EXPLANATORY STATEMENT
NATIONAL HEALTH (EMERGENCY TREATMENT PROGRAM)
SPECIAL ARRANGEMENTS INSTRUMENT 2010.
INSTRUMENT NUMBER PB 41 of 2010
Summary
This instrument is a special arrangement made under subsection 100 (1) of the National Health Act 1953 (the Act) and a declaration under paragraph 100AA (1)(a) of the Act. For subsection 100AA (2) of the Act, this instrument declares certain drugs or medicinal preparations to be special pharmaceutical products. For subsection 100(1) of the Act, this instrument makes the special arrangements for the supply of certain special pharmaceutical products, known as emergency treatment drugs, by medical practitioners for emergency treatment, other than for hospital treatment.
Authority
Part VII of the Act is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
a. who are living in isolated areas; or
b. who are receiving medical treatment in such circumstances that pharmaceutical benefits:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
Subsection 100 (2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100 (3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
Paragraph 100AA (1)(a) provides that a special pharmaceutical product, for which special arrangements may be made under section 100, includes a drug or medicinal preparation to which section 100AA applies.
Subsection 100AA (2) of the Act provides that the Minister may declare in writing :
- that a drug or medicinal preparation is a drug or medicinal preparation to which this section applies; or
- that an additive to a drug or medicinal preparation covered by paragraph (a) is an additive to which this section applies.
Paragraph 100AA (4)(a) of the Act provides that the Minister must not make a declaration under subsection (2) unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the Minister do so.
Purpose and operation
The Emergency Treatment Program is a set of arrangements made under subsection
100(1) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available as ‘emergency treatment drugs’ to persons who are receiving emergency treatment by a medical practitioner, other than hospital treatment.
The emergency treatment drugs are supplied free of charge to patients. A medical practitioner may supply an emergency treatment drug to a person who is entitled to receive pharmaceutical benefits under Part VII of the Act.
The declaration under subsection 100AA (2) provides for specified drugs or medicinal preparations to be declared as special pharmaceutical products. The drug or medicinal preparation in the specified form, manner of administration and brand is the emergency treatment drug to which these arrangements apply. These arrangements set out the maximum quantity or number of units of an emergency treatment drug which may be obtained by a medical practitioner during a specified period and that the medical practitioner may only obtain the special pharmaceutical product as prescribed. These arrangements also set out the conditions for the Commonwealth to make payments to approved pharmacists and approved medical practitioners for supplying or obtaining emergency treatment drugs.
At the July 2009 meeting, the PBAC, for the purposes of subsection 100AA(4), recommended that methoxyflurane be declared a drug or medicinal preparation to which section 100AA applies. This instrument provides that the drug methoxyflurane is a special pharmaceutical product. Methoxyflurane in the form, liquid for inhalation 999.9 mg per g,
3 mL (with inhaler), Penthrox brand, and with a manner of administration, “Inhalation by mouth”, is an emergency treatment drug. The details of the drug are listed in Schedule 1 of the arrangements.
For the purposes of administration, methoxyflurane will be listed with other emergency treatment drugs in the Emergency Supply (Doctor’s Bag) list in the PBS schedule and managed by Medicare Australia in the same manner as other pharmaceutical benefits obtained under section 93 of the Act.
This instrument, expressed to commence on 1 May 2010, was made on
28 April 2010.
A provision-by-provision description of this instrument is contained in the Attachment.
Consultations
The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
The PBAC, at the July 2008 meeting, recommended the listing of methoxyflurane on the Pharmaceutical Benefits Scheme (PBS) Doctor's Bag Item List only, on the basis of an acceptable incremental cost per extra paediatric responder with upper limb fracture. For a drug or medicinal product to be available for emergency supply (Doctor’s Bag) under section 93 of the National Health Act 1953, it must be declared as a pharmaceutical benefit under section 85(2). The PBAC recommendation was that this product was not to be available for the purposes of prescribing under section 85.
