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2004-2005-2006-2007
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
SENATE
NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS)
BILL 2007
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and Ageing,
the Honourable Tony Abbott MP)
NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS)
BILL 2007
OUTLINE
The National Health Amendment (Pharmaceutical Benefits) Bill 2007 (`the Bill') allows for
the enactment of an Act as follows:
· Schedule 1 amends the National Health Act 1953 and the Health Insurance Act 1973
to allow authorised optometrists to prescribe certain ophthalmic (eye) medicines for
supply under the Pharmaceutical Benefits Scheme (PBS), as announced in the 2007-
08 Budget; and
· Schedule 2 amends the National Health Act 1953 to clarify the intent in relation to
the supply of pharmaceutical benefits by approved pharmacists.
Schedule 1 PBS prescribing by optometrists
Schedule 1 of the Bill proposes amendments which provide for:
· suitably qualified optometrists to be approved to prescribe medicines as
pharmaceutical benefits;
· regulating the prescribing of pharmaceutical benefits by optometrists in a similar
manner as applies under the PBS for medical practitioners and dentists;
· pharmaceutical benefits to be specified for prescribing by authorised optometrists;
and
· entitlements associated with pharmaceutical benefits, including subsidies and PBS
safety net benefits, to apply when supplied on the prescription of an authorised
optometrist.
The majority of the amendments in Schedule 1 of the Bill commence on Royal Assent.
Several amendments commence on 1 January 2008 to give effect to the supply and subsidy of
pharmaceutical benefits on prescriptions written by authorised optometrists from that date.
Amendments to the National Health Act 1953
The PBS operates under Part VII of the National Health Act 1953 which regulates the supply
of pharmaceutical benefits and limits who can prescribe pharmaceutical benefits. At present,
only medical practitioners and participating dental practitioners can prescribe pharmaceutical
benefits.
Schedule 1 of the Bill amends Part VII to extend prescribing under the PBS to authorised
optometrists. Optometrists will be able to apply to the Secretary (of the Department of Health
and Ageing) to be an authorised optometrist with authority to prescribe pharmaceutical
benefits. The Minister may determine, by legislative instrument, any criteria that must be
satisfied by an optometrist prior to being approved and any conditions that will apply to that
approval.
A decision made by the Secretary not to approve an optometrist or to suspend or revoke an
authorised optometrist's approval is subject to reconsideration by the Secretary and appeal to
the Administrative Appeals Tribunal. Optometrists will be provided with a period of notice
and the opportunity to provide written submissions to the Secretary prior to a decision being
made to either suspend or revoke their approval.
A new term, PBS prescriber, is introduced to describe practitioners authorised to prescribe
under the PBS. A PBS prescriber is defined to mean a medical practitioner, a participating
dental practitioner or an authorised optometrist. PBS prescriber is used in those amendments
in Schedule 1 where it is intended that the same provisions apply for authorised optometrists as
for medical practitioners and participating dental practitioners. In relation to the writing of
prescriptions, this will include the circumstances in which a person is entitled to have a
prescription supplied as a pharmaceutical benefit, the patient payment amounts to be taken into
account for the purposes of the PBS safety net, and the recording of Medicare card numbers.
Schedule 1 provides for the Minister to determine the pharmaceutical benefits that may be
prescribed by an authorised optometrist. Pharmaceutical benefits can only be included on the
PBS on the recommendation of the Pharmaceutical Benefits Advisory Committee.
The amendments proposed in Schedule 1 with respect to prescribing by authorised optometrists
under the PBS also apply for supply of pharmaceutical benefits under the Repatriation
Pharmaceutical Benefits Scheme (RPBS) via reference in the Veterans' Entitlements Act 1986
and arrangements under section 91 of that Act to Part VII of the National Health Act 1953.
Amendments to the Health Insurance Act 1973
Schedule 1 of the Bill also provides for optometrists and authorised optometrists (with an
authority under Part VII of the National Health Act 1953) to be subject to the same
arrangements under the Professional Services Review (PSR) Scheme as applies for medical
practitioners and participating dental practitioners in relation to the prescribing of
pharmaceutical benefits.
The PSR Scheme is concerned with the conduct of health professionals participating in
Medicare and the PBS. It provides for the examination of an individual health practitioner's
conduct by a PSR Committee (a committee of peers) to ascertain whether the practitioner has
engaged in `inappropriate practice' (as defined in section 82 of the Health Insurance Act 1973)
and if so, to provide for certain action to be taken in relation to the practitioner. The essence of
the PSR Scheme is one of peer review to ensure that the technical and professional issues of
providing services are appropriately considered in the review process.
The amendments include that the definition of service is amended to include prescribing of a
pharmaceutical benefit by an optometrist. The PSR Scheme is amended to include
suspension of an authorised optometrist's authority to prescribe.
Schedule 2 Approved Pharmacists
Schedule 2 of the Bill amends the National Health Act 1953 to clarify the intention of that
Act in relation to the supply of pharmaceutical benefits "at or from" approved premises. The
policy intention is that, at a minimum, members of the public will have access to
pharmaceutical benefits "at" the approved premises at reasonable times.
