National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 3)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00398 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. 3)

PB 25 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 fulvestrant, indacaterol with glycopyrronium and mometasone, and romosozumab and the deletion of the listed drug nadroparin. It also provides for the addition of forms of the listed drugs apomorphine and sertraline and the deletion of forms of the listed drugs cefuroxime and paracetamol.  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 April 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.3)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 3) and may also be cited as PB 25 of 2021.

 

2 Commencement

This section provides that the instrument commences on 1 April 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

 

Fulvestrant

 

Indacaterol with glycopyrronium and mometasone

Romosozumab

 

Listed Drugs Deleted

Listed Drug

 

Nadroparin

 

Listed Forms Added

Listed Drug

Form

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL

 

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

 

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe

Sertraline

Tablet 50 mg (as hydrochloride) (USP)

 

Tablet 100 mg (as hydrochloride) (USP)

Listed Forms Deleted

Listed Drug

Form

Cefuroxime

Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL

Paracetamol

Suppositories 500 mg, 24


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. 3)

(PB 25 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. 3) 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. 3) is an amendment made under the authority of subsection 89A(3) of the National Health Act 1953. This legislative instrument seeks to refine the list of pharmaceutical benefits eligible for continued dispensing by approved pharmacists without a prescription in emergency situations, aligning with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendment aims to ensure that the list of drugs available for continued dispensing reflects current therapeutic needs and regulatory updates. Consultations were conducted with relevant peak bodies and state and territory Departments of Health prior to the implementation of this instrument. The amendments involve adding certain drugs and forms of drugs to the list and removing others, thereby enhancing the flexibility and responsiveness of the pharmaceutical supply chain during emergencies. This determination does not override state and territory poisons laws, and states and territories have been asked to consider any necessary amendments to their laws to facilitate access to the eligible medicines.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 3) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020, which pertains to the supply of pharmaceutical benefits without a prescription by approved pharmacists, known as Continued Dispensing. This legislative instrument applies to approved pharmacists supplying pharmaceutical benefits, operating from premises approved for such activities, and is intended to respond to emergency measures in the context of public health. The amendments made by this instrument are designed to align with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These amendments involve the addition and deletion of specific drugs and their forms from the list of pharmaceutical benefits eligible for Continued Dispensing. This instrument operates under the authority of subsection 89A(3) of the National Health Act 1953 and is made to ensure compatibility with human rights, particularly advancing the right to the highest attainable standard of physical and mental health by facilitating access to essential medications. This instrument has a national reach, applying across Australia, and it does not override state and territory poisons laws, although states and territories have been asked to consider necessary amendments to their laws to support the access to eligible medicines. The amendments made by this instrument are effective from 1 April 2021 and include the addition of fulvestrant, indacaterol with glycopyrronium and mometasone, and romosozumab, while removing nadroparin from the list of eligible drugs. Additionally, specific forms of apomorphine and sertraline are added, and certain forms of cefuroxime and paracetamol are removed. The instrument is compatible with human rights as it supports the progressive realisation of the right to health by providing access to necessary medications through the Pharmaceutical Benefits Scheme.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 3) (referred to as the Amendment Determination) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 (the Principal Instrument), which sets out the pharmaceutical benefits eligible for continued dispensing by approved pharmacists without a prescription, under Part VII of the National Health Act 1953. The Amendment Determination (sections 3 and 4) includes changes to the list of pharmaceutical benefits that can be supplied as Continued Dispensing. Specifically, it adds fulvestrant, indacaterol with glycopyrronium and mometasone, and romosozumab to the list, while removing nadroparin. It also modifies the forms of apomorphine and sertraline that can be supplied, and removes certain forms of cefuroxime and paracetamol from the list (Schedule 1). These changes reflect updates made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. Under the Amendment Determination, approved pharmacists are required to adhere to the updated list of pharmaceutical benefits eligible for Continued Dispensing, ensuring they supply only those drugs and forms that are now permitted or no longer permitted under the Principal Instrument as amended. This includes ensuring that any changes in supply are made in accordance with the conditions specified in the Principal Instrument. The Amendment Determination does not override state and territory poisons laws, and states and territories have been informed and encouraged to review their laws to facilitate access to the eligible medicines. There are no direct offences, penalties, or civil/criminal consequences outlined in the Amendment Determination itself. However, any failure to comply with the National Health Act 1953, including the provisions for Continued Dispensing, may lead to enforcement actions under that Act. The National Health Act includes provisions for offences related to the unauthorised supply of pharmaceutical benefits and can impose penalties, including fines and imprisonment, for breaches. For instance, under section 101A of the Act, unauthorised supply of a pharmaceutical benefit can result in fines of up to $22,200 for individuals and $111,000 for bodies corporate, as well as potential imprisonment for up to two years.

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