National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No.3) (PB 36 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00522 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. 3)

PB 36 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 brigatinib and upadacitinib and the addition of a form of the listed drug sapropterin. Additionally, it also provides for the deletion of a form of the listed drugs folinic acid and nystatin from 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 May 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. 3)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 3) and may also be cited as PB 36 of 2020.

 

2 Commencement

This section provides that the instrument commences on 1 May 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 two drugs, the addition of a form of a listed drug, and the deletion of a form (each) of two listed drugs from 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

Brigatinib

Upadacitinib

Forms Added

Listed Drug

Form

Sapropterin

Powder for oral solution 500 mg (as dihydrochloride)

Forms Deleted

Listed Drug

Form

Folinic acid

Injection containing calcium folinate equivalent to 1000 mg folinic acid in 100 mL

Nystatin

Cream 100,000 units per g, 15 g


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. 3)

(PB 36 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. 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 of two drugs, the addition of a form of a listed drug, and the deletion of a form (each) of two listed drugs 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 Daniel

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. 3) is an amendment to the National Health (Continued Dispensing – Emergency Measures) Determination 2020, enacted to address the challenges posed by the COVID-19 pandemic in managing the demand on the health system. This determination was made under the authority of subsection 89A(3) of the National Health Act 1953, allowing the Minister to specify the pharmaceutical benefits that can be supplied without a prescription by an approved pharmacist, known as 'Continued Dispensing'. The primary policy objective of this amendment is to expand the list of pharmaceutical benefits eligible for Continued Dispensing to assist in ensuring continued access to essential medications during the pandemic. The amendments include the addition of specific drugs and forms to the list, as well as the removal of certain forms, reflecting updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument is intended to be temporary, aligning with the emergency measures put in place to respond to the pandemic.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 3) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to adjust 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, and the conditions for such a supply, referred to as ‘Continued Dispensing’. This adjustment is aimed at facilitating continued access to Pharmaceutical Benefits Scheme (PBS) subsidised medicines to manage the demand on the health system during the COVID-19 outbreak. The amendments involve adding two new drugs, a form of a listed drug, and removing specific forms of two listed drugs from the list of pharmaceutical benefits eligible for Continued Dispensing supply. This legislative instrument applies to approved pharmacists supplying pharmaceutical benefits, at or from premises in respect of which the pharmacist is approved, and is intended to operate alongside state and territory poisons laws. No end date is specified, though it is intended to be temporary. States and territories have been informed of the changes and 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. 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 (section 4). This amendment, made under subsection 89A(3) of the Act, modifies the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. Specifically, the amendment adds brigatinib and upadacitinib to the list of eligible drugs, includes a form of sapropterin (powder for oral solution 500 mg (as dihydrochloride)), and removes a form of folinic acid (injection containing calcium folinate equivalent to 1000 mg folinic acid in 100 mL) and a form of nystatin (cream 100,000 units per g, 15 g) from the list (Schedule 1). This change is intended to provide continued access to essential medicines during the COVID-19 outbreak. The amendments impose specific obligations on approved pharmacists who are permitted to supply these pharmaceutical benefits without a prescription. They must adhere to the conditions outlined in the Act and the Determination, ensuring that the supply of these medications is safe and appropriate. The pharmacists must ensure that the patients they supply these medications to meet the eligibility criteria and that the medications are used in accordance with the specified conditions. The approved pharmacists are also required to maintain records of the supply of these medications in line with the regulatory requirements. The Determination does not specify any new offences or penalties for breach of its provisions. However, any breach of the conditions for Continued Dispensing may result in penalties under the National Health Act 1953. The Act provides for various civil and criminal penalties for breaches, including fines and imprisonment, depending on the nature and severity of the breach. The penalties for contravening the Act can be severe, reflecting the importance of ensuring safe and appropriate supply of pharmaceutical benefits. This legislative instrument is compatible with human rights as it advances the protection of human rights by ensuring continued access to essential medicines during the COVID-19 outbreak, thereby assisting in the realisation of the right to the highest attainable standard of physical and mental health as recognised by the International Covenant on Economic, Social and Cultural Rights. The Pharmaceutical Benefits Scheme (PBS) ensures that access to these medicines is evidence-based and subsidised, further supporting the protection of human rights.

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