National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) (No. PB 49 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01459 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 49 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 Schedule 4 to the Principal Determination to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9), commencing on 1 August 2013, by adding the listed drug diazepam in the form oral liquid 1 mg in 1 mL, 100 mL.  Schedule 4 is also amended by the deletion of the listed drug lacosamide as a result of a change of form description.

Variation and revocation

Unless there is an express power to revoke or vary PB 119 of 2008 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 119 of 2008.

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 August 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 49 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 one form of a listed drug to Schedule 4 of the Determination and deletes one listed drug.

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, enacted in 2013, amends the conditions for payments under the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 established the PBS, which ensures Australians have reliable, timely, and affordable access to a range of medicines. The Minister, through the Pharmaceutical Benefits Advisory Committee, determines the conditions under which payments for pharmaceutical benefits are made by the Commonwealth. The amendment to the Principal Determination, effective from 1 August 2013, adds diazepam oral liquid to Schedule 4 of the PBS, reflecting recent legislative changes, and removes lacosamide due to a change in its form description. This legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring access to necessary medications through the PBS.

Scope and Application

This legislative instrument, Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 49 of 2013), pertains to the conditions under which the Commonwealth makes payments for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. The National Health Act 1953 is a Commonwealth statute that forms the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable medications. The Amendment Determination specifically modifies Schedule 4 of the Principal Determination, which details the conditions for pharmaceutical payments, by adding diazepam in the form of oral liquid 1 mg in 1 mL, 100 mL and removing lacosamide due to a change in its form description. This amendment aligns with changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9), which commenced on 1 August 2013. The changes to the PBS are informed by recommendations from the Pharmaceutical Benefits Advisory Committee, which comprises experts from various relevant fields, ensuring the decisions are evidence-based.

Key Provisions

The key provisions of this Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 49 of 2013) amend the conditions for payments made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This determination specifically revises Schedule 4 to the Principal Determination (PB 119 of 2008) by adding diazepam in the form of an oral liquid 1 mg in 1 mL, 100 mL, and removing lacosamide due to a change in its form description. These changes are aligned with the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9), which commenced on 1 August 2013. The Amendment Determination imposes specific obligations on parties involved in the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). Approved pharmacists and approved medical practitioners must adhere to the updated conditions set forth in Schedule 4 of the amended determination to be eligible for Commonwealth payments. This includes ensuring that the drugs they supply meet the criteria specified by the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which medicines should be included in the scheme, ensuring that decisions are evidence-based and consider the interests of consumers, health economists, and various medical professionals. Failure to comply with the conditions stipulated in the amended determination can lead to significant consequences. Although the Act does not explicitly detail specific offences, penalties, or civil/criminal consequences for non-compliance, any breach of the conditions under which payments are made could potentially result in the withholding of payments by the Commonwealth. Additionally, any failure to comply with the PBS regulations could be subject to penalties under other relevant legislation, such as the National Health Act 1953 or the Acts Interpretation Act 1901. These consequences underscore the importance of adhering to the updated conditions to maintain eligibility for Commonwealth payments.

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