Source: https://www.global-regulation.com/law/australia/221044/national-health-%2528pharmaceutical-benefits%2529-amendment-%2528price-disclosure%2529-regulation-2014.html
Timestamp: 2018-10-20 11:15:23
Document Index: 768831772

Matched Legal Cases: ['art 6', 'art 6', 'art 6', 'art 6', 'art 8', 'art 8']

National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014 (Australia)
National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014
Link to law: https://www.comlaw.gov.au/Details/F2014L00636
Select Legislative Instrument No. 60, 2014
National Health (Pharmaceutical Benefits) Regulations 1960 2
This regulation is the National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014.
This regulation is made under the National Health Act 1953.
data collection period, for a brand of a pharmaceutical item: see regulation 37C.
final day, in relation to a data collection period, means the last day of the data collection period.
(e) indirectly for the brand (for a group of brands of pharmaceutical items or other products, for example).
last listed brand, of a pharmaceutical item, means the brand of the pharmaceutical item that was the last to become a delisted brand before the final day.
price sampling day: see regulation 37D.
related brand, of a brand of a pharmaceutical item, means a brand of a pharmaceutical item that has the same drug and manner of administration as the first pharmaceutical item (including another brand of the same pharmaceutical item), but does not include a brand of an exempt item.
Note: For the definition of exempt item, see subsection 84(1) of the Act.
Part 6A—Price reduction and price disclosure
3 Division 1 of Part 6A
37A Reduction day
For paragraph 99ADH(2)(b) of the Act, 1 August and 1 December in any year are prescribed.
4 Division 1A of Part 6A (heading)
5 Divisions 2 to 4 of Part 6A
Subdivision 1—Interpretation
37C Meaning of data collection period
Example 1: If a brand to which subregulation (2) applies has a start day of 1 July 2014, and the data collection period for a related brand ends on 30 September 2014:
Example 2: If a brand to which subregulation (3) applies has a start day of 1 August 2014:
Example 3: If a brand to which subregulation (3) applies has a start day of 1 December 2014:
37D Meaning of price sampling day
37E Special rules for certain listed brands
(1) Subregulations (3), (4) and (5) apply to a listed brand of a pharmaceutical item if:
(2) Subregulations (4) and (5) apply to a listed brand of a pharmaceutical item if:
(3) For paragraph 99ADB(3B)(c) of the Act, the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the relevant day is the approved ex‑manufacturer price of the brand on the start day minus any amount that would have been added, and plus any amount that would have been deducted, because of a price adjustment, had the brand been a listed brand in the period:
(4) For the purpose of determining the weighted average disclosed price of the listed brand under Subdivision 2, the brand is taken to have had a data collection period:
(5) For the purpose of determining the weighted average disclosed price of the listed brand under Subdivision 2, the approved ex‑manufacturer price of the listed brand on a price sampling day is taken to have been the approved ex‑manufacturer price of the listed brand on the brand’s start day minus any amount that would have been added, and plus any amount that would have been deducted, because of a price adjustment, had the brand been a listed brand in the period:
Subdivision 2—Weighted average disclosed price
37F Method for determining weighted average disclosed price of listed brand of pharmaceutical item
(1) This Subdivision is made for subsection 99ADB(6) of the Act.
(2) Regulations 37G to 37S prescribe the method for determining the weighted average disclosed price of a listed brand of a pharmaceutical item in respect of a data collection period for the listed brand.
(3) When using the method, the Minister may disregard information provided under regulation 37T for a data collection period if the information is incomplete.
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.
37G Step 1—Net revenue for brand
37H Step 2—Adjusted volume for brand
Note: For the definition of pricing quantity, see subsection 84AK(1) of the Act.
37J Step 3—Average approved ex‑manufacturer price for brand
Note: A price sampling day may be within the data collection period for another brand of the same pharmaceutical item (see regulation 37D).
(3) If the pricing quantity of a brand on a price sampling day is different from the pricing quantity of the brand on the final day, for the purposes of subregulation (2) the approved ex‑manufacturer price of the brand on the price sampling day is taken to be:
37K Step 4—Disclosed price for brand
37L Step 5—Price percentage difference of brand
37M Step 6—Repeat steps for each brand of pharmaceutical item
37N Step 7—Total adjusted volume of brands of pharmaceutical item
37P Step 8—Weighted average percentage difference of brands of pharmaceutical item
37Q Step 9—Repeat steps for each pharmaceutical item with related brands
(2) The price percentage of difference of a brand of the other pharmaceutical item is worked out using steps 1 to 5, reading references to the listed brand as references to the brand of the other pharmaceutical item.
37R Step 10—Weighted average percentage difference for listed brand and all related brands
37S Step 11—Weighted average disclosed price for listed brand of pharmaceutical item
Subdivision 3—Price disclosure requirements
37T Price disclosure requirements
(1) This regulation is made for subsection 99ADC(1) of the Act.
(4) The information mentioned in each of paragraphs (2)(h), (i) and (j), to the extent that the information relates to the brand’s initial month, must be provided separately.
(7) The responsible person must provide the information in a form approved by the Secretary.
(9) Subject to subregulation (10), the responsible person must provide the information:
6 Division 1 of Part 8
7 Regulations 51 and 52
8 At the end of Part 8
Division 3—Provisions for National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014
54 Application of Regulations
(1) These Regulations, as amended by the National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014, apply in relation to a data collection period that ends after 1 February 2014.
(2) This regulation applies subject to regulation 55.
55 Data collection periods
(1) The data collection period for a brand that, under the old Regulations:
(a) started on a date, or between the dates, mentioned in column 1 of the following table (the brand’s start date); and
(b) was due to end on the date mentioned in column 2 of the table;
instead ends on the date mentioned in column 3 of the table.
New data collection period end dates
Starts on or between
Due to end on
Instead ends on
2 February 2013 to
2 June 2013 to
2 October 2013 to 1 February 2014
2 February 2014 to
2 April 2014 to
(2) If the brand is a listed brand, the next data collection period for the brand starts on the day after the date mentioned in column 3 of the table.
(3) The responsible person for a brand to which item 6, 7 or 8 of the table applies must provide the information required under regulation 37H of the old Regulations for the period between the brand’s start date and 31 March 2014, in accordance with regulations 37HA to 37J of the old Regulations, before the end of 12 May 2014.
brand means a listed or delisted brand of a pharmaceutical item, other than an exempt item.
old Regulations means these Regulations as in force immediately before these Regulations were amended by the National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014.
56 Expiry of this Division
This Division expires on 3 April 2016 as if it had been repealed by another regulation.
9 Schedules 7 and 8