National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 7) (PB 86 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01386 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. 7)

PB 86 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. 9), commencing on 1 November 2017.  Schedule 1 to the Principal Determination is amended by the addition of cefuroxime with water ─ purified BP in the form powder for oral suspension 125 mg (as axetil) per 5 mL, 100 mL.  Schedule 4 to the Principal Determination is amended by the addition of cefuroxime in the form powder for oral suspension 125 mg (as axetil) per 5 mL, 100 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, 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 November 2017.

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. 7)
(PB 86 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.  Schedules 1 and 3 are each amended by the addition 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.

 

Lisa La Rance

Assistant Secretary

Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953 forms the foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and reliable medications. This Act empowers the Minister to establish the conditions under which payments are made for the supply of pharmaceutical benefits by authorised pharmacists and medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 7) (PB 86 of 2017) was introduced to update the existing conditions set by the Principal Determination (PB 119 of 2008) to reflect changes enacted by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 9), effective from 1 November 2017. The policy objective is to ensure that the PBS remains a progressive and evidence-based scheme that continues to advance the human right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. This legislative instrument is compatible with human rights and ensures the PBS remains a benefit scheme that provides subsidised access to medicines based on recommendations from the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 7) applies to approved pharmacists and approved medical practitioners involved in the supply of pharmaceutical benefits within the Pharmaceutical Benefits Scheme (PBS), which is governed by the National Health Act 1953. This legislation ensures that the conditions under which payments are made by the Commonwealth for the supply of these benefits are clearly defined and updated as necessary. The amendment specifically adds cefuroxime with water – purified BP in the form powder for oral suspension 125 mg (as axetil) per 5 mL, 100 mL, to Schedule 1 and Schedule 4 of the Principal Determination, thereby altering the conditions subject to which these payments will be made. This change is effective from 1 November 2017 and is a legislative instrument under the Legislation Act 2003. The amendment is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health by ensuring reliable access to necessary medications through the PBS.

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2017 (No. 7) amends the Principal Determination under the National Health Act 1953 (the Act) to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 9) (paragraphs 1, 4). The changes involve the addition of a new pharmaceutical item, cefuroxime with water - purified BP in the form powder for oral suspension 125 mg (as axetil) per 5 mL, 100 mL, to Schedule 1 (for general beneficiaries) and Schedule 4 (for concessional beneficiaries) of the Principal Determination (paragraph 5). These schedules list the pharmaceutical benefits that are eligible for Commonwealth payments under the Pharmaceutical Benefits Scheme (PBS). The Act imposes specific obligations on parties involved in the PBS, including approved pharmacists and approved medical practitioners. These obligations include providing pharmaceutical benefits in accordance with the conditions set out in the Determination (subsection 85(1) of the Act). Approved pharmacists and approved medical practitioners must adhere to these conditions to be eligible for Commonwealth payments. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in advising the Minister on which medicines should be subsidised through the PBS, ensuring decisions are evidence-based (paragraph 11). Failure to comply with the conditions set out in the Determination may result in civil or criminal consequences, although specific penalties are not outlined in the Amendment. The Act generally provides for enforcement mechanisms to ensure compliance with its provisions, and breaches can lead to legal action. However, the exact penalties for non-compliance are not specified in this particular Amendment but would typically be found in other sections of the Act or related regulations. The Amendment is designed to be compatible with human rights, as it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by facilitating access to subsidised medicines under the PBS, which supports the right to the highest attainable standard of physical and mental health (paragraph 18). The involvement of the PBAC ensures that decisions about which medicines are subsidised are based on evidence and recommendations from a diverse committee, thereby respecting human rights through the provision of accessible and equitable healthcare services.

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