Federal Register of Legislation - Australian Government

Primary content

PB 8 of 2006 Determinations/Health as made
The Determination is an incorporation of the pharmacy location rules including the restriction on supermarket pharmacies.
Administered by: Health
General Comments: This Determination continues to apply in relation to the consideration, by the Authority, of an application made before 1 July 2006.
Registered 10 Jan 2006
Tabling HistoryDate
Tabled HR07-Feb-2006
Tabled Senate07-Feb-2006
Date of repeal 01 Jul 2006
Repealed by National Health (Australian Community Pharmacy Authority Rules) Determination 2006 (No. PB 23 of 2006)

Pharmaceutical Benefits

Determination under subsection 99L (1)

No. PB 8 of 2006

I, TONY ABBOTT, Minister for Health and Ageing, make this Determination under subsection 99L (1) of the National Health Act 1953.

Dated                                  6 / 1 /  2006

 

 Tony Abbott

 


 

Commencement

 

1.    (a)   This Determination commences on 30 December 2005.

 

(b)      Determination No. PB 8 of 2000 made on 11 July 2000, as amended, is

                 revoked.

 

Interpretation

 

2.    (a)   In this Determination:

 

“approved pharmacist” has the same meaning as in subsection 84 (1) of the Act;

 

“commercial establishment” means premises that are used, primarily and principally, for sale by retail of goods, food or beverages, or for the provision of services, or for some combination of those activities, but does not include:

 

(a)      premises used by insurance companies or agents or brokers, accountants, lawyers, planners, architects, analysts, surveyors, engineers, stockbrokers, real estate agents and the like; or

 

(b)     any other premises used as commercial office space; or

 

(c)      council offices and government or statutory corporation offices and shopfronts (other than Australia Post or Australian Broadcasting Corporation shops) or;

 

(d)     libraries (other than video shops); or

 

(e)      kindergarten, child care or child minding facilities of any kind; or

 

(f)       storerooms or other storage areas; or

 

(g)   temporary selling points; or

 

(h)   automatic teller machines or automatic dispensing machines;

 

“definite community need”, in relation to the catchment area serviced or proposed to be serviced by a pharmacy, means:

 

(a)   that the catchment area has a population of not less than 3,000 for most of the year; and

 

(b)   that the catchment area has the equivalent of a full-time medical practitioner; and

 

(c)   that the catchment area has general shopping facilities;

 

“large shopping centre” means a shopping complex, under a single management, that:

 

(a)   is an aggregation of discrete commercial establishments and associated facilities; and

 

(b)   has a total gross leasable area of not less than 5,000 square metres; and

 

(c)      includes a supermarket that occupies not less than 1,000 square metres, and not less than 30 other commercial establishments operating independently of one another; and

 

(d)     has customer parking facilities provided within the shopping complex;

 

“pharmacist” has the same meaning as in subsection 4 (1) of the Act;

 

“pharmacy” has the same meaning as in subsection 90 (3AB) of the Act;

 

“supermarket”:

 

(a)      includes any retail store, or market, selling food and other domestic goods, whether or not by self-service operation and regardless of size; and

 

(b)     does not include a retail store or market:

 

(i)        commonly known as a department store; or

 

(ii)      in any case - in which food or produce is sold only in a café, coffee shop, restaurant or other prepared food or beverage counter;

 

“the Act” means the National Health Act 1953;

 

“the Authority” means the Australian Community Pharmacy Authority established under section 99J of the Act;

 

“the Department” means the Department responsible from time to time for the administration of the Act;

 

“the PhARIA index” means the Pharmacy Access/Remoteness Index of Australia (PhARIA) Report 2001/2002 produced by the Department, the National Key Centre for Social Applications of Geographical Information Systems, University of Adelaide and the Pharmacy Guild of Australia and current at 1 July 2002;

 

“the Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act;

 

“the statistical local area” means the statistical local area as defined in the Australian Standards Geographical Classification 2001 produced by the Australian Bureau of Statistics and current at 1 July 2002;

 

 “the Secretary” means the Secretary to the Department of Health and Ageing.

 

(b)   Where in this Determination a reference is made to a straight line measurement in relation to two premises, that reference is to a straight line measurement from the mid point at floor level of the public access door opening of the first mentioned premises to the same point of the second mentioned premises and where either premises has more than one such opening, the reference is to the shortest such straight line measurement which can be made in relation to the two premises.

