Pharmaceutical Benefits Determination under subsection 99L(1) (No. PB 14 of 2005)

Administered by Department of Health, Disability and Ageing

Legislation au F2005L01888 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health and Ageing

 

National Health Act 1953

 

Department of Health and Ageing Determination No. PB 14 of 2005

 

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.  Rules have been determined by the Minister in relation to the location of pharmacies.

 

Subsection 99L(2) of the Act provides that a determination made under subsection 99L(1) is a disallowable instrument.

 

Section 99L of the Act is located in Division 4B of Part VII.   The operation of that Division has now been extended by the Health Legislation Amendment (Australian Community Pharmacy Authority) Act 2005, and will now operate until 31 December 2005.  A consequence of that extension is that, rather than expire on 30 June 2005, the Rules will remain in effect until 31 December 2005.

This is in accordance with the Government’s decision to extend the existing Rules until 31 December 2005 to allow the Government time to consider, and make decisions in relation to, the findings and recommendations of the review of the Rules.  The review is expected to report early in the 2005/06 financial year.

The Department of Health and Ageing Determination No. PB 14 of 2005 (the Determination) amends Determination No. PB 8 of 2000 made on 11 July 2000 (as amended 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 and Determination No. PB 14 of 2004 made on 12 August 2004).

 

The Determination amends the existing Rules to preclude pharmacies which are located within, adjacent to, or connected to, a supermarket, and to which members of the public have direct access from within the premises of the supermarket, from being recommended by the ACPA for approval under section 90 of the Act to supply pharmaceutical benefits.

 

The Determination makes the same amendments that were made by Determination No. PB 14 of 2004. However, Determination No. PB 14 of 2004 is expressed to cease to have effect after 30 June 2005, whereas the Determination will operate until 31 December 2005.  

 

Details of the amendments are provided in the Attachment.


The Determination commences on 1 July 2005.

 

The Pharmacy Guild of Australia, the body which represents a majority of pharmacy owners, has been consulted on this matter. 

 


ATTACHMENT

 

DETAILS OF THE AMENDMENT OF DETERMINATION UNDER SUBSECTION 99L(1) OF THE NATIONAL HEALTH ACT 1953

 

Clause 1 provides for the Determination to commence on 1 July 2005.

 

Clause 2 provides that the Determination will cease to have effect after 31 December 2005.

 

Clause 3 provides for Schedule 1 to amend the Determination made under subsection 99L(1) of the National Health Act 1953 on 11 July 2000, as amended.

 

Schedule 1 – Amendments

 

Item 1 inserts a definition of “supermarket”.  The word supermarket is intended to have its ordinary meaning. In addition, it includes any retail store, or market, selling food and other domestic goods whether or not by self-service and regardless of size. However, the definition of supermarket does not include a retail store or market commonly known as a department store or in which food or produce is sold only in a café, coffee shop, restaurant or other prepared food or beverage counter.

 

Item 2 makes a consequential amendment to paragraph 5 to include reference to new paragraph 5A.

 

Item 3 inserts new paragraph 5A.  New paragraph 5A provides that a recommendation must not be made under paragraph 5 in relation to an applicant’s premises if the applicant’s premises are located within, adjacent to, or connected to, a supermarket, and members of the public have direct access to the applicant’s premises from within the premises of the supermarket.

 

Item 4 makes a consequential amendment to paragraph 6 to include reference to new paragraph 9A.

 

Item 5 makes a consequential amendment to paragraph 6A to include reference to new paragraph 9A.

 

Item 6 makes a consequential amendment to paragraph 6B to include reference to new paragraph 9A.

 

Item 7 makes a consequential amendment to paragraph 7 to include reference to new paragraph 9A.

 

Item 8 inserts new paragraph 9A. New paragraph 9A provides that a recommendation must not be made under paragraph 6, 6A, 6B or 7 in relation to an applicant’s premises if the applicant’s premises are located within, adjacent to, or connected to, a supermarket, and members of the public have direct access to the applicant’s premises from within the premises of the supermarket.

 

Overview

The Department of Health and Ageing Determination No. PB 14 of 2005 amends the rules under the National Health Act 1953 to address the problem of pharmacies being located within supermarkets, which can lead to conflicts with other health services and potentially compromise the quality of pharmaceutical care. This determination was enacted to ensure that pharmacies are situated in environments conducive to providing appropriate pharmaceutical advice and services, without the distractions and conflicts that can arise in supermarket settings. The policy objective of the amendment is to maintain the integrity of pharmaceutical services by preventing the approval of pharmacies in supermarkets where the public has direct access from within the supermarket premises. The Australian Government, through the Minister for Health and Ageing, made this determination to align with the findings and recommendations of a review on the location of pharmacies, allowing for a more structured approach to pharmacy placements and ensuring the delivery of high-quality health services.

Scope and Application

The National Health Act 1953, as amended by the Department of Health and Ageing Determination No. PB 14 of 2005, provides a framework for the approval of pharmacists to supply pharmaceutical benefits at particular premises. The Australian Community Pharmacy Authority (ACPA) is responsible for considering applications for approval and making recommendations to the Secretary, adhering to rules determined by the Minister. These rules, now extended until 31 December 2005, were subject to a review, which is expected to report early in the 2005/06 financial year. The Determination No. PB 14 of 2005 modifies existing rules to explicitly prevent the ACPA from recommending approval for pharmacies located within, adjacent to, or connected to supermarkets, where the public has direct access from within the supermarket premises. This amendment is intended to ensure that pharmacies maintain a distinct identity and separation from supermarket operations, thereby preserving the integrity of the pharmaceutical supply chain and ensuring that pharmacies are not overly influenced by the commercial environment of supermarkets. The rules provide a clear definition of "supermarket" to encompass various retail formats selling food and domestic goods but exclude department stores and venues where food is only sold through prepared food or beverage counters.

Key Provisions

The main operative sections of the Department of Health and Ageing Determination No. PB 14 of 2005, as related to the National Health Act 1953, include the provisions that establish the Australian Community Pharmacy Authority (ACPA) as the body responsible for considering applications for pharmacists to supply pharmaceutical benefits at or from particular premises (section 90, 99J). The determination further outlines the rules (Rules) that the ACPA must follow when making recommendations, including specific rules concerning the location of pharmacies (section 99L). The Determination No. PB 14 of 2005 modifies these rules to prevent the ACPA from recommending approval for pharmacies located within, adjacent to, or connected to a supermarket where the public has direct access from within the supermarket (Clause 3 and new paragraph 5A, Schedule 1). The obligations and requirements imposed by the Act and the Determination on the parties governed by these provisions include the necessity for the ACPA to comply with the Rules when considering applications for pharmacist approvals. The ACPA must ensure that recommendations for approval do not include pharmacies situated within, adjacent to, or connected to a supermarket with public access from within the supermarket. This requirement extends to ensuring that the new paragraph 5A and 9A, which were added by the Determination, are adhered to in the application review process. Breaches of these provisions, including failure to comply with the Rules regarding the location of pharmacies, may lead to civil or criminal consequences. While the explanatory statement does not explicitly detail the penalties for non-compliance, under the National Health Act 1953, penalties for non-compliance can include fines and, in severe cases, criminal charges. The maximum penalties would depend on the specific nature and severity of the breach, as outlined in the broader legislative framework of the National Health Act 1953 and other applicable laws. The Determination ensures that the Rules remain in effect until 31 December 2005, allowing for the necessary time to review and make decisions based on the findings of the review of the Rules, which is expected to report early in the 2005/06 financial year.

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