National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009

Administered by Department of Health, Disability and Ageing

Legislation au C2009A00071 In force Act

Legislation content

 

 

 

 

 

 

National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009

 

No. 71, 2009

 

 

 

 

 

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

 

 

Contents

1 Short title

2 Commencement

3 Schedule(s)

Schedule 1—Cost recovery

National Health Act 1953

 

 

 

 

National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009

No. 71, 2009

 

 

 

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

[Assented to 22 July 2009]

The Parliament of Australia enacts:

1  Short title

  This Act may be cited as the National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009.

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.

22 July 2009

2.  Schedule 1

1 July 2008.

1 July 2008

Note: This table relates only to the provisions of this Act as originally passed by both Houses of 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  Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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—Cost recovery

 

National Health Act 1953

1  After Division 4B of Part VII

Insert:

Division 4C—Cost recovery

Subdivision A—Preliminary

99YB  What this Division is about

This Division enables fees to be charged for certain services provided by the Commonwealth in order to recover the cost to the Commonwealth of providing those services. Those services relate to the exercise of certain powers of the Minister under this Act.

Subdivision B provides for regulations to set out the fees that are payable for those services, as well as other matters relating to the payment of those fees and the provision of those services (including some consequences of failing to pay a fee).

Subdivision C sets out another possible consequence of failing to pay a fee by providing for the Minister to refuse to exercise certain powers until the fee is paid.

Subdivision D provides that the Minister must cause a review to be undertaken of the impact of cost‑recovery measures provided for under this Division and any regulations made under this Division, and must table an annual report on related processes.

Subdivision B—Payment of fees etc. for certain services

99YBA  Payment of fees etc. for certain services

 (1) The regulations may make provision in relation to services provided by the Commonwealth in relation to the exercise of a power by the Minister under any of the following:

 (a) section 9B;

 (b) a provision in Part VII (other than a provision in that Part prescribed by the regulations).

 (2) Without limiting subsection (1), the regulations may make provision in relation to the following:

 (a) the making of applications for those services;

 (b) prescribing fees for those services;

 (c) the time that prescribed fees are due and payable (including extending the time for payment of the fees);

 (d) the manner of payment of prescribed fees (including payment by instalments);

 (e) the payment of penalties in respect of late payment of prescribed fees;

 (f) exemptions from prescribed fees;

 (g) the waiver, remission or refund of prescribed fees;

 (h) the refusal to provide those services until a prescribed fee is paid;

 (i) the review of decisions made under the regulations.

 (3) A prescribed fee must not be such as to amount to taxation.

 (4) A prescribed fee is payable to the Commonwealth.

 (5) A prescribed fee that is due and payable may be recovered by the Commonwealth as a debt due to the Commonwealth.

Subdivision C—Consequences if fees not paid

99YBB  Minister may refuse to exercise certain powers if prescribed fees not paid

 (1) If:

 (a) a person applies for a service referred to in subsection 99YBA(1) in relation to the exercise of a power by the Minister; and

 (b) either:

 (i) a fee prescribed under paragraph 99YBA(2)(b) is payable by the person for the service; or

 (ii) a fee prescribed under paragraph 99YBA(2)(b) is payable by the person for another service referred to in subsection 99YBA(1) that the person has applied for;

then, without limiting any power the Minister may otherwise have under section 9B or this Part, the Minister may refuse to exercise the power until the prescribed fee is paid.

 (2) A refusal referred to in subsection (1) is not a legislative instrument.

Subdivision D—Review of cost‑recovery measures

99YBC  Review of impact of cost‑recovery measures

Review

 (1) The Minister must cause an independent review of the impact of cost‑recovery measures provided for under this Division and any regulations made under this Division to be undertaken as soon as possible after the second anniversary of the commencement of this Division and completed within 4 months of that anniversary.

 (2) The review must report on:

 (a) the average number of times a submission is presented before gaining approval and the reasons provided for requiring applicants to resubmit;

 (b) the average fee for submissions by type of submission (major/minor/generic according to Department of Health and Ageing classifications);

 (c) the number of applications where the population is likely to be small and utilisation of the drug, medicinal preparation or vaccine is likely to be highly targeted;

 (d) the number of reviews requested by applicants;

 (e) the number of fee waivers given to applicants and the reasons why waivers were given;

 (f) the length of time taken for submissions to be approved;

 (g) the number of applications that fail to gain a listing, the reasons why and the types of drugs concerned;

 (h) any increase in operating costs of the Pharmaceutical Benefits Advisory Committee;

 (i) any increase in the cost of pharmaceutical benefits scheme medications to patients;

 (j) any other matters considered relevant.

 (3) The review must be conducted by a panel which must comprise not less than five persons, including:

 (a) a medical professional nominated by the Minister;

 (b) a nominee of the Consumers Health Forum of Australia;

 (c) three other persons nominated by the Minister, each of whom must have relevant professional qualifications and must not be employed within the pharmaceuticals industry.

