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2019
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS)
BILL 2019
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health, the Hon Greg Hunt MP)
NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS)
BILL 2019
OUTLINE
The Pharmaceutical Benefits Scheme (PBS) operates under Part VII of the National
Health Act 1953 (Act) and provides Australians with timely, reliable and affordable
access to necessary and cost-effective medicines.
The National Health Amendment (Pharmaceutical Benefits) Bill 2019 (the Bill)
amends Part VII of the Act to implement measures relating to the PBS, including one
budget-related measure which will recover costs associated with the processing of
applications for pharmacy approvals.
The other measure will provide for continuity of supply of PBS medicines following
bankruptcy, or external administration, affecting pharmacies.
Cost recovery for pharmacy approval process
The amendment in Schedule 1 will introduce a fee for consideration of applications
by pharmacists for approval to supply PBS medicines at particular premises. This
amendment is required to implement a 2018-19 Budget measure which provides for
full cost recovery for these services.
Schedule 1 will provide for an application fee for an application made under
subsection 90(1) or 90(3) of the Act. It will provide the Minister with the power to
determine the application fees by legislative instrument.
Supply of pharmaceutical benefits following bankruptcy or external administration
The amendments in Schedule 2 will enable pharmaceutical benefits to continue to be
supplied following bankruptcy or where there is an external administrator in relation
to the pharmacy.
The amendments allow the Secretary of the Department of Health ('the Secretary') to
grant permission to a trustee in bankruptcy to supply pharmaceutical benefits at a
premises in respect of which an approved pharmacist is bankrupt. This permission is
granted for a temporary period of time until the pharmacy business is transferred
(sold) to another pharmacist. This will ensure community access to pharmaceutical
benefits at an affected pharmacy is not compromised. Consumers will not be required
to travel to another pharmacy, not affected by bankruptcy, in these circumstances.
Specifically, schedule 2 will permit a trustee in bankruptcy, or external administrator,
to supply pharmaceutical benefits at premises in respect of which a pharmacist is
approved under section 90 of the Act ('approved pharmacist'), using the approved
pharmacist's existing approval number. It will also allow the appointed administrator
to request cancellation of the approval of the pharmacist to allow another pharmacist
to be approved to supply pharmaceutical benefits at the same or different premises.
Financial Impact Statement
The amendments in Schedule 1 of the Bill are required to implement a measure
announced by the Australian Government as part of the 2018-19 Budget. This
measure will generate estimated revenue of around $2.8 million per year.
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Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny)
Act 2011
NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS)
BILL 2019
This Bill is compatible with the human rights and freedoms recognised or declared in
the international instruments listed in section 3 of the Human Rights (Parliamentary
Scrutiny) Act 2011.
Overview of the Bill
The National Health Amendment (Pharmaceutical Benefits) Bill 2019 (the Bill)
amends the National Health Act 1953 (Act) to implement measures relating to the
Pharmaceutical Benefits Scheme (PBS), including one budget-related measure which
will recover costs associated with the processing of applications for pharmacy
approvals.
The 2018-19 Budget measure in the Bill provides for full cost recovery of services
required to decide applications by pharmacists for approval to supply PBS medicines
at particular pharmacy premises. The amendments to the Act will provide for
application fees to be payable for such applications, and provide for the Minister to
make a legislative instrument to determine those fees.
The Bill will also amend the Act to enable the Secretary to grant permission to a
trustee in bankruptcy to manage the supply of pharmaceutical benefits at
PBS-approved pharmacy premises following bankruptcy of the approved pharmacist
or where there is an external administrator in relation to the pharmacy.
Human rights implications
This Bill is compatible with Articles 2 and 12 of the International Covenant on
Economic, Social and Cultural Rights by assisting with the progressive realisation by
all appropriate means of the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health. The PBS assists with advancement
of this human right by providing subsidised access to medicines for Australians.