Schedule 2 will:
· clarify that a pharmacist who is approved under section 90 of the National Health
Act 1953 (`approved pharmacist') is required to supply pharmaceutical benefits to
persons who are "at" those premises when the supply of the pharmaceutical benefit is
made; and may choose to also supply pharmaceutical benefits "from" those premises
to persons who are not "at" the premises when the supply of pharmaceutical benefits
is made (for example, to a resident of a nursing home or to a person by mail order);
· provide that an approval under section 90 can only be granted on or after the day a
pharmacist is "able" to supply pharmaceutical benefits at the particular premises, that
is, when the pharmacist is physically and legally ready and able to carry on the
business of a pharmacist;
· provide that an approval under section 90 can only be granted if the public has access
to the approved premises for the purpose of receiving pharmaceutical benefits at
reasonable times; and
· provide that the Secretary may cancel an approval granted under section 90 if a
pharmacist is not supplying pharmaceutical benefits at the approved premises, or if
the public does not have access to the approved premises for the purpose of receiving
pharmaceutical benefits at reasonable times.
FINANCIAL IMPACT STATEMENT
Schedule 1 PBS prescribing by optometrists
The 2007-08 Budget provides funding of $10.7 million over four years which includes
funding for additional costs to the PBS and the RPBS, and to Medicare Australia for
prescriber approvals, system changes and claims processing. The funding incorporates some
offset of costs through reduced costs for Medicare and Veterans' benefits from a small
reduction in doctors' consultations no longer necessary to obtain PBS prescriptions for eye
medications.
2007-08 2008-09 2009-10 2010-11 4 Year Total
Expense 2.0 2.1 2.9 3.7 10.7
$m
Schedule 2 Approved Pharmacists
Schedule 2 of the Bill has no financial impact.
NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS)
BILL 2007
NOTES ON CLAUSES
Clause 1 Short title
Clause 1 provides that the amending Act may be cited as the National Health Amendment
(Pharmaceutical Benefits) Act 2007.
Clause 2 - Commencement
This clause provides commencement information for specific provisions. Sections 1 to 3
commence on the day on which the Act receives the Royal Assent. Schedule 1 items 1 to 11
commence on the day on which the Act receives the Royal Assent, items 12 and 13
commence on 1 January 2008, items 14 to 35 commence on Royal Assent, item 36
commences on 1 January 2008, items 37 to 42 commence on Royal Assent, item 43
commences on 1 January 2008, and items 44 to 71 commence on Royal Assent. Schedule 2
commences on the day after the Bill receives the Royal Assent.
Clause 3 Schedules
Clause 3 provides that each Act specified in a Schedule to this Act is amended or repealed as
set out in the applicable items in the relevant Schedule. Any other item in a Schedule has
effect according to its terms. The Bill contains two Schedules. Schedule 1 amends the
Health Insurance Act 1973 and the National Health Act 1953 according to the Schedule.
Schedule 2 amends the National Health Act 1953 according to the Schedule.
SCHEDULE 1 PBS PRESCRIBING BY OPTOMETRISTS
AMENDMENTS TO THE HEALTH INSURANCE ACT 1973
Item 1
Item 1 amends the definition of a service for the purposes of the Professional Services
Review Scheme (PSR) to include a service rendered by way of the prescribing or dispensing
of a pharmaceutical benefit by an optometrist. The PSR aims to protect the integrity of the
medicare benefits and pharmaceutical benefits programs by investigating and reviewing the
provision of services by health professionals participating in Medicare and the
Pharmaceutical Benefits Scheme (PBS). The amendment provides for an individual
optometrist's conduct in relation to pharmaceutical benefits to be examined under the PSR.
Similar provisions apply for medical practitioners and participating dental practitioners.
Item 2
Subsection 92(2) sets out the action that may be specified in a written agreement resulting from
a Director's review of a person under the PSR where the person acknowledges that they have
engaged in inappropriate practice. Paragraph 92(2)(e) specifies that if the person is a medical
practitioner or dental practitioner with authority to prescribe or dispense under Part VII of
National Health Act 1953 (a Part VII authority) and the inappropriate practice involves
prescribing or dispensing a pharmaceutical benefit, the Part VII authority is taken to be
suspended for a period of not more than three years from when the agreement takes effect.
Item 2 amends paragraph 92(2)(e) to provide that action to suspend a Part VII authority for the
purposes of a written agreement resulting from a Director's review of a `person' (whether or
not a medical practitioner, dental practitioner or an optometrist) engaged in inappropriate
practice that involves prescribing or dispensing a pharmaceutical benefit applies in respect of
any `person' who is a practitioner under review and for whom a Part VII authority is in force.
Item 3
Subsection 92(7) specifies the authorities and approvals for medical practitioners and dental
practitioners to prescribe or dispense pharmaceutical benefits under Part VII of the National
Health Act 1953 that fall within the meaning of a Part VII authority for the purposes of, and
which may be subject to action in, written agreements resulting from a Director's review
under the PSR of a person engaged in inappropriate practice that involves prescribing or
dispensing a pharmaceutical benefit.
Item 3 inserts a new paragraph into subsection 92(7) to provide for an approval of an
optometrist as an authorised optometrist (under section 84AAB of the National Health
Act 1953) to prescribe pharmaceutical benefits to be within the meaning of a
Part VII authority for the purposes of the section.
