Statute Details
- Title: Healthcare Services (Collaborative Prescribing Service) Regulations 2023
- Act Code: HSA2020-S398-2023
- Type: Subsidiary Legislation (sl)
- Enacting Act: Healthcare Services Act 2020 (powers under section 57)
- Commencement: 26 June 2023
- Latest status noted in extract: Current version as at 27 Mar 2026
- Key subject: Regulation of “collaborative prescribing services” in specified healthcare settings
- Key provisions (from extract): Regulations 1–4 and definitions in regulation 2
- Important institutional mechanisms: Credentialing committee; service review committee; medical practitioner-in-charge (CP); collaborative practice agreements
What Is This Legislation About?
The Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (“Collaborative Prescribing Regulations”) create a regulatory framework allowing certain healthcare professionals—specifically pharmacists and registered nurses—to prescribe specified health products and order specified diagnostic tests or radiological procedures, but only when they do so under a structured collaborative model.
In plain terms, the Regulations are designed to ensure that collaborative prescribing is not “independent prescribing” by another profession. Instead, it is a supervised, credentialed, and governance-driven service delivered by a licensed healthcare provider (“licensee”) through an approved “collaborative prescribing practitioner”. The model requires formal agreements, internal committees, and oversight by a medical practitioner-in-charge.
The Regulations also tie the service to particular types of healthcare settings—such as acute hospitals, community hospitals, nursing homes, and outpatient medical services—so that the collaborative prescribing framework is implemented within environments that can support clinical governance, escalation pathways, and patient safety controls.
What Are the Key Provisions?
1. Definitions and scope (Regulation 2)
The Regulations define the core concepts that determine who may prescribe, what may be prescribed, and which healthcare services are eligible. “Collaborative prescribing service” is limited to two categories of clinical actions provided by a licensee through a collaborative prescribing practitioner: (a) the prescription of a health product; and (b) the prescription of a laboratory test or radiological procedure. This is important because it narrows the regulatory permission to specific clinical activities rather than a broad authorisation to prescribe anything.
The Regulations also define “collaborative prescribing practitioner” as a pharmacist or registered nurse approved by the credentialing committee. “Licensee” is a person who holds a licence to provide a relevant licensable healthcare service and is approved to provide the collaborative prescribing service as a specified service for that licensable healthcare service. This means the permission is not automatic; it is layered: licensing approval plus internal credentialing approval plus compliance with the governance requirements.
2. Requirements for provision of the collaborative prescribing service (Regulation 3)
Regulation 3 is the operational heart of the framework. A licensee intending to provide a collaborative prescribing service must, among other things:
- Restrict provision to approved practitioners: ensure that no one provides the collaborative prescribing service for and on behalf of the licensee unless the person is a collaborative prescribing practitioner.
- Ensure each collaborative prescribing practitioner has an appropriate agreement: the practitioner must have an in-force “collaborative practice agreement” before providing any collaborative prescribing service for the licensee.
- Constrain practice to the agreement: the practitioner must provide the service only in accordance with the agreement’s terms.
- Provide supervision: the practitioner must provide the service under the supervision of the medical practitioner specified in the agreement.
- Appoint a medical practitioner-in-charge (CP): appoint and ensure the CP carries out specified functions.
- Establish governance committees: establish a credentialing committee and a service review committee.
- Provide records to the Director-General: supply records or information relating to the activities of the credentialing committee or service review committee as the Director-General may require.
Collaborative practice agreement requirements (Regulation 3(2))
The Regulations require the collaborative practice agreement to be in writing and entered into by the collaborative prescribing practitioner with both: (i) the licensee; and (ii) a medical practitioner employed or engaged by the licensee to supervise the practitioner. The agreement must set out:
- a description of the type of collaborative prescribing service the practitioner may provide;
- the conditions under which the practitioner may provide that service;
- the list of health products the practitioner may prescribe;
- the circumstances in which the practitioner must seek advice from the supervising medical practitioner or refer the patient for assessment/care; and
- an escalation pathway if the supervising medical practitioner is not available (including seeking advice from another medical practitioner who is licensee personnel or referring the patient).
For practitioners, the agreement is not a mere administrative document. It is the compliance mechanism that defines the boundaries of clinical authority, the escalation triggers, and the patient referral/advice workflow.
3. Medical practitioner-in-charge (CP) (Regulation 4)
Regulation 4 sets eligibility and duties for the “medical practitioner-in-charge (CP)”. The CP must be:
- a medical practitioner and personnel of the licensee;
- the medical director, or a member of the medical board or clinical board of the licensee; and
- not have been subject, within the three years before employment/engagement, to certain disciplinary orders made by a Disciplinary Tribunal under specified provisions of the Medical Registration Act 1997.
