National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022

Administered by Department of Health, Disability and Ageing

Legislation au F2022L01030 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022

PB 73 of 2022

Authority

Subsection 89A(3) of the National Health Act 1953 (the Act) provides that the Minister may, by legislative instrument, determine the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription, and the conditions that must be satisfied when making a supply of those pharmaceutical benefits.

Purpose

The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to implement the Therapeutic Goods Administration (TGA) decision to revoke pharmacist substitution of some benefits.

The Principal Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a TGA Serious Scarcity Substitution Instrument (SSSI). The Principal Determination incorporated the TGA arrangements to permit pharmacist substitution of abatacept injection 125 mg in 1 mL single dose autoinjector and single dose pre-filled pen in brands Orencia and Orencia ClickJect, consistent with the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Amendment Instrument 2022.

 

The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Amendment Instrument 2022 was in force until 30 June 2022. Approved pharmacists are no longer permitted to supply the nominated substitute pharmaceutical benefits in place of the prescribed pharmaceutical benefits without a prescription.

 

Patients will continue to be able to access abatacept injection 125 mg in 1 mL single dose autoinjector and single dose pre-filled pen at PBS subsidised prices but will be required to have the correct pharmaceutical benefits written on their prescriptions.

 

The Principal Determination will be re‑made or revoked, as appropriate, each time the Therapeutic Goods Administration (TGA) issues or rescinds a SSSI in respect of a PBS listed drug.

The Amendment Determination commences on 1 August 2022.

The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.

A provision-by-provision description of the Amendment Determination is contained in the Attachment.

 

 

 

 

 

ATTACHMENT A

Details of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022

Section 1 Name

This section provides that the name of the Amendment Determination is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022.

This section also provides that the instrument may be cited as PB 73 of 2022.

Section 2 Commencement

This section provides that the Amendment Determination commences on 1 August 2022.

Section 3 Authority

This section provides that the Amendment Determination is made under subsection 89A(3) of the National Health Act 1953.

Section 4  Schedules

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

Schedule 1 - Amendments

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021

Item 1 – Subsection 5(8)

This item repeals two items from the table at subsection 5(8) of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021:

Item

Column 1
Prescribed pharmaceutical benefit

 

Column 2

Substitute pharmaceutical benefit

6

Listed drug: Abatacept

Listed drug: Abatacept

 

Form: Injection 125 mg in 1 mL single dose autoinjector

Form: Injection 125 mg in 1 mL single dose pre‑filled syringe

 

Manner of administration: Injection

Manner of administration: Injection

 

Brand: Orencia ClickJect

Brand: Orencia

7

Listed drug: Abatacept

Listed drug: Abatacept

 

Form: Injection 125 mg in 1 mL single dose pre‑filled syringe

Form: Injection 125 mg in 1 mL single dose autoinjector

 

Manner of administration: Injection

Manner of administration: Injection

 

Brand: Orencia

Brand: Orencia ClickJect


Statement of Compatibility with Human Rights

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

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022

This Disallowable 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 Disallowable Legislative Instrument

The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to revoke pharmacist substitution of specified pharmaceutical benefits as they are no longer subject to Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instruments (SSSIs). This is being done following the resolution of shortages of abatacept injection 125 mg in 1 mL single dose autoinjector and single dose pre-filled pen in the brands Orencia and Orencia ClickJect.

 

Human rights implications

 

The Amendment Determination engages Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Amendment Determination assists in 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 Amendment Determination does not impact equitable access to medicines as abatacept injection 125 mg in 1 mL single dose autoinjector and single dose pre-filled pen in the brands Orencia and Orencia ClickJect continue to be available at PBS subsidised prices for patients with prescriptions written for these pharmaceutical benefits.

 

Conclusion

The Amendment Determination is compatible with human rights, as it promotes the protection of human rights.

 

 

Nikolai Tsyganov

Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

Overview

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022 was enacted to address the need for flexibility in the supply of pharmaceutical benefits during shortages, particularly concerning abatacept injection. This legislative instrument amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021, revoking the substitution of certain pharmaceutical benefits by pharmacists without a prescription, following the resolution of the shortage of abatacept injection in specified forms. The determination is made under subsection 89A(3) of the National Health Act 1953, empowering the Minister to regulate the supply of pharmaceutical benefits under specific conditions. The policy objective of this amendment is to ensure that while the Therapeutic Goods Administration (TGA) has resolved the shortage, patients can still access necessary medications at subsidised prices, albeit with a requirement for correct prescriptions. This amendment reflects the dynamic nature of pharmaceutical availability and the importance of maintaining access to critical medications, while ensuring that the substitution of medicines is done under controlled and monitored conditions. The revocation of the substitution rights for abatacept injection highlights the government's commitment to adapting to changes in pharmaceutical availability and ensuring that public health measures are both effective and responsive to current needs.

Scope and Application

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022 is a legislative instrument made under the National Health Act 1953. It amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 to revoke the substitution of specified pharmaceutical benefits by approved pharmacists. This Amendment Determination applies to approved pharmacists and pharmaceutical benefits in the context of shortages resolved by the Therapeutic Goods Administration (TGA). The Amendment Determination specifically addresses the revocation of pharmacist substitution for abatacept injection 125 mg in 1 mL single dose autoinjector and single dose pre-filled pen in the brands Orencia and Orencia ClickJect, aligning with the TGA's decision to revoke certain Serious Scarcity Substitution Instruments (SSSIs). The Amendment Determination commenced on 1 August 2022 and is subject to potential revocation or re-making in line with future TGA decisions regarding SSSIs. The instrument does not contain any exclusions or exemptions and is compatible with human rights, promoting the right to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2022 (Amendment Determination) primarily serves to modify the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) by revoking the substitution of certain pharmaceutical benefits by pharmacists without a prescription. This change is due to the resolution of shortages related to abatacept injection 125 mg in 1 mL single dose autoinjector and single dose pre-filled pen in the brands Orencia and Orencia ClickJect. Under the Principal Determination, pharmacists were allowed to supply substitute pharmaceutical benefits when the prescribed medicine was subject to a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI). However, with the revocation of the SSSI for abatacept, approved pharmacists can no longer supply these substitute benefits without a prescription. The Amendment Determination imposes specific obligations on pharmacists and patients. Pharmacists must ensure that they do not supply the specified substitute pharmaceutical benefits (abatacept injection 125 mg in 1 mL single dose autoinjector and single dose pre-filled pen in the brands Orencia and Orencia ClickJect) without a prescription. Patients, on the other hand, must have their prescriptions written correctly, specifying the exact pharmaceutical benefits they require. This ensures that patients continue to access abatacept at PBS subsidised prices but with the necessary prescription details. Breaches of the provisions outlined in the Amendment Determination could lead to various consequences. While the determination does not explicitly outline specific offences, penalties, or consequences for non-compliance, the overarching National Health Act 1953 provides a framework for handling such breaches. Pharmacists found to be in violation of the Act's provisions may face penalties, which can include fines or other sanctions as determined by the relevant authorities. These penalties are intended to enforce compliance and uphold the integrity of the pharmaceutical supply and prescription processes. The Amendment Determination is designed to be compatible with human rights, particularly Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), which pertains to the right to the highest attainable standard of physical and mental health. By ensuring that abatacept remains available at subsidised prices with the correct prescription, the Amendment Determination supports equitable access to necessary medications, thereby promoting the protection of human rights. The revocation of the SSSI does not negatively impact the availability or accessibility of the specified pharmaceutical benefits, thereby maintaining the balance between regulatory compliance and patient access to essential medicines.

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