Commonwealth Numbered Regulations Commonwealth Numbered Regulations
[1] Subregulation 5 (1), definition of authority prescription
substitute
"authority prescription" means a prescription that prescribes a pharmaceutical benefit and that has been authorised:
(a) in accordance with subregulation 13 (5); or
(b) under authority required procedures that are part of the circumstances determined by the Minister for paragraph 85 (7) (b) of the Act for the pharmaceutical benefit.
Note A determination under subsection 85 (7) of the Act contains procedures that are called 'authority required procedures' that are part of the circumstances determined by the Minister for paragraph 85 (7) (b) of the Act and that only apply to certain pharmaceutical benefits specified in the determination .
[2] Regulations 9AAA and 9AAB
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[3] Before regulation 37A
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Division 1 General
[4] Regulation 37A, after definition of approved price to pharmacists
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"data collection period" has the meaning given by subregulation 37EC (1).
"disclosure cycle" has the meaning given by subregulation 37EB (1).
[5] Regulation 37A, definition of first mandatory brand
substitute
"interim supplementary disclosure cycle" means the disclosure cycle mentioned in paragraph 37EB (2) (b).
[6] Regulation 37A, after the definition of listed
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"main disclosure cycle" means a disclosure cycle mentioned in paragraph 37EB (2) (a).
[7] Regulation 37A, definition of mandatory brand
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[8] Regulation 37A, definition of related brand
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"reporting period" means a reporting period mentioned in regulation 37J or 37JA for a brand of a pharmaceutical item.
[9] Regulation 37A, definition of subsequent mandatory brand
substitute
"supplementary disclosure cycle A" means a disclosure cycle mentioned in paragraph 37EB (2) (c).
"supplementary disclosure cycle B" means a disclosure cycle mentioned in paragraph 37EB (2) (d).
[10] Regulation 37A, definition of volunteered brand
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[11] Regulation 37D, heading
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37D Approved ex‑manufacturer price -- general
[12] Regulation 37D
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item
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(other than a listed brand of a pharmaceutical item to which regulation 37DA applies)
[13] After regulation 37D
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37DA Approved ex‑manufacturer price -- listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements and prior disclosure cycle
(1) This regulation applies to a brand of pharmaceutical item (the relevant brand ) to which regulation 37F applies if the circumstances mentioned in subregulation 37F (3) apply.
Note Regulation 37F applies to listed brands of pharmaceutical items that have the same drug and manner of administration as listed brands that are already subject to price disclosure requirements.
(2) For subsection 99ADB (3) of the Act, the method for working out the approved ex‑manufacturer price of the relevant brand on the last day of the data collection period for the brand in the prior disclosure cycle is as follows:
(a) if the reference price of the brand on the day is $1 000 or less -- by dividing the reference price for the relevant brand by 1.0752 and rounding the result to the nearest cent (rounding 0.5 cents upwards); or
(b) in any other case -- by taking $69.94 from the reference price for the relevant brand.
Note The price worked out under this subregulation is used to work out the weighted average disclosed price for the brand in the prior disclosure cycle in step 11 of regulation 37G.
(3) For subregulation 37DA (2), the reference price for a relevant brand is the sum of the following amounts:
(a) the approved price to pharmacists on the relevant day; and
(b) any amount that the Act would have required to be deducted from the approved price to pharmacists if the relevant brand had been a listed brand on and after the last day of the data collection period for the brand in the prior disclosure cycle to and including the relevant day.
(4) In this regulation:
"prior disclosure cycle" has the meaning given by subregulation 37F (3).
"relevant day" has the meaning given by paragraph 37F (1) (a).
Division 2 Weighted average disclosed price
37DB Application
For subsection 99ADB (6) of the Act, this Division:
(a) prescribes the method for determining the weighted average disclosed price of a listed brand of a pharmaceutical item; and
(b) provides for matters that are relevant to that method.
Note The method is set out in regulation 37G.
[14] Subregulation 37E (1)
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(1) This regulation deals with how information provided under the price disclosure requirements may be used with the method in regulation 37G for determining the weighted average disclosed price of a listed brand of a pharmaceutical item.
[15] Subregulation 37E (2)
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for the reporting period
[16] Subregulation 37E (2)
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provided about
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provided for the whole of the data collection period for
[17] Subregulation 37E (4), note
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Note For reporting periods, see regulations 37J and 37JA.
