EXPLANATORY STATEMENT
STATUTORY RULES 1985 NO. 184
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 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 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 prepartion. 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 repeal the existing Schedules 1 to 5 to the Regulations and replace them with amended Schedules to give effect to the Pharmaceutical Benefits Advisory Committee’s recommendations of 7-8 February 1985 to the Minister. The Statutory Rules came into operation on 1 August 1985.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1985 No. 184, issued under the authority of the Minister for Health, were enacted to amend the existing regulations concerning the availability and prescription of pharmaceutical benefits under the National Health Act 1953. This legislative amendment aimed to address the need for regular updates to the list of drugs and medicinal preparations available as pharmaceutical benefits, ensuring that the Pharmaceutical Benefits Scheme remains current and effective in providing necessary medications to the public. The regulations reflect the recommendations of the Pharmaceutical Benefits Advisory Committee, which advises the Minister on matters pertaining to the operation of the pharmaceutical benefits scheme and the suitability of drugs for inclusion in the scheme.
The policy objective of these amendments is to ensure that the Pharmaceutical Benefits Scheme is efficient, effective, and responsive to medical advancements and public health needs. By updating the schedules of drugs and medicinal preparations available under the scheme, the regulations aim to provide access to the most appropriate and cost-effective medications, while also considering factors such as efficacy, toxicity, and the availability of alternative treatments. This legislative action underscores the importance of ongoing review and adaptation of the pharmaceutical benefits scheme to meet evolving healthcare requirements.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1985 No. 184, issued under Section 140 of the National Health Act 1953, amend the Regulations to reflect the recommendations of the Pharmaceutical Benefits Advisory Committee regarding the availability of pharmaceutical benefits. This amendment applies to all persons and entities within the Commonwealth of Australia, ensuring the consistent application of pharmaceutical benefit regulations across the country. The Regulations determine which drugs and medicinal preparations are available as pharmaceutical benefits, including those listed in the British Pharmacopoeia and others that are not, as well as fixed combinations of drugs and medicinal preparations, and additives that may be used with pharmaceutical benefits. The Regulations also specify conditions and restrictions on the prescription of certain pharmaceutical benefits. The amendments came into operation on 1 August 1985, replacing the existing Schedules 1 to 5 with updated schedules to incorporate the Committee's recommendations.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1985 No. 184 introduce amendments to the existing regulations concerning the availability of pharmaceutical benefits under the National Health Act 1953 (the Act). The main operative sections (sections 85, 88A, and 101) are integral to the operation of Part VII of the Act, which pertains to the supply of drugs and medicinal preparations as pharmaceutical benefits. Section 85 of the Act outlines the availability of drugs and medicinal preparations listed in the British Pharmacopoeia as pharmaceutical benefits, subject to prescribed exceptions and additions found in Schedule 1 to the Regulations. Section 88A specifies the circumstances under which prescriptions for these pharmaceutical benefits can be written, while Section 101 establishes the Pharmaceutical Benefits Advisory Committee, whose role is to recommend drugs and medicinal preparations for inclusion as pharmaceutical benefits and to advise the Minister on related matters.
The amended Regulations impose specific obligations and requirements on parties and entities governed by the Act. Healthcare providers, for instance, must ensure that their prescriptions align with the conditions and restrictions set forth in Schedule 5 of the Regulations, which lists pharmaceutical benefits subject to certain conditions and restrictions. Manufacturers and suppliers of pharmaceutical benefits are required to adhere to the updated lists in the Schedules, ensuring that only those drugs and medicinal preparations explicitly listed as available are supplied. The Pharmaceutical Benefits Advisory Committee is tasked with making recommendations to the Minister based on efficacy, toxicity, and the need for single-drug therapies, as well as considering the disuse of certain drugs.
Breaches of the amended Regulations can lead to various civil or criminal consequences. For instance, healthcare providers who write prescriptions in circumstances not permitted by the Regulations may face disciplinary action, including fines or suspension of their practice licenses. Suppliers and manufacturers who fail to comply with the updated Schedules may also face penalties, including fines or the prohibition of supply. The specific penalties for breaches of the Regulations are not detailed in the provided text, but generally, such breaches can result in significant legal and financial repercussions for the offending parties.
The Statutory Rules, which came into operation on 1 August 1985, replace the existing Schedules 1 to 5 with amended versions that reflect the Pharmaceutical Benefits Advisory Committee’s recommendations made to the Minister on 7-8 February 1985. This amendment ensures that the Regulations are up-to-date with the latest recommendations regarding which drugs and medicinal preparations should be available as pharmaceutical benefits, thereby maintaining the efficacy and safety standards expected under the Act.