The amendment in relation to bankrupt pharmacies is intended to ensure continuity of
supply of PBS medicines for the community. If a pharmacy was to cease operating
due to bankruptcy then the community may no longer have access to the supply of
PBS medicines, which could be detrimental in communities without access to other
pharmacies, such as in rural areas. The amendment will help to ensure that the
community maintains reasonable access to pharmaceutical benefits.
Conclusion
This Bill is compatible with human rights as it does not raise any human rights issues.
The amendments made by this Bill will have a beneficial impact on human rights
though improved access to medicines.
The Hon Greg Hunt MP, the Minister for Health
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NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS)
BILL 2019
NOTES ON CLAUSES
Clause 1 - Short Title
Clause 1 provides for the short title of the Act to be the National Health Amendment
(Pharmaceutical Benefits) Act 2019.
Clause 2 - Commencement
This clause provides that sections 1 to 3 of the Bill will commence on Royal Assent.
Other parts of the Bill commence as follows:
Schedule 1 will commence 2 months after Royal Assent; and
Schedule 2 will commence on a single day to be fixed by Proclamation.
However, if the provisions do not commence within the period of 6 months
beginning on the day this Act receives the Royal Assent, they commence on
the day after the end of that period.
Clause 3 - Schedule(s)
This clause provides that legislation that is specified in a Schedule to the Bill is
amended or repealed as set out in the applicable items in the Schedule concerned, and
any other item in a Schedule has effect according to its terms. Each of the Schedules
to the Bill amends the National Health Act 1953 (the Act).
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SCHEDULE 1 -- Application fees for pharmacist applications
Item 1
This item inserts a new subsection (aa) to paragraph 6(1) to include that the Minister's
power under the new subsection 90(10), which relates to the determination of
application fees payable for application under section 90(1) or 90(3), cannot be
delegated.
Item 2
This item inserts a note at the end of subsection 90(1) to indicate that there is an
application fee for an application made under this subsection of the Act, and that this
fee is provided for in subsection 90(9). This provides for application fees to be
payable for certain services relating to the exercise of the Secretary's powers under
this Act. For further information on subsection 90(9), inserted by this schedule, see
item 6 below.
Item 3
This item amends subsection 90(2) by inserting "under subsection (1)" after "a
separate application" to make clear that a separate application is required under
subsection 1 where a pharmacist wishes to supply pharmaceutical benefits at more
than one premises.
Item 4
This item inserts a note at the end of subsection 90(3) to indicate that there is an
application fee for an application made under this subsection of the Act, and that this
fee is provided for in subsection 90(9).
Item 5
This item amends subsection 90(3A) to include an additional circumstance under
which an application is not required to be referred to the Australian Community
Pharmacy Authority ('the Authority'). The addition of subsection 90(13) to this
subsection provides that an application is not required to be referred to the Authority
if the application fee has not been paid.
Item 6
This item inserts six new subsections at the end of section 90, under a subheading
Application fee.
Subsection 90(9) specifies that an application under section 90(1) or 90(3) must be
accompanied by an application fee, and that the application fee is as determined in an
instrument made by the Minister.
'Accompanied by' may include:
- the provision of credit card details when the application is made to the
Secretary, to allow the application fee to be processed and charged to the
credit card following validation of the application; or
- automated payments made online when an application is made to the Secretary
through an online portal.
Subsection 90(10) provides for the Minister to make a legislative instrument to
determine the application fees payable for applications under section 90(1) or 90(3) of
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the Act, to supply pharmaceutical benefits at particular premises. The inclusion of
Item 1 above provides that the Minister's power to determine the application fees
payable for such applications cannot be delegated.
Subsection 90(11) allows for the Minister to determine different fees for different
kinds of applications. The intention is to allow the Minister to determine that a higher
fee is payable for applications that require referral to the Australian Community
Pharmacy Authority (the Authority), as the assessment of such applications is more
complex and requires more resources than for applications that do not require referral
to the Authority. It is intended that a lower fee would apply for applications that do
not require referral to the Authority.
Subsection 90(12) requires that the fee that applies to an application must not amount
to taxation.
