EXPLANATORY STATEMENT
STATUTORY RULES 1986 NO 38
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 10-11 October 1985 to the Minister. There were no amendments to Schedule 4.
The Statutory Rules came into operation on 1 April 1986.
Overview
The National Health Act 1953 was enacted to provide a framework for the provision of health services in Australia, including the regulation of pharmaceutical benefits. One of its key purposes was to ensure that certain drugs and medicinal preparations are accessible to the public as part of the national health scheme. The Act established the Pharmaceutical Benefits Advisory Committee to recommend drugs and medicinal preparations for inclusion as pharmaceutical benefits. The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1986, issued by the authority of the Minister for Health, were introduced to amend the regulations under the Act, ensuring they align with the recommendations made by the Committee. These amendments sought to maintain the availability of effective and safe pharmaceutical benefits, while also ensuring that resources are allocated efficiently by removing or updating listings as necessary. The policy objective was to ensure that the pharmaceutical benefits provided under the Act remain current, effective, and reflective of the latest medical evidence and public health needs.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1986 No 38 applies to the regulation of pharmaceutical benefits under the National Health Act 1953, specifically concerning the listing of drugs and medicinal preparations available as benefits, the writing of prescriptions for these benefits, and the establishment and role of the Pharmaceutical Benefits Advisory Committee. The Regulations amend the National Health (Pharmaceutical Benefits) Regulations to reflect the recommendations of the Committee, which advises the Minister for Health on the drugs and preparations to be listed as pharmaceutical benefits. These Regulations apply across Australia, as they are an extension of Commonwealth legislation. The Regulations cover entities such as medical practitioners, pharmacists, and patients who are directly involved in the supply and use of pharmaceutical benefits. They also address the inclusion or exclusion of specific drugs and medicinal preparations, their compounds, fixed combinations, and additives from the list of pharmaceutical benefits, as well as any conditions or restrictions on their prescribing. The amendments to Schedules 1, 2, 3, and 5 of the Regulations incorporate the Committee’s recommendations from its meeting on 10-11 October 1985. The changes took effect on 1 April 1986, with no amendments made to Schedule 4, which pertains to additives used with pharmaceutical benefits.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1986, made under the authority of the Minister for Health, amend the National Health (Pharmaceutical Benefits) Regulations by modifying Schedules 1, 2, 3, and 5. These amendments reflect the recommendations of the Pharmaceutical Benefits Advisory Committee, which were approved by the Minister for Health and aimed at updating the list of drugs and medicinal preparations available as pharmaceutical benefits (section 140). Specifically, Schedule 1 lists drugs and medicinal preparations excluded from pharmaceutical benefits; Schedule 2 includes fixed combinations of drugs available as benefits; Schedule 3 lists drugs and preparations available as benefits that are not in the British Pharmacopoeia; and Schedule 5 details the conditions and restrictions on the prescribing of certain pharmaceutical benefits.
The regulations impose specific obligations on healthcare providers and patients to ensure compliance with the updated lists of available pharmaceutical benefits. Healthcare providers must adhere to the conditions and restrictions outlined in Schedule 5 when prescribing medications, ensuring that they only prescribe drugs and medicinal preparations listed in Schedules 2 and 3. Patients, in turn, are expected to be aware of which drugs and medicinal preparations are covered by pharmaceutical benefits and to comply with any restrictions or conditions imposed on their prescriptions. This compliance is crucial for maintaining the integrity of the pharmaceutical benefits scheme and ensuring equitable access to necessary medications.
Failure to comply with the provisions of these regulations can result in both civil and criminal consequences. For instance, healthcare providers who knowingly prescribe drugs not listed as pharmaceutical benefits or who ignore the conditions and restrictions specified in Schedule 5 may face penalties. The maximum penalties for such offences are not explicitly stated in the provided text but generally, penalties for non-compliance with health regulations can include fines and, in severe cases, imprisonment. Additionally, any person who falsely claims entitlement to a pharmaceutical benefit may be subject to prosecution, which could result in fines or other legal repercussions.
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1986 serve to update and maintain the list of drugs and medicinal preparations available under the pharmaceutical benefits scheme, ensuring that healthcare providers and patients are aware of what is covered. These regulations impose specific obligations on both providers and patients to ensure compliance with the scheme’s provisions. Non-compliance can lead to significant penalties, including fines and potential imprisonment for healthcare providers, underscoring the importance of adhering to the updated schedules and conditions set forth in the regulations.