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PB 89 of 2015 Determinations/Health as made
This instrument amends the National Health (Australian Community Pharmacy Authority Rules) Determination 2011 (PB 65 of 2011).
Administered by: Health
Registered 22 Oct 2015
Tabling HistoryDate
Tabled HR09-Nov-2015
Tabled Senate09-Nov-2015
Date of repeal 11 Nov 2015
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

 

 

PB 89 of 2015

National Health (Australian Community Pharmacy Authority Rules) Amendment Determination 2015 (No. 1) 1 

 

National Health Act 1953

_____________________________________________________________________

 

 

I, SUSSAN LEY, Minister for Health, make this Amendment Determination under subsection 99L (1) of the National Health Act 1953.

Dated 13 October 2015

 

 

 

 

 

 

 

 

 

 

 

 

SUSSAN LEY

Minister for Health

_____________________________________________________________________

 

 

               

 

 

 

__________________________________________________________________

 

1              Name of Determination

 

(1)                This Determination is the National Health (Australian Community Pharmacy Authority Rules) Amendment Determination 2015 (No. 1).

 

(2)                This Determination may also be cited as PB 89 of 2015.

 

2               Commencement

This Determination commences on 10 November 2015.

3              Amendments to PB 65 of 2011

Schedule 1 amends the National Health (Australian Community Pharmacy Authority Rules) Determination 2011 (PB 65 of 2011).

 

 


 

Schedule 1             Amendments

(section 3)

[1]            Part 1, Section 4

omit:

Transitional

                The National Health (Australian Community Pharmacy Authority Rules) Determination 2006, also known as Determination No. PB 23 of 2006, as in force immediately before 18 October 2011, continues to apply in relation to the consideration, by the Authority, of an application made before 18 October 2011.

 

insert:

Transitional

                The National Health (Australian Community Pharmacy Authority Rules) Determination 2011, also known as Determination No. PB 65 of 2011, as in force immediately before 10 November 2015, continues to apply in relation to the consideration, by the Authority, of an application made before 10 November 2015.

[2]            Part 1, Section 5

insert after definition of Act and before definition of application:

all relevant times means:

                (a)    on the day on which the application was made; and

               (b)    the day on which the application is considered by the Authority.

[3]            Part 1, Section 5

omit:

facility means:

                (a)    a small shopping centre; or

               (b)    a large shopping centre; or

                (c)    a large medical centre; or

               (d)    a private hospital.

 

insert:

facility means:

                (a)    a small shopping centre; or

               (b)    a large shopping centre; or

                (c)    a large medical centre; or

               (d)    a large private hospital.

 

 

[4]            Part 1, Section 5

omit:

full-time means:

                (a)    for a prescribing medical practitioner, providing the services of a prescribing medical practitioner for at least 38 hours each week; and

               (b)    for a PBS prescriber, providing the services of a PBS prescriber for at least 38 hours each week.

 

insert:

full-time means:

                (a)    for a prescribing medical practitioner, providing the services of a prescribing medical practitioner for 38 hours in a week; and

               (b)    for a PBS prescriber, providing the services of a PBS prescriber for 38 hours in a week.

[5]            Part 1, Section 5

omit:

gross leasable area means:

                (a)    for a shopping centre — the total floor area of the shopping centre excluding loading docks and car parks; and

               (b)    for a supermarket — the total floor area of the supermarket excluding loading docks.

 

insert:

gross leasable area means:

                (a)    for a small shopping centre or a large shopping centre — the total floor area of the small shopping centre or the large shopping centre excluding loading docks and car parks; or

               (b)    for a supermarket — the total floor area of the supermarket that is accessible by customers for the purpose of purchasing supermarket items, excluding loading docks and car parks.

 

 

[6]            Part 1, Section 5

insert after definition of large medical centre and before definition of large shopping centre:

large private hospital means a private hospital that can admit at least 150 patients at any one time in accordance with the private hospital’s license or registration under the law of the State or Territory in which the private hospital is located.

[7]            Part 1, Section 5

omit:

large shopping centre means a shopping centre that:

                (a)    has a gross leasable area of at least 5 000 m2; and

               (b)    contains a supermarket that occupies a gross leasable area of at least 1 000 m2; and

                (c)    contains at least 50 other commercial establishments; and

               (d)    has customer parking facilities.

