National Health (Application Fees for Pharmacist Approvals) Determination 2020

The determination directly affects any person who makes an application under subsection 90(1) or (3) of the National Health Act 1953 for approval as a pharmacist to supply pharmaceutical benefits. This includes individual pharmacists seeking approval to operate a pharmacy, and possibly partnerships or corporations if the Act permits such applicants. The higher fee of $1,370 applies when the application must be referred to the Australian Community Pharmacy Authority. That Authority is itself a key actor: it receives and considers referred applications, and its workload is indirectly regulated by the fee structure. The Department of Health (or the Secretary) administers the application process and collects the fees. The determination does not impose obligations on third parties such as patients or other health professionals. However, indirectly, the fee levels may influence the number of pharmacy approvals and thus affect the distribution of pharmacies and access to pharmaceutical benefits for the general public. The determination also affects the legal practitioners and compliance professionals who advise pharmacists on the approval process. They must know the current fee amount and whether the application triggers the referral requirement. The amendment history shows that the fees have changed over time, so practitioners must ensure they are using the correct compilation. The instrument is a legislative instrument made by the Minister or delegate, and its operation is subject to parliamentary scrutiny under the Legislation Act 2003. The fees are paid into the Consolidated Revenue Fund unless otherwise specified. The determination does not distinguish between new applicants and existing approval holders seeking amendments or transfers; all applications under subsections 90(1) and (3) are covered.

The primary duty arising from this determination is the obligation to pay the prescribed fee when making an application under subsection 90(1) or (3) of the National Health Act 1953. The duty is not expressed as a penal obligation but rather as a condition precedent. If the fee is not paid, the application may be considered invalid or may not be processed. The determination itself does not specify a mechanism for payment, the form of payment, or the consequences of non-payment; those matters are left to the administrative practice of the Department or to the Act. A key right conferred by the determination is the right to have an application processed upon payment of the correct fee, provided the application meets all other statutory requirements. The determination does not create a right to a refund if the application is withdrawn or refused, nor does it address whether fees are refundable. That would be governed by the Act or by general law. Another right is that of equal treatment: the fee is fixed and applies uniformly to all applicants in the same category. There is no discretion to waive or reduce the fee within the determination; any such discretion would have to be found elsewhere in the Act or in another instrument. The determination also gives the applicant the right to know which fee applies: $465 for standard applications and $1,370 for applications that must be referred to the Authority. An applicant who believes their application has been incorrectly categorised as requiring referral may challenge that decision under the Act’s review provisions. The determination does not create any rights of review itself; those rights arise from the National Health Act or the Administrative Appeals Tribunal Act. The determination does not impose any duties on the Authority or the Secretary beyond the implied duty to correctly classify applications and accept the appropriate fee.

This determination does not contain any penalty provisions, offence clauses, or enforcement mechanisms. It is a fee-setting instrument only. The word penalty does not appear in the text. Enforcement of the fee obligation is indirect. If an applicant fails to pay the correct fee, the Secretary or the Australian Community Pharmacy Authority would likely refuse to accept or process the application. That refusal is not a penalty but an administrative consequence. The underlying National Health Act 1953 may contain provisions regarding false or misleading statements in connection with an application, which could attract criminal or civil penalties, but those are not part of this determination. The determination does not create a debt or a right to sue for unpaid fees; the fee is payable at the time of application, so non-payment simply means the application proceeds no further. There is no provision for late payment fees, interest, or surcharges. The determination also does not specify any sanction for paying the wrong fee by mistake; presumably the Department would request the correct amount before processing. The determination is a legislative instrument, and as such it is enforceable as law. However, it does not create any monitoring or inspection powers. The legislation history shows that the amending determinations were made with no application, saving or transitional provisions, meaning that once an amendment takes effect, the old fee no longer applies to any application received after the commencement date. Enforcement of the correct fee at the correct time is a matter of administrative procedure, not of penal law. The determination is silent on what happens if an application is filed with the incorrect fee and then the fee changes before the applicant corrects it; presumably the fee in force at the time of original lodgement would apply, but this is not stated.

This determination is made under subsection 90(10) of the National Health Act 1953 and is therefore subsidiary to that Act. Its operation is entirely dependent on the Act. The determination refers specifically to subsections 90(1), 90(3) and 90(3A) of the Act. Any amendment to those subsections could directly affect the scope of the determination. The determination also interacts with the Australian Community Pharmacy Authority’s constituting provisions, which are likely found elsewhere in the National Health Act or in regulations. The note in section 4 clarifies that the Authority is the Australian Community Pharmacy Authority. The determination does not stand alone; it must be read together with the Act to determine what constitutes an application under subsection 90(1) or (3), and which applications must be referred under subsection 90(3A). The determination also interacts with the Legislation Act 2003, under which it is registered and compiled. The endnotes refer to provisions of the Legislation Act, such as s 48D (which repealed section 2 of the original determination) and s 15V (regarding editorial changes). The interpretation of the determination is governed by the Acts Interpretation Act 1901 and the Legislation Act 2003. There is no express interaction with state or territory pharmacy laws, but in practice the federal approval process under the National Health Act must be satisfied in addition to any state licensing requirements. The determination does not purport to override or conflict with other Commonwealth laws. It is a relatively self-contained instrument. The compilation includes presentational changes authorised by the Legislation Act 2003, which do not alter the legal effect. The determination may be affected by other determinations made under the National Health Act, for example those prescribing the form of applications or the criteria for approval, but none are referenced. The fee amounts are not indexed to any external measure (such as CPI) within the determination itself; adjustments are done by amending determination.