[18] Regulations 37F to 37H
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37EA Disclosure cycles and data collection periods for listed brands of pharmaceutical items -- general
Regulations 37EB to 37F set out matters about disclosure cycles and
data collection periods to be used for the method in regulation 37G for
determining the weighted average disclosed price s of a listed brand s of
pharmaceutical item s .
Note Section 99ADA of the Act provides that Division 3B (Price disclosure) of Part VII of the Act does not apply to brands of exempt items.
37EB Disclosure cycles
(1) For the purposes of determining the weighted average disclosed price of a listed brand of pharmaceutical item there are several kinds of disclosure cycles during which:
(a) information is provided in compliance with price disclosure requirements; and
(b) data is processed; and
(c) a reduction day occurs.
(2) For these Regulations, t he kinds of disclosure cycles a re as follows:
(a) main disclosure cycles;
(b) the interim supplementary disclosure cycle;
(c) supplementary disclosure cycles A;
(d) supplementary disclosure cycles B.
Note 1 Regulations 37ED and 37F set out when a brand of pharmaceutical item is in a particular cycle. Regulations 37EG and 37EH set out when a brand of pharmaceutical item moves from a supplementary disclosure cycle to a main disclosure cycle.
Note 2 For transitional arrangements, see Part 2 of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 5).
(3) There is only 1 interim supplementary disclosure cycle.
(1) In each disclosure cycle, there are data collection periods for which information about brands of pharmaceutical items must be provided in compliance with price disclosure requirements.
(2) In a disclosure cycle:
(a) there is only 1 data collection period for each brand of a pharmaceutical item; and
(b) all brands of pharmaceutical items that have the same drug and manner of administration have the same data collection period; and
(c) the data collection periods for brands of pharmaceutical items that have different drugs, or that have the same drug with a different manner of administration, can commence on different days; and
(d) all data collection periods in the disclosure cycle end on the same day.
37ED Listed brand having a drug and manner of administration not subject to price disclosure requirements before relevant day -- first di sclosure cycle and beginning of data collection period for brand
(1) This regulation applies to a listed brand of a pharmaceutical item (the relevant brand ) if:
(a) the price disclosure requirements first apply under section 99ADD of the Act for the relevant brand on a day (the relevant day ); and
(b) no requirement to comply with the price disclosure requirements has arisen under the Act before the relevant day for:
(i) the relevant brand; or
(ii) any other listed brand of any pharmaceutical item having the same drug and manner of administration as the relevant brand.
(2) The relevant brand is in a main disclosure cycle if the relevant day for the brand is:
(a) between 2 June and 1 October in a year (both dates inclusive); or
(b) 1 December 2010.
(3) The relevant brand is in the interim supplementary disclosure cycle if the relevant day for the brand is between 2 December 2010 and 1 June 2011 (both dates inclusive).
(4) Except where subregulation (3) applies, the relevant brand is in a supplementary disclosure cycle A if the relevant day for the brand is between 2 October in a year and 1 February in the next year (both dates inclusive).
(5) Except where subregulation (3) applies, the relevant brand is in a supplementary disclosure cycle B if the relevant day for the brand is between 2 February and 1 June in a year (both dates inclusive).
(6) The data collection period for the relevant brand in the first disclosure cycle for the brand begins on the relevant day.
Note The data collection period for a brand in the main disclosure cycle and to which section 99ADJ of the Act applies begins on 1 December 2010 and ends at the end of 30 September 2011.
37EE End dates for data collection periods for relevant brands covered by regulation 37ED
(1) The data collection period for a relevant brand in a main disclosure cycle ends at the end of 30 September in the year after the year in which the relevant day for the brand occurs.
(2) The data collection period for a relevant brand in the interim supplementary disclosure cycle ends at the end of 31 May 2012.
(3) The data collection period for a relevant brand in a supplementary disclosure cycle A ends:
(i) if the relevant day for the brand is between 2 October in a year and 31 December in the year (both dates inclusive) -- at the end of 31 January in the second year after the year in which the relevant day for the brand occurs; and
(ii) if the relevant day for the brand is between 1 January in a year and 1 February in the year (both dates inclusive) -- at the end of 31 January in the year after the year in which the relevant day for the brand occurs.
(4) The data collection period for a relevant brand in a supplementary disclosure cycle B ends at the end of 31 May in the year after the year in which the relevant day for the brand occurs.
Note For how a listed brand moves from a supplementary disclosure cycle to a main disclosure cycle, see regulations 37EG and 37EH.