 

insert:

large shopping centre means:

(a)     a group of shops and associated facilities that is under single management; and

(b)     has a gross leasable area of at least 5 000 m2; and

(c)     contains a supermarket that occupies a gross leasable area of at least 1 000 m2; and

(d)    contains at least 50 other commercial establishments; and

(e)     has customer parking facilities.

[8]            Part 1, Section 5

repeal:

shopping centre means a group of shops and associated facilities that is under single management.

[9]            Part 1, Section 5

omit:

single management, for a shopping centre or medical centre:

                 (a)   means management of the centre as a whole:

                          (i)    by one manager, or by 2 or more managers working cooperatively under an agreement; and

                         (ii)    to encourage the use of the centre as a single integrated facility; and

                        (iii)    including management of the following matters for the centre:

                                   (A)     security;

                                   (B)     pedestrian and vehicular access;

                                   (C)     cleaning;

                                   (D)     signage;

                                   (E)     trading hours;

                                    (F)     marketing;

                                   (G)     maintenance of buildings, common areas and utilities; and

                 (b)   does not include independent owners or tenants of premises in a building or centre that cooperate:

                          (i)    on particular occasions; or

                         (ii)    in relation to some, but not all, of the matters mentioned in subparagraph (a) (iii) in relation to the building or centre.

 

 insert:

 single management, for a small shopping centre, a large shopping centre or a  medical centre:

 (a)    means an arrangement in which a single entity, or 2 or more entities working    cooperatively under an agreement, is responsible for marketing, maintenance and administration for the centre as a whole; and

               (b)    does not include independent owners or tenants of premises in a building or centre that cooperate:

                          (i)    on particular occasions; or

                         (ii)    in relation to some, but not all, of the matters mentioned in paragraph (a) in relation to the building or centre.

[10]          Part 1, Section 5

omit:

small shopping centre means a shopping centre that:

                (a)    has a gross leasable area of at least 5 000 m2; and

               (b)    contains a supermarket that occupies a gross leasable area of at least 2 500 m2; and

                (c)    contains at least 15 other commercial establishments; and

               (d)    has customer parking facilities.

 

insert:

small shopping centre means:

(a)a group of shops and associated facilities that is under single management; and

(b)     has a gross leasable area of at least 5 000 m2; and

(c)        contains a supermarket that occupies a gross leasable area of at least 2 500 m2;       and

(d)     contains at least 15 other commercial establishments; and

(e)  has customer parking facilities.

[11]          Part 1, Section 6

insert new subsection after subsection 6(2):

(3)   When counting the number of approved premises in Item 132(1) and Item 134(2), approved premises for the purpose of subsection 6(1)(b) shall not include premises recommended to be approved by the Authority under Items 122, 123 or 124 of Schedule 1.

[12]          Part 1, Section 7

omit:

                 Meaning of commercial establishment

                (1)   In this Determination, subject to subsection (2):

        commercial establishment means premises:

                             (a)     in a shopping centre; and

                        (b)     occupied by, or likely to be occupied by:

                                      (i)      a shop where goods, food or beverages are sold retail; or

                                     (ii)      a bar, café, restaurant or takeaway; or

                                    (iii)      a business that provides services to customers.

                (2)        For subsection (1), commercial establishment does not include:

                             (a)     commercial office space; or

                             (b)     premises occupied by an accountant, analyst, architect, engineer,           lawyer, planner, stockbroker or surveyor, unless the premises are              occupied as a shopfront; or

                             (c)     premises occupied by a real estate agent or an insurance company,                  agent or broker, unless the premises are occupied as a shopfront for                   the real estate agent or insurance company; or

                             (d)     a council office or government or statutory corporation office or                     shopfront, other than an Australia Post shopfront, an Australian                         Broadcasting Corporation shop or a Medicare or Centrelink                           shopfront; or

                             (e)     a car wash or car parking facilities; or

                             (f)      a library; or

                             (g)     a kindergarten or preschool; or

                             (h)     a child care centre or child minding facility, unless the centre or                      facility is regularly available for use by customers of the shopping                    centre while the customers are at the shopping centre; or

                             (i)      a storeroom or storage area; or

                             (j)      a temporary selling point; or

                             (k)     an automatic teller machine or automatic dispensing machine.

