{"id":"F2025L01158","name":"National Health (Originator Brand) Determination 2025","slug":"national-health-originator-brand-determination-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":106927,"registerId":"commonwealth-F2025L01158-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n (1) This instrument is the National Health (Originator Brand) Determination 2025.\n (2) This instrument may also be cited as PB 114 of 2025.","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

1 October 2025

1 October 2025

\n```\n\n> Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Repeal","content":"#### 3 Repeal\n\n The National Health (Originator Brand) Determination 2015 (PB 100 of 2015) is repealed.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Authority","content":"#### 4 Authority\n\n This instrument is made under subsection 99ADB(6B) of the National Health Act 1953.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Definitions","content":"#### 5 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 84 of the Act, including the following:\n\n (a) brand\n (b) exempt item\n (c) pharmaceutical item\n In this instrument:\n\n> Act means the National Health Act 1953.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Originator Brand","content":"#### 6 Originator Brand\n\n (1) For subsection 99ADB(6B) of the Act, unless subsections (2) or (3) of this section apply, an originator brand specified in column 3 of an item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2 of the same item in Schedule 1.\n (2) Where a manner of administration is specified in column 4 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 of the same item in Schedule 1.\n (3) Where a form is specified in column 5 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 and the form specified in column 5 of the same item in Schedule 1.\n\n> Note: A brand of an exempt item is not an originator brand due to section 99ADA of the Act.","sortOrder":5}],"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"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This appears to be a straightforward re-enactment/replacement of the 2015 determination with the same scope and purpose. The structure mirrors the 2015 version (repealed by section 3), maintaining the same functional approach of listing originator brands in a schedule format. No expansion of scope is evident from the face of the instrument."},"complexity_factors":["Very short instrument (only 6 substantive sections)","Minimal defined terms (only 'Act' defined; relies on external definitions from parent Act)","Simple conditional structure with three cascading subsections (general rule, then manner of administration qualifier, then form qualifier)","Heavy reliance on external Schedule 1 table (not provided in excerpt) which likely contains the bulk of the operational content","Single cross-reference to parent Act (section 99ADB(6B)) and one note referencing section 99ADA","No nested exceptions or complex logical operators"],"plain_english_summary":"This instrument updates which brand-name medicines are treated as \"originator brands\" under the PBS, replacing the 2015 determination with a new 2025 version that takes effect 1 October 2025. It matters because originator status drives PBS pricing and subsidy calculations when generics enter the market, affecting pharmaceutical manufacturers, the Department of Health and Aged Care, pharmacists, and patients."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"The instrument repeals the 2015 Determination and replaces it with a new list-based determination (s 3; s 6). Mechanically it confines its scope to designating originator brands under subsection 99ADB(6B). Because Schedule 1 is not included here, the extent of substantive change to which specific brands are designated cannot be determined from the text provided."},"complexity_factors":["Cross-reference to the National Health Act (authority under subsection 99ADB(6B)) creates dependence on external statutory provisions (s 4).","Relies on detailed entries in Schedule 1 to produce operational effect; schedule content determines scope and compliance obligations (s 6).","Interaction with other Act provisions—definitions in s 84 and exemption rule in s 99ADA—affects application and exclusions (s 5; note to s 6).","Repeal of prior instrument (PB 100 of 2015) replaces earlier determinations, requiring stakeholders to compare lists (s 3).","Commencement timing is fixed and retrospective/forward application might matter to supply and regulatory planning (s 2)."],"plain_english_summary":"This instrument designates which pharmaceutical brands count as “originator brands” under the National Health Act by listing them in Schedule 1. Designations apply to all brands containing the same listed drug, and can be limited by manner of administration or form (s 6). It repeals the 2015 determination and takes effect 1 October 2025 (ss 2–4). This changes how brands are classified under the Act, so sponsors, manufacturers and others regulated by the Act must follow the Schedule 1 listings and the Act’s exemption rule (note to s 6)."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-originator-brand-determination-2025","history":"/api/acts/national-health-originator-brand-determination-2025/history","analysis":"/api/acts/national-health-originator-brand-determination-2025/analysis","conflicts":"/api/acts/national-health-originator-brand-determination-2025/conflicts","importantCases":"/api/acts/national-health-originator-brand-determination-2025/important-cases","documents":"/api/acts/national-health-originator-brand-determination-2025/documents"}}