Open consultation

Proposal to amend the Human Medicines Regulations 2012 to support the ongoing supply and deployment of vaccinations across the UK - consultation document

Published 5 September 2025

Executive summary

In response to the COVID-19 pandemic, the Human Medicines Regulations 2012 (HMRs) were amended by the:

• Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020
• Human Medicines (Coronavirus) (Further Amendments) Regulations 2020

These amendments supported the rollout of both the COVID-19 and influenza vaccination programmes and ensured that there was a sufficient vaccination workforce to deliver them.

The aim of the proposals set out in this consultation is to further amend the HMRs to ensure that lessons learned during this period can be used to support the safe supply, distribution and administration of a wider range of vaccines both now and in the future. This consultation focuses on the following regulations within the HMRs, the current remit of which is summarised below:

• regulation 3A (R3A) enables trained healthcare professionals or staff under the supervision of trained healthcare professionals to conduct the final stage of assembly, preparation and labelling of COVID-19 vaccines without additional marketing authorisations or manufacturer’s licences being required
• regulation 19 (4A) to (4D) (R19) allows COVID-19 and influenza vaccines to be moved between different NHS service providers at the end of the supply chain by providers operating under NHS arrangements or the medical services of His Majesty’s Armed Forces, without the need for a wholesale dealer’s licence
• regulation 247A (R247A) enables the use of an extended workforce who are legally and safely able to administer COVID-19 or influenza vaccines without the input of a prescriber, using an approved protocol
• regulation 233 (8) (R233) enables persons lawfully conducting a retail pharmacy business, to deliver COVID-19 and influenza vaccination services off the registered premises under a patient group direction (PGD)
• regulation 3 enables doctors, dentists, nurses and midwives to be able to prepare or assemble medicines for a patient in the course of their treatment without a manufacturers’ licence
• schedule 17 (S17) enables occupational health vaccinators who are permitted, as part of an occupational health scheme (OHS) under the written directions of a doctor, to administer COVID-19 and influenza vaccines as part of an NHS or local authority OHS

Medicines regulation is a devolved matter in relation to Northern Ireland and a reserved matter (to the UK Parliament) in relation to Scotland and Wales.

The Secretary of State for Health and Social Care, in relation to England, Wales and Scotland, acting jointly with the Department of Health in Northern Ireland in relation to Northern Ireland, is seeking views on the proposals to amend the HMRs (pursuant to section 45 (1) of the Medicines and Medical Devices Act 2021) in relation to the above provisions and as outlined in this consultation.

Introduction

In 2020, as part of the response to the COVID-19 pandemic, several temporary amendments were made to the HMRs to:

• provide greater flexibilities for the movement and supply of COVID-19 and influenza vaccines
• enable COVID-19 and influenza vaccines to be deployed safely at scale and pace

To support the smooth continuation of these vaccination programmes, R3A, R19 and R247A were subsequently extended in 2022 and then extended again in 2024. Temporary amendments to R233 and S17 were made permanent in 2022.

Through the continued use of these regulations during the COVID-19 pandemic, we have learned some important lessons about how the regulatory framework can help to improve collaboration and the use of staff and resources across the health system and ultimately help improve access to vaccines. This consultation proposes further amendments to the HMRs which build upon those successes to help develop a vaccination system that is fit for the future.

R3A, R19 and R247A are time-limited regulations with sunset provisions, which mean that they will cease to have effect from 1 April 2026.

If these regulations were to lapse, it may not be possible to deliver future COVID-19 and influenza vaccination services in their current form. This will likely reduce flexibility and slow the delivery of vaccination efforts. Although R233 (along with the proposed amendments to regulation 3) and S17 are not subject to the same time-limited provisions, these proposals suggest ways to better use these regulations, helping to ensure vaccination services are as effective as possible.

Policy objective

The overarching policy objective is to help safeguard public health in accordance with section 2 (2) of the Medicines and Medical Devices Act 2021. This is designed to protect public health and promote the safety of patients.

The COVID-19 pandemic vaccination programme was the largest vaccination programme undertaken in the history of the NHS which saved tens of thousands of lives across the UK. Provisions in the HMRs which were established to facilitate the delivery of the COVID-19 and influenza vaccination programmes have proved vital to their success and enabled the continued safe and effective deployment of vaccines across the UK to help safeguard public health.

The proposed amendments to these regulations are designed to build upon the benefits that the HMRs have provided to date, as well as the wider lessons learned during the pandemic and recent polio and MMR vaccine catch-up programmes. In amending these regulations, we are seeking to maintain important safety measures, while increasing access to vaccines to support uptake, and increasing effectiveness within the system (workforce, supply chain and administrative).

These changes will help enable the health service to implement improvements which will facilitate the shift to prevention as described in England’s 10 Year Health Plan. The ambition of the 10 Year Health Plan is to create a new model of care, fit for the future which takes the NHS’ founding principles and entirely reimagines how the NHS does care so patients have real choice and control. This includes restoring trust in vaccinations, harnessing technological advances, and ultimately increasing vaccine uptake. It will also see community pharmacies play a bigger role in prevention by expanding their role in vaccine delivery and these proposals help to support this ambition.

The NHS vaccination strategy in England outlines the future approach to the deployment of vaccination services, building on the learning from COVID-19 and other vaccination programmes. It will give integrated care boards (ICBs) increased responsibility to design local delivery networks that are high quality, convenient to access and tailored to the needs of local people, while operating within the national policy framework set by the Department of Health and Social Care (DHSC). This will be supported by locally commissioned targeted outreach aimed at increasing uptake among underserved populations, delivered through integrated neighbourhood teams. These teams will be flexible, with the ability to scale-up or scale-down their activities in response to outbreaks of disease.

The other devolved nations have or are planning their own vaccination strategies.

The UK-wide amendments proposed in this consultation will support vaccination across all nations of the UK by regulating:

• the movement, preparation and labelling of vaccinations in defined circumstances (R3A and R19)
• the premises from which community pharmacies can deliver vaccination services to allow them to deliver targeted outreach (R233 and regulation 3)
• the use of a flexible workforce for vaccine administration (S17 and the proposed new legal provisions replacing R247A)

Regulation 3A proposed amendments

Background

R3A came into effect in 2020 when the HMRs were amended by the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020. This amendment:

• enables trained healthcare professionals, or staff under the supervision of trained healthcare professionals, to conduct the final stage of assembly and preparation of COVID-19 vaccines without additional marketing authorisations or manufacturer’s licences being required (R3A (1) and (2))
• permits holders of wholesale dealer’s licences, who do not hold manufacturer’s licences, to label COVID-19 vaccines to reflect changes in shelf life resulting from product thawing (R3A (3))
• makes provision in relation to the application of the packaging and package leaflet requirements to take account of these allowances (R3A (4))

In practice, R3A has permitted all professionally justified acts of preparation and assembly of a COVID-19 vaccine to be undertaken by, or under the supervision of, a doctor, nurse or pharmacist, without requiring a manufacturer’s licence or marketing authorisation. This is provided those acts are carried out under NHS arrangements or arrangements as part of the medical services of His Majesty’s Armed Forces. It also allows for authorised medicinal products used for the reformulation of COVID-19 vaccines (for example, diluents) to be re-assembled at the end of the medicines supply chain without the resultant products needing marketing authorisations in order to be supplied. 

Before the introduction of R3A, existing provisions under regulation 3 of the HMRs only provided limited exemptions for doctors, dentists, registered nurses and midwives to prepare or assemble medicines for individual patient care, and did not permit bulk preparation at scale. This was therefore not suitable to support collaborative working models like those used in the COVID-19 vaccination programme.

The flexibility provided by R3A has resulted in NHS teams in England being able to work more efficiently through the mass vaccination centre model or primary care network (PCN) groupings. This has enabled effective collaborative working in order to maximise the uptake of COVID-19 vaccines while maintaining safety through robust governance structures. These flexibilities brought significant operational benefits and resulted in NHS teams being able to deliver the COVID-19 vaccination programme at the pace necessary, as well as maintaining a proportionate approach to managing the risk associated with the preparation and assembly of vaccines. They have been similarly useful for vaccination programmes in devolved nations.

R3A is a temporary time-limited provision. Initially this was due to lapse in March 2022, however, due to the continuing requirements of the COVID-19 vaccination programme, it has been extended twice. R3A is now due to lapse on 1 April 2026 following a consultation on supporting the delivery of COVID-19 and influenza vaccination in 2023.

In the 2023 consultation, respondents noted how the provisions had improved operational delivery and continued to play an important role in the COVID-19 vaccination programme due to the supply chain arrangements. They also flagged how the regulation had helped increase flexibility and efficiency in the system and helped to improve access.

