National Health Act 1953 - Amendment determination under paragraph 98C(1)(b) (No. PB 59 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01578 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 59 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. 10), commencing on 1 September 2013, by adding the listed drug tafluprost in the form eye drops 15 micrograms per mL, single dose units 0.3 mL, 30. 

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 September 2013.

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 59 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 listed drug to Schedule 4 of the Determination.

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.

 

Adriana Platona

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health and Ageing

Overview

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 59 of 2013) was enacted to adjust the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and medical practitioners. This amendment is necessary to incorporate the changes introduced by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 10), effective from 1 September 2013. The determination is made by the Minister under the authority of the National Health Act 1953, which governs the Pharmaceutical Benefits Scheme (PBS), a vital mechanism for ensuring Australians have affordable access to a wide range of medicines. The policy objective is to enhance the accessibility of essential medications by updating the list of pharmaceutical benefits to include new drugs, in this case, tafluprost in the form of eye drops, thereby improving patient care and aligning the PBS with current medical needs.

Scope and Application

The Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 amends 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 determination specifically modifies Schedule 4 of the Principal Determination to include the drug tafluprost in the form of eye drops 15 micrograms per mL, single dose units 0.3 mL, 30. This change is effective from 1 September 2013 and is intended to reflect the updates made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 10). The determination applies to approved pharmacists and approved medical practitioners who are involved in the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). The PBS is a Commonwealth initiative designed to provide Australians with affordable access to a wide range of medicines. The Amendment Determination ensures that the conditions for Commonwealth payments for these benefits are updated to include the newly listed drug, thereby extending the scope of the PBS to cover this specific pharmaceutical product.

Key Provisions

The main sections of this Amendment Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 59 of 2013) are focused on altering the conditions under which payments are made by the Commonwealth for pharmaceutical benefits supplied by approved pharmacists and approved medical practitioners. Specifically, the Amendment Determination modifies Schedule 4 of the Principal Determination (PB 119 of 2008) to incorporate the new drug tafluprost in the form of eye drops (15 micrograms per mL, single dose units 0.3 mL, 30). This change reflects the updates made by the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 10) that commenced on 1 September 2013. The amendment is intended to ensure that the conditions for Commonwealth payments align with the most recent updates to the Pharmaceutical Benefits Scheme (PBS). The Amendment Determination imposes specific obligations on parties involved in the PBS. Approved pharmacists and approved medical practitioners must adhere to the updated conditions for payments to ensure they are reimbursed appropriately for their services. This includes complying with the new listing for tafluprost, ensuring that the correct dosage and form are supplied to patients. The Department of Health and Ageing is responsible for implementing these changes and ensuring that all relevant stakeholders are informed about the updates. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role by providing recommendations to the Minister, ensuring that the decisions regarding pharmaceutical benefits are evidence-based and align with public health needs. The Amendment Determination does not explicitly state specific offences, penalties, or civil/criminal consequences for breaches of its provisions. However, non-compliance with the conditions set out in the Principal Determination could lead to legal repercussions under the National Health Act 1953 and other relevant legislation. For instance, failure to adhere to the updated conditions for pharmaceutical benefits could result in the Commonwealth not making the appropriate payments to approved pharmacists and approved medical practitioners. While the Amendment Determination itself does not introduce new penalties, any breach of the conditions under the National Health Act 1953 could lead to enforcement actions, including fines or other sanctions as stipulated in the Act. The penalties for non-compliance would depend on the specific provisions of the National Health Act 1953 and any other applicable laws.

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