National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 10) (PB 114 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01495 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2020 (No. 10)

PB 114 of 2020

 

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 deletion of a form of the listed drug posaconazole from the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply.  It also provides for the addition of the listed drugs beclometasone with formoterol and protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A and for the addition of a form of the listed drugs norethisterone with ethinylestradiol, paracetamol and rivaroxaban to that list.  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 December 2020.

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 2020 (No. 10)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 10) and may also be cited as PB 114 of 2020.

 

2 Commencement

This section provides that the instrument commences on 1 December 2020.

 

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 drugs and the addition and deletion of forms of listed drugs to and from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes are summarised below. 

 

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) DETERMINATION 2020 MADE BY THIS INSTRUMENT

Listed Drugs Added

Listed Drug

Beclometasone with formoterol

Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A

Forms Added

Listed Drug

Form

Norethisterone with ethinylestradiol

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP

Paracetamol

Suppository 500 mg

Rivaroxaban

Tablet 2.5 mg

Forms Deleted

Listed Drug

Form

Posaconazole

Oral suspension 40 mg per mL, 105 mL


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 2020 (No. 10)

(PB 114 of 2020)

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 2020 (No. 10) 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 drugs and the addition and deletion of forms of listed drugs to and from 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.

 

 

 

 

Thea Connolly

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 10) is an amendment to the National Health (Continued Dispensing – Emergency Measures) Determination 2020, which was enacted to address the need for flexibility in the supply of pharmaceutical benefits during the COVID-19 pandemic. This amendment was made under subsection 89A(3) of the National Health Act 1953 by the Minister for Health and seeks to align the list of pharmaceutical benefits that can be supplied by approved pharmacists under Part VII of the Act without a prescription with changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislative instrument does not override state and territory poisons laws and states and territories have been informed of the changes and asked to consider amendments to their laws if necessary. The amendments, detailed in Schedule 1, involve the addition of specific drugs and forms of listed drugs to the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on the same day. The instrument underwent consultation with relevant peak bodies and state and territory Departments of Health, and it was deemed that further consultation was unnecessary due to the comprehensive nature of prior consultations. This instrument is compatible with human rights as it aids in the progressive realisation of the right to the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 10) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to update the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. This applies to approved pharmacists who can supply these medicines without a prescription under Part VII of the National Health Act 1953. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument does not override state and territory poisons laws, and states and territories have been asked to consider necessary amendments to their laws. The amendments involve adding certain drugs and forms of listed drugs to the Continued Dispensing list, and removing a form of one listed drug from the list. This instrument is made under subsection 89A(3) of the National Health Act 1953 and commences on 1 December 2020. It is compatible with human rights by assisting with the realisation of the right to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 10) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to modify 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 (sections 2 and 4). Specifically, Schedule 1 to the Amendment Determination removes posaconazole oral suspension from the list of eligible drugs and adds beclometasone with formoterol, a protein formula with vitamins and minerals low in potassium, phosphorus, calcium, chloride and vitamin A, and forms of norethisterone with ethinylestradiol, paracetamol, and rivaroxaban to the list (section 4). This instrument is intended to align with amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency across the relevant legislative frameworks. The Act imposes specific obligations on approved pharmacists who supply pharmaceutical benefits as a Continued Dispensing supply. These obligations include adhering to the updated list of eligible drugs and forms as specified in the amended Determination (section 89A). Pharmacists must ensure they comply with the conditions for such a supply, which include maintaining records of the supply and adhering to any additional requirements specified by the Minister (section 89B). These obligations are intended to facilitate the timely and appropriate supply of essential medications during emergency situations. Breach of the provisions in the National Health Act 1953, including those amended by the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 10), can result in both civil and criminal consequences. Civil penalties can include fines, with the exact amount determined by the court based on the severity and nature of the breach. Criminal penalties can include imprisonment, with the maximum penalty varying depending on the specific offence. For instance, supplying a pharmaceutical benefit without proper authorisation can result in a penalty of up to two years imprisonment, while more severe breaches may attract higher penalties as outlined in the relevant sections of the Act. These measures are in place to ensure compliance with the legislative requirements and to protect public health and safety.

Legal classification tags

Area of Law
Health Law
Instrument
Statutory Instrument
Concepts
Commencement Provisions
Licensing & Registration
Reporting & Disclosure Obligations
Regulatory Standards
Catchwords
Continued Dispensing
Pharmaceutical Benefits

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.