National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 10)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01489 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2021 (No. 10)

PB 112 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 budesonide with glycopyrronium and formoterol, daratumumab, and darolutamide, and the deletion of forms of the listed drugs calcipotriol with betamethasone, and pindolol, for 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 November 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. 10)

Section 1 Name

This section provides that the Instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 10) and may also be cited as PB 112 of 2021.

Section 2 Commencement

This section provides that the Instrument commences on 1 November 2021.

Section 3 Authority

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

Section 4 Schedules

Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition of listed drugs, and the 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

Budesonide with glycopyrronium and formoterol

Daratumumab

Darolutamide

Forms Deleted

Listed Drug

Form

Calcipotriol with betamethasone

Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g

Pindolol

Tablet 5 mg (as hydrochloride) (USP)

 


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. 10)

(PB 112 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. 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 listed drugs, and the 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. 10) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to alter the list of pharmaceutical benefits that can be provided by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, known as 'Continued Dispensing'. This legislative instrument was introduced to address the need for flexibility in pharmaceutical access during emergency situations, such as the COVID-19 pandemic. Enacted under subsection 89A(3) of the National Health Act 1953, the policy objective of this amendment is to ensure that patients have continued access to essential medications, facilitating the timely and appropriate management of health conditions while reducing the burden on the healthcare system. This determination reflects updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and it aims to streamline the process by which certain drugs can be dispensed without a prescription, thereby enhancing the efficiency and responsiveness of the healthcare system. The amendments include the addition of specific drugs such as budesonide with glycopyrronium and formoterol, daratumumab, and darolutamide, while also removing certain forms of other drugs like calcipotriol with betamethasone and pindolol from the Continued Dispensing list. The changes are designed to align with current therapeutic needs and regulatory updates.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 10) 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 Part VII of the National Health Act 1953. This instrument applies to approved pharmacists supplying pharmaceutical benefits, and its amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on the same day. The changes include the addition of certain listed drugs, such as budesonide with glycopyrronium and formoterol, daratumumab, and darolutamide, and the deletion of forms of listed drugs like calcipotriol with betamethasone and pindolol from the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply. This instrument is made under subsection 89A(3) of the National Health Act 1953, and it does not override state and territory poisons laws. States and territories have been informed of the intended changes and have been asked to consider any necessary amendments to their laws to allow access to the eligible medicines. This determination is a legislative instrument for the purposes of the Legislation Act 2003 and commences on 1 November 2021. It is compatible with human rights as it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation 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 that assists with the advancement of this human right by providing for subsidised access by patients to medicines, ensuring that decisions about subsidised access to medicines on the PBS are evidence-based through the Pharmaceutical Benefits Advisory Committee (PBAC).

Key Provisions

The main operative sections of this legislative instrument (F2021L01489) are sections 1 through 4, which outline the name, commencement, authority, and schedules of the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 10). Specifically, Section 1 provides the official title of the instrument and an alternative citation, Section 2 specifies the commencement date, Section 3 refers to the authority under which the instrument is made, and Section 4 details the amendments to the National Health (Continued Dispensing – Emergency Measures) Determination 2020. The Act imposes obligations on approved pharmacists to adhere to the conditions for the supply of pharmaceutical benefits without a prescription, as amended by this instrument. These conditions include ensuring the supply of specified drugs, such as budesonide with glycopyrronium and formoterol, daratumumab, and darolutamide, and avoiding the supply of certain forms of drugs like calcipotriol with betamethasone and pindolol. The Act also requires that these supplies are conducted in compliance with state and territory poisons laws, which are not overridden by this instrument. Failure to comply with the conditions set out in the Act may result in civil or criminal consequences. While the Act itself does not specify the penalties for breaches, penalties for contraventions of the National Health Act 1953 or the regulations made under the Act can include fines and imprisonment. For example, under Section 228 of the Act, a person who contravenes certain provisions may be liable to a fine of up to $22,200 for an individual or $111,000 for a body corporate, as well as potential imprisonment terms. This instrument is designed to ensure that approved pharmacists can supply certain pharmaceutical benefits without a prescription under specified conditions, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments aim to expand the list of drugs available for Continued Dispensing during emergency measures while ensuring alignment with state and territory laws.

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