Proposed amendments

Following the previous 2023 consultation, the government committed to undertake detailed consideration of the long-term mechanisms used to support the assembly, preparation and labelling of COVID-19 vaccines under R3A. Following consideration with a range of stakeholders, this consultation proposes:

• allowing R3A (1) and (2) to lapse from 1 April 2026
• retaining the provisions under R3A (3) and (4) as permanent legislation
• expanding R3A (3) and (4) to cover all vaccinations against ‘a vaccine preventable disease’ (defined as an infectious disease caused by a virus or bacteria that can be prevented with a vaccine)

The provisions under R3A (1) and (2) have provided the necessary flexibility to support the final stage preparation of vaccines outside a hospital, pharmacy or licenced manufacturing facility in order to meet the demands and scale of the COVID-19 vaccination programme during the pandemic and were necessary to overcome the limitations of regulation 3 of the HMRs.

Outside of a pandemic scenario and given the more targeted approach of recent COVID-19 vaccination campaigns, we propose that the provisions under R3A (1) and (2) are no longer required. Should these or similar provisions be required for potential future pandemic scenarios, the Medicines and Medical Devices Act 2021 would enable amending legislation to be brought forward, and, if needed, enables emergency legislation to be brought forward allowing for disapplication of provisions of the HMRs. However, based on the current circumstances, and as we move further away from the COVID-19 pandemic, the proposal put forward in this consultation is to allow R3A (1) and (2) to lapse.

This consultation also puts forward the proposal to retain provisions R3A (3) and (4) and to expand them to include all vaccinations against ‘a vaccine preventable disease’, rather than being limited to COVID-19 vaccinations only. Through its continued use during the COVID-19 vaccination programme, the use of R3A (3) and (4) has demonstrated how these provisions can be applied safely and effectively. Retaining R3A (3) and (4) permanently will support the continuation of current and potential future supply chains within the COVID-19 programme. In addition, broadening to other vaccine preventable diseases will help support the development of future supply chains more widely so that the UK has the potential to use enhanced vaccine technologies, such as those used by mRNA vaccinations.

In the UK, all COVID-19 vaccines currently deployed are mRNA vaccines and delivered to the UK Health Security Agency (UKHSA) either frozen or at ultra-low temperatures (dependent on the vaccine characteristics), before being thawed and relabelled for use as and when required. This ensures shelf life is maximised and wastage is reduced. If these provisions are not in place there would be a risk that some locations who do not hold a manufacturing licence, for example the crown dependencies and overseas territories, would not be able to receive the vaccine due to the short shelf life and transportation restrictions of some vaccine formulations and their vaccine characteristics. 

Broadening the scope to other vaccine preventable diseases will also help support the development of future supply chains for vaccines which use ultra-low temperature storage conditions, such as mpox vaccines or new emerging vaccines - ensuring the regulation is future proofed. It will also help improve operational delivery and increase efficiency in the system by supporting greater flexibility in the safe and effective thawing and relabelling of vaccines.

Questions

Do you agree or disagree with the proposal to let the provisions under R3A (1) and (2) lapse from 1 April 2026?

Do you agree or disagree with the proposal to retain the provisions under R3A (3) and (4) as permanent legislation?

Do you agree or disagree with the proposal to expand the provisions under R3A (3) and (4) to all vaccine preventable diseases?

Regulation 19 proposed amendments

Background 

Paragraphs (4A) to (4D) of R19, came into effect in 2020 when the HMRs were amended by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020. These amendments allow for:

• COVID-19 and influenza vaccines to be moved between different NHS service providers at the end of the supply chain without the need for a wholesale dealer’s licence (R19 (4A) and (4C)). This is provided the movement is conducted by providers operating under NHS arrangements or the medical services of His Majesty’s Armed Forces
• a medicinal product to be supplied or administered, in accordance with a protocol, by providers operating under NHS arrangements or the medical services of His Majesty’s Armed Forces, to someone who is authorised to give the vaccine to a patient (either themselves or through someone they employ). This operates in accordance with regulation 247, with permission from the relevant health authority to make this supply without the need for a wholesale dealer’s licence (R19 (4B) and (4C)).

The processes under paragraphs (4A) to (4C) of R19 are subject to the same levels of quality and safety assessment set by the UK’s independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), with robust governance and safeguards implemented to ensure the integrity of the vaccines and cold chain are upheld.

R19 (4A) to (4C) is a temporary, time-limited provision which is due to lapse on 1 April 2026 (as stated in R19 (4D)). As with R3A, it originally included a sunset provision set for March 2022, which was first extended to April 2024, and then extended again to April 2026 following a consultation on supporting the delivery of COVID-19 and influenza vaccination in 2023.

In the recent 2023 consultation, respondents stated that the amendments made to R19 helped to reduce vaccine wastage, with the increased flexibility allowing vaccines to be moved swiftly and safely between sites in response to need. They also noted how R19 had helped achieve a more efficient use of resources and enabled timely access to vaccinations which has in turn helped to reduce health inequalities. Stakeholders also flagged how the flexibility has helped facilitate co-administration and improved access to vaccines.

If the provisions under R19 (4A) to (4C) lapse (which will happen without intervention), this is likely to negatively impact the NHS’ ability to quickly respond to need and could result in the excess wastage of COVID-19 and influenza vaccinations.

This consultation therefore proposes new amendments.

Proposed amendments

Following the previous 2023 consultation, the government committed to undertaking detailed consideration of the long-term mechanisms for supporting the safe and appropriate movement of COVID-19 and influenza vaccines. This consultation proposes:

• retaining the proposed provisions under R19 (4A) to (4C) as permanent legislation with appropriate safeguards and governance built in
• expanding provisions under R19 (4A) to (4C) to cover all vaccinations against ‘a vaccine preventable disease’ (defined as an infectious disease caused by a virus or bacteria that can be prevented with a vaccine)

The supply of vaccines from one healthcare organisation to another would normally be classed as a wholesale distribution supply, and subject to having a wholesale dealer’s licence under regulation 18 of the HMRs. If such a licence was not held by the organisation (because it is not required for normal business), and R19 (4A) to (4C) was not in place, this could have led to delays with moving COVID-19 and influenza vaccines between service providers in response to need and increased the risk of vaccine wastage.

The use of R19 (4A) to (4C) during the pandemic has shown how the health system can work effectively and collaboratively to safely ensure vaccines can rapidly be deployed in response to need. These proposals therefore aim to extend the provisions to include all vaccinations against a vaccine preventable disease, while ensuring their use remains the exception rather than the rule, supported by clear safeguards and appropriate oversight. This will help reduce wastage across vaccination programmes and allow the system to respond quickly should it be required.

These processes will be set out alongside R19 (4A) to (4C) and will be subject to the usual vigorous safety standards - that is ensuring robust governance and safeguards are in place, and the integrity of the vaccines and cold chain are upheld. This includes adding conditions to ensure that the distribution of vaccines takes place only when necessary, and that the storage and transportation of the product are in accordance with the summary of the product characteristics. These are preconditions, with the proposed legislation making clear that if the distribution is not carried out in accordance with the terms of the product authorisation, the exemption will not apply and a wholesale dealer’s licence will be required. It is expected that the use of these provisions will be supported by policy provided under the relevant NHS arrangements.

Not only will this help support flexibility, but the proposed amendments to these provisions also strengthen the governance structure, ensuring the safety and efficacy of vaccines when they need to be moved between sites.

Questions

Do you agree or disagree with the proposal to retain the provisions under R19 (4A) to (4C) as permanent legislation to support distribution when necessary?

Do you agree or disagree with the proposal to expand the provisions under R19 (4A) to (4C) to all vaccine preventable diseases?

Do you agree or disagree that the legislation should set out preconditions and safeguards to regulate the use of R19 (4A) to (4C)?

Regulation 247A proposed amendments

Background 

R247A has been used since December 2020 when the HMRs were amended by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020. It has provided the mechanism that enables an expanded workforce to legally and safely administer COVID-19 and influenza vaccines without the input of a prescriber, using an approved protocol.

R247A introduced a new type of national protocol (which must be authorised by ministers in each of the 4 nations of the UK) that allows the classes of persons designated in the national protocol to safely administer a COVID-19 or influenza vaccine without the input of a prescriber. This includes:

• those who are registered healthcare professionals who cannot ordinarily administer medicines or vaccines
• non-registered healthcare workers (such as assistant practitioners, healthcare assistants or maternity support workers)

In practice, and in the height of the pandemic, the national protocol model was an important tool to support COVID-19 and influenza vaccination and is still used where necessary today. For example, where:

• administration takes place at vaccination sites with large numbers of people being vaccinated in a single day
• various vaccination roles are split between several different people (namely patient assessment, clinical advice and informed consent, vaccine preparation, vaccine administration and record keeping)

It helps to ensure that there is sufficient workforce to deliver vaccines to a large number of people.

