{"id":"C2012A00087","name":"National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012","slug":"national-health-amendment-pharmaceutical-benefits-scheme-act-2012","collection":"act","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":"87 of 2012","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":8408,"registerId":"commonwealth-C2012A00087-current","compilationNumber":null,"startDate":"2026-03-30","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![](image.001.png)\n\n \n\n \n\n \n\n \n\n \n\n \n\nNational Health Amendment (Pharmaceutical Benefits Scheme) Act 2012\n\n \n\nNo. 87, 2012\n\n \n\n \n\n \n\n \n\n \n\nAn Act to amend the National Health Act 1953, and for related purposes\n\n \n\n \n\nContents\n\n1 Short title\n\n2 Commencement\n\n3 Schedule(s)\n\nSchedule 1—Approved ex‑manufacturer price\n\nPart 1—Amendments\n\nNational Health Act 1953\n\nPart 2—Application, saving and transitional provisions\n\nDivision 1—Preliminary\n\nDivision 2—Converting approved price to pharmacists to approved ex‑manufacturer price of brands of pharmaceutical items (other than single brands of combination items)\n\nDivision 3—Converting approved price to pharmacists to approved ex‑manufacturer price of single brands of combination items\n\nDivision 4—Converting claimed prices of brands of pharmaceutical items\n\nDivision 5—Other\n\nSchedule 2—Price disclosure\n\nPart 1—Amendments\n\nNational Health Act 1953\n\nPart 2—Application provision\n\nSchedule 3—Prescriber bag supplies\n\nPart 1—Amendments\n\nNational Health Act 1953\n\nPart 2—Application, saving and transitional provisions\n\n \n\n![](image.001.png)\n\n \n\n \n\nNational Health Amendment (Pharmaceutical Benefits Scheme) Act 2012\n\nNo. 87, 2012\n\n \n\n \n\n \n\nAn Act to amend the National Health Act 1953, and for related purposes\n\n[Assented to 28 June 2012]\n\nThe Parliament of Australia enacts:\n\n1  Short title\n\n  This Act may be cited as the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012.\n\n2  Commencement\n\n  This Act commences on 1 October 2012.\n\n3  Schedule(s)\n\n  Each Act 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.\n\n\n\n\nSchedule 1—Approved ex‑manufacturer price\n\nPart 1—Amendments\n\nNational Health Act 1953\n\n1  Subsection 84(1)\n\nInsert:\n\napproved ex‑manufacturer price of a listed brand of a pharmaceutical item means:\n\n (a) if a price agreement is in force in relation to the brand of the pharmaceutical item—the amount in force under the agreement as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item; or\n\n (b) if a price determination is in force in relation to the brand of the pharmaceutical item—the amount in force under the determination as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.\n\n2  Subsection 84(1) (definition of approved price to pharmacists)\n\nRepeal the definition.\n\n3  Subsection 84(1) (paragraphs (a) and (b) of the definition of Commonwealth price)\n\nAfter “Commonwealth price”, insert “for the particular quantity or number of units of the pharmaceutical benefit”.\n\n4  Subsection 84(1) (paragraph (c) of the definition of Commonwealth price)\n\nOmit “the benefit”, insert “the particular quantity or number of units of the pharmaceutical benefit”.\n\n5  Subsection 84(1)\n\nInsert:\n\ndetermined quantity of a listed brand of a pharmaceutical item: see subsection 84AK(3).\n\n6  Subsection 84(1)\n\nInsert:\n\npack quantity of a listed brand of a pharmaceutical item: see subsection 84AK(2).\n\n7  Subsection 84(1)\n\nInsert:\n\npricing quantity of a listed brand of a pharmaceutical item: see subsection 84AK(1).\n\n8  Subsection 84(1)\n\nInsert:\n\nproportional ex‑manufacturer price of a listed brand of a pharmaceutical item: see section 85D.\n\n9  Subsection 84(1) (definition of special patient contribution)\n\nOmit “85B(4)”, substitute “85B(5)”.\n\n10  Subsection 84C(7)\n\nOmit “the manner in which the price for”, substitute “, by legislative instrument, the manner in which the price for particular quantities or numbers of units of”.\n\n11  Paragraph 84C(8)(a)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price or a proportional ex‑manufacturer price”.\n\n12  Subsection 84C(10)\n\nRepeal the subsection.\n\n13  At the end of Division 1 of Part VII\n\nAdd:\n\n84AK  Quantities of pharmaceutical items\n\nPricing quantity\n\n (1) The pricing quantity of a listed brand of a pharmaceutical item is the lowest of any pack quantity of any listed brand of the pharmaceutical item.\n\nPack quantity\n\n (2) The Minister may, by legislative instrument, determine for a listed brand of a pharmaceutical item that one or more quantities or numbers of units of the pharmaceutical item is a pack quantity of the brand of the pharmaceutical item.\n\nDetermined quantity\n\n (3) The Minister may, by legislative instrument, determine for a listed brand of a pharmaceutical item that one or more quantities or numbers of units of the pharmaceutical item is a determined quantity of the brand of the pharmaceutical item.\n\n14  Subsection 85AD(1)\n\nRepeal the subsection, substitute:\n\n (1) The Minister and the responsible person for a listed brand of a pharmaceutical item may, from time to time, agree, by reference to the pricing quantity of the brand of the pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.\n\nNote: Section 85C and Division 3A limit the Minister’s power to agree to amounts for the purposes of subsection (1).\n\n15  Subsection 85AD(2)\n\nOmit all the words after paragraph (b), substitute:\n\n ; or (c) the quantity or number of units of the item is not yet a pricing quantity; or\n\n (d) the brand is not yet a listed brand.\n\nHowever, those matters must be satisfied at the time the amount referred to in subsection (1) comes into force.\n\n16  Section 85B\n\nRepeal the section, substitute:\n\n85B  Price determinations and special patient contributions\n\nApplication\n\n (1) This section applies to a listed brand of a pharmaceutical item.\n\nPrice determination\n\n (2) If the Minister and the responsible person have been unable to make a price agreement for the brand of the pharmaceutical item, then the Minister may, by legislative instrument, determine, by reference to the pricing quantity of the listed brand of a pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.\n\nNote: Section 85C and Division 3A limit the Minister’s power to determine amounts under subsection (2).\n\nClaimed price determination\n\n (3) The Minister may, by legislative instrument, determine, by reference to a pack quantity of the listed brand of the pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the price of the brand of the pharmaceutical item claimed by the responsible person for that quantity.\n\nSpecial patient contribution\n\n (4) If the Minister makes a determination under subsection (3), then the Minister may, by legislative instrument, determine the circumstances in which the Commonwealth is to pay the special patient contribution for the brand of the pharmaceutical item.\n\n (5) The special patient contribution for a quantity or number of units of a listed brand of a pharmaceutical item is the amount that is the difference between:\n\n (a) the price that would have been the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item if that Commonwealth price had been based on the claimed price for that quantity or number of units; and\n\n (b) the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item.\n\n17  After section 85B\n\nInsert:\n\n85C  Each brand of a pharmaceutical item is to have the same approved ex‑manufacturer price\n\n  If there are 2 or more listed brands of a pharmaceutical item, then the Minister must ensure, when agreeing an amount under subsection 85AD(1) or determining an amount under subsection 85B(2), that the approved ex‑manufacturer price of each listed brand of the pharmaceutical item is the same.\n\n85D  Proportional ex‑manufacturer price\n\n  The proportional ex‑manufacturer price for a pack quantity (other than the pricing quantity) of a listed brand of a pharmaceutical item on a day is the amount worked out as follows:\n\n![](image.002.png)\n\nwhere:\n\nAEMP means the approved ex‑manufacturer price of the brand of the pharmaceutical item in force on that day.\n\nPkQ means the pack quantity of the brand of the pharmaceutical item on that day.\n\nPQ means the pricing quantity of the brand of the pharmaceutical item on that day.\n\n18  Subsection 87(2A)\n\nOmit “section 85B”, substitute “subsection 85B(3)”.\n\n19  Paragraph 98B(1)(a)\n\nOmit “Commonwealth price of”, substitute “Commonwealth price for particular quantities or numbers of units of”.\n\n20  Paragraph 98B(2)(a)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price or a proportional ex‑manufacturer price”.\n\n21  Subsection 98B(3) (definition of approved price to pharmacists)\n\nRepeal the definition.\n\n22  Paragraph 98C(1)(a)\n\nOmit “Commonwealth price of”, substitute “Commonwealth price for particular quantities or numbers of units of”.\n\n23  Paragraph 99(2AA)(b)\n\nOmit “85B(5)”, substitute “85B(4)”.\n\n24  Subsection 99(4)\n\nAfter “supply of”, insert “particular quantities or numbers of units of”.