Statute Details
- Title: Healthcare Services (Collaborative Prescribing Service) Regulations 2023
- Act Code: HSA2020-S398-2023
- Type: Subsidiary Legislation (sl)
- Authorising Act: Healthcare Services Act 2020
- Enacting power: Section 57 of the Healthcare Services Act 2020
- Commencement: 26 June 2023
- Primary subject: Regulatory framework for “collaborative prescribing services” delivered by approved pharmacists or registered nurses on behalf of a licensed healthcare provider
- Key provisions (from extract): Regulations 1–4 and definitions in Regulation 2; Regulations 3–4 set core eligibility, governance, and supervision requirements
- Most relevant regulated entities: “Licensees” providing specified healthcare services; “collaborative prescribing practitioners” (pharmacists or registered nurses); medical practitioner-in-charge (CP); credentialing and service review committees
- 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 structured, safety-focused legal framework allowing certain pharmacists and registered nurses to prescribe specified health products and order specified tests or radiological procedures, but only when doing so is authorised within a licensed healthcare provider’s governance model.
In plain language, the Regulations recognise that some healthcare settings may benefit from collaborative models of prescribing—where non-medical healthcare professionals prescribe within defined boundaries, while medical oversight and internal review mechanisms ensure clinical safety, accountability, and appropriate escalation to doctors.
The Regulations sit under the Healthcare Services Act 2020 and operate as a “conditions and governance” layer. They do not merely permit collaborative prescribing; they require licensees to put in place formal agreements, appoint responsible medical leadership, establish committees to credential practitioners and review service quality, and maintain records for regulatory oversight.
What Are the Key Provisions?
1. Core definitions and scope (Regulation 2)
The Regulations define the key terms that determine who may do what, and for which healthcare services. “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 definition is important because it confines the regulatory permission to specific prescribing-related activities.
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 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 (with an amendment reflected in the extract).
2. Conditions for providing a collaborative prescribing service (Regulation 3)
Regulation 3 is the central compliance provision. A licensee intending to provide a collaborative prescribing service must ensure that only approved “collaborative prescribing practitioners” provide the service on the licensee’s behalf. It also requires that each collaborative prescribing practitioner has an in-force “collaborative practice agreement” before they are allowed to provide any collaborative prescribing service.
Crucially, Regulation 3(1)(b) requires that the practitioner provides the service only in accordance with the agreement’s terms, and that the service is provided under the supervision of the medical practitioner specified in the agreement. This makes the agreement not a mere administrative document, but a legal gatekeeping instrument that defines clinical boundaries and escalation pathways.
3. The collaborative practice agreement (Regulation 3(2))
The Regulations specify minimum content for the collaborative practice agreement. It must be (a) in writing; (b) entered into by the collaborative prescribing practitioner with both the licensee and a medical practitioner employed or engaged by the licensee to supervise the practitioner; and (c) set out required matters.
Those required matters include: a description of the type of collaborative prescribing service the practitioner may provide; the conditions under which the practitioner may provide it; a list of health products the practitioner may prescribe; and the circumstances requiring the practitioner to seek advice from the supervising medical practitioner or refer the patient for assessment or care. The agreement must also address what happens if the supervising medical practitioner is not available—namely, seeking advice from another medical practitioner who is the licensee’s personnel or referring the patient accordingly.
From a practitioner’s perspective, this is a compliance “checklist” embedded in law. If the agreement does not contain these elements, the licensee risks being in breach of the Regulations even if the clinical practice appears otherwise safe.
4. Medical practitioner-in-charge (CP) and eligibility (Regulation 4)
Regulation 4 requires the licensee to appoint a “medical practitioner-in-charge (CP)” (a medical doctor) to carry out defined oversight functions. Eligibility is tightly framed: the CP must be (a) a medical practitioner and personnel of the licensee; (b) the medical director or a member of the medical board or clinical board; and (c) not have been subject, within the three years before employment/engagement, to certain disciplinary orders made by a Disciplinary Tribunal under the Medical Registration Act 1997.
This “cooling-off” / disqualification approach is designed to ensure that the person responsible for oversight has not recently been subject to serious professional discipline. It also creates a clear due diligence obligation for licensees when appointing the CP.
