Part 1
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Commonwealth legislation
This law sets a cost‑recovery fee system requiring pharmaceutical companies to pay for government assessment and listing-related services for the PBS and National Immunisation Program. Fees, scaled by application complexity, cover ATAGI advice, pre‑submission meetings, submissions, pricing negotiations and list management, ranging from a few thousand up to nearly $300,000.
It affects companies seeking listings (and indirectly patients through pricing), includes exemptions/refunds for emergencies or rare‑disease cases, notice requirements, and appeal rights.
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Direct links to the current provisions in National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022.
This instrument is the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022.
This instrument is made under the National Health Act 1953.
Note: See section 99YBA of the National Health Act 1953.
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) designated vaccine;
(b) Secretary;
(c) vaccine.
In this instrument:
Act means the National Health Act 1953.
amount includes a nil amount.
approved ex‑manufacturer price has the meaning given by subsection 84(1) of the Act.
ATAGI means the Commonwealth body known as the Australian Technical Advisory Group on Immunisation.
ATAGI advice has the meaning given by subsection 7(1).
ATAGI application has the meaning given by subsection 7(1).
ATAGI application due day has the meaning given by subsection 10(3).
Australian Register of Therapeutic Goods means the register maintained under section 9A of the Therapeutic Goods Act 1989.
brand has the meaning given by subsection 84(1) of the Act.
Committee means the Pharmaceutical Benefits Advisory Committee established under section 100A of the Act.
complex category ATAGI application fee has the meaning given by subsection 7(2).
cost‑effectiveness test means an assessment of:
(a) the extent (if any) to which the efficacy and toxicity of the therapy proposed in a submission for a disease or disorder differs from the efficacy and toxicity of any alternative therapy for the disease or disorder; and
(b) the cost of the proposed therapy relative to the cost of the alternative therapy.
designated orphan drug has the same meaning as in the Therapeutic Goods Regulations 1990.
economic evaluation, for a submission and a drug, medicinal preparation or vaccine the subject of the submission, means data that is a comparative analysis of the costs and outcomes of:
(a) the therapy to be provided by the drug, medicinal preparation or vaccine; and
(b) any other therapy that the applicant nominates as an alternative therapy to the drug, medicinal preparation or vaccine.
evaluation category means an evaluation category referred to in the table in subsection 22(2).
high added therapeutic value: a drug, medicinal preparation or vaccine has high added therapeutic value if the drug, medicinal preparation or vaccine:
(a) addresses a high and urgent unmet clinical need; and
(b) is expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapy.
listed brand of a pharmaceutical item has the meaning given by subsection 84(1) of the Act.
listed drug has the meaning given by subsection 84(1) of the Act.
list management application has the meaning given by paragraph 56(1)(a).
list management services has the meaning given by subsection 56(1).
medicinal food means food that is therapeutic goods within the meaning of paragraph (a) or (b) of the definition of therapeutic goods in subsection 3(1) of the Therapeutic Goods Act 1989.
MSAC means the body known as the Medical Services Advisory Committee.
notification:
(a) for an ATAGI application—means a notification given under whichever of subsections 11(1), (2) and (3) is relevant to the ATAGI application or a notice of intent in relation to the ATAGI application; or
(b) for a pre‑submission meeting application—means a notification given under subsection 17(1); or
(c) for a submission—means a notification given under whichever of subsections 33(1), (2) and (3) is relevant to the submission or a notice of intent in relation to the submission; or
(d) for a pricing application—means a notification given under whichever of subsections 50(1), (2) and (3) is relevant to the pricing application or a notice of intent in relation to the pricing application; or
(e) for a list management application—means a notification given under section 58.
PBS prescriber has the meaning given by subsection 84(1) of the Act.
pharmaceutical item has the meaning given by section 84AB of the Act.
pre‑submission meeting application has the meaning given by paragraph 14(a).
pricing application has the meaning given by subsection 40(1).
pricing category means a pricing category referred to in the table in subsection 41(1).
pricing services has the meaning given by subsection 40(1).
reviewable decision has the meaning given by section 71.
submission means a submission referred to in subsection 21(1).
submission due day has the meaning given by subsection 31(3).
submission services has the meaning given by subsection 22(1).
