Statute Details
- Title: Healthcare Services (Collaborative Prescribing Service) Regulations 2023
- Act Code: HSA2020-S398-2023
- Legislative Type: Subsidiary Legislation (SL)
- Authorising Act: Healthcare Services Act 2020
- Enacting Power: Section 57 of the Healthcare Services Act 2020
- Citation and Commencement: Commenced on 26 June 2023
- Current Version (as indicated): Current version as at 27 Mar 2026
- Key Provisions (from extract): Regulations 1–4 and definitions in regulation 2; Regulations 3–4 set core operational requirements and the role of the medical practitioner-in-charge (CP)
- Amendment Noted in Timeline: Amended by S 838/2023 with effect from 18/12/2023
- Related Legislation (listed): Health Products Act 2007; Healthcare Services Act 2020; Medical Registration Act 1997; Midwives Act 1999; Pharmacists Registration Act 2007
What Is This Legislation About?
The Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (“Collaborative Prescribing Regulations”) create a regulated framework for a specific model of care: collaborative prescribing. In plain terms, the Regulations allow certain healthcare professionals—namely pharmacists and registered nurses—to prescribe specified health products and order specified tests or radiological procedures, but only when they are operating within a structured “collaborative” arrangement under a licensed healthcare provider.
The Regulations sit under the Healthcare Services Act 2020 and are designed to manage clinical risk. Prescribing is a high-stakes activity. The Regulations therefore require formal governance structures, written agreements, supervision/clinical escalation pathways, and ongoing review mechanisms. They also impose eligibility and disciplinary-history constraints on the senior medical oversight role, reflecting the need for accountability where prescribing authority is delegated or shared.
Practically, the Regulations target licensed healthcare services such as acute hospitals, community hospitals, nursing homes, and outpatient services (including outpatient renal dialysis). The model is not “free-standing” prescribing by pharmacists or nurses; it is prescribing performed “for and on behalf of” a licensee, under conditions set by the licensee and approved through internal committees and oversight roles.
What Are the Key Provisions?
1. Core definitions and scope (Regulation 2)
The Regulations define the key terms that determine who may prescribe, what may be prescribed, and which services are covered. “Collaborative prescribing service” is limited to two categories of activity provided by a licensee through a “collaborative prescribing practitioner”: (a) prescription of a health product; and (b) prescription of a laboratory test or radiological procedure. This is important because it narrows the regulatory permission to specific prescribing functions rather than broad clinical decision-making.
The Regulations also define “licensee” as a person who both (i) holds a licence to provide a relevant licensable healthcare service and (ii) is approved to provide a collaborative prescribing service as a specified service for that licensable healthcare service. This means the Regulations do not automatically grant prescribing authority to all pharmacists or nurses; the authority is tied to the licensee’s licensing status and approval.
2. Requirements to provide the service (Regulation 3)
Regulation 3 is the operational “gateway” provision. A licensee intending to provide a collaborative prescribing service must, among other things:
- Restrict participation: ensure that only a person who is a “collaborative prescribing practitioner” provides the service for and on behalf of the licensee.
- Ensure practitioner-level governance: each collaborative prescribing practitioner must (i) have an in-force “collaborative practice agreement” meeting the statutory requirements before providing any collaborative prescribing service; (ii) provide the service only according to the agreement; and (iii) provide the service under the supervision of the medical practitioner identified in the agreement.
- Appoint a medical practitioner-in-charge (CP): appoint and ensure the medical practitioner-in-charge carries out the functions required under Regulation 4.
- Establish a credentialing committee: establish a credentialing committee under Regulation 5 to carry out the functions under Regulation 6.
- Establish a service review committee: establish a service review committee under Regulation 7 to carry out the functions under Regulation 8.
- Regulatory transparency: provide the Director-General with records or information relating to the activities of the credentialing and service review committees as the Director-General may require.
Collaborative practice agreement content (Regulation 3(2))
A central compliance requirement is that the collaborative practice agreement must be in writing and entered into by the collaborative prescribing practitioner with both the licensee and a supervising medical practitioner employed or engaged by the licensee. The agreement must set out:
- 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 requiring the practitioner to seek advice from the supervising medical practitioner or refer the patient for assessment/care;
- and, if the supervising medical practitioner is unavailable, the circumstances requiring escalation to another medical practitioner who is the licensee’s personnel.
For practitioners and compliance teams, this is a practical drafting checklist. It also shows that the Regulations treat escalation and patient referral pathways as mandatory elements of the prescribing governance model.
3. Medical practitioner-in-charge (CP) (Regulation 4)
Regulation 4 creates a specific senior medical oversight role. The medical practitioner-in-charge (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, within the three years before employment/engagement, been the subject of certain disciplinary tribunal orders under the Medical Registration Act 1997 (sections 59D(2) or 59E).
