Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006

Administered by Department of Health, Disability and Ageing

Legislation au C2006A00037 In force Act

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Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006

 

No. 37, 2006

 

 

 

 

 

An Act to amend the National Health Act 1953, and for related purposes

 

 

Contents

1 Short title

2 Commencement

3 Schedule(s)

Schedule 1—Amendments relating to Australian Community Pharmacy Authority

Part 1—Amendments commencing on Royal Assent

National Health Act 1953

Part 2—Amendments commencing on 1 July 2006

National Health Act 1953

Part 3—Technical amendments

National Health Act 1953

Schedule 2—Amendments relating to approval of pharmacists

Part 1—Minister’s discretion to grant approval

National Health Act 1953

Part 2—Expanded or contracted premises

National Health Act 1953

 

 

 

Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006

No. 37, 2006

 

 

 

An Act to amend the National Health Act 1953, and for related purposes

[Assented to 3 May 2006]

The Parliament of Australia enacts:

1  Short title

  This Act may be cited as the Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006.

2  Commencement

 (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1.  Sections 1 to 3 and anything in this Act not elsewhere covered by this table

The day on which this Act receives the Royal Assent.

3 May 2006

2.  Schedule 1, Part 1

The day on which this Act receives the Royal Assent.

3 May 2006

3.  Schedule 1, Part 2

1 July 2006.

1 July 2006

4.  Schedule 1, Part 3

Immediately after the commencement of item 14 of Schedule 1 to the National Health Amendment Act (No. 1) 2000.

1 July 2000

5.  Schedule 2

1 July 2006.

1 July 2006

Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.

 (2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act.

3  Schedule(s)

  Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.


Schedule 1—Amendments relating to Australian Community Pharmacy Authority

Part 1—Amendments commencing on Royal Assent

National Health Act 1953

1  Subsection 90(3C)

Omit “30 June 2006”, substitute “30 June 2010”.

2  Section 99Y

Omit “30 June 2006”, substitute “30 June 2010”.


Part 2—Amendments commencing on 1 July 2006

National Health Act 1953

3  At the end of subsection 99N(1)

Add:

 ; (e) a person who, in the Minister’s opinion, is an appropriate person to represent the interests of consumers.

4  Subsection 99N(5)

Omit “or (c)”, substitute “, (c) or (e)”.


Part 3—Technical amendments

National Health Act 1953

5  Subsection 105AD(1) (definition of reviewable recommendation)

Omit “any of paragraphs (2)(a) to (2)(g)”, substitute “paragraph (2)(a) or (aa)”.

6  Paragraph 105AD(2)(aa)

Omit “subject;”, substitute “subject.”.


Schedule 2—Amendments relating to approval of pharmacists

Part 1—Minister’s discretion to grant approval

National Health Act 1953

1  After paragraph 6(1)(aa)

Insert:

 (ab) the Minister’s powers under sections 90A and 90B; or

2  At the end of subsection 90(5)

Add:

Note: In certain circumstances, the Minister may substitute for a decision of the Secretary rejecting an application for approval, a decision granting the approval (see section 90A).

3  At the end of section 90

Add:

 (8) Nothing in this section prevents the approval of more than one pharmacist for the purpose of supplying pharmaceutical benefits at or from particular premises.

4  After section 90

Insert:

90A  Minister may substitute decision approving pharmacist

 (1) This section applies in relation to a decision of the Secretary under section 90 rejecting an application by a pharmacist for approval to supply pharmaceutical benefits at or from particular premises, if:

 (a) the application was made on or after 1 July 2006; and

 (b) the decision was made on the basis that the application did not comply with the requirements of the relevant rules determined by the Minister under section 99L.

 (2) The Minister may substitute for the Secretary’s decision a decision approving the pharmacist for the purpose of supplying pharmaceutical benefits at or from the particular premises if the Minister is satisfied that:

 (a) the Secretary’s decision will result in a community being left without reasonable access to pharmaceutical benefits supplied by an approved pharmacist; and

 (b) it is in the public interest to approve the pharmacist.