The PBAC, at the July 2009 meeting, for the purposes of section 100AA(4), further recommended that methoxyflurane be declared a drug or medicinal preparation to which section 100AA applies. Methoxyflurane was recommended as a special pharmaceutical product under section 100AA of the Act to enable methoxyflurane to be available on the PBS without listing as a pharmaceutical benefit under section 85.
The manufacturer of methoxyflurane, liquid for inhalation 999.9 mg per g, 3 mL (with inhaler) (Penthrox®), has been consulted throughout the process in regard to the provision for this product to be made available for emergency treatment only.
ATTACHMENT
Clause 1 provides that this instrument is the National Health (Emergency Treatment Program) Special Arrangements Instrument 2010 and that this instrument may also be cited as No. PB 41 of 2010.
Clause 2 provides that this instrument commences on 1 May 2010.
Clause 3 defines a number of terms used in this instrument.
Clause 4 provides for the declaration of drugs or medicinal preparations to which section 100AA of the Act applies. Drugs or medicinal preparations to which section 100AA applies are ‘special pharmaceutical products’, which may be the subject of special arrangements under section 100 of the Act.
Subclause 4(1) provides that a drug or medicinal preparation mentioned in Schedule 1 is declared to be a drug or medicinal preparation to which section 100AA of the Act applies. A drug or medicinal preparation declared under section 100AA is a special pharmaceutical product.
Subclause 4(2) specifies that a special pharmaceutical product will be an ‘emergency treatment drug’ if it is in the form, manner of administration and brand mentioned in Schedule 1.
An emergency treatment drug is the drug or medicinal preparation:
(a) in a form mentioned for the drug or medicinal preparation in Schedule 1, by reference to strength, type of unit, size of unit or otherwise;
(b) with the manner of administration mentioned in Schedule 1for the drug or medicinal preparation in that form; and
(c) with a brand mentioned in Schedule for the drug or medicinal preparation in that form and with that manner of administration..
Clause 5 provides that a medical practitioner may supply an emergency treatment drug in certain circumstances. A medical practitioner may supply an emergency treatment drug:
(a) to a person who is entitled to receive pharmaceutical benefits under Part VII of the Act (as provided for under section 86 of the Act);
(b) for emergency medical treatment of the person, but only if the treatment is not hospital treatment (noting that ‘hospital treatment is a defined term in the Act).
Clause 6 sets out the limits on the quantity of an emergency treatment drug that a medical practitioner may obtain, and the process for a medical practitioner (other than an approved medical practitioner) to obtain emergency treatment drugs from an approved pharmacist.
(1) Provides that a medical practitioner may obtain, only once in any calendar month, the maximum quantity or number of units for the emergency treatment drug mentioned in Schedule 1, less the quantity or number of units of the drug that:
(a) is still in the medical practitioner’s possession; and
(b) was previously obtained by the medical practitioner according to the provisions of this arrangement
(2) Provides for a medical practitioner who is not an approved medical practitioner:
(a) to obtain an emergency treatment drug only from an approved pharmacist; and
(b) must do so in the way described in regulation 16 of the Regulations and in the same manner as for obtaining a pharmaceutical benefit under section 93 of the Act.
(3) Provides that if a medical practitioner obtains an emergency treatment drug as mentioned in subclause (2):
(a) the medical practitioner must give a receipt for the emergency treatment drug to the approved pharmacist; and
(b) must do so as described in subregulation 16(3) of the Regulations and in the same manner as if receiving a pharmaceutical benefit under section 93 of the Act.
(4) Provides that an approved medical practitioner must not obtain an emergency treatment drug from an approved pharmacist.
Clause 7 provides for the notice required to be given by an approved medical practitioner to the Secretary in order to obtain an emergency treatment drug.
(1) Provides that an approved medical practitioner who obtains an emergency treatment drug under subclause 6(1) must give notice to the Secretary that he or she has obtained the drug.
