National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 9) (PB 74 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01286 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health Determination under paragraph 98C(1)(b)
Amendment 2014 (No. 9)

PB 74 of 2014

 

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 2014 (No. 10), commencing on 1 October 2014.  Schedule 4 of the Principal Determination is amended by the addition of: glucose indicator―blood in the form test strips, 100 (EasyMate II); oestradiol and oestradiol with dydrogesterone in the form pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg; and the removal of the drug polyethylene glycol 400, which has been de-listed.  Schedule 4 is also amended by a change in form description for the drug aclidinium.

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 October 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

 

National Health Determination under paragraph 98C(1)(b) Amendment 2014
(No. 9)
(PB 74 of 2014)

 

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 forms of two listed drugs to Schedule 4 of the Principal Instrument, removes one listed drug from Schedule 4 and changes the description of form for one drug.

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 National Health Act 1953, enacted by the Australian Parliament, forms the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), ensuring Australians have affordable access to a broad range of medications. The Act empowers the Minister to determine the conditions under which payments are made for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 9) (PB 74 of 2014) updates the Principal Determination to reflect recent changes in the listing of pharmaceutical benefits, enhancing the scheme’s ability to provide timely access to necessary medications. This legislative instrument engages with human rights by promoting the highest attainable standard of physical and mental health, aligning with Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, and ensuring that decisions about pharmaceutical subsidies are evidence-based through the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 9) (PB 74 of 2014) amends the conditions under which the Commonwealth will make payments for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislative instrument is applicable to entities involved in the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS), which is administered under Part VII of the National Health Act 1953. The determination applies to the entire Commonwealth of Australia, ensuring uniform conditions for the provision of pharmaceutical benefits across the country. The changes introduced by this instrument include the addition of specific forms of certain drugs to Schedule 4, the removal of a drug that has been de-listed, and a change in the form description for another drug. The Pharmaceutical Benefits Advisory Committee (PBAC) was consulted during this process, ensuring that the amendments are evidence-based and aligned with public health needs. The instrument does not specify exclusions or exemptions but relies on the Acts Interpretation Act 1901 for the revocation or variation of the Principal Determination (PB 119 of 2008).

Key Provisions

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 9) (PB 74 of 2014) amends the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and medical practitioners. This determination, outlined in the National Health Act 1953, specifies the criteria for these payments. The amendment introduces changes effective from 1 October 2014, altering the provisions in Schedule 4 of the Principal Determination. Specifically, it adds glucose indicator-blood test strips (EasyMate II) and oestradiol and oestradiol with dydrogesterone in specific forms to the list of pharmaceutical benefits. Conversely, it removes polyethylene glycol 400 from the list, reflecting its de-listing. Additionally, the description of the form for the drug aclidinium is amended. This Act imposes several obligations on the parties involved. Approved pharmacists and medical practitioners must adhere to the conditions set forth in the amended determination when supplying pharmaceutical benefits to ensure they qualify for the Commonwealth payments. These conditions include the appropriate listing and form of the drugs supplied. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role by providing recommendations to the Minister based on evidence and expert opinions, ensuring that the changes to the pharmaceutical benefits list are substantiated. The Minister, in turn, determines the conditions based on these recommendations and the statutory authority provided by paragraph 98C(1)(b) of the National Health Act 1953. Breaches of the conditions specified in this determination can lead to significant consequences. The Act does not explicitly outline specific offences or penalties for non-compliance with the payment conditions. However, general principles of administrative law and the Acts Interpretation Act 1901 could be invoked in cases of non-compliance, potentially leading to revocation or variation of the determination. The Pharmaceutical Benefits Advisory Committee’s role in ensuring evidence-based recommendations helps maintain the integrity of the scheme and minimises the risk of non-compliance by ensuring that only eligible drugs are listed for subsidy. In cases where the conditions are not met, the Commonwealth may withhold payments, and there could be administrative or legal repercussions for the non-compliant parties.

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