{"id":"BILL-r7406","name":"Health Legislation Amendment (Prescribing of Pharmaceutical Benefits) Bill 2025","slug":"health-legislation-amendment-prescribing-of-pharmaceutical-benefits-bill-2025","collection":"bill","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":445952,"registerId":"commonwealth-BILL-r7406-current","compilationNumber":null,"startDate":"2026-05-05","status":"introduced","reasons":null,"registeredAt":null},"sections":[],"analysis":{"summary":{"status_summary":"The bill has passed the House of Representatives and is awaiting second reading debate in the Senate on 1 April 2026.","complexity_score":4,"likely_questions":["Which medicines will authorised nurse prescribers be able to prescribe under the Pharmaceutical Benefits Scheme?","What steps must a registered nurse take to become an authorised nurse prescriber?"],"complexity_factors":["establishes new approval processes for nurse prescribers","requires supporting legislative instruments for implementation"],"plain_english_summary":"The Health Legislation Amendment (Prescribing of Pharmaceutical Benefits) Bill 2025 amends the National Health Act 1953 and the Health Insurance Act 1973. These changes establish a process for approving certain registered nurses as authorised nurse prescribers. Once approved, these nurses can prescribe specific pharmaceutical benefits listed under the Pharmaceutical Benefits Scheme.\n\nThe bill sets out how eligible registered nurses may apply for approval by the Secretary. The Minister will determine the exact criteria through a legislative instrument. These criteria can cover qualifications, nursing experience and endorsement by the Nursing and Midwifery Board of Australia for prescribing scheduled medicines as a designated registered nurse prescriber. Approved nurses must operate under a nurse prescriber agreement with another type of PBS prescriber.\n\nPatients who receive prescriptions from authorised nurse prescribers will be able to obtain the medicines through the Pharmaceutical Benefits Scheme. The Minister will decide which pharmaceutical benefits can be prescribed by these nurses, taking advice from the Pharmaceutical Benefits Advisory Committee. The bill also ensures that the Professional Services Review can examine the prescribing activities of authorised nurse prescribers under the Health Insurance Act 1973.\n\nThe amendments include provisions for the Secretary to suspend or revoke approvals where necessary. There are also mechanisms for reviewing decisions related to these approvals. This framework applies the same standards of oversight to nurse prescribers as to other health professionals who prescribe under the scheme.\n\nThe bill will commence on the day after it receives Royal Assent. However, no nurse can apply for approval or prescribe pharmaceutical benefits until the required delegated legislation is prepared and in place. The Senate Community Affairs Legislation Committee has been asked to inquire into the bill and report by 26 February 2026.\n\nThe bill was introduced in the House of Representatives on 26 November 2025. It passed all stages in the House on 5 February 2026. It was then introduced in the Senate on 5 February 2026, with the second reading debate set for 1 April 2026."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"The Bill implements the stated policy objective of enabling registered nurses (who meet set criteria) to prescribe certain PBS medicines and to be subject to the same PSR oversight as other PBS prescribers. It remains within that original scope: creating an approval and oversight framework and delegating the detailed decisions (eligibility, conditions, and the list of permitted PBS medicines) to disallowable instruments. It does not materially expand beyond that core purpose in this text; rather, it leaves substantive scope decisions to subordinate instruments and existing registration/endorsement processes (NMBA and state/territory regulation)."