EXPLANATORY STATEMENT
STATUTORY RULES 1983 NO. 116
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 preparation 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 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.
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 in accordance with regulation 14.
The Statutory Rules which came into effect on 1 August 1983 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.
The Statutory Rules also amended Schedules 1, 2, 3 and 5 to the Regulations to accommodate the commencement on 1 August 1983 of the 1982 Addendum to the British Pharmacopoeia for Australian purposes.
The amendments to the Schedules since the last consolidation on 1 August 1982 are included in the Statutory Rules.
Overview
The National Health Act 1953, enacted by the Australian Parliament, addresses the provision of healthcare services, particularly the supply of drugs and medicinal preparations through the Pharmaceutical Benefits Scheme. The Act aims to ensure that certain pharmaceutical benefits are available to the public under the oversight of the Commonwealth. The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1983, issued by the Minister for Health under Section 140 of the Act, were introduced to implement changes recommended by the Pharmaceutical Benefits Advisory Committee. These regulations aim to adjust the lists of drugs and medicinal preparations that are available as pharmaceutical benefits, ensuring that the most effective and least toxic treatments are accessible while removing those that are outdated or less effective. The policy objective is to maintain an efficient and effective pharmaceutical benefits scheme that reflects current medical practices and advancements in drug therapies.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1983 pertain to the regulation of pharmaceutical benefits under the National Health Act 1953. These regulations apply to drugs and medicinal preparations listed in the British Pharmacopoeia, prescribing conditions for their availability, and to fixed combinations of drugs that the Pharmaceutical Benefits Advisory Committee recommends for inclusion. The regulations cover both the listing and delisting of pharmaceutical benefits and the conditions and restrictions under which certain drugs may be prescribed. The amendments, which came into effect on 1 August 1983, primarily reflect the recommendations of the Pharmaceutical Benefits Advisory Committee and the incorporation of the 1982 Addendum to the British Pharmacopoeia for Australian purposes. The regulations extend to the whole of Australia, as they are made under the authority of the Commonwealth. The Statutory Rules also incorporate subsequent amendments made to the Schedules of the Regulations, thereby extending their application and ensuring the continued relevance of the listed pharmaceutical benefits.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) provide for the implementation of recommendations made by the Pharmaceutical Benefits Advisory Committee under section 101 of the National Health Act 1953. These regulations, in particular, amend Schedules 1, 2, 3, and 5 of the Regulations to align with the Committee’s recommendations regarding which drugs and medicinal preparations should be available as pharmaceutical benefits, and which should not. For instance, Section 85 of the Act specifies that drugs listed in the British Pharmacopoeia are available as benefits unless otherwise prescribed, while Section 88A ensures that prescriptions for pharmaceutical benefits can only be written under specific circumstances as prescribed by regulation. The amendments to the Schedules are designed to ensure that the list of available pharmaceutical benefits is up-to-date and reflects the most current medical and pharmaceutical standards.
The regulations impose several obligations on various parties involved in the pharmaceutical benefits scheme. Firstly, the Pharmaceutical Benefits Advisory Committee is tasked with recommending drugs and medicinal preparations that should be made available as benefits, considering factors such as effectiveness and toxicity. The Minister for Health, in turn, is required to review these recommendations and, if accepted, approve the drafting of Statutory Rules to amend the Regulations accordingly. Additionally, the regulations mandate that certain drugs and medicinal preparations must meet specific criteria to be listed or delisted as benefits, ensuring that only those that meet the required standards are available to the public. These obligations ensure that the scheme operates efficiently and effectively, providing the public with access to the most suitable pharmaceutical benefits.
There are also specific offences and penalties outlined in the National Health Act 1953 for breaches of the regulations. For example, supplying a pharmaceutical benefit contrary to the Regulations can lead to both civil and criminal consequences. Civil penalties may include fines, while criminal penalties can result in imprisonment, reflecting the seriousness of non-compliance. The exact penalties depend on the nature and severity of the breach but are designed to deter individuals and entities from violating the regulations. It is crucial for all parties involved, including healthcare providers and pharmaceutical companies, to adhere to these regulations to avoid facing the legal consequences associated with non-compliance.