National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 1) (PB 15 of 2021)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00154 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (COMMONWEALTH PRICE AND CONDITIONS FOR COMMONWEALTH PAYMENTS FOR SUPPLY OF PHARMACEUTICAL BENEFITS) AMENDMENT DETERMINATION 2021 (No. 1)

PB 15 of 2021

 

Purpose

The purpose of this legislative instrument, made under section 98C(1) of the National Health Act 1953 (the Act), is to amend the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (the Principal Determination) to make changes to the pharmaceutical benefits and ingredients in relation to which particular rules apply for ascertaining the Commonwealth price payable to an approved medical practitioner or an approved pharmacist for supply, and to make changes to the list of pharmaceutical benefits that must be supplied in complete packs.

The National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 sets out the manner in which the Commonwealth price for the supply of pharmaceutical benefits by approved medical practitioners will be ascertained, and the conditions subject to which payments will be made to approved pharmacists and approved medical practitioners for the supply of pharmaceutical benefits (including listing the pharmaceutical benefits to which certain conditions apply).

Authority

Paragraph 98C(1)(a) of the Act provides that the Minister may, from time to time, determine the manner in which the Commonwealth price for all or any pharmaceutical benefits is to be ascertained for the purpose of payments to approved medical practitioners for the supply of pharmaceutical benefits.

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.

Variation and revocation

Unless there is an express power to revoke or vary the Principal Determination cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary the Principal Determination.

Changes to the Principal Determination made by this Instrument

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Schedule 1 to this Instrument provides for the addition of the drug ozanimod and a form of the listed drug desmopressin to the list of pharmaceutical benefits to be supplied as complete packs only (Schedule 4 to the Principal Determination).  These changes are summarised, by subject matter, in the Attachment.

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)(a) of the Act provides that the Minister may, from time to time, determine the manner in which the Commonwealth price for all or any pharmaceutical benefits is to be calculated for the purpose of payments to approved medical practitioners for the supply 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.

Consultations

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.  The PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.  The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015.  When recommending the listing of a medicine on the PBS, PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings.  This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, guarantee of supply and agreement to final listing details.

It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.

This Instrument commences on 1 March 2021.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (COMMONWEALTH PRICE AND CONDITIONS FOR COMMONWEALTH PAYMENTS FOR SUPPLY OF PHARMACEUTICAL BENEFITS) AMENDMENT DETERMINATION 2021 (No. 1)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 1) and may also be cited as PB 15 of 2021.

Section 2 Commencement

This section provides that the Instrument commences on 1 March 2021.

Section 3 Amendment of National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019

This section provides that Schedule 1 amends the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019.

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition of a drug and form of a listed drug to the list of Pharmaceutical Benefits to be supplied as complete packs only.  These changes are summarised below.

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (COMMONWEALTH PRICE AND CONDITIONS FOR COMMONWEALTH PAYMENTS FOR SUPPLY OF PHARMACEUTICAL BENEFITS) DETERMINATION 2019 MADE BY THIS INSTRUMENT

Drugs Added - Pharmaceutical Benefits to be Supplied as Complete Packs Only

Listed Drug

Ozanimod

Forms Added - Pharmaceutical Benefits to be Supplied as Complete Packs Only

Listed Drug

Form

Desmopressin

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL


Statement of Compatibility with Human Rights

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

National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 1)

(PB 15 of 2021)

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 National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 1) amends the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 which sets out the manner in which the Commonwealth price for the supply of pharmaceutical benefits by approved medical practitioners will be ascertained and the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners (including listing the pharmaceutical benefits to which certain conditions apply).

The amendments in Schedule 1 involve the addition of a drug and form of a listed drug to the list of Pharmaceutical Benefits to be supplied as complete packs only.

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.

 

 

 

 

Thea Connolly

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 1) was enacted to amend the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019. This amendment was made under the authority of the National Health Act 1953, specifically sections 98C(1)(a) and 98C(1)(b), which allow the Minister to determine the Commonwealth price for pharmaceutical benefits and the conditions for payments to approved medical practitioners and pharmacists, respectively. The determination addresses the need to update the list of pharmaceutical benefits, particularly in relation to drugs that must be supplied as complete packs, thereby ensuring that the Pharmaceutical Benefits Scheme remains aligned with current medical practices and regulatory requirements. The policy objective of this amendment is to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the Pharmaceutical Benefits Scheme continues to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. By including the drug ozanimod and a form of desmopressin in the list of pharmaceutical benefits that must be supplied as complete packs, the amendment maintains the integrity and effectiveness of the scheme in delivering essential medications under controlled conditions. The determination commenced on 1 March 2021, ensuring that the updated provisions were implemented without delay.

Scope and Application

The National Health (Commonw­ealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 1) amends the National Health (Commonw­ealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019. This amendment applies to the ascertainment of the Commonwealth price for the supply of pharmaceutical benefits by approved medical practitioners and the conditions under which payments are made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. These changes include adding a drug and a form of a listed drug to the list of Pharmaceutical Benefits to be supplied as complete packs only. The Act applies to the Commonwealth, and the changes made by this Instrument will affect pharmaceutical companies and healthcare professionals who supply pharmaceutical benefits in Australia. There are no specific exclusions or thresholds mentioned in the text, but the changes reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes made by this Instrument are effective from 1 March 2021. The application of the Act may be extended or restricted through subordinate instruments as necessary.

Key Provisions

The National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 1) (the Determination) amends the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (the Principal Determination) (sections 2 and 3). This is done to update the rules for determining the Commonwealth price for the supply of pharmaceutical benefits and to modify the list of pharmaceutical benefits that must be supplied in complete packs. Specifically, the Determination adds the drug ozanimod and a form of the listed drug desmopressin (desmopressin nasal spray) to the list of pharmaceutical benefits that must be supplied as complete packs only (Schedule 1). The Determination imposes obligations on parties involved in the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). Approved medical practitioners and pharmacists must comply with the new rules for ascertaining the Commonwealth price for the supply of the specified drugs and must supply the listed drugs in complete packs. Pharmaceutical companies are required to ensure their products comply with these conditions to be eligible for PBS listing and reimbursement. Breach of the provisions in the Determination may result in civil or criminal penalties, although the specific consequences are not detailed in the Explanatory Statement. The PBS is overseen by the Department of Health, which enforces compliance with the scheme's rules. Non-compliance can lead to financial penalties, exclusion from the PBS, or other regulatory actions as deemed appropriate by the Minister under the National Health Act 1953. The Determination is designed to enhance the administration and integrity of the PBS by ensuring that certain drugs are supplied under the correct conditions, which may include ensuring patient safety and controlling costs. By adding specific drugs to the list of benefits that must be supplied in complete packs, the Determination aims to mitigate risks associated with incomplete supplies and ensure that patients receive their medications in a controlled and regulated manner. The changes are aligned with the broader objectives of the PBS to provide affordable and timely access to essential medicines for all Australians.

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