\n\n25  Subsection 99ACB(5)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n26  Subsection 99ACB(6)\n\nRepeal the subsection, substitute:\n\nApportioning if pricing quantity changes\n\n (6) If the pricing quantity of the existing brand of the existing item on the day before the determination day is different from the pricing quantity of the existing brand of the existing item on the determination day, then, for the purposes of subsection (5), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day is taken to be the amount worked out as follows:\n\n![](image.003.png)\n\nwhere:\n\nAEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day.\n\nPQ1 means the pricing quantity of the existing brand of the existing item on the day before the determination day.\n\nPQ2 means the pricing quantity of the existing brand of the existing item on the determination day.\n\n27  Subparagraph 99ACC(4A)(d)(i)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n28  Paragraph 99ACC(4B)(a)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n29  Subsection 99ACD(5)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n30  Paragraphs 99ACD(6)(b) and (c)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n31  Subsection 99ACD(7)\n\nRepeal the subsection, substitute:\n\nApportioning if pricing quantity changes\n\n (7) If the pricing quantity of the existing brand of the existing item on the day before the determination day is different from the pricing quantity of the existing brand of the existing item on the determination day, then, for the purposes of subsection (5), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day is taken to be the amount worked out as follows:\n\n![](image.003.png)\n\nwhere:\n\nAEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day.\n\nPQ1 means the pricing quantity of the existing brand of the existing item on the day before the determination day.\n\nPQ2 means the pricing quantity of the existing brand of the existing item on the determination day.\n\n32  Subsection 99ACE(2)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n33  Subsection 99ACE(2)\n\nOmit “The claimed price”, substitute “Each claimed price”.\n\n34  Subparagraph 99ACE(3)(a)(ii)\n\nOmit “(5), (5A) and (5B), does not exceed the agreed price”, substitute “(4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price”.\n\n35  Paragraph 99ACE(3)(b)\n\nOmit “determination under section 85B for the related brand of the related item, specify a determined price”, substitute “price determination, specify a determined price for the related brand of the related item”.\n\n36  Subparagraph 99ACE(3)(b)(ii)\n\nOmit “subsections (5), (5A) and (5B), does not exceed the agreed price”, substitute “subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price”.\n\n37  Subsection 99ACE(4)\n\nOmit “If a determination under section 85B was in force for the related brand of a related item”, substitute “If a price determination was in force for the related brand of the related item”.\n\n38  Paragraph 99ACE(4)(a)\n\nRepeal the paragraph, substitute:\n\n (a) in a price determination, specify a determined price for the related brand of the related item that:\n\n (i) comes into force on the reduction day; and\n\n (ii) subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%; or\n\n39  Paragraph 99ACE(4)(b)\n\nRepeal the paragraph, substitute:\n\n (b) in a price agreement, specify an agreed price for the related brand of the related item that:\n\n (i) comes into force on the reduction day; and\n\n (ii) subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%.\n\n40  After subsection 99ACE(4)\n\nInsert:\n\n (4A) If a determination under subsection 85B(3) was in force for a particular pack quantity of the related brand of the related item on the day before the reduction day, the Minister may, in a determination under subsection 85B(3), specify a claimed price for that pack quantity of the related brand of the related item that:\n\n (a) comes into force on the reduction day; and\n\n (b) subject to subsections (5), (5A) and (5B), does not exceed the claimed price in force for that pack quantity of the related brand of the related item on the day before that day, reduced by 16%.\n\nApportioning if pricing quantity changes\n\n (4B) If the pricing quantity of the related brand of the related item on the day before the reduction day is different from the pricing quantity of the related brand of the related item on the reduction day, then, for the purposes of subparagraphs (3)(a)(ii), (3)(b)(ii), (4)(a)(ii) and (4)(b)(ii), the approved ex‑manufacturer price of the related brand of the related item on the day before the reduction day is taken to be the amount worked out as follows:\n\n![](image.003.png)\n\nwhere:\n\nAEMP1 means the amount that was the approved ex‑manufacturer price of the related brand of the related item on the day before the reduction day.\n\nPQ1 means the pricing quantity of the related brand of the related item on the day before the reduction day.\n\nPQ2 means the pricing quantity of the related brand of the related item on the reduction day.\n\n41  Paragraphs 99ACE(5)(b) and (c)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n42  Subsection 99ACEA(4)\n\nRepeal the subsection, substitute:\n\n (4) Subject to subsection (5), the agreed price of the new brand of the trigger item that comes into force on the reduction day must not exceed the approved ex‑manufacturer price, on the day before the reduction day, of the existing brand of the existing item, reduced by the same amount that the approved ex‑manufacturer price of the existing brand of the existing item is reduced by on the reduction day under item 6 or 7 of the table in section 99ACF.\n\n43  Subsection 99ACEA(5)\n\nRepeal the subsection, substitute:\n\nApportioning if pricing quantity changes\n\n (5) If the pricing quantity of the existing brand of the existing item on the day before the reduction day is different from the pricing quantity of the existing brand of the existing item on the reduction day, then, for the purposes of subsection (4), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the reduction day is taken to be the amount worked out as follows:\n\n![](image.003.png)\n\nwhere:\n\nAEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the reduction day.\n\nPQ1 means the pricing quantity of the existing brand of the existing item on the day before the reduction day.\n\nPQ2 means the pricing quantity of the existing brand of the existing item on the reduction day.\n\n44  Paragraph 99ACF(1)(c)\n\nRepeal the paragraph, substitute:\n\n (c) on the day before the reduction day, an approved ex‑manufacturer price was, or one or more claimed prices were, in force for the listed brand of the pharmaceutical item;\n\n45  Subsection 99ACF(1)\n\nOmit “the agreed price is, or the determined price and the claimed price are,”, substitute “subject to subsection (2A), the approved ex‑manufacturer price is, and (if applicable) each of the claimed prices are,”.\n\n46  Paragraph 99ACF(2)(b)\n\nBefore “on the reduction day”, insert “subject to subsection (2A),”.\n\n47  Paragraph 99ACF(2)(b)\n\nOmit “approved price to pharmacists” (wherever occurring), substitute “approved ex‑manufacturer price”.\n\n48  Paragraph 99ACF(2)(c)\n\nRepeal the paragraph, substitute:\n\n (c) if, on the day before the reduction day and on the reduction day, a determination under subsection 85B(3) was in force in relation to a particular pack quantity of the listed brand of the pharmaceutical item—the claimed price for that pack quantity of the brand of the pharmaceutical item does not exceed the claimed price for the same pack quantity of the brand of the pharmaceutical item in force on the day before the reduction day, reduced by more than the percentage or amount specified in column 3 of the table for the section referred to in column 2.\n\n49  After subsection 99ACF(2)\n\nInsert:\n\nApportioning if pricing quantity changes\n\n (2A) If the pricing quantity of the listed brand of the pharmaceutical item on the day before the reduction day is different from the pricing quantity of the listed brand of the pharmaceutical item on the reduction day, then, for the purposes of subsection (1) and paragraph (2)(b), the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the day before the reduction day is taken to be the amount worked out as follows:\n\n![](image.003.png)\n\nwhere:\n\nAEMP1 means the amount that was the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the day before the reduction day.\n\nPQ1 means the pricing quantity of the listed brand of the pharmaceutical item on the day before the reduction day.\n\nPQ2 means the pricing quantity of the listed brand of the pharmaceutical item on the reduction day.\n\n50  Paragraph 99ACF(3)(b)\n\nOmit “the determined price and the claimed price, or the agreed price,”, substitute “the approved ex‑manufacturer price, and (if applicable) each claimed price,”.\n\n51  Subparagraph 99ACK(3)(b)(ii)\n\nRepeal the subparagraph, substitute:\n\n (ii) if, on the day before the reduction day concerned and on the reduction day concerned, a determination under subsection 85B(3) was in force in relation to a particular pack quantity of the brand of the pharmaceutical item—a percentage of the claimed price in force in relation to that pack quantity of the brand of the pharmaceutical item on the day before the reduction day concerned.\n\n52  Section 99AD (last paragraph)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n53  Subsection 99ADB(1) (definition of adjusted approved price to pharmacists)\n\nRepeal the definition.\n\n54  Subsection 99ADB(1) (definition of agreed quantity)\n\nRepeal the definition.\n\n55  Subsection 99ADB(1) (definition of approved ex‑manufacturer price)\n\nRepeal the definition.