Therapeutic Goods Administration means the part of the Department known as the Therapeutic Goods Administration.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
This instrument is the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022.
This instrument is made under the National Health Act 1953.
Note: See section 99YBA of the National Health Act 1953.
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) designated vaccine;
(b) Secretary;
(c) vaccine.
In this instrument:
Act means the National Health Act 1953.
amount includes a nil amount.
approved ex‑manufacturer price has the meaning given by subsection 84(1) of the Act.
ATAGI means the Commonwealth body known as the Australian Technical Advisory Group on Immunisation.
ATAGI advice has the meaning given by subsection 7(1).
ATAGI application has the meaning given by subsection 7(1).
ATAGI application due day has the meaning given by subsection 10(3).
Australian Register of Therapeutic Goods means the register maintained under section 9A of the Therapeutic Goods Act 1989.
brand has the meaning given by subsection 84(1) of the Act.
Committee means the Pharmaceutical Benefits Advisory Committee established under section 100A of the Act.
complex category ATAGI application fee has the meaning given by subsection 7(2).
cost‑effectiveness test means an assessment of:
(a) the extent (if any) to which the efficacy and toxicity of the therapy proposed in a submission for a disease or disorder differs from the efficacy and toxicity of any alternative therapy for the disease or disorder; and
(b) the cost of the proposed therapy relative to the cost of the alternative therapy.
designated orphan drug has the same meaning as in the Therapeutic Goods Regulations 1990.
economic evaluation, for a submission and a drug, medicinal preparation or vaccine the subject of the submission, means data that is a comparative analysis of the costs and outcomes of:
(a) the therapy to be provided by the drug, medicinal preparation or vaccine; and
(b) any other therapy that the applicant nominates as an alternative therapy to the drug, medicinal preparation or vaccine.
evaluation category means an evaluation category referred to in the table in subsection 22(2).
high added therapeutic value: a drug, medicinal preparation or vaccine has high added therapeutic value if the drug, medicinal preparation or vaccine:
(a) addresses a high and urgent unmet clinical need; and
(b) is expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapy.
listed brand of a pharmaceutical item has the meaning given by subsection 84(1) of the Act.
listed drug has the meaning given by subsection 84(1) of the Act.
list management application has the meaning given by paragraph 56(1)(a).
list management services has the meaning given by subsection 56(1).
medicinal food means food that is therapeutic goods within the meaning of paragraph (a) or (b) of the definition of therapeutic goods in subsection 3(1) of the Therapeutic Goods Act 1989.
MSAC means the body known as the Medical Services Advisory Committee.
notification:
(a) for an ATAGI application—means a notification given under whichever of subsections 11(1), (2) and (3) is relevant to the ATAGI application or a notice of intent in relation to the ATAGI application; or
(b) for a pre‑submission meeting application—means a notification given under subsection 17(1); or
(c) for a submission—means a notification given under whichever of subsections 33(1), (2) and (3) is relevant to the submission or a notice of intent in relation to the submission; or
(d) for a pricing application—means a notification given under whichever of subsections 50(1), (2) and (3) is relevant to the pricing application or a notice of intent in relation to the pricing application; or
(e) for a list management application—means a notification given under section 58.
PBS prescriber has the meaning given by subsection 84(1) of the Act.
pharmaceutical item has the meaning given by section 84AB of the Act.
pre‑submission meeting application has the meaning given by paragraph 14(a).
pricing application has the meaning given by subsection 40(1).
pricing category means a pricing category referred to in the table in subsection 41(1).
pricing services has the meaning given by subsection 40(1).
reviewable decision has the meaning given by section 71.
submission means a submission referred to in subsection 21(1).
submission due day has the meaning given by subsection 31(3).
submission services has the meaning given by subsection 22(1).
Therapeutic Goods Administration means the part of the Department known as the Therapeutic Goods Administration.
This instrument is the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022.
This instrument is made under the National Health Act 1953.
Note: See section 99YBA of the National Health Act 1953.
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) designated vaccine;
(b) Secretary;
(c) vaccine.