Item 4
Subsection 106U sets out the directions one or more of which must be contained in draft or
final determinations of a Determining Authority under the PSR where the person has engaged
in inappropriate practice. Paragraph 106U(1)(f) specifies that if the person is a medical
practitioner or dental practitioner with authority to prescribe or dispense under Part VII of the
National Health Act 1953 and the inappropriate practice involves prescribing or dispensing a
pharmaceutical benefit, the Part VII authority is taken to be suspended.
Item 4 amends paragraph 106U(1)(f) to provide that a direction to suspend an authority or
approval to prescribe or dispense under Part VII of the National Health Act 1953 for the
purposes of a draft or final determination by a Determining Authority involving prescribing or
dispensing a pharmaceutical benefit applies in respect of any person under review for whom a
Part VII authority is in force.
Item 5
Subsection 106U(5) specifies the authorities and approvals for medical practitioners and
dental practitioners to prescribe or dispense pharmaceutical benefits under Part VII of the
National Health Act 1953 that fall within the meaning of Part VII authority for the purposes
of directives in draft or final determinations of a Determining Authority in relation to a
person engaged in inappropriate practice involving prescribing or dispensing a
pharmaceutical benefit.
Item 5 inserts a new paragraph into subsection 106U(5) to provide for an approval of an
optometrist as an authorised optometrist (under section 84AAB of the National Health
Act 1953) to prescribe pharmaceutical benefits to be within the meaning of Part VII authority
for the purposes of the section.
SCHEDULE 1 PBS PRESCRIBING BY OPTOMETRISTS
AMENDMENTS TO THE NATIONAL HEALTH ACT 1953
Item 6
Section 4(2) provides that a reference in the National Health Act 1953 (the Act) to a
prescription for the supply of a pharmaceutical benefit is a reference to a prescription written
in accordance with subsection 88(1) or (1A).
Subsection 88(1) provides that medical practitioners are authorised to write prescriptions for
pharmaceutical benefits. Subsection 88(1A) provides that participating dental practitioners
(approved under section 84A of the Act) are authorised to write prescriptions for those
pharmaceutical benefits determined by the Minister for prescribing by participating dental
practitioners.
Schedule 1 of the Bill includes under item 15 an amendment to insert subsection 88(1C)
which provides for optometrists approved as authorised optometrists under section 84AAB
(as amended under item 11) to write prescriptions from 1 January 2008 for pharmaceutical
benefits determined by the Minister for prescribing by authorised optometrists.
Item 6 amends section 4(2) to provide that a reference in the Act to a prescription for the
supply of a pharmaceutical benefit is a reference to a prescription written in accordance with
subsection 88(1), (1A) or (1C) (i.e. by a medical practitioner, by a participating dental
practitioner for a pharmaceutical benefit for prescribing by participating dental practitioners,
or by an authorised optometrist for a pharmaceutical benefit for prescribing by authorised
optometrists).
Item 7
Item 7 amends subsection 84(1) to add a definition of authorised optometrist for the
purposes of Part VII of the Act. This is defined to mean an optometrist in relation to whom
an approval is in force under section 84AAB of the Act. Schedule 1 of the Bill provides,
under new section 84AAB, for an optometrist to be approved as an authorised optometrist
and under new subsection 88(1C) for an authorised optometrist to write prescriptions from
1 January 2008 for certain pharmaceutical benefits as determined by the Minister.
Item 8
Item 8 amends subsection 84(1) to add a definition of optometrist for the purposes of Part VII
of the Act. This is defined to mean a person registered or licensed as an optometrist or
optician under a law of a State or an internal Territory that provides for the registration or
licensing of optometrists or opticians. This is the same as the definition for optometrist in the
Health Insurance Act 1973.
Item 9
Item 9 amends subsection 84(1) to add a definition of PBS prescriber for the purposes of
Part VII of the Act. This is defined to mean a medical practitioner, or a participating dental
practitioner, or an authorised optometrist. The term is used in the Bill to amend provisions
relating to pharmaceutical benefits so as to include authorised optometrists in arrangements
relating to regulating the writing of prescriptions, and the supply and subsidy of
pharmaceutical benefits.
Item 10
Subsection 84AA(1) sets out the requirements for a prescription written by a medical
practitioner or participating dental practitioner for a pharmaceutical benefit to be supplied
under the PBS as a prescription for a concessional beneficiary or a dependant of the
concessional beneficiary. Similarly, subsection 84AA(1A) sets out the requirements for
prescriptions for pharmaceutical benefits to be supplied under PBS safety net arrangements
as a concession card or entitlement card prescription.
Item 10 amends subsections 84AA(1) and (1A) to substitute PBS prescriber in place of
`medical practitioner or participating dental practitioner'. This has the effect of including
prescriptions written by authorised optometrists (along with prescriptions written by medical
practitioners and participating dental practitioners) as being subject to the requirements for
writing prescriptions for a concessional beneficiary or a dependant of the concessional
beneficiary, or for pharmaceutical benefits to be supplied under PBS safety net arrangements
as a concession card or entitlement card prescription.
Item 11
Under this item of Schedule 1, the Bill amends the Act to introduce new provisions for:
· optometrists to be authorised to prescribe pharmaceutical benefits;
· approvals as authorised optometrists to be suspended or revoked; and
· decisions, made by the Secretary, not to approve an optometrist or to suspend or
revoke an authorised optometrist's approval, to be subject to internal reconsideration
and merits review.