\n\n56  Subsections 99ADB(2) and (3)\n\nRepeal the subsections.\n\n57  Subsection 99ADB(7)\n\nRepeal the subsection, substitute:\n\n (7) A determination made under subsection (4) in relation to a brand of a pharmaceutical item may include the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item.\n\n58  Subsection 99ADH(3)\n\nOmit “approved price to pharmacists” (wherever occurring), substitute “approved ex‑manufacturer price”.\n\n59  At the end of subsection 99ADH(3)\n\nAdd:\n\nNote: If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity on the reduction day, then, for the purposes of subsection (3), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is worked out under subsection (4A).\n\n60  Subsection 99ADH(4)\n\nRepeal the subsection, substitute:\n\nClaimed price reduction\n\n (4) If, on the reduction day:\n\n (a) a determination under subsection 85B(3) is in force in relation to a particular pack quantity of the brand of the pharmaceutical item; and\n\n (b) the approved ex‑manufacturer price of the brand of the pharmaceutical item is reduced because of subsection (3);\n\nthen, on the reduction day the claimed price for that pack quantity of the brand of the pharmaceutical item is taken to be reduced by the percentage worked out as follows:\n\n![](image.004.png)\n\nwhere:\n\nAAEMP means the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item.\n\nAEMP means the amount that would have been the approved ex‑manufacturer price of the brand of the pharmaceutical item on the reduction day if the reduction under subsection (3) had not occurred.\n\nNote: If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity on the reduction day, then, for the purposes of subsection (4), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is worked out under subsection (4A).\n\nApportioning if pricing quantity changes\n\n (4A) If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity of the brand of the pharmaceutical item on the reduction day, then, for the purposes of subsections (3) and (4), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is taken to be the amount worked out as follows:\n\n![](image.005.png)\n\nwhere:\n\nPQ1 means the pricing quantity of the brand of the pharmaceutical item on the relevant day.\n\nPQ2 means the pricing quantity of the brand of the pharmaceutical item on the reduction day.\n\nWADP means the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item.\n\n61  After section 99ADH\n\nInsert:\n\n99ADHA  Price reduction for brands listing after end of data collection period\n\nWhen this section applies\n\n (1) This section applies if:\n\n (a) a determination under subsection 85(6) is in force on the reduction day in relation to a brand (the new brand) of a pharmaceutical item (the existing item); and\n\n (b) the determination came into force:\n\n (i) after the last day of the period in respect of which the weighted average disclosed price is determined for another brand (the existing brand) of the existing item; and\n\n (ii) before the reduction day; and\n\n (c) the approved ex‑manufacturer price of the existing brand of the existing item is reduced on the reduction day under subsection 99ADH(3).\n\nPrice reduction\n\n (2) On the reduction day, the approved ex‑manufacturer price of the new brand of the existing item is taken to be reduced to the same amount as the approved ex‑manufacturer price of the existing brand of the existing item on that day.\n\nClaimed price reduction\n\n (3) If, on the reduction day:\n\n (a) a determination under subsection 85B(3) is in force in relation to a particular pack quantity of the new brand of the existing item; and\n\n (b) the approved ex‑manufacturer price of the new brand of the existing item is reduced because of subsection (2);\n\nthen, on the reduction day the claimed price for that pack quantity of the new brand of the existing item is taken to be reduced by the percentage worked out as follows:\n\n![](image.006.png)\n\nwhere:\n\nAEMP1 means the amount that would have been the approved ex‑manufacturer price of the new brand of the existing item on the reduction day if the reduction under subsection (2) had not occurred.\n\nAEMP2 means the approved ex‑manufacturer price of the new brand of the existing item on the reduction day.\n\n62  Paragraph 99AED(2)(d)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n63  Section 99AEI (heading)\n\nRepeal the heading, substitute:\n\n99AEI  Minister may increase approved ex‑manufacturer price if guaranteed brand delisted\n\n64  Paragraph 99AEI(2)(b)\n\nRepeal the paragraph, substitute:\n\n (b) under subsection 85B(2), make or vary a determination to increase the determined price; or\n\n (ba) under subsection 85B(3), make or vary a determination to increase one or more claimed prices;\n\n65  Subsection 99AEI(2)\n\nOmit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.\n\n\n\n\nPart 2—Application, saving and transitional provisions\n\nDivision 1—Preliminary\n\n66  Definitions\n\nIn this Part:\n\napproved ex‑manufacturer price of a brand of a pharmaceutical item on the commencement day means:\n\n (a) if item 68 or 69 applies to the brand of the pharmaceutical item—the amount worked out under item 70; and\n\n (b) if items 68 and 69 do not apply to the brand of the pharmaceutical item and a price agreement in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85AD(1) of the new Act—the amount in force under that agreement; and\n\n (c) if items 68 and 69 do not apply to the brand of the pharmaceutical item and a price determination in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85B(2) of the new Act—the amount in force under that determination.\n\nNote: For the purposes of paragraph (b), if item 73 applies to the brand of the pharmaceutical item, the new price agreement will also need to comply with the requirements of subitem 73(4).\n\napproved price to pharmacists of a brand of a pharmaceutical item has the same meaning as in subsection 98B(3) of the old Act.\n\ncommencement day means the day this Schedule commences.\n\ndetermined quantity of a brand of a pharmaceutical item has the same meaning as in subsection 84AK(3) of the new Act.\n\nmaximum quantity of a brand of a pharmaceutical item means any maximum quantity or number of units for which there is a determination in force under paragraph 85A(2)(a) of the new Act in relation to the brand of the pharmaceutical item.\n\nnew Act means the National Health Act 1953 as amended by this Act.\n\nold Act means the National Health Act 1953 as in force on the day before the commencement day.\n\npack quantity of a brand of a pharmaceutical item has the same meaning as in subsection 84AK(2) of the new Act.\n\npricing quantity of a brand of a pharmaceutical item has the same meaning as in subsection 84AK(1) of the new Act.\n\nquantity of a brand of a pharmaceutical item means the quantity or number of units of the brand of the pharmaceutical item.\n\nsection 100 only circumstances means circumstances determined in a determination in force under paragraph 85(8)(b) of the new Act in relation to a brand of a pharmaceutical item.\n\n67  Rounding amounts\n\nIf an amount worked out under this Part is not a number of whole cents, round the amount to the nearest cent (rounding 0.5 cents upwards).\n\nDivision 2—Converting approved price to pharmacists to approved ex‑manufacturer price of brands of pharmaceutical items (other than single brands of combination items)\n\n68  Price agreements\n\n(1) Subject to item 72, this item applies if:\n\n (a) a brand (the relevant brand) of a pharmaceutical item is a listed brand of the pharmaceutical item on both the commencement day and the day before that day; and\n\n (b) a price agreement in relation to the relevant brand of the pharmaceutical item is in force on the day before the commencement day under subsection 85AD(1) of the old Act.\n\nNote: Item 72 sets out situations when this item does not apply. One of those situations is when the brand of the pharmaceutical item is a single brand of a combination item (in which case, see item 73).\n\n(2) Despite the amendment made by item 14, on the commencement day:\n\n (a) the price agreement is taken to continue in force (and may be dealt with) on and after that day, as if it were made under subsection 85AD(1) of the new Act; and\n\n (b) the approved ex‑manufacturer price of the brand of pharmaceutical item on that day (see item 70) is taken to be the amount in force under the agreement; and\n\n (c) the pricing quantity of the brand of the pharmaceutical item on that day is taken to be the quantity by reference to which the amount was agreed.\n\n69  Price determinations\n\n(1) Subject to item 72, this item applies if:\n\n (a) a brand (the relevant brand) of a pharmaceutical item is a listed brand of the pharmaceutical item on both the commencement day and the day before that day; and\n\n (b) a price determination in relation to the relevant brand of the pharmaceutical item is in force on the day before the commencement day under subsection 85B(2) of the old Act.\n\nNote: Item 72 sets out situations when this item does not apply. One of those situations is when the brand of the pharmaceutical item is a single brand of a combination item (in which case, see item 73).