 

 

Approval to Supply Pharmaceutical Benefits — General

 

3.    For the purposes of paragraph 99K (1) (b) of the Act, the rules with which the Authority must comply in making a recommendation on an application by a pharmacist for approval under section 90 of the Act in respect of particular premises are set out in paragraphs 4 to 10.

 

4.    Approval of a pharmacist under section 90 of the Act in respect of particular premises must not be recommended except as provided for in paragraphs 5 to 10.

 

4A. Where the Authority recommends the approval of a pharmacist under section 90 of the Act in respect of particular premises, it must also make a recommendation that the recommendation for approval will lapse (unless the Authority, on application by the pharmacist, has granted an extension of time), if the pharmacist has not been granted that approval within 6 months after the day on which the pharmacist is notified of the recommendation for approval.

 

4B.  For the purposes of paragraphs 5 to 8, “premises in respect of which a pharmacist is approved under section 90 of the Act” includes premises in respect of which, while no pharmacist is approved under section 90 of the Act, the Authority has recommended the approval of a pharmacist under section 90 of the Act, unless that recommendation has, pursuant to paragraph 4A, lapsed.

 

Approval to Supply Pharmaceutical Benefits — New Pharmacies

 

5.    Subject to paragraph 5A, approval of a pharmacist (“the applicant”) under section 90 of the Act in respect of particular premises must be recommended if the applicant has a legal right to occupy those premises for the purpose of operating a pharmacy and:

 

(a)   (i)    those premises are situated at least 1.5 kilometres, by straight line measurement from the nearest other premises in respect of which a pharmacist is approved under section 90 of the Act; and

 

(ii)   the Authority is satisfied that there is a definite community need for pharmaceutical services in the area in which those premises are situated; or

 

(b)   (i)    those premises are situated at least 10 kilometres, measured door to door by the shortest lawful access route, from the nearest other premises in respect of which a pharmacist is approved under section 90 of the Act; and

 

(ii)   those premises are situated in a location classified as category 2, 3, 4, 5 or 6 in the PhARIA index.

 

5A. A recommendation must not be made under paragraph 5 in relation to an applicant’s premises if:

 

(a)      the applicant’s premises are within, adjacent to or connected to, a supermarket; and

 

(b)      members of the public have direct access to the applicant’s premises from within the premises of the supermarket.

 

Approval to Supply Pharmaceutical Benefits — Relocation of Existing Pharmacies

 

6.    Subject to paragraphs 8, 9 and 9A, approval of a pharmacist (“the applicant”) under section 90 of the Act in respect of particular premises must be recommended if the applicant has a legal right to occupy those premises for the purpose of operating a pharmacy, and either:

 

(aa) the applicant is approved under section 90 of the Act in respect of other premises and the applicant has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; or

 

(ab) another pharmacist:

 

(i)    is approved under section 90 of the Act in respect of other premises and that pharmacist has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; and

 

(ii)   has indicated, in writing, that the cancellation is intended to enable recommendation, under these rules, of approval of the applicant; and

 

in either case, if the approved pharmacist has ceased to carry on business as a pharmacist at the other premises, the Secretary:

 

(ac) is aware of the cessation and the reasons for it; and

 

(ad) has decided, under section 98 of the Act, not to cancel the approval concerned;

 

and one of the following circumstances applies:

 

(a)   the premises in respect of which approval is sought are situated

      

       (i)    not more than 1 kilometre by straight line measurement from the premises from which pharmaceutical benefits are to cease being supplied (the existing premises); or

 

       (ii)   more than 1 kilometre but not more than 1.5 kilometres by straight line measurement from the existing premises and not less than 500 metres by straight line measurement from all premises in respect of which a pharmacist is approved under section 90 of the Act except those premises which are situated not more than 1 kilometre by straight line measurement from the existing premises; or

 

(b)      the proposed premises are situated at least:

 

(i)    1.5 kilometres by straight line measurement from the nearest other premises in respect of which a pharmacist is approved under section 90 of the Act; or

 

(ii)   2 kilometres by the shortest lawful access route measured from the mid point at floor level of the public access door opening of the proposed premises nearest to the mid point at floor level of the nearest public access door opening of the nearest other premises in respect of which a pharmacist is approved under section 90 of the Act.