Firstly, item 11 inserts new section 84AAB to provide for optometrists to apply to the
Secretary (of the Department of Health and Ageing) for approval to be an authorised
optometrist. The provisions in this section include that applications for approval as an
authorised optometrist must satisfy any criteria, and approvals are subject to any conditions,
determined by the Minister by legislative instrument. The Secretary must approve or reject
applications for approval as soon as practicable and notify applicants in writing of the
decision.
By requiring that an application by an optometrist for approval as an authorised optometrist
must satisfy any criteria determined by the Minister, the Bill allows the Minister to impose
criteria in addition to the criterion of the applicant being an optometrist as defined in the Act.
This provides a mechanism for the Minister to specify certain criteria aimed to ensure, for
example, that only optometrists with appropriate qualifications and training required for
approval to prescribe under State or Territory legislation will be approved to prescribe
pharmaceutical benefits.
In practice, the power provided in section 84AAB for the Secretary to consider applications
for approval as authorised optometrists, and to approve or reject those applications, would be
expected to be delegated to a delegate within Medicare Australia.
Secondly, item 11 inserts new section 84AAC to provide for an authorised optometrist's
approval to be suspended or revoked by the Secretary. Under subsection 84AAC(1),
approvals may be suspended or revoked if an authorised optometrist does not meet the
criteria in force for new approvals at that time, has breached a condition of the approval or
has breached a condition to which new approvals would be subject at that time.
Subsection 84AAC(2) requires that before suspending or revoking an approval, the Secretary
must give notice to the optometrist in writing, including reasons why the suspension or
revocation is being considered, and invite the optometrist to make written submission to the
Secretary within 28 days (the submission period) after being given the notice.
Under subsection 84AAC(3) the Secretary must consider any written submissions made by
the optometrist within the submission period and, under subsection 84AAC(4), must notify
the optometrist of that decision in writing and in the case of a suspension, the period for
which approval as an authorised optometrist is suspended.
Subsection 84AAC(5) provides that if the Secretary does not give written notice of the
decision to the optometrist within 60 days after the end of the submission period, the
Secretary is taken to have decided not to suspend or revoke the approval.
Subsection 84AAC(6) provides that if the Secretary's decision is to suspend the approval, the
Secretary may give written notice at any time to further suspend or revoke the approval under
subsection 84AAC(1) or remove the suspension. Action to further suspend or revoke an
already suspended approval would be subject to the same requirements under subsection
84AAC(1), (2), (3), (4) and (5) as an initial suspension; that is, written notification by the
Secretary of an intention to further suspend or revoke an approval, the reasons for considering
suspension or revocation and advising of the Secretary's decision. The same time periods for
an optometrist to make written submission and for the Secretary to notify a decision would also
apply.
Thirdly, item 11 inserts section 84AAD which provides for optometrists to request, by
application in writing, reconsideration by the Secretary of a decision not to approve an
application for approval as an authorised optometrist, or to suspend or revoke an approval.
Subsections 84AAD(2), (3) and (4) set out the action to be taken by the Secretary in response
to requests for reconsideration. In practice, it would be expected that the Secretary may
consider requests for reconsideration personally, or delegate the reconsideration to another
appropriate person.
Section 84AAD(5) provides that, for the purposes of section 84AAD, decision has the same
meaning as in the Administrative Appeals Tribunal Act 1975. Under item 44, a person may
apply to the Administrative Appeals Tribunal for review of a decision, resulting from
reconsideration under section 84AAD, not to grant an approval as an authorised optometrist
or to suspend or revoke an approval as an authorised optometrist.
Legislative notes under sections 84AAB, 84AAC and 84AAD indicate that section 105AC of
the Act requires that when a person is notified of a decision to not approve, suspend or
revoke an approval as an authorised optometrist, or is notified of a decision resulting from the
reconsideration of a decision, that person is to be notified of their review rights.
Item 12
Section 84C sets out the requirements for eligibility for safety net concession and
pharmaceutical benefit entitlement cards. Subparagraph 84C(4)(a)(i) provides that the supply
or repeated supply of a pharmaceutical benefit cannot be taken into account for the purposes
of determining eligibility for safety net concession or pharmaceutical benefit entitlement
cards (i.e. cannot be counted for the purposes of accrual to the safety net threshold), unless it
is supplied on a prescription (written or communicated) by a medical practitioner or
participating dental practitioner.
Item 12 amends subparagraph 84C(4)(a)(i) to substitute PBS prescriber in place of medical
practitioner or participating dental practitioner. This has the effect of including prescriptions
prescribed (written or communicated) by authorised optometrists (along with prescriptions
prescribed by medical practitioners and participating dental practitioners) for the purposes of
determining eligibility for concession or entitlement cards. That is, prescriptions for
pharmaceutical benefits prescribed by authorised optometrists will be eligible to be accrued
to the safety net threshold.
Item 13
Section 86 specifies the persons who are entitled to receive pharmaceutical benefits for a
charge which is in accordance with the PBS charges set out in section 87 of the Act.
Subsection 86(a) specifies that this entitlement applies to a person who is, or is to be treated
as, an eligible person with the meaning of the Health Insurance Act 1973; and
subsection 86(b) specifies that the person must also be receiving medical treatment by a
medical practitioner or dental treatment by a participating dental practitioner.