Subsection 90(13) provides that a consequence of the applicant not paying the
application fee for an application under subsection 90(1) or (3), is that the application
is not required to be referred to the Authority under subsection (3A). The intention is
to provide the ability to 'halt' the application assessment process by not referring the
application to the Authority under subsection 90(3A), where the applicant has not
paid the application fee.
Subsection 90(14) provides that a consequence of the applicant not paying the
application fee for an application to the Secretary under subsection 90(1) or (3), is that
the Secretary may refuse to make a decision on the application. This is intended to
provide the Secretary with the ability to not make a decision whether or not to grant
approval to an applicant, if that applicant has not paid, or refuses to pay, the
application fee, or if the processing of the payment of the application fee fails.
Item 7
This item provides that the amendments to section 90 made under Schedule 1 apply in
relation to an application made under subsection 90(1) or (3) of the Act, on or after
commencement of this item. The commencement information for the Bill specifies
that the amendments outlined in Schedule 1 commence 2 months after Royal Assent,
meaning that an application fee will apply to any application under subsection 90(1)
or (3), made on or after this date.
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SCHEDULE 2--Supply of pharmaceutical benefits following bankruptcy or
external administration
Items 1 and 2
These items expand the meaning of approved pharmacist to include a person treated
as having been approved under the new provision inserted by this schedule.
Item 3
This item inserts a new section 91B to provide for the supply of pharmaceutical
benefits following the bankruptcy of an approved pharmacist or where the pharmacy,
at the premises in respect of which the pharmacist is approved, is under external
administration.
Section 91B provides that permission can only be granted where an approval under
the existing section 90 is in force in respect of particular premises. If an approval
under section 90 is not in force in respect of particular premises, then permission
under section 91B must not be granted.
The provision applies where the approved pharmacist is an individual or more than
one individual (i.e. partnership).
Subsection 91B(1) sets out the circumstances where the Secretary must grant, or
refuse to grant, permission for a trustee in bankruptcy to supply pharmaceutical
benefits following the bankruptcy of an approved pharmacist who is an individual.
A refusal to grant permission by the Secretary does not prevent the approved
pharmacist continuing/resuming supplying pharmaceutical benefits at the premises for
which they are approved, if the pharmacist is able to do so.
If the pharmacy has ceased operating at the premises in respect of which the
pharmacist is approved and if the pharmacy is unable to resume operating within a
reasonable period, then the community no longer has access to the supply of
pharmaceutical benefits at those premises. Permission should not be granted and
consideration should be given to cancelling the pharmacist's approval in respect of
those premises under subsection 98(3).
If the pharmacy is not accessible by the public for the purpose of receiving
pharmaceutical benefits at reasonable times and is unable to be accessible by the
public at reasonable times, then the community does not have reasonable access to
pharmaceutical benefits. Permission should not be granted and consideration should
be given to cancelling the pharmacist's approval in respect of those premises under
subsection 98(3). What is considered reasonable is explained in subsection 91B(7).
Subsection 91B(2) sets out the circumstances where the Secretary must grant, or
refuse to grant, permission for a trustee in bankruptcy to supply pharmaceutical
benefits following the bankruptcy of an approved pharmacist that is a partnership
comprising only of individuals and each of the partners is bankrupt.
Where a pharmacist who is a member of a partnership becomes bankrupt, their assets
will vest in a trustee in bankruptcy but the bankrupt pharmacist will retain the section
90 approval jointly with the other members of the partnership. Regardless of whether
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the partnership is dissolved or survives the section 90 approval, permission should not
be granted, as the remaining partner/s can continue to supply PBS medicines in
accordance with their approval.
Subsection 91B(3) sets out the circumstances where the Secretary must grant, or
refuse to grant, permission for an external administrator to supply pharmaceutical
benefits following the appointment of the external administrator over the pharmacy.
