National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) (No. PB 95 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L02287 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953

PB 95 OF 2012

 

Authority

Paragraph 98C(1)(b) of the National Health Act 1953 (the Act) provides that the Minister may determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.  PB 119 of 2008 (Determination under paragraph 98C(1)(b) of the National Health Act 1953) (the Principal Determination) sets out the conditions subject to which these payments will be made.

Purpose

This Amendment Determination amends the Principal Determination to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 8) commencing on 1 December 2012 by:

  • adding the listed drug Atenolol in the form oral solution 50 mg in 10 mL,
    300 mL to Schedule 4;
  • adding the listed drug Hyaluronic acid in the forms eye drops containing sodium hyaluronate 1 mg per mL, 10 mL and eye drops containing sodium hyaluronate 2 mg per mL, 10 mL to Schedule 4;
  • adding the listed drug Naproxen in the form oral suspension 125 mg per 5 mL,
    474 mL to Schedule 4; and
  • removing the listed drug Neomycin with Bacitracin from Schedule 4.

A provision by provision description of this Instrument is contained in the Attachment.

Background

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

Consultations

The Department consulted with the Pharmaceutical Benefits Advisory Committee (PBAC) during the regular process of its meetings to consider applications in order to recommend to the Minister which medicines should be subsidised through the Pharmaceutical Benefits Scheme.  The Committee is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.  The Committee has received submissions and representations from interested pharmaceutical companies and has recommended the changes to the Minister who has determined the changes to the conditions under paragraph 98C(1)(b) which appear in this Determination. 

 

This Instrument commences on 1 December 2012.

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 


 

ATTACHMENT

 

Details of the Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953

 

Section 1 Name of Determination

This section provides that the title of the Determination is the Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 and that it may also be cited as PB 95 of 2012.

Section 2 Commencement

This section provides for the Determination to commence on 1 December 2012.

Section 3 Amendment of Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008)

This section provides that Schedule 1 amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008).

 

SCHEDULE 1―AMENDMENTS

Item [1] – Section 4

This item inserts the listed drug Atenolol in the form oral solution 50 mg in 10 mL, 300 mL.

Item [2] – Section 4

This item inserts the listed drug Hyaluronic acid in the forms eye drops containing sodium hyaluronate 1 mg per mL, 10 mL and eye drops containing sodium hyaluronate 2 mg per mL,
10 mL.

Item [3] – Section 4

This item inserts the listed drug Naproxen in the form oral suspension 125 mg per 5 mL,

474 mL.

Item [4] – Section 4

This item omits the entry for Neomycin with Bacitracin.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Determination under paragraph 98C(1)(b) of the National Health Act 1953

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the Legislative Instrument

The determination under paragraph 98C(1)(b) of the National Health Act 1953 sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.

This legislative instrument amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008). The amendments provide for changes to the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This instrument adds three listed drugs and forms to Schedule 4 of the Determination and removes one listed drug from Schedule 4.

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

This Legislative Instrument is compatible with human rights because it advances the protection of human rights.

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

Overview

The National Health Act 1953, enacted by the Australian Parliament, establishes the Pharmaceutical Benefits Scheme (PBS) to ensure affordable access to a range of medicines for Australians. The Act allows the Minister for Health to determine the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and medical practitioners. The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 95 of 2012) updates the conditions of these payments to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 8), which came into effect on 1 December 2012. This Amendment Determination adds three new pharmaceutical products to Schedule 4 and removes one, thereby ensuring the PBS remains aligned with contemporary health needs and evidence-based recommendations from the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 modifies the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This determination specifically adjusts the Principal Determination to incorporate changes mandated by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 8), which took effect on 1 December 2012. The amendment adds three new pharmaceutical products to Schedule 4 of the Determination—Atenolol in the form of an oral solution, Hyaluronic acid in two forms of eye drops, and Naproxen in the form of an oral suspension—while removing Neomycin with Bacitracin from the same schedule. The determination applies nationally across Australia, ensuring consistency in the provision of pharmaceutical benefits and compliance with the overarching framework of the Pharmaceutical Benefits Scheme (PBS). There are no specific exclusions or exemptions mentioned in this determination, and its application is primarily confined to the adjustments listed within the schedules.

Key Provisions

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 amends the Principal Determination to update the conditions under which payments will be made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. This is achieved by modifying Schedule 4, which lists the drugs eligible for these benefits (sections 1-3). The primary changes include adding three new drugs—Atenolol in the form of an oral solution, Hyaluronic acid in two forms of eye drops, and Naproxen in the form of an oral suspension—while removing Neomycin with Bacitracin from the list. The obligations imposed by this Amendment Determination on the parties involved—primarily the Commonwealth, approved pharmacists, and approved medical practitioners—are to adhere to the updated conditions for making and receiving payments for the listed pharmaceutical benefits. These obligations ensure that the supply and reimbursement of the specified drugs are conducted in accordance with the new terms established by the Act (section 3). Breaches of the conditions set out in this Amendment Determination may result in legal consequences. While the specific penalties are not detailed in the text, it is common for violations of conditions under the National Health Act 1953 to incur civil or criminal penalties, depending on the severity and intent of the breach. These penalties can include fines, imprisonment, or both, as prescribed by the relevant laws governing the Act. The exact maximum penalties would be found in the main body of the Act or in related legislation.

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