},"complexity_factors":["Introduces new prescriber category with multiple defined terms (\"eligible nurse prescriber\", \"authorised nurse prescriber\").","Relies heavily on delegated legislative instruments (Minister sets eligibility, approval criteria, permitted medicines) — significant details left to subordinate law.","Cross‑references and interaction with multiple regimes: NH Act, HI Act (Part VAA/PSR), NMBA endorsement under the Health Practitioner Regulation National Law, and state/territory poisons legislation.","Administrative decision points: Secretary approvals, suspension/revocation, and review rights (proposed ss 84AAN, 84AAP, 84AAQ) add conditional administrative processes.","Conditional commencement: although the Act commences quickly, practical operation depends on subsequent instruments and state/territory regulatory alignment (implementation sequencing risk).","Clinical governance requirements: nurse prescriber agreements, mentorship and endorsement requirements (external standards from NMBA) create nested compliance obligations.","Policy discretion: Minister must have regard to PBAC advice but retains discretion to specify permitted PBS medicines (disallowable instrument) — adds political and technical contingency to outcomes.","Stakeholder complexity: multiple affected groups (nurses, GPs, pharmacists, state health authorities) increasing implementation negotiation and potential legal contests."],"plain_english_summary":"**What this Bill does (mechanics)**\n\n- Adds a new category of Commonwealth PBS prescriber called an **authorised nurse prescriber** by amending the National Health Act 1953 (NH Act) and updates the Health Insurance Act 1973 (HI Act) so nurse prescribers are subject to the same Professional Services Review (PSR) oversight as other PBS prescribers.\n- Creates a two‑stage regulatory mechanism:\n  - The Minister may, by disallowable legislative instrument, specify which registered nurses are *eligible nurse prescribers* (requirements may include qualifications, experience, or endorsement by the Nursing and Midwifery Board of Australia). (proposed ss 84AAM–84AAQ in the NH Act)\n  - The Secretary may approve eligible nurses as **authorised nurse prescribers**, and may suspend or revoke those approvals; approval criteria and conditions (for example, requirements for a written nurse prescriber agreement with an authorised health practitioner) are set by the Minister in delegated instruments. (proposed s 84AAN and s 84AAP)\n- Gives the Minister authority to determine (by legislative instrument) which pharmaceutical benefits on the PBS authorised nurse prescribers may prescribe, and requires the Minister to have regard to advice from the Pharmaceutical Benefits Advisory Committee (PBAC) when making that determination. (insertion to s 88 and related provisions)\n- Ensures authorised nurse prescribers’ PBS prescribing can be reviewed under the PSR scheme in the HI Act (so they are treated like other PBS prescribers for oversight). (amendments to Part VAA of the HI Act)\n- Includes review rights for administrative decisions about approvals and provides for the Secretary’s power to suspend or revoke approvals. (proposed s 84AAQ and s 84AAP)\n\n**Who this affects**\n\n- Registered nurses who meet the eligibility criteria and obtain approval from the Secretary (they may become authorised nurse prescribers and, where permitted, write PBS prescriptions).\n- Patients who currently obtain PBS medicines — they may be able to receive prescriptions from authorised nurse prescribers for medicines the Minister permits on the PBS list.\n- Other PBS prescribers (doctors, nurse practitioners, midwives, etc.) and the health services that arrange collaborative prescribing agreements (because authorised nurse prescribers must generally operate in partnership with an authorised health practitioner under a written agreement).\n- The Department of Health and the Secretary (who approve, monitor, suspend and revoke approvals) and the PBAC (whose advice is to be considered when the Minister decides which medicines nurse prescribers can access on the PBS).\n\n**Why it matters (purposes claimed and how it works in practice)**\n\n- The Explanatory Memorandum and Ministerial statements say the Bill implements recommendations from the Strengthening Medicare Taskforce and a Scope of Practice Review to allow nurses to work to their full scope, ease primary care workforce pressures, and improve access — especially in rural and remote areas.\n- Mechanically, the Bill does not itself list which medicines nurse prescribers can prescribe. Instead, it establishes the approval framework and delegates the detailed decisions (eligibility rules, approval conditions, and the list of PBS medicines nurse prescribers may prescribe) to the Minister via disallowable legislative instruments. That means the practical reach of the reform will largely be determined after the Act commences, by delegated rules.