(5) In this regulation:
" relevant brand " has the meaning given by subregulation 37ED (1).
" relevant day " has the meaning given by paragraph 37ED (1) (a).
37EF Subsequent main disclosure cycle --subsequent data collection periods
A subsequent data collection period for a brand in a subsequent main disclosure cycle:
(a) begins on 1 October of the year in which the previous data collection period in the previous main disclosure cycle for the brand ended; and
(b) ends at the end of 30 September in the following year.
37EG Listed brand moving from supplementary disclosure cycle A to main disclosure cycle
(1) This regulation applies to a listed brand of a pharmaceutical item if:
(a) the brand is in a supplementary disclosure cycle A; and
(b) the data collection period in the supplementary disclosure cycle ends at the end of 31 January in a year.
(2) The brand moves to a main disclosure cycle on 1 February in the year.
(3) The data collection period for the brand in the main disclosure cycle:
(a) begins on 1 February in the year; and
(b) ends at the end of 30 September in the next year.
37EH Listed brand moving from interim supplementary disclosure cycle and supplementary disclosure cycle B to main disclosure cycle
(1) This regulation applies to a listed brand of a pharmaceutical item if:
(a) the brand is in:
(i) the interim supplementary disclosure cycle; or
(ii) a supplementary disclosure cycle B; and
(b) the data collection period in the disclosure cycle ends at the end of 31 May in a year.
(2) The brand moves to a main disclosure cycle on 1 June in the year.
(3) The data collection period for the brand in the main disclosure cycle:
(a) begins on 1 June in the year; and
(b) ends at the end of 30 September in the next year.
37F Listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements -- disclosure cycle and beginning of data collection period for brand
(1) This regulation applies to a listed brand of a pharmaceutical item (the relevant brand ) if:
(a) the price disclosure requirements first apply under section 99ADD of the Act for the relevant brand on a day (the relevant day ); and
(b) both on and before the relevant day, the price disclosure requirements apply for any other listed brand of any pharmaceutical item having the same drug and manner of administration (the other brand ) as the relevant brand.
(2) If the end of a data collection period for a disclosure cycle (the relevant disclosure cycle ) for the other brand is after the relevant day, then:
(a) the relevant brand is in the relevant disclosure cycle; and
(b) the relevant brand joins the data collection period for the other brand on the relevant day.
(3) If the other brand is in both the relevant disclosure cycle and a disclosure cycle (the prior disclosure cycle ) before the relevant disclosure cycle, and the relevant day is before the reduction day for the other brand in the prior disclosure cycle, then the relevant brand:
(a) is also in the prior disclosure cycle; and
(b) is in the data collection period for the other brand for the purposes of calculating the weighted average disclosed price for the relevant brand.
Note Although data is not required to be provided for the relevant brand for the prior disclosure c ycle, a weighted average disclosed price is determined for the relevant brand using the method in regulat ion 37G. Regulation 37DA provides a method for working out the approved ex‑manufacturer price on the last day of the data collection period in the prior disclosure cycle.
37G Weighted average disclosed price
(1) This regulation sets out the method for determining the weighted average disclosed price of:
(a) a listed brand of a pharmaceutical item; and
(b) every listed brand of every pharmaceutical item having the same drug and manner of administration;
for the data collection period for the brands in a disclosure cycle.
Step 1
(2) Add up the sales revenue for the brand, excluding sales to public hospitals (as disclosed under the price disclosure requirements) for the data collection period for the brand in the disclosure cycle.
(3) However, for a first reporting period to which subregulation 37J (3) or (4) applies:
(a) if subregulation 37J (3) applies to the reporting period -- exclude the sales revenue for the brand for the first month of the first reporting period if the brand was not a listed brand immediately before the relevant day mentioned in paragraph 37ED (1) (a); or
(b) if subregulation 37J (4) applies to the reporting period -- exclude the sales revenue for the brand for the first month of the first reporting period.
Step 2
(4) From the amount worked out under step 1, take away the incentives for the brand (as disclosed under the price disclosure requirements) for the data collection period for the brand in the disclosure cycle, to give the net revenue for the data collection period in the disclosure cycle.
Step 3
(5) Add up the adjusted volume of the brand sold for the data collection period for the brand in the disclosure cycle (the volume of the brand sold, based on the number of packs sold, is disclosed under the price disclosure requirements).
