National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 4)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00527 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2021 (No. 4)

PB 41 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 drug cannabidiol.  It also provides for the addition of forms of the listed drugs aciclovir and mesalazine, and the deletion of forms of the listed drugs aciclovir and norethisterone with ethinylestradiol.  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 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. 4)

 

1 Name

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 4) and may also be cited as PB 41 of 2021.

 

2 Commencement

This section provides that the instrument commences on 1 May 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 of a drug 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 Drug Added

Listed Drug

 

Cannabidiol

Forms Added

Listed Drug

Form

Aciclovir

Eye ointment 30 mg per g, 4.5 g

Mesalazine

Tablet 1.6 g (enteric coated)

Forms Deleted

Listed Drug

Form

Aciclovir

Eye ointment 30 mg per g, 4.5 g (Acivision)

Norethisterone with ethinylestradiol

Pack containing 21 tablets 1 mg‑35 micrograms and 7 inert tablets 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. 4)

(PB 41 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. 4) 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 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. 4) (PB 41 of 2021) was enacted to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020. This amendment responds to the evolving needs of the community during emergency situations, particularly by expanding 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. The determination was enacted by the Minister for Health under the authority provided by subsection 89A(3) of the National Health Act 1953. The primary policy objective of this amendment is to ensure continued access to essential medications during emergencies, thereby supporting the health and wellbeing of Australians. The instrument is effective from 1 May 2021, and it builds on the changes made by the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislative instrument aligns with the human rights recognised in international instruments by facilitating access to healthcare, thereby contributing to the enjoyment of the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 4) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to modify the list of pharmaceutical benefits eligible for supply under the National Health Act 1953 without a prescription by approved pharmacists. This amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, effective from the same date. The determination applies to approved pharmacists supplying pharmaceutical benefits at or from premises where they are approved. The amendment adds the drug cannabidiol to the list of eligible medicines and modifies the forms of listed drugs aciclovir and mesalazine, as well as deleting specific forms of aciclovir and norethisterone with ethinylestradiol. These changes are effective from 1 May 2021 and do not override state and territory poisons laws, though states and territories have been advised to consider necessary amendments to their laws to align with these changes.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 4) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 (subsection 89A(3) of the National Health Act 1953). The primary changes involve the addition of the drug cannabidiol to the list of pharmaceutical benefits that can be supplied by an approved pharmacist without a prescription, referred to as ‘Continued Dispensing’ (Schedule 1). This determination also modifies the forms of the drugs aciclovir and mesalazine that can be supplied as a Continued Dispensing supply by adding specific forms while removing others. These changes are made to align with amendments in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also took effect on the same day. Approved pharmacists who supply pharmaceutical benefits under Part VII of the Act must adhere to the conditions stipulated in the National Health (Continued Dispensing – Emergency Measures) Determination 2020, as amended by this instrument. This includes the proper identification of eligible drugs and their forms, ensuring that they supply only those listed in the amended Schedule 1. Pharmacists must also ensure compliance with any additional conditions set forth by state and territory poisons laws, which remain unaffected by this federal amendment. Additionally, the Department of Health has engaged in consultations with relevant peak bodies and state/territory health departments to facilitate smooth implementation and ensure pharmacists are well-informed about the changes. Breaches of the conditions for Continued Dispensing supply, as outlined in the amended determination, can result in both civil and criminal consequences. Under the National Health Act 1953, failure to comply with the conditions for dispensing pharmaceutical benefits without a prescription can lead to penalties, including fines and potential criminal charges. The specific penalties for non-compliance are detailed within the Act and may vary depending on the severity and nature of the breach. Additionally, any actions that contravene state and territory poisons laws, while not directly addressed by this federal instrument, could result in separate penalties imposed by the respective state or territory authorities. In summary, the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 4) updates the list of pharmaceutical benefits eligible for Continued Dispensing by an approved pharmacist. This legislative instrument imposes specific obligations on pharmacists to ensure compliance with the amended conditions and highlights the potential civil and criminal penalties for non-compliance. These changes aim to enhance access to essential medications during emergency measures, ensuring that patients can receive necessary treatments with minimal disruption.

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