National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 7) (PB 74 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01298 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2016 (No. 7)

PB 74 of 2016

 

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 2016 (No. 8), commencing on 1 September 2016.  Schedule 3 to the Principal Determination is amended by the deletion of hydromorphone in the form injection containing hydromorphone hydrochloride 500 mg in 50 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 September 2016.

This Instrument is a legislative instrument for the purposes of the Legislation 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 2016
(No. 7)
(PB 74 of 2016)

 

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.  Schedule 3 to the Principal Determination is amended by the deletion of one form of a pharmaceutical item. 

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.

 

Penny Shakespeare
First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 7) was enacted in 2016 to align with changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 8), which took effect on 1 September 2016. This amendment to the National Health Act 1953 was introduced by the Australian Government to update the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. The purpose of this amendment is to reflect the changes in the Pharmaceutical Benefits Scheme (PBS) by removing certain pharmaceutical items from the list of benefits covered. The legislative instrument was prepared in accordance with the Legislation Act 2003 and 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 affordable medicines through the PBS.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 7) applies to the conditions governing payments made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as specified under the National Health Act 1953. This legislation is national in scope, applying across Australia, and is aimed at ensuring the reliable, timely, and affordable access to a wide range of medicines for all Australians. The amendment specifically alters the conditions of the Pharmaceutical Benefits Scheme (PBS), removing the listing for hydromorphone injection containing hydromorphone hydrochloride 500 mg in 50 mL, effective from 1 September 2016. The changes reflect recommendations made by the Pharmaceutical Benefits Advisory Committee, an independent body comprising representatives from various health-related sectors. The determination ensures that decisions regarding the PBS are evidence-based, thereby supporting the progressive realisation of the right to the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The main operative sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 7) (PB 74 of 2016) concern the conditions governing payments made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners, as outlined in the National Health Act 1953. This Amendment Determination specifically addresses the Principal Determination (PB 119 of 2008) to incorporate changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 8), effective from 1 September 2016. One of the key changes is the deletion of hydromorphone in the form of an injection containing hydromorphone hydrochloride 500 mg in 50 mL from Schedule 3 of the Principal Determination. The obligations and requirements imposed by this Amendment Determination ensure that the updated conditions are reflected in the payment process for pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). Approved pharmacists and medical practitioners must adhere to these updated conditions when supplying pharmaceutical benefits. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body with expertise from various fields including health economics, pharmacy, and medicine, has provided recommendations to the Minister based on evidence and submissions from stakeholders. These recommendations have led to the Minister's determination of the changes, which are now enshrined in this Amendment Determination. The Amendment Determination does not explicitly outline specific offences, penalties, or consequences for breach in its text. However, any breach of the conditions set out in the Principal Determination or the amended conditions under this Amendment Determination could lead to non-compliance with the PBS requirements. This non-compliance might result in the Commonwealth withholding payments for pharmaceutical benefits supplied, which could have financial repercussions for the approved pharmacists and medical practitioners involved. The overarching legislative framework, including the Acts Interpretation Act 1901 and the National Health Act 1953, would provide the basis for any further enforcement actions or legal consequences.

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