National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 8)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01350 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. 8)

PB 99 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.

The amendments made by this Instrument include the addition of the listed drug ciclosporin and the deletion of the listed drug nedocromil for 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.

General

A provision-by-provision description of this Instrument is contained in the Attachment.

This Instrument commences on 1 October 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. 8)

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. 8) and may also be cited as PB 99 of 2021.

Section 2 Commencement

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

Section 3 Authority

This section states that this Instrument is made under paragraph 98C(1) of the National Health Act 1953.

Section 4 Schedules

Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition and deletion of listed drugs for 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

Listed Drug Added - Pharmaceutical benefits to be supplied as complete packs only

Listed Drug

Ciclosporin

Listed Drug Deleted - Pharmaceutical benefits to be supplied as complete packs only

Listed Drug

Nedocromil

 

 

 

 

 

 

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. 8)

(PB 99 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. 8) 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 and deletion of listed drugs for 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.

 

 

 

 

Nikolai Tsyganov

Assistant Secretary (Acting)

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. 8) was enacted to amend the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019, thereby updating the pharmaceutical benefits and the ingredients in relation to which particular rules apply for ascertaining the Commonwealth price payable to approved medical practitioners or pharmacists for supply, as well as changing the list of pharmaceutical benefits that must be supplied in complete packs. This amendment was introduced to align with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and it is made under section 98C(1) of the National Health Act 1953. The purpose of these amendments is to ensure that the pharmaceutical benefits scheme remains effective and responsive to the needs of the Australian population, providing reliable, timely, and affordable access to medicines. The instrument is subject to consultation with relevant parties, including the Pharmaceutical Benefits Advisory Committee, and commences on 1 October 2021.

Scope and Application

The National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 8) amends the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019. This amendment is made under section 98C of the National Health Act 1953 and applies to the ascertainment of the Commonwealth price for the supply of pharmaceutical benefits by approved medical practitioners and the conditions subject to which payments will be made to approved pharmacists and approved medical practitioners for the supply of pharmaceutical benefits. The amendment applies across Australia, as the National Health Act is a Commonwealth Act. It includes specific changes to the list of pharmaceutical benefits that must be supplied in complete packs, adding the drug ciclosporin and removing the drug nedocromil from the list. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and is effective from 1 October 2021.

Key Provisions

The National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Amendment Determination 2021 (No. 8) amends the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019 (the Principal Determination) (section 4). The changes primarily involve modifications to the list of pharmaceutical benefits that must be supplied as complete packs (Schedule 4 to the Principal Determination). Specifically, the listed drug ciclosporin has been added to the list, while the listed drug nedocromil has been removed (Schedule 1). The purpose of these changes is to update the list of pharmaceutical benefits subject to specific conditions for ascertaining the Commonwealth price payable to approved medical practitioners or approved pharmacists for the supply of these benefits. The Act imposes certain obligations and requirements on the parties and entities it governs. Approved medical practitioners and approved pharmacists must adhere to the conditions specified in the Principal Determination for receiving payments from the Commonwealth for the supply of pharmaceutical benefits. This includes complying with the rules and procedures for ascertaining the Commonwealth price and ensuring that pharmaceutical benefits are supplied in accordance with the requirements set out in the Determination. Additionally, pharmaceutical companies are required to engage in consultations with the Pharmaceutical Benefits Advisory Committee (PBAC) and other relevant stakeholders throughout the process of listing their medicines on the Pharmaceutical Benefits Scheme (PBS) and any subsequent changes to those listings. Failure to comply with the provisions of the Principal Determination and the amendments made by the Amendment Determination may result in civil or criminal consequences. However, the Amendment Determination itself does not specify any offences, penalties, or maximum penalties for breaches. The consequences of non-compliance would depend on the specific provisions of the Principal Determination and other applicable legislation. It is important for approved medical practitioners, approved pharmacists, and pharmaceutical companies to ensure that they are aware of and adhere to the conditions and requirements set out in the Principal Determination and the Amendment Determination to avoid any potential penalties or consequences. The Amendment Determination is made under section 98C(1) of the National Health Act 1953 (the Act) (section 3). This authority allows the Minister to determine the manner in which the Commonwealth price for pharmaceutical benefits is to be ascertained and the conditions subject to which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. The changes made by the Amendment Determination reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which are made under sections 84AF, 84AK, 85, 85A, 88, and 101 of the Act. The Amendment Determination also engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The PBS, which is the legislative basis of the Pharmaceutical Benefits Scheme, assists with the 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.

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