National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 2) (PB 16 of 2021)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00164 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2021 (No. 2)

PB 16 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 duplilumab, indacaterol with mometasone, and ozanimod and the deletion of the listed drugs amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid, cefalotin, cimetidine, grazoprevir with elbasvir, metformin with glibenclamide, and sucralfate to and from the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply. It also provides for the addition of forms of the listed drugs amino acid formula with vitamins and minerals without methionine, amino acid formula with vitamins and minerals without phenylalanine and tyrosine, amino acid formula with vitamins and minerals without valine, leucine and isoleucine, and desmopressin and the deletion of forms of the listed drugs captopril, erythromycin, tamoxifen, and verapamil.  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 March 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.2)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 2) and may also be cited as PB 16 of 2021.

 

2 Commencement

This section provides that the instrument commences on 1 March 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 and deletion 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

 

Dupilumab

 

Indacaterol with mometasone

 

Ozanimod

 

Listed Drugs Deleted

Listed Drug

 

Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid

 

Cefalotin

 

Cimetidine

 

Grazoprevir with elbasvir

 

Metformin with glibenclamide

 

Sucralfate

 

 


Listed Forms Added

Listed Drug

Form

Amino acid formula with vitamins and minerals without methionine

Sachets containing oral powder 29 g, 30 (HCU Lophlex)

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

Sachets containing oral powder 28 g, 30 (TYR Lophlex)

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

Sachets containing oral powder 28 g, 30 (MSUD Lophlex)

Desmopressin

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL

Listed Forms Deleted

Listed Drug

Form

Captopril

Tablet 12.5 mg

Erythromycin

Tablet 400 mg (as ethyl succinate)

Tamoxifen

Tablet 10 mg (as citrate)

Verapamil

Tablet containing verapamil hydrochloride 40 mg


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. 2)

(PB 16 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. 2) 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 and deletion 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 2021 (No. 2) is a legislative instrument made under subsection 89A(3) of the National Health Act 1953. This Act, enacted in 1953, addresses the need for streamlined access to certain pharmaceutical benefits during emergencies by allowing approved pharmacists to supply these medications without a prescription under specific conditions. This amendment was introduced to further refine the list of pharmaceutical benefits eligible for Continued Dispensing during emergency measures, reflecting recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments involve adding and deleting specific drugs and their forms from the list, thereby expanding or restricting access to certain medications. This legislative instrument aims to ensure the Pharmaceutical Benefits Scheme continues to support the highest attainable standard of health for Australians, particularly in emergency contexts. This determination was enacted by the Australian Government and commenced on 1 March 2021. It does not override state and territory poisons laws, although states and territories have been informed and encouraged to consider necessary amendments to their laws to facilitate access to eligible medicines. The changes made by this instrument were preceded by consultations with relevant stakeholders, including peak bodies such as the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia, and state and territory Departments of Health.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 2) amends 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. This amendment applies to approved pharmacists who supply pharmaceutical benefits under Part VII of the National Health Act 1953. The determination specifies the conditions under which certain drugs can be supplied without a prescription, reflecting amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This instrument does not override state and territory poisons laws but encourages these jurisdictions to amend their laws accordingly to allow access to eligible medicines. The amendments involve the addition and deletion of specific drugs and their forms from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. The changes take effect from 1 March 2021 and are made under the authority of subsection 89A(3) of the National Health Act 1953.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 2) ((F2021L00164)) 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 (the Act) without a prescription, and the conditions for such a supply (a ‘Continued Dispensing’ supply) ((s 4)). This Amendment Determination modifies the list of pharmaceutical benefits eligible for Continued Dispensing by adding and removing certain drugs and forms of drugs ((Schedule 1)). The Amendment Determination imposes obligations on approved pharmacists to comply with the updated list of pharmaceutical benefits eligible for Continued Dispensing. Pharmacists must ensure that they are supplying only those drugs and forms of drugs that are now included in the list, and must not supply any drugs or forms of drugs that have been removed from the list ((s 4)). These obligations are intended to ensure that patients continue to have access to necessary medications while also maintaining safety and quality standards in the supply of these medications. There are no explicit offences or penalties specified in the Amendment Determination for breaches of the Continued Dispensing provisions. However, any breach of the requirements to supply eligible pharmaceutical benefits without a prescription could potentially lead to regulatory action under the National Health Act 1953 or other relevant legislation. Such action could include fines, suspension or revocation of approval, or other administrative penalties. The exact penalties would depend on the nature and severity of the breach, as well as any relevant state or territory laws. In summary, the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 2) updates the list of pharmaceutical benefits that can be supplied by pharmacists without a prescription in emergency situations. Approved pharmacists must comply with the updated list, and any breaches could potentially lead to regulatory action under the National Health Act or other relevant laws. The Amendment Determination is intended to help ensure that patients continue to have access to necessary medications during public health emergencies, while also maintaining safety and quality standards.

Legal classification tags

Area of Law
Health Law
Instrument
Statutory Instrument
Concepts
Definitions & Interpretation
Commencement Provisions
Regulatory Standards
Compliance Obligations

Interactions

Authorises

All Versions

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.