(6) However, for a first reporting period to which subregulation 37J (3) or (4) applies:
(a) if subregulation 37J (3) applies to the reporting period -- exclude the adjusted volume of the brand sold in the first month of the first reporting period if the brand was not a listed brand immediately before the relevant day mentioned in paragraph 37ED (1) (a); or
(b) if subregulation 37J (4) applies to the reporting period -- exclude the adjusted volume of the brand sold in the first month of the first reporting period.
Step 4
(7) Work out the disclosed price for the brand by dividing the net revenue for the brand by its adjusted volume.
Step 5
(8) Work out the price percentage difference for the brand (expressed as a percentage to 2 decimal places) by:
(a) subtracting its disclosed price from its applicable approved ex‑manufacturer price; and
(b) dividing that amount by its applicable approved ex‑manufacturer price.
Step 6
(9) Work out the adjusted price percentage difference for the brand (expressed as a percentage to 2 decimal places) as follows:
(a) if the price percentage difference for the brand is less than zero, the adjusted price percentage difference is equal to zero; and
(b) if the price percentage difference for the brand is equal to or greater than zero, the adjusted price percentage difference is equal to the price percentage difference.
Step 7
(10) Repeat steps 1 to 6 for every brand of the pharmaceutical item.
Step 8
(11) Work out the weighted average percentage difference for the pharmaceutical item as follows:
(a) for each brand of the pharmaceutical item -- multiply its adjusted volume by its adjusted price percentage difference; and
(b) add up the amounts worked out in paragraph (a); and
(c) add up the adjusted volume for each brand of the pharmaceutical item; and
(d) divide the amount worked out in paragraph (b) by the amount worked out in paragraph (c).
Step 9
(12) Repeat steps 1 to 8 for every pharmaceutical item having the same drug and manner of administration.
Step 10
(13) Work out the weighted average percentage difference (expressed as a percentage to 2 decimal places) for every brand of every pharmaceutical item having the same drug and manner of administration in the following way:
(a) for each pharmaceutical item -- multiply the percentage worked out in step 8 by:
(i) the PBS volume of the pharmaceutical item, as recorded by the Department; and
(ii) the applicable approved ex‑manufacturer price for the brands of the pharmaceutical item;
(b) for each pharmaceutical item -- multiply the PBS volume of the pharmaceutical item by the applicable approved ex‑manufacturer price for the brands of the pharmaceutical item;
(c) add up the amounts worked out for each pharmaceutical item under paragraph (a);
(d) divide the amount worked out under paragraph (c) by the sum of the amounts worked out under paragraph (b).
Step 11
(14) The weighted average disclosed price for every brand of every pharmaceutical item having the same drug and manner of administration is the applicable approved ex‑manufacturer price for the brands, reduced by the percentage worked out under step 10.
(15) In this regulation:
adjusted volume , of a listed brand of a pharmaceutical item that is sold , is the volume worked out as if the pack sizes in which the brand was sold were equivalent to:
(a) a maximum quantity of the pharmaceutical item that is determined under paragraph 85A (2) (a) of the Act; or
(b) if no maximum quantity of the pharmaceutical item is determined under paragraph 85A (2) (a) of the Act -- an agreed quantity for a brand of the pharmaceutical item.
"agreed quantity" has the same meaning as in Division 3B of Part VII of the Act.
Division 3 Price disclosure requirements
37H Price disclosure requirements -- content of information for reporting periods
(1) For paragraph 99ADC (1) (a) of the Act, the information to be provided for the supply of a listed brand of a pharmaceutical item for a reporting period is:
(a) the name of the responsible person; and
(b) the name of the drug in the pharmaceutical item; and
(c) the brand; and
(d) the form of the drug, including its strength; and
(e) the manner of administration of the form of the drug; and
(f) the number or quantity of units in a pack (for example, the number of tablets per pack); and
(g) the period to which the information relates; and
(h) for each period to which the information relates:
(i) the sales revenue for the brand, excluding sales to public hospitals (expressed in Australian dollars, excluding GST and rounded to the nearest whole dollar, rounding 50 cents upwards); and
(ii) the volume of the brand sold, based on the number of packs sold; and
(i) the kind of incentives (if any) given for the brand for the reporting period ; and
(j) the value of the incentives given for the brand for the reporting period (expressed in Australian dollars, excluding GST and rounded to the nearest whole dollar, rounding 50 cents upwards).
