National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 6) (PB 65 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01196 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. 6)

PB 65 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. 7), commencing on 1 August 2016.  Schedule 3 to the Principal Determination is amended as detailed in the summary below.

Schedule 4 to the Principal Determination is amended by the deletion of betamethasone, methylprednisolone and mometasone as the conditions of Schedule 4 do not apply to these items.  

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 2016.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.

 

SUMMARY OF CHANGES

SCHEDULE 3

Forms Added

Morphine

Injection containing morphine hydrochloride 10 mg in 1 mL
Injection containing morphine hydrochloride 20 mg in 1 mL
Injection containing morphine hydrochloride 50 mg in 5 mL
Injection containing morphine hydrochloride 100 mg in 5 mL

 


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. 6)
(PB 65 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 addition of four forms of a pharmaceutical item.  Schedule 4 to the Principal Determination is amended by the deletion of several 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.

 

Penny Shakespeare
First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 6) was introduced to amend the existing conditions for payments made by the Commonwealth under the Pharmaceutical Benefits Scheme (PBS) as outlined in the National Health Act 1953. This legislative instrument, which is subject to the Legislation Act 2003, was enacted by the Minister for Health to address discrepancies arising from the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 7). The amendment ensures that the PBS continues to provide reliable, timely, and affordable access to medicines for all Australians by updating the conditions for pharmaceutical benefits. The changes were made following consultations with the Pharmaceutical Benefits Advisory Committee (PBAC), which includes representatives from various relevant interests and professions to ensure evidence-based decision-making. This amendment reflects the commitment to the highest attainable standard of physical and mental health as recognised in international human rights instruments. The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 6) also engages with Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by ensuring the progressive realisation of the right to the highest attainable standard of health through the PBS. The Pharmaceutical Benefits Advisory Committee's role in recommending changes ensures that decisions about which medicines are subsidised are evidence-based and aligned with public health needs. The amendments to the Principal Determination, including the addition of specific forms of morphine and the removal of certain pharmaceutical items, aim to enhance the efficiency and effectiveness of the PBS, ensuring that Australians have access to the medications they need. This legislative instrument is considered compatible with human rights, as it advances the protection of the right to health through accessible and affordable pharmaceutical benefits.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2016 (No. 6) applies to 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 amends the principal determination under the National Health Act 1953, reflecting changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 7), which commenced on 1 August 2016. The amendment involves modifications to Schedule 3 by adding new forms of a pharmaceutical item and adjustments to Schedule 4 by removing specific pharmaceutical items. This legislation operates within the Commonwealth jurisdiction and is subject to changes that can be implemented through subordinate instruments, as noted in the explanatory statement. The amendments aim to ensure that the Pharmaceutical Benefits Scheme provides reliable, timely, and affordable access to a wide range of medicines for all Australians, aligning with the human rights framework by facilitating access to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 6) amends the National Health Determination under paragraph 98C(1)(b) of the National Health Act 1953 (the Act) (F2016L01196). This amendment primarily affects the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Specifically, it alters the listing of pharmaceutical benefits by adding certain forms of morphine injections to Schedule 3 and removing betamethasone, methylprednisolone, and mometasone from Schedule 4 (Schedule 3, para 1; Schedule 4, para 2). These changes are effective from 1 August 2016. The obligations under this amendment require approved pharmacists and approved medical practitioners to adhere to the updated conditions set out in the Principal Determination, ensuring that they are aware of the specific pharmaceutical benefits that are now covered or excluded under the Pharmaceutical Benefits Scheme (PBS). This includes being up-to-date with the new forms of morphine injections that are now eligible for Commonwealth payments and understanding the removal of certain pharmaceutical items from the list. Such changes necessitate adjustments in the way these professionals manage and bill for pharmaceutical benefits provided to patients. Failure to comply with the conditions outlined in the amended Determination can lead to legal consequences. While the specific penalties for non-compliance are not detailed in the text, it is understood that breaches of the conditions for payments under the PBS can result in financial penalties, legal actions, or other administrative sanctions. The exact penalties would be in line with those specified under the National Health Act 1953 or other relevant legislation, which may include fines or other civil and criminal penalties depending on the nature and severity of the breach. The overarching aim is to ensure adherence to the conditions to maintain the integrity and effectiveness of the PBS.

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