National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 7) (PB 81 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01070 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2020 (No. 7)

PB 81 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 drug acalabrutinib and for the addition of forms of the listed drugs imipramine and methylphenidate 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 September 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. 7)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 7) and may also be cited as PB 81 of 2020.

 

2 Commencement

This section provides that the instrument commences on 1 September 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 a drug 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

Acalabrutinib

Forms Added

Listed Drug

Form

Imipramine

Tablet containing imipramine hydrochloride 25 mg USP

Methylphenidate

Capsule containing methylphenidate hydrochloride 60 mg (modified release)


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. 7)

(PB 81 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. 7) 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 a drug 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.

 

 

 

 

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. 7) was enacted to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020, which was initially introduced to address the challenges posed by the COVID-19 pandemic. This amendment aims to expand the list of pharmaceutical benefits that can be supplied by approved pharmacists without a prescription, facilitating continued access to essential medications for consumers. This measure is intended to alleviate the strain on the health system during the emergency. The determination is made under the authority of subsection 89A(3) of the National Health Act 1953 and was introduced by the Australian Government through the Department of Health. The policy objective is to ensure that during the COVID-19 outbreak, patients have continued access to their medications in a timely manner, thereby supporting public health efforts. The amendments introduced by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commenced on the same day. These amendments add acalabrutinib, imipramine hydrochloride 25 mg, and methylphenidate hydrochloride 60 mg (modified release) to the list of pharmaceutical benefits eligible for continued dispensing. This legislative instrument is compatible with human rights, specifically advancing the right to the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 7) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to modify the pharmaceutical benefits that can be supplied by an approved pharmacist under the National Health Act 1953 without a prescription, referred to as ‘Continued Dispensing’. This amendment is intended to support the management of demand on the health system during the COVID-19 outbreak by ensuring continued access to certain medications. The determination applies to approved pharmacists operating at or from premises in respect of which they are approved, and the amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This instrument does not override state and territory poisons laws, though states and territories have been requested to consider necessary amendments to their laws to facilitate access to the eligible medicines. The instrument includes the addition of acalabrutinib and specific forms of imipramine and methylphenidate to the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply, effective from 1 September 2020.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 7) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020. It expands the list of pharmaceutical benefits that can be supplied by an approved pharmacist without a prescription, under the National Health Act 1953 (the Act) (section 4). This amendment includes the addition of acalabrutinib and forms of imipramine and methylphenidate to the list of eligible pharmaceutical benefits (Schedule 1). This change allows for a continued option for consumers to obtain PBS-subsidised access to these medicines, assisting in managing the demand on the health system during the COVID-19 outbreak. The Act imposes specific obligations on approved pharmacists to ensure compliance with the requirements for Continued Dispensing. These obligations include adhering to the conditions set out in the National Health (Continued Dispensing – Emergency Measures) Determination 2020 and ensuring that the supply of listed pharmaceutical benefits is done in accordance with the amended determination (sections 4 and 89A(3)). Pharmacists must also be aware of and comply with any relevant state or territory poisons laws, as this instrument does not override those laws (section 3). Breaches of the obligations and requirements under the Act may have civil or criminal consequences, although specific penalties are not detailed in this instrument. In general, penalties for breaches of the Act can include fines and, in some cases, imprisonment. For example, under section 89B of the Act, an approved pharmacist who supplies a pharmaceutical benefit not listed in the National Health (Listing of Pharmaceutical Benefits) Instrument, or who supplies a pharmaceutical benefit in a manner not permitted by the Act, may be subject to a fine of up to $22,200. Additionally, state and territory laws may impose further penalties for non-compliance with local regulations.

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