National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2018 (Cth)

National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2018 No. 1, 2018 Compilation No. 1 Compilation date: 14 December 2021 Includes amendments up to: Act No. 139, 2021 Registered: 14 January 2022 About this compilation This compilation This is a compilation of the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2018 that shows the text of the law as amended and in force on 14 December 2021 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents 1 Short title 2 Commencement 3 Schedules Schedule 1—Price reductions for new brands of pharmaceutical items Part 1—25% price reduction National Health Act 1953 Schedule 2—Statutory price reductions Part 1—Amendments commencing day after Royal Assent National Health Act 1953 Schedule 3—Price disclosure price reduction thresholds Part 1—Amendments commencing day after Royal Assent National Health Act 1953 Schedule 4—New brands Part 1—Amendments commencing day after Royal Assent National Health Act 1953 Schedule 5—Pharmacy location rules Part 1—Australian Community Pharmacy Authority National Health Act 1953 Part 2—Miscellaneous National Health Act 1953 Schedule 6—Name changes National Health Act 1953 Schedule 7—Safety net National Health Act 1953 Schedule 8—Prescription and supply National Health Act 1953 Schedule 9—Data collection National Health Act 1953 Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history An Act to amend the National Health Act 1953, and for related purposes 1 Short title This Act is the National Health Amendment (Pharmaceutical Benefits—Budget and Other Measures) Act 2018. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day this Act receives the Royal Assent. 20 February 2018 2. Schedule 1, Part 1 1 October 2018. 1 October 2018 3. Schedule 1, Part 2 1 July 2022. 1 July 2022 4. Schedule 2, Part 1 The day after this Act receives the Royal Assent. 21 February 2018 5. Schedule 2, Part 2 1 July 2022. 1 July 2022 6. Schedule 3, Part 1 The day after this Act receives the Royal Assent. 21 February 2018 7. Schedule 3, Part 2 1 July 2022. 1 July 2022 8. Schedule 4, Part 1 The day after this Act receives the Royal Assent. 21 February 2018 9. Schedule 4, Part 2 1 July 2022. 1 July 2022 10. Schedules 5 to 9 The day after this Act receives the Royal Assent. 21 February 2018 Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act. (2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act. 3 Schedules Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Price reductions for new brands of pharmaceutical items Part 1—25% price reduction National Health Act 1953 1 Subsection 84(1) Repeal the following definitions: (a) definition of subject to a 12.5% price reduction; (b) definition of subject to a 16% price reduction. 2 Subsection 84(1) Insert: 12.5% price reduction: see subsection 99ACA(2). 16% price reduction: see subsection 99ACA(2A). 25% price reduction: see subsection 99ACA(2B). 3 Section 99AC Omit "16% price reduction" (wherever occurring), substitute "25% price reduction". 4 Subsections 99ACA(2) and (2A) Repeal the subsections, substitute: (2) A listed component drug contained in a drug in a combination item has been subject to a 12.5% price reduction if a pharmaceutical item that has: (a) the listed component drug; and (b) the same manner of administration as the combination item; is in a class of pharmaceutical items to which a 12.5% administrative price reduction has applied. (2A) A listed component drug contained in a drug in a combination item has been subject to a 16% price reduction if a pharmaceutical item that has: (a) the listed component drug; and (b) the same manner of administration as the combination item; is in a class of pharmaceutical items to which a 16% administrative price reduction has applied. (2B) A listed component drug contained in a drug in a combination item has been subject to a 25% price reduction if a pharmaceutical item that has: (a) the listed component drug; and (b) the same manner of administration as the combination item; is in a class of pharmaceutical items to which a 25% administrative price reduction has applied. 5 Subdivision B of Division 3A of Part VII (heading) Repeal the heading, substitute: Subdivision B—25% price reductions for new brands of pharmaceutical items that are not combination items 6 Section 99ACB (heading) Repeal the heading, substitute: 99ACB 25% price reduction for new brands of pharmaceutical items that are not combination items 7 Paragraphs 99ACB(2)(a), (b) and (c) Omit "or 16%", substitute ", 16% or 25%". 