EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 50
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;
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 regulations which came into effect on 1 April 1984 amended Schedules 1, 2, 3 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) 1996 were enacted to provide for amendments to the Pharmaceutical Benefits Schedule, ensuring that the availability of certain drugs and medicinal preparations aligns with the recommendations made by the Pharmaceutical Benefits Advisory Committee. This amendment was necessary to update the regulations in accordance with the latest recommendations, which aimed to ensure that only drugs deemed more effective or less toxic, and not in disuse, are included in the Pharmaceutical Benefits Schedule. The amendments were issued under the authority of the Minister for Health, pursuant to Section 140 of the National Health Act 1953, which empowers the Governor-General to make regulations necessary for carrying out or giving effect to the Act. The policy objective of these regulations is to ensure the availability of pharmaceutical benefits that meet the evolving health needs of the Australian population, while maintaining the integrity and efficacy of the Pharmaceutical Benefits Scheme.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1984 No. 50 apply to the management and supply of pharmaceutical benefits under the National Health Act 1953. This Act and its regulations apply to the Commonwealth, and specifically pertain to the provision of certain drugs and medicinal preparations as pharmaceutical benefits, which are subject to monographs in the British Pharmacopoeia. The regulations are designed to ensure that only specified drugs and medicinal preparations are available as benefits, with the Pharmaceutical Benefits Advisory Committee playing a crucial role in recommending which drugs should be included or excluded from the benefits list. The amendments to the regulations, as detailed in the Statutory Rules, reflect the Committee’s recommendations and are intended to update the lists of drugs and medicinal preparations, as well as the conditions and restrictions on prescribing certain pharmaceutical benefits. The application of these regulations is national, as they are issued under the authority of the Minister for Health and apply across Australia. Exclusions and specific conditions are outlined in the various schedules of the regulations, which detail which drugs are not to be provided as benefits and which are subject to particular prescribing conditions.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1984 No. 50, made under the authority of the Minister for Health, amend the existing regulations to incorporate the latest recommendations from the Pharmaceutical Benefits Advisory Committee. The Act (section 85) specifies that drugs and medicinal preparations listed in the British Pharmacopoeia, along with their prescribed compounds, are available as pharmaceutical benefits unless specifically excluded. Section 88A of the Act mandates that prescriptions for these benefits can only be written under prescribed circumstances. The Pharmaceutical Benefits Advisory Committee, established by section 101, evaluates drugs for their effectiveness, toxicity, and necessity, recommending which should be added or removed from the list of pharmaceutical benefits.
The amended regulations primarily affect the lists in Schedules 1, 2, 3, and 5 of the National Health (Pharmaceutical Benefits) Regulations. Schedule 1 includes drugs that, despite being in the British Pharmacopoeia, are not recommended for Commonwealth supply as pharmaceutical benefits. Schedule 2 lists fixed combinations of drugs that are recommended for availability. Schedule 3 contains drugs not in the British Pharmacopoeia but recommended for availability. Schedule 5 includes pharmaceutical benefits subject to specific conditions and restrictions. These schedules are updated based on the committee's recommendations, ensuring that the most effective and least toxic drugs are available while removing outdated or less effective ones.
The amended regulations impose specific obligations on healthcare providers and pharmaceutical companies. Healthcare providers must adhere to the conditions and restrictions outlined in Schedule 5 when prescribing pharmaceutical benefits. This includes complying with any specified conditions for the use of certain drugs. Pharmaceutical companies are required to ensure that their products comply with the listings and restrictions in the amended schedules. Any changes to the availability of pharmaceutical benefits must follow the recommendations of the Pharmaceutical Benefits Advisory Committee and subsequent ministerial approvals.
Breaches of the regulations can result in both civil and criminal consequences. For instance, writing a prescription not in accordance with the regulations could be considered a civil offence, potentially leading to fines or other penalties. Additionally, providing pharmaceutical benefits that do not comply with the listed conditions may result in legal action against both the healthcare provider and the pharmaceutical company. The exact penalties are not specified in the explanatory statement but generally align with the severity of the breach, potentially including fines or imprisonment for more serious violations.