Statute Details
- Title: Healthcare Services (Exemption for Influenza Vaccination at Approved Retail Pharmacies) Order 2024
- Act Code: HSA2020-S752-2024
- Legislative Type: Subsidiary Legislation (SL)
- Authorising Act: Healthcare Services Act 2020
- Enacting Power: Section 53 of the Healthcare Services Act 2020
- Commencement: 1 October 2024
- SL Number: S 752/2024
- Status: Current version as at 27 March 2026
- Key Provisions: Section 1 (Citation and commencement); Section 2 (Definitions); Section 3 (Exemption in relation to administration of influenza vaccine at approved retail pharmacy)
- Core Exemptions: Exemption from Section 8 of the Healthcare Services Act 2020; limited exemption from Section 31(1) (advertising restrictions)
- Operational Context: Applies only where influenza vaccination is administered at an “approved retail pharmacy” under a “sandbox trial”
What Is This Legislation About?
The Healthcare Services (Exemption for Influenza Vaccination at Approved Retail Pharmacies) Order 2024 (“the Order”) is a targeted regulatory instrument that temporarily relaxes certain legal requirements under the Healthcare Services Act 2020 (“HSA”) for a specific public health activity: the administration of influenza vaccines at approved retail pharmacies.
In plain terms, the Order allows approved retail pharmacies—under a Ministry of Health (MOH) “sandbox trial”—to administer influenza vaccinations through approved pharmacists, without being constrained by particular provisions of the HSA that would otherwise apply to pharmacy licence holders. The policy rationale is to test feasibility and safety in a controlled environment, while enabling pharmacies to participate in vaccination delivery more broadly than traditional healthcare settings.
Because the Order is tied to a sandbox trial and to conditions set out in referenced regulations, it is not a general permission for all pharmacies at all times. It is a conditional exemption designed for trial governance, compliance control, and risk management.
What Are the Key Provisions?
1) Citation and commencement (Section 1)
Section 1 provides the formal name of the Order and states that it comes into operation on 1 October 2024. For practitioners, this matters for determining whether any conduct—such as advertising or vaccination administration—falls within the temporal scope of the exemption.
2) Definitions and cross-references (Section 2)
Section 2 defines key terms by reference to other regulatory instruments, notably the Health Products (Therapeutic Products) Regulations 2016 and its Third Schedule. The Order defines:
- “approved pharmacist” and “approved retail pharmacy” by reference to Part 2 of the Third Schedule to the 2016 Regulations;
- “holder of a pharmacy licence” as a person holding a pharmacy licence in respect of an approved retail pharmacy;
- “pharmacy licence” by reference to regulation 2(1) of the 2016 Regulations;
- “sandbox trial” as a trial conducted by MOH under terms and conditions issued by MOH to a holder of a pharmacy licence to test feasibility and safety of influenza vaccine administration by approved pharmacists.
These definitions are crucial because the exemption in Section 3 is triggered only when the vaccination is administered in the precise circumstances described. If a pharmacy is not an “approved retail pharmacy,” or if the pharmacist is not an “approved pharmacist,” or if the activity is not conducted under a “sandbox trial,” the exemption will not apply.
3) The exemption framework (Section 3(1))
Section 3(1) sets out the conditions under which the Order applies. The exemption is engaged only where an influenza vaccine is administered at an approved retail pharmacy under a sandbox trial, and specifically:
- (a) the vaccine is administered by an approved pharmacist who is employed by the holder of the pharmacy licence issued in respect of the approved retail pharmacy; and
- (b) the administration is in accordance with the conditions specified in the third column of item 4 of Part 1 of the Third Schedule to the 2016 Regulations.
For legal compliance, this is a “checklist” trigger. Practitioners should advise clients to document: (i) the pharmacist’s approved status; (ii) the employment relationship; and (iii) adherence to the specific conditions in the referenced Third Schedule item. The cross-reference to the Third Schedule is particularly important because it effectively imports operational requirements into the exemption.
4) Exemption from Section 8 of the HSA (Section 3(2))
Section 3(2) states that Section 8 of the Act does not apply to a holder of a pharmacy licence issued in respect of an approved retail pharmacy in relation to the administration of an influenza vaccine at the approved retail pharmacy.
