EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
National Health Act 1953
Department of Health and Ageing, Determination under subsection 99L(1)
No. PB 8 of 2006
Section 90 of the National Health Act 1953 (the Act) provides for the Secretary to approve a pharmacist to supply pharmaceutical benefits at or from particular premises.
The Australian Community Pharmacy Authority (the ACPA) is the body, established under section 99J of the Act, which considers applications under section 90 and makes recommendations to the Secretary as to whether or not a pharmacist should be approved in respect of particular premises.
In making recommendations in relation to applications, the ACPA must comply with the rules (Rules) determined by the Minister under subsection 99L(1) of the Act.
Section 99L of the Act is located in Division 4B of Part VII. The operation of that Division will cease at the end of 30 June 2006 and, accordingly, the Rules will cease to have effect after that date.
This Determination sets out the same Rules as made by Determination PB 8 of 2000 made on 11 July 2000 and the amendments made by Determination No. PB 13 of 2000 made on 5 September 2000, Determination No. PB 9 of 2002 made on 10 June 2002, Determination No. PB 15 of 2002 made on 30 October 2002, Determination No. PB 14 of 2004 made on 12 August 2004, Determination No. PB 14 of 2005 made on 29 June 2005 and Determination No. PB 1 of 2006 made on 23 December 2005.
The Rules set out the circumstances in which the ACPA must recommend that an applicant be approved under section 90 of the Act in respect of particular premises. The ACPA must not recommend approval if the criteria are not met.
If a pharmacist makes an application to establish a new pharmacy, the ACPA must recommend approval if the proposed pharmacy premises are:
- at least 1.5 km (by straight line) from the nearest other approved pharmacy and the catchment area the pharmacy proposes to service contains at least 3,000 people, the equivalent of a full-time medical practitioner and general shopping facilities; or
- at least 10 km (by shortest lawful access route) from the nearest other approved pharmacy and are in a rural location.
If a pharmacist makes an application to relocate an existing pharmacy, the ACPA must recommend approval if the proposed pharmacy premises are:
- no more than 1 km (by straight line) from the existing site; or
- more than 1 km but no more than 1.5 km (by straight line) from the existing site and at least 500 m (by straight line) from the nearest other approved pharmacy (provided that pharmacy is more than 1 km from the existing premises); or
- at least 1.5 km (by straight line) from the nearest other approved pharmacy; or
- at least 2 km (by shortest lawful access route) from the nearest other approved pharmacy; or
- in a rural location which contains only one existing approved pharmacy and where the ACPA is satisfied that the existing provision of pharmaceutical benefits is substantially inadequate; or
- in an urban location and are at least 500 m (by straight line) from the only other approved pharmacy in that location, and the subject statistical local area contains a population of at least 8,000 people which has grown by more than 7% over each of the 2 prior years; or
- in a large shopping centre which contains no approved pharmacy; or
- in a large shopping centre which contains at least 100 shops an only one approved pharmacy; or
- in a large shopping centre which contains at least 200 shops and only two approved pharmacies; or
- in a private hospital which contains no approved pharmacy and has at least 150 beds or can treat at least 150 patients.
Regardless of the circumstances described above, the ACPA must not recommend approval:
- if the proposed premises are publicly accessible from within a supermarket; or
- if a pharmacy approved under the special new rural pharmacy arrangements proposes to relocate from the town in which it was approved; or
- the pharmacy proposed to be relocated has not been at its existing site for at least 2 years.
The Rules provide some exceptions to the 2 year restriction such as to allow for temporary relocations resulting from refurbishment or for relocations within a large shopping centre.
Any recommendation for approval made by the ACPA is valid for a period of 6 months during which time the applicant may commence operation of an approved pharmacy. However, applicants may seek an extension of this time by the ACPA.
The Rules provide that the ACPA will regard any site in respect of which it has recommended approval of a pharmacist, to be treated as if it were an approved pharmacy, for as long as that recommendation is valid.
Further details of the Determination are provided in the Attachment.
The Determination commences on 30 December 2005. The Determination will apply retrospectively to provide for the continuation of the Rules that were in force immediately before 30 December 2005. It also gives effect to the Fourth Community Pharmacy Agreement between the Australian Government and the Pharmacy Guild of Australia, which commenced on 1 December 2005 and provided that the Rules in force at that time would continue until 30 June 2006.
The Pharmacy Guild of Australia, the body which represents a majority of pharmacy owners, has been consulted on all previous Determinations of the Rules and this Determination represents a consolidation of those Determinations.
