National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No.5) (PB 58 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00848 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. 5)

PB 58 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 semaglutide and the deletion of the listed drugs idarubicin and prasugrel.  Additionally, it also provides for the deletion of forms of the listed drugs aspirin, diazepam, heparin, levodopa with carbidopa, ondansetron, phenelzine and whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose 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 July 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. 5)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 5) and may also be cited as PB 58 of 2020.

 

2 Commencement

This section provides that the instrument commences on 1 July 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 one drug, the deletion of two listed drugs and the deletion of forms of seven 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

Semaglutide

Listed Drugs Deleted

Listed Drug

Idarubicin

Prasugrel

Forms Deleted

Listed Drug

Form

Aspirin

Tablet, dispersible, 300 mg

Diazepam

Injection 10 mg in 2 mL

Heparin

Injection 35,000 units (as sodium) in 35 mL

Levodopa with carbidopa

Tablet 250 mg‑25 mg (USP)

Ondansetron

I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL


Phenelzine

Tablet 15 mg (as sulfate) (USP)

Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose

Sachets containing oral powder 100 g, 10 (RenaStart)


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. 5)

(PB 58 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. 5) 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 one drug, the deletion of two listed drugs and the deletion of forms of seven 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. 5) was enacted to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020, thereby adjusting the list of pharmaceutical benefits that can be supplied by an approved pharmacist under the National Health Act 1953 without a prescription during the COVID-19 pandemic. This temporary measure, made under subsection 89A(3) of the National Health Act 1953, aims to facilitate continued access to essential medicines by consumers, thereby alleviating pressure on the health system. The determination, which does not override state and territory poisons laws, was developed with consultation from relevant peak bodies and state and territory health departments. This legislative instrument is designed to be compatible with human rights, engaging Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by supporting the progressive realisation of the right to the highest attainable standard of physical and mental health. It ensures that decisions about which medicines are subsidised under the Pharmaceutical Benefits Scheme are evidence-based, thereby advancing the protection of human rights. The changes introduced by this amendment are intended to be temporary and reflect the evolving nature of the COVID-19 pandemic.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 5) 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'). This amendment is made under subsection 89A(3) of the Act and is intended to provide continued access to Pharmaceutical Benefits Scheme (PBS) subsidised medicines to assist in managing the demand on the health system during the COVID-19 outbreak. The changes include the addition of semaglutide and the deletion of idarubicin and prasugrel from the list of pharmaceutical benefits eligible for Continued Dispensing. Additionally, certain forms of aspirin, diazepam, heparin, levodopa with carbidopa, ondansetron, phenelzine, and whey protein formula are also deleted from the list. This instrument does not override state and territory poisons laws, and states and territories have been informed and asked to consider necessary amendments to their laws to allow access to the eligible medicines. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on the same day.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 5) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to modify 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 legislative instrument expands the list of PBS subsidised medicines that can be provided as a Continued Dispensing supply. Specifically, it adds the drug semaglutide and removes idarubicin and prasugrel from the list. Additionally, it removes certain forms of aspirin, diazepam, heparin, levodopa with carbidopa, ondansetron, phenelzine, and whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply (section 4). The Act imposes obligations on approved pharmacists to comply with the conditions set out in the Determination. Approved pharmacists must ensure that the pharmaceutical benefits they supply under the Continued Dispensing provisions are within the updated list and meet the specified conditions. They must also adhere to any additional requirements or guidelines issued by the Minister or relevant authorities. Pharmacists must maintain accurate records of the supplies made and ensure that they comply with all relevant legislation, including state and territory poisons laws. Furthermore, pharmacists are required to consult with patients and ensure that the supply of medicines is in the patient’s best interest. Any breach of the provisions under this Determination may result in civil or criminal penalties. While the specific penalties are not detailed in the instrument, breaches of the National Health Act 1953 can attract significant penalties, including fines and imprisonment, depending on the nature and severity of the offence. The penalties may vary according to the specific provisions of the Act and any other relevant legislation. Pharmacists who fail to comply with the requirements may face disciplinary action from professional regulatory bodies, which can include fines, suspension, or revocation of their registration. These consequences underscore the importance of adherence to the legislative requirements.

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