{"id":"F2018L01673","name":"National Health (Highly Specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018 (PB 107 of 2018 (No. 11))","slug":"national-health-highly-specialised-drugs-program-amendment-approval-of-certain-hospital-authorities-","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439852,"registerId":"F2018L01673-fast-fetch-1775955717052","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health (Highly Specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018 (PB 107 of 2018 (No. 11))","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\nPB 107 of 2018 (No. 11)\n\nNational Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018\n\n \n\nNational Health Act 1953\n\n___________________________________________________________________________\n\n \n\nI, JULIANNE QUAINE, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.\n\nDated 4 December 2018\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\nJULIANNE QUAINE\n\nAssistant Secretary\n\nPharmacy Branch\n\nTechnology Assessment and Access Division\n\nDepartment of Health\n\n___________________________________________________________________________\n\n\n\n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Schedules\n\nSchedule 1  Amendments\n\nSchedule 2  Transitional provisions\n\n\n\n\n___________________________________________________________________________\n\n \n\n \n\n# 1 Name\n\n1.            This Instrument is the National Health (Highly Specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018.\n2.            This Instrument may also be cited as PB 107 of 2018 (No. 11).\n\n\n# 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 \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole instrument 21 December 2018\n\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\n# 3 Authority\n\nThis instrument is made under section 100 of the National Health Act 1953.\n\n# 4 Schedules\n\n         Each instrument that is specified in a Schedule to this instrument is amended or  repealed as set out in the applicable items in the Schedule concerned, and any other               item in a Schedule to this instrument has effect according to its terms.\n\n \n\n \n\n \n\n\n\n\n# Schedule 1  Amendments\n\n \n\nNational Health (Highly specialised drugs program) Special Arrangement 2010\n\n \n\n1 Section 4 (subparagraph (a)(ii) of the definition of approved hospital authority)\n\n Omit 'Chief Executive Medicare', substitute 'Secretary'.\n\n2 Section 4 (definition of Regulations)\n\nOmit 'National Health (Pharmaceutical Benefits) Regulations 1960', substitute 'National Health (Pharmaceutical Benefit) Regulations 2017'.\n\n3 Section 19 (including heading)\n\n Repeal the section, substitute:\n\n19 Application of section 51 of the Regulations\n\n         Section 51 of the Regulations does not apply to the supply of HSD pharmaceutical benefits.\n\n4 Paragraph 21(a)\n\nOmit 'regulation 19', substitute 'section 40'.\n\n5 Paragraph 21(b)\n\nOmit 'regulation 19AA', substitute 'section 41'.\n\n6 Section 21 (note)\n\nOmit 'Regulation 13', substitute 'section 30'.\n\n7 Section 23\n\nOmit 'regulation 19', substitute 'section 40'.\n\n8 Section 26 (including heading)\n\nRepeal the section, substitute:\n\n26  Application of section 30 of the Regulations in relation to CAR drugs\n\nSection 30 of the Regulations does not apply in relation to a prescription for an HSD pharmaceutical benefit that has a CAR drug supplied under this Special Arrangement.\n\n9 Paragraph 51(b)\n\nOmit 'regulation 8A', substitute 'section 16'.\n\n \n\n \n\n \n\n10 Subsection 52(4)\n\nOmit 'subregulation 8A(1)', substitute 'subsection 16(4)'.\n\n \n\n11 Section 52\n\n Omit 'Chief Executive Medicare' (wherever appearing), substitute 'Secretary'.\n\n12 Subsection 54(4)\n\nOmit 'the Regulations', substitute 'the National Health (Pharmaceutical Benefits) Regulations 1960 as in force immediately before the commencement of the Regulations'.\n\n \n\n \n\n\n\n\n# Schedule 2  Transitional provisions\n\n \n\n1 Definitions\n\n(1)       In this Schedule:\n\ncommencement day means the day on which the National Health (Highly specialised drugs program) Amendment (Approval of certain hospital authorities) Special Arrangement 2018 commences.\n\nnew Special Arrangement means the National Health (Highly specialised drugs program) Special Arrangement 2010 as in force on the commencement day.\n\nold Special Arrangement means the National Health (Highly specialised drugs program) Special Arrangement 2010 as in force immediately before the commencement day.\n\n2 Applications for approval of public hospital authority\n\n \n\n(1) This item applies where an application under section 52 of the old Special Arrangement for approval of the hospital authority of a public hospital has been made but a decision whether to approve the hospital authority has not been made before the commencement day.\n\n \n\n(2) From the commencement day the decision may be made by:\n\n (a) the Secretary, as if the application had been made to the Secretary; or\n\n (b) the Chief Executive Medicare, as if the amendments made  by the National Health               (Highly specialised drugs program) Amendment (Approval of certain hospital               authorities) Special Arrangement 2018 had not commenced;\n\n \n\n3 Transition of approvals granted and things done by the Chief Executive               Medicare\n\n \n\n(1) This item applies in relation to an approval for a hospital authority for a public hospital, granted under section 52 of the old Special Arrangement, that was in force immediately before the commencement day.