Item 13 repeals the existing subsection 86(b) and substitutes new paragraphs 86(b)(i), (ii) and
(iii) which results in subsection 86(b) being expanded to include medical treatment by a
medical practitioner or dental treatment by a participating dental practitioner or optometric
treatment by an authorised optometrist as being the circumstances in which a person eligible
under 86(a) would be entitled to receive pharmaceutical benefits.
Item 14
Section 86D relates to approved suppliers of pharmaceutical benefits recording and retaining
medicare numbers or medicare numbers and their expiry dates supplied by or on behalf of
patients, including under subsection 86D(2) when a prescription is communicated to the
approved supplier by a medical practitioner or participating dental practitioner.
(Communication of prescriptions is provided for under the Act and the National Health
(Pharmaceutical Benefits) Regulations 1960).
Item 14 amends paragraph 86D(2)(b) to substitute PBS prescriber in place of `medical
practitioner or participating dental practitioner'. This has the effect of allowing an approved
supplier to record and retain medicare numbers and their expiry dates for prescriptions
communicated by authorised optometrists, in addition to prescriptions communicated by
medical practitioners and participating dental practitioners.
Item 15
Section 88 sets out the types of practitioners who are authorised to write prescriptions for
pharmaceutical benefits and certain requirements relating to the writing or communicating of
such prescriptions. Under subsection 88(1), a medical practitioner can write prescriptions for
pharmaceutical benefits. Under subsection 88(1A), a participating dental practitioner can
write prescriptions for the supply of those pharmaceutical benefits that the Minister has
determined can be prescribed by a participating dental practitioner.
Item 15 inserts new subsection 88(1C) which allows an authorised optometrist (refer to
item 11), from 1 January 2008, to write prescriptions for pharmaceutical benefits that the
Minister has determined can be prescribed by an authorised optometrist.
Item 15 also inserts new subsection 88(1D) which provides that prescriptions written by an
authorised optometrist for the supply of pharmaceutical benefits need not specify a brand or a
manner of administration of the pharmaceutical item being prescribed as the pharmaceutical
benefit.
Item 16
Item 16 amends subsection 88(2) to substitute PBS prescriber in place of `medical
practitioner or a participating dental practitioner'. This will mean that medical practitioners,
participating dental practitioners and authorised optometrists must not authorise the supply of
a narcotic drug as a pharmaceutical benefit for their own use.
Item 17
Item 17 repeals subsection 88(3) and substitutes paragraphs 88(3)(a), (b) and (c). New
paragraphs 88(3)(a) and (b) prohibit medical practitioners and participating dental
practitioners from writing prescriptions for pharmaceutical benefits except, respectively, for
the medical treatment or dental treatment of the person requiring it (as in existing
subsection 88(3)). New paragraph 88(3)(c) prohibits authorised optometrists from writing a
prescription for a pharmaceutical benefit other than in relation to the optometrical treatment
of the person requiring it.
Items 18 to 23
Subsections 88(3A), (3B) and (3C) set out provisions and certain requirements for medical
practitioners and participating dental practitioners in relation to requesting, recording,
retaining and providing to an approved supplier, a person's medicare number and expiry date
for the purposes of prescribing pharmaceutical benefits for the person.
Items 18 to 23 amend provisions in subsections 88(3A), (3B) and (3C) by substituting
PBS prescriber in place of `medical practitioner or a participating dental practitioner' or
`practitioner' as the case may be. This has the effect of extending the same provisions and
requirements to authorised optometrists.
Items 24 to 26
Subsections 88(4), (5) and (7) relate to the prescribing of pharmaceutical benefits by medical
practitioners and participating dental practitioners, including in relation to matters determined
by the Minister under subsections 85A(1) and (2) regarding the type, form, strength, manner
of administration, number of units, maximum quantity, and number of repeats for a
pharmaceutical item.
Items 24 to 26 amend subsections 88(4), (5) and (7) to substitute PBS prescriber in place of
references to `medical practitioner or a participating dental practitioner' and similar
expressions where occurring. This has the effect of extending the existing provisions and
requirements relating to the prescribing of pharmaceutical benefits as contained in those
subsections (and applicable determinations) to authorised optometrists.
Items 27 to 35
Subsections 88AA(1), (2) and (3) relate to medical practitioners and participating dental
practitioners requesting, recording, retaining, maintaining accuracy, and safeguarding a
person's medicare number and expiry date obtained for the purposes of prescribing
pharmaceutical benefits for the person, either at the time or at a later time.
Items 27 to 35 amend subsections 88AA(1), (2) and (3) by substituting PBS prescriber in
place of `medical practitioner or a participating dental practitioner' or `practitioner' as the
case may be. This has the effect of extending the same provisions and requirements as exist
currently for medical practitioners and participating dental practitioners to authorised
optometrists.
Item 36
Item 36 amends paragraph 89(a) to substitute PBS prescriber in place of references to
`medical practitioner or a participating dental practitioner'. This has the effect of including
prescriptions written or communicated by authorised optometrists (in addition to
prescriptions by medical practitioners and participating dental practitioners) as being
prescriptions in respect of which a person would be entitled to receive pharmaceutical
benefits.
This item commences on 1 January 2008 to make clear that a person is not entitled to receive a
pharmaceutical benefit on a prescription written by an authorised optometrists before that date.