In this instrument:
Act means the National Health Act 1953.
amount includes a nil amount.
approved ex‑manufacturer price has the meaning given by subsection 84(1) of the Act.
ATAGI means the Commonwealth body known as the Australian Technical Advisory Group on Immunisation.
ATAGI advice has the meaning given by subsection 7(1).
ATAGI application has the meaning given by subsection 7(1).
ATAGI application due day has the meaning given by subsection 10(3).
Australian Register of Therapeutic Goods means the register maintained under section 9A of the Therapeutic Goods Act 1989.
brand has the meaning given by subsection 84(1) of the Act.
Committee means the Pharmaceutical Benefits Advisory Committee established under section 100A of the Act.
complex category ATAGI application fee has the meaning given by subsection 7(2).
cost‑effectiveness test means an assessment of:
(a) the extent (if any) to which the efficacy and toxicity of the therapy proposed in a submission for a disease or disorder differs from the efficacy and toxicity of any alternative therapy for the disease or disorder; and
(b) the cost of the proposed therapy relative to the cost of the alternative therapy.
designated orphan drug has the same meaning as in the Therapeutic Goods Regulations 1990.
economic evaluation, for a submission and a drug, medicinal preparation or vaccine the subject of the submission, means data that is a comparative analysis of the costs and outcomes of:
(a) the therapy to be provided by the drug, medicinal preparation or vaccine; and
(b) any other therapy that the applicant nominates as an alternative therapy to the drug, medicinal preparation or vaccine.
evaluation category means an evaluation category referred to in the table in subsection 22(2).
high added therapeutic value: a drug, medicinal preparation or vaccine has high added therapeutic value if the drug, medicinal preparation or vaccine:
(a) addresses a high and urgent unmet clinical need; and
(b) is expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapy.
listed brand of a pharmaceutical item has the meaning given by subsection 84(1) of the Act.
listed drug has the meaning given by subsection 84(1) of the Act.
list management application has the meaning given by paragraph 56(1)(a).
list management services has the meaning given by subsection 56(1).
medicinal food means food that is therapeutic goods within the meaning of paragraph (a) or (b) of the definition of therapeutic goods in subsection 3(1) of the Therapeutic Goods Act 1989.
MSAC means the body known as the Medical Services Advisory Committee.
notification:
(a) for an ATAGI application—means a notification given under whichever of subsections 11(1), (2) and (3) is relevant to the ATAGI application or a notice of intent in relation to the ATAGI application; or
(b) for a pre‑submission meeting application—means a notification given under subsection 17(1); or
(c) for a submission—means a notification given under whichever of subsections 33(1), (2) and (3) is relevant to the submission or a notice of intent in relation to the submission; or
(d) for a pricing application—means a notification given under whichever of subsections 50(1), (2) and (3) is relevant to the pricing application or a notice of intent in relation to the pricing application; or
(e) for a list management application—means a notification given under section 58.
PBS prescriber has the meaning given by subsection 84(1) of the Act.
pharmaceutical item has the meaning given by section 84AB of the Act.
pre‑submission meeting application has the meaning given by paragraph 14(a).
pricing application has the meaning given by subsection 40(1).
pricing category means a pricing category referred to in the table in subsection 41(1).
pricing services has the meaning given by subsection 40(1).
reviewable decision has the meaning given by section 71.
submission means a submission referred to in subsection 21(1).
submission due day has the meaning given by subsection 31(3).
submission services has the meaning given by subsection 22(1).
Therapeutic Goods Administration means the part of the Department known as the Therapeutic Goods Administration.
ATAGI advice
ATAGI may, on application (an ATAGI application) by a person, provide advice to the person to be included in the person’s proposed submission to the Committee.
A fee is payable for the service of ATAGI providing the advice (unless a fee exemption applies or the fee is waived). The amount of the fee depends on whether the ATAGI application is categorised as complex or simple. A person may request the Secretary to decide whether the person’s ATAGI application is in a simple category.
The person will generally need to have given the Department a notice of intent in relation to the ATAGI application at least 10 business days before the ATAGI application due day for the application.
