National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 6)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00898 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

National Health Act 1953

NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2021 (No. 6)

PB 63 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 infliximab, and for the deletion of the listed drug interferon alfa‑2a.  It also provides for the addition of forms of the listed drugs guselkumab, hydromorphone, imipramine, pancreatic extract, progesterone, and tofacitinib, and for the deletion of forms of the listed drug captopril 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 July 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. 6)

1 Name

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 6) and may also be cited as PB 63 of 2021.

2 Commencement

This section provides that the instrument commences on 1 July 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 and deletion of listed drugs, and the addition and 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

Infliximab

Listed Drug Deleted

Listed Drug

Interferon alfa‑2a

Forms Added

Listed Drug

Form

Guselkumab

Injection 100 mg in 1 mL single use pre-filled pen

Hydromorphone

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL

Imipramine

Tablet containing imipramine hydrochloride 10 mg USP

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 35,000 BP units of lipase activity

Progesterone

Capsule 200 mg

Tofacitinib

Tablet 10 mg

Forms Deleted

Listed Drug

Form

Captopril

Tablet 25 mg

 

Tablet 50 mg

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. 6)

(PB 63 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. 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 and deletion of listed drugs, and the addition and 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. 6) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 under subsection 89A(3) of the National Health Act 1953. The purpose of this legislative instrument is to update the list of pharmaceutical benefits that can be supplied by an approved pharmacist without a prescription, reflecting recent changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment ensures that the list of medications available for continued dispensing during emergency situations remains current and comprehensive. The changes, effective from 1 July 2021, include the addition of new drugs such as infliximab and various forms of other drugs, as well as the removal of certain drugs and forms from the list. This amendment aims to facilitate easier access to necessary medications during emergencies, while ensuring compliance with state and territory poisons laws. The enacting authority for this determination lies with the Minister for Health, who has the power to modify the list of pharmaceutical benefits under the National Health Act 1953. The policy objective is to enhance the availability of essential medications during emergencies by allowing approved pharmacists to dispense them without the need for a prescription, thereby supporting the progressive realisation of the right to the highest attainable standard of physical and mental health, as outlined in the International Covenant on Economic, Social and Cultural Rights. The Department of Health has consulted with relevant stakeholders, including the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia, to ensure the changes are practical and effective.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 6) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 under the National Health Act 1953, specifying the pharmaceutical benefits that can be supplied by an approved pharmacist without a prescription, a provision termed 'Continued Dispensing'. This amendment applies to approved pharmacists supplying pharmaceutical benefits from premises where they are approved. It does not override state and territory poisons laws, although states and territories have been asked to consider necessary amendments to their laws to facilitate access to the eligible medicines. The changes reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on the same day as this instrument. The amendments involve adding and deleting listed drugs and forms of listed drugs for the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. The instrument is compatible with human rights as it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation of the right of everyone to the highest attainable standard of physical and mental health through the Pharmaceutical Benefits Scheme (PBS). This instrument commences on 1 July 2021.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 6) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020, which governs the supply of pharmaceutical benefits by approved pharmacists without a prescription under Part VII of the National Health Act 1953 (the Act) (sections 1, 2, and 4). The amendment, effective from 1 July 2021, modifies the list of pharmaceutical benefits eligible for continued dispensing during emergencies by adding and removing certain drugs and forms of drugs (section 4). Specifically, the listed drug infliximab is added, and interferon alfa-2a is removed. Additionally, forms of certain listed drugs, such as guselkumab injection, hydromorphone oral solution, imipramine tablets, pancreatic extract capsules, progesterone capsules, and tofacitinib tablets, are added, while specific forms of captopril tablets are removed (Schedule 1). Under the amended determination, approved pharmacists are required to comply with the updated list of pharmaceutical benefits that can be supplied without a prescription during emergencies. This involves ensuring that the medications they dispense fall within the newly defined scope of continued dispensing, which is crucial for maintaining compliance with the Act and ensuring patient access to necessary medications during emergencies (section 4). Furthermore, these pharmacists must be aware of the specific forms of drugs that are now eligible or ineligible for continued dispensing, as outlined in Schedule 1, to avoid any inadvertent breaches of the Act. Failure to comply with the amended provisions could result in legal consequences, although specific offences, penalties, or civil/criminal consequences are not explicitly detailed in the explanatory statement. However, it is implied that any non-compliance with the provisions of the Act could lead to enforcement actions by the relevant authorities. This could include potential penalties under the National Health Act 1953, which typically involve fines or other administrative sanctions for breaches of the Act's provisions. It is also important to note that state and territory poisons laws are not overridden by this instrument, and jurisdictions have been asked to consider necessary amendments to their laws to align with the Commonwealth changes (section 3).

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