EXPLANATORY STATEMENT
ISSUED BY AUTHORITY OF THE MINISTER FOR
HOUSING AND AGED CARE
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS)
REGULATIONS (AMENDMENT)
1988 No. 56
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 for carrying out or giving effect to the Act.
2. Section 105 of the Act provides that the regulations may -
“(a) prescribe the terms and conditions subject to which pharmaceutical benefits shall be supplied;
(b) make provision for or in relation to the writing of prescriptions.”
3. In addition, subsection 85A(3) of the Act provides -
“(3) The regulations may make provision authorising the variation of the application, in relation to persons included in a class of persons, of a determination under paragraph 2(a) or (b) and, where such a variation is made, the determination shall be deemed to have effect as varied.”
4. The two principal amendments which the Regulations make are first, the repeal of the previous regulation 13 of the Principal Regulations and its substitution with a new regulation 13 and, secondly, the insertion of a new regulation which limits the use of NHS prescription forms.
5. The previous regulation 13 of the Principal Regulations set out the procedure by which the Minister could vary his determinations under paragraphs 85A(2)(a) and (b) of the Act of the maximum quantity or number of units of a pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion and the maximum number of occasions on which the supply of the pharmaceutical benefit may in one prescription be directed to be repeated.
However, since the previous regulation 13 was made, a simpler administrative procedure than that prescribed for approving an application to vary a determination under paragraph 85A(2)(a) or (b) has been implemented. The new regulation 13 gives formal recognition to the administrative procedures currently in practice for approving those applications.
6. A new regulation 19B is inserted which limits the use of NHS prescription forms to authorised purposes. A $40 penalty attaches to breach of this new regulation.
7. The Regulations make a number of further amendments which are minor or consequential upon the principal amendments.
8. The amendments are to take effect from 1 May 1988.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1988 No. 56 amends the National Health Act 1953 by introducing two key changes to the regulatory framework governing pharmaceutical benefits under the Act. This amendment was enacted by the Governor-General in accordance with the authority granted by the Minister for Housing and Aged Care. The primary objective of these amendments is to streamline the administrative process for varying certain determinations and to impose limits on the use of NHS prescription forms, thus ensuring that these forms are only used for authorised purposes. These changes aim to enhance the efficiency and control over pharmaceutical benefits distribution, reflecting an updated approach to administrative procedures and compliance monitoring.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1988 No. 56, under Section 140 of the National Health Act 1953, introduces amendments to the existing regulations governing pharmaceutical benefits, impacting the terms and conditions for supplying pharmaceutical benefits and the writing of prescriptions. This amendment applies to the entire Commonwealth of Australia, affecting all entities and individuals involved in the supply and prescription of pharmaceutical benefits. The primary amendments include the substitution of the previous regulation 13 with a new one that formalises current administrative procedures for varying determinations on maximum quantities and repetitions of prescriptions, and the introduction of a new regulation 19B that restricts the use of NHS prescription forms to authorised purposes, with a penalty of $40 for breaches. These amendments aim to streamline the administrative processes and ensure compliance with prescribed protocols. The changes are set to take effect from 1 May 1988.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1988 No. 56 (the "Regulations") amend the existing Pharmaceutical Benefits regulations under the National Health Act 1953. These Regulations primarily focus on the supply of pharmaceutical benefits, the writing of prescriptions, and the administrative procedures related to these areas.
Section 105 of the Act allows the regulations to prescribe the terms and conditions for supplying pharmaceutical benefits and to make provisions in relation to the writing of prescriptions. The Regulations introduce a new regulation 13 that updates the administrative procedures for varying determinations under paragraphs 85A(2)(a) and (b) of the Act. This change formalises the existing simpler administrative procedure for approving variations in the maximum quantity or number of units of a pharmaceutical benefit that can be supplied in one prescription, as well as the maximum number of times the supply can be repeated. Regulation 19B introduces a new provision that restricts the use of National Health Service (NHS) prescription forms to authorised purposes.
The Regulations impose obligations on the parties involved, including the Minister, to adhere to the updated administrative procedures outlined in regulation 13. Additionally, entities using NHS prescription forms must ensure their use is strictly for authorised purposes, as mandated by regulation 19B.
The Regulations also establish consequences for breaches. Specifically, section 19B of the Regulations imposes a penalty of $40 for any breach of the provision limiting the use of NHS prescription forms to authorised purposes. This penalty serves as a deterrent against misuse of NHS prescription forms, ensuring compliance with the authorised purposes outlined in the Regulations.
In summary, the Regulations update the administrative procedures for varying pharmaceutical benefit determinations and impose restrictions on the use of NHS prescription forms. Compliance with these regulations is essential to avoid the specified penalties, ensuring that pharmaceutical benefits are supplied and prescriptions are written in accordance with the updated administrative guidelines.