{"id":"F2020L00973","name":"National Health (subsection 99ACB(1) taken not to have applied) Determination 2020 (PB 76 of 2020)","slug":"national-health-subsection-99acb-1-taken-not-to-have-applied-determination-2020-pb-76-of-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440557,"registerId":"F2020L00973-fast-fetch-1775956144440","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health (subsection 99ACB(1) taken not to have applied) Determination 2020 (PB 76 of 2020)","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![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nPB 76 of 2020\n\n \n\nNational Health (subsection 99ACB(1) taken not to have applied) Determination 2020\n\nI, Nikolai Tsyganov, Acting Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make the following determination.\n\nDated 30 July 2020  \n\nNIKOLAI TSYGANOV\n\nActing Assistant Secretary\n\nPricing and PBS Policy Branch\n\nTechnology Assessment and Access Division\n\nDepartment of Health\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Subsection 99ACB(1) is taken not to have applied\n\n \n\n \n\n1  Name\n\n  This instrument is the National Health (subsection 99ACB(1) taken not to have applied) Determination 2020.\n\n  This instrument may also be cited as PB 76 of 2020.\n\n2  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 \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument 1 August 2020.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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.\n\n3  Authority\n\n  This instrument is made under section 99AEI of the National Health Act 1953.\n\n4  Definitions\n\n  In this instrument:\n\nAct means the National Health Act 1953.\n\n5  Subsection 99ACB(1) is taken not to have applied \n\n (1) For the purposes of subsection 99ACB(3) of the Act, subsection 99ACB(1) of the Act is taken not to have applied to the MERCAPTOPURINE-LINK brand of mercaptopurine, tablet containing mercaptopurine monohydrate 50 mg, oral.\n\n \n","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument confines its effect to a single listed product by treating subsection 99ACB(1) as not having applied to that brand (s5). There is no text indicating expansion beyond that product or a broader change to the Act; commencement and authority are standard (s2, s3)."},"complexity_factors":["Very narrow scope: single-product effect limited to MERCAPTOPURINE-LINK mercaptopurine 50 mg (s5).","Relies on cross-references to the National Health Act (subsections 99ACB(1) and 99ACB(3)) to reveal practical effect — requires reading the Act for full consequences (s5).","Made by delegated instrument under statutory power (s3), so understanding delegation and procedural limits may be needed.","Simple commencement mechanics but retrospective or treated-as-not-applied effect adds a timing nuance (commencement 1 Aug 2020, s2).","No explanatory material or procedural detail in the instrument increases reliance on external sources for implementation context."],"plain_english_summary":"This determination treats subsection 99ACB(1) of the National Health Act 1953 as if it did not apply to the MERCAPTOPURINE-LINK brand of mercaptopurine 50 mg tablets, thereby changing how subsection 99ACB(3) operates for that specific product (s5). The instrument was made by a ministerial delegate under s99AEI (s3) and commenced 1 August 2020 (s2). It mechanically alters the Act’s regulatory treatment for one branded medicine without wider amendments."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This determination performs exactly the function intended by section 99AEI of the National Health Act 1953 — to allow the Minister (or delegate) to disapply subsection 99ACB(1) in specific cases where it would produce inappropriate pricing outcomes. The scope remains tightly constrained to the specific pharmaceutical product identified."},"complexity_factors":["Extremely short instrument (5 sections, approximately 300 words total)","Only 1 defined term ('Act')","Single operative provision (section 5) with straightforward conditional logic","No cross-references to other legislation beyond the enabling Act and specific subsections","No nested exceptions or conditional layering","Highly specific application to a single branded pharmaceutical product"],"plain_english_summary":"This determination directs the government to disregard subsection 99ACB(1) of the National Health Act 1953 when calculating the PBS price for MERCAPTOPURINE-LINK (mercaptopurine). It’s a technical fix to prevent an unfair or unintended pricing outcome for this specific brand, affecting the manufacturer, PBS pricing administrators and potentially patients via the medicine’s subsidy and cost."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-subsection-99acb-1-taken-not-to-have-applied-determination-2020-pb-76-of-2020","history":"/api/acts/national-health-subsection-99acb-1-taken-not-to-have-applied-determination-2020-pb-76-of-2020/history","analysis":"/api/acts/national-health-subsection-99acb-1-taken-not-to-have-applied-determination-2020-pb-76-of-2020/analysis","conflicts":"/api/acts/national-health-subsection-99acb-1-taken-not-to-have-applied-determination-2020-pb-76-of-2020/conflicts","importantCases":"/api/acts/national-health-subsection-99acb-1-taken-not-to-have-applied-determination-2020-pb-76-of-2020/important-cases","documents":"/api/acts/national-health-subsection-99acb-1-taken-not-to-have-applied-determination-2020-pb-76-of-2020/documents"}}