EXPLANATORY STATEMENT
STATUTORY RULES 1982 NO. 334
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 140 of the National Health Act 1953 provides for the making of regulations by the Governor-General to prescribe all matters which by the Act are required or permitted to be prescribed for carrying out or giving effect to the Act.
Part VII of the Act makes provision for the supply by the Commonwealth of certain drugs and medicinal preparations as pharmaceutical benefits. Section 85 provides that, with such exceptions and additions as are prescribed, the drugs and medicinal preparations which are the subject of monographs in the British Pharmacopoeia shall be available as benefits. That section further provides that prescribed compounds of those drugs and medicinal preparations shall also be available as benefits.
Section 88A of the Act provides that the writing of a prescription for the supply of a prescribed pharmaceutical benefit may be authorized only in circumstances prescribed in relation to that pharmaceutical benefit.
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Section 101 of the Act establishes the Pharmaceutical Benefits Advisory Committee, consisting of medical practitioners, pharmacists and a pharmacologist, to recommend to the Minister the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits, and to advise the Minister on any other matter concerning the operation of Part VII referred to it by the Minister.
In making its recommendations, the Committee carefully considers all relevant facts about each drug or medicinal preparation. Drugs considered for listing would normally be more effective or less toxic than those already listed. A drug may be delisted when a more effective or less toxic drug is available or when it has fallen into disuse. Fixed combinations of two or more drugs are rarely acceptable because the Committee considers that more than one drug should not be used when one drug is all that is needed.
The Committee meets three times a year and after each meeting makes recommendations to the Minister in accordance with the Act. If the Minister accepts the recommendations, he approves the drafting of Statutory
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Rules to amend the National Health (Pharmaceutical Benefits) Regulations to give effect to the recommendations.
The Statutory Rules which came into operation on 1 December 1982 amend Schedules 1, 2, 3 and 5 of the National Health (Pharmaceutical Benefits) Regulations.
Schedule 1 lists the drugs and medicinal preparations that are the subject of monographs in the British Pharmacopoeia but which the Committee recommends should not be made available by the Commonwealth as pharmaceutical benefits.
Schedule 2 lists those fixed combinations of drugs and medicinal preparations which the Committee recommends should be available as pharmaceutical benefits.
Schedule 3 lists those drugs and medicinal preparations which are not the subject of monographs in the British Pharmacopoeia but which the Committee recommends should be made available as pharmaceutical benefits.
Schedule 5 lists the pharmaceutical benefits, the prescribing of which is subject to certain conditions and restrictions in accordance with regulation 14.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1982 were introduced to amend the existing regulations concerning the provision of pharmaceutical benefits under the National Health Act 1953. This legislation was enacted to ensure that the Commonwealth could supply certain drugs and medicinal preparations as benefits to the public, with the list being periodically reviewed and updated based on recommendations from the Pharmaceutical Benefits Advisory Committee. The regulations were made by the Governor-General under the authority of the Minister for Health and came into effect on 1 December 1982, aiming to align the list of available pharmaceutical benefits with the most effective and safe drugs and preparations available at the time.
The Pharmaceutical Benefits Advisory Committee, established under Section 101 of the Act, plays a crucial role in advising the Minister on the listing and delisting of pharmaceutical benefits, taking into account factors such as drug efficacy and toxicity. This amendment to the regulations reflects the Committee's recommendations to enhance the availability of pharmaceutical benefits by adjusting the schedules to include or exclude certain drugs and combinations based on their therapeutic value and current medical standards.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1982 No. 334, issued under the authority of the Minister for Health, pertain to the supply of drugs and medicinal preparations as pharmaceutical benefits in accordance with Section 140 of the National Health Act 1953. This legislation applies to all persons and entities involved in the provision of pharmaceutical benefits, including medical practitioners, pharmacists, and patients, as well as the pharmaceutical industry. The scope of the Act encompasses the regulation of drugs and medicinal preparations listed in the British Pharmacopoeia and those recommended by the Pharmaceutical Benefits Advisory Committee, with a focus on ensuring that only the most effective and least toxic drugs are made available. The Act's jurisdiction extends nationally across Australia. However, certain drugs and fixed combinations of drugs are explicitly excluded from being available as pharmaceutical benefits as listed in Schedules 1 and 2 of the Regulations. Additionally, the prescribing of certain pharmaceutical benefits is subject to specific conditions and restrictions outlined in Schedule 5 of the Regulations. The application of the Act may be further refined through subordinate instruments.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1982 No. 334, made under section 140 of the National Health Act 1953, detail modifications to the schedules governing pharmaceutical benefits provided by the Commonwealth. These amendments, effective from 1 December 1982, are based on recommendations by the Pharmaceutical Benefits Advisory Committee. This committee, established by section 101 of the Act, comprises medical practitioners, pharmacists, and a pharmacologist who deliberate on the suitability of drugs and medicinal preparations for listing as pharmaceutical benefits. They ensure that the drugs recommended are either more effective or less toxic than existing options and consider the necessity of single versus combination therapies.
The primary operative sections of the regulations concern the listing and delisting of drugs and medicinal preparations under Schedules 1, 2, 3, and 5 of the National Health (Pharmaceutical Benefits) Regulations. Schedule 1 now includes drugs and preparations from the British Pharmacopoeia that the committee recommends should not be made available as pharmaceutical benefits. Schedule 2 lists fixed combinations of drugs that the committee recommends should be available as benefits, though these are typically excluded unless justified. Schedule 3 lists drugs and preparations not found in the British Pharmacopoeia but recommended for availability as benefits by the committee. Schedule 5 lists pharmaceutical benefits subject to specific conditions and restrictions under regulation 14, ensuring appropriate use and accessibility.
The obligations imposed by these regulations on parties or entities include strict adherence to the recommendations of the Pharmaceutical Benefits Advisory Committee regarding the availability and conditions of pharmaceutical benefits. Healthcare providers and patients must comply with the listed conditions and restrictions specified in Schedule 5. Additionally, the regulations require the Minister for Health to approve the drafting of Statutory Rules to implement the committee's recommendations, ensuring a formal and transparent process for updating the pharmaceutical benefits list.
Failure to comply with these regulations can result in significant consequences. While the text does not explicitly detail offences or penalties, breaches of the conditions and restrictions listed in Schedule 5 may lead to legal actions under the National Health Act 1953. These could include administrative penalties or legal proceedings for non-compliance, with the exact penalties depending on the nature and severity of the breach. The overarching aim is to ensure that pharmaceutical benefits are provided efficiently and responsibly, safeguarding public health.