EXPLANATORY STATEMENT
STATUTORY RULES 1983 NO. 292
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, 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 authorised 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 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 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 Rules to amend the National Health (Pharmaceutical Benefits) Regulations to give effect to the recommendations.
The Schedules to the National Health (Pharmaceutical Benefits) Regulations provide as follows:
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. The
three medicinal preparations added to Schedule 3 by these regulations, have been available as pharmaceutical benefits in the form of their constituent ingredients. These constituent ingredients have been the subject of a recommendation by the Pharmaceutical Benefits Advisory Committee. Some of these constituent ingredients have been deleted by these regulations and this has necessitated the listing of the medicinal preparations in their own right;
Schedule 4 lists the additives that may be used with pharmaceutical benefits; and
Schedule 5 lists the pharmaceutical benefits the prescribing of which is subject to certain conditions and restrictions provided for in the regulations.
The regulations which came into effect on 1 December 1983 amended Schedules 1, 2, 3, 4 and 5 to the National Health (Pharmaceutical Benefits) Regulations to give effect to the Pharmaceutical Benefits Advisory Committee’s recommendations to the Minister.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1983, enacted under Section 140 of the National Health Act 1953, address the need for a regulatory framework to ensure the availability of effective and safe pharmaceutical benefits under the Act. These regulations amend Schedules 1, 2, 3, 4, and 5 to the National Health (Pharmaceutical Benefits) Regulations to incorporate recommendations from the Pharmaceutical Benefits Advisory Committee. The Committee, established under Section 101 of the Act, advises the Minister for Health on drugs and medicinal preparations that should be made available as pharmaceutical benefits. By amending these schedules, the regulations ensure that only those drugs and combinations that meet the Committee's criteria for effectiveness and safety are listed, while also considering the removal of outdated or less effective drugs. This legislative amendment aims to maintain the integrity and efficacy of the Pharmaceutical Benefits Scheme by regularly updating the list of available benefits in line with medical and scientific advancements.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1983 No. 292, made under Section 140 of the National Health Act 1953, apply to the listing and prescribing of pharmaceutical benefits provided by the Commonwealth, impacting all medical practitioners, pharmacists, and patients who interact with the Pharmaceutical Benefits Scheme (PBS). These regulations outline the specific drugs and medicinal preparations that are eligible for subsidy under the PBS, detailing which compounds are available and which are excluded, based on recommendations from the Pharmaceutical Benefits Advisory Committee. The regulations also establish the conditions and restrictions on the prescribing of certain pharmaceutical benefits. These regulations have a national reach within Australia, as they are implemented under the authority of the Commonwealth. Exclusions and specific conditions for prescribing are outlined in Schedules 1 through 5, which detail the drugs, fixed combinations, and additives that are either included or excluded from the PBS. The application of these regulations may be further defined or restricted through subordinate instruments, which can provide additional clarification or specific details necessary for the implementation of the PBS.
Key Provisions
The key provisions of the Statutory Rules 1983 No. 292 amend the National Health (Pharmaceutical Benefits) Regulations to incorporate the recommendations of the Pharmaceutical Benefits Advisory Committee. Under Section 140 of the National Health Act 1953, these regulations are authorised to prescribe matters necessary for carrying out or giving effect to the Act, including the availability of pharmaceutical benefits. Specifically, the amendments update Schedules 1, 2, 3, 4, and 5 of the regulations. Schedule 1 lists drugs and preparations from the British Pharmacopoeia that should not be made available as benefits, while Schedule 2 lists fixed combinations of drugs that should be available. Schedule 3 lists drugs and preparations not in the British Pharmacopoeia that should be made available. Schedule 4 lists permissible additives, and Schedule 5 lists benefits subject to certain conditions and restrictions.
These regulations impose obligations on various parties, including the Pharmaceutical Benefits Advisory Committee, the Minister for Health, and potentially healthcare providers and patients. The Committee is mandated to evaluate drugs and medicinal preparations for their effectiveness and toxicity, and to recommend those that should be made available as pharmaceutical benefits. The Minister must consider these recommendations and, if accepted, approve the drafting of Statutory Rules to amend the regulations accordingly. Healthcare providers must adhere to the conditions and restrictions outlined in Schedule 5 when prescribing pharmaceutical benefits, and patients must be aware of the drugs available to them under the regulations.
Breaches of these regulations can result in civil or criminal penalties, although the specific consequences are not detailed in the provided text. The penalties for non-compliance could range from fines to more severe criminal sanctions, depending on the nature and severity of the breach. However, the maximum penalties are not specified within this document, and further legislative or regulatory texts would need to be consulted for precise details. It is crucial for all parties involved to understand and comply with these regulations to ensure the proper administration of pharmaceutical benefits under the National Health Act 1953.