Item 37
Paragraphs 98(1)(a), (aa) and (b) provide for the Secretary to cancel the approval of an
approved pharmacist, participating dental practitioner and an approved medical practitioner
at their request.
Item 37 inserts paragraph 98(1)(c) to allow the Secretary to cancel the approval of an
authorised optometrist, at their request.
Items 38 to 40
Sections 99ZJ and 99ZK relate to detention of certain drug like substances, including
pharmaceutical benefits, being carried out of or exported from Australia and for retention of
related documents.
Items 38 and 39 respectively amend paragraph 99ZJ(4)(a) and subparagraph 99ZJ(4)(b)(ii) to
extend these provisions to include:
(i) an optometrist's letter (signed on or after 1 January 2008); or
(ii) in the case of subparagraph 99ZJ(4)(b)(ii), the name and address of the
optometrist who prescribed the drug like substances (on or after 1 January 2008)
to be used as a means of satisfying a Customs officer that the substances are for the personal
use of the person or a person accompanying them.
Item 40 replaces paragraph 99ZK(3)(c) with a new paragraph 99ZK(3)(c) which has a similar
effect to paragraph (i) above (in relation to item 38) in the context of consignment of articles
containing drug like substances.
Items 41 to 42
Section 103 relates to offences in relation to pharmaceutical benefits. Paragraph 103(4AA)(a)
provides, among other things, that a person must not have in his or her possession a quantity of
a pharmaceutical benefit that exceeds the designated quantity of that pharmaceutical benefit,
unless it was supplied to the person by an approved supplier for the medical or dental treatment
of the person.
Item 41 amends Paragraph 103(4AA)(a) to include optometrical treatment as a purpose for
which a pharmaceutical benefit is supplied to the person.
Item 42 amends subsection 103(4A) to substitute PBS prescriber in place of the reference to
`medical practitioner or participating dental practitioner'. This has the effect of extending to
authorised optometrists a requirement not to include, or permit to be included on a
prescription for a pharmaceutical benefit for a person (in relation to requirements under
subsection 84AA(1) or (1A)), any information connected to the person's status which is false
or misleading.
Item 43 amends paragraph 103(5)(d) to substitute PBS prescriber in place of `medical
practitioner or a participating dental practitioner'. This has the effect of including authorised
optometrists as persons who can write prescriptions for pharmaceutical benefits. This item
commences on 1 January 2008 to maintain the prohibition on authorised optometrists writing
prescriptions for the supply of pharmaceutical benefits until that date.
Item 44
Section 105AB sets out the decisions regarding which an application for review may be made
to the Administrative Appeals Tribunal (AAT).
Item 44 inserts subsection 105AB(2) to provide that an application may be made to the AAT
for review of a decision of the Secretary made under paragraph 84AAD(2)(a) or (3)(a). That
is, a decision resulting from a reconsideration of the initial decision not to approve an
application as an authorised optometrist or to suspend or revoke the approval of an authorised
optometrist.
Item 45
Section 107 is the interpretation provision for the purposes of Committees of Inquiry under
Part VIII of the Act. Subsection 107(1A) provides that approved pharmacist and
participating dental practitioner have the same meanings as in Part VII of the Act.
Item 45 substitutes PBS prescriber in place of `participating dental practitioner'. This has the
effect of including the same meaning for PBS prescriber as defined in Part VII. This allows
the term PBS prescriber to be used for amendments where it is necessary to expand
provisions relating to medical practitioners and participating dental practitioners to include
authorised optometrists for the purposes of Part VIII.
Item 46
Division 3 (which includes sections 113-117) of Part VIII of the Act relates to provisions and
requirements that apply to Pharmaceutical Services Committees of Inquiry. Under
section 114, a Pharmaceutical Services Federal Committee of Inquiry is authorised to inquire
into and report to the Minister or the Secretary on matters regarding or arising out of the
services or conduct of approved pharmacists in connection with the supply of pharmaceutical
benefits. Under section 117, the Committee of Inquiry, in performing its functions in relation
to approved pharmacists, is not authorised to report on the conduct of a medical practitioner
or participating dental practitioner but can refer to the conduct of a medical practitioner or
participating dental practitioner where it is incidental to the report on the approved
pharmacist.
Item 46 amends the heading of section 117 and subsections 117(1) and (2) to substitute PBS
prescriber or PBS prescribers, as the case may be, in place of references to medical
practitioner(s) and participating dental practitioner(s). This has the effect of extending the
existing provisions for medical practitioners and participating dental practitioners to apply
also to authorised optometrists.
Items 47 to 52
Division 4 of Part VIII of the Act sets out provisions and requirements that apply generally to
Committees of Inquiry conducted under Part VIII. Section 125 requires that a medical
practitioner, participating dental practitioner or approved pharmacist affected by an inquiry
must be given notice of the inquiry.
Items 47 to 52 amend the heading of section 125 and subsections 125(1), (2), (4), (5) and (7)
to substitute PBS prescriber or PBS prescribers, as the case may be, in place of references to
medical practitioner(s) and participating dental practitioner(s). This has the effect of
requiring that an authorised optometrist affected by an inquiry must be given notice of the
inquiry.
Items 53 to 56
Section 133 sets out provisions relating to the effect of prosecution for an offence.
