Welcome to Part 2 on how to set up a pharmacy business without falling into the most common legal pitfalls. Here we will take a closer look at how to establish a new pharmacy business, and the different rules that apply depending on where and how it is set up.
Establishing a new pharmacy business
Establishing a new pharmacy business is a little more complex than merely relocating or changing the size of an existing pharmacy. There are six rules which govern the location of a new pharmacy. Make sure you understand which rule applies to your situation and ensure that you submit the required evidence to ACPA to ensure that your application to establish a new pharmacy is recommended for acceptance.
Rule 130 – New Pharmacy (at least 1.5km)
You want to run a new pharmacy. Your new pharmacy must be more than 1.5km by straight line from the nearest approved pharmacy. Additionally, there must be, within 500m in a straight line from the proposed premises:
- at least one full time prescribing medical practitioner and a supermarket with a gross leasable area of at least 1000 metres squared; or
- a supermarket with a gross leasable area of greater than 2500 metres squared.
Rule 131 – New Pharmacy (at least 10km)
You want to run a new pharmacy. What if there is no full time prescribing medical practitioner and a large supermarket nearby? In this case, rule 131 applies. To establish a new pharmacy where the requirements of rule 130 do not apply, your pharmacy must be at least 10km, by shortest lawful access route from the nearest approved pharmacy.
Rule 132 – New Additional Pharmacy (at least 10km)
In situations where you would like to establish a new pharmacy and the proposed premises are:
- in the same town as an approved pharmacy;
- located at least 200m in a straight line from the nearest approved pharmacy;
- at least 10km by shortest lawful access route from the second nearest approved pharmacy; and
- ACPA is satisfied that within the same town as the existing approved premises and the proposed premises, there are at least the equivalent of four full time prescribing medical practitioners and one, or a maximum of two supermarkets with a combined total gross leasable area of at least 2500 metres squared; then a pharmacy can be established.
Rule 133 – New Pharmacy in a Facility (small shopping centre)
If you would like to set up a pharmacy in a small shopping centre, then the proposed premises must be at least 500m in a straight line from the nearest approved pharmacy and there must be no approved pharmacies already in the shopping centre
Rule 134 – New Pharmacy Facility (large shopping centre)
To set up a pharmacy in a large shopping centre, there must be:
- for a shopping centre that contains between 50 and 100 shops – no approved pharmacies in the shopping centre; or
- for a shopping centre that contains between 100 and 200 shops – no more than one approved pharmacy in the shopping centre; or
- for a shopping centre that contains at least 200 shops – no more than two approved pharmacies in the shopping centre.
Rule 135 – New Pharmacy in a Facility (private hospital)
To set up a pharmacy in a private hospital, there must be no pharmacy that already exists and the hospital authority is not approved under section 94 of the National Health Act 1953 (Cth) for the supply of pharmaceutical benefits. In addition, the private hospital must be registered or licensed under the law of the state or territory in which it is located:
- to contain at least 150 beds to provide health services to patents; or
- to treat, accommodate or lodge at least 150 patients at any one time.
Rule 136 – New Pharmacy in a Facility (large medical centre)
What about if you would like to set up a pharmacy in a large medical centre? You must make sure that there are no approved pharmacies which already exist in the medical centre and the proposed premises are at least 500m, in a straight line, from the nearest approved pharmacy other than an approved pharmacy in a small shopping centre, a large shopping centre or a private hospital.
In addition, ACPA must be satisfied that at all relevant times, the number of PBS prescribers at the medical centre is equivalent to at least 8 full time PBS subscribers, of which at least 7 PBS subscribers must be prescribing medical practitioners. Finally, you need to demonstrate to ACPA that you will make all reasonable attempts to ensure that the operating hours of the proposed premises will meet the needs of patients in the medical centre.
The Pharmacy Location Rules are designed to meet the needs of Australians in delivering high quality healthcare where it is most needed. Running your own pharmacy is often rewarding, but as with any business there are regulatory requirements you must comply with. When you are altering the size of your pharmacy, relocating or establishing a new pharmacy, familiarise yourself with the Pharmacy Location Rules and ensure that you provide the necessary evidence to ACPA, to make sure your application is accepted.
If you need the assistance of a business lawyer, get in touch today at 1300 544 755 for a fixed-fee quote!