EXPLANATORY STATEMENT
STATUTORY RULES 1985 NO. 32
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 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, namely those noted in Schedule 1 to the National Health (Pharmaceutical Benefits) Regulations (‘the Regulations’), 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 (namely those listed in Schedule 2 to the Regulations).
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.
Section 101 of the Act establishes the Pharmaceutical Benefits Advisory Committee, consisting of medical practitioners, pharmacists and a pharmacologist, to recommend to the Minister for Health (‘the Minister’) the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits, and to advise the Minister on any matter concerning the operation of Part VII of the Act referred to it by the Minister.
The Committee meets three times a year and after each meeting makes recommendations to the Minister in accordance with the Act. 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. If the Minister accepts the Committee’s recommendations, he agrees to the drafting of Statutory Rules to amend the Regulations to give effect to the recommendations.
The Schedules to the Regulations provide as follows:
Schedule 1 lists those drugs and medicinal preparations that are the subject of monographs in the British Pharmacopoeia but which are not available as pharmaceutical benefits;
Schedule 2 lists those fixed combinations of drugs and medicinal preparations which are 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 are available as pharmaceutical benefits;
Schedule 4 lists the additives that may be used with pharmaceutical benefits;
Schedule 5 lists the pharmaceutical benefits, the prescribing of which is subject to certain conditions and restrictions provided for in the Regulations.
The Statutory Rules which are expressed to come into effect on 1 April 1985 amend Schedules 1,
2, 3 and 5 to the Regulations to give effect to the Pharmaceutical Benefits Advisory Committee’s recommendations of 11-12 October 1984 to the Minister.
In addition the Statutory Rules consolidate all those amendments made to the Schedules since the last consolidation on 1 August 1983.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1985 were introduced to address the need for an updated and consolidated set of regulations governing the pharmaceutical benefits available under the National Health Act 1953. This amendment was enacted to streamline and clarify the pharmaceutical benefits listed in the regulations, reflecting the recommendations of the Pharmaceutical Benefits Advisory Committee. The rules were issued under the authority of the Minister for Health and the primary objective was to ensure that the benefits provided align with the latest medical advice and the availability of more effective or less toxic drugs. The amendments also aimed to enhance the clarity and accessibility of the regulations by consolidating all changes made since the last consolidation in August 1983. This legislative update was necessary to maintain the effectiveness and relevance of the pharmaceutical benefits scheme within the Australian healthcare system.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1985 No. 32, made under Section 140 of the National Health Act 1953, govern the supply of drugs and medicinal preparations as pharmaceutical benefits by the Commonwealth. The Act applies to individuals and entities involved in the prescription, supply, and administration of pharmaceutical benefits, and it encompasses a wide range of industries and conduct related to these drugs and preparations. The Regulations provide a detailed framework for determining which drugs and medicinal preparations are available as pharmaceutical benefits, including those listed in the British Pharmacopoeia and other compounds, and also outline the conditions and restrictions on prescribing certain pharmaceutical benefits. The Regulations are applicable nationally, covering the entire Commonwealth of Australia. Exclusions and specific conditions for pharmaceutical benefits are detailed in the Schedules to the Regulations, which list drugs and preparations not available as benefits, fixed combinations that are available, and those subject to certain conditions and restrictions. The Regulations also allow for further amendments and specifications through subordinate instruments, ensuring the framework remains current and responsive to new recommendations and medical advancements.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1985 No. 32 amend and consolidate the schedules to the National Health (Pharmaceutical Benefits) Regulations, governing the availability of certain drugs and medicinal preparations as pharmaceutical benefits under the National Health Act 1953. The amendments, which come into effect on 1 April 1985, are based on the recommendations of the Pharmaceutical Benefits Advisory Committee made to the Minister for Health in October 1984. These amendments and consolidations primarily affect Schedules 1, 2, 3, and 5 of the Regulations.
Under these Regulations, the Minister is empowered to make rules concerning the pharmaceutical benefits provided by the Commonwealth, subject to the provisions of the Act. The Regulations specify which drugs and medicinal preparations are available as benefits, including those listed in the British Pharmacopoeia, fixed combinations, and those not in the Pharmacopoeia but still eligible as benefits. These schedules detail what drugs are excluded from benefits, what combinations are permitted, and what specific drugs are included despite not being in the Pharmacopoeia. Additionally, they list the additives that may be used with pharmaceutical benefits and outline the conditions and restrictions on prescribing certain pharmaceutical benefits.
The Regulations impose several obligations on parties involved, including healthcare providers, pharmacists, and patients. Healthcare providers must ensure that prescriptions for pharmaceutical benefits comply with the conditions and restrictions outlined in the Regulations. Pharmacists are responsible for verifying that the drugs dispensed meet the criteria for pharmaceutical benefits and that they comply with any specific conditions. Patients, in turn, need to be aware of the drugs that are covered under pharmaceutical benefits and understand any restrictions that apply to their prescriptions.
Failure to comply with the provisions of the Regulations can result in various consequences. For instance, prescribing a pharmaceutical benefit outside the allowed conditions could lead to civil or criminal penalties. The Act provides for fines and imprisonment for certain violations, although the specific penalties are not detailed in the explanatory statement. Generally, non-compliance can lead to legal action, fines, and in severe cases, imprisonment, depending on the nature and severity of the breach.