While the extract provided does not reproduce Section 8 itself, the legal effect is clear: the pharmacy licence holder is carved out from the application of Section 8 for the specified activity. In practice, Section 8 likely imposes a baseline regulatory requirement or restriction on healthcare service delivery. The Order’s function is to remove that barrier for the trial context, but only for influenza vaccination administered at the approved retail pharmacy under the conditions in Section 3(1).
5) Limited exemption from advertising restrictions (Section 3(3))
Section 3(3) provides that Section 31(1) of the Act does not apply to two categories of persons:
- (a) a holder of a pharmacy licence who advertises (or causes to be advertised) information relating to the administration of an influenza vaccine at the approved retail pharmacy to which the pharmacy licence relates; and
- (b) a person who, acting on the authority of a holder of a pharmacy licence, advertises (or causes to be advertised) such information.
This is a significant practical provision. Advertising rules can be a major compliance friction point for healthcare-related services. The Order permits advertising of influenza vaccination information in relation to the approved retail pharmacy, but only within the scope of the licence holder’s authority and the activity described. Practitioners should still ensure that advertising content remains accurate and consistent with the trial conditions and the pharmacist’s authorisation status, because the exemption is not a blanket permission to advertise any healthcare service—only information relating to influenza vaccine administration at the relevant approved retail pharmacy.
6) Making date and formalities
The Order was made on 27 September 2024 by the Permanent Secretary (Policy and Development), Ministry of Health. For legal interpretation, the “made on” date is relevant for understanding legislative history, but the operative commencement is 1 October 2024.
How Is This Legislation Structured?
The Order is structured as a short, three-section instrument:
- Section 1 (Citation and commencement): identifies the Order and sets the commencement date.
- Section 2 (Definitions): defines the key terms used in the exemption, largely by reference to the Health Products (Therapeutic Products) Regulations 2016 and its Third Schedule.
- Section 3 (Exemption in relation to administration of influenza vaccine at approved retail pharmacy): contains the operative provisions, including the conditions for applicability and the specific exemptions from Sections 8 and 31(1) of the Healthcare Services Act 2020.
Notably, the Order is highly dependent on cross-referenced regulatory schedules. This means that practitioners must read the Order together with the referenced provisions in the 2016 Regulations to understand the full compliance requirements.
Who Does This Legislation Apply To?
The Order applies to holders of pharmacy licences issued in respect of an approved retail pharmacy, but only for the specific activity of administering influenza vaccines at that pharmacy under a MOH sandbox trial.
It also affects approved pharmacists (who must be employed by the pharmacy licence holder) and advertising actors (including persons acting on the authority of the licence holder) because Section 3(3) creates a carve-out from the HSA’s advertising restriction for influenza vaccine administration information.
Why Is This Legislation Important?
This Order is important because it operationalises a policy shift: enabling vaccination delivery through retail pharmacy channels, but only within a controlled trial framework. From a practitioner’s perspective, the Order reduces legal uncertainty for pharmacy licence holders and approved pharmacists who participate in MOH’s sandbox trials by clarifying that certain HSA provisions will not apply to the trial activity.
Equally important, the Order addresses a common compliance bottleneck—advertising. Without the Section 3(3) exemption, pharmacy licence holders might be constrained from communicating vaccination availability to the public, or might face enforcement risk for promotional conduct. The carve-out allows targeted advertising of influenza vaccine administration information, supporting public access and uptake during influenza seasons.
Finally, the conditional nature of the exemption means that compliance is not optional. The exemption is triggered only when the vaccination is administered by an approved pharmacist employed by the licence holder and in accordance with the specific conditions in the referenced Third Schedule. Practitioners should therefore focus on governance: trial participation documentation, staff authorisation verification, adherence to schedule conditions, and advertising compliance processes.
Related Legislation
- Healthcare Services Act 2020 (including Sections 8 and 31(1))
- Health Products (Therapeutic Products) Regulations 2016 (including Third Schedule, Part 2 and Third Schedule, Part 1 item 4)
Source Documents
This article provides an overview of the Healthcare Services (Exemption for Influenza Vaccination at Approved Retail Pharmacies) Order 2024 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.