If the pharmacy, at the premises in respect of which a pharmacist is approved, is
under external administration, then the external administrator can apply for
permission to supply pharmaceutical benefits at those premises. This can occur where
the approved pharmacist is a company, or where the approved pharmacist is an
individual/s who is/are the director/s of the company that operates the pharmacy.
Subsection 91B(4) sets out how and when a trustee, or external administrator, may
request the Secretary grant permission under subsection 91B(1), (2) or (3).
It provides that a request must be in writing in a form approved by the Secretary.
It provides that a request must be made within 10 business days of the appointment of
the trustee (or external administrator).
It provides that, in the case of a partnership, a request must be made within
10 business days of a trustee becoming the trustee of the estate for all of the bankrupt
partners (i.e. the appointment of the last trustee).
It provides that the Secretary may, in certain circumstances, accept an application
outside of that period. This may occur, for example, if the trustee (or external
administrator) is not immediately aware of the existence of a pharmacy, or if there is
some delay in the trustee ascertaining the business affairs of the bankrupt pharmacist
and/or undertaking an assessment of the viability in continuing to operate the
pharmacy business.
It provides that a request must include certain documentary evidence. This includes
evidence that the trustee (or external administrator) has been appointed and that the
appointment covers the pharmacy operating at the premises in respect of which the
pharmacist is approved under section 90.
It provides that the application must include information about the status of the
pharmacy and whether it is operating as a pharmacy and can continue to operate as a
pharmacy after permission is granted. If the pharmacy is not operating at the premises
in respect of which the pharmacist is approved under section 90, then the application
must include information about the day the pharmacy ceased operating and when the
pharmacy is proposed to resume operating. This includes the grounds on which the
pharmacy can continue or resume operating at the premises. For example, the leasing
status of the premises, stock levels and staffing arrangements are all factors that may
determine whether a pharmacy is able to operate or resume operating as a pharmacy.
Where the pharmacist is approved to supply pharmaceutical benefits at more than one
premises, a separate application is required to be made for each of those premises for
which permission is being sought.
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Subsection 91B(5) provides that, in considering an application, the Secretary may
request the applicant provide additional information, or produce specified documents,
to assist with making a decision. Such a request must be made in writing and specify
the period in which the requested information is to be provided.
Subsection 91B(6) provides that, if the applicant does not provide the information
requested under subsection 91B(5) by a given date, the application may be treated by
the Secretary as having been withdrawn.
An application for permission treated as having been withdrawn does not prevent the
approved pharmacist continuing/resuming supplying pharmaceutical benefits at the
premises for which they are approved, if the pharmacist is able to do so.
If an application for permission is treated as having been withdrawn, and if the
pharmacy has ceased operating and is unable to resume operating within a reasonable
period, then the community no longer has access to the supply of pharmaceutical
benefits at those premises and the Secretary may cancel the pharmacist's approval in
respect of those premises under subsection 98(3).
If an application for permission is treated as having been withdrawn, and if the
pharmacy is not accessible by the public for the purpose of receiving pharmaceutical
benefits at reasonable times and is unable to do so within a reasonable period, then the
community does not have reasonable access to pharmaceutical benefits at those
premises and the Secretary may cancel the pharmacist's approval in respect of those
premises under subsection 98(3).
Subsection 91B(7) outlines the circumstances where the Secretary must grant
permission. It provides that if a pharmacy is operating and can continue to operate at
the pharmacy premises, and if the premises are accessible to the public at times that
are reasonable, then permission must be granted.
The Secretary is not prevented from granting permission in circumstances where the
pharmacy has ceased operating at the premises, but can resume operating when and if
permission is granted.
Reasonable times generally means providing access to the physical pharmacy
premises during normal business hours. What is considered reasonable may vary
according to the particular circumstances, For example, in a heavily populated urban
area a pharmacy should 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.
Subsection 91B(8) provides that the Secretary must not grant any further permissions
if a permission has already been granted to a trustee (or external administrator) to
supply pharmaceutical benefits at the particular premises. In circumstances where
there has been a change in trustee, the permission can be varied under
subsection 91B(14) to transfer the permission to the new trustee.