8 At the end of subsection 99ACB(2) Add: ; or (d) on the day before the determination day: (i) the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or (ii) if subparagraph (i) does not apply—the original approved ex‑manufacturer price of the first listed brand of the existing item; has, by virtue of previous price reductions, been reduced by 40% or more. 9 Subparagraph 99ACB(3)(a)(ii) Omit "item 1 of the table in section 99ACF", substitute "section 99ACH". 10 At the end of paragraph 99ACB(3)(a) Add: (iii) subsection 99ACF(2AB) or (2AC); 11 Subsection 99ACB(4) (heading) Repeal the heading, substitute: 25% price reduction 12 Subsection 99ACB(5) Repeal the subsection, substitute: (4A) If, on the day before the determination day: (a) the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or (b) if paragraph (a) does not apply—the original approved ex‑manufacturer price of the first listed brand of the existing item; has, by virtue of previous price reductions, been reduced by: (c) 15% or less, subsection (5) applies; and (d) more than 15% but less than 40%, subsection (5A) applies. Note: If previous price reductions have been 40% or more, see paragraph (2)(d). (5) Subject to subsections (6) and (6A), the agreed price of the new brand of the trigger item that comes into force on the determination day must not exceed the approved ex‑manufacturer price, on the day before the determination day, of the existing brand of the existing item, reduced by 25%. (5A) Subject to subsections (6) and (6B), the agreed price of the new brand of the trigger item that comes into force on the determination day must not exceed: (a) 60% of the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or (b) if paragraph (a) does not apply—60% of the original approved ex‑manufacturer price of the first listed brand of the existing item. 13 Subsection 99ACB(6) Omit "subsection (5)", substitute "subsections (5) and (5A)". 14 After subsection 99ACB(6) Insert: Ministerial discretion not to apply, or to reduce, statutory price reduction (6A) For the purposes of subsection (5), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price mentioned in that subsection is to be worked out using a lower percentage (including zero %) specified in the determination. (6B) For the purposes of paragraphs (5A)(a) and (b), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price mentioned in those paragraphs is to be worked out using a higher percentage specified in the determination. (6C) In making a determination under subsection (6A) or (6B): (a) the Minister must take into account what the agreed price of the new brand of the trigger item would otherwise be under this section in relation to the particular determination day if a determination were not made; and (b) the Minister may take into account any other matter that the Minister considers relevant. (6D) If the Minister makes a determination under subsection (6A) or (6B), the agreed price of the new brand of the trigger item is not to be further reduced under this section on any determination day that occurs after the determination day specified in the determination made under the relevant subsection. 15 At the end of subsection 99ACC(4A) Add: ; and (e) to the extent that the single brand of the combination item contains one or more component drugs that are not listed component drugs—must take into account the matters mentioned in paragraph (d) in relation to each component drug that is not a listed component drug (the non‑listed component drug) as if: (i) in the case of one non‑listed component drug—a declaration under subsection 85(2) was in force in relation to the non‑listed component drug on the day the declaration under subsection 85(2) came into force in relation to the listed component drug, or if there is more than one listed component drug, the first listed component drug, of the single brand of the combination item; and (ii) in the case of more than one component drug that is a non‑listed component drug—a declaration under subsection 85(2) was in force in relation to each non‑listed component drug on the day the declaration under subsection 85(2) came into force in relation to the listed component drug, or if there is more than one listed component drug, the first listed component drug, of the single brand of the combination item. 16 Subsection 99ACC(4B) Repeal the subsection, substitute: (4B) If subsection (4) does not apply, then, in agreeing the new price of the single brand of the combination item, the Minister must take into account: (a) in relation to the listed component drug, or each listed component drug, that became subject to statutory price reduction: (i) the approved ex‑manufacturer price, on the reduction day, of each brand of a pharmaceutical item that has the drug that is the listed component drug; and (ii) the quantity of the listed component drug contained in the combination item; and (b) to the extent that the single brand of the combination item contains one or more component drugs that are not listed component drugs—the matters mentioned in paragraph (a) in relation to each component drug that is not a listed component drug as if a declaration under subsection 85(2) was in force in relation to each non‑listed component drug, as described in paragraph (4A)(e). 