This “cooling-off” requirement is a risk-control measure: it aims to ensure that the person responsible for oversight has not recently been disciplined through the medical regulatory disciplinary process.
The CP’s functions include:
- Overseeing safe delivery: to oversee provision of the collaborative prescribing service to ensure it is provided in a proper, effective and safe manner.
- Responding to service review findings: to consider findings of the service review committee and ensure necessary measures are implemented.
- Escalation and cessation recommendation: where satisfied that a collaborative prescribing practitioner has not provided the service properly/effectively/safely, to recommend cessation of the service by that practitioner and provide reasons to the licensee.
Practically, this gives the CP a decisive governance role. The CP is the internal “accountability node” that translates committee findings into corrective action and, if necessary, removal of a practitioner from the collaborative prescribing role.
4. Credentialing committee and service review committee (Regulations 5–8, as indicated)
The extract confirms that the Regulations establish two committees with distinct functions:
- Credentialing committee (Regulation 5): responsible for credentialing/approval of collaborative prescribing practitioners and carrying out functions under Regulation 6.
- Service review committee (Regulation 7): responsible for ongoing review and carrying out functions under Regulation 8.
Although the extract truncates the remainder of Regulation 5, it clearly states that the credentialing committee must consist of at least three members, including at least one medical practitioner. The Regulations also appear to integrate with broader healthcare governance requirements (for example, the extract references quality assurance committee requirements under the Healthcare Services (General) Regulations 2021). This suggests that the credentialing committee may need to coordinate with or draw from existing quality assurance structures.
From a compliance perspective, the key practitioner takeaway is that collaborative prescribing is not a one-off approval. It is a credentialed service with continuing governance: credentialing for entry and service review for monitoring, quality assurance, and safety improvement.
How Is This Legislation Structured?
The Regulations are structured as a short, operational subsidiary instrument with an enacting formula and a set of numbered regulations. Based on the extract, the main structure is:
- Regulation 1: Citation and commencement (26 June 2023).
- Regulation 2: Definitions (including “collaborative practice agreement”, “collaborative prescribing practitioner”, “collaborative prescribing service”, “licensee”, and the relevant healthcare services).
- Regulation 3: Requirements for provision of the collaborative prescribing service (licence-holder obligations, agreement requirements, supervision, appointment of CP, and committee establishment).
- Regulation 4: Medical practitioner-in-charge (CP) eligibility and functions.
- Regulations 5–6: Credentialing committee composition and functions.
- Regulations 7–8: Service review committee composition and functions.
- Regulation 9: Requirement to notify the Director-General (as indicated by the enacting formula list).
Overall, the structure reflects a “permission + governance + oversight” model: the licensee must set up internal governance bodies and documentation, and must maintain records and notifications to the regulator.
Who Does This Legislation Apply To?
The Regulations apply to licensees that (i) hold a licence to provide a relevant licensable healthcare service and (ii) are approved to provide the collaborative prescribing service as a specified service for that licensable healthcare service. The “relevant licensable healthcare service” list in the definitions includes acute hospital service, ambulatory surgical centre service, community hospital service, contingency care service, nursing home service, outpatient medical service, and outpatient renal dialysis service.
They also apply to the collaborative prescribing practitioners (pharmacists or registered nurses) who are approved by the credentialing committee, and to the medical practitioner-in-charge and supervising medical practitioners who must be involved through the collaborative practice agreement and supervision arrangements.
Why Is This Legislation Important?
These Regulations are significant because they operationalise a controlled expansion of prescribing-related clinical functions beyond doctors, while embedding patient safety safeguards. By requiring written collaborative practice agreements, defined lists of permissible health products, and explicit escalation/referral pathways, the Regulations reduce ambiguity about clinical authority and responsibility.
For healthcare providers, the compliance burden is not limited to appointing staff. It includes establishing committees, maintaining records, and ensuring ongoing monitoring through service review. The CP’s functions—especially the power to recommend cessation where safe practice is not met—create a strong internal enforcement mechanism that can protect patients and manage clinical risk.
For practitioners and counsel advising licensees, the Regulations also highlight the importance of aligning internal governance with statutory requirements. Failure to maintain the agreement in force, to restrict practice to the agreement’s terms, or to ensure supervision and escalation can undermine the legality of collaborative prescribing and expose the licensee to regulatory action.
Related Legislation
- Health Products Act 2007
- Healthcare Services Act 2020
- Medical Registration Act 1997
- Midwives Act 1999
- Pharmacists Registration Act 2007
- Healthcare Services (General) Regulations 2021 (referenced for quality assurance committee context)
Source Documents
This article provides an overview of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.