ATTACHMENT
DETAILS OF THE DETERMINATION UNDER SUBSECTION 99L(1) OF THE NATIONAL HEALTH ACT 1953
Commencement
Paragraph 1(a) provides that the Determination to commence on 30 December 2005.
Paragraph 1(b) revokes the previous Determination of the rules, as amended.
Interpretation
Paragraph 2(a) defines the common terms used in the Determination.
Paragraph 2(b) describes the meaning of a straight line measurement, and how it is to be measured in respect of two premises and premises with more than one door.
Approval to Supply Pharmaceutical Benefits – General
Paragraph 3 provides that paragraphs 4 to 10 are rules for the purpose of the ACPA considering applications and making recommendations as to whether or not they be approved.
Paragraph 4 provides that the ACPA must only recommend approval in accordance with the rules.
Paragraph 4A provides that an ACPA recommendation for approval is valid for 6 months. It also provides that pharmacists may apply to the ACPA for an extension of this time.
Paragraph 4B provides that a site in respect of which a pharmacist has been recommended for approval by the ACPA will be regarded as an approved pharmacy for as long as that recommendation is valid. This means that when the ACPA is considering which pharmacy is the nearest other approved pharmacy to a proposed site (e.g. for the purpose of assessing a distance), it may take into account a site at which an approval has been recommended.
Approval to Supply Pharmaceutical Benefits – New Pharmacies
Paragraph 5 provides for the establishment of new pharmacies.
The ACPA must recommend approval of a pharmacist to establish a new pharmacy if it is satisfied that:
- the applicant has a legal right to occupy the proposed premises (such as a lease or a contract for purchase of the property);
- the premises can be used for the purpose of operating a pharmacy (such as local government or council approval that the site is suitable for that use); and
- and the applicant meets either of the two circumstances described below:
New pharmacy
The proposed premises are be at least 1.5 km (by straight line) from the nearest other approved pharmacy and there is a definite community need in the catchment area which the pharmacy proposes to service. A definite community need is defined in paragraph 2(a) as relating to a catchment area which has:
a population of at least 3,000 people for most of the year; and
the equivalent of a full-time medical practitioner; and
general shopping facilities; or
New rural pharmacy
The proposed premises is at least 10 km (by shortest lawful access route) from the nearest other approved pharmacy and in a location which is classified by PhARIA as category 2, 3, 4, 5 or 6.
Paragraph 5A provides that the ACPA must not recommend approval in relation to a new pharmacy if the proposed premises are directly accessible from within a supermarket.
Approval to Supply Pharmaceutical Benefits – Relocation of Existing Pharmacies
Paragraph 6 provides for the relocation of existing approved pharmacies.
The ACPA must be satisfied that either the applicant, or another pharmacist, is already approved under section 90 in respect of a different site and that is the approval which will facilitate the application under consideration. It also provides for the ACPA to consider applications which propose to relocate pharmacies which have ceased trading.
The ACPA must recommend approval of a pharmacist to relocate an existing pharmacy if it is satisfied that:
- the applicant has a legal right to occupy the proposed premises (such as a lease or a contract for purchase of the property);
- the premises can be used for the purpose of operating a pharmacy (such as local government or council approval that the site is suitable for that use); and
- and the applicant meets any of the circumstances described below:
Short relocations
(i) The proposed premises are not more that 1 km (by straight line) of the site from which the pharmacist proposes to relocate (the existing site); or
(ii) The proposed premises are more than 1 km and not more than 1.5 km (by straight line) from the existing site and at least 500 m (by straight line) from the nearest other approved pharmacy (provided that pharmacy is at least 1 km from the existing site.
Long relocations
(i) The proposed premises are at least 1.5 km (by straight line) from the nearest other approved pharmacy; or
(ii) The proposed premises are at least 2 km (by shortest lawful access route) from the nearest other approved pharmacy.
Paragraph 6A provides for the relocation of existing approved pharmacies to rural areas under exceptional circumstances.
The ACPA must be satisfied that either the applicant, or another pharmacist, is already approved under section 90 in respect of a different site and that is the approval which will facilitate the application under consideration. It also provides for the ACPA to consider applications which propose to relocate pharmacies which have ceased trading.