 (3) For the purposes of subsection (2):

community means a group of people that, in the opinion of the Minister, constitutes a community.

reasonable access, in relation to pharmaceutical benefits supplied by an approved pharmacist, means access that, in the opinion of the Minister, is reasonable.

 (4) The power under subsection (2) may only be exercised:

 (a) on request by the pharmacist made under section 90B; and

 (b) by the Minister personally.

 (5) Subject to subsection 90B(5), the Minister does not have a duty to consider whether to exercise the power under subsection (2) in respect of the Secretary’s decision.

 (6) The power under subsection (2) does not authorise the Minister to approve a pharmacist for the purpose of supplying pharmaceutical benefits at or from particular premises at which the pharmacist is not permitted, under the law of the State or Territory in which the premises are situated, to carry on business.

 (7) A decision by the Minister not to exercise the power under subsection (2) in respect of the Secretary’s decision does not prevent the pharmacist from making an application to the Administrative Appeals Tribunal under subsection 105AB(7) for review of the Secretary’s decision.

 (8) For the purposes of this section (other than subsection (7)):

 (a) a reference to a decision of the Secretary includes a reference to a decision of the Secretary that has been affirmed by a decision of the Administrative Appeals Tribunal or an order of a federal court; and

 (b) a reference to a decision of the Administrative Appeals Tribunal includes a reference to a decision of the Administrative Appeals Tribunal that has been affirmed by an order of a federal court.

90B  Request to Minister to approve pharmacist

 (1) If section 90A applies to a decision of the Secretary under section 90 rejecting an application by a pharmacist, the pharmacist may, in writing, request the Minister to exercise the Minister’s power under subsection 90A(2) in respect of the Secretary’s decision.

 (2) The Minister may determine the form in which a request under subsection (1) must be made and, if the Minister does so, such a request must be made in that form.

 (3) A request under subsection (1) must be made:

 (a) within 30 days after the pharmacist is notified of the Secretary’s decision; or

 (b) if the pharmacist has applied to the Administrative Appeals Tribunal for review of the Secretary’s decision—within 30 days after:

 (i) the pharmacist is given a copy of the Administrative Appeals Tribunal’s decision affirming the Secretary’s decision; or

 (ii) the application has been discontinued, withdrawn or dismissed; or

 (c) if the pharmacist has sought an order from a federal court in respect of the Secretary’s decision or a decision of the Administrative Appeals Tribunal affirming the Secretary’s decision—within 30 days after:

 (i) the court has made an order affirming the Secretary’s decision or the Administrative Appeals Tribunal’s decision, as the case requires; or

 (ii) the court proceeding has been discontinued, withdrawn or dismissed.

 (4) The Minister must, within 3 months after receiving a request under subsection (1), personally decide whether to consider the request. If the Minister has not made a decision within this period, the Minister is taken to have decided not to consider the request.

 (5) If the Minister decides to consider a request under subsection (1), the Minister must, within 3 months after making that decision, personally decide whether to exercise the power under subsection 90A(2) in respect of the Secretary’s decision. If the Minister has not made a decision within this period, the Minister is taken to have decided not to exercise the power under subsection 90A(2) in respect of the Secretary’s decision.

 (6) The Secretary must, by notice in writing, advise the pharmacist of:

 (a) the decision made, or taken to have been made, by the Minister under subsection (4); and

 (b) if applicable, the decision made, or taken to have been made, by the Minister under subsection (5).

90C  Circumstances in which request may not be made

 (1) A request must not be made under subsection 90B(1) in relation to a decision of the Secretary to which section 90A applies if:

 (a) the Secretary’s decision is the subject of a proceeding before the Administrative Appeals Tribunal or a federal court; and

 (b) the proceeding has not been discontinued, withdrawn or dismissed, or otherwise finally determined.

 (2) A request under subsection 90B(1) is taken to have been withdrawn if, before the Minister has made a decision in relation to the request under subsection 90B(4) or (if applicable) subsection 90B(5), the Secretary’s decision becomes the subject of a proceeding before the Administrative Appeals Tribunal or a federal court.

