National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 8) (PB 110 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01628 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2017 (No. 8)

PB 110 of 2017

 

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 2017 (No. 11), commencing on 1 January 2018.  Schedule 4 to the Principal Determination is amended by the deletion of:

  • cromoglycic acid in the form eye drops containing sodium cromoglycate 20 mg per mL, 10 mL; and
  • testosterone in the form transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses.

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, medical specialists and a pharmaceutical industry nominee.  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 January 2018.

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 2017
(No. 8)
(PB 110 of 2017)

 

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 4 is amended by the deletion of one form of two pharmaceutical items.

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.

 

Julianne Quaine

First Assistant Secretary (Acting)

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953, amended by the National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 8), was enacted to refine the conditions under which pharmaceutical benefits are paid by the Commonwealth to approved pharmacists and approved medical practitioners. This Amendment Determination, effective from 1 January 2018, was introduced to update the Principal Determination to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 11). This revision involved the deletion of specific pharmaceutical items from Schedule 4 of the Principal Determination. The amendments were made following consultations with the Pharmaceutical Benefits Advisory Committee (PBAC), which advises the Minister on which medicines should be subsidised through the Pharmaceutical Benefits Scheme (PBS). The PBS is integral to providing affordable access to a wide range of medicines for all Australians, thereby progressively realising the human right to the highest attainable standard of physical and mental health. The changes align with the human rights and freedoms recognised in international instruments, ensuring that decisions about medicine subsidies are evidence-based and contribute to the advancement of this human right.

Scope and Application

The National Health Act 1953, specifically amended through the National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 8), governs the conditions under which the Commonwealth makes payments for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This Act applies nationally across Australia, impacting approved pharmacists, approved medical practitioners, and patients who access the Pharmaceutical Benefits Scheme (PBS) through these healthcare providers. The determination outlines the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits, and it is subject to amendments as needed to reflect changes such as updates to the list of subsidised medicines. Notably, the current amendment removes specific forms of pharmaceutical items from Schedule 4, impacting the scope of available benefits under the PBS. The changes are effective from 1 January 2018, and the determination can be further extended or restricted through subordinate instruments, ensuring flexibility in adapting to new health requirements and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC).

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 8) (PB 110 of 2017) amends the Principal Determination (PB 119 of 2008) which sets out 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. This amendment, effective from 1 January 2018, primarily involves the deletion of specific pharmaceutical items from Schedule 4 of the Principal Determination. Specifically, it removes cromoglycic acid in the form of eye drops containing sodium cromoglycate 20 mg per mL, 10 mL, and testosterone in the form of transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses. This Act imposes certain obligations and requirements on approved pharmacists and approved medical practitioners who supply pharmaceutical benefits. They must ensure that their practice adheres to the conditions specified in the Determination, which include the criteria for eligibility for Commonwealth payments. These conditions are designed to ensure that the Pharmaceutical Benefits Scheme (PBS) operates efficiently and effectively, providing reliable, timely, and affordable access to medicines for all Australians. Approved pharmacists and approved medical practitioners are also required to consult the Principal Determination to understand the specific requirements and conditions applicable to their practice. The Act does not explicitly detail specific offences, penalties, or consequences for breach within the text provided. However, general provisions within the National Health Act 1953, as well as related legislative instruments, likely apply. Typically, breaches of the conditions under which Commonwealth payments are made could result in financial penalties, legal action, or other administrative consequences. The exact penalties would depend on the nature and severity of the breach, as well as any additional provisions or regulations that may be in force. It is important for practitioners to remain compliant with the Act and its associated determinations to avoid any adverse outcomes.

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