Subsection 91B(9) provides that the Secretary must notify the applicant in writing of
whether or not the Secretary has decided to grant the applicant permission to supply
8
pharmaceutical benefits at the premises for which the pharmacist is approved. This
includes where an application is taken to be withdrawn when information has been
requested but has not been provided within the timeframe specified in the request.
If the Secretary's decision is to refuse to grant permission, then the notice of refusal
must include the reasons for the refusal.
Subsection 91B(10) provides that where the Secretary grants permission to a trustee
(or external administrator) to supply pharmaceutical benefits at particular premises,
then the holder of the permission is treated, for all purposes of the Act, as if the holder
of the permission is approved in respect of those premises for the duration of the
permission period.
The purpose of this provision is to make clear that the permission holder, who has
been granted permission to supply pharmaceutical benefits, is not as a matter of law
an approved pharmacist, but is treated as such.
If the Secretary grants permission, the commencement of the permission period is
taken to be from the date the application for permission is made.
Any claims made for pharmaceutical benefits supplied on and after the date of
application, under section 99, will be processed with payment held until the Secretary
makes a decision in relation to the application for permission. If the decision is to
grant permission, then payment for those claims will be released to the permission
holder. If the decision is not to grant permission, then payment for those claims will
be released to the approved pharmacist.
It provides that where a permission is granted under subsection 91B(1), (2) or (3) to
supply pharmaceutical benefits at a pharmacy, the permission holder may also supply
pharmaceutical benefits from that pharmacy.
The term from in this context is intended to convey that supply of pharmaceutical
benefits is made from the pharmacy premises to a person or persons who are located
away from the pharmacy premises, for example, to a resident of an aged care facility,
a patient of a private hospital, a person in their home, or by a mail order facility.
It provides that where permission is granted to supply pharmaceutical benefits, the
supply of pharmaceutical benefits at or from the particular premises, during the
permission period, will be treated as if they were supplied by the approved pharmacist
in respect of the pharmacy at the premises that relate to the pharmacist's approval.
Any pharmaceutical benefits supplied to a person, at or from the pharmacy at
premises in respect of which the pharmacist is approved, during the permission
period, will count towards the person's safety net.
It provides that if a permission is granted under subsection 91B(1),(2) or (3), because
that permission is treated as an approval under section 90 (by virtue of paragraph
91B(8)(a)), the permission is subject to all conditions to which an approval granted
under section 90 is subject. The new paragraph makes clear that the conditions
include any conditions imposed by means of a determination made by the Minister
under paragraph 92A(1)(f).
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Subsection 91B(11) provides that the permission can continue at the pharmacy
premises until it is revoked by the Secretary, under subsection 12, or until the
Secretary grants another approval under section 90 in respect of those premises.
It provides that if the permission holder requests the cancellation of the approval in
support of an approval being granted to another pharmacist to supply pharmaceutical
benefits at the pharmacy premises, then the permission will cease immediately prior
to the Secretary granting approval to that other pharmacist under section 90.
Subsection 91B(12) provides the circumstances that the Secretary may revoke a
permission granted under subsection 91B(1), (2) or (3).
It provides that if there has been a contravention of a condition under section 92A,
then the Secretary may revoke the permission.
It provides that if the pharmacy business is not operating and supplying
pharmaceutical benefits at the premises in respect of which the pharmacist is
approved, then the Secretary may revoke the permission.
It provides that if the pharmacy is not accessible to the public during times that are
reasonable, then the Secretary may revoke the permission.
Paragraph 91B(12)(d) provides that the Secretary may revoke the permission if the
Secretary is satisfied that it is otherwise appropriate in the circumstances to revoke the
permission. Such circumstances include where the Secretary is satisfied that the
trustee is no longer able to carry on business as a pharmacist under the relevant State
or Territory law.
Where the Secretary makes a decision to revoke a permission, the Secretary must give
written notice of that decision to the holder of the permission.