Before the introduction of R247A - and currently for the national vaccination programmes that do not cover COVID-19 or influenza - this type of vaccination would have had to be administered by an appropriate practitioner. It would also have had to be administered in accordance with a prescription or direction given by an appropriate practitioner under a patient specific direction (PSD), or more commonly, by a patient group direction (PGD).

PGDs permit specified registered healthcare professionals (as listed in schedule 16, part 4 of the HMRs) to vaccinate individuals who may not be identified before presenting for treatment without a prescription (for example, patients who present to walk-in centres, mass vaccination centres or infant immunisation clinics). However, the regulations regarding PGDs do not permit delegation of any part of the process of medicine or vaccine supply or administration to any other person. As a result, each vaccination under a PGD must be completed in its entirety by the same registered healthcare professional. This requirement, combined with the restriction in which registered healthcare professionals can work under a PGD, would have meant that mass vaccination for COVID-19 and influenza could only have been carried out by registered professionals - an already stretched workforce.

The national protocol under R247A addressed this gap by allowing a wholly new vaccinator workforce of appropriately trained and competent individuals who are not themselves registered healthcare professionals to undertake parts of the vaccination process, provided they met conditions specified in the protocol.

Patient safety has been maintained in the use of R247A by strong national governance systems. Across all 4 nations, new vaccinators working under the national protocol are required to:

1. Complete a comprehensive online training package, developed nationally by an appropriate body.
2. Undergo practical training within NHS services.
3. Pass a competency assessment to ensure they can safely administer vaccines to patients under the clinical supervision of an experienced healthcare professional.

Following one year of using the regulation, an evaluation published in April 2022 was undertaken to identify whether there had been any adverse effects on patient safety. The regulation was found to have been widely used across the UK, with stakeholders providing positive feedback about the impact it was having on their ability to deliver both COVID-19 and influenza vaccination programmes. No adverse consequences for patient safety were identified by those responding to the review.

Consequently, the introduction of this regulation means that there are now appropriately trained, competent and supervised non-registered healthcare workers supplying and administering COVID-19 and influenza vaccines. These vaccinators are used as part of a skill-mixed model to improve the efficiency and flexibility of services while reducing pressure on the system. This significantly increased the NHS’ capability to respond throughout the pandemic. While much of this extended workforce, comprising a mix of temporary staff and volunteers, was mobilised on a time-limited basis and is no longer in place at the same scale, it continues to play an important role in supporting vaccine delivery across the UK. In some nations this extended workforce equates to just under half of the vaccination workforce and has become vital in the way in which vaccines are delivered.

In October 2023, a consultation on supporting the delivery of COVID-19 and influenza vaccination was run and proposed extending the sunset period for lapse of R247A. As part of this, we heard from a wide range of respondents about the regulation’s important role in easing workforce pressures on registered staff. The flexibility it provided was seen as instrumental in significantly increasing capacity. Respondents also highlighted that the effective use of an extended workforce has not only been essential for the delivery of vaccinations but has also helped optimise staffing and enabled qualified healthcare professionals to deliver other forms of care across the system.

Similarly to R3A and R19 (4A) to (4C), R247A is subject to a sunset clause, and due to lapse on 1 April 2026.

Proposed amendments

As committed to in the October 2023 consultation, the UK government has undertaken detailed consideration of the longer-term mechanisms that can be deployed to better support the use of an extended vaccination workforce.

This consultation proposes to replace R247A with a new permanent provision to support the use of an extended workforce to supply and administer vaccinations.

These proposals include a provision that would omit R247A and instead introduce a new legal mechanism to support the use of an extended workforce to administer (and in certain cases, such as nasal influenza, supply) vaccinations as part of the wider national vaccination programme, as well as during any potential future pandemic. Specifically, the proposed new legal provision would introduce a vaccine group direction (VGD), which would make permanent the ongoing use of non-registered healthcare workers and registered healthcare workers who are unable to operate under a PGD, to deliver certain parts of the vaccination process provided they are under the supervision of a specified registered healthcare professional. The proposal is to also expand their use to vaccination programmes which provide protection against any vaccine preventable disease.

This is in recognition of the successful and safe use of trained non-registered healthcare workers and registered healthcare workers who are unable to operate under a PGD in administering vaccination under national protocols as part of the influenza and COVID-19 programmes, and the wish to continue using this workforce in the ongoing delivery of these programmes and any future pandemics. We also recognise that there are a range of vaccination programmes that could benefit from the use of this workforce to improve accessibility. In addition, new vaccination programmes on the horizon could also be supported by this group.

The proposed new legal provision will help us to meet this need by allowing the use of non-registered healthcare workers and registered healthcare workers who are unable to operate under a PGD in a wider range of vaccination programmes.

However, while we are supportive of enabling an expanded workforce to deliver a wider set of vaccination programmes, we are clear that there are important limits which should be set on this expansion. Consequently, we propose to place the following requirements within the regulation in relation the application of a VGD.

The VGD must be authored by a national public health agency

This has been specified to provide a strong guardrail against the inappropriate use of a VGD across a range of scenarios where it would not be appropriate for vaccines to be administered by a non-registered professional or registered healthcare worker who is unable to operate under a PGD.

By requiring a public health agency such as UKHSA (in the English context), Public Health Scotland (PHS) (for Scotland), the Welsh Medicines Advice Service (for Wales), or Public Health Agency (for Northern Ireland) to author the VGD, we would have a built-in governance structure which can assess the appropriate use of a VGD. This mitigates the risk of a VGD being used in a way that the relevant public health agency deems inappropriate, or potentially of risk to patient safety. This provision also removes the need to include overly prescriptive language in the regulation, in relation to the specifics required in each VGD, the inclusion of which could have unintended consequences. For example, if the omission of certain activities from that prescriptive language is perceived as an indication that those activities are an appropriate use of the VGD, even when it may not be.

The VGD can only be authorised and used within a specified set of bodies which will go down to the level of NHS trust or board and local authority but not below

This includes where those public bodies make arrangements with independent contractors such as GPs and pharmacies. For example, GPs and pharmacies will need to be providing vaccination through a contractual arrangement with an NHS board and use a VGD which has been authorised by that NHS board.

It will only be possible to use the VGD for vaccination programmes which protect against vaccine preventable disease, and which are an approved national vaccination programme

The conditions set out have been specified so as to limit the scope of the VGD to national NHS commissioned vaccination programmes (for example, COVID-19, influenza, respiratory syncytial virus (RSV), shingles, that is vaccines which, in England, full under section 7A agreements) which are supported by significant governance mechanisms and where the mechanism offers an opportunity to improve vaccine coverage and efficiency. This is to prevent the use of VGDs in scenarios where vaccination is being administered outside the scope of NHS programmes or for a specific indication based on individual clinician assessment, and so there is no need for delegation, and where there is generally less national oversight and governance, such as for provision of non-NHS commissioned travel vaccinations.

The VGD will be required to cover many of the same particulars as a PGD as outlined in part 1 of schedule 16 of the HMRs

The intention is that the VGD operates like the existing PGDs which are currently used to deliver our national vaccination programmes. We are not proposing to amend the regulation which supports the use of PGDs as these apply to all prescription only medicines (except radiopharmaceuticals and abortifacients), not just vaccinations. It is felt that expanding the workforce for supply and administration of all such medical products would not be appropriate, particularly where there is currently no evidence for or against whether this can be done safety.

To administer vaccine under a VGD the individual administering the vaccine must have been given delegated authority to do so

This will be done by having shown they meet the required training and competency requirements by an appropriate authoriser (for example, their manager or clinical supervisor). When working under a VGD, a non-registered healthcare worker, or registered healthcare worker who is unable to operate under a PGD, must work with the registered healthcare professional who:

• has clinically approved the vaccination administration under the VGD
• is authorised to administer vaccines either under the VDG or under a separate PGD
• is on site with them overseeing the delivery of the vaccination at all times

To ensure vaccine safety in the administration of the vaccine we will require as a condition of the regulations that appropriate supervision is in place to support delivery of the vaccine.

In addition to the above explicit conditions, we are also considering the best mechanism for ensuring that the VGD is used with appropriate cohorts of individuals. In most circumstances, we believe that it would be preferable to use registered healthcare professionals to deliver vaccinations in routine infant programmes. These programmes are often complex and dynamic, and the scale and scheduling mean they can normally be delivered without the need for an expanded workforce.

