EXPLANATORY STATEMENT
STATUTORY RULES 1986 NO. 194
ISSUED BY 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 provides 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 pharmaceutical benefits. Section 85 also provides that prescribed compounds of those drugs and medicinal preparations shall also be available as pharmaceutical benefits.
The Schedules to the National Health (Pharmaceutical Benefits) Regulations (“the Regulations”) prescribe the exceptions, additions and compounds provided for in the Act as follows -
• Schedule 1 lists the drugs and medicinal preparations
in the British Pharmacopoeia that are not to be supplies as or, except as specially provided, used in pharmaceutical benefits.
• Schedule 2 lists the allowable compounds (if any) of certain drugs or medicinal preparations.
• Schedule 3 lists the drugs and medicinal preparations additional to the drugs and medicinal preparations in the British Pharmacopoeia.
• Schedule 4 lists the additives that may be used with drugs and medicinal preparations.
• Schedule 5 lists the conditions and restrictions on the prescribing of pharmaceutical benefits.
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 drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits. The Committee meets three times each year.
The Committee has made a number of recommendations to the Minister, which have been accepted. The National Health (Pharmaceutical Benefits) Regulations (Amendment) will give effect to those recommendations by repealing the five Schedules to the Regulations and substituting new Schedules
which incorporate the recommendations.
Regulation 1 provides for the amendments to come into operation on 1 August 1986.
Overview
The National Health Act 1953 was enacted to provide a framework for the supply of certain drugs and medicinal preparations as pharmaceutical benefits, ensuring access to essential medications for the Australian population. This legislation was introduced to address the need for a coordinated national approach to the provision of pharmaceutical benefits, thereby improving public health outcomes and ensuring that all Australians could access necessary medications. The Act empowers the Governor-General to make regulations necessary for its implementation, and these regulations are detailed in the National Health (Pharmaceutical Benefits) Regulations. The policy objective of this Act, as overseen by the Parliament of Australia, is to ensure that a wide range of drugs and medicinal preparations are available as pharmaceutical benefits, subject to certain exceptions, additions, and conditions. This regulatory framework is designed to facilitate the ongoing assessment and adjustment of the pharmaceutical benefits list, ensuring it remains relevant and effective in meeting the health needs of the community.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1986 No. 194, issued under the authority of the Minister for Health, amends the National Health (Pharmaceutical Benefits) Regulations to implement recommendations from the Pharmaceutical Benefits Advisory Committee. This committee, composed of medical practitioners, pharmacists, and a pharmacologist, advises the Minister on drugs and medicinal preparations to be made available as pharmaceutical benefits. The Act applies to all persons and entities involved in the supply and use of drugs and medicinal preparations within Australia, including pharmaceutical manufacturers, healthcare providers, and patients. The regulations extend nationally, covering all states and territories of Australia. The primary exclusions and conditions for pharmaceutical benefits are outlined in the five schedules of the Regulations, which list exceptions, compounds, additional drugs, allowable additives, and prescribing restrictions. The amendments, which came into effect on 1 August 1986, replace the existing schedules with updated lists based on the committee's recommendations, thereby refining the scope and application of pharmaceutical benefits under the Act.
Key Provisions
The primary operative sections of these regulations are sections 85 and 101 of the National Health Act 1953 (the Act). Section 85 permits the supply of certain drugs and medicinal preparations as pharmaceutical benefits, subject to exceptions, additions, and compounds prescribed in the Regulations. The Pharmaceutical Benefits Advisory Committee, established under section 101, advises the Minister for Health on which drugs and preparations should be included as pharmaceutical benefits. The Regulations are amended to incorporate the Committee's recommendations, which will be effective from 1 August 1986.
The Act imposes obligations on the parties involved in the pharmaceutical benefits scheme. The Commonwealth is required to supply certain drugs and medicinal preparations as pharmaceutical benefits, as outlined in the Act and further defined in the Regulations. The Pharmaceutical Benefits Advisory Committee must provide recommendations to the Minister for Health based on its expertise in medical, pharmaceutical, and pharmacological fields. Additionally, the Regulations, as amended, must be adhered to by all parties in determining which drugs and preparations are eligible for pharmaceutical benefits.
The Regulations outline several schedules that detail the drugs, compounds, additives, and conditions for pharmaceutical benefits. For instance, Schedule 1 specifies drugs and preparations in the British Pharmacopoeia that are excluded from pharmaceutical benefits unless specially provided. Schedule 2 lists allowable compounds of certain drugs or preparations, while Schedule 3 includes additional drugs and preparations. Schedule 4 specifies additives that may be used with drugs and preparations, and Schedule 5 outlines conditions and restrictions on prescribing pharmaceutical benefits. Failure to comply with these schedules may result in penalties or other legal consequences.
Under the Act, there are no explicit criminal offences or civil penalties stated for breaches of the Regulations. However, non-compliance with the Regulations could result in the Commonwealth not supplying certain drugs and preparations as pharmaceutical benefits, thereby affecting the availability and access to these pharmaceutical items. The precise legal consequences of non-compliance would depend on the specific nature of the breach and the context in which it occurs.