Subsection 91B(13) provides that the Secretary must revoke the permission if the
holder of the permission has requested, in writing, that it be revoked. This may occur
if the permission holder is transferring the pharmacy to a pharmacist and the Secretary
is granting approval to that pharmacist, or if the pharmacy is no longer viable and the
permission holder has decided to cease the operation of the pharmacy.
Subsection 91B(14) provides that the Secretary may vary a permission, granted under
subsection 91B(1), (2) or (3), to reflect changes in the trustee or external
administrator.
It provides that a variation should take effect on the day that the permission holder
requests it takes effect, to coincide with the date that the transfer of trustee/external
administrator takes effect.
Subsection 91B(15) seeks to make clear the content of the power of the Secretary to
grant permission under subsection 91B(1), (2) or (3).
It provides that the Secretary should not be concerned with the operation of any laws
of any State or Territory, but only with the granting or refusal to grant permission to
supply pharmaceutical benefits for the purpose of the PBS.
10
It provides that a permission granted under subsection 91B(1), (2) or (3) does not
cover any permits, licences or approvals a pharmacist may also be required to obtain
in order to comply with a law of the State or Territory in which the particular
premises are situated, in order to carry on the business of a pharmacist. That is, the
permission holder also needs to be permitted by the laws of the relevant State or
Territory laws to carry on the business of a pharmacist at the particular premises in
respect of which the permission holder has been granted permission under subsection
91B(1), (2) or (3).
It is for the relevant authority in the State or Territory to apply and enforce the laws of
that State or Territory.
Subsection 91B(16) provides for the definition of an external administrator which
is:
an administrator of the pharmacy; or
a managing controller (within the meaning of the Corporations Act
2001) in relation to property of any company operating the pharmacy; or
an external administrator (within the meaning of section 5-20 of
Schedule 2 to the Corporations Act 2001) of any company operating the
pharmacy.
It does not provide for any person, appointed under the Corporations Act 2001 or
under State or Territory law, who is not able to carry on the business of a pharmacy,
for example a receiver (that is not a receiver and manager) or a controller (that is not a
managing controller).
Subsection 91B(17) provides for the definition of a pharmacy to be a business in the
course of the carrying on of which pharmaceutical benefits are supplied.
A pharmacy must be physically accessible to the public for the purpose of receiving
pharmaceutical benefits.
Subsection 91B(18) provides that an application involving more than one trustee must
be made jointly by those trustees and that any reference to a trustee is a reference to
all of those trustees.
Subsection 91B(19) provides that an application involving more than one external
administrator must be made jointly by those external administrators and that any
reference to an external administrator is a reference to all of those external
administrators.
Item 4
This item inserts a new subsection 98(2A) after subsection 98(2) to provide that the
Secretary may refuse to cancel an approval of an approved pharmacist at the request
of the approved pharmacist if the approved pharmacist is bankrupt or an appointment
of an external administrator is in force in respect of the pharmacy situated at those
premises.
It seeks to make clear that if an approved pharmacist requests the cancellation of the
pharmacist's approval either prior to, or after, the Secretary receives an application for
permission under subsection 91B(1), (2) or (3) and where the date of effect of that
11
cancellation is after the date the Secretary receives the application for permission, the
Secretary should refuse to cancel the pharmacist's approval and instead grant
permission under subsection 91B(1), (2) or (3).
Item 5
This item inserts a new subsection 98(3AA) and 98(3AB) after subsection 98(3) to
provide additional circumstances in which an approval of a pharmacist be cancelled
by the Secretary.
It provides that if the permission holder requests that the pharmacist's approval be
cancelled, the Secretary must cancel the approval. This could occur if the permission
holder has sold the pharmacy to another pharmacist and that pharmacist is applying
for approval under section 90 to supply pharmaceutical benefits at particular premises.
Alternatively, the permission holder may have decided that it is not viable to continue
operating the pharmacy and is closing the pharmacy at the premises for which it is
approved. In this instance the permission holder may be transferring the approval to
another pharmacist who is applying to relocate the approval or closing the pharmacy
indefinitely.
