National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 1) 2002 No. 239
EXPLANATORY STATEMENT
STATUTORY RULES 2002 No. 239
Issued by Authority of the Minister for Health and Ageing
National Health Act 1953
National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 1)
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.
Paragraph 105(b) of the Act provides that the regulations may make provision for, or in relation to, the writing of prescriptions.
Under paragraph 103(2)(a) of the Act, it is an offence for a pharmacist, to whom a prescription is presented, to supply anything other than the pharmaceutical benefit as specified in the prescription. However, subsection 103(2A) of the Act provides an exception whereby a pharmacist may substitute a different brand of the pharmaceutical benefit from that prescribed under certain conditions.
One of those conditions, in paragraph 103(2A)(a) of the Act, is that the prescriber of the pharmaceutical benefit did not indicate on the prescription that only that benefit was to be supplied. Prescription forms issued by the Health Insurance Commission to medical practitioners and participating dental practitioners contain a box to be marked by the prescriber if brand substitution is not to be permitted. That is, the prescriber must consider for each individual prescription whether or not to prohibit the substitution of another brand. If the box is not marked, and the other conditions specified in subsection 103(2A) are satisfied, the pharmacist may substitute another brand of the same pharmaceutical benefit. Brand substitution normally occurs to enable the patient to avoid additional cost when the brand prescribed is more expensive than other brands of the same medication.
Regulation 19 of the National Health (Pharmaceutical Benefits) Regulations 1960 governs the writing of prescriptions. It provides that prescriptions may be prepared:
• by handwriting on a prescription form;
• by computer on a prescription form; or
• by another method approved in writing by the Secretary, which includes by computer on paper other than standard prescription forms.
For computer prepared prescriptions, some prescription-writing computer programs allow a default to be set that has the effect of automatically prohibiting brand substitution for all prescriptions.
The purpose of the Regulations is to provide that a computer-prepared prescription must not be prepared using a computer program that permits a default automatically prohibiting brand substitution. This will put computer-prepared prescriptions on the same basis as handwritten prescriptions, by requiring the prescriber to make a conscious decision in the case of each prescription whether or not to prohibit brand substitution.
Details of the Regulations are in the Attachment.
The Regulations commence on 1 February 2003.
ATTACHMENT
Regulation 1 of the amending regulations provides that the name of the amending regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 1).
Regulation 2 of the amending regulations provides that the amending regulations will commence on 1 February 2003.
Regulation 3 of the amending regulations provides that the National Health (Pharmaceutical Benefits) Regulations 1960 will be amended as set out in Schedule 1.
Item 1 of the Schedule defines "brand" to have the same meaning as in Part VII of the Act, namely, a trade name under which a manufacturer sells a drug or medicinal preparation or the name of the manufacturer who sells a drug or medicinal preparation.
Item 2 of the Schedule inserts new subregulation 19(5) which provides that a prescription must not be prepared using a computer program that enables a default to be set that only the brand of pharmaceutical benefit specified in the prescription is to be supplied.
Overview
The National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 1) were enacted to address a specific issue related to the regulation of brand substitution in pharmaceutical prescriptions under the National Health Act 1953. This regulation was issued under the authority of the Minister for Health and Ageing and aims to ensure that the writing of computer-prepared prescriptions is aligned with handwritten prescriptions in terms of brand substitution. The objective of these regulations is to prevent the automatic prohibition of brand substitution in computer-prepared prescriptions by requiring prescribers to make an active decision for each prescription about whether to permit or prohibit brand substitution, thus maintaining consistency in the prescription process.
The regulations amend the National Health (Pharmaceutical Benefits) Regulations 1960 to introduce a new subregulation that explicitly states a computer program used to prepare prescriptions must not allow a default setting that automatically prohibits brand substitution. This change ensures that each prescription, whether handwritten or computer-prepared, requires a deliberate decision by the prescriber regarding brand substitution, thereby facilitating cost-effective medication options for patients while maintaining the integrity of the prescription process. The regulations came into effect on 1 February 2003.
Scope and Application
The National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 1) apply to medical practitioners, pharmacists, and any other individuals or entities involved in the prescription and supply of pharmaceutical benefits under the National Health Act 1953. These regulations are specifically concerned with the method of preparing prescriptions, whether by handwriting, computer, or other approved means, and the conditions under which brand substitution of pharmaceuticals may occur. The regulations aim to standardise the process of writing prescriptions by computer to ensure that the decision to prohibit brand substitution is made consciously by the prescriber for each prescription, aligning computer-prepared prescriptions with handwritten ones. Geographically, these regulations have a national reach, applying across Australia in accordance with the provisions of the National Health Act 1953. The regulations do not explicitly state any exclusions, but they do clarify the circumstances under which brand substitution can occur, providing a clear framework for prescribers and pharmacists to follow. The application of these regulations can be further detailed or restricted through subordinate instruments issued under the authority of the Minister for Health and Ageing.
Key Provisions
The National Health (Pharmaceutical Benefits) Amendment Regulations 2002 (No. 1) amend the existing National Health (Pharmaceutical Benefits) Regulations 1960 to address the way prescriptions are prepared and the conditions under which brand substitution can occur. Section 140 of the National Health Act 1953 (the Act) allows the Governor-General to make regulations that are necessary or convenient to carry out or give effect to the Act. Under paragraph 105(b) of the Act, these regulations can include provisions for the writing of prescriptions. The primary amendment introduced by these regulations, detailed in Regulation 19(5), stipulates that prescriptions must not be prepared using a computer program that defaults to prohibiting brand substitution of pharmaceutical benefits unless the prescriber explicitly indicates this on the prescription form.
Under the amended regulations, prescribers are required to make a conscious decision for each prescription about whether to prohibit brand substitution. This change aims to align computer-prepared prescriptions with handwritten prescriptions, where the prescriber must manually indicate if brand substitution should be prohibited. Regulation 19 of the original regulations allows prescriptions to be prepared by handwriting, computer on a prescription form, or another method approved by the Secretary. The new subregulation 19(5) ensures that for computer-prepared prescriptions, the default setting cannot automatically prohibit brand substitution without specific instruction from the prescriber.
The regulations impose obligations on pharmacists and prescribers to ensure compliance with the requirements for brand substitution. Pharmacists must adhere to the prescription details and only supply the specified pharmaceutical benefit unless the prescriber has indicated that brand substitution is not permitted. Conversely, prescribers must explicitly mark the prescription form if they wish to prohibit brand substitution. Failure to comply with these requirements can result in legal consequences. Under subsection 103(2) of the Act, it is an offence for a pharmacist to supply anything other than the pharmaceutical benefit specified in the prescription. However, under subsection 103(2A), a pharmacist may substitute a different brand of the pharmaceutical benefit if the prescriber did not indicate that only the specified brand was to be supplied and other conditions are met.
In terms of penalties and consequences, the Act does not specify maximum penalties within the explanatory statement provided. However, the potential legal ramifications for non-compliance are significant. Pharmacists who supply the wrong pharmaceutical benefit may face criminal charges, while prescribers who fail to make a clear indication regarding brand substitution may inadvertently allow substitutions that could lead to additional costs for patients. These regulations are designed to ensure transparency and clarity in the prescription process, ultimately protecting patients from unintended financial burdens and ensuring they receive the prescribed treatment as intended.