National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) (No. PB 5 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00071 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 5 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.  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 2013 (No. 2), which commences on 22 January 2013, by adding the listed drug morphine in the form injection containing morphine sulphate 10 mg in 1 mL (with preservative) to
Schedule 3.

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. 

 

General

This Instrument commences on 22 January 2013, on commencement of the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 2).

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

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 one form of a listed drug to Schedule 3 of the Determination.

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 Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953, published in 2013, was enacted to adjust the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This amendment responds to changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 2), which introduced morphine injection containing morphine sulphate 10 mg in 1 mL (with preservative) to Schedule 3 of the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 forms the foundation of the PBS, ensuring Australians have timely and affordable access to a wide range of medicines. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which medicines should be subsidised, ensuring that decisions are evidence-based and aligned with human rights standards, particularly those related to the right to health. This legislative instrument is consistent with the International Covenant on Economic, Social and Cultural Rights by progressively realising the highest attainable standard of physical and mental health 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 the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This instrument specifically amends the Principal Determination to incorporate the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 2), which became effective on 22 January 2013. It involves the addition of a specific form of the drug morphine, namely morphine injection containing morphine sulphate 10 mg in 1 mL (with preservative), to Schedule 3 of the Principal Determination. This Amendment Determination is applicable across Australia as it pertains to the national Pharmaceutical Benefits Scheme (PBS) established under the National Health Act 1953. The legislative instrument ensures that the conditions of the payments are updated to reflect the latest amendments, thereby maintaining the integrity and efficiency of the PBS.

Key Provisions

The main operative sections of this Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (sections 1 to 5) revise the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, it amends the Principal Determination (PB 119 of 2008) to incorporate changes resulting from the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 2), which came into effect on 22 January 2013. This amendment adds a specific form of the drug morphine to Schedule 3 of the Determination, affecting the conditions for its supply and reimbursement. The obligations and requirements imposed by this Act on the parties involved include ensuring compliance with the updated conditions for the supply of pharmaceutical benefits. Approved pharmacists and approved medical practitioners must adhere to the new conditions set forth in the Amendment Determination to be eligible for Commonwealth payments. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising the Minister on which medicines should be subsidised, ensuring that the decisions are evidence-based and consider a range of professional and consumer perspectives. Additionally, the Pharmaceutical Benefits Division within the Department of Health and Ageing is responsible for implementing and monitoring compliance with these conditions. Breaches of the conditions outlined in the Amendment Determination can lead to significant consequences. Approved pharmacists and approved medical practitioners who fail to comply with the updated conditions may be ineligible for Commonwealth payments for the specified pharmaceutical benefits. While the explanatory statement does not detail specific penalties, it is reasonable to infer that non-compliance could result in financial penalties or other administrative actions as outlined in the National Health Act 1953 or related regulations. The precise penalties would depend on the nature and severity of the breach, and any relevant administrative or legal processes would be followed to address such non-compliance.

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