Note 1 The form issued by the Department for responsible persons to provide the information may include a list of different kinds of incentives (for example, rebates or cash backs) and the responsible person would fill in the values for the kind of incentives for which information is being provided.
Note 2 For transitional arrangements, see Part 2 of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 5).
(2) However, for the first reporting period to which subregulation 37G (3) or (6) applies, the information mentioned in paragraph (1) (h) for the first month of the reporting period must be provided separately.
(3) If an incentive is given over a period of time or indirectly for a brand, the value of the incentive for the brand for the reporting period is the value apportioned to the brand for the reporting period.
Note No methodology is prescribed for apportioning the value of incentives for a brand for a period. However, the methodology used by a responsible person should be reasonable and documented.
(4) If information must be provided under paragraph (1) (h), it must not also be provided under paragraph (1) (i) or (j).
(5) The information must relate to the period from the beginning of the reporting period to the end of the reporting period.
(6) For this regulation, incentives includes anything given as an incentive to take supply of the brand, whether given:
(a) before the supply of the brand, but on condition of taking supply; or
(b) at the time of the supply of the brand; or
(c) at a later date; or
(d) over a period of time; or
(e) directly for the brand; or
(f) indirectly for the brand (for example, for a group of brands or other products).
[19] Subregulation 37I (1)
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37G and
[20] Regulation 37J
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37J Price disclosure requirements -- information and reporting periods
(1) For paragraph 99ADC (1) (c) of the Act, the information mentioned in regulation 37H must be provided within 6 weeks after the end of each reporting period for the brand of the pharmaceutical item.
(2) Subject to subregulations (3) to (6) and regulation 37JA, a reporting period for a brand of a pharmaceutical item is:
(a) the period of 6 months ending at the end of 31 March of each year and 30 September of each year; and
(b) each successive period of 6 months in which the brand is subject to the price disclosure requirements.
(3) However, the first reporting period for a relevant brand to which regulation 37ED applies:
(a) begins on the relevant day mentioned in regulation 37ED for the relevant brand; and
(b) ends at the end of the first of the following dates to happen after the relevant day:
(i) 31 March;
(ii) 30 September.
(4) Also, the first reporting period for a relevant brand in the relevant disclosure cycle mentioned in regulation 37F to which that regulation applies:
(a) begins on the relevant day mentioned in regulation 37F; and
(b) ends at the end of:
(i) if the other brand mentioned in regulation 37F is in the interim supplementary disclosure cycle or a supplementary disclosure cycle A or supplementary disclosure cycle B -- the reporting period for the other brand; or
(ii) in any other case -- the first of the following dates to happen after the relevant day:
(A) 31 March;
(B) 30 September.
(5) Also, the first reporting period in the data collection period in the first main disclosure cycle for a brand of a pharmaceutical item to which regulation 37EG applies:
(a) begins on 1 February in the year the brand moves to the main disclosure cycle; and
(b) ends at the end of 31 March in the year.
(6) Also, the first reporting period in the data collection period in the first main disclosure cycle for a brand of a pharmaceutical item to which regulation 37EH applies:
(a) begins on 1 June in the year the brand moves to the main disclosure cycle; and
(b) ends at the end of 30 September in the year.
Note For transitional arrangements, see Part 2 of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 5).
37JA Price disclosure requirements -- additional reporting periods
(1) Subregulation (2) applies if:
(a) a listed brand of a pharmaceutical item is in a supplementary disclosure cycle A; and
(b) the data collection period in the supplementary disclosure cycle ends at the end of 31 January in a year.
(2) Another reporting period in that data collection period begins on 1 October in the year before the year and ends at the end of 31 January in the year.
(3) Subregulation (4) applies if:
(a) a listed brand of a pharmaceutical item is in a supplementary disclosure cycle B; and
(b) the data collection period in the supplementary disclosure cycle ends at the end of 31 May in a year.
(4) Another reporting period in that data collection period begins on 1 April in the year and ends at the end of 31 May in the year.
(5) Subregulation (6) applies if:
(a) a listed brand of a pharmaceutical item is in the interim supplementary disclosure cycle; and
(b) the data collection period in the disclosure cycle ends at the end of 31 May 2012.
(6) Another reporting period in that data collection period begins on 1 April 2012 and ends at the end of 31 May 2012.
Note For transitional arrangements, see Part 2 of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 5).
[21] Before regulation 37K
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Division 4 Price reduction day
[22] Regulation 37K
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or 1 August
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, 1 August or 1 December
[23] Schedules 1 and 2
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