EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 169
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, 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 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 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 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 regulations which came into effect on 1 August 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 of 9-10 February 1984 to the Minister.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1984 No. 169, enacted under the authority of the Minister for Health, aim to update the pharmaceutical benefits available under the National Health Act 1953. This regulation addresses the need for a dynamic and responsive pharmaceutical benefits scheme by allowing for the periodic review and amendment of the pharmaceutical benefits list, ensuring that the most effective and safest medications are accessible to the public. The amendments are based on recommendations from the Pharmaceutical Benefits Advisory Committee, which evaluates drugs and medicinal preparations for their efficacy, toxicity, and disuse, ensuring the scheme remains current and effective.
The policy objective behind these regulations is to maintain a pharmaceutical benefits list that reflects the latest medical evidence and technological advancements, providing Australians with access to beneficial and cost-effective pharmaceutical treatments. By amending the schedules of the National Health (Pharmaceutical Benefits) Regulations, the regulations ensure that the Pharmaceutical Benefits Scheme can adapt to new medical discoveries, changes in drug formulations, and shifts in clinical practices, thereby enhancing public health outcomes and ensuring the sustainability of the scheme.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1984 No. 169, issued under the authority of the Minister for Health, govern the supply of pharmaceutical benefits within Australia, operating under the provisions of the National Health Act 1953. These regulations apply to all individuals and entities involved in the supply and prescription of pharmaceutical benefits, encompassing medical practitioners, pharmacists, and patients who are recipients of such benefits. The regulations determine which drugs and medicinal preparations are available as benefits, including those listed in the British Pharmacopoeia and those not listed but still available, as well as fixed combinations and additives. The reach of these regulations is nationwide, as they pertain to the Commonwealth of Australia and apply across all states and territories. Certain exclusions and conditions are specified within the schedules of the Regulations, detailing which pharmaceutical products are not available as benefits, which combinations are permitted, and which benefits come with prescribing restrictions. The application of these regulations may be extended or refined through subordinate instruments, allowing for further specification and adaptation to changes in medical practice and pharmaceutical availability.
Key Provisions
The main sections of the National Health (Pharmaceutical Benefits) Regulations (Amendment) provide specific details about the drugs and medicinal preparations available as pharmaceutical benefits under the National Health Act 1953 (the Act). Section 85 of the Act indicates that drugs and medicinal preparations listed in the British Pharmacopoeia are available as benefits, with certain exceptions and additions prescribed in Schedule 1 of the Regulations (section 85(1)). Additionally, prescribed compounds of these drugs and medicinal preparations are available as benefits as listed in Schedule 2 (section 85(2)). This means that any drug or medicinal preparation not listed in Schedule 1 and any compound not listed in Schedule 2 will be considered a pharmaceutical benefit, subject to further conditions in Schedules 3 and 5.
The Regulations impose obligations on healthcare providers and patients. Healthcare providers, such as medical practitioners, must adhere to the criteria set out in Schedule 5, which includes specific conditions and restrictions on the prescribing of certain pharmaceutical benefits. For example, some drugs may only be prescribed under certain circumstances or with specific approvals. Patients must comply with these conditions to be eligible for pharmaceutical benefits. Furthermore, the Regulations require that any prescription for a pharmaceutical benefit must be written under circumstances prescribed in relation to that benefit, as stipulated in section 88A of the Act.
Failure to comply with the provisions of these Regulations can lead to various consequences. For instance, prescribing a pharmaceutical benefit outside the conditions outlined in Schedule 5 can result in the provider facing penalties under the Act. The exact penalties are not specified in the Regulations but could include fines or other administrative actions. Additionally, patients who do not adhere to the prescribed conditions for receiving pharmaceutical benefits may not be eligible for the benefits, potentially impacting their access to necessary medications. The precise civil or criminal consequences for non-compliance are not detailed in the provided text, but they can include financial penalties or other legal actions as determined by the relevant authorities.