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2010-2011
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
NATIONAL HEALTH AMENDMENT
(FIFTH COMMUNITY PHARMACY AGREEMENT INITIATIVES)
BILL 2011
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and Ageing,
the Hon Nicola Roxon MP)
NATIONAL HEALTH AMENDMENT (FIFTH COMMUNITY PHARMACY
AGREEMENT INITIATIVES) BILL 2011
OUTLINE
The Fifth Community Pharmacy Agreement (Fifth Agreement) between the
Australian Government and the Pharmacy Guild of Australia commenced on
1 July 2010. The Fifth Agreement provides funding for a number of
professional pharmacy programs to be implemented in community pharmacy
sector.
This Bill will support the implementation of two new initiatives funded through the
Fifth Community Pharmacy Agreement, `Continued Dispensing of Pharmaceutical
Benefits Scheme (PBS) Medicines in Defined Circumstances' and `Supply and PBS
Claiming from a Medication Chart in Residential Aged Care Facilities'. The Bill will
enable pharmacists to claim pharmaceutical benefits where the following types of
supply have occurred:
a) a pharmaceutical benefit has been provided by an approved pharmacist to a
patient, in accordance with specific conditions, where a patient is unable to
present a valid prescription.
b) eligible medicines have been provided from a standardised medication chart
for persons receiving care in a residential care services. The PBS prescriber
will not be required to prepare a separate PBS/RPBS prescription form for
these supplies.
The Bill also makes some technical changes which will support efficient prescribing
practices for certain authority required medicines, and determination of rules for
decisions about increased quantities and repeats.
Financial Impact Statement
Funding of up to $1 million for the Continued Dispensing of PBS Medicines in
Defined Circumstances initiative and up to $3 million for the Supply and PBS
claiming from a Medication Chart in Residential Aged Care Facilities initiative is
included under the Fifth Agreement.
The funding included in the Fifth Agreement was approved by the Department of
Finance and Deregulation as part of the Agreement negotiations and announced as
part of the 2010-2011 Budget.
The funding allocation to each initiative is for implementation purposes only and
covers the development, education materials and training as well as a review of the
initiative. There is no ongoing funding for either of these initiatives. There is no
expected further financial impact as a result of the implementation of these initiatives.
The Continued Dispensing initiative introduces an additional mechanism to trigger
supply of pharmaceutical benefits where a prescription is not available. In these
circumstances, prior to this initiative being implemented, pharmacists would have the
option to undertake the supply via a communicated prescription and therefore this
initiative should have no impact on PBS growth as volumes for these medicines will
not be affected.
The technical amendments in Schedule 3 concerning prescriptions for the supply of
pharmaceutical benefits have no financial implications.
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NATIONAL HEALTH AMENDMENT (FIFTH COMMUNITY PHARMACY
AGREEMENT INITIATIVES) BILL 2011
NOTES ON CLAUSES
Clause 1 - Short Title
This clause provides that the Bill, once enacted, may be cited as the National Health
Amendment (Fifth Community Pharmacy Agreement Initiatives) Act 2011.
Clause 2 - Commencement
This clause provides that the Bill commences on Royal Assent and the Schedules to
the Bill commence on the dates specified (1 July 2012).
Clause 3 - Schedule(s)
This clause provides that each Act that is specified in a Schedule to this Bill is
amended or repealed as set out in the applicable items in the Schedule concerned, and
any other item has effect according to its terms. Schedules 1, 2 and 3 amend the
National Health Act 1953.
SCHEDULE 1 -- CONTINUED DISPENSING OF PHARMACEUTICAL
BENEFITS
Item 1
Paragraph 89(b)
This item entitles a person to receive a pharmaceutical benefit without a prescription
where the requirements of the new section 89A have been met.
Item 2
89A When pharmaceutical benefits may be supplied by approved pharmacists
without prescription
Under this item the pharmacist must be satisfied that certain conditions have been met
prior to undertaking a supply in accordance with this section. The specific conditions
which must be met as well as the limited pharmaceutical benefits eligible to be
supplied will be set out in a legislative instrument.
The Act contemplates that a pharmaceutical benefit can only be supplied upon
presentation of a prescription or in limited circumstances when a prescription is
communicated orally. Subsection 89A(1) creates a new section that provides for an
exception enabling an approved pharmacist to supply a pharmaceutical benefit in the
absence of a prescription. Subsection 89A(2) operates to deem a record created at the
point of supply of the pharmaceutical benefit as a prescription for the purposes of the
Act.
