Pharmaceutical Benefits Determination under subsection 99L (1) (No. PB 1 of 2006)

Administered by Department of Health, Disability and Ageing

Legislation au F2005L04167 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 1 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.  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 Act 2005, and will now operate until 30 June 2006.  A consequence of that extension is that, rather than expire on 31 December 2005, the Rules will remain in effect until 30 June 2006.

This is in accordance with the Government’s decision to extend the existing Rules until 30 June 2006.  New Rules will be implemented from 1 July 2006.

The Department of Health and Ageing Determination No. PB 1 of 2006 (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, Determination No. PB 14 of 2004 made on 12 August 2004 and Determination No. PB 14 of 2005 made on 29 June 2005).

 

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 2005. However, Determination No. PB 14 of 2005 is expressed to cease to have effect after 31 December 2005, whereas the Determination will operate until 30 June 2006.  

 

Details of the amendments are provided in the Attachment.


The Determination commences on 1 January 2006.

 

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 January 2006.

 

Clause 2 provides that the Determination will cease to have effect after 30 June 2006.

 

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 National Health Act 1953, as amended by the Health Legislation Amendment Act 2005, governs the approval of pharmacists to supply pharmaceutical benefits at or from particular premises. The Australian Community Pharmacy Authority (ACPA), established under the Act, evaluates applications under section 90 and makes recommendations to the Secretary about whether a pharmacist should be approved for specific premises. These recommendations must adhere to rules determined by the Minister under subsection 99L(1) of the Act. The Department of Health and Ageing Determination No. PB 1 of 2006, made under the authority of the Minister for Health and Ageing, extends the operation of these rules until 30 June 2006. The primary objective of this legislation is to regulate the location of pharmacies to ensure they do not operate in supermarkets, which would provide direct public access from within the supermarket premises. This amendment aims to maintain the integrity and accessibility of community pharmacies, ensuring they remain distinct from other retail environments.

Scope and Application

The Department of Health and Ageing Determination No. PB 1 of 2006 amends the rules under section 99L of the National Health Act 1953, specifically concerning the approval of pharmacists to supply pharmaceutical benefits from particular premises. This amendment applies to pharmacists and pharmacy premises located within, adjacent to, or connected to supermarkets, where members of the public have direct access from within the supermarket premises. The rules remain in effect until 30 June 2006, following an extension from the original expiry date of 31 December 2005. The Australian Community Pharmacy Authority (ACPA), established under section 99J of the Act, must consider applications and make recommendations to the Secretary in compliance with these rules. The amendment effectively precludes the ACPA from recommending approval for pharmacies situated within, adjacent to, or connected to supermarkets, and accessible directly from within the supermarket premises. This amendment, which is a disallowable instrument under subsection 99L(2) of the Act, aims to regulate the location of pharmacies to ensure compliance with the legislative framework.

Key Provisions

The National Health Act 1953 (the Act) under Section 90 allows the Secretary to approve pharmacists to supply pharmaceutical benefits from specific premises. The Australian Community Pharmacy Authority (ACPA), established under Section 99J of the Act, reviews applications under Section 90 and advises the Secretary on whether to approve a pharmacist for certain premises. The ACPA must follow the rules (Rules) determined by the Minister under subsection 99L(1) of the Act when making recommendations. The Rules cover the location of pharmacies and are considered disallowable instruments under subsection 99L(2) of the Act. The Health Legislation Amendment Act 2005 extended the operation of Division 4B of Part VII until 30 June 2006, meaning the Rules remain in effect until that date. The Department of Health and Ageing Determination No. PB 1 of 2006 amends the existing Rules to prevent pharmacies located within, adjacent to, or connected to a supermarket, with direct public access from the supermarket premises, from being recommended by the ACPA for approval to supply pharmaceutical benefits. This determination replaces Determination No. PB 14 of 2005, which expired on 31 December 2005. The Determination will operate until 30 June 2006. It includes definitions and amendments to ensure that recommendations are not made for premises situated in or connected to supermarkets. The obligations imposed by the Determination include defining "supermarket" to include retail stores or markets selling food and other domestic goods, excluding those commonly known as department stores or where food is only sold in prepared food or beverage counters. Paragraphs 5, 6, 6A, 6B, and 7 are amended to include references to new paragraph 9A, which stipulates that recommendations must not be made for premises within, adjacent to, or connected to a supermarket where the public has direct access from the supermarket. This amendment aims to prevent the approval of pharmacies in such locations to ensure compliance with the rules governing pharmacy locations. The Act does not specify offences, penalties, or consequences for breaching the Determination. However, the disallowance provision under subsection 99L(2) allows Parliament to review and potentially disallow the Determination. This means that if the Determination is challenged, it can be subject to parliamentary scrutiny and possible disallowance. The Determination, therefore, carries the risk of being disallowed if found not to comply with legislative requirements or public interest considerations.

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