                (3)        In working out the number of commercial establishments in a shopping                    centre:

                             (a)     2 or more commercial establishments occupied by, or likely to be                    occupied by, one business are counted as one commercial                                       establishment; and

                             (b)     the maximum number of shopfronts for accountants, analysts,                         architects, engineers, lawyers, planners, stockbrokers or surveyors             that can be counted towards the total number of commercial                          establishments in a shopping centre is:

                                     (i)       for a small shopping centre — one; or

                                    (ii)       for a large shopping centre — 2.

 

 

                    insert:

                    Meaning of commercial establishment

                   (1)     In this Determination, subject to subsection (2):

             commercial establishment means premises:

                             (a)     in a small shopping centre or a large shopping centre; and

                             (b)     occupied by, or likely to be occupied by:

                                     (i)       a shop where goods, food or beverages are sold retail; or

                                    (ii)       a bar, café, restaurant or takeaway; or

                                   (iii)       a business that provides services to customers.

                (2)        For subsection (1), commercial establishment does not include:

                             (a)     commercial office space; or

                             (b)     premises occupied by an accountant, analyst, architect,                                    engineer, lawyer, planner, stockbroker or surveyor,                                            unless the premises are occupied as a shopfront; or

                             (c)     premises occupied by a real estate agent or an insurance                                   company, agent or broker, unless the premises are                                               occupied as a shopfront for the real estate agent or                                                insurance company; or

                             (d)     a council office or government or statutory corporation office or                     shopfront, other than an Australia Post shopfront, an Australian                         Broadcasting Corporation shop or a Medicare or Centrelink                           shopfront; or

                             (e)     a car wash or car parking facilities; or

                             (f)      a library; or

                             (g)     a kindergarten or preschool; or

                             (h)     a child care centre or child minding facility, unless the centre or                      facility is regularly available for use by customers of the small                           shopping centre or the large shopping centre while the                              customers are at the small shopping centre or the large                                  shopping; or

                             (i)      a storeroom or storage area; or

                             (j)      a temporary selling point; or

                             (k)     an automatic teller machine or automatic dispensing machine.

                (3)        In working out the number of commercial establishments in a small                          shopping centre or a large shopping centre:

                             (a)     2 or more commercial establishments occupied by, or likely to                         be occupied by, one business are counted as one commercial                              establishment; and

                             (b)     the maximum number of shopfronts for accountants, analysts,                         architects, engineers, lawyers, planners, stockbrokers or                                      surveyors that can be counted towards the total number                               of commercial establishments in a small shopping                                        centre or a large shopping centre is:

                                     (i)       for a small shopping centre — one; or

                                    (ii)       for a large shopping centre — 2.

[13]          Part 2, Section 11

omit:

When Authority must recommend applicant not be approved

                The Authority must recommend that an applicant not be approved under section 90 of the Act in relation to particular premises if a requirement, under paragraph 10 (a) or (b), that applies in relation to the application is not met.

 

insert:

When Authority must recommend applicant not be approved

                The Authority must recommend that an applicant not be approved under section 90 of the Act in relation to particular premises if:

(a)            a requirement, under paragraph 10 (a) or (b), that applies in relation to the   application is not met; or

(b)           an application involves the cancellation of an existing approval and that existing approval is subject to a recommendation by the Authority that an applicant be approved under section 90 of the Act.

 [14]         Schedule 1, Part 1

repeal:

 

  125

Short distance relocation (more than 1 km)

1.       The application was made before 16 April 2012.

2.       The proposed premises are more than 1 km, but not more than 1.5 km, in a straight line, from the existing premises.

3.       Either:

(a)     if the existing premises are not in a private hospital or large shopping centre — the proposed premises must be at least 500 m, in a straight line, from all approved premises other than approved premises that are no more than 1 km, in a straight line, from the existing premises; or

 

 

(b)     if the existing premises are in a private hospital or large shopping centre — the proposed premises must be at least 500 m, in a straight line, from all approved premises other than approved premises in the private hospital or large shopping centre.

4.       The Authority is satisfied that, before 18 October 2011, the applicant had a legal right to occupy the proposed premises on or after 18 October 2011.