Subsection 133(1) refers to circumstances where a medical practitioner, a participating dental
practitioner or an approved pharmacist is charged before a court as having committed an
offence against the Act or the regulations or against another law of the Commonwealth in
connection with the supply of pharmaceutical benefits. It also provides that the Secretary
may suspend the relevant person's approval to prescribe or supply pharmaceutical benefits.
Item 53 amends subsection 133(1) by replacing `a participating dental practitioner' with
other PBS prescriber. This results in the practitioners included under the provision being
`a medical practitioner, other PBS prescriber or approved pharmacist' and has the effect of
extending the existing provisions to apply also to authorised optometrists. Item 53 also
introduces the term defendant to mean, for the purposes of section 133, a medical
practitioner, other PBS prescriber or approved pharmacist (who is charged before a court).
Items 54 and 56 amend paragraphs 133(1)(a), (b) and (c) to incorporate the term defendant by
amending `in the case of a (an)' to read `in the case of a defendant who is a (an)' in relation
to a medical practitioner, participating dental practitioner, and approved pharmacist,
respectively.
Item 55 inserts new paragraph 133(1)(ba) which provides for the Secretary to suspend the
approval of an authorised optometrist where the defendant charged before a court with
having committed an offence involving the supply of pharmaceutical benefits as an
authorised optometrist.
Items 57 and 58
Subsection 133(2) provides for the Minister to suspend, further suspend or revoke an
approval relating to a medical practitioner, participating dental practitioner, or approved
pharmacist where the person is convicted of an offence connected with the supply of
pharmaceutical benefits. Subsection 133(5) provides that in the event that a person charged
with an offence under 133(1) is acquitted, any suspension of the person's approval by the
Secretary imposed as a consequence of the person being charged for that offence, ceases to
have effect. Subsection 133(6) provides that where a medical practitioner, participating
dental practitioner, or approved pharmacist is charged before a court with an offence
connected with the supply of pharmaceutical benefits, any act or conduct to which the charge
relates must not be referred to a Committee of Inquiry and any investigation by a Committee
of Inquiry ceases.
Items 57 and 58 amend subsections 133(2), (5) and (6) to insert reference to an optometrist
wherever occurring. This has the effect of including optometrists as persons to whom those
provisions apply.
Items 59 and 60
Items 59 and 60 provide that authorised optometrist and PBS prescriber have the same
meanings as in Part VII.
Items 61 and 62
Section 134 outlines the effect of suspending or cancelling an approval or authority of a
medical practitioner or a participating dental practitioner. Subsection 134(1) provides that
where a medical practitioner's authority or a participating dental practitioner's approval is
suspended or revoked, that person must not write a prescription for a pharmaceutical benefit.
Further, an approved supplier must not supply pharmaceutical benefits on the prescription of
a medical practitioner or a participating dental practitioner whose authority or approval is
suspended or revoked.
Item 61 inserts paragraph 134(1)(c) which extends the provisions under 134(1) to apply also
to an optometrist whose approval as an authorised optometrist has been suspended or
revoked.
Item 62 amends subsection 134(1) by including optometrists for the purposes of those
provisions.
Item 63
Section 135A contains provisions which require officers, as defined in subsection 135A(24),
to observe secrecy in regard to information acquired concerning third parties. Subsection
135A(8) prevents information from being divulged when it is obtained in the rendering of:
medical or dental services; provision of hospital treatment or nursing home care; the supply
of pharmaceutical benefit or special pharmaceutical product and where the divulgence of this
information is likely to lead to the identification of the person to whom the service, treatment,
care, benefit or product was provided.
Item 63 amends subsection 135A(8) by including optometrical services for the purpose of
that provision.
Items 64 to 67
Section 135AAA contains provisions which require that prescribers and approved suppliers
must observe secrecy regarding medicare numbers and expiry dates provided for the purposes
of the PBS.
Items 65 amends subsection 135AAA(1) by replacing `such a practitioner' with PBS
prescriber.
Items 64, 66 and 67 amend paragraphs 135AAA(1)(a) and (2)(c), and subparagraphs
135AAA(5)(a)(i) and (ii), by replacing `medical practitioner or participating dental
practitioner' with PBS prescriber. This has the effect of including authorised optometrists
for the purposes of those provisions.
Items 68 and 69
Item 68 repeals the definition of `participating dental practitioner' which is no longer needed
for the purposes of the section having been incorporated into the definition of
PBS prescriber. Item 69 amends subsection 135AAA(10) to add a definition of PBS
prescriber which is defined to have the same meaning as in Part VII.
Item 70
Subsection 135AAA(11) provides that the provisions under section 135 which require that
prescribers and approved suppliers observe secrecy regarding medicare numbers and their
expiry dates that are provided to approved suppliers for PBS purposes apply also when
communicating a prescription to the supplier.
Item 70 amends subsection 135AAA(11) to substitute PBS prescriber in place of `medical
practitioner or a participating dental practitioner'. This has the effect of extending the
existing provisions for medical practitioners and participating dental practitioners to apply
also to authorised optometrists.
Item 71
Section 139A contains provisions relating to evidence. Subsection 139A(1) provides that the
Secretary may certify in writing that, during a period or on a date specified in that certificate,
certain approvals and authorisations relating to medical practitioners, approved medical
practitioners, participating dental practitioners, approved pharmacists, approved hospitals,
approved nursing homes and approved hospital authorities, as the case requires, were or were
not in force.