(2) The notice provided must be:
(a) in a form approved by the Secretary as described in paragraph 18A(4)(a) of the Regulations and in the same manner as for obtaining a pharmaceutical benefit under section 93 of the Act, and
(b) signed and dated by the approved medical practitioner.
(3) The medical practitioner must keep a copy of the notice for at least 1 year after the date on which notice is given to the Secretary.
Clause 8 provides for the supply of emergency treatment drug by an approved pharmacist. If an approved pharmacist supplies an emergency treatment drug to a medical practitioner not known to the pharmacist, the pharmacist must:
(a) obtain the medical practitioner’s full name, address and medical practitioner registration number; and
(b) must specify these details on the order form mentioned in subregulation 16(1) of the regulations and lodged for the purpose of obtaining an emergency treatment drug as described in subclause 6(2).
Clause 9 requires approved pharmacists to retain the order forms lodged by a medical practitioner to obtain an emergency treatment drug.
(a) if the drug was supplied in a way described in paragraph 16 (1) (a) of the regulations, retain the duplicate of the order for at least 1 year after the date of supply; or
(b) if the drug was supplied in a way described in paragraph 16 (1) (b) of the regulations, keep the electronic order form mentioned for at least 1 year after the date of supply.
Clause 10 provides for the payment to an approved pharmacist for the supply of an emergency treatment drug.
(1) An approved pharmacist is entitled to be paid by the Commonwealth for the supply of an emergency treatment drug to a medical practitioner (but not an approved medical practitioner) the amount determined under subclause (2).
(2) For subsection 1, the amount that is paid is the sum of :
(a) the amount agreed between the Minister and the manufacturer of the emergency treatment drug for the sale of the drug; and
(b) a mark-up on the agreed amount that is in accordance with the amount determined under a determination, in force from time to time, made under paragraph 98B(1)(a) of the Act, as if
(i) the amount agreed under (2)(a) is the approved price to pharmacists under the determination; and
(ii) the emergency treatment drug is a ready prepared pharmaceutical benefit under the determination; and
(c) the ready prepared dispensing fee as mentioned in the determination.
Clause 11 provides for the payment to an approved medical practitioner for the supply of an emergency treatment drug.
(1) An approved medical practitioner is entitled to be paid by the Commonwealth for the supply of an emergency treatment drug that has been obtained in accordance with paragraph 6 and complies with subclause (2). The amount paid to the approved medical practitioner is the amount worked out under subclause 10(2) as if the approved medical practitioner were an approved pharmacist.
(2) The requirements are that the approved medical practitioner:
(a) provides a notice under subclause 7(2) to the Secretary about obtaining the emergency treatment drug; and
(b) provides a claim for the payment to the Secretary under clause 12 and on the form made available to approved medical practitioners under paragraph 18A(7)(c) of the Regulations, as if the emergency treatment drug were a pharmaceutical benefit obtained for purpose of section 93 of the Act; and
(c) complete the form in accordance with the directions on the form.
Clause 12 sets out how an approved pharmacist or approved medical practitioner claims for payment for the supply of an emergency treatment drug.
(1) Provides that an approved pharmacist or an approved medical practitioner, who wants to receive payment from the Commonwealth, for the supply of an emergency treatment drug must make a claim for payment to the Secretary;
(2) Provides that the claim must be made in accordance with the provisions set out in section 99AAA of the Act. The claim for the emergency treatment drug will be in the same manner as a claim made for a pharmaceutical benefit supplied under section 93 of the Act.
Clause13 provides that a medical practitioner or approved medical practitioner must not demand or receive payment or other valuable consideration from a person, as described in paragraph 5, for the supply of an emergency treatment drug. This ensures that patients are not charged for the supply of an emergency treatment drug.
Schedule 1 specifies the drugs or medicinal preparations which are declared for the purposes of subsection 100AA (2) and specifies the form, manner and administration of the drug which is an emergency treatment drug. It also specifies the maximum quantity of the emergency treatment drug.