The determination has been amended four times since its original making. The original determination, PB 31 of 2020, was registered on 30 April 2020 and commenced on 1 July 2020. The first amendment, the National Health (Application Fees for Pharmacist Approvals) Amendment Determination 2021, PB 59 of 2021, was registered on 30 June 2021. It had a split commencement: Schedule 1 item 1 commenced retrospectively on 1 July 2020 (the original commencement date), and the remainder commenced on 1 July 2021. This suggests that the original fee amounts may have been corrected or confirmed from the start, or a different kind of change was made with retrospective effect. The second amendment, PB 65 of 2022, was registered on 8 July 2022 and commenced on 1 August 2022. The third amendment, PB 48 of 2024, was registered on 7 June 2024 and commenced on 1 July 2024. The fourth and most recent amendment, PB 73 of 2025, was registered on 30 July 2025 and commenced on 1 August 2025. All amendments affected only section 4 (the fee provision). No other sections were amended; section 2 was repealed by operation of law (s 48D of the Legislation Act 2003) rather than by an amending instrument. The amendment history in endnote 4 confirms that section 4 was amended by each of the four amending determinations. The fees as at the compilation date (1 August 2025) are $1,370 and $465. The previous fee amounts are not recorded in this compilation, but the legislation history table indicates that no application, saving or transitional provisions accompanied any of the amendments. This means that each amendment took full effect on its commencement date without special arrangements for pending applications. The amendment history is important for legal research: a practitioner dealing with an application lodged before a particular commencement date must check which version of the determination was in force at that time.

The instrument itself, the endnotes, and the compilation contain no references to any litigation or court decisions. The determination has not been the subject of any reported judicial consideration in the materials provided. This is consistent with its narrow scope: it merely sets fee amounts. Challenges to fee determinations under the National Health Act would be possible, for example on grounds of ultra vires or procedural error in making the instrument, but no such cases are recorded in the instrument. The absence of litigation history does not mean no legal disputes have arisen; it means that this compilation does not include any such information. A researcher would need to conduct independent searches of court records. The determination is a legislative instrument, and any legal challenge would likely be brought in the Federal Court or the Administrative Appeals Tribunal (if arising from a decision to refuse an application based on the fee). The determination itself is not a reviewable decision; it is the underlying application decision that would be challenged. The note about the Authority being the Australian Community Pharmacy Authority could be relevant in litigation if there is a dispute about whether an application should have been referred. But again, no cases are mentioned. The compilation includes standard endnotes about editorial changes and misdescribed amendments, which do not evidence any litigation. The determination is relatively new (since 2020), and its fee amounts are modest by comparison to the cost of litigation, which may explain the lack of reported challenges.

Several features of this determination could trap the unwary. First, the fee amounts are not static; they change with each amending determination. The compilation date is critical. Any application made on a given day must use the fee in force at that time. The amendment history shows that amendments took effect on different dates (1 July, 1 August), and the 2021 amendment had retrospective operation to 1 July 2020 for one item. A practitioner relying on a previous compilation could pay the wrong fee. Second, the distinction between the two fee tiers is entirely dependent on whether the application must be referred to the Authority under subsection 90(3A) of the National Health Act. That subsection is not set out in the determination, so the applicant must understand the Act’s referral rules. If an applicant erroneously pays the lower fee for a referral-required application, the application may be rejected or delayed. Conversely, paying the higher fee when not required is wasteful. Third, the determination does not provide for refunds or adjustments. If an applicant pays the higher fee but the application turns out not to require referral, there is no statutory right to a refund within this instrument. Fourth, the repeal of section 2 (commencement) by the Legislation Act is a technical point but could cause confusion if someone looks for a commencement provision in the text. Fifth, the endnotes indicate that the 2021 amendment had a retrospective item; this could affect applications lodged in the period 1 July 2020 to 30 June 2021 if the original fee was different. The retrospective change may mean that the fee legally payable for some earlier applications was different from what was paid. Sixth, the instrument does not address how the fee is to be paid (e.g., cheque, electronic transfer). The Department’s administrative practice is not part of the law. Seventh, the determination uses the term application fee without defining whether it applies per application or per approval. Multiple simultaneous applications might attract multiple fees. Finally, the instrument is short, but the endnotes contain complex abbreviations and cross-references that may be overlooked. Practitioners should read the entire compilation, including the notes.

Compliance with this determination is straightforward in concept but requires attention to detail. Step one: determine whether the intended application falls under subsection 90(1) or (3) of the National Health Act 1953. This determination applies to those applications only. Step two: ascertain whether the application must be referred to the Australian Community Pharmacy Authority under subsection 90(3A) of the Act. That determination is a matter of law under the Act, not the fee determination. If the application is of a type that must be referred, the fee is $1,370. If not, the fee is $465. Step three: verify the current compilation of the determination to ensure the fee amounts have not been amended since the version on hand. As at 1 August 2025, the amounts are $1,370 and $465. Step four: pay the correct fee at the time of making the application, using whatever method the Department prescribes (e.g., online payment portal, bank cheque). The determination does not specify the mode of payment, so the applicant should follow instructions provided by the Department of Health or on the application form. Step five: retain proof of payment and a copy of the determination in force at the date of application, in case of later dispute. Step six: if the fee amount is in doubt, seek legal advice or contact the Department directly. Do not rely on secondary sources. Step seven: if the application is made close to the commencement date of an amending determination, carefully note the exact commencement date (often 1 July or 1 August) and use the fee applicable on the day of lodgement. Step eight: if the application is rejected due to incorrect fee, be prepared to re-lodge with the correct amount; there is no provision for correction within the same application. Step nine: monitor future amendments to this determination, as the history suggests annual or biennial changes. Subscribe to the Federal Register of Legislation for updates. Compliance is a matter of paying the precise fee as at the date of application; no other obligations flow from this determination.