STATUTORY RULES.
1962. No. 114.
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REGULATIONS UNDER THE NATIONAL HEALTH ACT 1953-1962.*
I, THE GOVERNOR-GENERAL in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953-1962.
Dated this twenty-first
day of December, 1962.
Governor-General.
By His Excellency’s Command,
(SGD.) H. W. WADE
Minister of State for Health.
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Amendments of the National Health (Pharmaceutical Benefits) Regulations.†
Commencement.
1. These Regulations shall come into operation on the first day of January, 1963.
Second Schedule.
2. The Second Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended—
(a) by omitting the words—
“Ergotamine Tartrate B.P. | Ergotamine Tartrate B.P. with Caffeine B.P. Ergotamine Tartrate B.P. with Caffeine Citrate B.P.C. and Diphenhydramine Hydrochloride B.P. Ergotamine Tartrate B.P. with Caffeine B.P. and Meclozine Hydrochloride B.P.” |
and inserting in their stead the words— |
“ Ergotamine Tartrate B.P. | Ergotamine Tartrate B.P. with Caffeine B.P. Ergotamine Tartrate B.P. with Caffeine Citrate B.P.C. and Diphenhydramine Hydrochloride B.P.”; and |
(b) by omitting the words and symbol— |
“ Meclozine Hydrochloride B.P.C. .. .. | —,”. |
* Notified in the Commonwealth Gazette on 24th December, 1962.
† Statutory Rules 1960, No. 17, as amended by Statutory Rules 1960, Nos. 90 and 102; 1961, Nos. 59 and 137; and 1962, Nos. 34 and 101.
11233/62.—Price 3d. 10/13.12.1962.
Third Schedule.
3. The Third Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by omitting the words “Meclozine Hydrochloride, B.P.C.”.
Fifth Schedule
4. The Fifth Schedule to the National Health (Pharmaceutical Benefits) Regulations is amended by inserting after the words—
“Methicillin...................... | Any disease or condition in a patient receiving treatment in or at an approved hospital” |
the words— |
“Methotrexate.................... | The leukaemias and neo-plastic disease”. |
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By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.
Overview
The Statutory Rules 1962, No. 114, made under the National Health Act 1953-1962, provide amendments to the National Health (Pharmaceutical Benefits) Regulations. These Regulations, enacted by the Governor-General in accordance with the Federal Executive Council's advice, aim to update the list of pharmaceutical benefits covered under the National Health scheme. Specifically, they adjust the formulations of certain medications, such as ergotamine and meclozine, and introduce methotrexate for specific conditions like leukaemia and neo-plastic diseases. The amendments are designed to ensure that the pharmaceutical benefits align with contemporary medical practices and needs, reflecting a commitment to maintaining an effective and relevant health care system. These Regulations came into operation on 1 January 1963, indicating a timely response to address gaps or updates in the pharmaceutical benefits list.
Scope and Application
The Regulations under the National Health Act 1953-1962, specifically the amendments to the National Health (Pharmaceutical Benefits) Regulations, apply to the Commonwealth of Australia. These Regulations affect entities and persons involved in the provision and reimbursement of pharmaceutical benefits, including pharmaceutical companies, pharmacies, healthcare providers, and patients who are eligible for the Pharmaceutical Benefits Scheme (PBS). The amendments modify the list of approved medications for which the Commonwealth provides financial assistance, impacting the scope of pharmaceutical benefits available to the public. These changes are geographically confined to the national level, as they are promulgated under federal legislation. The Regulations do not explicitly state exclusions or exemptions, but they do affect the threshold for what pharmaceutical treatments are subsidised by the government. The application of these Regulations can be further extended or restricted through subordinate instruments, which may provide additional details or clarifications on the implementation of these changes.
Key Provisions
The Statutory Rules 1962 No. 114 amends the National Health (Pharmaceutical Benefits) Regulations. The Regulations, which come into operation on 1 January 1963, make several modifications to the existing schedules. These include removing specific medications and conditions from the lists of approved pharmaceutical benefits. For instance, under the Second Schedule (section 2(a)), the medications Meclozine Hydrochloride B.P. and Meclozine Hydrochloride B.P.C. are removed, and the condition treated by these medications is also omitted. The Third Schedule (section 3) removes Meclozine Hydrochloride B.P.C. from its list. Furthermore, the Fifth Schedule (section 4) adds Methotrexate to the list of approved medications for treating leukaemias and neo-plastic diseases.
These amendments impose obligations on the entities administering the pharmaceutical benefits scheme, particularly in terms of updating and maintaining the schedules of approved medications and conditions. The modifications mean that healthcare providers and patients can no longer claim certain medications for specific conditions, thereby affecting the scope of pharmaceutical benefits available under the scheme.
Any breach of these Regulations could potentially lead to civil or criminal consequences. For example, individuals or entities that continue to claim benefits for medications or conditions that have been removed from the approved lists may face penalties. The exact nature of these penalties is not detailed in the text, but generally, under Australian law, breaches of regulations can result in fines or other legal actions. The maximum penalties would depend on the specific nature of the breach and the relevant legislation governing the enforcement of the Regulations.