The condition that a public health agency must author the VGD will provide a guardrail against the inappropriate use of a VGD. However, to provide additional safeguards to ensure that a VGD is not used for certain cohorts, we are considering including a specific condition which outlines which cohorts this regulation can be applied to and would restrict its use to very specific scenarios and programmes. An example could be setting a lower age limit to prevent the use of a VGD for infants as part of the routine childhood immunisation schedule.

There may also be consequential amendments needed as a result of the introduction of the VGD and the new permanent provision.

It is important to emphasise that safety is central to any public health vaccination programme. Any additional workforce operating under the proposed VGD, as currently required under a national protocol, will be trained and shown to be competent through a training programme provided nationally by an appropriate body, and through continued supervision and oversight. Providers commissioned by public bodies to provide vaccination services would be responsible for ensuring all vaccinators are competent to administer vaccines in accordance with nationally agreed competence frameworks, to ensure patient safety. In addition to the regulations and employer oversight, there is also an expectation that across all nations there will be significant supporting guidance and governance to ensure that the regulations are used as intended, and never in a way that compromises patient safety. Please see below for further details on how each nation would use the expanded workforce while ensuring patient safety.

Intended use of the proposed VGD legal provision across the nations

Engagement with each nation has identified that the use of non-registered healthcare workers, and registered healthcare workers unable to operate under a PGD, has become an embedded practice for COVID-19 and influenza vaccinations, and that the removal of the ability to use this workforce would negatively impact the ongoing delivery of these programmes.

Further, in light of the lessons learned from COVID-19, all nations have been reviewing the delivery of all their existing national vaccination programmes, with the expectation that these will be expanded to include new programmes and exploring new models of delivery, potentially using an expanded workforce. The following outlines how each nation might use this new provision to deliver their vaccine strategies.

England

The 10 Year Health Plan for England outlined the importance of vaccination as an immediate opportunity to deliver prevention, with the detailed approach to future deployment described under ‘Our proposals’ in the NHS vaccination strategy. This outlines that the future approach will give ICBs the ability to design person-centred, preventative care delivered by flexible integrated neighbourhood teams that span primary and community care as well as other sectors.

Providers will determine the appropriate deployment of the vaccination workforce that will support delivery of vaccination services, including the use of a non-registered workforce. This will be in line with nationally set service specifications and financial and contracting frameworks, and will be influenced by their experience of the deployment of staff for the COVID-19 vaccination programme and their understanding of how this workforce can be deployed appropriately and safely to other vaccination programmes. The workforce involved in vaccinations will continue to adhere to the national minimum standards and core curriculum for vaccination training. This ensures delivery of high quality, safe and effective vaccination programmes that achieve high uptake. They will be supported by nationally developed legal mechanisms for the supply and administration of vaccines, authored by UKHSA and authorised by the relevant commissioner. 

Initially, commissioners may be guided to apply the VGD model to high-volume programmes such as influenza and COVID-19, where compressed timescales and large eligible populations make the use of an expanded workforce most beneficial. Other suitable programmes for initial expansion could include:

• shingles and RSV for older adults
• school-based programmes delivering human papillomavirus (HPV), DTP (diphtheria, tetanus, and polio), MenACWY (meningococcal bacteria that cause meningitis and septicaemia (blood poisoning): groups A, C, W, and Y)
• potentially MMR catch up vaccinations, depending on the age and setting of the target cohorts

The delivery model would follow the structure already used in England for vaccination protocols, with a registered healthcare professional undertaking a clinical assessment of the individual’s eligibility and suitability to receive the vaccine, provide information and seek informed consent. Subsequent tasks such as drawing up the vaccine, administration and record keeping could then be delegated to suitably trained and competent non-registered staff. Safety will be maintained through appropriate training, competency assessment and supervision of all staff involved.

In the future, the VGD model could be used:

• in response to future pandemics (for example, influenza or coronavirus) or epidemics (for example, mpox)
• for routine delivery in settings such as antenatal clinics where, for example, a midwife may assess and consent a patient before delegating administration to a healthcare support worker

Wales

Recognising a clear rationale for the continued safe use of trained healthcare support workers to administer vaccinations, Wales would use the proposed new permanent provision to:

• give greater support to health boards in the delivery of a range of vaccinations
• improve vaccination outreach and uptake
• preserve capacity in the wider system for delivery by registered NHS staff

Ensuring continued safety in vaccine delivery would be of primary importance. To support this, Wales would implement clear guidance and restrictions on the safe and effective use of non-registered healthcare workers. This would include continuing to use the existing framework for non-registered healthcare workers delivering vaccination of compulsory online and practical training, with assurance delivered through practical assessments. 

Wales believe that the proposed provision would have an immediate benefit in removing the operational delivery risk of losing non-registered healthcare workers undertaking vaccination responsibilities for both the COVID-19 and influenza programmes. This is because it would support both vaccination programmes to be delivered in line with existing arrangements.

Wales anticipates that Welsh health boards would be responsible for reviewing, authorising and providing local sign-off of the proposed VGDs, with the authoring of these VGDs being undertaken by the Welsh Medicines Advice Service for NHS Wales. The drafting would be supported by input from the relevant experts such as Public Health Wales and would follow a similar process to what is currently done for authorising PGDs.

Finally, Wales would consider further opportunities for engaging non-registered healthcare workers in the delivery of vaccination programmes to protect against vaccine preventable disease. In particular, the proposed new permanent provision creates opportunities to support the delivery of adult vaccination programmes outside of COVID-19 and influenza, such as RSV catch-up programmes, or in response to recommended cohort changes.

Wales has no immediate plans to move beyond the use as stated here but is optimistic of the opportunities in promoting effective public health protection and will consider further use in consultation with public health partners.

Scotland

Scotland’s vaccination services have benefited from the successful and safe delivery of COVID-19 and influenza vaccinations under national protocols by well-trained non-registered healthcare workers. These vaccinators continue to be a valued and important part of many health boards’ immunisation workforce.

A number of full-time non-registered healthcare workers are employed in vaccination roles in Scotland, and the proposed provision removes the operational risk of losing these valued roles and allows them to work on other programmes year-round. It also removes the risks of having to replace non-registered staff with registered healthcare workers which would pose a recruitment challenge and have financial implications.

Strengthening the capacity and capability of the multi-disciplinary vaccination workforce to ensure that resources can be used flexibly to meet changing requirements is a core part of Scotland’s 5-year vaccination and immunisation framework and delivery plan, which recognises that the delivery of the vaccination programmes is based on building and retaining a trained and skilled workforce.

The proposed new provision would enable health boards in Scotland to continue to use this expanded workforce in existing influenza and COVID-19 vaccination programmes, as well as for other vaccination programmes where safe and appropriate to do so. As part of our approach, PHS will author VGDs.

Continued patient safety is the absolute priority and clear national guidance around the use of VGDs would be developed by PHS within the governance of the Scottish Vaccination and Immunisation Programme, which provides leadership on vaccination and immunisation in Scotland, delivered in partnership with the Scottish Government, territorial health boards and PHS. This would include clinical consideration of whether a VGD would be appropriate, on a vaccine-by-vaccine basis.

PHS would create a national specimen VGD template, which health boards would take through their own local governance processes for authorisation, but not for alteration. This would include accountability for, and assurance, that there is a trained and competent workforce to deliver the programmes, while ensuring that the use of VGDs is consistent across Scotland. 

Non-registered healthcare workers delivering vaccinations would continue to be required to complete mandated training and education for the programmes they work on, including rigorous assessment by appropriate registered healthcare practitioners, and under the existing Framework for the Administration of Medicines (see NHS Education for Scotland’s Health and care support worker development page). Following assessment of proficiency, non-registered healthcare workers would continue to always operate as part of a team with access to the support of a registered healthcare practitioner on site, in an appropriate ratio in order to provide patient focused care.

Northern Ireland

Northern Ireland acknowledges the considerations from the other UK nations regarding the appropriate use of non-registered healthcare workers in the continued safe delivery of vaccination programmes. Northern Ireland agrees with the approaches towards training, education, governance and competency, which for Northern Ireland, would be similar to the current arrangements used for implementing the national protocols.

Northern Ireland anticipates that the reviewing, authorising and providing local sign-off of the proposed VGDs would follow a similar process to what is currently done for authorising PGDs. The responsibility for drafting would be supported by the relevant experts from the Northern Ireland Department of Health’s Strategic Planning and Performance Group (SPPG), with authorisation from the Public Health Agency (PHA).