\n\n(2) Despite the amendment made by item 16, on the commencement day:\n\n (a) the price determination is taken to continue in force (and may be dealt with) on and after that day, as if it were made under subsection 85B(2) of the new Act; and\n\n (b) the approved ex‑manufacturer price of the brand of pharmaceutical item on that day (see item 70) is taken to be the amount in force under the determination; and\n\n (c) the pricing quantity of the brand of the pharmaceutical item on that day is taken to be the quantity by reference to which the amount was determined.\n\n70  The approved ex‑manufacturer price on the commencement day\n\nFor the purposes of items 68 and 69, the approved ex‑manufacturer price of the relevant brand of the pharmaceutical item on the commencement day is:\n\n (a) if the regulations prescribe that an amount is to be the approved ex‑manufacturer price of the brand of the pharmaceutical item on the commencement day—that prescribed amount; and\n\n (b) otherwise—the default approved ex‑manufacturer price of the brand of the pharmaceutical item (see item 71).\n\n71  Working out the default approved ex‑manufacturer price\n\n(1) For the purposes of item 70, the default approved ex‑manufacturer price of the relevant brand of the pharmaceutical item is worked out as follows.\n\nStep 1—Identify the APP and agreed quantity\n\n(2) Identify the approved price to pharmacists (the relevant APP) of the relevant brand of the pharmaceutical item on the day before the commencement day, and the quantity (the agreed quantity) by reference to which the relevant APP was agreed or determined.\n\nStep 2—Work out the ex‑manufacturer price for the agreed quantity\n\n(3) List any maximum quantity or determined quantity on the commencement day of each listed brand of the pharmaceutical item on that day (other than any maximum quantity that relates to a supply of any of those brands in section 100 only circumstances).\n\n(4) From that list, identify the relevant quantity of the relevant brand of the pharmaceutical item, which is:\n\n (a) the quantity that is the highest whole number multiple of the agreed quantity of the relevant brand of the pharmaceutical item from:\n\n (i) any maximum quantity on the list; or\n\n (ii) if subparagraph (a)(i) does not apply—any determined quantity on the list; or\n\n (b) if paragraph (a) does not apply—the quantity that is the closest to the agreed quantity of the relevant brand of the pharmaceutical item (or, if 2 quantities are equally close, the higher of those quantities) from:\n\n (i) any maximum quantity on the list; or\n\n (ii) if subparagraph (b)(i) does not apply—any determined quantity on the list.\n\n(5) Work out the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item as follows:\n\n![](image.007.png)![](image.008.png)\n\nwhere:\n\nAPP means the relevant APP of the relevant brand of the pharmaceutical item.\n\nAQ means the agreed quantity of the relevant brand of the pharmaceutical item.\n\nPTP means the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item.\n\nRQ means the relevant quantity of the relevant brand of the pharmaceutical item.\n\n(6) If the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item is less than, or equal to, $1,000, then the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item is the amount worked out as follows:\n\n![](image.009.png)\n\nwhere:\n\nAPP means the relevant APP of the relevant brand of the pharmaceutical item.\n\nEMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.\n\n(7) If:\n\n (a) the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item is more than $1,000; and\n\n (b) the relevant quantity and the agreed quantity of the relevant brand of the pharmaceutical item are the same;\n\nthen the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item is the amount worked out as follows:\n\n![](image.010.png)\n\nwhere:\n\nAPP means the relevant APP of the relevant brand of the pharmaceutical item.\n\nEMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.\n\n(8) If:\n\n (a) the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item is more than $1,000; and\n\n (b) the relevant quantity and the agreed quantity of the relevant brand of the pharmaceutical item are not the same;\n\nthen the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item is the amount worked out as follows:\n\n![](image.011.png)\n\nwhere:\n\nAPP means the relevant APP of the relevant brand of the pharmaceutical item.\n\nAQ means the agreed quantity of the relevant brand of the pharmaceutical item.\n\nEMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.\n\nRQ means the relevant quantity of the relevant brand of the pharmaceutical item.\n\nStep 3—Work out the proportional ex‑manufacturer price\n\n(9) Work out the proportional ex‑manufacturer price for the pricing quantity of the relevant brand of the pharmaceutical item on the commencement day as follows:\n\n![](image.012.png)\n\nwhere:\n\nAQ means the agreed quantity of the relevant brand of the pharmaceutical item.\n\nEMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.\n\nPEMP means the proportional ex‑manufacturer price for the pricing quantity of the relevant brand of the pharmaceutical item.\n\nPQ means the pricing quantity of the relevant brand of the pharmaceutical item on the commencement day.\n\nStep 4—Repeat steps 1 to 3 for each relevant brand\n\n(10) Repeat steps 1 to 3 above for each approved price to pharmacists of each relevant brand of the pharmaceutical item on the day before the commencement day.\n\nStep 5—Work out the default approved ex‑manufacturer price\n\n(11) The default approved ex‑manufacturer price of the relevant brand of the pharmaceutical item, and each of the relevant brands of the pharmaceutical item, on the commencement day is:\n\n (a) if, under subitem (9), there was only one proportional ex‑manufacturer price worked out for all of the relevant brands of the pharmaceutical item—the amount worked out under subitem (9); and\n\n (b) if, under subitem (9), there was more than one proportional ex‑manufacturer price worked out for those brands:\n\n (i) if the amount worked out under subitem (9) is the same for all of those brands—that amount; or\n\n (ii) otherwise—the lowest amount worked out under that subitem for all of those brands.\n\n72  When price agreements or determinations are not preserved under item 68 or 69\n\n(1) Items 68 and 69 do not apply to continue in force a price agreement (the relevant agreement) or price determination (the relevant determination) in relation to a brand of a pharmaceutical item that was in force on the day before the commencement day if:\n\n (a) a new price agreement in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85AD(1) of the new Act; or\n\n (b) a new price determination in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85B(2) of the new Act; or\n\n (c) item 73 (which is about single brands of combination items) applies to the brand of the pharmaceutical item; or\n\n (d) both of the following subparagraphs apply:\n\n (i) there was another price agreement or price determination in relation to the brand of the pharmaceutical item in force on the day before the commencement day;\n\n (ii) the amount in force under that other agreement or determination was agreed or determined by reference to a quantity of the brand of the pharmaceutical item that is equal to the pricing quantity of the brand of the pharmaceutical item on the commencement day.\n\n(2) Item 68 also does not apply to continue in force the relevant agreement if:\n\n (a) there was another price agreement in relation to the brand of the pharmaceutical item in force on the day before the commencement day; and\n\n (b) the amount in force under that other agreement was agreed by reference to a quantity of the brand of the pharmaceutical item that is less than the quantity by which the amount of the relevant agreement was agreed.\n\n(3) Item 69 also does not apply to continue in force the relevant determination if:\n\n (a) there was a price agreement in relation to the brand of the pharmaceutical item in force on the day before the commencement day; or\n\n (b) both of the following subparagraphs apply:\n\n (i) there was another price determination in relation to the brand of the pharmaceutical item in force on the day before the commencement day;\n\n (iii) the amount in force under that other determination was determined by reference to a quantity of the brand of the pharmaceutical item that is less than the quantity by which the amount of the relevant determination was determined.\n\n(4) If, because of subitem (1), (2) or (3), item 68 or 69 does not apply to continue in force the relevant agreement or relevant determination, then the relevant agreement or relevant determination ceases to have effect at the end of the day before the commencement day.\n\nDivision 3—Converting approved price to pharmacists to approved ex‑manufacturer price of single brands of combination items\n\n73  Price agreements for single brands of combination items\n\n(1) This item applies to a brand (the relevant brand) of a pharmaceutical item that is a combination item if:\n\n (a) on the commencement day, subsection 85AB(5) of the new Act applies to the drug in a combination item; and\n\n (b) on both the commencement day and the day before that day, the relevant brand of the combination item is the only listed brand of the combination item; and\n\n (c) on the commencement day or the day before that day, there is or was no listed brand of another combination item that:\n\n (i) is bioequivalent or biosimilar to the relevant brand of the combination item; and\n\n (ii) has the same manner of administration as the relevant brand of the combination item; and\n\n (d) on the day before the commencement day, a price agreement (the existing price agreement) was in force for the relevant brand of the combination item.