National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 4)

Administered by Department of Health, Disability and Ageing

Legislation au F2023L01583 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 122 OF 2023

 

NATIONAL HEALTH ACT 1953

National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 4)

Purpose

 

The purpose of this legislative instrument, made under section 84AH of the National Health Act 1953 (the Act), is to amend the legislative instrument titled National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84AH) Determination 2017 (PB 81 of 2017) to make changes to the pharmaceutical items that are determined to be exempt items.

 

Background

 

Part VII of 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.

 

Drugs and medicinal preparations to which Part VII applies are declared as such by the Minister, by legislative instrument under subsection 85(2) of the Act. These are listed drugs (as defined in subsection 84(1)). The Minister may also determine by legislative instrument the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)) and the manner of administration of the form of the listed drug so determined (subsection 85(5)). If a drug has a declaration under subsection 85(2) in force in respect of it and determinations under subsections 85(3) and 85(5) in force in respect of it, then that declared drug in that determined form with that determined manner of administration is a pharmaceutical item. The Minister may also determine, by legislative instrument, brands of pharmaceutical items (subsection 85(6)).

 

Section 84AH empowers the Minister to determine, by legislative instrument, that a pharmaceutical item is an ‘exempt item’ if the pharmaceutical item satisfies the criteria in section 84AH. The criteria in section 84AH are as follows:

(a)   that there is only one listed brand of the relevant pharmaceutical item; and

(b)   there are no listed brands of other pharmaceutical items that are bioequivalent or biosimilar to the one listed brand of the relevant pharmaceutical item; and

(c)   there is at least one other pharmaceutical item that has the same listed drug as the relevant pharmaceutical item; and

(d)   the Minister is satisfied (having regard to advice, if any, from the Pharmaceutical Benefits Advisory Committee that:

  1. the listed drug in the relevant pharmaceutical item represents suitable therapy for a particular patient population; and
  2. the relevant pharmaceutical item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration; and
  3. no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item.

 

The effect of a pharmaceutical item being determined to be an exempt item is that the listed brand of that pharmaceutical item is excluded from certain statutory price reductions and price disclosure requirements under Divisions 3A and 3B of Part VII of the Act. The intention is to encourage the availability of certain pharmaceutical items with particular formulations of drugs that are used by a demographic subgroup (e.g. children or geriatric patients) for whom other formulations of the drug are not suitable.

 

Changes to PB 81 of 2017 made by this instrument

 

This instrument makes the following changes to PB 81 of 2017:

 

One pharmaceutical item (listed drug = Ranitidine, form = Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL, manner of administration = Oral) is no longer determined to be an exempt item because it is delisting from the PBS as requested by the responsible person.  In addition, one new pharmaceutical item (listed drug = Tofacitinib, form = Oral solution 1 mg per mL, 240 mL, manner of administration = Oral) is determined to be an exempt item as advised by PBAC under Section 101 (4AB) of the National Health Act.

 

Variation and revocation

Unless there is an express power to revoke or vary PB 81 of 2017 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 81 of 2017.

 

Consultation

Consultation on the Amending Determination has taken place with the relevant pharmaceutical company regarding the removal of exempt status on the specified form of ranitidine.  Advice from the Pharmaceutical Benefits Advisory Committee (PBAC) was requested regarding the delisting of the specified form of ranitidine. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The PBAC considered that the deletion of ranitidine syrup would not result in an unmet clinical need. No additional consultations with experts was undertaken regarding this determination because consultation with the affected company drew on the knowledge of persons with relevant expertise.

General

This instrument commences on 1 December 2023.

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


Statement of Compatibility with Human Rights

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

 

National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 4) (PB 122 of 2023)

 

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

This National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Determination 2017 (the Principal Determination) determines exempt pharmaceutical items. This instrument (the Amending Determination) amends the principal determination which provides for the allocation of drugs to the exempt list if the pharmaceutical item satisfies the criteria in section 84AH of the National Health Act 1953 (the Act).

This instrument amends the principal determination by removing the specified form of the drug ranitidine from the exempt list because it is delisting from the Pharmaceutical Benefits Scheme (PBS) as requested by the responsible person.  In addition, this instrument also adds a specified form of the drug tofacitinib to the exempt list as recommended by PBAC.

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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 providing subsidised access to medicines for people. This is a positive and supportive step towards attaining the highest standard of health for all Australians. Determining exempt items under section 84AH of the Act encourages the availability of certain pharmaceutical items with particular formulations of drugs that are used by a demographic subgroup (e.g. children or geriatric patients) for whom other formulations of the drug are not suitable. The recommendatory role of the Pharmaceutical Benefits Advisory Committee ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

This legislative instrument is compatible with human rights. Human rights continue to be protected by retaining on the PBS clinically important medicines and maintaining exemptions from pricing reductions only where appropriate under the legislation.