The proposed VGDs would continue to offer operational benefit to those providers that currently continue to use the national protocol to enable non-registered healthcare workers to be embedded in the delivery of COVID-19 and influenza seasonal vaccination programmes in primary care. For example, Northern Ireland community pharmacies continue to depend on the skills of suitably trained non-registered pharmacy staff (for example, pharmacy technicians and pharmacy students) to support the delivery of the COVID-19 and influenza seasonal vaccination programmes. This has not only enabled the increase in vaccination capacity within community pharmacy but has also helped reduce pressures on delivery of other pharmacy services arising from participation in vaccination programmes. Similar benefits have been seen in those GP practices who use non-registered healthcare assistants, and public health agency seasonal vaccinators through the national protocol to support the seasonal vaccination programmes.

Although the health and social care trusts in Northern Ireland do not currently use non-registered healthcare workers for delivering the COVID-19 and influenza seasonal vaccination programmes, the national protocol was used during the COVID-19 pandemic to enable non-registered healthcare workers to support in the mass vaccination centres (MVCs). Northern Ireland recognises that the proposed VGD would be useful to health and social care trusts in this context, offering operational advantages in response to an emergency or pandemic situation.

The decision to use non-registered healthcare workers through the proposed VGD beyond its current scope, outside of COVID-19 and influenza, would require consideration and recommendation by PHA, and would be dependent on patient safety, eligibility, vaccine characteristics and/or workforce and operational capacity within the programme.

Questions

Do you agree or disagree with the proposal to let R247A lapse from 1 April 2026?

Do you agree or disagree with the proposal to introduce a new permanent provision from 1 April 2026 to support the use of an extended workforce to supply and administer COVID-19 and influenza vaccines, with the option for this provision to be used on other vaccination programmes commissioned by the NHS?

Do you agree or disagree that an age condition should be included in the proposed provision which specifies that a VGD cannot be used to vaccinate those below a certain age (principally infants eligible to receive a vaccination as part of the routine childhood immunisation schedule)?

Regulation 233 and regulation 3 proposed amendments

Background

R233 was amended by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 in response to the COVID-19 pandemic. Paragraphs (8) and (9) were inserted into R233 in 2020 which provided temporary provisions allowing retail pharmacies providing COVID-19 or influenza vaccinations under a PGD to provide that service away from their registered premises. Following consultation this was embedded as permanent legislation in 2022.

Under normal circumstances, prescription only medicines and pharmacy medicines must be sold or supplied, by, or under the supervision of, a pharmacist and on a registered pharmacy premises. R233 (8) enables persons lawfully conducting a retail pharmacy business to deliver COVID-19 and influenza services off the registered premises under a PGD, for example at pop up vaccinations sites.

In the previous consultation to review the temporary provisions made to the HMRs to support COVID-19 and influenza vaccination campaigns, respondents indicated that this provision had been useful in supporting outreach opportunities. The responses indicated that the flexibility provided by R233 (8), had been used regularly by community pharmacy-run COVID-19 vaccination sites, where the main site was located away from their normal registered premises. It had also allowed many hundreds of pharmacies to offer pop up clinics, particularly supporting groups where there were infection clusters or in locations where there were clusters of unvaccinated patients. Additionally, this flexibility has allowed teams to vaccinate residents and carers in care homes.

While R233 (8) is currently not time-limited, the role of community pharmacies in vaccination services has steadily been increasing. It is likely that community pharmacies will play an even bigger role in the future, including offering bespoke vaccination services, tailored to the needs of the populations they serve. Equally, the clinical functions of community pharmacists have also been evolving, with many now qualified as independent prescribers.

Proposed amendments

To enable community pharmacies to provide wider outreach vaccination services, this consultation proposes widening the scope of R233 (8) to include all ‘vaccinations against a vaccine preventable disease’ (defined as an infectious disease caused by a virus or bacteria that can be prevented with a vaccine).

Expanding R233 (8) in this way will help provide parity between pharmacy businesses and other healthcare providers, who can already provide offsite vaccinations in places such as community centres or places of worship. It will also help support the health system’s ability to react quickly to emerging outbreaks and allow providers to offer services tailored to local needs. This in turn will help to increase access to vaccinations, support uptake and ultimately help to protect the public’s health, while maintaining important safety assurances.

To support increasing legal mechanisms for the supply or administration of vaccines that community pharmacies will have access to, the regulations may need amendments to allow the use of prescriber led models of service delivery offsite.

Currently, pharmacists, pharmacy technicians or pharmacy support staff who are working under the supervision of a pharmacist, are also able to undertake the preparation or assembly of a vaccine on registered pharmacy or hospital premises without needing a manufacturers’ licence (under the exemption for retail pharmacies and hospitals set out in section 10 of the Medicines Act 1968). This is provided the assembly or preparation is not on a large scale or conducted using industrial processes.

During the pandemic, the additional exemption under R3A enabled pharmacists (and doctors and nurses) to supervise the preparation or assembly of COVID-19 and influenza vaccines at locations other than a registered pharmacy or hospital setting. The proposal to remove the provisions under R3A (1) and (2) means that pharmacists would no longer be able to prepare or assemble a vaccine when working at a location away from the registered retail pharmacy or hospital premises (where they could rely on the section 10 exemption of the Medicines Act 1968).

To address this and reflect the changing clinical role of pharmacists more broadly, we propose to make provision in regulation 3 for pharmacists and pharmacy technicians to be able to prepare or assemble medicines for a patient in the course of the treatment of that patient without needing a manufacturers’ licence. The exemption would be subject to the same conditions as are placed on doctors, dentists, nurses and midwives, who all have such an exemption in regulation 3 (4) and (5) respectively.

To further ensure safety, in Great Britain, any concerns about offsite pharmacy services can be investigated and addressed by the General Pharmaceutical Council (GPhC). The GPhC is the independent regulatory body for pharmacies, pharmacists and pharmacy technicians. The GPhC has responsibility for ensuring that the health, safety and wellbeing of users of pharmacy services is maintained through appropriate safeguards. In addition, where a pharmacy vaccination service has been commissioned, the commissioner of the pharmacy vaccination service has responsibility for ensuring vaccination sites are appropriate. In making their decision on the appropriateness of a site, the commissioner will consider a large range of factors. The intention is to set out by directions and service specifications that a pharmacy is required to:

• ensure the vaccination site is appropriate
• notify the commissioner of the offsite vaccination site
• have a governance framework in place that sets out how the vaccination healthcare professional will interact with the superintendent and the responsible pharmacist in the pharmacy business
• ensure the name of the pharmacy and the details of the healthcare professionals vaccinating are displayed at the vaccination site

In Northern Ireland, the Department of Health’s SPPG will outline the requirements for community pharmacy vaccination service providers in the relevant service specification. The Pharmaceutical Society of Northern Ireland (PSNI) will also continue to liaise closely with the SPPG and Medicines Regulatory Group (MRG) to support safe and effective delivery of off-site pharmacy services. Where vaccination services are delivered from locations other than the registered pharmacy premises, pharmacists must ensure that these sites are clinically appropriate, safe, and clearly linked to a registered pharmacy for governance and accountability. The PSNI has the ability to investigate concerns raised about any aspect of pharmacy practice, including services delivered off the registered premises. Pharmacists will therefore be encouraged to maintain high standards of care, ensure robust record-keeping, and notify PSNI of any planned off-site vaccination activity as a matter of good professional practice.

Questions

Do you agree or disagree with the proposal to extend the provisions under R233 (8) to all other vaccine preventable diseases?

Do you agree or disagree with the proposed amendment to regulation 3 to make provision for pharmacists and pharmacy technicians to prepare or assemble medicines for patients without a manufacturer’s licence?

Schedule 17 proposed amendments

Background 

S17 was amended in 2020 by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 in response to the COVID-19 pandemic. These temporary provisions introduced a category of ‘occupational health vaccinators’ who are permitted, under the written directions of a doctor, to administer COVID-19 and influenza vaccines as part of an NHS or local authority OHS. Following consultation, this provision was embedded as permanent legislation in 2022.

S17 (part 2, paragraph 6a) is widely used by NHS and local authority provided OHSs to deliver COVID-19 and influenza vaccinations to their employees and, by some organisations, to provide these vaccinations to employees of other organisations they provide OHS services to. The expansion of S17 to include the wider ‘occupational health vaccinator’ role has increased the workforce able to provide these vaccinations and has supported an increase in access as a result of a larger workforce being able to provide vaccinations as part of an OHS.

To ensure safety, each individual working as an occupational health vaccinator under S17 is expected to have completed the underpinning knowledge, skills and competency requirements set out within the written instruction they are approved by their employer to operate under. Training may be provided locally or using national resources, such as those provided by UKHSA. Each vaccinator should be authorised to work under their organisation’s written instructions by an OHS doctor, suitable clinical supervisor or similar. These written instructions should include contraindications whereby a person is referred to an OHS professional (for example, a doctor or specialist nurse) if there are any concerns about suitability. Clinical oversight lies with the OHS team or medical lead for the programme, noting the written instructions must be signed by a doctor.

