National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 2) (PB 13 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00163 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2018 (No. 2)

PB 13 of 2018

 

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 2018 (No. 3), commencing on 1 March 2018.  Schedule 4 to the Principal Determination is amended by the deletion of the listed drug Risedronic Acid and Calcium in the form Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate). Risedronic Acid and Calcium continues to be listed in Schedule 4 in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate).

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 March 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 2018 (No. 2)
(PB 13 of 2018)

 

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 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 PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health Act 1953, as amended by the National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 2), addresses the need to regulate and update the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This legislative instrument was enacted to streamline and modernise the Pharmaceutical Benefits Scheme (PBS) by the Australian Government, ensuring that the supply of medicines remains efficient and affordable. The amendment was made under the authority of the Act, specifically paragraph 98C(1)(b), which empowers the Minister to determine the conditions for these payments. The policy objective of these amendments is to reflect changes in the pharmaceutical market, ensuring the PBS remains effective in providing access to necessary medications while maintaining fiscal responsibility. This amendment, which came into effect on 1 March 2018, ensures that the conditions for pharmaceutical benefit payments are aligned with contemporary medical needs and market conditions.

Scope and Application

The National Health Act 1953, through its Amendment Determination 2018 (No. 2), outlines the conditions under which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislation applies to all entities involved in the supply of pharmaceutical benefits, including pharmacists, medical practitioners, and pharmaceutical companies. The geographic reach of this Act is national, as it governs the Pharmaceutical Benefits Scheme (PBS) across Australia. The Act's application extends to all approved pharmaceutical benefits listed under Schedule 4, with specific amendments to the conditions of supply for certain drugs, such as the deletion of Risedronic Acid and Calcium in a particular form while retaining it in another form. The Act does not explicitly state exclusions or thresholds but operates through subordinate instruments to define specific conditions and variations. This legislative instrument ensures compatibility with human rights by promoting access to affordable medications, thereby advancing the right to health under international covenants.

Key Provisions

The National Health Act 1953 governs the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides access to a wide range of medicines. Section 98C(1)(b) allows the Minister to determine conditions for payments for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 2) amends the Principal Determination to reflect changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 3), which commenced on 1 March 2018. Schedule 4 of the Principal Determination is amended by deleting the listing for Risedronic Acid and Calcium in the form Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg, while retaining the listing for the same drug in another form. The Act imposes obligations on parties to adhere to the conditions set out in the Determination for receiving payments for pharmaceutical benefits. Approved pharmacists and medical practitioners must comply with these conditions to be eligible for Commonwealth payments for supplied pharmaceutical benefits. The Amendment Determination specifies changes to these conditions, including the removal of certain pharmaceutical listings, which parties must abide by. For breaches of the conditions set out in the Determination, there are no specific offences or penalties outlined in the Act or the Amendment Determination itself. However, non-compliance with the conditions for Commonwealth payments could potentially lead to denial of payments for pharmaceutical benefits supplied. Parties that fail to adhere to the amended conditions may face administrative or financial consequences, such as being ineligible for payments or facing audits and reviews by relevant authorities to ensure compliance with the PBS conditions.

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