\n\n**Costs, incentives, trade‑offs and implementation risks**\n\n- Who pays: Prescriptions written by authorised nurse prescribers that fall within the Minister’s PBS list will be subsidised by the PBS in the same way as other prescribers’ prescriptions — that changes who can originate subsidised PBS claims but not how PBS subsidies are paid. Administrative costs for approvals, monitoring, and PSR oversight will be borne by the Department and by prescribers who must comply with approval conditions.\n- Bureaucratic discretion and regulatory dependence: The Bill vests significant detail in delegated (disallowable) instruments — eligibility criteria, required agreements, conditions of approval, and the list of medicines. This concentrates choice about scope and limits in the Minister’s regulatory instruments rather than in the primary Act (see proposed ss 84AAM–84AAQ and s 88(1EAA)).\n- Compliance burden on nurses and employers: Prospective authorised nurse prescribers must meet training/endorsement and approval requirements, maintain written nurse prescriber agreements, and be subject to review and possible suspension or revocation. The NMBA’s endorsement standard (already adopted separately) adds requirements such as postgraduate education and a six‑month mentorship; those training and supervision costs fall on nurses and their employers or funders.\n- Interaction with state/territory regulation: Prescribing of scheduled medicines remains regulated under state and territory poisons laws and the National Law endorsement process (NMBA). Implementation thus requires alignment across Commonwealth delegated rules, NMBA endorsement standards, and state/territory legislation and regulatory practice — a coordination risk before nurse prescribers can operate (the EM notes that applications and prescribing cannot begin until associated delegated instruments are in place).\n- Effects on private provision and markets: The Bill changes who may legally originate PBS prescriptions. That can alter demand for GP services (possible substitution toward nurse prescribers in certain settings), affect clinical workflows in clinics and pharmacies, and alter how primary care teams contract and assign roles. The Bill does not directly alter PBS pricing, dispensing margins, or pharmacy ownership rules. Any material impact on PBS expenditure depends on which medicines are authorised by the Minister and how prescribing patterns change — those details are left to delegated instruments and future practice patterns.\n- Oversight and patient safety trade‑offs: The Bill subjects nurse prescribers to the PSR (same oversight as other PBS prescribers) and allows the Secretary to suspend or revoke approvals. But the specifics of permitted medicines, conditions on approvals (for example, limits on Schedule 8 medicines), and required governance arrangements are to be set later, so the balance between access and controls will depend on the delegated instruments and their enforcement.\n\n**Net practical picture**\n\n- The Act (if passed) creates the statutory framework for registered nurses to become PBS prescribers subject to approval, conditions, and PSR oversight. The substantial operational detail — who is eligible, what they can prescribe, and the exact approval conditions — will be determined by the Minister in disallowable instruments and by NMBA endorsement and state/territory rules. That means the on‑the‑ground effect will be shaped mostly after the Bill becomes law, not solely by the Act’s text.\n\nReferences to the Bill’s structure: proposed NH Act inserts 84AAM–84AAQ (approval, criteria, suspension/revocation, review); amendment to s 88(1EAA) re start date and Ministerial specification of permitted PBS medicines; amendments to HI Act Part VAA to include eligible nurse prescribers within PSR oversight."}},"importantCases":[],"_links":{"self":"/api/acts/health-legislation-amendment-prescribing-of-pharmaceutical-benefits-bill-2025","history":"/api/acts/health-legislation-amendment-prescribing-of-pharmaceutical-benefits-bill-2025/history","analysis":"/api/acts/health-legislation-amendment-prescribing-of-pharmaceutical-benefits-bill-2025/analysis","conflicts":"/api/acts/health-legislation-amendment-prescribing-of-pharmaceutical-benefits-bill-2025/conflicts","importantCases":"/api/acts/health-legislation-amendment-prescribing-of-pharmaceutical-benefits-bill-2025/important-cases","documents":"/api/acts/health-legislation-amendment-prescribing-of-pharmaceutical-benefits-bill-2025/documents"}}