90D  Provision of further information

 (1) For the purpose of deciding whether to consider a request made by a pharmacist under subsection 90B(1) or whether to exercise the power under subsection 90A(2) in relation to such a request:

 (a) the Minister may, by notice in writing given to the pharmacist, require the pharmacist to provide such further information, or produce such further documents, to the Minister as the Minister specifies, within the period specified in the notice; and

 (b) the Minister may give a notice in writing to any other person:

 (i) advising the person of the request; and

 (ii) inviting the person to provide comments on, or information or documents relevant to, the request within the period specified in the notice.

 (2) If:

 (a) the Minister gives a notice to a pharmacist under paragraph (1)(a); and

 (b) the pharmacist does not provide the information specified in the notice or produce the documents specified in the notice within the period specified in the notice;

the Minister may treat the request as having been withdrawn.

 (3) If the Minister gives a notice to a person under paragraph (1)(b), the Minister:

 (a) is only required to consider comments, information or documents provided by the person during the period specified in the notice; and

 (b) if the person does not provide any comments, information or documents within that period—is not required to take any further action to obtain such comments, information or documents.

90E  Effect of decision by Minister to approve pharmacist

  If the Minister decides to substitute for a decision of the Secretary to which section 90A applies a decision approving a pharmacist for the purpose of supplying pharmaceutical benefits at or from particular premises:

 (a) the pharmacist is to be treated for all purposes of this Act as if the pharmacist is approved under section 90 in respect of those premises; and

 (b) references in this Act to an approval granted under section 90 include references to an approval treated as having been granted under section 90 by paragraph (a) of this section; and

 (c) the conditions to which an approval granted under section 90 is subject (including any condition that is imposed by means of a determination under paragraph 92A(1)(f)) apply also to an approval that is treated as having been granted under section 90 by paragraph (a) of this section; and

 (d) the rights conferred and obligations imposed on an approved pharmacist apply to the pharmacist in his or her activities as an approved pharmacist.

5  Paragraph 92A(1)(f)

After “condition”, insert “(including, but not limited to, a condition relating to premises)”.

6  At the end of subsection 105AB(7)

Add:

Note: In certain circumstances, the Minister may substitute for a decision of the Secretary rejecting an application for approval under section 90 (including a decision that has been affirmed by the Administrative Appeals Tribunal), a decision granting the approval (see section 90A).

7  At the end of Part VIIA

Add:

105AE  Time limits

 (1) This section applies if:

 (a) section 90A applies to a decision of the Secretary under section 90 rejecting an application by a pharmacist; and

 (b) the pharmacist makes a request under section 90B that the Minister exercise the Minister’s power under subsection 90A(2) in respect of the Secretary’s decision; and

 (c) the Minister:

 (i) decides, or is taken to have decided, not to consider the request; or

 (ii) decides, or is taken to have decided, not to exercise the Minister’s power under subsection 90A(2) in respect of the Secretary’s decision.

 (2) For the purpose of making an application to the Administrative Appeals Tribunal or a federal court in respect of the Secretary’s decision, the Secretary’s decision is taken to have been made on the day on which notice of the Minister’s decision is given to the pharmacist under subsection 90B(6).


Part 2—Expanded or contracted premises

National Health Act 1953

8  Subsection 90(3A)

Omit “subsection (3AA)”, substitute “subsections (3AA) and (3AE)”.

9  Subsection 90(3AB)

Omit “subsection (3AA)”, substitute “subsections (3AA) and (3AE)”.

10  After subsection 90(3AD)

Insert:

 (3AE) Subsection (3A) does not apply to an application for an approval if:

 (a) the application arises out of an expansion or contraction of particular premises (the original premises) at which a pharmacy is situated; and

 (b) the expanded or contracted premises occupy any of the space occupied by the original premises.

 (3AF) However, the Secretary may, at his or her discretion, refer to the Authority an application referred to in subsection (3AE).

11  Subsection 90(3B)

Omit “to which subsection (3A) applies”, insert “that has been referred to the Authority under subsection (3A) or (3AF)”.

12  Subsection 90(3C)

After “(3AD)”, insert “, (3AE), (3AF)”.

13  Application

The amendments of section 90 of the National Health Act 1953 made by this Part apply to an application for approval under that section made on or after 1 July 2006.