It provides that if the permission to supply pharmaceutical benefits is revoked under
subsection 98B(12) or (13), the Secretary may cancel the pharmacist's approval. This
could occur if the grounds for revoking the permission are because the Secretary is
not satisfied that pharmaceutical benefits are able to be supplied at the pharmacy. If,
however, the permission holder is returning the pharmacy to the approved pharmacist,
then the Secretary may decide not to cancel the pharmacist's approval provided the
approved pharmacist is able to supply pharmaceutical benefits at the premises in
respect of which the pharmacist is approved.
It provides that if the Secretary does cancel the pharmacist's approval, the Secretary
must give written notice of that decision to the approved pharmacist and to the holder
of the permission.
Item 6
This item inserts a new subsection 105AB(7AC) to provide that an application may be
made to the Administrative Appeals Tribunal (AAT) for review of a decision of the
Secretary refusing to grant permission for an application under new subsection
91B(1), (2) or (3) or treating an application as having been withdrawn under new
subsection 91B(6), or revoking a permission under new subsection 91B(10).
The revocation of a permission under new section 91B(10) is not expected to be
common. The most likely reason for revocation would be that a pharmacy business
has ceased operating at the premises in respect of which the pharmacist is approved
and is unable to resume operating. This could occur where the lease has been
transferred to an unrelated business.
This new subsection does not provide for review by the AAT of a decision by the
Secretary to grant a permission under new subsection 91B(1), (2) or (3). Given the
circumstances in which permissions can be granted, the limited time for which they
apply, and the availability of revocation on grounds which include it being in the
public interest to do so, allowing permissions to be challenged via merits review by
the AAT may impede the overall objective of the provisions. To do otherwise may
12
create an unnecessary mechanism for the approved pharmacist to challenge the
Secretary's decision, even though the permission meets the requirements under new
subsections 91B(1), (2) or (3) and serves the policy intent of maintaining supply of
pharmaceutical benefits for the community for which the pharmacist is approved.
There is no provision for an approved pharmacist to seek merits review of the
Secretary's decision to grant permission to a trustee or external administrator to
supply pharmaceutical benefits following their bankruptcy or external administration
of their pharmacy. A permission is granted to a trustee or external administrator to
ensure the community continues to have access to pharmaceutical benefits, despite the
bankruptcy of the approved pharmacist or external administration of the pharmacy. A
permission is generally for a short period of time and only until the pharmacy is
transferred to another pharmacist or closed. To provide merits review that would
enable the approved pharmacist, who opposes the permission being granted, would
not be consistent with the policy intention of ensuring the continued supply of
pharmaceutical benefits to the community. If such merits review was provided, it
could result in an interruption of supply of pharmaceutical benefits to the local
community.
Item 7
This item corrects a typographical error in subsection 105AB(8A) that an application
to the AAT for a review of a decision of the Secretary under subsection 98(3A) is in
relation to a decision to cancel, not revoke, an approval.
It provides for an application to the AAT for a review of a decision of the Secretary to
cancel an approval under new subsection 98(3AB), following the revocation of a
permission under subsection 91B(12) or (13).
Item 8
This item provides that section 91B applies where the approved pharmacist becomes
bankrupt, or where there is an external administrator in relation to the pharmacy, on or
after commencement, regardless of whether the pharmacist was approved under
section 90 before, on or after that commencement. That is, this provision does not
apply where the approved pharmacist becomes bankrupt prior to commencement.
Where the approved pharmacist comprises more than one individual, this provision
only applies where each of those individuals becomes bankrupt after commencement.
That is, this provision does not apply in cases where all of those individuals become
bankrupt prior to commencement.
It provides that the Secretary may refuse to cancel the approval of an approved
pharmacist where the approved pharmacist has requested the cancellation, if the
approved pharmacist is bankrupt, or where there is an external administrator in
relation to the pharmacy, on or after the date of commencement.
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