EXPLANATORY STATEMENT
STATUTORY RULES 1982 NO. 179
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 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.
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 operation on 1 August 1982 amend 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 amend Schedules 1, 2, 3 and 5 to the Regulations to accommodate the commencement on 1 August 1982 of the 1981 Addendum to the British Pharmacopoeia for Australian purposes.
The amendments to the Schedules since the last consolidation on 1 August 1981 are included in the Statutory Rules.
Overview
The National Health Act 1953, enacted by the Australian Parliament, was introduced to provide a framework for the administration of health services and the supply of certain drugs and medicinal preparations as pharmaceutical benefits. A key aspect of the Act is the establishment of the Pharmaceutical Benefits Advisory Committee, which advises the Minister for Health on the drugs and preparations that should be available as pharmaceutical benefits under the Act. The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1982, issued under the authority of the Minister for Health, amended Schedules 1, 2, 3 and 5 of the Regulations to implement the Committee's recommendations and to incorporate changes from the 1981 Addendum to the British Pharmacopoeia for Australian purposes. These amendments sought to ensure the availability of more effective or less toxic drugs, and to remove fixed combinations of drugs that are no longer necessary or have fallen into disuse. The policy objective of these amendments is to ensure that the Pharmaceutical Benefits Scheme remains efficient and effective in providing access to necessary pharmaceutical benefits.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1982 pertain to the regulation of pharmaceutical benefits under the National Health Act 1953, and specifically amend the schedules of the National Health (Pharmaceutical Benefits) Regulations. This legislation applies to individuals and entities involved in the supply and prescription of pharmaceutical benefits, including medical practitioners, pharmacists, and pharmaceutical companies. The regulations are applicable nationally across Australia, as they are made under the authority of the Commonwealth. The Act allows for the inclusion or exclusion of certain drugs and medicinal preparations as pharmaceutical benefits, with the Pharmaceutical Benefits Advisory Committee making recommendations to the Minister for Health, who has the final authority to approve the drafting of Statutory Rules to implement these recommendations. The amendments to the schedules reflect the Committee’s decisions on which drugs should be listed or delisted, and adjustments to accommodate the 1981 Addendum to the British Pharmacopoeia for Australian purposes. These regulations establish the framework within which pharmaceutical benefits are determined and regulated, ensuring that the supply of drugs and medicinal preparations is managed effectively to benefit public health.
Key Provisions
The primary sections of the National Health (Pharmaceutical Benefits) Regulations (Amendment) concern the updates and modifications to Schedules 1, 2, 3, and 5, which are the main components that list drugs and medicinal preparations available as pharmaceutical benefits, as well as the conditions and restrictions under which they can be prescribed (section 140). Section 85 stipulates that drugs and medicinal preparations included in the British Pharmacopoeia are available as benefits, along with their prescribed compounds. Section 88A sets out the conditions under which prescriptions for pharmaceutical benefits can be written. The amendments made to the regulations in these schedules reflect the Pharmaceutical Benefits Advisory Committee’s recommendations (section 101).
The obligations imposed by these regulations on parties and entities primarily revolve around compliance with the listed drugs and medicinal preparations, their compounds, and the conditions and restrictions outlined in the amended schedules. The Pharmaceutical Benefits Advisory Committee is mandated to evaluate and recommend drugs and medical preparations for listing as pharmaceutical benefits based on their effectiveness and toxicity compared to existing options (section 101). Health practitioners must adhere to the updated lists and conditions specified in the schedules when prescribing pharmaceutical benefits. Additionally, entities such as pharmaceutical companies and suppliers must ensure their products align with the regulatory requirements for being listed as pharmaceutical benefits.
The National Health Act 1953 does not explicitly outline specific offences, penalties, or consequences for breaches of the regulations within the provided text. However, the broader framework of the Act suggests that non-compliance with the regulations could result in legal action, which might include fines or other penalties as determined by the relevant authorities. It is essential for all parties involved to adhere to the updated schedules to avoid potential legal repercussions, although the exact penalties for non-compliance are not detailed in the provided statutory rules.