulations, which requires pharmacists to record the amount charged, with effect from 1 August 1990. The repeal of this requirement will not prejudice the rights of any person existing at the date of notification of the Regulations, nor will it impose any liabilities on any person in respect of anything done or omitted to be done before the date of notification. The amendment imposes obligations on pharmacists to accurately record the supply of pharmaceutical benefits on the prescription record form, including the agreed price, if the form is presented by the holder at the time of supply. The agreed price is determined by the Minister, after consultation with the Pharmacy Guild of Australia, based on several factors outlined in the Act. Pharmacists are not compelled to charge only the agreed price, but if they do not, they cannot record the supply on the prescription record form. The repeal of the requirement to record the amount charged on the prescription record form removes this obligation from pharmacists, allowing the Department to rely on its administrative measures to ensure the agreed price is charged. There are no offences, penalties, or civil/criminal consequences specifically outlined in the amendment for breach of the requirements or obligations. However, the National Health Act 1953 and other relevant legislation may contain provisions that address non-compliance with the requirements and obligations related to the supply and recording of pharmaceutical benefits. The penalties for breach of these provisions may vary depending on the nature and severity of the offence, and the relevant legislation should be consulted for further information.

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Pharmaceutical Law
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