 

 

Nikolai Tsyganov

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division
Department of Health and Aged Care

Overview

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 4) was enacted to amend the National Health (Pharmaceutical Benefits Scheme-Exempt items – Section 84AH) Determination 2017 (PB 81 of 2017) under the authority of section 84AH of the National Health Act 1953. This legislative instrument aims to modify the list of pharmaceutical items that are exempt from certain statutory price reductions and disclosure requirements under the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) provided recommendations, particularly regarding the suitability of certain drugs for specific patient populations based on their form and manner of administration. The changes made by this instrument include the removal of a specified form of ranitidine from the exempt list due to its delisting from the PBS and the addition of a specified form of tofacitinib to the exempt list based on PBAC's advice. The purpose of this determination is to ensure that the PBS continues to provide reliable, timely, and affordable access to essential medicines while accommodating the specific needs of certain patient groups, such as children or geriatric patients, for whom other formulations of certain drugs may not be suitable. This amendment reflects the intent to support the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. The involvement of the PBAC ensures that decisions regarding access to medicines on the PBS are evidence-based and appropriate for the targeted patient subgroups.

Scope and Application

The National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 4) amends the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Determination 2017 to adjust the pharmaceutical items that are classified as exempt items under the Pharmaceutical Benefits Scheme (PBS) as outlined in Part VII of the National Health Act 1953. This Act applies to pharmaceutical items listed under the PBS, administered by the Commonwealth of Australia. Specifically, this instrument removes the specified form of the drug ranitidine from the exempt list due to its delisting from the PBS as requested by the responsible person, while adding a specified form of the drug tofacitinib to the exempt list as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The criteria for an item to be considered an exempt item are outlined in section 84AH of the Act, which includes conditions such as the uniqueness of the drug brand, the absence of bioequivalent or biosimilar listed brands, and the suitability of the drug for a particular patient subgroup. This legislative instrument ensures that the PBS continues to provide reliable and affordable access to a wide range of medicines, with certain formulations exempted from certain price reductions and disclosure requirements if they are deemed suitable for specific patient demographics. The amendment does not extend the application of the PBS beyond its current jurisdictional scope within the Commonwealth of Australia, nor does it introduce new exclusions or exemptions outside of the criteria already established in section 84AH of the Act. The instrument relies on the existing provisions under the Acts Interpretation Act 1901 for any necessary revocation or variation of the principal determination. This legislative instrument is compatible with human rights, as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring the availability of certain pharmaceutical items that are suitable for specific patient subgroups. The determination process is evidence-based, with the recommendatory role of PBAC ensuring that decisions on the PBS are informed and justified.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination 2023 (No. 4) (PB 122 of 2023) involve amending the Pharmaceutical Benefits Scheme-Exempt items determination. This instrument, made under section 84AH of the National Health Act 1953, modifies the Pharmaceutical Benefits Scheme-Exempt items – Section 84AH Determination 2017 (PB 81 of 2017) to adjust the pharmaceutical items that are exempt from certain statutory price reductions and price disclosure requirements. Specifically, this determination removes the specified form of ranitidine from the exempt list and adds a specified form of tofacitinib to the exempt list (section 2). The Act imposes several obligations and requirements on the parties it governs. The Minister is responsible for determining the pharmaceutical items that qualify as exempt items based on specific criteria, such as the uniqueness of the brand, the absence of bioequivalent or biosimilar brands, and the suitability of the drug for a particular patient population (section 84AH). The Pharmaceutical Benefits Advisory Committee provides advice to the Minister, ensuring that decisions are evidence-based and consider the clinical needs of patients (subsection 101(4AB)). Additionally, pharmaceutical companies must comply with the determinations made by the Minister regarding the listing and exempt status of their products (subsection 85(2)). There are no specific offences, penalties, or civil/criminal consequences outlined in the instrument for breaches of the Act or its determinations. However, the Act generally provides for enforcement mechanisms, including fines and other penalties, for non-compliance with the provisions of the National Health Act 1953 and related legislative instruments. The penalties for breaches can vary depending on the nature and severity of the offence, with maximum fines and imprisonment terms stipulated in the Act for serious violations. This legislative instrument ensures that the Pharmaceutical Benefits Scheme continues to provide affordable access to essential medicines while maintaining exemptions for specific pharmaceutical items that meet the criteria outlined in section 84AH. By removing ranitidine from the exempt list and adding tofacitinib, the instrument responds to changes in the market and clinical needs, ensuring that the scheme remains effective and responsive to patient requirements. The determination process, involving consultation with the Pharmaceutical Benefits Advisory Committee and relevant stakeholders, ensures that decisions are well-informed and in the best interest of public health.

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