National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 5) (PB 49 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00764 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2015 (No. 5)

PB 49 of 2015

 

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 changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 5), commencing on 1 June 2015.  Schedule 4 of the Principal Determination is amended by the deletion of calcipotriol, which has been delisted, and the deletion of chloramphenicol in the form ear drops (aqueous) 5 mg per mL, 5 mL.  

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 June 2015.

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

 

National Health Determination under paragraph 98C(1)(b) Amendment 2015
(No. 5)
(PB 49 of 2015)

 

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 removes one listed drug and one form of a listed drug from Schedule 4 of the Principal Instrument.

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

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 5) (PB 49 of 2015) amends the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as set out in the Principal Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act). Enacted by the Australian Parliament, the Act was originally introduced in 1953 to establish the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have access to affordable medicines. This Amendment Determination, which came into effect on 1 June 2015, removes calcipotriol and chloramphenicol ear drops from Schedule 4, thereby adjusting the conditions for pharmaceutical benefit payments accordingly. The policy objective is to align the conditions with recent changes in the listing of pharmaceutical benefits, ensuring the PBS remains effective and evidence-based through recommendations from the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2015 (No. 5) pertains to the National Health Act 1953, specifically targeting the conditions under which payments will be made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This determination applies to entities and individuals involved in the provision of pharmaceutical benefits as outlined in the Act, including approved pharmacists and approved medical practitioners. It reflects the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 5), which commenced on 1 June 2015. This legislative instrument amends the Principal Determination by removing certain drugs from Schedule 4, specifically calcipotriol and chloramphenicol in the form of ear drops (aqueous) 5 mg per mL, 5 mL. The changes are made to align with the updated listing of pharmaceutical benefits. The instrument has a national reach, applying across Australia, and is subject to the provisions of the Acts Interpretation Act 1901 for its revocation or variation. The Pharmaceutical Benefits Advisory Committee (PBAC) was consulted during the process, ensuring evidence-based recommendations for the Minister's decision on changes to the Pharmaceutical Benefits Scheme (PBS).

Key Provisions

The main operative sections of this Amendment Determination (F2015L00764) under paragraph 98C(1)(b) of the National Health Act 1953, are those that specify the conditions subject to which payments will be made by the Commonwealth for the supply of pharmaceutical benefits. The determination modifies the conditions by removing certain pharmaceutical products from the list of benefits, as detailed in Schedule 4 of the Principal Determination (PB 119 of 2008). Specifically, it removes calcipotriol and chloramphenicol in the form of ear drops (aqueous) 5 mg per mL, 5 mL. This means that from the commencement date of 1 June 2015, these products are no longer eligible for Commonwealth payments under the Pharmaceutical Benefits Scheme (PBS). This Amendment Determination imposes obligations on parties involved in the PBS, such as approved pharmacists and approved medical practitioners, to ensure that any pharmaceutical benefits supplied are in compliance with the updated conditions. The determination ensures that these practitioners and pharmacists must adhere to the revised list of eligible pharmaceutical products to receive Commonwealth payments. Additionally, the determination requires that the Pharmaceutical Benefits Advisory Committee (PBAC) play a key role in recommending changes to the Minister, who then determines the conditions. The determination outlines that there are civil and criminal consequences for non-compliance with the conditions set out in the determination. Specifically, the determination relies on the Acts Interpretation Act 1901 for the power to revoke or vary the Principal Determination. Failure to comply with the amended conditions may result in penalties for the parties involved, such as pharmacists and medical practitioners, who may face financial penalties for supplying ineligible pharmaceutical benefits. The exact penalties are not specified in the text, but they may include fines or other financial sanctions as prescribed by the relevant laws. Additionally, any fraudulent or deliberate non-compliance could lead to more severe criminal penalties.

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