EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 342
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 December 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 14-15 June 1984 to the Minister.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) Statutory Rules 1984 No. 342, issued under Section 140 of the National Health Act 1953, aim to update the pharmaceutical benefits available under the National Health Act by incorporating the recommendations of the Pharmaceutical Benefits Advisory Committee. The Committee, established under Section 101 of the Act, provides expert advice on drugs and medicinal preparations suitable for inclusion as pharmaceutical benefits. The regulations address the need for an efficient and effective system to list pharmaceutical benefits by amending the schedules of the National Health (Pharmaceutical Benefits) Regulations to include new drugs and medicinal preparations, as well as to delist certain items that no longer meet the criteria for inclusion. This amendment ensures that the Pharmaceutical Benefits Scheme remains aligned with contemporary medical standards and practices.
The Australian Parliament enacted these regulations to provide a structured process for updating the list of pharmaceutical benefits, ensuring that the Pharmaceutical Benefits Scheme can adapt to new medical advancements and maintain its efficacy. The policy objective is to ensure that Australians have access to necessary and effective pharmaceutical benefits, while maintaining a rigorous assessment process to ensure the inclusion of only those drugs and preparations that offer significant therapeutic value or improved safety profiles.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations, as amended, apply to the provision of certain drugs and medicinal preparations under the National Health Act 1953. These regulations govern the availability of pharmaceutical benefits within the Commonwealth of Australia, ensuring that specified drugs and medicinal preparations, as well as prescribed compounds, are available to the public. The regulations are structured to include comprehensive schedules detailing which drugs and preparations are covered, those that are excluded, and any conditions or restrictions on prescribing certain benefits. The Pharmaceutical Benefits Advisory Committee plays a crucial role by recommending drugs for inclusion in the pharmaceutical benefits scheme based on efficacy and safety considerations. The scope of these regulations extends to both the listing and delisting of drugs based on recommendations from this committee, which is tasked with advising the Minister for Health on matters concerning the operation of Part VII of the Act. The regulations also establish conditions under which certain drugs can be prescribed, reflecting the legislative intent to balance access to necessary medications with appropriate controls over their use.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1996 provides a framework for the availability of drugs and medicinal preparations as pharmaceutical benefits under the National Health Act 1953. The main sections of the Act relevant to these regulations include Section 85, which stipulates that drugs and medicinal preparations listed in the British Pharmacopoeia are available as benefits, subject to exceptions in Schedule 1 of the Regulations, and compounds listed in Schedule 2. Section 88A further outlines the circumstances under which a prescription for a pharmaceutical benefit may be written, and Section 101 establishes the Pharmaceutical Benefits Advisory Committee, tasked with recommending drugs for inclusion in the pharmaceutical benefits list. The Regulations amend the schedules to reflect the Committee's recommendations.
These Regulations impose obligations on parties and entities involved in the supply of pharmaceutical benefits. For instance, they mandate that only drugs and medicinal preparations listed in Schedules 1 to 5 of the Regulations can be provided under the scheme. This includes ensuring that any prescriptions issued comply with the conditions set out in the Regulations, particularly those listed in Schedule 5. The Regulations also require that the Pharmaceutical Benefits Advisory Committee's recommendations be considered by the Minister, who must then draft Statutory Rules to implement any approved changes.
Breaches of these Regulations can lead to various consequences. While the explanatory statement does not detail specific offences or penalties, the overarching framework of the National Health Act 1953 suggests that non-compliance could result in civil or criminal penalties. For instance, unauthorised supply of pharmaceutical benefits or failure to adhere to the prescribed conditions could be considered offences under the Act, potentially leading to fines or other legal repercussions. The exact penalties would depend on the nature and severity of the breach, as well as any applicable state or territory laws.