EXPLANATORY STATEMENT
STATUTORY RULES 1985 NO. 320
ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH
National Health Act 1953
National Health (Pharmaceutical Benefits) Regulations (Amendment)
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 or convenient 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, namely those noted in Schedule 1 to the National Health
(Pharmaceutical Benefits) Regulations (‘the Regulations’), 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 (namely those listed in Schedule 2 to the Regulations).
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 (‘the Committee’), consisting of medical practitioners, pharmacists and a pharmacologist, to recommend to the Minister for Health (‘the Minister’) 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 of the Act referred to it by the Minister.
The Committee meets three times a year and after each meeting makes recommendations to the Minister in accordance with the Act. 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. If the Minister accepts the Committee’s recommendations, he agrees to the drafting of Statutory Rules to amend the Regulations to give effect to the recommendations.
The Schedules to the Regulations provide as follows:
Schedule 1 lists those drugs and medicinal preparations that are the subject of monographs in the British Pharmacopoeia but which are not available as pharmaceutical benefits;
Schedule 2 lists those fixed combinations of drugs and medicinal preparations which are 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 are 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 Statutory Rules amended Schedules 1, 2, 3 and 5 to the Regulations and in so doing gave effect to the Committee’s recommendations of 13-14 June 1985 to the Minister. There were no amendments to Schedule 4.
Regulations 22 and 26 of the Regulations provide, amongst other things, that a pharmaceutical benefit is not to be supplied if the prescription, or the duplicate of the prescription in the case of a repeat authorization, is dated more than 6 months before the date of supply. Regulations 3 and 4 of the Statutory Rules extended that 6 month period to 12 months.
The Statutory Rules are expressed to come into operation on 1 December 1985.
Overview
The National Health Act 1953, enacted by the Australian Parliament, addresses the provision and regulation of pharmaceutical benefits within Australia. This Act enables the Commonwealth to supply certain drugs and medicinal preparations, ensuring they are available to the public under a structured framework. One significant aspect of the Act is the establishment of the Pharmaceutical Benefits Advisory Committee, which advises the Minister for Health on which drugs should be included in the pharmaceutical benefits schedule, based on factors such as effectiveness and toxicity. The problem the Act was introduced to address was the need for a systematic and authoritative approach to managing the availability of pharmaceuticals, ensuring they are both effective and accessible. The policy objective, as stated in the Act, is to provide a coordinated and comprehensive pharmaceutical benefits scheme that meets the health needs of Australians. The recent amendments to the National Health (Pharmaceutical Benefits) Regulations, through Statutory Rules 1985 No. 320, further refine these provisions by extending the validity period of prescriptions from six to twelve months, thus enhancing the efficiency and accessibility of the pharmaceutical benefits scheme.
Scope and Application
The National Health Act 1953, through its Pharmaceutical Benefits Regulations, governs the availability of certain drugs and medicinal preparations as pharmaceutical benefits within Australia. The Act applies to all individuals and entities involved in the prescription, supply, and administration of these pharmaceutical benefits, which include drugs and medicinal preparations listed in the British Pharmacopoeia or specified in the Schedules of the Regulations. These Schedules detail which drugs are available as benefits, fixed combinations that are permissible, non-pharmacopoeia drugs that are included, allowable additives, and conditions under which certain drugs can be prescribed. The Act’s jurisdiction is nationwide, extending to all states and territories within the Commonwealth of Australia. Notably, the Act excludes drugs and preparations listed in Schedules 1 and 2 of the Regulations from being available as pharmaceutical benefits unless specifically prescribed otherwise. Additionally, the Act can be further refined through subordinate instruments, which may impose additional conditions or restrictions on the supply and prescription of pharmaceutical benefits.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1985 No. 320, made under Section 140 of the National Health Act 1953, amend the Pharmaceutical Benefits to give effect to the Pharmaceutical Benefits Advisory Committee's recommendations dated 13-14 June 1985. These amendments update the Schedules of the Regulations to align with the Committee's decisions on the availability of various drugs and medicinal preparations as pharmaceutical benefits. The amendments modify Schedules 1, 2, 3, and 5, while Schedule 4, concerning additives, remains unchanged.
The Regulations, as amended, impose specific obligations on parties involved in the pharmaceutical benefits scheme. For example, prescribers must ensure that any prescriptions for pharmaceutical benefits are not older than 12 months from the date of supply, as per the amendments to Regulations 3 and 4. Additionally, the Pharmaceutical Benefits Advisory Committee is mandated to recommend to the Minister for Health the drugs and medicinal preparations that should be made available as pharmaceutical benefits. The Committee must base its recommendations on comprehensive evaluations of the effectiveness and toxicity of the drugs compared to existing options.
Failure to comply with the amended Regulations can result in civil or criminal consequences. For instance, supplying a pharmaceutical benefit based on an outdated prescription, which is now dated more than 12 months old, can be considered a breach. Penalties for such breaches can include fines and other sanctions as prescribed by the relevant legislation. However, the exact penalties are not specified in the Statutory Rules but are likely to be outlined in other relevant laws or regulations.
In summary, the Statutory Rules 1985 No. 320 implement changes to the Pharmaceutical Benefits scheme based on the recommendations of the Pharmaceutical Benefits Advisory Committee. These changes update the availability of certain drugs and medicinal preparations as pharmaceutical benefits and extend the validity period of prescriptions. Compliance with these regulations is crucial to avoid potential penalties for non-compliance, which can include fines and other enforcement actions.