17 Subsection 99ACC(6) Repeal the subsection, substitute: Subject to statutory price reduction etc. (6) The following provisions have effect: (a) a listed component drug contained in a drug in a combination item becomes subject to statutory price reduction if section 99ACB or 99ADH, or subsection 99ACF(1), (2), (2AB) or (2AC) because of section 99ACH, has applied to a listed brand of a pharmaceutical item that: (i) has the listed component drug; and (ii) has the same manner of administration as the combination item; (b) whichever provision mentioned in paragraph (a) applied, that provision applies to the listed component drug contained in the drug in the combination item in the same way as that provision applies to the listed brand of the pharmaceutical item that: (i) has the listed component drug; and (ii) has the same manner of administration as the combination item; (c) a listed component drug contained in a drug in a combination item becomes subject to statutory price reduction if subsection 99ACF(1) or (2) because of item 2, 3, 4, 5 or 6 in the table in section 99ACF has applied to a listed brand of a pharmaceutical item that has the listed component drug; (d) whichever provision mentioned in paragraph (c) applied, that provision applies to the listed component drug contained in the drug in the combination item in the same way as that provision applies to the listed brand of the pharmaceutical item that has the listed component drug. 18 Section 99ACD (heading) Repeal the heading, substitute: 99ACD 25% price reduction for new brands of combination items 19 Paragraphs 99ACD(1A)(a), (b) and (c) Omit "or 16%", substitute ", 16% or 25%". 20 At the end of subsection 99ACD(1A) Add: ; or (d) on the day before the determination day: (i) the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or (ii) if subparagraph (i) does not apply—the original approved ex‑manufacturer price of the first listed brand of the existing item; has, by virtue of previous price reductions, been reduced by 40% or more. 21 Subsection 99ACD(4) (heading) Repeal the heading, substitute: 25% price reduction 22 Subsections 99ACD(5), (6), (6A) and (6B) Repeal the subsections, substitute: (4A) If, on the day before the determination day: (a) the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or (b) if paragraph (a) does not apply—the original approved ex‑manufacturer price of the first listed brand of the existing item; has, by virtue of previous price reductions, been reduced by: (c) 15% or less, subsection (5) applies; and (d) more than 15% but less than 40%, subsection (5A) applies. Note: If previous price reductions have been 40% or more, see paragraph (1A)(d). (5) Subject to subsections (7) and (7A), the agreed price of the new brand of the trigger combination item that comes into force on the determination day must not exceed the approved ex‑manufacturer price, on the day before the determination day, of the existing brand of the existing item, reduced by 25%. (5A) Subject to subsections (7) and (7B), the agreed price of the new brand of the trigger combination item that comes into force on the determination day must not exceed: (a) 60% of the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or (b) if paragraph (a) does not apply—60% of the original approved ex‑manufacturer price of the first listed brand of the existing item. 23 Subsection 99ACD(7) Omit "subsection (5)", substitute "subsections (5) and (5A)". 24 After subsection 99ACD(7) Insert: Ministerial discretion not to apply, or to reduce, statutory price reduction (7A) For the purposes of subsection (5), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price mentioned in that subsection is to be worked out using a lower percentage (including zero %) specified in the determination. (7B) For the purposes of paragraphs (5A)(a) and (b), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price mentioned in those paragraphs is to be worked out using a higher percentage specified in the determination. (7C) In making a determination under subsection (7A) or (7B): (a) the Minister must take into account what the agreed price of the new brand of the trigger combination item would otherwise be under this section in relation to the particular determination day if a determination were not made; and (b) the Minister may take into account any other matter that the Minister considers relevant. (7D) If the Minister makes a determination under subsection (7A) or (7B), the agreed price of the new brand of the trigger combination item is not to be further reduced under this section on any determination day that occurs after the determination day specified in the determination made under the relevant subsection. 