 

  126

 

Long distance relocation

 

1.       The application was made before 16 April 2012.

2.       The proposed premises are:

(a)     at least 1.5 km, in a straight line, from the nearest     approved premises; or

(b)     if paragraph (a) does not apply — at least 2 km, by the shortest lawful access route, from each approved premises that is within 1.5 km, in a straight line, from the proposed premises.

3.       The Authority is satisfied that, before 18 October 2011, the applicant had a legal right to occupy the proposed premises on or after 18 October 2011.

 

  127

Relocation to a population growth area

1.       The application was made before 16 April 2012.

2.       The proposed premises are at least 500 m, in a straight line, from the nearest approved premises.

3.       The Authority is satisfied that:

(a)     the resident population of the catchment area for the proposed premises:

                   (i)      is, for most of the year, at least 8 000; and

                   (ii)     has grown by at least 5% in each of the 2 years before the day on which the application was made; and

(b)     the catchment area for the proposed premises contains only one approved premises; and

         (c)      the applicant had, before 18 October 2011, a legal right to occupy the proposed premises on or after 18 October 2011.

[15]          Schedule 1, Part 2, Item 130

repeal:

3.   For this item, all relevant times means:

         (a)  on the day on which the application was made; and

        (b)  the day on which the application is considered by the Authority.

[16]          Schedule 1, Part 2, Item 132 

repeal:

3.  For this item, all relevant times means:

         (a)  on the day on which the application was made; and

         (b)  the day on which the application is considered by the Authority.   

[17]          Schedule 1, Part 2, Item 134

omit:

 

New pharmacy in a facility (large shopping centre)

1.   The proposed premises are in a large shopping centre.

2.   There are:

     

   (a)  for a shopping centre that contains at least 50, but few than 100, commercial establishments – no approved premises in the shopping centre; or

  (b)  for a shopping centre that contains at least 100, but fewer than 200, commercial establishments – no more than one approved premises in the shopping centre; or

  (c)   for a shopping centre that contains at least 200 commercial establishments – no more than 2 approved premises in the shopping centre.

 

 

 

 

insert:

 

 

New pharmacy in a facility (large shopping centre)

1.   The proposed premises are in a large shopping centre.

2.   There are:      

                (a)   for a large shopping centre that contains at least 50, but few          than 100, commercial establishments – no approved premises in the large shopping centre; or

  (b)   for a large shopping centre that contains at least 100, but fewer than 200, commercial establishments – no more than one approved premises in the large shopping centre; or

     (c)   for a large shopping centre that contains at least 200 commercial establishments – no more than 2 approved premises in the large shopping centre.

[18]          Schedule 1, Part 2, Item 135

omit:

 

New pharmacy in a facility (private hospital)

1.   The proposed premises are in a private hospital.

2.   There are no approved premises in the private hospital.

3.   The hospital authority for the private hospital is not approved under section 94 of the Act.

4.   The private hospital is registered or licensed, under the law of  the State or Territory in which the private hospital is located:

(a)   to contain at least 150 beds to provide health services to                patients; or

(b)   to treat, accommodate or lodge at least 150 patients at           any one time.

insert:

 

 

New pharmacy in a facility (large private hospital)

      1.  The proposed premises are in a large private hospital.

2.   2.  There are no approved premises in the large private hospital.

3.  The hospital authority for the large private hospital is not             approved under section 94 of the Act.

[19]          Schedule 1, Part 2, Item 136

omit:

1.   The proposed premises are in a large medical centre.

2.   There are no approved premises in the large medical centre.

3.   The proposed premises are at least 500 m, in a straight line, from the nearest approved premises other than an approved premises in a small shopping centre, large shopping centre or private hospital.

4.   The Authority is satisfied that, at all relevant times, the number of PBS prescribers at the medical centre is equivalent to at least 8 full-time PBS prescribers, of which at least 7 PBS prescribers must be prescribing medical practitioners.

5.   For this item, all relevant times means:

(a)   on the day on which the application was made; and

(b)   at all times during the 2 months before the day on which the application was               made; and

 (c)    at all times during the 2 months before the day on which the application  is  considered by the Authority.