\n\n(2) The existing price agreement ceases to have effect at the end of the day before the commencement day.\n\n(3) The Minister may make a new agreement under subsection 85AD(1) of the new Act that comes into force on the commencement day.\n\n(4) For the purposes of subitem (3), in agreeing the approved ex‑manufacturer price of the relevant brand of the combination item under the new agreement the Minister must take into account, in relation to each listed component drug in the combination item:\n\n (a) the approved ex‑manufacturer price, on the commencement day, of each brand of a pharmaceutical item that:\n\n (i) has the listed component drug in the combination item; and\n\n (ii) has the same manner of administration as the relevant brand of the combination item; and\n\n (b) the quantity of the listed component drug in the combination item.\n\n(5) For the purposes of subitem (3), if the Pharmaceutical Benefits Advisory Committee has given advice to the Minister under subsection 101(4AC) of the old Act in relation to the combination item, then the Minister may take that advice into account in agreeing the approved ex‑manufacturer price of the relevant brand of the combination item under the new agreement.\n\n(6) This item does not limit the Minister’s powers, after the commencement day, to make further price agreements in relation to the brand of the combination item.\n\nDivision 4—Converting claimed prices of brands of pharmaceutical items\n\n74  Claimed prices\n\n(1) This item applies if:\n\n (a) a brand (the relevant brand) of a pharmaceutical item is a listed brand of the pharmaceutical item on both the commencement day and the day before that day; and\n\n (b) a determination in relation to a quantity of the relevant brand of the pharmaceutical item is in force under subsection 85B(3) of the old Act on the day before the commencement day; and\n\n (c) the quantity is a pack quantity on the commencement day; and\n\n (d) a determination in relation to that quantity of the relevant brand of the pharmaceutical item does not come into force on the commencement day under subsection 85B(3) of the new Act; and\n\n (e) before the commencement day, the responsible person for the brand does not notify the Minister, in writing, that the responsible person does not claim a price for that quantity on the commencement day.\n\n(2) Despite the amendment made by item 16, on the commencement day:\n\n (a) the determination referred to in paragraph (1)(b) is taken to continue in force (and may be dealt with) on and after that day, as if it were made under subsection 85B(3) of the new Act; and\n\n (b) the claimed price for that quantity of the brand of pharmaceutical item on that day (see item 75) is taken to be the amount in force under the determination.\n\n75  The claimed price on the commencement day\n\n(1) For the purposes of item 74, the claimed price for a quantity of the relevant brand of the pharmaceutical item on the commencement day is worked out as follows.\n\nStep 1—Identify the claimed price and relevant quantity\n\n(2) Identify:\n\n (a) the amount (the old claimed price) specified in a determination in force under subsection 85B(3) of the old Act in relation to the relevant brand of the pharmaceutical item on the day before the commencement day; and\n\n (b) the quantity (the relevant quantity) by reference to which the claimed price of the brand of the pharmaceutical item was determined.\n\nStep 2—Identify the old determined price for that quantity\n\n(3) Identify the amount (the old determined price) specified in a determination in force under subsection 85B(2) of the old Act in relation to the relevant quantity of the relevant brand of the pharmaceutical item on the day before the commencement day.\n\nStep 3—Identify the new price for that quantity\n\n(4) Identify the amount (the new price) for the relevant brand of the pharmaceutical item, which is:\n\n (a) if, on the commencement day, the relevant quantity is a pricing quantity of the brand of the pharmaceutical item—the approved ex‑manufacturer price of the relevant brand of the pharmaceutical item on the commencement day; and\n\n (b) if, on the commencement day, the relevant quantity is not a pricing quantity of the brand of the pharmaceutical item—the proportional ex‑manufacturer price for that quantity of the relevant brand of the pharmaceutical item on the commencement day worked out under section 85D of the new Act.\n\nStep 4—Work out the percentage difference\n\n(5) Work out the percentage (the relevant percentage) by which the new price is greater or lesser than the old determined price.\n\nStep 5—Work out the claimed price\n\n(6) The claimed price for the relevant quantity of the relevant brand of the pharmaceutical item on the commencement day is:\n\n (a) if the new price is greater than the old determined price—the old claimed price increased by the relevant percentage; and\n\n (b) if the new price is less than the old determined price—the old claimed price decreased by the relevant percentage; and\n\n (c) if the new price is the same as the old determined price—the old claimed price.\n\nDivision 5—Other\n\n76  Application of amendments (other than those relating to price disclosure)\n\nThe amendments made by Part 1 (other than items 52 to 61) of this Schedule apply on and after the commencement day in relation to supplies of pharmaceutical benefits made on or after that day.\n\n77  Application of amendments and transitional provision relating to price disclosure\n\nApplication\n\n(1) The amendments made by items 52 to 61 of this Schedule apply on and after the commencement day in relation to supplies of pharmaceutical benefits made before, on or after that day.\n\nTransitional provision\n\n(2) The Minister may, for the purposes of determining the weighted average disclosed price of the brand of the pharmaceutical item under subsection 99ADB(4) of the new Act after the commencement day, work out the amount of that weighted average disclosed price by reference to information about supplies of pharmaceutical items before or on the commencement day.\n\n(3) Subject to subitems (4) and (5), if:\n\n (a) before the commencement day, the Minister determines the weighted average disclosed price of the brand of the pharmaceutical item under subsection 99ADB(4) of the old Act; and\n\n (b) before the commencement day, the Minister determines a reduction day for the brand of the pharmaceutical item for the purposes of section 99ADH of the old Act; and\n\n (c) the reduction day is after the commencement day;\n\nthen, for the purposes of applying section 99ADH of the new Act to the brand of the pharmaceutical item on or after the commencement day, the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item on the reduction day referred to in paragraph (b) is the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item referred to in paragraph (a).\n\n(4) If, on or after the commencement day, the Minister:\n\n (a) revokes the determination referred to in paragraph (3)(a); and\n\n (b) determines a new weighted average disclosed price of the brand of the pharmaceutical item under subsection 99ADB(4) of the new Act;\n\nthen a reference in subitem (3) to the weighted average disclosed price of the brand of the pharmaceutical item is taken to be a reference to the new weighted average disclosed price referred to in paragraph (a) of this subitem.\n\n(5) If, on or after the commencement day, the Minister:\n\n (a) revokes the determination referred to in paragraph (3)(b); and\n\n (b) determines a new reduction day for the brand of the pharmaceutical item for the purposes of section 99ADH of the new Act;\n\nthen a reference in subitem (3) to the reduction day of the brand of the pharmaceutical item is taken to be a reference to the new reduction day referred to in paragraph (b) of this subitem.\n\n78  Making price agreements before the commencement day\n\nSection 4 of the Acts Interpretation Act 1901 applies in relation to the power to make an agreement under subsection 85AD(1) of the new Act in the same way it would apply if the power to make an agreement under that subsection were a power to make an appointment.\n\n79  Reductions to the AEMP to include previous reductions to the APP\n\nOn and after the commencement day, a reference to the approved ex‑manufacturer price of a brand of a pharmaceutical item in subsection 99ACD(6), 99ACE(5) or 99AEI(2) of the new Act is taken to include a reference to the approved price to pharmacists of the brand of the pharmaceutical item in force on any day before the commencement day.\n\n80  Transitioning regulations made for paragraph 99ACK(3)(b)\n\nRegulations that:\n\n (a) were made for the purposes of paragraph 93ACK(3)(b) of the old Act; and\n\n (b) were in force immediately before the commencement day;\n\ncontinue in force (and may be dealt with) on and after that day as if they had been made for the purposes of paragraph 93ACK(3)(b) of the new Act.\n\n81  Regulations\n\n(1) The regulations may prescribe matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments and repeals made by this Schedule.\n\n(2) The Governor‑General may make regulations prescribing matters:\n\n (a) required or permitted by this Schedule to be prescribed; or\n\n (b) necessary or convenient to be prescribed for carrying out or giving effect to this Schedule.