25 Section 99ACE (heading) Repeal the heading, substitute: 99ACE Flow‑on of 25% price reduction to related brands of combination items 26 After subsection 99ACE(1) Insert: (1A) If paragraph 99ACD(1A)(d) has applied in relation to a new brand of a new combination item, then this section applies to the related brand of the related item as if: (a) section 99ACD had applied to the new brand of the new combination item; and (b) the current price for the new brand of the new combination item is the new agreed price; and (c) the day that paragraph 99ACD(1A)(d) is satisfied is the same day as the reduction day. Circumstances in which section does not apply (1B) This section does not apply in relation to the related brand of the related item if, on the day before the reduction day: (a) the approved ex‑manufacturer price of the related brand of the related item on 1 January 2016; or (b) if paragraph (a) does not apply—the original approved ex‑manufacturer price of the first listed related brand of the related item; has, by virtue of previous price reductions, been reduced by 40% or more. 27 Subsection 99ACE(2) (heading) Repeal the heading, substitute: 25% price reduction 28 After subsection 99ACE(2) Insert: (2A) If, on the day before the reduction day: (a) the approved ex‑manufacturer price of the related brand of the related item on 1 January 2016; or (b) if paragraph (a) does not apply—the original approved ex‑manufacturer price of the related brand of the related item; has, by virtue of previous price reductions, been reduced by: (c) 15% or less, paragraph (3)(a) or (c), or (4)(a) or (c), as the case requires, applies; and (d) more than 15% but less than 40%, paragraph (3)(b) or (d), or (4)(b) or (d), as the case requires, applies. Note: If previous price reductions have been 40% or more, see subsection (1B). (2B) If, on the day before the reduction day: (a) the claimed price for a particular pack quantity of the related brand of the related item on 1 January 2016; or (b) if paragraph (a) does not apply—the original claimed price for a particular pack quantity of the related brand of the related item; has, by virtue of previous price reductions, been reduced by: (c) 15% or less, paragraph (4A)(a) applies; and (d) more than 15% but less than 40%, paragraph (4A)(b) applies. Note: If previous price reductions have been 40% or more, see subsection (1B). 29 Paragraphs 99ACE(3)(a) and (b) Repeal the paragraphs, substitute: (a) in a price agreement, specify an agreed price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5), does not exceed the approved ex‑manufacturer price for the related brand of the related item, on the day before the reduction day, reduced by 25%; or (b) in a price agreement, specify an agreed price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5A), does not exceed: (i) 60% of the approved ex‑manufacturer price of the related brand of the related item on 1 January 2016; or (ii) if subparagraph (i) does not apply—60% of the original approved ex‑manufacturer price of the related brand of the related item; or (c) in a price determination, specify a determined price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5), does not exceed the approved ex‑manufacturer price for the related brand of the related item, on the day before the reduction day, reduced by 25%; or (d) in a price determination, specify a determined price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5A), does not exceed: (i) 60% of the approved ex‑manufacturer price of the related brand of the related item on 1 January 2016; or (ii) if subparagraph (i) does not apply—60% of the original approved ex‑manufacturer price of the related brand of the related item. 30 Paragraphs 99ACE(4)(a) and (b) Repeal the paragraphs, substitute: (a) in a price determination, specify a determined price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5), does not exceed the approved ex‑manufacturer price for the related brand of the related item, on the day before the reduction day, reduced by 25%; or (b) in a price determination, specify a determined price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5A), does