National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No.4) (PB 44 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00643 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. 4)

PB 44 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 amino acid formula with carbohydrate without phenylalanine, amino acid formula with fat, carbohydrate without methionine, amino acid formula with fat, carbohydrate without phenylalanine and tyrosine, and amino acid formula with fat, carbohydrate without valine, leucine and isoleucine and the addition of a form of the listed drug ferric derisomaltose to the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. It also provides for the deletion of a form of the listed drugs levodopa with carbidopa and protein formula with carbohydrate, fat, vitamins and minerals from the list. 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 June 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. 4)

 

1 Name

 

This section provides that the instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 4) and may also be cited as PB 44 of 2020.

 

2 Commencement

This section provides that the instrument commences on 1 June 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 four 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

Amino acid formula with carbohydrate without phenylalanine

Amino acid formula with fat, carbohydrate without methionine

Amino acid formula with fat, carbohydrate without phenylalanine and tyrosine

Amino acid formula with fat, carbohydrate without valine, leucine and isoleucine

Forms Added

Listed Drug

Form

Ferric derisomaltose

Injection 1000 mg (iron) in 10 mL

Forms Deleted

Listed Drug

Form

Levodopa with carbidopa

Tablet (modified release) 200 mg‑50 mg

Protein formula with carbohydrate, fat, vitamins and minerals

Oral liquid 500 mL, 8 (Nutrini Peptisorb Energy)


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. 4)

(PB 44 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. 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 four 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. 4) was enacted to address the challenges posed by the COVID-19 pandemic on the supply of pharmaceutical benefits. This amendment to the National Health Act 1953 is aimed at temporarily expanding the list of pharmaceutical benefits that can be supplied by approved pharmacists without a prescription, to alleviate demand on the health system during the pandemic. Made under subsection 89A(3) of the Act, the purpose of this instrument is to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, thus updating the list of drugs that can be supplied as a Continued Dispensing supply. The determination includes the addition of certain drugs and the deletion of others, facilitating continued access to essential medications for patients during the emergency. This legislative instrument was developed through consultation with relevant peak bodies such as the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia, as well as direct consultation with Services Australia and state and territory Departments of Health. It was determined that further consultation was unnecessary due to the comprehensive nature of previous consultations. The instrument is compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health, as stipulated in the International Covenant on Economic, Social and Cultural Rights. The amendments took effect on 1 June 2020, and no end date is specified, indicating the temporary nature of these emergency measures.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 4) amends 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. This amendment is made under subsection 89A(3) of the National Health Act 1953 and is intended to assist in managing the demand on the health system during the COVID-19 outbreak by providing a continued option for consumers to obtain Pharmaceutical Benefits Scheme (PBS) subsidised access to their medicines. The changes involve adding four new drugs and a form of an existing drug to the list of pharmaceutical benefits that can be supplied without a prescription, while also deleting a form of two existing drugs from this list. This instrument is intended to be temporary and does not override state and territory poisons laws. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which are also scheduled to commence on 1 June 2020. The instrument affects approved pharmacists supplying a pharmaceutical benefit from approved premises.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 4) 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 (a ‘Continued Dispensing’ supply) (section 4). This legislative instrument specifies the addition of four types of amino acid formulas and a form of ferric derisomaltose to the list of Continued Dispensing supplies, and the deletion of a form each of levodopa with carbidopa and protein formula with carbohydrate, fat, vitamins and minerals from the list (Schedule 1). The purpose of these amendments is to respond to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also amend the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply (Explanatory Statement). The amendments made by this instrument impose obligations on approved pharmacists, who must comply with the updated list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. The amended list in the National Health (Continued Dispensing – Emergency Measures) Determination 2020 specifies the types of medicines that can be supplied without a prescription, and the conditions that must be met for such a supply. Approved pharmacists must ensure that they are familiar with the updated list and that they are supplying the correct medications in accordance with the conditions specified in the Act (section 4). The amendments also impose an obligation on the Minister for Health to ensure that the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply is kept up to date and reflects changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (section 3). The National Health Act 1953 does not specify any offences, penalties, or civil or criminal consequences for breach of the provisions in the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 4). However, approved pharmacists who supply pharmaceutical benefits that are not listed in the Determination, or who supply listed pharmaceutical benefits in a manner that does not comply with the conditions specified in the Act, may be subject to disciplinary action by the relevant professional body, or may be liable to criminal prosecution for offences under state and territory poisons laws (Explanatory Statement). The maximum penalties for such offences will depend on the relevant state or territory law.

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