\n\n\n\n\nSchedule 2—Price disclosure\n\nPart 1—Amendments\n\nNational Health Act 1953\n\n1  Subsection 99ADB(1) (definition of adjusted approved ex‑manufacturer price)\n\nRepeal the definition, substitute:\n\nadjusted approved ex‑manufacturer price of a brand of a pharmaceutical item is the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item.\n\n2  Subsection 99ADB(1) (definition of applicable approved ex‑manufacturer price)\n\nRepeal the definition, substitute:\n\napplicable approved ex‑manufacturer price: see subsection (3A).\n\n3  Subsection 99ADB(1)\n\nInsert:\n\nrelevant day means:\n\n (a) if 30 September 2012 is the last day of the period in respect of which the weighted average disclosed price of a brand of the pharmaceutical item is determined—1 October 2012; and\n\n (b) otherwise—the last day of the period in respect of which the weighted average disclosed price of the brand of the pharmaceutical item is determined.\n\n4  Before subsection 99ADB(4)\n\nInsert:\n\nApplicable approved ex‑manufacturer price\n\n (3A) The applicable approved ex‑manufacturer price of a brand of a pharmaceutical item is the approved ex‑manufacturer price of the brand on the relevant day.\n\n (3B) For the purposes of subsection (3A), if:\n\n (a) apart from this subsection, the brand of the pharmaceutical item would not have an approved ex‑manufacturer price on the relevant day; and\n\n (b) the brand of the pharmaceutical item has an approved ex‑manufacturer price before the first reduction day that:\n\n (i) is determined under paragraph 99ADH(1)(aa) in relation to the brand of the pharmaceutical item; and\n\n (ii) occurs after the relevant day;\n\nthen:\n\n (c) the regulations may prescribe the approved ex‑manufacturer price, or a method or formula for working out the approved ex‑manufacturer price, of the brand of the pharmaceutical item on the relevant day; and\n\n (d) if the regulations do so, the amount so worked out is taken to be the approved ex‑manufacturer price of the brand of the pharmaceutical item on the relevant day.\n\n5  Section 99ADJ\n\nRepeal the section.\n\n\n\n\nPart 2—Application provision\n\n6  Application provision\n\nThe amendments made by this Schedule apply on and after the day this Schedule commences in relation to supplies of pharmaceutical benefits made before, on or after that day.\n\n\n\n\nSchedule 3—Prescriber bag supplies\n\nPart 1—Amendments\n\nNational Health Act 1953\n\n1  Subsection 84(1)\n\nInsert:\n\nprescriber bag provisions means the following:\n\n (a) section 93 (supplies by medical practitioners);\n\n (b) section 93AA (supplies by authorised midwives);\n\n (c) section 93AB (supplies by authorised nurse practitioners).\n\n2  Subsection 85(1) (note 1)\n\nOmit “(see section 85AA) can only be supplied under this Part”, substitute “(see sections 85AAA and 85AA) can only be supplied under this Part under the prescriber bag provisions or”.\n\n3  After subsection 85(2)\n\nInsert:\n\nDrugs etc. that can only be supplied under the prescriber bag provisions\n\n (2AA) If:\n\n (a) the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and\n\n (b) the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AACA) that the drug be supplied only under one or more of the prescriber bag provisions;\n\nthen the Minister must, by legislative instrument, declare that the drug can only be supplied under that provision or those provisions.\n\nNote: If the Minister makes a declaration in relation to a drug or medicinal preparation under this subsection, the Minister cannot vary or revoke that declaration without first satisfying the conditions set out in subsection 101(4AACC).\n\n4  After subsection 85(7)\n\nInsert:\n\nPharmaceutical benefits that can only be supplied under the prescriber bag provisions\n\n (7A) The Minister may, by legislative instrument, determine that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions.\n\n5  After section 85\n\nInsert:\n\n85AAA  Pharmaceutical benefits that can only be supplied under the prescriber bag provisions\n\n (1) If the Minister makes a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation (the drug) declaring that the drug can only be supplied under one or more of the prescriber bag provisions, then every pharmaceutical benefit that has that drug can only be supplied under this Part under that provision or those provisions.\n\n (2) If the Minister makes a determination under subsection 85(7A) that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions, then that pharmaceutical benefit can only be supplied under this Part under that provision or those provisions.\n\n (3) Despite subsections (1) and (2), if:\n\n (a) the Minister makes a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more (but not all) of the prescriber bag provisions (the drug prescriber bag provision); and\n\n (b) the Minister makes a determination under subsection 85(7A) determining that a pharmaceutical benefit that has the drug can only be supplied under a different prescriber bag provision or different prescriber bag provisions (the pharmaceutical benefit prescriber bag provision);\n\nthen the pharmaceutical benefit can only be supplied under this Part under the drug prescriber bag provision and the pharmaceutical benefit prescriber bag provision.\n\n6  Paragraph 89(b)\n\nAfter “section 93AA,”, insert “section 93AB,”.\n\n7  Section 93 (heading)\n\nRepeal the heading, substitute:\n\n93  Prescriber bag supplies—medical practitioners\n\n8  Subsection 93(1)\n\nAfter “Minister”, insert “, by legislative instrument,”.\n\n9  Subsection 93(2)\n\nAfter “Minister may”, insert “, by legislative instrument,”.\n\n10  Subsection 93(2A)\n\nRepeal the subsection.\n\n11  Section 93AA\n\nRepeal the section, substitute:\n\n93AA  Prescriber bag supplies—authorised midwives\n\n (1) Except as prescribed by the regulations, an authorised midwife is authorised to supply such pharmaceutical benefits as the Minister, by legislative instrument, determines to persons who are entitled under this Part to receive those pharmaceutical benefits.\n\n (2) For the purposes of this section, the Minister may, by legislative instrument, determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by an authorised midwife during a specified period.\n\n (3) The regulations may make provision for or in relation to the obtaining of pharmaceutical benefits by an authorised midwife for the purposes of this section.\n\n (4) The regulations may make provision for or in relation to payments by the Commonwealth in respect of the supply of pharmaceutical benefits under this section.\n\n93AB  Prescriber bag supplies—authorised nurse practitioners\n\n (1) Except as prescribed by the regulations, an authorised nurse practitioner is authorised to supply such pharmaceutical benefits as the Minister, by legislative instrument, determines to persons who are entitled under this Part to receive those pharmaceutical benefits.\n\n (2) For the purposes of this section, the Minister may, by legislative instrument, determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by an authorised nurse practitioner during a specified period.\n\n (3) The regulations may make provision for or in relation to the obtaining of pharmaceutical benefits by an authorised nurse practitioner for the purposes of this section.\n\n (4) The regulations may make provision for or in relation to payments by the Commonwealth in respect of the supply of pharmaceutical benefits under this section.\n\n12  After subsection 101(4AAC)\n\nInsert:\n\nFunctions relating to declarations under subsection 85(2AA)\n\n (4AACA) The Pharmaceutical Benefits Advisory Committee must make recommendations to the Minister from time to time as to the drugs and medicinal preparations which it considers should only be supplied under one or more of the prescriber bag provisions.\n\n (4AACB) The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation.\n\n (4AACC) If:\n\n (a) under subsection (4AACB), the Minister proposes to revoke or vary a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more of the prescriber bag provisions; and\n\n (b) on and after the day the revocation or variation comes into force, the drug could be supplied under this Part otherwise than under one or more of the prescriber bag provisions;\n\nthen the Minister can only make the revocation or variation if:\n\n (c) the Minister also revokes or varies the declaration under subsection 85(2), in accordance with subsections (4AAA), (4AAB) and (4AAC) of this section, so that the drug ceases to be a listed drug on and after the day the revocation or variation of the subsection 85(2) declaration comes into force; or\n\n (d) the Pharmaceutical Benefits Advisory Committee recommends against the Minister taking the action in paragraph (c).\n\n13  Subparagraph 133(1)(bc)(ii)\n\nOmit “93AA”, substitute “93AB”.\n\n14  Paragraph 134(4)(d)\n\nRepeal the paragraph, substitute:\n\n (d) an authority conferred upon an authorised midwife by section 93AA;\n\n (e) an authority conferred upon an authorised nurse practitioner by section 93AB.\n\n15  Paragraph 139A(1)(de)\n\nAfter “93AA”, insert “or 93AB”.\n\n\n\n\nPart 2—Application, saving and transitional provisions\n\n16  Definitions\n\nIn this Part:\n\ncommencement day means the day this Schedule commences.\n\nNational Health Act means the National Health Act 1953.