EXPLANATORY STATEMENT
STATUTORY RULES 1983 NO. 28
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 140 of the National Health Act 1953 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.
Part VII of the Act makes provisions for the supply by the Commonwealth of certain drugs and medicinal preparations as pharmaceutical benefits. Section 85 provides that, the drugs and medicinal preparations that are the subject of monographs in the British Pharmacopoeia, and such other drugs and medicinal preparations as prescribed, shall be available as pharmaceutical 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 pharmaceutical benefit may be authorised only in circumstances prescribed in relation to that pharmaceutical benefit.
Section 101 of the Act establishes a Pharmaceutical Benefits Advisory Committee consisting of pharmacists, medical practitioners, and a pharmacologist, whose function is to make recommendations to the Minister for Health from time to time as to the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits under Part VII of the Act. The Committee also advises the Minister upon any other matter concerning the operation of Part VII referred to it by him.
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, so that 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 Rules to amend the National Health (Pharmaceutical Benefits) Regulations to give effect to the recommendations.
The Statutory Rules which came into effect on 1 April 1983 amended 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 1983 were enacted to provide a regulatory framework for the supply of pharmaceutical benefits under the National Health Act 1953. This amendment aimed to address the need for a structured approach in determining which drugs and medicinal preparations should be available as pharmaceutical benefits, ensuring that only those that meet specific criteria of effectiveness and safety are included. The Minister for Health, exercising the power under Section 140 of the National Health Act, issued these regulations to align with the recommendations of the Pharmaceutical Benefits Advisory Committee, which was established to advise on the listing and delisting of drugs based on their therapeutic value and safety profile.
The policy objective of these regulations is to facilitate the provision of pharmaceutical benefits that are both effective and safe for public use, by allowing the inclusion of certain drugs and medicinal preparations in the Pharmaceutical Benefits Scheme while excluding others that do not meet the established criteria. The regulations were designed to give effect to the recommendations of the Advisory Committee, thereby ensuring that the Pharmaceutical Benefits Schedule is regularly updated to reflect the latest therapeutic advancements and public health needs.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1983 No. 28, issued under the authority of the Minister for Health, pertain to the administration of pharmaceutical benefits in Australia as outlined in the National Health Act 1953. These regulations specifically amend the National Health (Pharmaceutical Benefits) Regulations to reflect recommendations made by the Pharmaceutical Benefits Advisory Committee. The Committee, which comprises pharmacists, medical practitioners, and a pharmacologist, advises the Minister on which drugs and medicinal preparations should be made available as pharmaceutical benefits. The amendments to the regulations, which came into effect on 1 April 1983, adjust Schedules 1, 2, 3, and 5, addressing the listing of drugs and medicinal preparations based on their effectiveness, toxicity, and necessity. These regulations apply to all entities involved in the supply and prescription of pharmaceutical benefits within Australia, ensuring that the availability and conditions of these benefits are regulated in accordance with the recommendations of the Advisory Committee.
Key Provisions
The key operative sections of the National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1983 No. 28 revolve around the amendments to the schedules of the Regulations which list drugs and medicinal preparations available as pharmaceutical benefits. Section 85 of the National Health Act 1953 allows for the inclusion of drugs and preparations listed in the British Pharmacopoeia, as well as other prescribed drugs, to be made available as pharmaceutical benefits. Section 88A specifies that prescriptions for pharmaceutical benefits must be written under circumstances prescribed by regulation. The amendments to the Schedules (Schedules 1, 2, 3 and 5) reflect the recommendations of the Pharmaceutical Benefits Advisory Committee, which are subject to the Minister's approval.
The obligations imposed by the Act on the parties it governs primarily concern the Pharmaceutical Benefits Advisory Committee, which is tasked with recommending drugs and medicinal preparations that should be made available as pharmaceutical benefits. The Committee must consider all relevant facts about each drug or preparation, ensuring that recommended drugs are either more effective or less toxic than those already listed. Additionally, the Committee advises the Minister on matters concerning the operation of Part VII of the Act. The Minister, upon accepting the Committee's recommendations, is responsible for approving the drafting of Statutory Rules to amend the Regulations, thereby implementing the recommended changes.
Under the amended Regulations, the Committee's recommendations are enforced through the listing or delisting of drugs and medicinal preparations in the schedules. For instance, Schedule 1 lists drugs that should not be made available as pharmaceutical benefits, while Schedules 2 and 3 list those that should be made available. Schedule 5 outlines the conditions and restrictions on prescribing certain pharmaceutical benefits. These listings and conditions are legally binding, and entities such as pharmaceutical companies and healthcare providers must comply with the provisions set out in the amended Regulations.
Breaches of the amended Regulations may result in both civil and criminal consequences. For example, prescribing a pharmaceutical benefit that is not listed or failing to adhere to the conditions and restrictions specified in Schedule 5 may be considered an offence. The Act does not specify maximum penalties for such offences, but it does allow for the imposition of fines and other penalties as deemed appropriate by the courts. Additionally, healthcare providers who do not comply with the Regulations may face disciplinary actions from their respective professional boards, which could include suspension or revocation of their licenses to practice.