The ATAGI application must be given to the Department on or before the ATAGI application due day.
ATAGI will not provide advice in response to the ATAGI application if a notice of intent in relation to the ATAGI application was not given, unless a notice of intent was not required because of an urgent public health need.
If a notice of intent in relation to a proposed ATAGI application is withdrawn soon after it is given, or an ATAGI application is withdrawn soon after it is made, the fee amount (if any) paid, except the amount of the deposit included in the fee amount, will be refunded. If no fee amount was paid before the withdrawal, a fee for the provision of administrative services by the Department in relation to the notice of intent or the ATAGI application will be payable.
Pre‑submission meetings
The Department may, on application (a pre‑submission meeting application) by a person, hold a pre‑submission meeting with the person in relation to the preparation of the person’s proposed submission to the Committee.
A fee is payable for the service of the Department holding the pre‑submission meeting. The amount of the fee depends on the category of the pre‑submission meeting.
If a pre‑submission meeting application is withdrawn before a certain time, the fee amount (if any) paid for the service of the Department holding the meeting will be refunded in full.
(1) A person may make an application (an ATAGI application) for the service of ATAGI providing advice (ATAGI advice) to the person for the person to include in a proposed submission to the Committee that the Committee recommend to the Minister to exercise a power under section 9B of the Act. (2) Subject to section 8 of this instrument, the fee (the complex category ATAGI application fee) for providing the ATAGI advice to the person is $220,795. This fee includes a deposit of $465.
Secretary may decide that ATAGI application is in simple category (1) The Secretary may, in writing and on request, decide whether or not a person’s ATAGI application is in a simple category.
Note 1: The request must be included in the notice of intent for the ATAGI application or, if a notice of intent for the ATAGI application is not required, in the ATAGI application (see subsection (5)).
Note 2: A decision that the person’s ATAGI application is not in a simple category is reviewable (see section 71).
Note 3: Regardless of subsection 7(2) and this section, in some circumstances the person will be fully exempt from paying a fee in relation to the ATAGI application (see section 67).
When is ATAGI application in simple category (2) The Secretary must decide under subsection (1) that a person’s ATAGI application is in a simple category if: (a) the person’s ATAGI application is only proposing: (i) that a new brand of vaccine be determined under subsection 9B(2) of the Act to be a designated vaccine; and (ii) that the proposed determination is to specify the vaccine by reference to characteristics (other than brand) that are the same as, or similar to, those specified for another vaccine that is already a designated vaccine; or (b) the person’s ATAGI application is only proposing: (i) to vary the circumstances specified in a determination under subsection 9B(2) of the Act in which a designated vaccine may be provided; and (ii) that the variation is to extend the vaccine’s eligible patient population to a new group of patients who are no more vulnerable to a poor outcome from either the relevant disease or the vaccine; or (c) the Secretary is satisfied that providing the ATAGI advice to the person will not involve the degree of data analysis and consideration that would justify payment of the complex category ATAGI application fee.
Note: For examples of the characteristics referred to in subparagraph (a)(ii), see subsection 9B(3) of the Act.
(3) For the purposes of paragraph (2)(a), brand has the same meaning as in section 9B of the Act. Reduced fee for ATAGI applications in simple category (4) If the Secretary decides under subsection (1) that a person’s ATAGI application is in a simple category, the fee for providing the ATAGI advice to the person is $121,775. This fee includes a deposit of $465. Applicant who wants Secretary to decide whether ATAGI application is in simple category must include request in notice of intent or ATAGI application (5) A person (the applicant) who wants the Secretary to make a decision under subsection (1) must: (a) request this: (i) in the notice of intent in relation to the proposed ATAGI application; or (ii) if a notice of intent in relation to the proposed ATAGI application is not required—in the person’s ATAGI application; and (b) include reasons in the notice of intent or the ATAGI application (as the case may be) why the Secretary should do so. (6) The Secretary may, by written notice given to the applicant, seek further information from the applicant in relation to the applicant’s request. (7) Giving a notice under subsection (6) seeking further information pauses the period of 15 business days referred to in subsection 11(3) for giving the no
This is an opening excerpt, not the complete document.