\n\n17  Application of amendments\n\nThe amendments made by this Schedule apply on and after the commencement day in relation to supplies of pharmaceutical benefits made on or after that day.\n\n18  Transitioning subordinate legislation relating to prescriber bag supplies\n\n(1) A legislative instrument that:\n\n (a) was made for the purposes of subsection 85(2A) of the National Health Act; and\n\n (b) declared that the drug methoxyflurane can only be supplied under special arrangements under section 100 of the National Health Act; and\n\n (c) was in force immediately before the commencement day;\n\ncontinues in force (and may be dealt with) on and after that day as if:\n\n (d) it had been made for the purposes of subsection 85(2AA) of the National Health Act (as amended by this Act); and\n\n (e) it declared that methoxyflurane can only be supplied under section 93 of the National Health Act (as amended by this Act).\n\n(2) Regulations that:\n\n (a) were made for the purposes of section 93AA of the National Health Act; and\n\n (b) were in force immediately before the commencement day;\n\ncontinue in force (and may be dealt with) on and after that day as if they had been made for the purposes of sections 93AA and 93AB of the National Health Act (as amended by this Act).\n\n(3) A legislative instrument that:\n\n (a) was made for the purposes of section 93AA of the National Health Act; and\n\n (b) was in force immediately before the commencement day;\n\ncontinues in force (and may be dealt with) on and after that day as if it had been made for the purposes of section 93AB of the National Health Act (as amended by this Act).\n\n \n\n \n\n \n\n[Minister’s second reading speech made in—\n\nHouse of Representatives on 23 May 2012\n\nSenate on 18 June 2012]\n\n(78/12)\n\n \n","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"The amendments keep the PBS framework but materially broaden the statutory pricing architecture. Originally the PBS used the ‘approved price to pharmacists’ as the statutory price benchmark; this Act replaces that with an ex‑manufacturer price measure and builds a parallel system of quantity definitions, proportional pricing formulas, and price‑disclosure links. It also adds a separate set of prescriber‑bag supply powers for midwives and nurse practitioners and new PBAC advisory functions. In short, the law grows from a single technical change (price base) into a package that changes pricing mechanics, embeds transaction‑level price disclosure into statutory adjustments, and adjusts supply‑by‑prescribers arrangements — increasing regulatory discretion and operational complexity compared with the original single‑purpose proposition."},"complexity_factors":["Extensive replacement of a core defined term across many sections (the old “approved price to pharmacists” removed and substituted with AEMP across Parts VII and IX)","Introduction of 4 new/altered defined concepts (pricing quantity, pack quantity, determined quantity, proportional ex‑manufacturer price) with ministerial instrument powers (new s84AK)","Numerous cross‑references and interdependencies between s85B, s85AD, s99AC–99ADH, and other pricing/reduction provisions (many items amend related subsections)","Multiple conditional, numeric apportionment formulas (apportioning when pricing quantity changes) repeated in several sections (items 26, 31, 40, 43, 49, etc.)","Complex transitional conversion algorithm (five step method) to convert existing approved price to pharmacists into default AEMP on commencement day (items 70–71)","Price‑disclosure integration: defines adjusted AEMP as weighted average disclosed price and introduces ‘relevant day’ and ‘applicable AEMP’ rules (Schedule 2, items 1–4)","Specific percentage reduction mechanics and claimed‑price reduction rules (including 16% reduction mechanism and formulae in ss99ACE/99ACEA family)","Addition of prescriber‑bag regime changes and new PBAC advisory duties, expanding functional scope (Schedule 3)","Heavy reliance on subordinate instruments/regulations for key details (Minister to determine pack quantities, prescriber supplies limits, regulation may prescribe AEMP when lacking)"],"plain_english_summary":"**What this law changes, mechanically**\n\n- Renames and reworks the basic pricing measure used across the Pharmaceutical Benefits Scheme (PBS). The previous concept “approved price to pharmacists” (the price that included pharmacist mark-up) is replaced with an **approved ex‑manufacturer price (AEMP)** — a price measured at the manufacturer level (Schedule 1, items 1–3, 21, many substitutions across Part VII).\n\n- Introduces three quantity concepts and gives the Minister power to declare them by legislative instrument:\n  - **pricing quantity** (the smallest pack size used for price-setting),\n  - **pack quantity** (one or more pack sizes for a brand), and\n  - **determined quantity** (quantities the Minister can specify for other purposes) (Schedule 1, item 13; new s84AK).\n\n- Requires price agreements and price determinations to be set by reference to the **pricing quantity** (Schedule 1, items 14 and 16; new/altered s85AD and s85B).\n\n- Requires that where multiple brands of the same pharmaceutical item are listed, the Minister must ensure **each brand has the same approved ex‑manufacturer price** (Schedule 1, item 17; new s85C).\n\n- Adds a mathematical method to convert an AEMP for the pricing quantity into a **proportional ex‑manufacturer price** for other pack sizes (Schedule 1, item 17; new s85D — includes formula).\n\n- Keeps and reworks many downstream, technical provisions so existing mechanisms that depend on the old price measure continue to operate but now reference AEMP or proportional AEMP instead of the old approved price to pharmacists (Schedule 1, many items replacing terminology across ss99A–99ADH and related sections).\n\n- Sets out detailed transitional rules converting existing “approved price to pharmacists” agreements, determinations and claimed prices into the new AEMP framework on commencement day (Schedule 1, Part 2, items 66–81). This conversion is multi‑step and includes:\n  - a default calculation method to derive an AEMP from the old approved price to pharmacists and quantities (items 70–71);\n  - special rules for single brands of combination items (item 73);\n  - rules for claimed prices and apportioning when pricing quantities change (items 74–75 and multiple apportioning provisions such as items 26, 31, 40, 43, 49).\n\n- Revises the price‑disclosure mechanism: the “adjusted approved ex‑manufacturer price” is explicitly defined as the **weighted average disclosed price**; introduces an “applicable” AEMP and clarifies the relevant day for calculations; allows regulations to prescribe an AEMP where needed for disclosure calculations (Schedule 2, Part 1, items 1–5).\n\n- Expands the “prescriber bag” rules (the limited supply of medicines by prescribers outside ordinary pharmacy dispensing):\n  - formalises that the Minister can declare by legislative instrument that particular drugs or pharmaceutical benefits can only be supplied under specified prescriber‑bag provisions (Schedule 3, items 2–5; new s85AAA and amendments to s85);\n  - authorises the Minister, by legislative instrument, to determine what authorised midwives and nurse practitioners can supply, and to set maximum quantities for them; gives the regulations scope to address payment arrangements for these supplies (Schedule 3, items 11 and 5; new ss93AA and 93AB).\n\n**Who is affected**\n\n- **Manufacturers (responsible persons)**: AEMP is the new focal price. Manufacturers will negotiate price agreements with the Minister or be subject to price determinations set by reference to the pricing quantity (Schedule 1, items 14–16). Equal AEMP across brands of the same item changes competitive pricing incentives (new s85C).\n\n- **Pharmacists**: Their historic “approved price to pharmacists” is removed as the legal PBS benchmark. PBS reimbursements and many downstream calculations are shifted to AEMP or proportional AEMP; pharmacists’ margins are no longer embedded in the principal statutory price measure (multiple substitutions throughout Schedule 1).\n\n- **Patients and the Commonwealth payer**: Commonwealth subsidy calculations and special patient contributions are re‑specified to work off AEMP and proportional AEMP (Schedule 1, item 16; new s85B and amended s85B(5)). The law also contains explicit formulas for reductions (for example, 16% reductions in certain circumstances in ss99ACE/99ACEA family of provisions) and adjusts how claimed prices and reductions are applied.\n\n- **Regulators and the Minister**: The Minister gains administrative powers to set pack/pricing/determined quantities, to declare drugs restricted to prescriber bag supply, and to make price agreements or determinations by legislative instrument. The Pharmaceutical Benefits Advisory Committee (PBAC) gets added functions to advise on which drugs should be restricted to prescriber‑bag arrangements (Schedule 3, items 12).\n\n- **Authorised midwives and nurse practitioners**: They are explicitly authorised (subject to regulations and Ministerial instruments) to supply PBS items specified by the Minister and may be subject to quantity limits and payment rule changes (Schedule 3, items 11 and 5; new ss93AA and 93AB).