In the previous consultation to review the temporary provisions made to the HMRs to support COVID-19 and influenza vaccination campaigns, it was found that the provisions which expanded the workforce for both NHS bodies or local authorities operating under an OHS were useful in providing the flexibility to enable to effective delivery of OHSs. Respondents also noted how S17 enabled better usage of additional workforce across the health and social care system, thereby improving the reach and uptake of vaccines.

While these provisions have had a useful impact, recent evidence from system partners, including NHS England, suggests that it has been limited for the following reasons:

• S17 is currently restricted to a cohort of registered healthcare professionals which does not align with those listed under part 4 of schedule 16 of the HMRs which enables certain registered healthcare professionals, under a PGD, to supply and administer certain medicinal products. This practice has led to confusion; for example, certain healthcare professionals can operate under the exemption permitted by S17 but are not permitted to work under PGDs, and similarly many registered healthcare professionals permitted to work under PGDs cannot work under S17. Additionally, restricting this role to a very limited group of registered healthcare professionals limits the provision of vaccinations through an OHS
• the provisions in S17 are currently restricted to NHS and local authority OHS provision only. The inability of private providers, for example, to operate under this exemption means that they are unable to fully use their workforce as part of their OHS provision. Many private OHS providers provide OHS services to NHS and other public sector bodies but cannot always provide large scale OHS vaccination programmes such as seasonal influenza vaccinations as they are limited to administration by registered nurses only and may not have a large enough nursing workforce to provide these services
• S17 is also currently restricted to influenza and COVID-19 vaccines. In reality OHSs offer a wide range of vaccinations to healthcare staff where relevant to their roles, as advised by chapter 12 of the green book on immunisation against infectious disease, for example, hepatitis B, MMR, pertussis and tetanus vaccinations

Proposed amendments

After careful consideration of some of the limitations observed following usage of S17 and the potential benefits of expanding this regulation, we propose making the following amendments:

• expand the definition of ‘occupational health vaccinator’ to cover individuals belonging to one of the classes specified in part 4 of schedule 16 of the HMRs
• expand S17 to allow private OHS providers to operate under this provision
• expand these provisions to cover all vaccinations or immunisations offered as part of an OHS

These proposals seek to align named groups in schedule 16 with S17 and amend the definition of ‘occupational health vaccinator’ to cover individuals belonging to one of the classes specified in part 4 of schedule 16. At the time of drafting, this would currently include:

• pharmacists
• registered pharmacy technicians
• registered chiropodists and podiatrists
• registered dental hygienists
• registered dental therapists
• registered dietitians
• registered midwives
• registered nurses
• registered occupational therapists
• registered optometrists
• registered orthoptists
• registered orthotists and prosthetists
• registered paramedics
• registered physiotherapists
• registered radiographers
• registered speech and language therapists

This alignment will help to expand the workforce able to deliver OHSs across the system and improve access. Aligning with schedule 16 will also help to reduce confusion amongst staff. As set out above, the misalignment between S17 and part 4 of schedule 16 has caused issues and resulted in a lack of clarity of what is permitted under different regulations. However, these proposals should help provide a clear and consistent approach of who can safely administer vaccinations under an OHS.

The proposal to also expand the workforce to include private providers will allow private providers to use the OHS vaccinator role and, like NHS and local authority services, they would be able to use a wider workforce to increase potential workforce capacity and vaccine provision. It could also be used to potentially enable rapid stand up of services in case of a future pandemic, or where the vaccination of large staff cohorts is advised by national guidance, ensuring this regulation is future proofed.

The further proposals to expand the provision under S17 to cover all vaccinations that fall under an OHS will help ensure healthcare staff are more easily able to access all vaccinations relevant to their role in a timely and effective manner. Improving access to a wider range of vaccines should help support vaccine uptake and ensure healthcare staff are adequately protected in the vital roles they do.

Questions

Do you agree or disagree with the proposal to expand the category of occupational health vaccinators in S17 to include a wider cohort of healthcare professionals in alignment with part 4 of schedule 16?

Do you agree or disagree with the proposal to extend the relevant provisions under S17 to include private healthcare providers?

Do you agree or disagree with the proposal to extend the provisions related to the category of occupational health vaccinators in S17 to cover all vaccinations or immunisations offered as part of an OHS?

Legal duties

Equality Act 2010

The general equality duty that is set out in the Equality Act 2010 requires public authorities, in the exercise of their functions, to have due regard to the need to:

• eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the act
• advance equality of opportunity between people who share a protected characteristic and those who do not
• foster good relations between people who share a protected characteristic and those who do not

The view of DHSC is that the proposals detailed in this document will not have an adverse or differential impact on individuals with protected characteristics. The overarching aim of these proposals is to protect public health for all and promote public safety as the health service implements improvements which will facilitate the shift to prevention.

The UK-wide amendments proposed in this consultation will support vaccination across all nations by regulating the movement and preparation of vaccinations in defined circumstances. It will also regulate the premises from which community pharmacies can deliver vaccination services offsite, as well regulating the use of a trained and flexible workforce for vaccine administration. This will help promote access to vaccinations to all those who are eligible. Amending the provisions to cover a wider range of vaccines will help ensure vaccination services are as effective as possible and has the potential to help prevent illness against a greater number of diseases for a greater number of people.

In relation to the Equality Act 2010, these proposals:

• eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the act, by helping promote access to vaccinations to all and using the skills of the vaccination workforce to ensure vaccines can be administered safely and effectively
• advance equality of opportunity between people who share a protected characteristic and those who do not by supporting vaccine uptake for everyone
• foster good relations between people who share a protected characteristic and those who do not, by removing barriers in access and helping enable more locally commissioned targeted outreach aimed at increasing vaccine uptake among underserved populations

National Health Service Act 2006

The National Health Service Act 2006 also contains a number of overarching duties on the Secretary of State for Health and Social Care which apply to the exercise of functions, including in relation to the health service. These duties include:

The duty to continue to promote a comprehensive health service in England (section 1)

The view of DHSC is that these proposals support the duty to promote a comprehensive health service as they promote vaccine uptake, improve access and increase the effectiveness across the health system (including in the vaccination workforce and supply chains), while maintaining important safety measures. This is set out in more detail below:

• R3A - the proposed amendments promote a comprehensive health service by not only supporting the continuation of current and any future supply chains within the COVID-19 programme, but by broadening to other vaccine preventable diseases, it will help support the development of future supply chains more widely so that the UK has the potential to use enhanced vaccine technologies going forward. Ensuring vaccine supply both now and in the future is fundamental to promoting a comprehensive health service, especially in the context of the 10 Year Health Plan for England and the shift to prevention
• R19 - the proposed amendments will promote a comprehensive health service by ensuring vaccines can be moved between service providers when necessary and ensure the health service can quickly respond to need. Not only does this help support flexibility, but the proposed amendments to these provisions strengthen the governance structures and ensures the safety and efficacy of vaccines when they need to be moved between sites
• Replacement of R247A - the proposed amendments will promote a comprehensive health service by introducing a new legal mechanism to support the use of an extended workforce to administer vaccines through a VGD. This will ensure there is a sufficient skilled and trained workforce able to deliver vaccinations across the UK. More widely, it also has the potential to alleviate some of the wider workforce pressures observed across the health service
• R233 and regulation 3 - the proposed amendments will promote a comprehensive health service by enabling community pharmacies to provide wider outreach vaccination services which includes all vaccinations against a vaccine preventable disease. It will also help support the health system’s ability to react quickly to emerging outbreaks and allow providers to offer vaccination services tailored to local needs for a wider range of vaccine preventable diseases. This will in turn increase access to vaccinations, support uptake and ultimately help to protect the public’s health
• S17 - the proposed amendments will promote a comprehensive health service by: amending the definition of ‘occupational health vaccinators’ to cover individuals belonging to one of the classes specified in part 4 of schedule 16; expanding to allow private OHS providers to operate under this provision; and expanding these provisions to cover all vaccinations or immunisations offered as part of an OHS. In doing so, this will help to expand the workforce able to deliver OHSs across the system, ensuring eligible staff have improved access to the vaccinations offered to them under an OHS and therefore ensuring a healthier workforce to help deliver a comprehensive health service

The duty as to improvement in quality of services (section 1A)

The view of DHSC is that this proposal supports the duty to improve the quality of service by facilitating access to vaccinations and ensuring there is a trained and effective vaccination workforce that is able to deliver these programmes. Through the continued use of these regulations during the COVID-19 pandemic and recent vaccine catch-up programmes, we have learnt some important lessons about how the regulatory framework can help improve the quality of health care services provided. The aim of these proposals is to further build upon that success to help develop a vaccination system that is fit for the future. This is set out in more detail below:

• R3A - the proposed amendments will help improve the quality of services by supporting the development of future supply chains for vaccines which use ultra-low temperature storage conditions, such as mpox vaccines or new emerging vaccine technologies like those used in mRNA vaccines - ensuring the regulation is future proofed. This will help improve operational delivery and increase efficiency in the system by supporting greater flexibility in the safe and effective thawing and relabelling of vaccines
• R19 - the proposed amendments will help improve the quality of services by ensuring the health system can work effectively and collaboratively to safely ensure all vaccinations against a vaccine preventable disease can be moved between different NHS service providers when necessary. This will help improve services by reducing wastage across vaccination programmes and allow the system to respond quickly should it be required
• Replacement of R247A - the proposed amendments will help improve the quality of services by allowing the use of non-registered healthcare workers and registered healthcare workers who are unable to operate under a PGD to help deliver a wider range of vaccination programmes. This will improve the quality of services by increasing access and reducing wider workforce pressures. In addition, new vaccination programmes on the horizon could also be supported by this group, ensuring a long-lasting benefit and improvement to the health system
• R233 and regulation 3 - the proposed amendments will promote an improvement in quality of services by allowing community pharmacies to deliver a wider programme of vaccination services offsite, and allows them to provide more bespoke vaccination services, tailored to the needs of the populations they serve. This is also set out in the 10 Year Health Plan for England, whereby the ambition is for community pharmacies to play a bigger role in prevention by expanding their role in vaccine delivery. This will help improve the quality of services by increasing access and has the potential to help reduce wider system pressures in the NHS
• S17 - the proposed amendments will promote an improvement in quality of services by improving clarity for healthcare professionals of who can administer certain vaccines through the alignment with individuals belonging to one of the classes specified in part 4 of schedule 16. This alignment will help to expand the workforce to help deliver OHSs across the system and improve access. It also has the potential to improve services during instances when a rapid stand up of services is required, for example during a future pandemic, or where vaccination of large staff cohorts is advised by national guidance - ensuring this regulation is future proofed

The duty as to reducing inequalities (section 1C)

DHSC has also considered section 1C and is of the view that this proposal supports the duty to reduce inequalities by helping to increase access to vaccinations. In line with the NHS vaccination strategy in England, ICBs will be given increased responsibility to design local delivery networks that are high quality, convenient to access, and tailored to the needs of local people, while operating within the national policy framework set by DHSC. This will be supported by locally commissioned targeted outreach aimed at increasing uptake among underserved populations, delivered through integrated neighbourhood teams. The proposals set out here will help support this ambition by broadening the scope of vaccinations which can be delivered by community pharmacies off the registered premises (R233), for example at pop up vaccinations centres at places of worship or community centres. It will also ensure there is an adequate vaccination workforce to deliver these bespoke vaccination programmes, which together should help to promote access and reduce health inequalities.

Northern Ireland

In Northern Ireland, section 75 of the Northern Ireland Act 1998 similarly requires designated public authorities to have due regard to the need to promote equality of opportunity and good relations across various categories, including religious belief, political opinion, and racial group. These duties apply when developing, implementing, and reviewing policy.

We do not consider this proposal to have any differential negative impacts on individuals with protected characteristics. 

Questions

DHSC does not believe the proposals risk impacting people differently with reference to their protected characteristics. Do you agree or disagree with this statement?

The Department of Health in Northern Ireland does not believe the proposals risk impacting people differently with reference where they live geographically in Northern Ireland. Do you agree or disagree with this statement?

How to respond

Please respond through our online survey.

Do not provide personal data when responding to free-text survey questions. Any personal data included will be removed before analysis of these responses and will therefore not be considered in the consultation outcome.

The consultation is open for 12 weeks and will close at 11:59pm on 28 November 2025. If you respond after this date, your response will not be considered.

While this is public consultation and we welcome views from all, we acknowledge that these proposals will affect operations within the health system, and we would therefore encourage stakeholders within the health system of the UK to actively engage with this consultation as soon as possible.

If you have any queries on this consultation, email hmr.consultation@dhsc.gov.uk. Do not send your consultation answers or any personal information to this email address. 

Consultation questions

About you

In what capacity are you responding to this survey?

• An individual sharing my personal views and experiences (such as a patient, carer or member the public)
• An individual sharing my professional views
• On behalf of an organisation

Questions for individuals

Where do you live in the UK? (Optional)

• England
• Northern Ireland
• Scotland
• Wales
• I live outside the UK

If you live in England, which area of England do you live in? (Optional)

• North East England
• North West England
• Yorkshire and the Humber
• East of England
• East Midlands
• West Midlands
• South East England
• South West England
• London

Do you work for the NHS? (Optional)

• Yes
• No

Are you responding as a healthcare professional? (Optional)

• Yes
• No

Which of the following best describes you or your profession? (Optional)

• NHS or health service delivery
• Social care
• Government or civil service
• Other public sector
• Private sector
• Charity or third sector
• Retired
• Student
• Other

Questions for organisations

What is the name of your organisation? (Optional)

What type of organisation are you responding on behalf of? (Optional)

• Business
• Not for profit organisation
• Academic institution
• Public sector body

Where does your organisation operate or provide service? (Optional, select all that apply)

• England
• Northern Ireland
• Scotland
• Wales
• The whole of the UK
• Outside of the UK

Regulation 3A proposed amendments

R3A (1) and (2) enable trained healthcare professionals, or staff under the supervision of healthcare professionals, to conduct the final stage of assembly and preparation of COVID-19 vaccines without additional marketing authorisations or manufacturer’s licences being required. These provisions are due to lapse on 1 April 2026.

Do you agree or disagree with the proposal to let the provisions under R3A (1) and (2) lapse from 1 April 2026?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

R3A (3) permits holders of wholesale dealer’s licences, who do not hold manufacturer’s licences, to label COVID-19 vaccines to reflect changes in shelf life resulting from product thawing. R3A (4) makes provision in relation to the application of the packaging and package leaflet requirements to take account of these allowances.

Do you agree or disagree with the proposal to retain the provisions under R3A (3) and (4) as permanent legislation?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Do you agree or disagree with the proposal to expand the provisions under R3A (3) and (4) to all vaccine preventable diseases?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Regulation 19 proposed amendments

R19 (4A) to (4C) allows for:

• COVID-19 and influenza vaccines to be moved between different NHS service providers at the end of the supply chain by providers operating under NHS arrangements or the medical services of His Majesty’s Armed Forces, without the need for a wholesale dealer’s licence
• a medicinal product to be supplied or administered, in accordance with a protocol, by providers operating under NHS arrangements or the medical services of His Majesty’s Armed Forces, to someone who is authorised to give the vaccine to a patient (either themselves or through someone they employ). This operates in accordance with regulation 247, with permission from the relevant health authority to make this supply without the need for a wholesale dealer’s licence (R19 (4B) and (4C)).

These provisions are due to lapse on 1 April 2026.

Do you agree or disagree with the proposal to retain the provisions under R19 (4A) to (4C) as permanent legislation to support distribution when necessary?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Do you agree or disagree with the proposal to expand the provisions under R19 (4A) to (4C) to all vaccine preventable diseases?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Do you agree or disagree that the legislation should set out preconditions and safeguards to regulate the use of R19 (4A) to (4C)?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Regulation 247A proposed amendments

R247A provides a mechanism that expands the workforce who are legally and safely able to administer a COVID-19 or influenza vaccine without the input of a prescriber, using an approved protocol. Taking the learnings from R247A’s usage during the COVID-19 pandemic, DHSC, working alongside system partners, proposes to replace R247A with a new legal mechanism that supports the use of an extended vaccination workforce through a VGD.

Do you agree or disagree with the proposal to let R247A lapse from 1 April 2026?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Do you agree or disagree with the proposal to introduce a new permanent provision from 1 April 2026 to support the use of an extended workforce to supply and administer COVID-19 and influenza vaccines, with the option for this provision to be used on other vaccination programmes commissioned by the NHS?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. If you have any comments on the scope and content of the proposed legal provision, please include them here. (Optional, maximum 500 words)

Do you agree or disagree that an age condition should be included in the proposed provision which specifies that a VGD cannot be used to vaccinate those below a certain age (principally infants eligible to receive a vaccination as part of the routine childhood immunisation schedule)?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 500 words)

Regulation 233 and regulation 3 proposed amendments

R233 (8) enables persons lawfully conducting a retail pharmacy business to deliver COVID-19 and influenza vaccination services off the registered premises under a PGD.