This item omits from the operation of the deeming provision certain sections of the
Act under subsection 89A(2)(c). This is to address the issue of the express
requirement for the presentation of a prescription to enable the lawful supply of a
pharmaceutical benefit.
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Subsection 89A(2)(d) amends the definition of concessional benefit prescription,
concession card prescription and entitlement card prescription to remove reference to
section 84AA. Section 84AA provides that access to concessional pharmaceutical
benefits can only occur when a prescription has been written by a PBS prescriber.
Subsection 89A(3) creates a power for the Minister to make a legislative instrument
setting out the class of pharmaceutical benefits that may be supplied by an approved
pharmacist under this arrangement. The legislative instrument must also set out the
conditions that the approved pharmacist must be satisfied have been met prior to
undertaking a supply in accordance with this section.
Item 3
Application of Amendment
This item indicates that supplies enabled under this Schedule can occur from the
commencement of the Schedule, that is, 1 July 2012.
SCHEDULE 2 -- SUPPLY OF CERTAIN PHARMACEUTICAL BENEFITS
TO PERSONS RECEIVING CARE IN RESIDENTIAL
CARE SERVICES
Item 1
At the end of subsection 93A(2)
This item inserts a note of clarification that is intended to allow determinations under
this subsection to be made that can differentiate between conditions for persons
receiving treatment in private hospitals as opposed to conditions that are determined
for persons receiving care in residential care services
SCHEDULE 3 - PRESCRIPTIONS FOR THE SUPPLY OF
PHARMACEUTICAL BENEFITS
Item 1
Subsection 85A(2A)
Proposed new subsection 85A(2A) provides for the Minister to make a determination
setting conditions that must be satisfied when writing a prescription to which a
particular maximum quantity or repeats determination made under paragraph
85A(2)(a) or (b) applies.
The Minister may determine a maximum quantity and a number of repeats for all
purposes or for particular purposes under s85A(2). Where a particular medicine has a
number of different uses, and the appropriate dosage or length of treatment differs, the
Minister is able to specify different maximums for different uses (or `purposes'). For
example a medicine may be prescribed for any purpose with a maximum quantity of
25 and 0 repeats, but a maximum quantity of 50 and 3 repeats if prescribed for initial
palliative care purposes or a maximum quantity of 50 and 5 repeats if prescribed for
malignant neoplasia (late stage).
If a determination has been made for a particular maximum quantity or number of
repeats for a specific purpose, then conditions may be set for the writing of a
prescription to which that specific maximum quantity or repeats determination applies.
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Using the example above, it is envisaged that the Minister could determine a condition
requiring that prescribers get authority from Medicare (including using existing
streamlined authority processes) before prescribing the quantities or repeats permitted
for initial palliative care. The determination might only require the authority to be
obtained if prescribing more than the `general' maximum quantity (ie: more than 25
and 0 repeats in the example above).
When making the proposed determinations the Minister may take into account advice
already routinely given by the Pharmaceutical Benefits Advisory Committee as part of
its functions for PBS listing recommendations. This is similar to what currently
happens for some other determinations, like maximum quantities and repeats for PBS
medicines.
Item 2
Subsection 85A(3A)
Proposed new subsection 85A(3A) provides that the Minister may make a
determination setting out rules that must be applied when deciding on an application
under Regulation 13 of the National Health (Pharmaceutical Benefits) Regulations
1960 (the Regulations) to vary the maximum quantity or number of repeats that may
be prescribed in one prescription.
The provision allows parameters to be placed on administrative decisions concerning a
variation to quantities and repeats that may be prescribed in one prescription. For
example, for certain medicines, it may not be appropriate for any increases in
maximum quantity or repeats to be permitted, or those increases may need to be
capped. It is envisaged that the approach to determining rules would be consistent
with current guidelines on quantity increases set out in the Schedule of Pharmaceutical
Benefits.
When making the proposed determinations the Minister may take into account advice
already routinely given by the Pharmaceutical Benefits Advisory Committee as part of
its functions for PBS listing recommendations. This is similar to what currently
happens for some other determinations, like maximum quantities and repeats for PBS
medicines.
Item 3
Subsection 85A(4)
Proposed new subsection 85A(4) provides that the determinations made under section
85A are legislative instruments.
Item 4
Application of amendments
This proposed provision provides that the amendments made by this Schedule apply
to prescriptions written on and after the commencement of the Schedule. In practice,
the changes set out in subsections 85A(2A) and 85A(3A) would become effective on
commencement of any conditions or rules determined under those new subsections.
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