 

6A. (a)   Subject to paragraphs 8, 9 and 9A, approval of a pharmacist (“the applicant”) under section 90 of the Act in respect of particular premises may be recommended if the applicant has a legal right to occupy those premises for the purpose of operating a pharmacy, and either:

 

              (i)    the applicant is approved under section 90 of the Act in respect of other premises and the applicant has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; or

 

              (ii)   another pharmacist:

 

                     (A)  is approved under section 90 of the Act in respect of other premises and that pharmacist has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; and

 

                     (B)  has indicated, in writing, that the cancellation is intended to enable recommendation, under these rules, of approval of the applicant; and

 

in either case, if the approved pharmacist has ceased to carry on business as a pharmacist at the other premises, the Secretary:

 

       (iii)  is aware of the cessation and the reasons for it; and

      

       (iv)  has decided, under section 98 of the Act, not to cancel the approval concerned:

 

       and the following circumstances apply:

 

       (v)   (A)   those premises are situated in a location classified as category 2, 3, 4, 5 or 6 in the PhARIA index;

 

              (B)  there is only one premises in that location in respect of which a pharmacist (the existing pharmacist) is approved under section 90 of the Act; and

 

              (C)  the Authority is satisfied that the provision of pharmaceutical benefits by the existing pharmacist in that location is substantially inadequate.

 

(b)   In considering, for the purposes of sub-sub-subparagraph 6A(a)(v)(C), whether the provision of pharmaceutical benefits by the existing pharmacist in that location is substantially inadequate, the Authority shall have regard to:

 

(i)    whether at least 10% of the persons residing in that location have a gross income which does not exceed $299 per week;

 

(ii)   whether the hours of opening of the existing pharmacist’s premises are less than 40 hours per week over less than 5½ days per week;

 

(iii)  whether there is a lack of reasonably available, affordable and frequent public transport such that the population in that location cannot without real difficulty travel to an area outside that location where pharmaceutical benefits from an approved supplier other than the existing pharmacist can reasonably be obtained; and

 

(iv)  whether the existing pharmacist has not complied with his or her obligations under the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act concerning presentation of prescriptions in trading hours (regulation 27), presentation of urgent prescriptions (regulation 28) and proper stocks to be kept (regulation 33).

 

6B.  (a)   Subject to paragraphs 8, 9 and 9A, approval of a pharmacist (“the applicant”) under section 90 of the Act in respect of particular premises may be recommended if the applicant has a legal right to occupy those premises for the purpose of operating a pharmacy, and  either:

 

              (i)    the applicant is approved under section 90 of the Act in respect of other premises and the applicant has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; or

 

              (ii)   another pharmacist:

 

                     (A)  is approved under section 90 of the Act in respect of other premises and that pharmacist has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; and

 

                     (B)  has indicated, in writing, that the cancellation is intended to enable recommendation, under these rules, of approval of the applicant; and

 

in either case, if the approved pharmacist has ceased to carry on business as a pharmacist at the other premises, the Secretary:

 

       (iii)  is aware of the cessation and the reasons for it; and

      

       (iv)  has decided, under section 98 of the Act, not to cancel the approval concerned:

 

       and the following circumstances apply:

 

       (v)   (A)   those premises are situated in a location classified as category 1 in the PhARIA index;

 

              (B)  there is only one premises in that location in respect of which a pharmacist (the existing pharmacist) is approved under section 90 of the Act; and

 

              (C)  the Authority is satisfied that:

 

                     i       the population of the statistical local area in which the location is situated exceeds 8,000 residents;

 

                     ii      the average rate of population growth in the statistical local area in which the location is situated exceeded 7% over each of the two calendar years prior to the date of the application; and

 

iii     the proposed premises are situated not less than 500 metres by straight line measurement from the nearest other premises in respect of which a pharmacist is approved under section 90 of the Act.

 

(b)   In considering whether to recommend approval of the applicant under this paragraph, the Authority may have regard to whether, as a consequence of closure, within 6 months prior to the date of application, of premises in respect of which a pharmacist was approved under section 90 of the Act, or of an amalgamation within that time of two or more such premises, there is a reduced level of pharmaceutical benefits service available in the location.

