Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 - PB 91 of 2013

Administered by Department of Health, Disability and Ageing

Legislation au F2013L02167 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953

PB 91 of 2013

 

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 Schedule 4 to the Principal Determination to reflect the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 14), commencing on 1 January 2014, by adding to the listed drug budesonide with eformoterol the form powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2.

Schedule 4 is also amended by removing budesonide with eformoterol in the forms: pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2; pressurised inhalation containing budesonide 100 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2; and pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses, 2.  These forms are removed as a consequence of pack size change.

Schedule 4 of the Principal Determination is further amended by the deletion of: aprepitant in the form pack containing 1 capsule 125 mg and 2 capsules 80 mg; leflunomide in the form pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg; and miconazole in the form lotion containing miconazole nitrate 20 mg per mL, 30 g.  These forms are no longer pharmaceutical 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 January 2014.

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

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 91 of 2013)

 

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. This instrument adds one form of a listed drug to Schedule 4 of the Determination.  Three forms of the same drug have been removed from Schedule 4 as a consequence of pack size change.  A further three forms of listed drugs have been removed from Schedule 4 as they are no longer 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.

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 91 of 2013) amends the conditions for Commonwealth payments concerning the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners, as established by the Principal Determination (PB 119 of 2008). This legislative instrument updates Schedule 4 to reflect changes resulting from the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 14), which came into effect on 1 January 2014. The changes include adding a new form of the drug budesonide with eformoterol to Schedule 4 and removing three forms of budesonide with eformoterol and three other pharmaceutical items due to pack size changes and their status as no longer pharmaceutical items. This amendment ensures that the Pharmaceutical Benefits Scheme continues to provide timely and affordable access to a wide range of medicines for all Australians, aligning with the scheme's policy objective of enhancing health outcomes through evidence-based decision-making facilitated by the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 is a legislative instrument that amends the conditions subject to which payments are made by the Commonwealth for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This Amendment Determination is made under the authority provided by the National Health Act 1953, which underpins the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have access to affordable medicines. The Act applies to approved pharmacists and approved medical practitioners who supply pharmaceutical benefits listed under the PBS. The geographic reach of this Act is national, as it pertains to the Commonwealth's provision of benefits across Australia. The Amendment Determination specifically amends Schedule 4 of the Principal Determination by adding a new form of the drug budesonide with eformoterol and removing three forms of budesonide with eformoterol due to pack size changes, as well as removing three forms of other drugs that are no longer classified as pharmaceutical items. The instrument does not explicitly mention any exclusions, exemptions, or thresholds, but it does specify the conditions under which payments will be made for the listed pharmaceutical benefits. The changes are effective from 1 January 2014, and the determination process involves consultation with the Pharmaceutical Benefits Advisory Committee, which includes representatives from various health-related fields to ensure recommendations are evidence-based.

Key Provisions

The Amendment determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 91 of 2013) (section 2) amends Schedule 4 to 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 adds a new form of the drug budesonide with eformoterol to Schedule 4, specifically the form powder for oral inhalation in a breath-actuated device containing 400 micrograms of budesonide with 12 micrograms of eformoterol fumarate dihydrate per dose, 60 doses. Concurrently, it removes three other forms of budesonide with eformoterol from Schedule 4 due to a pack size change, and three other forms of listed drugs because they are no longer considered pharmaceutical items. The obligations imposed by this Amendment Determination on the parties involved, primarily the Commonwealth, approved pharmacists, and approved medical practitioners, are to adhere to the new conditions set out in Schedule 4 of the amended Principal Determination. These conditions govern the manner in which payments for pharmaceutical benefits will be made. Approved pharmacists and approved medical practitioners must ensure that the drugs they supply and for which they claim payments comply with the updated Schedule 4. There are no explicit offences, penalties, or civil or criminal consequences outlined for breaches of the conditions set out in this Amendment Determination. However, under the overarching National Health Act 1953, any non-compliance with the conditions for payments could potentially lead to legal consequences under the general provisions of the Act, including administrative sanctions or the withholding of payments. Given the context, the emphasis remains on ensuring that the conditions for the provision and reimbursement of pharmaceutical benefits are accurately and effectively updated to reflect current medical practices and available pharmaceutical products.

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