National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) (No. PB 9 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00186 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 9 OF 2013

 

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.  Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008) (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 the following changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 2) commencing on 1 March 2013 by:

  • adding the listed drug Macrogol 3350 in the form sachets containing powder for oral solution 17 g, 30 to Schedule 4;
  • adding the listed drug Testosterone in the form transdermal solution (pump pack)
    30 mg per 1.5 mL dose, 60 doses to Schedule 4.

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 March 2013.

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

 


Statement of Compatibility with Human Rights

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

 

Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 9 of 2013)

 

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, to Schedule 4 of the Determination, one form of each of two listed drugs.

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.

 

Kim Bessell

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health and Ageing

Overview

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 2) amends the National Health Act 1953 to adjust the conditions for pharmaceutical benefit payments by the Commonwealth, effective from 1 March 2013. The Minister for Health has the authority to determine these conditions under paragraph 98C(1)(b) of the Act, and this Amendment Determination modifies the Principal Determination (PB 119 of 2008) to incorporate recent changes. Specifically, the Amendment Determination adds Macrogol 3350 sachets and Testosterone transdermal solution to Schedule 4 of the Principal Determination, thereby expanding the list of pharmaceuticals eligible for subsidy through the Pharmaceutical Benefits Scheme (PBS). This legislative instrument was enacted by the Commonwealth Parliament and aims to ensure timely and affordable access to a broader range of medicines for Australians, aligning with the policy objective of enhancing healthcare outcomes through the PBS.

Scope and Application

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 applies to the conditions governing payments made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. This legislative instrument pertains specifically to the Pharmaceutical Benefits Scheme (PBS), which is established under Part VII of the National Health Act 1953. The determination amends the existing conditions by adding Macrogol 3350 in sachets containing powder for oral solution 17 g, 30 and transdermal Testosterone solution (pump pack) 30 mg per 1.5 mL dose, 60 to Schedule 4, effective from 1 March 2013. This amendment ensures that these specified pharmaceutical products are subject to the conditions under which Commonwealth payments are made, thereby facilitating their inclusion in the PBS. The amendment extends the application of the National Health Act 1953 to include these newly listed drugs, ensuring their provision and reimbursement align with the scheme's objectives of providing reliable, timely, and affordable access to medicines for all Australians.

Key Provisions

The main operative sections of this Amendment Determination (PB 9 of 2013) under paragraph 98C(1)(b) of the National Health Act 1953 (the Act) include the amendments to the Principal Determination (PB 119 of 2008) which set out the conditions for Commonwealth payments in respect of pharmaceutical benefits. The primary changes introduced by this Amendment Determination involve the addition of specific pharmaceutical products to Schedule 4, which details the conditions under which these benefits are supplied. These additions are Macrogol 3350 in the form of sachets containing powder for oral solution 17 g, 30 and Testosterone in the form of transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses. The obligations imposed on parties under this Amendment Determination primarily concern approved pharmacists and medical practitioners who supply pharmaceutical benefits. These parties must comply with the updated conditions outlined in Schedule 4 of the Principal Determination, ensuring that the newly listed drugs are supplied under the specified conditions. This includes adhering to the payment conditions and any other regulatory requirements that accompany the provision of these pharmaceutical benefits through the Pharmaceutical Benefits Scheme (PBS). In terms of consequences for breach, the Act itself does not explicitly state penalties for non-compliance with the conditions set out in the Amendment Determination. However, non-compliance with PBS regulations generally can lead to various civil and administrative penalties, including fines, recovery of benefits, and potential exclusion from the PBS. The extent and nature of penalties are typically determined by the Commonwealth and can be enforced through the relevant Commonwealth authorities, such as the Department of Health. The seriousness of the breach and any prior history of non-compliance are factors that may influence the severity of the penalties imposed.

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