National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 7)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01060 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2021 (No. 7)

PB 77 of 2021

 

Purpose

The purpose of this legislative instrument, made under subsection 89A(3) of the National Health Act 1953 (the Act), is to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to make changes to the pharmaceutical benefits eligible to be provided as a Continued Dispensing supply.

The National Health (Continued Dispensing – Emergency Measures) Determination 2020 (the Principal Instrument) expands the list of pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the Act without a prescription, and provides the conditions for such a supply (a ‘Continued Dispensing’ supply).

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.

Authority

Subsection 89A(3) of the National Health Act 1953 (the Act) provides that the Minister may determine the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the Act without a prescription, and the conditions for such a supply (‘Continued Dispensing’).

This instrument does not override state and territory poisons laws. States and territories have been informed of the intended Commonwealth changes and asked to consider amendments that may be required to their law to allow access to the eligible medicines.

Amendments made by this Instrument

Schedule 1 to this instrument provides for the addition of the listed drugs alirocumab, and fremanezumab, and for the addition of forms of the listed drugs adrenaline (epinephrine), and paraffin.  It also provides for the deletion of a form of the listed drug exenatide from the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply.  These changes are summarised, by subject matter, in the Attachment.

Consultation

This instrument affects approved pharmacists, at or from premises in respect of which the pharmacist is for the time being approved, supplying a pharmaceutical benefit. Consultation was undertaken prior to commencement of the Principal Instrument with relevant peak bodies including the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia. The Department has also undertaken direct consultation with Services Australia and has consulted with state and territory Departments of Health about implementation.

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 August 2021.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF National Health (Continued Dispensing – Emergency Measures) AMENDMENT Determination 2021 (No. 7)

1 Name

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 7) and may also be cited as PB 77 of 2021.

2 Commencement

This section provides that the instrument commences on 1 August 2021.

3 Authority

This section states that this instrument is made under subsection 89A(3) of the National Health Act 1953.

4  Amendments to the National Health (Continued Dispensing – Emergency Measures) Determination 2020

The amendments in Schedule 1 involve the addition of listed drugs, and the addition and deletion of forms of listed drugs, for the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes are summarised below. 

SUMMARY OF CHANGES TO THE CONTINUED DISPENSING – EMERGENCY MEASURE MADE BY THIS INSTRUMENT

Listed Drugs Added

Listed Drug

Alirocumab

Fremanezumab

Forms Added

Listed Drug

Form

Adrenaline (epinephrine)

Solution for injection 1 mg (as tartrate) in 1 mL (1 in 1,000)

Paraffin

Eye drops containing liquid paraffin, glycerol, tyloxapol, poloxamer-188, trometamol hydrochloride, trometamol, cetalkonium chloride, 10 mL (preservative free)

Forms Deleted

Listed Drug

Form

Exenatide

Injection (modified release) 2 mg single dose pre-filled pen


Statement of Compatibility with Human Rights

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

National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 7)

(PB 77 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 (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 7) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 which specifies the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, and the conditions for such a supply (‘Continued Dispensing’).

The amendments in Schedule 1 involve the addition of listed drugs, and the addition and deletion of forms of listed drugs, for the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply.

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 Pharmaceutical Benefits Scheme (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 (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 7) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to update the list of pharmaceutical benefits that can be supplied by an approved pharmacist without a prescription under the National Health Act 1953. This legislative instrument is made under subsection 89A(3) of the Act and reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on 1 August 2021. The purpose of these amendments is to align the Continued Dispensing provisions with the most recent updates to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme. States and territories have been informed and encouraged to consider any necessary changes to their laws to facilitate access to these eligible medicines. This amendment was developed with consultation from relevant peak bodies and state and territory health departments. The changes include the addition of drugs such as alirocumab and fremanezumab, along with certain forms of adrenaline (epinephrine) and paraffin, and the removal of a specific form of exenatide from the list of pharmaceutical benefits eligible for Continued Dispensing. The 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 continued access to necessary medications, particularly in emergency situations.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 7) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020, modifying the list of pharmaceutical benefits that can be supplied by an approved pharmacist without a prescription under Part VII of the National Health Act 1953. This legislative instrument applies to approved pharmacists who supply pharmaceutical benefits at or from approved premises. It operates nationally and does not override state and territory poisons laws. The amendments in Schedule 1 involve adding listed drugs alirocumab and fremanezumab, and forms of listed drugs adrenaline (epinephrine) and paraffin, while also removing a form of exenatide from the list of eligible Continued Dispensing supplies. The instrument is compatible with human rights, specifically advancing Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by enhancing access to medicines and ensuring the highest attainable standard of health through the Pharmaceutical Benefits Scheme (PBS). The determination was made under subsection 89A(3) of the National Health Act 1953 and commenced on 1 August 2021.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 7) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 (sections 3 and 4). The amendment involves the addition of new listed drugs and the addition and deletion of forms of listed drugs to the list of pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, known as 'Continued Dispensing' (section 4). The amendments in Schedule 1 provide for the addition of the listed drugs alirocumab, fremanezumab, and for the addition of forms of the listed drugs adrenaline (epinephrine) and paraffin. It also provides for the deletion of a form of the listed drug exenatide from the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply. The determination imposes obligations on approved pharmacists, requiring them to adhere to the updated list of pharmaceutical benefits that can be supplied without a prescription. The changes in the list mean that pharmacists can now dispense certain drugs and drug forms that were previously unavailable under Continued Dispensing measures. Additionally, pharmacists must ensure that they comply with the conditions for such supplies as outlined in the Determination. Failure to comply with the provisions of the Determination could result in legal consequences. Although the Act does not specify particular offences, penalties, or civil/criminal consequences for breach, non-compliance with regulations related to pharmaceutical supplies can lead to regulatory action by the Therapeutic Goods Administration (TGA). This may include fines, suspension or revocation of approval to supply pharmaceutical benefits, or other administrative penalties as deemed appropriate by the TGA. The exact penalties for non-compliance are not stated in the Act but are determined on a case-by-case basis according to the severity and nature of the breach.

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