National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No.6) (PB 70 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00977 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. 6)

PB 70 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). This will provide a continued option for consumers to obtain Pharmaceutical Benefits Scheme (PBS) subsidised access to their medicines to assist in managing the demand on the health system during the COVID-19 outbreak. No end date is specified in the instrument, however it is intended to be temporary.

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 entrectinib, lorlatinib and stiripentol and for the addition of forms of the listed drugs metformin and salbutamol to the list of pharmaceutical benefits that can 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 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. 6)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 6) and may also be cited as PB 70 of 2020.

 

2 Commencement

This section provides that the instrument commences on 1 August 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 three drugs and the addition of a form (each) of two listed drugs to the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes are summarised below.

 

Schedule 1 – Pharmaceutical Benefits

Listed Drugs Added

Listed Drug

Entrectinib

Lorlatinib

Stiripentol

Forms Added

Listed Drug

Form

Metformin

Tablet (prolonged release) containing metformin hydrochloride 500 mg

Salbutamol

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)


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. 6)

(PB 70 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. 6) 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 three drugs and the addition of a form (each) of two listed drugs to 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 2020 (No. 6) is an instrument made under the National Health Act 1953, aimed at amending the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to include additional pharmaceutical benefits that can be supplied by approved pharmacists without a prescription during the COVID-19 emergency. This legislation responds to the urgent need to alleviate pressure on the health system by enabling easier access to certain medications. The amendments were introduced to align with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which updated the list of eligible drugs. This measure ensures that consumers can continue to obtain PBS-subsidised access to necessary medications with less reliance on prescriptions, thereby supporting the health system's capacity to manage the outbreak. The enactment of this amendment by the Minister under subsection 89A(3) of the National Health Act 1953 seeks to temporarily enhance the flexibility of the Pharmaceutical Benefits Scheme (PBS) by broadening the scope of medications that can be supplied as a Continued Dispensing supply. This legislative adjustment is designed to be temporary, reflecting the emergency context of the COVID-19 pandemic, and does not override state and territory poisons laws. The policy objective is to facilitate access to essential medications, thereby supporting public health efforts during the crisis.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 6) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020, which allows approved pharmacists to supply certain pharmaceutical benefits without a prescription under Part VII of the National Health Act 1953. This amendment aims to facilitate continued access to essential medicines during the COVID-19 pandemic by expanding the list of pharmaceutical benefits eligible for Continued Dispensing. The amendment specifies the addition of three new drugs and particular forms of two other listed drugs, thereby broadening the scope of medications that can be provided under these emergency measures. This legislative instrument applies to approved pharmacists supplying pharmaceutical benefits at or from approved premises and is intended to be temporary, reflecting the urgent need to manage the health system's demand during the ongoing public health crisis. While the instrument does not override state and territory poisons laws, states and territories have been asked to consider necessary amendments to their laws to facilitate access to the eligible medicines.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 6) 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. Specifically, section 1 of Schedule 1 adds three drugs – entrectinib, lorlatinib and stiripentol – and the forms of two listed drugs – metformin and salbutamol – 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. This aims to provide continued access to PBS-subsidised medicines to assist in managing the demand on the health system during the COVID-19 outbreak. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commenced on the same day. The Act imposes obligations on approved pharmacists to ensure they comply with the conditions for supplying the listed drugs as a Continued Dispensing supply. Pharmacists must be aware of the updated list of eligible drugs and forms, and supply the drugs only in accordance with the specified conditions to maintain the integrity and safety of the supply process. The changes are intended to provide flexibility in the supply of medicines during the emergency period, while ensuring that consumers have continued access to necessary medications. Breaching the conditions set out in the Determination can result in civil or criminal penalties. While the specific penalties are not detailed in the explanatory statement, the Act provides for significant penalties for non-compliance with the conditions for supplying pharmaceutical benefits. These penalties can include fines and imprisonment, reflecting the seriousness of ensuring the safe and effective supply of medicines during the emergency period. The exact penalties would depend on the nature and extent of the breach, as well as any relevant state or territory laws.

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