 (4) The panel must give the Minister a written report of the review, and the Minister must cause a copy of the report to be tabled in each House of the Parliament within 15 sitting days of receiving the report.

Annual report on processes

 (5) The Secretary must, as soon as practicable after 30 June in each year, prepare and give to the Minister a report on processes leading up to the Pharmaceutical Benefits Advisory Committee consideration, including:

 (a) the extent and timeliness with which responsible persons are provided copies of documents relevant to their submission to the Pharmaceutical Benefits Advisory Committee;

 (b) the extent to which responsible persons exercise their right to comment on these documents, including appearing at hearings before the Pharmaceutical Benefits Advisory Committee;

 (c) the number of responsible persons seeking a review of a Pharmaceutical Benefits Advisory Committee recommendation.

 (6) The Minister must cause a copy of each report prepared under subsection (5) to be tabled in each House of the Parliament within 15 sitting days of receiving the report.

 

 

[Minister’s second reading speech made in—

House of Representatives on 12 May 2009

Senate on 14 May 2009]

(71/09)

 

Overview

The National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009, enacted by the Parliament of Australia, was designed to amend the National Health Act 1953 to enable the recovery of costs for certain pharmaceutical and other benefits provided by the Commonwealth. The Act introduces Division 4C, focusing on cost recovery, which allows for the charging of fees for specific services rendered by the Commonwealth, such as the provision of pharmaceutical benefits. This legislative change aimed to address the financial burden on the Commonwealth arising from the provision of these services by establishing a framework for the payment of fees, including the setting of fees, payment terms, penalties for late payments, and exemptions. The Act also mandates the Minister to refuse exercising certain powers until prescribed fees are paid and requires an independent review of the impact of these cost-recovery measures, with an annual report on related processes to be tabled in Parliament. The policy objective behind this legislation is to ensure the sustainability of the Pharmaceutical Benefits Scheme (PBS) by recovering costs associated with the administration and provision of benefits. By introducing a cost-recovery mechanism, the Act seeks to balance the financial responsibility of the Commonwealth with the need to provide essential health services. The implementation of fees for certain services under the PBS is intended to contribute to the financial sustainability of the scheme, allowing the Commonwealth to continue providing necessary pharmaceutical benefits to the Australian population while managing its expenditure.

Scope and Application

The National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009 amends the National Health Act 1953 to introduce cost recovery measures for certain services provided by the Commonwealth. The Act applies to services provided by the Commonwealth in relation to the exercise of powers by the Minister under the National Health Act, specifically those powers outlined in section 9B and other provisions in Part VII, excluding those prescribed by regulations. The regulations may cover the making of applications for these services, the prescription of fees, the time for fee payment, the manner of payment, penalties for late payments, exemptions, waivers, and the refusal to provide services until fees are paid. The Act also mandates the Minister to conduct an independent review of the impact of these cost-recovery measures every two years and to table an annual report on the processes leading up to the Pharmaceutical Benefits Advisory Committee's consideration. The fees prescribed must not amount to taxation and are payable to the Commonwealth, which may recover them as a debt. The Act applies nationally across Australia and extends its application through subordinate regulations.

Key Provisions

The National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Act 2009 introduces significant changes to the National Health Act 1953 by inserting a new Division 4C focused on cost recovery (sections 99YB to 99YBF). This division enables the charging of fees for certain services provided by the Commonwealth to recover the costs associated with exercising specific powers of the Minister (section 99YB). The regulations under this division can prescribe fees for these services, set the due dates for payment, specify payment methods, and outline penalties for late payments, among other things (section 99YBA). Importantly, these fees must not be considered taxation and are payable to the Commonwealth, which can recover them as debts (section 99YBA(3) to (5)). The Act imposes several obligations on parties and entities it governs. It mandates the Minister to refuse to exercise certain powers under specified conditions if a prescribed fee for a service is not paid (section 99YBB). The Minister is also required to commission an independent review of the impact of the cost-recovery measures and to table an annual report on related processes (sections 99YBC and 99YBD). These reviews and reports must cover various aspects such as the number of times submissions are resubmitted, average fees, the number of fee waivers, and the reasons behind them (section 99YBC(2)). There are specific consequences for non-compliance with the provisions of this Act. The Minister can refuse to exercise certain powers if a prescribed fee is not paid, effectively barring access to the service until the fee is settled (section 99YBB). Furthermore, while the Act does not explicitly state penalties for failing to comply with the review or reporting requirements, non-compliance could lead to scrutiny and potential legislative or administrative actions, though the Act does not detail specific penalties for such breaches. The broader legal framework and administrative practices would govern the consequences of such non-compliance.

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