 

 [Minister’s second reading speech made in—

House of Representatives on 16 February 2006

Senate on 29 March 2006]

(5/06)

 

Overview

The Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006 was enacted to address issues related to pharmacy locations and the approval process for pharmacists, amending the National Health Act 1953. The Act was passed by the Parliament of Australia and received Royal Assent on 3 May 2006. The primary objective of the Act is to provide the Minister with discretionary powers to approve pharmacists and to streamline the approval process, ensuring that communities have reasonable access to pharmaceutical benefits. This includes provisions for the Minister to substitute decisions made by the Secretary regarding the approval of pharmacists, as well as setting out the procedures for making such decisions and the conditions under which these powers can be exercised. The Act also aims to clarify and update the legislative framework concerning pharmacy locations and the approval of pharmacists to better meet contemporary health service needs.

Scope and Application

The Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006 is an Act of the Australian Commonwealth Parliament that amends the National Health Act 1953. It primarily concerns the amendments to the Australian Community Pharmacy Authority (ACPA) and the approval of pharmacists. The Act applies to the Minister for Health, the Secretary of the Department of Health, and pharmacists applying for approval to supply pharmaceutical benefits. It has a nationwide reach as it pertains to the Commonwealth's legislative authority over health and medical services. Certain provisions of the Act commence on the day of Royal Assent, 3 May 2006, while other amendments and technical changes commence on 1 July 2006. The Act provides for the Minister to substitute their decision for that of the Secretary in certain circumstances, particularly where a Secretary's decision to reject a pharmacist's application for approval may leave a community without reasonable access to pharmaceutical benefits, and where it is in the public interest to approve the pharmacist. The Act also outlines the procedure for pharmacists to request such substitutions and sets out time limits for the Minister's decisions. Additionally, it addresses scenarios involving expanded or contracted premises for pharmacy locations, providing the Secretary with discretion to refer certain applications to the ACPA.

Key Provisions

The Health Legislation Amendment (Pharmacy Location Arrangements) Act 2006 (the Act) makes several key amendments to the National Health Act 1953 (the Act) concerning the approval of pharmacists and the Australian Community Pharmacy Authority (the Authority). Firstly, the Act extends the deadline for the Authority to establish a pharmacy benefits schedule from 30 June 2006 to 30 June 2010 (sections 1 and 2). Secondly, it requires the Authority to include a consumer representative on its board (section 3). Thirdly, it alters the definition of "reviewable recommendation" to narrow the scope of recommendations that can be reviewed (section 5). Lastly, it introduces provisions to allow the Minister to approve a pharmacist if the Secretary's decision would leave a community without reasonable access to pharmaceutical benefits and it is in the public interest to do so (section 90A). The Minister can only exercise this power if the pharmacist requests it within 30 days of being notified of the Secretary’s decision and the decision is not under review (sections 90B and 90C). The Minister must decide whether to consider the request within three months, and if the request is considered, whether to exercise the power within another three months (sections 90D and 90E). The Act imposes several obligations on the parties it governs. The Secretary must notify pharmacists of decisions regarding their approval applications (subsection 90(5)). The Minister must decide whether to consider a pharmacist's request within three months and whether to exercise the power to approve the pharmacist within another three months (subsections 90D and 90E). The Minister may require pharmacists to provide further information to assist in making these decisions (subsection 90D(1)). Pharmacists must make requests to the Minister within 30 days of being notified of the Secretary's decision, unless the decision is under review (subsection 90B(3)). The Authority must refer certain applications to the Administrative Appeals Tribunal if the Secretary decides not to consider them (subsection 90(3B)). Breaches of the Act may lead to various consequences. Firstly, under section 90A(6), a decision by the Minister not to exercise the power to approve a pharmacist does not prevent the pharmacist from seeking review of the Secretary's decision by the Administrative Appeals Tribunal. Secondly, under subsection 90D(2), if a pharmacist fails to provide information requested by the Minister within the specified period, the Minister may treat the request as withdrawn. While the Act does not explicitly state civil or criminal penalties for non-compliance, actions that contravene the provisions of the National Health Act 1953 may be subject to penalties under that Act, which can include fines and imprisonment.

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