\n\n \n\n(2) From the commencement day:\n\n (a) the approval is taken to have been granted by the Secretary;\n\n (b) the conditions (if any) determined by the Chief Executive Medicare to which the               approval was subject are taken to have been determined by the Secretary; and\n\n (c) any number allotted to the approval by the Chief Executive Medicare is taken to               have been allotted by the Secretary.\n\n \n\n \n\n \n\n4 Transition of suspensions issued by Chief Executive Medicare\n\n \n\n(1) This item applies where, immediately before the commencement day, the approval of the hospital authority for a public hospital is suspended following a notice issued by the Chief Executive Medicare under subsection 52(7) of the old Special Arrangement.\n\n \n\n(2) The notice of suspension is taken to have been issued by the Secretary.\n\n \n\n \n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation maintains its original scope. It is a technical amendment instrument that updates administrative arrangements (changing approving officers and updating regulation references) without expanding the substantive scope of the Highly Specialised Drugs program."},"complexity_factors":["Short instrument (approximately 3 pages of substantive content)","Simple, linear structure with only 2 schedules","Limited defined terms (only 3 definitions in Schedule 2)","Straightforward amendments consisting mostly of textual substitutions ('omit X, substitute Y')","No nested conditional logic or exceptions to exceptions","Transitional provisions are mechanical and clearly drafted (handing over functions from one officer to another)","Cross-references are explicit and updated to current legislative instruments"],"plain_english_summary":"This instrument modernises the Highly Specialised Drugs program by transferring the hospital-approval role from the abolished Chief Executive Medicare to the Department Secretary and updating legal references to the 2017 Pharmaceutical Benefits Regulations. It’s an administrative fix to keep approvals and transitional arrangements intact so public hospitals, their pharmacists and administrators can continue supplying costly, life‑saving medicines without interruption, protecting patient access during the machinery‑of‑government change."},"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":3,"scope_assessment":{"changed":false,"description":"The instrument does not change the substantive scope of the HSD Special Arrangement (eligibility, entitlement or funding terms). It substitutes administrative responsibility to the Secretary, updates regulatory references, and states that specified Regulations do not apply to HSD supplies, while providing transitional treatment for pending and existing approvals (Schedule 1 and Schedule 2)."},"complexity_factors":["Administrative reallocation of decision‑making and record ownership from Chief Executive Medicare to the Secretary (Schedule 1 items 1 and 11; Schedule 2 items 2–4) increases procedural change but not substantive law.","Update of statutory cross‑references to more recent Regulations (Schedule 1 item 2), requiring alignment across the instrument and linked instruments.","Express exclusions of particular Regulations for HSD supplies (replacement of section 19; new section 26: Schedule 1 items 3 and 8) narrow application rules and change compliance checkpoints.","Multiple cross‑reference edits across the Special Arrangement (Schedule 1 items 4–10) require careful proofreading in implementation to avoid inconsistent application.","Transitional provisions for pending applications, existing approvals and suspensions (Schedule 2 items 2–4) preserve continuity but require administrative actions to re-record or reissue decisions under the Secretary.","Narrow subject matter and limited scope: no new eligibility criteria, pricing or entitlement changes are introduced, reducing substantive legal complexity (see Schedule 1 generally and section 3 'Authority')."],"plain_english_summary":"This instrument amends the Highly Specialised Drugs (HSD) Special Arrangement to transfer administrative authority from the Chief Executive Medicare to the Secretary, update regulatory cross‑references to the 2017 Pharmaceutical Benefits Regulations, and confirm certain Pharmaceutical Benefits Regulations (section 51 and section 30) do not apply to HSD supplies. It affects public hospital authorities applying for HSD approval, sponsors of CAR drugs supplied under the arrangement, and departmental processes by transitioning pending approvals, existing approvals and suspensions to the Secretary on commencement."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-highly-specialised-drugs-program-amendment-approval-of-certain-hospital-authorities-","history":"/api/acts/national-health-highly-specialised-drugs-program-amendment-approval-of-certain-hospital-authorities-/history","analysis":"/api/acts/national-health-highly-specialised-drugs-program-amendment-approval-of-certain-hospital-authorities-/analysis","conflicts":"/api/acts/national-health-highly-specialised-drugs-program-amendment-approval-of-certain-hospital-authorities-/conflicts","importantCases":"/api/acts/national-health-highly-specialised-drugs-program-amendment-approval-of-certain-hospital-authorities-/important-cases","documents":"/api/acts/national-health-highly-specialised-drugs-program-amendment-approval-of-certain-hospital-authorities-/documents"}}