Item 71 amends subsection 139A(1) by inserting paragraph 139A(1)(db) which provides that
the Secretary may certify in writing whether a person was or was not an authorised
optometrist under section 84AAB during a period or on a date specified in that certificate.
SCHEDULE 2 APPROVED PHARMACISTS
AMENDMENTS TO THE NATIONAL HEALTH ACT 1953
Schedule 2 contains amendments to the National Health Act 1953 which clarify the intention
of that Act in relation to the supply of pharmaceutical benefits by approved pharmacists.
These amendments take effect on the day after the Bill receives the Royal Assent (see
clause 2 in the Bill).
Item 1 - Before subsection 4(5)
This item inserts a new subsection 4(3) to clarify that the reference in the Act to the supply of
pharmaceutical benefits "at" premises means that the pharmaceutical benefits are supplied to
people who are physically at the premises when the supply is made.
Item 2 - Subsection 90(1)
This item amends subsection 90(1) to simplify the wording of the subsection and make clear
that the pharmacist is applying for approval to supply pharmaceutical benefits.
Items 3, 6, 9, 10, 11, 12, 13, 14, 15, 17, 19 and 20
These items remove the words "or from" to make clear that pharmaceutical benefits must be
supplied at approved premises. The reference to "at or from" is amended in these subsections
and paragraphs to ensure that this requirement is unambiguous.
Items 4 and 5 - Subsections 90(2) and (3)
These items amend subsections 90(2) and (3) to simplify the references to premises.
Item 7 - After subsection 90(3C)
This item inserts a new subsection 90(3D) to provide that the Secretary must not grant
approval to a pharmacist under section 90 of the Act if the Secretary is satisfied that the
pharmacist is unable to supply pharmaceutical benefits at the particular premises, or that the
premises are not accessible by members of the public to receive pharmaceutical benefits at
reasonable times.
This subsection requires that the Secretary must not grant approval under section 90 of the
Act if the pharmacist is "unable" to supply pharmaceutical benefits. A pharmacist can make
an application under section 90 of the Act to supply pharmaceutical benefits at particular
premises; however, a pharmacist may not be "able" to supply pharmaceutical benefits at the
time the pharmacist makes the application. This situation arises, for example, where the
requirements for preparing the premises for use as a pharmacy, such as the fit out of the
premises, the purchase of stock, and the need to obtain relevant State or Territory approval,
have not been completed. The amendment makes clear that the Secretary is not prohibited
from granting approval under section 90 of the Act unless the Secretary has reason to believe
that the pharmacist would be unable to supply pharmaceutical benefits.
In addition, the Secretary must not grant approval if the premises are not accessible by the
public for the purpose of receiving pharmaceutical benefits at "reasonable times".
Reasonable times, generally means providing access to the premises during normal business
hours. What is considered reasonable may vary according to the particular circumstances, for
example, in a heavily populated urban area it would be expected that a pharmacy would be
open at least each working day for the standard business hours. However, in a small rural
town where a pharmacy may be serviced by a pharmacist from another town, reasonable
times may be something less than standard business hours, and not necessarily each working
day. The amendment makes clear that the Secretary is not prohibited from granting approval
under section 90 of the Act unless the Secretary has reason to believe that the public would
not have access to the premises for the purpose of receiving pharmaceutical benefits during
reasonable times.
Item 8 - After subsection 90(5)
This item inserts a new subsection 90(5AA) to provide that pharmacists who are approved
under section 90 of the Act to supply pharmaceutical benefits "at" particular premises may
also supply pharmaceutical benefits "from" those premises.
The term "from" in this context is intended to convey that supply of pharmaceutical benefits
is made from the particular premises to a person or persons who are located away from the
premises, for example, to a resident of an aged care facility, a person in their home, or by a
mail order facility. While many approved pharmacists currently (and will continue to) supply
pharmaceutical benefits "from" approved premises, this amendment makes clear that the
supply of pharmaceutical benefits from approved premises is not mandatory.
Item 16 - Subsection 98(3)
This item repeals and replaces subsection 98(3) to provide that the Secretary may cancel an
approval granted under section 90 of the Act if the pharmacist is not carrying on business as a
pharmacist at the approved premises, or if the public is unable to access the approved
premises for the purpose of receiving pharmaceutical benefits at reasonable times.
The term "carrying on business as a pharmacist" at paragraph 98(3)(a) is intended to convey
the requirement that pharmaceutical benefits be supplied in the course of carrying on the
business of a pharmacist at the approved premises. See also item 18 below.
Item 18 - At the end of section 98
This item inserts a new subsection 98(6) to make clear that, if an approved pharmacist is not
supplying pharmaceutical benefits to members of the public at the approved premises, then
the approved pharmacist is not considered to be carrying on the business as a pharmacist.
Item 21 - Application
This item provides that the amendments to section 98 apply to all approvals granted under
section 90 of the Act before the commencement of the amendments as well as to approvals
granted on and after the amendments commence. This means that a pharmacist who has been
granted an approval before the commencement of the amendments will be subject to the
cancellation provisions in section 98, as amended. This item also provides that the
amendments to section 90, 90A and 91 apply to all approvals granted on and after the
commencement of the amendments.
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