 

7.    Subject to paragraphs 8, 9 and 9A, approval of a pharmacist (“the applicant”) under section 90 of the Act in respect of particular premises must be recommended if the applicant has a legal right to occupy those premises for the purpose of operating a pharmacy, and the Authority is satisfied that either:

 

(aa) the applicant is approved under section 90 of the Act in respect of other premises and the applicant has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; or

 

(ab) another pharmacist:

 

(i)    is approved under section 90 of the Act in respect of other premises and that pharmacist has agreed that that approval will be cancelled immediately before the approval under consideration, if granted, takes effect; and

 

(ii)   has indicated, in writing, that the cancellation is intended to enable recommendation, under these rules, of approval of the applicant; and

 

in either case, if the approved pharmacist has ceased to carry on business as a pharmacist at the other premises, the Secretary:

 

(ac) is aware of the cessation and the reasons for it; and

 

(ad) has decided, under section 98 of the Act, not to cancel the approval concerned;

 

       and either of the following circumstances applies:

 

(a)   the premises in respect of which approval is sought are situated in a large shopping centre, provided that:

 

(i)    if the shopping centre contains not more than 99 commercial establishments (including the premises in respect of which approval is sought), there are not already any premises in the shopping centre in respect of which a pharmacist is approved under section 90 of the Act; or

 

(ii)   if the shopping centre contains not less than 100, and not more than 199, commercial establishments (including the premises in respect of which approval is sought), there are not already more than 1 premises in the shopping centre in respect of which a pharmacist is approved under section 90 of the Act; or

 

(iii)  if the shopping centre contains not less than 200 commercial establishments (including the premises in respect of which approval is sought), there are not already more than 2 premises in the shopping centre in respect of which a pharmacist is approved under section 90 of the Act; or

 

(b)   the premises are situated within a private hospital being a private hospital within the meaning of the Health Insurance Act 1973 and being registered or licensed as a private hospital or a private health establishment under State or Territory legislation, provided that:

 

(i)    either:

 

       (A)  the private hospital or private health establishment has not less than 150 beds in respect of which it is registered or licensed under State or Territory legislation to render health services to patients; or

 

       (B)  the maximum number of patients the private hospital or private health establishment is registered or licensed under that State or Territory legislation to treat or accommodate or lodge at any one time is not less than 150; and

 

(ii)   there are no other premises within the private hospital or private health establishment in respect of which an approval under section 90 of the Act is in force; and

 

(iii)  the governing body or proprietor of the private hospital or private health establishment is not approved under section 94 of the Act in respect of that private hospital or private health establishment.

 

8.    A recommendation must not be made pursuant to paragraph 6 or 7 if approvals under section 90 of the Act in respect of the premises from which the applicant is seeking to relocate have been in force for a continuous period of less than 2 years (including the day on which the application was made), unless:

 

(a)   the application is in respect of the same or substantially the same premises, following renovation or redevelopment of those premises, as those in respect of which the applicant was approved under section 90 of the Act immediately before the granting of the current approval of the applicant under section 90 of the Act; or

 

(b)   the applicant’s approval in respect of the premises from which the applicant is seeking to relocate resulted from an application to which subsection 90 (3AA) of the Act applied and the pharmacist previously approved in respect of the premises from which the applicant is seeking to relocate was, before being approved in respect of the premises from which the applicant is seeking to relocate, approved in respect of the premises to which the applicant is seeking to relocate; or

 

(c)   the applicant satisfies the Authority that the application arises from exceptional circumstances, not involving commercial interest, which could not reasonably have been foreseen at the time of the application for the current approval; or

 

(d)   the applicant is currently approved under section 90 of the Act in respect of premises situated within a large shopping centre and the applicant proposes to relocate to other premises within the same large shopping centre; or

 

(e)   the applicant is currently approved under section 90 of the Act and proposes a relocation that involves the expansion of the applicant’s current premises into adjoining premises.

 

9.    A recommendation must not be made pursuant to paragraph 6 or 7 if the approval under section 90 of the Act in respect of the premises from which the applicant is seeking to relocate was granted pursuant to a recommendation under subparagraph 5 (b), unless the premises to which the applicant is seeking to relocate are situated in the same town as the premises from which the applicant is seeking to relocate.

 

9A. A recommendation must not be made under paragraph 6, 6A, 6B or 7 in relation to an applicant’s premises if:

 

(a)      the applicant’s premises are within, adjacent to or connected to, a supermarket; and

 

(b)      members of the public have direct access to the applicant’s premises from within the premises of the supermarket.

 

 

10.  Where approval of a pharmacist under section 90 of the Act has been granted in respect of particular premises pursuant to a recommendation under subparagraph 5 (b), any subsequent approval that is granted pursuant to:

 

(a)      a recommendation under paragraph 6 or 7, arising from an application for the relocation of the pharmacy situated at those premises; or

 

(b)      an application to which subsection 90 (3AA) of the Act applies, arising from a change in the ownership of the pharmacy situated at those premises;

 

will, for the purpose of paragraph 9, be deemed to have been granted pursuant to a recommendation under subparagraph 5 (b).