EXPLANATORY STATEMENT
STATUTORY RULES 1982 NO.76
NATIONAL HEALTH ACT 1953
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.
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 medical 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 Rules to amend the National Health (Pharmaceutical Benefits) Regulations to give effect to the recommendations.
The Statutory Rules which came into operation on 1 April 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 of certain conditions and restrictions in accordance with regulation 14.
Overview
The National Health Act 1953, as amended by the National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1982 No. 76, was enacted to facilitate the supply of certain drugs and medicinal preparations as pharmaceutical benefits by the Commonwealth. This legislation addresses the need to regulate and make available effective, less toxic, or newly discovered drugs as part of the national health scheme while ensuring the appropriate use of pharmaceuticals. The amendments were issued by the authority of the Minister for Health and were made to align the Pharmaceutical Benefits list with recommendations from the Pharmaceutical Benefits Advisory Committee. The Committee, consisting of medical practitioners, pharmacists, and a pharmacologist, assesses drugs and medicinal preparations to ensure they meet efficacy and safety standards before recommending their inclusion or exclusion from the list of available pharmaceutical benefits. The objective is to provide an effective, accessible, and well-regulated pharmaceutical benefits scheme for the Australian public.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) under the National Health Act 1953 applies to the provision of pharmaceutical benefits, specifically the supply of certain drugs and medicinal preparations by the Commonwealth. This legislation is applicable to entities and individuals involved in the prescription, supply, and administration of these benefits, as well as the pharmaceutical industry which produces and markets these drugs. The scope of the regulations extends to the entire nation, ensuring a consistent approach to pharmaceutical benefits across Australia. The Act excludes drugs and preparations listed in Schedule 1, which are not recommended for Commonwealth availability, and includes those listed in Schedules 2 and 3, which are approved for such availability. Furthermore, the Act allows for the amendment of these regulations through subordinate instruments, such as Statutory Rules, to keep up with new medical findings and market changes, thereby maintaining the relevance and effectiveness of the pharmaceutical benefits scheme.
Key Provisions
The key provisions of the National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1982 No. 76, under the National Health Act 1953, amend various schedules to enhance the availability and regulation of pharmaceutical benefits. Section 85 of the Act mandates that drugs and medicinal preparations listed in the British Pharmacopoeia, or their prescribed compounds, should be available as pharmaceutical benefits unless specified otherwise. Section 88A limits the prescription of these benefits to circumstances as prescribed, ensuring controlled access to certain medications. Section 101 establishes the Pharmaceutical Benefits Advisory Committee, tasked with recommending drugs and preparations for listing or delisting based on their efficacy and safety compared to existing options.
The regulations impose specific obligations on healthcare providers and entities involved in the supply of pharmaceutical benefits. Medical practitioners must adhere to the guidelines set forth in the amended schedules when prescribing drugs listed as benefits. The Pharmaceutical Benefits Advisory Committee is obligated to convene and deliberate on the suitability of drugs for inclusion or exclusion from the pharmaceutical benefits list, ensuring their recommendations are grounded in scientific and medical evidence. The Minister for Health, upon accepting these recommendations, is required to draft and enact Statutory Rules to amend the regulations accordingly, ensuring that the changes are implemented effectively and efficiently.
Violations of the provisions set out in these regulations may result in both civil and criminal consequences. For instance, prescribing a pharmaceutical benefit outside the prescribed circumstances can lead to penalties under the Act. The maximum penalties for contravening these regulations can include fines or imprisonment, depending on the severity of the breach. Additionally, entities involved in the supply of pharmaceutical benefits that fail to comply with the regulations may face legal action, which could result in fines or other sanctions as deemed appropriate by the courts. These consequences are intended to enforce compliance and maintain the integrity of the pharmaceutical benefits scheme.