National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 4) (No. PB 29 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L00401 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. 4)

PB 29 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. 4), commencing on 1 May 2014.  Schedule 4 of the Principal Determination is amended by the removal of: timolol in the form eye drops 2.5 mg (as maleate) per mL, 5 mL; and carbomer with triglyceride lipids in the form eye gel 2 mg-10 mg per g, 10 g. 

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 May 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. 4)
(PB 29 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 removes one listed drug and one form of a listed drug from Schedule 4 of the Principal Instrument.

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, as amended by the National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 4), addresses the need to update the conditions under which pharmaceutical benefits are paid by the Commonwealth to approved pharmacists and medical practitioners. This amendment was introduced to ensure the Pharmaceutical Benefits Scheme (PBS) remains effective and aligned with the most current medical and economic evidence. The amendment, which was enacted by the Parliament of Australia, is designed to reflect changes made to the listing of pharmaceutical benefits, thereby ensuring that the scheme continues to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. The policy objective of the Act is to progressively realise the right to the highest attainable standard of physical and mental health by providing affordable access to necessary medications.

Scope and Application

The National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 4) pertains to the conditions governing payments made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners under the National Health Act 1953. This determination is an amendment to the Principal Determination (PB 119 of 2008) and is made pursuant to the authority provided by paragraph 98C(1)(b) of the Act. It applies to all approved pharmacists and approved medical practitioners involved in the supply of pharmaceutical benefits, thereby affecting entities and individuals within the healthcare industry. The geographic reach of this amendment is national, as it applies across Australia under the Commonwealth's legislative framework. The amendment removes two pharmaceutical products, timolol in the form of eye drops and carbomer with triglyceride lipids in the form of eye gel, from Schedule 4 of the Principal Determination, reflecting changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 4), effective from 1 May 2014. The Act allows for further variation or revocation of the Principal Determination through subordinate instruments, although specific provisions for this are not detailed in the explanatory statement.

Key Provisions

The main operative sections of the National Health Determination under paragraph 98C(1)(b) Amendment 2014 (No. 4) (PB 29 of 2014) are those that amend the Principal Determination (PB 119 of 2008), specifically by removing timolol in the form of eye drops 2.5 mg (as maleate) per mL, 5 mL, and carbomer with triglyceride lipids in the form of eye gel 2 mg-10 mg per g, 10 g, from Schedule 4. This amendment reflects the changes made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 4), which commenced on 1 May 2014. The removal of these specific pharmaceutical products from the list of items eligible for Commonwealth payments under the Pharmaceutical Benefits Scheme (PBS) is a significant alteration to the conditions previously set out in the Principal Determination. The Act imposes obligations and requirements on approved pharmacists and approved medical practitioners to supply pharmaceutical benefits in accordance with the conditions set out in the determination. These conditions include the provision of specific pharmaceutical benefits as listed in the Schedule to the Determination. By amending the Principal Determination, the Act also updates the list of pharmaceutical benefits that can be supplied under the PBS. Approved pharmacists and approved medical practitioners must ensure that the pharmaceutical benefits they supply are listed in the current Schedule and comply with all conditions specified therein. Additionally, the Department of Health is required to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) to consider applications for inclusion or exclusion of pharmaceutical benefits on the PBS. This ensures that decisions about the pharmaceutical benefits provided under the PBS are evidence-based and consider various stakeholder inputs. Breach of the conditions set out in the determination can result in civil and criminal consequences. Approved pharmacists and approved medical practitioners who supply pharmaceutical benefits not listed in the Schedule or who do not comply with the conditions specified in the determination may face penalties. Under section 114 of the National Health Act 1953, an approved pharmacist or approved medical practitioner who makes a false statement or representation in relation to a pharmaceutical benefit supplied under the PBS can be fined up to $22,200 for an individual or $111,000 for a body corporate. Furthermore, supplying a pharmaceutical benefit not listed in the Schedule or supplying it contrary to the conditions set out in the determination may result in the Commonwealth not making any payment for that pharmaceutical benefit, thereby affecting the financial viability of the supply process. These penalties underscore the importance of compliance with the conditions outlined in the determination.

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