not exceed: (i) 60% of the approved ex‑manufacturer price of the related brand of the related item on 1 January 2016; or (ii) if subparagraph (i) does not apply—60% of the original approved ex‑manufacturer price of the related brand of the related item; or (c) in a price agreement, specify an agreed price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5), does not exceed the approved ex‑manufacturer price for the related brand of the related item, on the day before the reduction day, reduced by 25%; or (d) in a price agreement, specify an agreed price for the related brand of the related item that comes into force on the reduction day and, subject to subsections (4B) and (5A), does not exceed: (i) 60% of the approved ex‑manufacturer price of the related brand of the related item on 1 January 2016; or (ii) if subparagraph (i) does not apply—60% of the original approved ex‑manufacturer price of the related brand of the related item. 31 Subsection 99ACE(4A) After "of the related brand of the related item that", insert "comes into force on the reduction day and". 32 Paragraphs 99ACE(4A)(a) and (b) Repeal the paragraphs, substitute: (a) subject to subsection (5D), does not exceed the claimed price for that pack quantity of the related brand of the related item, on the day before the reduction day, reduced by 25%; or (b) subject to subsection (5E), does not exceed: (i) 60% of the claimed price for that pack quantity of the related brand of the related item on 1 January 2016; or (ii) if subparagraph (i) does not apply—60% of the original claimed price for that pack quantity of the related brand of the related item. 33 Subsection 99ACE(4B) Omit "subparagraphs (3)(a)(ii), (3)(b)(ii), (4)(a)(ii) and (4)(b)(ii)", substitute "paragraphs (3)(a) to (d) and (4)(a) to (d)". 34 Subsections 99ACE(5), (5A) and (5B) Repeal the subsections, substitute: Ministerial discretion not to apply, or to reduce, statutory price reduction (5) For the purposes of paragraph (3)(a) or (c) or (4)(a) or (c), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price mentioned in the relevant paragraph is to be worked out using a lower percentage (including zero %) specified in the determination. (5A) For the purposes of paragraph (3)(b) or (d) or (4)(b) or (d), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price mentioned in the relevant paragraph is to be worked out using a higher percentage specified in the determination. (5B) In making a determination under subsection (5) or (5A): (a) the Minister must take into account what the approved ex‑manufacturer price of the related brand of the related item would otherwise be under this section in relation to the particular reduction day if a determination were not made; and (b) the Minister may take into account any other matter that the Minister considers relevant. (5C) If the Minister makes a determination under subsection (5) or (5A), the agreed price or determined price of the related brand of the related item is not to be further reduced under this section on any reduction day that occurs after the reduction day specified in the relevant determination. (5D) For the purposes of paragraph (4A)(a), the Minister may, by written instrument, determine that the claimed price mentioned in that paragraph is to be worked out using a lower percentage (including zero %) specified in the determination. (5E) For the purposes of paragraph (4A)(b), the Minister may, by written instrument, determine that the claimed price mentioned in that paragraph is to be worked out using a higher percentage specified in the determination. (5F) In making a determination under subsection (5D) or (5E): (a) the Minister must take into account what the claimed price for the pack quantity of the related brand of the related item would otherwise be under this section in relation to the particular reduction day if a determination were not made; and (b) the Minister may take into account any other matter that the Minister considers relevant. (5G) If the Minister makes a determination under subsection (5D) or (5E), the claimed price for the pack quantity of the related brand of the related item is not to be further reduced under this section on any reduction day that occurs after the reduction day specified in the relevant determination. 