5. Functions of the CP (Regulation 4(2))
The CP’s functions include: overseeing the provision of the collaborative prescribing service to ensure it is provided in a proper, effective and safe manner; considering findings of the service review committee and ensuring necessary measures are implemented to address issues; and—importantly—recommending cessation of a collaborative prescribing practitioner’s service if the CP is satisfied that the practitioner has not provided the service properly, effectively, and safely, including providing reasons to the licensee.
This creates a formal accountability chain: internal review findings feed into CP oversight, and the CP has authority to recommend cessation where safety concerns arise.
6. Credentialing committee and service review committee (Regulations 5–8, as indicated)
Although the extract truncates the remainder of the text, the Regulations clearly establish two governance committees: a “credentialing committee” and a “service review committee.” Regulation 3 requires the licensee to establish both committees and ensure they carry out their functions.
The credentialing committee is tasked with credentialing—i.e., approving collaborative prescribing practitioners. The extract indicates that the credentialing committee must consist of at least three members, including at least one medical practitioner. The Regulations also appear to align committee composition with other quality assurance structures under the Healthcare Services (General) Regulations 2021 (for example, where a quality assurance committee is required, the credentialing committee composition may need to reflect that requirement).
The service review committee is intended to review the ongoing provision of the collaborative prescribing service and generate findings that the CP must consider and act upon. In other words, credentialing is the “front door” (who may prescribe), while service review is the “back end” (how well the service is performing and whether corrective action is needed).
7. Notification to the Director-General (Regulation 9)
Regulation 9 requires the licensee to notify the Director-General. While the extract does not show the details, this type of provision typically supports regulatory visibility and ensures that the Ministry of Health can monitor compliance and governance arrangements.
How Is This Legislation Structured?
The Regulations are structured as a short, operational compliance instrument with an enacting formula and nine regulations:
Regulation 1 sets the citation and commencement date (26 June 2023).
Regulation 2 provides definitions that define the regulated actors and the scope of “collaborative prescribing service.”
Regulation 3 sets the overarching requirements for a licensee to provide the service, including practitioner eligibility, written collaborative practice agreements, appointment of a medical practitioner-in-charge, and establishment of committees, plus record provision to the Director-General.
Regulation 4 establishes the medical practitioner-in-charge (CP), including eligibility criteria and CP functions.
Regulations 5–6 deal with the credentialing committee’s composition and functions.
Regulations 7–8 deal with the service review committee’s composition and functions.
Regulation 9 imposes a notification obligation to the Director-General.
Who Does This Legislation Apply To?
The Regulations apply to “licensees” that hold licences to provide specified healthcare services and that are approved to provide a collaborative prescribing service as a specified service for the relevant licensable healthcare service. In practice, this means the Regulations are aimed at healthcare institutions and service providers operating under the Healthcare Services Act 2020 licensing framework.
The Regulations also apply to the individuals and internal governance structures through which the licensee delivers collaborative prescribing: collaborative prescribing practitioners (pharmacists or registered nurses approved by the credentialing committee), the medical practitioner-in-charge (CP), and the credentialing and service review committees. The legal obligations are primarily imposed on the licensee, but the practitioner’s ability to prescribe is conditional on approval and compliance with the collaborative practice agreement and supervision arrangements.
Why Is This Legislation Important?
Collaborative prescribing can improve access to timely medication and diagnostic ordering, particularly in outpatient and institutional settings. However, prescribing and diagnostic test ordering carry clinical risk. These Regulations address that risk by requiring a governance model that combines (i) formal credentialing, (ii) written agreements defining scope and escalation, (iii) medical oversight through a CP, and (iv) ongoing service review with corrective action.
For practitioners advising healthcare providers, the Regulations are important because they translate clinical governance into enforceable legal duties. A licensee’s compliance is not assessed only by outcomes; it is also assessed by whether the required structures exist and whether the required documents and processes are in place—especially the collaborative practice agreement and the committee framework.
From an enforcement and risk-management perspective, the Regulations also create clear accountability points: the CP can recommend cessation of a practitioner’s collaborative prescribing role, and the licensee must provide records or information to the Director-General upon request. This means that documentation and internal audit trails are likely to be central in any regulatory review or incident investigation.
Related Legislation
- Healthcare Services Act 2020
- Health Products Act 2007
- Medical Registration Act 1997
- Pharmacists Registration Act 2007
- Midwives Act 1999
- Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021) (referenced for definitions and 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.