Commonwealth Numbered Regulations - Explanatory Statements

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NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS (AMENDMENT) 1994 NO. 348

STATUTORY RULES 1994 No. 348

Issued by Authority of the Minister for Human Services and 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 for the purposes of the Act. Certain other provisions in the Act also specifically provide for matters to be prescribed by regulation.

Subsection 84DA(3) of the Act provides that an application for the issue of a safety net concession card must contain such particulars as are prescribed.

Subsection l01(5) of the Act provides that the regulations may make provision for and in relation to the procedure of the Pharmaceutical Benefits Advisory Committee.

Section 105 of the Act provides that the regulations may prescribe the terms and conditions subject to which pharmaceutical benefits may be supplied, make provision for or in relation to the writing of prescriptions, and prescribe the standards of composition or purity of drugs, medicines or substances which may be supplied as pharmaceutical benefits or may be ingredients of pharmaceutical benefits.

Amendments have been made to the National Health (Pharmaceutical Benefits) Regulations (the Regulations) to increase the minimum interval between supplies of a pharmaceutical benefit, to provide for the administrative procedures for the Pharmaceutical Benefits Advisory Committee, and generally to bring the Regulations up to date.

The terms "authority prescription" and "pharmacist" have been substituted for "authorised prescription" and "pharmaceutical chemist" respectively throughout the Regulations. The words "authorized" and "authorization" have been replaced by "authorised" and "authorisation" respectively wherever occurring.

Regulation 5 has been amended to include a definition of "ready-prepared pharmaceutical benefit" to mean a pharmaceutical benefit in respect of which a determination is made under subsection 85(6) of the Act. This definition needs to be included as the term is used in the amendment to paragraph 19(1)(g).

Regulation 8 requires applications for approval under Part VII of the Act to be in accordance with the relevant form set out in Schedule 6 to the Regulations. Regulation 8 has been amended so as to enable these forms to be approved in writing by the Secretary, and, as a consequence, to omit regulation 6 and Schedule 6. Also included in regulation 8, as forms to be approved in writing by the Secretary, are the application forms for the payment of an essential pharmacy allowance and for grants of financial assistance in respect of the closure or amalgamation of pharmacies.

With effect from 1 January 1995, the general safety net under the Pharmaceutical Benefits Scheme will be restricted to eligible persons within the meaning of the Health Insurance Act 1973, i.e., to those eligible for Medicare benefits. Subregulation 9AA(1) has therefore been amended to require the Medicare card number of the applicant to be included in the details required in an application for a safety net concession card. Paragraphs 9AB(3)(b) and 9AC(2)(b) have also been amended to require the Medicare card number in an application for an additional or replacement safety net concession card respectively.

Schedule 7 to the Regulations has been amended to prescribe offices of the Health Insurance Commission for the lodgement of safety net documentation by approved suppliers. As this is the only remaining schedule, it has been renamed "The Schedule". Consequential amendments have been made to regulations 9AF and 9BA.

Regulations 16 and 18A have been amended to provide that a medical practitioner may obtain pharmaceutical benefits for the purpose of section 93 of the Act (Doctor's Bag Supplies) only once each month, and to require the relevant forms to be receipted.

Regulation 19 has been amended to facilitate the use of computer-generated prescriptions. it will no longer be necessary for the medical practitioner or participating dental practitioner to obtain specific approval by the Secretary to generate prescriptions by computer, provided that a form approved by the Secretary is used and the practitioner signs the prescription.

Other amendments to regulation 19 will require that the quantity of the pharmaceutical benefit to be supplied, and the number of occasions that the supply is to be repeated, be stated in the prescription; that it will be necessary to indicate the manner of administration only in the case of a prescription for the supply of a benefit which is not readyprepared; and that 'Reg 24' will be an acceptable abbreviation for the endorsement 'Regulation 24'.

Amendments to regulation 20 have been made to include participating dental practitioners in the provisions governing the recovery of cost of pharmaceutical benefits prescribed for persons not entitled or in excessive quantities.

Regulations 21 and 23 have been combined into a single regulation 21 which contains provisions relevant to the supply of a pharmaceutical benefit on the first presentation of a prescription. As a consequence regulation 23 has been omitted.

An amendment to regulation 22 has been made to enable the communication of urgent prescriptions by facsimile from the prescribing medical or dental practitioner to an approved pharmacist. A further amendment provides that where an urgent prescription is communicated to an approved pharmacist, the medical practitioner or participating dental practitioner must ensure that the written prescription is received by the approved pharmacist within 7 days after the pharmaceutical benefit was supplied.