This “cooling-off” disciplinary-history restriction is a significant gatekeeping mechanism. It signals that the CP role is intended to be held by individuals with a clean disciplinary record within a defined period, thereby strengthening public protection and institutional accountability.
The functions of the CP include:
- Overseeing safe provision: ensuring the collaborative prescribing service is provided in a proper, effective and safe manner.
- Responding to service review findings: considering findings of the service review committee and ensuring necessary measures are implemented to address issues raised.
- Recommending cessation: where the CP is satisfied that a collaborative prescribing practitioner has not provided the service properly, effectively and safely, making a recommendation for cessation of that practitioner’s collaborative prescribing and providing reasons to the licensee.
4. Credentialing committee and service review committee (Regulations 5–8)
The extract provided truncates the remainder of Regulation 5 and does not include the full text of Regulations 6–8. However, the structure is clear from the Regulations’ enacting scheme: the licensee must establish (i) a credentialing committee to credential/approve collaborative prescribing practitioners, and (ii) a service review committee to review the service’s ongoing performance and safety.
From the extract, Regulation 5(1) requires that the credentialing committee consist of at least three members, including at least one medical practitioner. The Regulations also cross-reference other governance requirements (for example, where the licensee is required to appoint a quality assurance committee under the Healthcare Services (General) Regulations). This suggests that the credentialing and review committees are intended to integrate with broader quality assurance and clinical governance systems.
For legal practitioners, the key takeaway is that the Regulations require both initial credentialing (who is approved to prescribe) and ongoing review (whether the service continues to be safe and effective). Even where the extract is incomplete, the compliance architecture is explicit: committees, defined functions, and reporting/notification duties.
5. Notification to the Director-General (Regulation 9)
The extract indicates a Regulation 9 requiring notification to the Director-General. While the full text is not provided, the presence of this provision reinforces that the regulatory model is not purely internal; it includes formal reporting obligations to the Ministry of Health’s Director-General.
How Is This Legislation Structured?
The Regulations are structured as a short, targeted instrument with an enacting formula and nine main regulations:
- Regulation 1: Citation and commencement (26 June 2023).
- Regulation 2: Definitions (including “collaborative prescribing service”, “collaborative practice agreement”, “collaborative prescribing practitioner”, “licensee”, and the relevant licensable healthcare services).
- Regulation 3: Requirements for provision of the collaborative prescribing service, including mandatory governance structures and the content requirements for the written collaborative practice agreement.
- Regulation 4: Medical practitioner-in-charge (CP)—eligibility criteria and functions.
- Regulation 5: Composition of the credentialing committee.
- Regulation 6: Functions of the credentialing committee (credentialing/approval-related duties).
- Regulation 7: Composition of the service review committee.
- Regulation 8: Functions of the service review committee (ongoing monitoring and review duties).
- Regulation 9: Requirement to notify the Director-General.
Who Does This Legislation Apply To?
The Regulations apply to licensees under the Healthcare Services Act 2020 who are (i) licensed to provide specified healthcare services and (ii) approved to provide a collaborative prescribing service as a specified service for the relevant licensable healthcare service. The “relevant licensable healthcare service” list includes acute hospital services, ambulatory surgical centre services, community hospital services, contingency care services, nursing home services, outpatient medical services, and outpatient renal dialysis services.
They also apply indirectly to collaborative prescribing practitioners—pharmacists or registered nurses approved by the credentialing committee—and to the medical practitioner-in-charge (CP) and supervising medical practitioners who must be identified in the collaborative practice agreement and who form part of the escalation and supervision framework.
Why Is This Legislation Important?
This Regulations instrument is important because it operationalises a controlled expansion of prescribing capability within healthcare teams. By allowing pharmacists and registered nurses to prescribe within defined boundaries, it supports care models that can improve access, continuity, and efficiency—while still maintaining clinical oversight.
From a compliance and risk-management perspective, the Regulations impose a layered safety architecture: written collaborative practice agreements, supervision requirements, committee-based credentialing, service review mechanisms, and a senior medical oversight role with authority to recommend cessation of a practitioner’s collaborative prescribing privileges. The disciplinary-history eligibility restriction for the CP role further strengthens accountability.
For practitioners advising healthcare providers, the most practical impact is that the Regulations require documented governance and institutional readiness. Licensees must be able to demonstrate (to the Director-General, if required) that their committees are properly constituted, that practitioners are credentialed, that collaborative practice agreements are in place and compliant, and that escalation pathways for advice and patient referral are clearly defined.
Related Legislation
- Healthcare Services Act 2020
- Health Products Act 2007
- Medical Registration Act 1997
- Midwives Act 1999
- Pharmacists Registration Act 2007
- Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021) (cross-referenced definition of “healthcare professional”)
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.