\n\n**Why it matters (stated aims and practical testing of effects)**\n\n- The stated aim in the drafting is to move price‑setting to an ex‑manufacturer base (AEMP) and to improve price disclosure while modernising supply arrangements for prescribers (Schedule 1 & 2 explanatory content implied by reforms). Shifting to AEMP focuses statutory price control at the manufacturer level rather than the pharmacy retail level.\n\n- Testing that claim against likely costs, incentives and trade‑offs:\n  - Who decides: the Minister (and delegated regulatory instruments) now has clearer and broader powers to set pack/pricing/determined quantities and to make price agreements/determinations (new s84AK, s85AD, s85B). That concentrates implementation discretion in the executive and increases reliance on subordinate instruments.\n  - Who pays: the Commonwealth remains the payer under PBS, but the base for reimbursement calculations shifts from a pharmacist‑facing price to a manufacturer‑facing price. That changes how much the Commonwealth reimburses directly and indirectly affects pharmacist margins and retail pricing (see new s85B and amendments across Part VII).\n  - Incentives for manufacturers: equalising AEMP across brands of the same item reduces the statutory price difference between brands — this tends to compress manufacturer‑level price differentials and can affect competitive positioning and product‑level margins (new s85C).\n  - Incentives for pharmacists: because the statutory benchmark no longer embeds pharmacy mark‑ups, pharmacists’ revenue calculations and business incentives may change; the Act relies on other provisions and regulations to preserve payment mechanisms to pharmacists, but the core legal measure is changed (multiple replacements of terminology throughout Schedule 1).\n  - Administrative and compliance costs: the conversion rules (Schedule 1 Part 2) are numerically detailed and require data on pack sizes, agreed quantities, weighted average disclosed prices, rounding rules and transitional apportioning. Implementing and auditing these conversions and ongoing proportional pricing formulas will be administratively intensive for the Department, industry and possibly courts (items 70–71, many apportioning formulas such as items 26, 31, 40, 43, 49, and Schedule 2 changes).\n  - Price‑disclosure interactions: defining the adjusted AEMP as the weighted average disclosed price brings commercial transaction data into statutory price adjustments (Schedule 2, item 1). This can improve alignment of statutory prices with observed market prices, but it creates data‑collection, confidentiality and verification tasks and introduces potential timing mismatches (see new definitions and relevant day rule, Schedule 2, items 3–4).\n  - Potential for substitution and gaming: ministerial powers to set pack/pricing quantities and declared restrictions on supply (prescriber bag) create levers that could change firm strategies (e.g., firms altering pack sizes to influence pricing calculation, or seeking special declarations). The law attempts to manage this by prescribing the pricing quantity as the lowest pack size and by specific apportioning rules, but those levers remain.\n  - Implementation risk and opportunity cost: moving a long‑standing PBS pricing architecture to a new base requires significant operational change (IT, contracts, regulatory instruments, industry education). That takes resources and creates short‑term risk of mis‑calculation or dispute; the Act includes transitional saving provisions and regulation‑making powers to manage that (Schedule 1 Part 2, items 76–81).\n\n**Concrete mechanisms to note (sections to consult directly for operations)**\n- New quantity definitions and ministerial instrument powers: s84AK (Schedule 1, item 13).\n- New price‑setting provisions and special patient contribution definitions: s85B (Schedule 1, item 16) and s85C (equal AEMP) and s85D (proportional AEMP) (Schedule 1, items 16–17).\n- Conversion of existing contracts and prices on commencement and the calculation algorithm: Schedule 1, Part 2 (items 66–75, in particular items 70–71 explain the multi‑step conversion formula).\n- Price‑disclosure changes linking adjusted AEMP to weighted average disclosed price: Schedule 2 (items 1–5).\n- Prescriber bag expansion and powers for midwives/nurse practitioners: Schedule 3 (items 2–12; new ss85AAA, 93AA, 93AB and PBAC functions in s101 additions).\n\nSummary sentence: The Act replaces the pharmacist‑facing statutory price measure with an ex‑manufacturer price, creates a small taxonomy of pack/pricing/determined quantities with ministerial instrument powers, prescribes formulas to apply proportional prices across pack sizes, embeds price‑disclosure data into price adjustments, and adds rules authorising (and limiting) supply of specified drugs via prescriber‑bag arrangements for midwives and nurse practitioners — all accompanied by elaborate transitional rules to convert existing PBS prices and agreements into the new framework."},"kimi_summary":{"content_quality":"ok","complexity_score":8,"scope_assessment":{"changed":false,"description":"The legislation remains focused on its original purpose of reforming PBS pricing mechanisms and expanding prescriber authorities. While Schedule 1 contains extensive technical detail for price conversion, this implements the intended pricing reform rather than expanding beyond it. The prescriber bag provisions in Schedule 3 stay within the health workforce scope indicated by the title."},"complexity_factors":["Extensive mathematical formulas for price calculations (5 separate algebraic formulas in Schedule 1 alone)","Multi-layered transitional provisions spanning 16 items (items 66-81) with step-by-step conversion algorithms","Nested conditional logic: e.g., item 71 has 8 subitems with cascading 'if/then' conditions based on price thresholds ($1,000 cut-off) and quantity comparisons","Cross-referencing between old Act and new Act definitions throughout transitional provisions","Special carve-outs for 'single brands of combination items' requiring separate calculation methods (Division 3)","Defined terms section in item 66 contains 10 complex definitions including recursive references to new Act provisions","Price disclosure amendments (Schedule 2) introduce temporal concepts ('relevant day', 'reduction day') requiring tracking of multiple date-based triggers","Prescriber bag provisions create overlapping authority structures between drug-level declarations and benefit-level determinations (section 85AAA)"],"plain_english_summary":"This Act makes three major changes to how the Pharmaceutical Benefits Scheme (PBS) works—the government program that subsidises prescription medicines for Australians.\n\n**1. Changing how medicine prices are set (Schedule 1)**\nThe Act replaces the old \"approved price to pharmacists\" system with a new \"approved ex‑manufacturer price\" (AEMP) system. This means:\n- Prices are now set based on what the manufacturer charges, not what the pharmacist pays\n- The \"pricing quantity\" (usually the smallest pack size) becomes the standard reference point for all pricing\n- All brands of the same medicine must have the same base price\n- Special rules apply for calculating prices when pack sizes change\n- Complex transitional rules convert old prices to the new system\n\n**2. Price disclosure rules (Schedule 2)**\nThis tightens up how the government uses actual market price data to reduce PBS prices. It ensures that when the government calculates price reductions based on what manufacturers are really charging, it uses the correct baseline price.\n\n**3. Prescriber bag supplies (Schedule 3)**\nThis expands which health professionals can supply emergency medicines directly to patients:\n- **Medical practitioners** (doctors) – already had this power, now clarified\n- **Authorised midwives** – can supply specific medicines to their patients\n- **Authorised nurse practitioners** – new category, can also supply specific medicines\n\nThe Minister can now declare that certain medicines can only be supplied through these \"prescriber bag\" arrangements (where the professional carries emergency supplies) rather than through normal pharmacy prescriptions.\n\n**Who it affects:**\n- Pharmaceutical companies (must adjust to new pricing calculations)\n- Pharmacists (pricing structures change)\n- Doctors, midwives and nurse practitioners (expanded powers to supply medicines)\n- Patients (potentially different access to some emergency medicines)\n- The government (better tools to control PBS costs)\n\n**Why it matters:**\nThis is part of ongoing reforms to make PBS pricing more transparent and sustainable. The shift to ex‑manufacturer pricing gives the government clearer visibility of actual drug costs. The prescriber bag changes recognise that midwives and nurse practitioners increasingly provide frontline care, especially in rural areas, and need appropriate authority to supply emergency medicines."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-amendment-pharmaceutical-benefits-scheme-act-2012","history":"/api/acts/national-health-amendment-pharmaceutical-benefits-scheme-act-2012/history","analysis":"/api/acts/national-health-amendment-pharmaceutical-benefits-scheme-act-2012/analysis","conflicts":"/api/acts/national-health-amendment-pharmaceutical-benefits-scheme-act-2012/conflicts","importantCases":"/api/acts/national-health-amendment-pharmaceutical-benefits-scheme-act-2012/important-cases","documents":"/api/acts/national-health-amendment-pharmaceutical-benefits-scheme-act-2012/documents"}}