Regulation 25 has been amended to increase from 3 clear days to 4 clear days the minimum interval between supplies of a pharmaceutical benefit to a patient. A further amendment provides that for those pharmaceutical benefits for which more than 4 repeats are allowable (other than those used for the treatment of eye conditions), the minimum interval between supplies will be 20 clear days. It will be possible to obtain a supply within that period if the supplier reasonably believes that a previous supply of the benefit has been destroyed, lost or stolen, or that having regard to the person's circumstances, the supply of the benefit is necessary, without delay, for the treatment of the person.

Amendments to regulation 26 have been made to clarify the requirements in preparing a repeat authorisation and to require, where applicable, the date on the most recent supply of the benefit was made.

In addition, from 1 December 1994, it will be allowable in certain circumstances for the approved pharmacist to supply a brand different from that prescribed by the medical practitioner or participating dental practitioner. Regulation 26 has been made to require that in such cases the name of the substituted brand be marked on any repeat authorisation for a subsequent supply.

Regulation 26A has been amended to require that a deferred supply authorisation is to be issued at the same time as the other benefit on the original prescription is supplied.

Regulation 27 has been made to omit the requirement that the notice specifying the normal trading hours of a pharmacy be in a form authorized by the Secretary.

Amendments to regulation 31 have been made to clarify the requirements for a person to whom a pharmaceutical benefit is supplied to provide a receipt for the benefit. When it is not practicable to obtain a receipt for the supply of a benefit, the supplier must state on the prescription the date of supply and the reason why it was not practicable to obtain a receipt.

An amendment to regulation 32 has been made to include the duplicates of notification forms under regulation 18A (the form for doctor's bag supplies obtained by an approved medical practitioner) among the documents to be retained by suppliers.

Regulation 34 has been omitted. This regulation previously provided that an approved pharmacist, who suspects that a prescription has been forged or fraudulently obtained, could require a statement to be furnished by the person presenting the prescription in accordance with a form authorised by the Secretary.

Regulation 35 has been amended to provide that a pharmaceutical benefit or an ingredient of a pharmaceutical benefit must comply with any standard for that drug, medicine or substance provided for by the Therapeutic Goods Act 1989. A consequential amendment to regulation 36 has removed the reference to the repealed Therapeutic Substances Act 1953.

After regulation 37 there has been inserted a new Part 7 Arrangements of the Pharmaceutical Benefits Advisory Committee in order to make provision for the administrative procedures of that Committee. The new Part comprises regulations 38 to 48.

Regulation 38 defines 'Chairperson', 'Committee' and 'member' for the purposes of Part 7 of the Regulations.

Regulation 39 requires the Minister to appoint one of the members of the Committee as the Chairperson of the Committee.

Regulation 40 provides for the resignation of the Chairperson or a member of the Committee to be given by notice in writing to the Minister, except in the case of the Departmental officer appointed by the Secretary, where the notice is to be given to the Secretary.

Regulation 41 provides for the Chairperson of the Committee to preside at meetings of the Committee, unless absent from the meeting, in which case the members present are to elect one of the members to preside at that meeting.

Regulation 42 provides for the Chairperson to convene meetings of the Committee by notice in writing to all members, allows meetings of the Committee to be held by telephone or closed circuit television, and requires minutes to be kept of the meetings.

Regulation 43 provides for a majority of the members of the Committee to constitute a quorum for a meeting.

Regulation 44 provides that for any matter requiring a decision at a meeting of the Committee, each member present at a meeting of the Committee has a deliberative vote, and in the event of an equality of votes, the member presiding at the meeting may exercise a casting vote, otherwise the matter is resolved in the negative. Decisions of the Committee will be required to be recorded in the minutes.

Regulation 45 requires each member of the Committee to provide an annual written statement to the Minister of any direct or indirect pecuniary interests of the member which could conflict with the member's duties. It also requires any member to disclose any direct or indirect pecuniary interest in a matter which is to be considered at a meeting, and for that member not to take part in the meeting during the consideration of that matter, unless participation is agreed to by the Committee. Such disclosures have to be recorded in the minutes.

Regulation 46 provides that where a majority of the members sign a document in support of a resolution set out in the document, the resolution is to be taken to have been passed at a meeting of the Committee.

Regulation 47 requires that reports or recommendations by the Committee to the Minister be in writing, and allows for a minority report when requested by a dissenting member.

Regulation 48 provides that members of the Committee, other than the Departmental member appointed by the Secretary, be paid such remuneration and allowances as are determined by the Remuneration Tribunal.

The Regulations will commence on 1 November 1994, with the exception of the amendment to paragraph 26A(1)(b) which will commence on 1 December 1994, and the amendment to regulations 9AA, 9AB and 9AC which will commence on 1 January 1995.