EXPLANATORY STATEMENT
National Health Act 1953
National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2024
PB 51 of 2024
Authority
Subsection 89A(3) of the National Health Act 1953 (the Act) provides that the Minister may, by legislative instrument, determine the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription, and the conditions that must be satisfied when making a supply of those pharmaceutical benefits.
Purpose
The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2024 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.
The Principal Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).
The pharmaceutical benefits containing abatacept products is anticipated to be in shortage from June 2024. In response, the TGA has issued the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2024, which allows pharmacists to supply Orencia ClickJect when presented with a valid prescription for Orencia and vice versa for the duration of the shortage provided the conditions specified by the TGA are met.
Orencia ClickJect and Orencia are currently PBS subsidised with a Dispensed Price per Maximum Quantity of $946.49 per dispensing. While the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2024 allows for patients to receive a clinically equivalent substitute without needing a new prescription, it does not allow PBS subsidised supply of the substitute. This means that instead of paying their usual PBS co‑payments ($7.70 for concessional patients and $31.60 for general patients), patients may need to pay up to $946.49 for each supply, which could result in such an arrangement being unaffordable and impractical.
The Amendment Determination enables PBS subsidisation of the arrangements that are be specified in the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2024. The Amendment Determination provides that Orencia ClickJect or Orencia may be supplied at the PBS co-payment rate to eligible patients when supplied at the discretion of the pharmacist. This minimises the burden on health care professionals and assist Australians with timely access to medicine supply for patients.
The Principal Determination permits the supply by an approved pharmacist of a specified substitute pharmaceutical benefit in situations where the substitute benefit may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989 and the substitute pharmaceutical benefit is supplied:
- to a person with a PBS prescription for the specified form of abatacept subject to serious shortages;
- where it is not practicable to obtain a prescription from a PBS prescriber for the specified substitute pharmaceutical benefits before the person needs the supply of abatacept;
- by the pharmacist having disclosed information about additional costs to the patient or their agent to that they are able to make an informed decision before proceeding with the substitute supply. This includes the cost to the patient if the substitution is subsidised through the PBS and the cost to the patient if the substitution is a private prescription; and
- the substitute pharmaceutical benefit containing abatacept in the manner of administration oral is eligible for dispensing as a pharmaceutical benefit as outlined in this instrument.
In order for the specified substitute pharmaceutical benefits to be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, among other things, the proposed specific circumstances of substitution are all of the following:
a) the patient is at least 18 years of age;
b) The pharmacist has advised the patient, or the person acting on behalf of the patient:
(i) on the suitable instructions in relation to the administration process of the substitutable medicine; or
(ii) to obtain instructions from the prescriber, or a suitably qualified health practitioner, in relation to the administration process of the substitutable medicine; and
c) The pharmacist has advised the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified.
The Amendment Determination commences on 15 May 2024.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
A provision-by-provision description of the Amendment Determination is contained in the Attachment.
Consultation
In relation to the Amendment Determination, consultation was undertaken with the Chair and relevant expert members of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body that recommends medicines for listing on the PBS. Consultation with PBAC experts focused on specific advice about the appropriateness of PBS subsidisation for the Amendment Determination. The PBAC experts endorsed the proposed approach as it was considered that the substitution arrangement is necessary, with limited other options available for patients during the current shortage needing replacement as quickly as possible.
It is noted the Therapeutic Goods Administration conducted consultation on the appropriateness of the substitutions and consultation on this Amendment Determination was limited to the appropriateness of a PBS subsidy for the substitute medicines. No further consultation was deemed necessary, as consultation with the PBAC Chair drew on the knowledge of relevant experts.
ATTACHMENT
Details of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2024
Section 1 Name
This section provides that the name of the Amendment Determination is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2024.
This section also provides that the Amendment Determination may be cited as PB 51 of 2024.
Section 2 Commencement
This section provides that the Amendment Determination commences on 15 May 2024.
Section 3 Authority
This section provides that the Amendment Determination is made under subsection 89A(3) of the National Health Act 1953.
Section 4 Schedules
This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2024
This Disallowable 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 Disallowable Legislative Instrument
The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2024 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.
The Amendment determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).
The pharmaceutical benefits containing the drug abatacept is currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2024).
The Amendment Determination specifies that abatacept 125 mg in 1 mL single dose autoinjector and single dose pre-filled syringe can be effectively substitutable at the pharmacy level without the need to obtain a new prescription from the prescriber at PBS subsidised prices for the duration of the TGA approval, where conditions in the Principal Determination are met and the supply is in accordance with section 30EL of the Therapeutic Goods Act 1989.
This means that eligible patients accessing a substitute pharmaceutical benefit containing abatacept under these arrangements will be paying PBS co-payment rates for the supply and will not be out of pocket. This minimises the burden of this shortage on health care professionals by reducing the need for interdisciplinary consultations and assists Australians with timely and equitable access to medicine supply for patients that is considerate of changing availabilities of abatacept products. It further bolsters the intended public health outcome of the serious shortage intervention by ensuring the substitution remains an affordable and practical alternative for patients.
Human rights implications
The Amendment Determination engages Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Amendment Determination assists in 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 PBS is a benefit scheme which assists with providing subsidised access for people to medicines. This is a positive and supportive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for the PBS support effective administration of the scheme. The Amendment Determination assists in 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 by ensuring that patients have continued access to their medicines while their supply is disrupted.
Conclusion
The Amendment Determination is compatible with human rights, as it promotes the protection of human rights.
Nikolai Tsyganov
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care