The Minister for Health and Ageing has amended the National Health (Australian Community Pharmacy Authority Rules) Determination (“The Rules”). The Determination was made in February and came into effect on the 17th March 2009 and applies to all applications made to the Australian Community Pharmacy Authority (“ACPA”) on or after that date.
Measurement of Distance
“Shortest lawful access” measurements are no longer permitted in applications for relocation for additional rural or urban pharmacies (items 107 and 108), small shopping centres (item 109) and large medical centres (112). The straight line method of measurement is now the only available method available in those applications.
The Explanatory Statement which accompanies the Determination indicates that the amendment is a response to an Administrative Appeals Tribunal Decision in Bray –v– ACPA which interpreted the phrase “genuine barrier” somewhat more broadly than the Minister would have liked.
Approved Premises
The term “approved premises” is now defined to include premises in respect in which the ACPA has recommended approval even though approval has not yet been granted, in all cases except in the case of “redundant premises” which are defined as premises which have been approved to relocate to another premises in which have ceased providing pharmaceutical benefits from the original premises (parked approvals).
Prior to the determination premises recommended for approval were regarded as “approved premises” only in relation to references to the nearest approved premises. The effect of the amendment is that recommended premises will now affect rural and urban additional pharmacy applications (items 107 and 108).
Large Medical Centres
A “full time” prescribing medical practitioner (or equivalent) is now defined as providing the services of a prescribing medical practitioner for at least 38 hours each week.
The Explanatory Statement goes on to suggest that time spent by the practitioner on administrative matters and undertaking duties outside the practice should not be counted. Nor would it appear should allowances for holiday leave, sick leave or long service leave.
The number of hours during which the centre is required to operate has increased from 55 hours to 70 hours. The rationale for the amendment is “the intention of having a pharmacy in a large medical centre is primarily to meet the needs of medical centre patients outside of normal business hours, where nearby pharmacies have closed”, although there is no reference to the business hours of other approved premises.
New Pharmacy Applications
Previously an applicant for a new approval in a rural area had the option of bringing an application under item 113 which carried the requirement of no other approved premise within 1.5km of the proposed site or under item 114 which required that there be no other approved premises within 10km measured by the shortest lawful access route. The Determination now requires that an applicant for premises in a rural area must bring the application under item 114.
General Requirements
There has been some amendment in item 201 to the requirement that applicants establish that the proposed premises can be used for the purpose of operating a pharmacy under applicable local government and state and territory laws primarily by the inclusion of a note in the Rules which provides that the requirement would be satisfied by evidence of appropriate zoning or the obtaining of planning approval but would not require an applicant to obtain a building works approval or certificate of occupancy or similar.
Item 201 has been further amended to require that an applicant demonstrate that on the date of the application and on the date on which the ACPA makes a recommendation the proposed premises “would be accessible by members of the public at large”.
The Explanatory Statement states that the amendment is “to ensure that pharmaceutical benefits are available to the Australian community at large and not restricted to certain members of the public, such as patients of a particular medical centre”. The effect of it however appears to be that applicants cannot make an application unless and until the premises are accessible. This will clearly have implications for applications in respect of new developments.
The amendments are significant and cannot be seen to benefit potential applicants. They are consistent with the Determinations of previous Ministers which have resolved issues considered to be controversial negatively rather than positively and coming a little more than a year before the expiry of the Rules suggest that there is unlikely to be any significant relaxation of location restrictions in the Fifth Community Pharmacy Agreement.
Steven Holzberger – Consultant
Level 10, 15 Adelaide Street, Brisbane QLD 4000
Email: stevenh@mpsolicitors.com.au
Office Ph: 3210 1833