35 Subsection 99ACF(1) (table item 1) Repeal the item. 36 After subsection 99ACF(2) Insert: Reduction by dollar amounts (2AA) Subject to section 99ACG, if: (a) section 99ACH applies to a listed brand (the related brand) of a pharmaceutical item (the related item) on a day specified in the section (the reduction day); and (b) on the day before the reduction day: (i) the approved ex‑manufacturer price of the related brand of the related item on 1 January 2016; or (ii) if subparagraph (i) does not apply—the original approved ex‑manufacturer price of the related brand of the related item; or (iii) if applicable, one or more claimed prices of the related brand of the related item on 1 January 2016; or (iv) if subparagraph (iii) does not apply—if applicable, one or more claimed prices, of the related brand of the related item; have, by virtue of previous price reductions, been reduced by: (v) 15% or less, subsection (2AB) applies; and (vi) more than 15% but less than 40%, subsection (2AC) applies. (2AB) Subject to subsections (2A) and (3AA), the approved ex‑manufacturer price, or (if applicable) each claimed price, for the related brand of the related item that comes into force on the reduction day must not exceed the approved ex‑manufacturer price, or each of the claimed prices, of the related brand of the related item, on the day before the reduction day, reduced by 25%. (2AC) Subject to subsections (2A) and (3AB), the approved ex‑manufacturer price, or (if applicable) each claimed price, for the related brand of the related item that comes into force on the reduction day must not exceed: (a) 60% of the approved ex‑manufacturer price, or each of the claimed prices, of the related brand of the related item on 1 January 2016; or (b) if paragraph (a) does not apply—60% of the original approved ex‑manufacturer price, or each of the claimed prices, of the related brand of the related item. 37 Subsection 99ACF(2A) Omit "subsection (1) and paragraph (2)(b)", substitute "subsection (1), paragraph (2)(b) and subsections (2AB) and (2AC)". 38 After subsection 99ACF(3) Insert: (3AA) For the purposes of subsection (2AB), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price, or (if applicable) each claimed price, mentioned in that subsection (the specified provision) is to be worked out using a lower percentage (including zero %) specified in the determination. (3AB) For the purposes of paragraphs (2AC)(a) and (b), the Minister may, by written instrument, determine that the relevant approved ex‑manufacturer price, or (if applicable) each claimed price, mentioned in those paragraphs (the specified provision) is to be worked out using a higher percentage specified in the determination. 39 Subsection 99ACF(3A) Omit "the application of item 2, 3, 4, 5, or 6 of the table in subsection (1)", substitute "the application of an item of the table in subsection (1), or subsection (2AB) or paragraphs (2AC)(a) and (b)". 40 At the end of subsection 99ACF(3B) Add ", (3AA) or (3AB)". 41 Subparagraph 99ACG(b)(iii) Omit "item 1 of the table in section 99ACF", substitute "section 99ACH". 42 At the end of paragraph 99ACG(b) Add: (iv) subsection 99ACF(2AB) or (2AC); 43 Section 99ACH (heading) Repeal the heading, substitute: 99ACH 25% statutory price reduction flow‑on to related brands 44 Paragraph 99ACH(1)(a) Omit "section 99ACB", substitute "subsection 99ACB(5) or (5A)". 45 After subsection 99ACH(1) Insert: (1A) If: (a) paragraph 99ACB(2)(d) applies in relation to a listed brand of the existing item; and (b) on or after the day that paragraph 99ACB(2)(d) applies, a price agreement or a determination under section 85B is in force in relation to any of the listed brands (the related brand) of a pharmaceutical item (the related item) mentioned in subsection (2); and (c) the related item is not a combination item; and (d) the related item is not an exempt item; then this section applies to the related brand of the related item as if: (e) section 99ACB had applied to the brand of the pharmaceutical item; and (f) the current price remains the agreed price for the brand (the new brand) of the pharmaceutical item (the new item); and (g) the agreed price comes into force on the day that paragraph 99ACB(2)(d) is satisfied (the reduction day). 46 Subsection 99ACH(2) Omit "paragraph (1)(c)", substitute "paragraphs (1)(c) and (1A)(b)". 47 Paragraph 99ACHA(1)(c) Omit "item 1 in the table in section 99ACF", substitute "section 99ACH". Schedule 2—Statutory price reductions Part 1—Amendments commencing day after Royal Assent National Health Act 1953 1 Section 99AC Omit: (b) arise if a pharmaceutical item has had a drug on F1 for 5 years on a particular day. substitute: (b) occur on a particular day if, on that day, the pharmaceutical item has a drug on F1 and that drug has been a listed drug for at least 5 years, 10 years or 15 years. Price reductions for listed brands of pharmaceutical items under this Division are subject to: (a) determinations made by the Minister to not apply, or reduce, the pric