6.   The Authority is satisfied that the applicant will make all reasonable attempts to ensure that the operating hours of the proposed premises will meet the needs of the patients of the medical centre.

insert:

1.     The proposed premises are in a large medical centre.

2.     There are no approved premises in the large medical centre.

3.     If the medical centre in which the proposed premises are located is:

     (a)   in a small shopping centre, a large shopping centre or a private hospital, the proposed premises are at least 500 m, in a straight line, from any approved premises, other than approved premises located in a different small shopping centre, large shopping centre, or private hospital; or

     (b)  not in a small shopping centre, a large shopping centre or a private hospital, the proposed premises are at least 500 m, in a straight line, from the nearest approved premises, other than an approved premises located in a small shopping centre, large shopping centre, or private hospital.

4.     The Authority is satisfied that, during the 2 months before the day on which the application is made and until the day the application is considered by the Authority, the number of PBS prescribers at the medical centre is equivalent to at least 8 full-time PBS prescribers, of which at least 7 PBS prescribers must be prescribing medical practitioners.

5.     The Authority is satisfied that the applicant will make all reasonable attempts to ensure that the operating hours of the proposed premises will meet the needs of the patients of the medical centre.

[20]          Schedule 2

omit

211

The Authority is satisfied that:

   (a)  the applicant had, on the day the application was made, and has, on the day the Authority makes a recommendation in relation to the application, a legal right to occupy the proposed premises on or after the day the application was made; and

  (b)  the proposed premises, on the day the application was made and on the day the Authority makes a recommendation in relation to the application:

            (i)   could be used for the operation of a pharmacy under    applicable local government and State or Territory laws relating to land development; and

         (ii)   would be accessible by members of the public at large; and

   (c)  within 6 months after the day on which the Authority makes a recommendation in relation to the application, the applicant will be able to begin operating a pharmacy at the proposed premises; and

  (d)  the proposed premises are not directly accessible by the public from within a supermarket.

 

 

Note   The requirement in subparagraph (b) (i) would be satisfied if, for example, planning approval for the proposed pharmacy has been obtained or, if this is not necessary in the State or Territory where the pharmacy would be located, the proposed premises are on land that is zoned so as to enable the operation of a pharmacy. An application to obtain a building works approval or a certificate of occupancy, or similar, is not required to satisfy this requirement. However, it may be needed for compliance with requirement (c), depending on the operation of applicable State or Territory land development laws.

 

212

The Authority is satisfied that, on the day on which the application is     made, the proposed premises are not approved premises.

 

 insert:

211

The Authority is satisfied that at all relevant times:

(a)     the proposed premises are not approved premises; and

(b)   the applicant has a legal right to occupy the proposed premises on or after the day the application was made; and

(c)     the proposed premises:

                       (i)      could be used for the operation of a pharmacy under applicable local government and State or Territory laws relating to land development; and

                     (ii)      would be accessible by the public.   

 

Note   The requirement in subparagraph (c) (i) would be satisfied if, for example, planning approval for the proposed pharmacy has been obtained or, if this is not necessary in the State or Territory where the pharmacy would be located, the proposed premises are on land that is zoned so as to enable the operation of a pharmacy. An application to obtain a building works approval or a certificate of occupancy, or similar, is not required to satisfy this requirement. However, it may be needed for compliance with the requirement in Item 212(a), depending on the operation of applicable State or Territory land development laws.

 

212

The Authority is satisfied that:

(a)     within 6 months after the day on which the Authority makes a     recommendation in relation to the application, the applicant will be able to begin operating a pharmacy at the proposed premises; and

(b)    the proposed premises are not directly accessible by the public from within a supermarket.

[21]          Schedule 3, Part 1, Item 312

omit:

                 (b)   if paragraph (a) does not apply:

 (i)     the proposed premises are in the same facility as the existing premises; or

(ii)     the proposed premises are in the same town as the existing premises; or

 

 

insert:

 (b)   if paragraph (a) does not apply:

     (i)     the proposed premises are in the same facility as the existing premises and the application is made under Item 122 of Part 1, Schedule 1; or

(ii)     the proposed premises are in the same town as the existing premises and the application is made under Item 123 of Part 1, Schedule 1; or

 

 

 

 

 

 

 

 

 

 

 

 

 

 

_____________________________________________________________________

 

Note

1.        All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See
http://www.frli.gov.au.