The ACPA may recommend approval of a pharmacist to relocate an existing pharmacy if it is satisfied that:
- the applicant has a legal right to occupy the proposed premises (such as a lease or a contract for purchase of the property);
- the premises can be used for the purpose of operating a pharmacy (such as local government or council approval that the site is suitable for that use);
- the premises are in a location which is classified by PhARIA as category 2, 3, 4, 5 or 6;
- there is only one approved pharmacy in that location; and
- the provision of pharmaceutical benefits by the existing pharmacist is substantially inadequate. In considering this, the ACPA will have regard to whether:
at least 10% of the local population have an income which does not exceed $299 per week;
the operating hours of the existing pharmacy are inadequate for the needs of the local population;
whether an insufficient local public transport system prevents the local population accessing pharmacy services in other locations;
whether the existing pharmacist has not met their obligations in supplying pharmaceutical benefits, specifically, that they have not appropriately advertised their normal trading hours, have not supplied urgent prescriptions or have not kept appropriate stocks of pharmaceutical benefits.
Paragraph 6B provides for the relocation of existing approved pharmacies to urban areas under exceptional circumstances.
The ACPA must be satisfied that either the applicant, or another pharmacist, is already approved under section 90 in respect of a different site and that is the approval which will facilitate the application under consideration. It also provides for the ACPA to consider applications which propose to relocate pharmacies which have ceased trading.
The ACPA may recommend approval of a pharmacist to relocate an existing pharmacy if it is satisfied that:
- the applicant has a legal right to occupy the proposed premises (such as a lease or a contract for purchase of the property);
- the premises can be used for the purpose of operating a pharmacy (such as local government or council approval that the site is suitable for that use);
- the premises are in a location which is classified by PhARIA as category 1;
- there is only one approved pharmacy in that location;
- the statistical local area for the subject location contains at least 8,000 residents;
- the average population growth rate of that statistical local area has exceeded 7% over each of the 2 prior years; and
- the proposed premises are at least 500 m (by straight line) from the existing approved pharmacy.
The ACPA may also have regard to whether or not a closure or amalgamation of an approved pharmacy in that location in the past 6 months has resulted in a reduced level of pharmacy services.
Paragraph 7 provides for the relocation of existing approved pharmacies into certain types of facilities.
The ACPA must be satisfied that either the applicant, or another pharmacist, is already approved under section 90 in respect of a different site and that is the approval which will facilitate the application under consideration. It also provides for the ACPA to consider applications which propose to relocate pharmacies which have ceased trading.
The ACPA must recommend approval of a pharmacist to relocate an existing pharmacy if it is satisfied that:
- the applicant has a legal right to occupy the proposed premises (such as a lease or a contract for purchase of the property);
- the premises can be used for the purpose of operating a pharmacy (such as local government or council approval that the site is suitable for that use); and
- and the applicant meets any of the circumstances described below:
Relocation into a large shopping centre
The proposed premises are located in a large shopping centre (as defined in paragraph 2(a)) which contains:
(i) no more than 99 commercial establishments (as defined in paragraph 2(a)) and no existing approved pharmacy; or
(ii) at least 100 but no more 199 commercial establishments and only one existing approved pharmacy; or
(iii) at least 200 commercial establishment and two existing approved pharmacies.
Relocation into a private hospital
The proposed premises are located in a private hospital or private health establishment which is not approved under section 94 of the Act (that is, approved to supply pharmaceutical benefits to patients of the hospital), does not contain an existing approved pharmacy, and is licensed or registered under the relevant State/Territory:
(i) with no less than 150 beds; or
(ii) to treat or accommodate or lodge at any given time at least 150 patients.
Paragraph 8 provides that pharmacies cannot be relocated more often than every two years.
The ACPA must not recommend approval of a pharmacist in respect of particular premises if the approval that is proposed to be relocated has not been in continuous force for at least 2 years, unless one of the following circumstances applies:
- the applicant is seeking to relocate back into the site at which they were previously approved, and from which they temporarily relocated for the purpose of a redevelopment or renovation;
- the applicant is seeking to relocate back to the site at which the previous owner of the pharmacy had been approved (for example, the original owner relocated the pharmacy temporarily so that the original site could be redeveloped, and sold the pharmacy before it had been relocated back to its original site);
- the relocation is the result of exceptional circumstances, not concerning commercial interest, which the applicant could not foresee at the time they were approved at their current site;
- the relocation is within the same large shopping centre (as defined in paragraph 2(a));
- the application if for an expansion of the existing premises.
Paragraph 9 provides that the ACPA cannot recommend approval in relation to the relocation of a new rural pharmacy (see paragraph 5) unless the relocation is to a site within the same town in which the pharmacy was originally approved.
Paragraph 9A provides that the ACPA must not recommend approval in relation to the relocation of an existing pharmacy if the proposed premises are directly accessible from within a supermarket.
Paragraph 10 provides that any subsequent approval granted in relation to a new rural pharmacy, such as where it is relocated within the same town or there is a change of ownership of the pharmacy, will be deemed to have been granted as in accordance with the provisions of paragraph 5(b).