Do you agree or disagree with the proposal to extend the provisions under R233 (8) to all other vaccine preventable diseases?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Regulation 3 provides a limited exemption for doctors, dentists, registered nurses and registered midwifes to prepare or assemble medicines for patients, provided the medicinal product is supplied to either:

• a patient in the course of the treatment of that patient
• a patient of another doctor who is a member of the same medical practice

We propose to expand regulation 3 to include pharmacists and pharmacy technicians.

Do you agree or disagree with the proposed amendment to regulation 3 to make provision for pharmacists and pharmacy technicians to prepare or assemble medicines for patients without a manufacturer’s licence?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Schedule 17 proposed amendments

S17 introduced a category of ‘occupational health vaccinators’ who are permitted, under the written directions of a doctor, to administer influenza and COVID-19 vaccines as part of an NHS or local authority OHS.

Do you agree or disagree with the proposal to expand the category of occupational health vaccinators in S17 to include a wider cohort of healthcare professionals in alignment with part 4 of schedule 16?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Do you agree or disagree with the proposal to extend the relevant provisions under S17 to include private healthcare providers?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Do you agree or disagree with the proposal to extend the provisions related to the category of occupational health vaccinators in S17 to cover all vaccinations or immunisations offered as part of an OHS?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Legal duties

Public sector equality duty

The government is required to consider the impact of new policies on the protected characteristics set out in section 149 of the Equality Act 2010, which are:

• age
• disability
• gender reassignment
• marriage and civil partnership
• pregnancy and maternity
• race
• religion or belief
• sex
• sexual orientation

DHSC does not believe the proposals risk impacting people differently with reference to their protected characteristics. Do you agree or disagree with this statement?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 150 words)

Questions for individuals who live in Northern Ireland and organisations who operate in Northern Ireland: equality and rural screening 

In Northern Ireland, new policies must be screened under section 75 of the Northern Ireland Act 1998, which places a statutory duty on public authorities to mainstream equality in all its functions so that equality of opportunity and good relations are central to policy making and service delivery. In addition, new or revised policies must be rural proofed in line with the Rural Needs Act (NI) 2016, which requires public authorities to have due regard to rural needs. 

The Department of Health in Northern Ireland does not believe the proposals risk impacting people differently with reference where they live geographically in Northern Ireland.

Do you agree or disagree with this statement?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer. (Optional, maximum 150 words).

Final question

If there are any further points you would like to make in relation to the proposals set out within this consultation, please include your comments here. (Optional, maximum 500 words)

Annex A: legal basis and the assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021

The Medicines and Medical Devices Act 2021 (‘the act’) received Royal Assent on 11 February 2021. We propose to make the legislative changes under part 2 of the act, which provides powers to make regulations about human medicines. 

This consultation is conducted in line with the consultation requirement in section 45 (1) of the act. Section 2 of the act (power to make regulations about human medicines) states that patient safety must be the overarching objective of the appropriate authority when making regulations. Section 2 also requires that when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to 3 factors: 

• the safety of human medicines
• the availability of human medicines
• the likelihood of the relevant part of the UK being seen as a favourable place in which to:
  • carry out research relating to human medicines
  • conduct clinical trials
  • manufacture or supply human medicines

We have assessed the proposals against each of these factors, outlined below. 

Safety of human medicines

The overall aim of the proposed amendments is to help safeguard public health in accordance with section 2 (2) of the Medicines and Medical Devices Act 2021. This is designed to protect public health and promote the safety of patients.

The COVID-19 vaccination programme was the largest vaccination programme undertaken in the history of the NHS and saved tens of thousands of lives across the United Kingdom. Provisions in the HMRs that were established to facilitate the delivery of the COVID-19 vaccination programme have played a vital role in protecting public health.

The proposed updates to these provisions are designed to build upon the benefits that the amendments to the HMRs have provided to date in supporting the continued safe and effective deployment of vaccines across the UK and helping to safeguard public health. Patient safety is at the heart of any public health vaccination programme and is at the forefront of policies proposed in this consultation. Further information on how the proposals contribute to the safety of human medicines is set out below:

• R3A - amendments to R3A (3) and (4) will not only support the continuation of current and potential future supply chains within the COVID-19 programme, but by broadening to other vaccine preventable diseases, will help support the development of future supply chains more widely so that the UK has the potential to effectively use enhanced vaccine technologies such as those used in mRNA vaccinations. To ensure the safety of human medicines, this process will be regulated and only vaccinations against a vaccine preventable disease which are authorised by the UK’s independent regulator, MHRA, will be permitted under the regulations
• R19 - this process would be subject to the same levels of quality and safety assessment set by the UK’s independent medicines regulator, MHRA, with robust governance and safeguards in place to ensure the integrity of the vaccines and cold chain are upheld
• R247A - patient safety has been maintained through strong national governance systems. Across all 4 nations, new vaccinators working under the national protocol are required to complete a comprehensive online training package developed nationally by an appropriate body, and then undergo practical training within NHS services, followed by a competency assessment to ensure they can safely administer vaccines to patients under the clinical supervision of an experienced healthcare professional. The replacement of R247A with the introduction of a new permanent provision to support the use of an extended workforce to supply and administer vaccinations will require the same levels of comprehensive training, and important limits will be set on its expansion to maintain safety
• R233 and regulation 3 - to ensure safety in Great Britain, any concerns about offsite pharmacy services can be investigated and addressed by the GPhC. The GPhC has responsibility for ensuring that the health, safety and wellbeing of users of pharmacy services is maintained through appropriate safeguards. In addition, where a pharmacy vaccination service has been commissioned, the commissioner of the pharmacy vaccination service has responsibility for ensuring vaccination sites are appropriate. In Northern Ireland, the Department of Health’s SPPG will outline the requirements for community pharmacy vaccination service providers in the relevant service specification. The PSNI will also continue to liaise closely with the SPPG and MRG to support safe and effective delivery of off-site pharmacy services. In regard to regulation 3, safety will be maintained by ensuring the proposed exemption would be subject to the same conditions as are placed on doctors, dentists, nurses and midwives
• S17 - patient safety is assured by ensuring only suitably trained professionals, who have undergone the same training and processes as those set out under schedule 16, can administer vaccinations as part of an OHS. It also helps provide clarity and a consistent approach of who can safely administer vaccinations under an OHS

Availability of human medicines

The proposals outlined are intended to support the supply and increase the availability of vaccines to all those eligible. The proposed provisions will help to support timely access to a wider range of vaccines. Further information on how the proposals contribute to the availability of human medicines is set out below:

• R3A - retaining the provisions under R3A (3) and (4) will help the continued access and availability of COVID-19 vaccines by supporting the continuation of current supply chains within the COVID-19 programme. Broadening the scope to other vaccine preventable diseases will also help support access and the development of future supply chains - ensuring the regulation is future proofed and able to use new emerging technologies, for example those stored at ultra-low temperatures
• R19 - the proposed amendments to R19 support the availability of vaccines by allowing vaccinations against a vaccine preventable disease to be moved between different NHS service providers at the end of the supply chain without the need for a wholesale dealer’s licence when necessary. The use of R19 (4A) to (4D) during the pandemic has shown how the health system can work effectively and collaboratively to safely ensure vaccines can be quickly delivered to respond to need
• R247A - this has provided the mechanism which has enabled an expanded the workforce to legally and safely administer a COVID-19 or influenza vaccine without the input of a prescriber, using an approved protocol. Replacing R247A with the introduction of a new permanent provision (VGD) to support the use of an extended workforce to supply and administer vaccinations will help to improve access and ensures that there is the workforce in place to administer vaccines
• R233 and regulation 3 - this will improve availability by broadening the scope of vaccinations which can be delivered by community pharmacies off the registered premises, for example at pop up vaccinations centres at places of worship or community centres. This will help improve access by supporting more localised vaccination efforts in order to help improve access. It will also help the health system react quickly to emerging outbreaks and allow providers to offer a more bespoke service, tailored to local service user needs. This will in turn increase access to vaccinations, support uptake and ultimately help to protect the public’s health, while maintaining important safety assurances
• S17 - this allows for registered nurses and other specified practitioners to supply and/or administer medicines, as part of an OHS, under the written directions of a doctor. Aligning the definition of ‘occupational health vaccinator’ with part 4 of schedule 16 will help to expand the workforce to help deliver OHSs across the system and improve access

The likelihood of the relevant part of the UK being seen as a favourable place in which to carry out research relating to human medicines, conduct clinical trials or manufacture or supply human medicines 

These regulations have helped the UK to be seen as a favourable place to supply medicines with the swift and safe distribution of COVID-19 and influenza vaccines, as well as ensuring that there is appropriately trained staff to administer these programmes. Expanding these regulations, for example, to include vaccinations against other vaccine preventable diseases and making the legislation permanent, will help to support this and provide a long-term solution to vaccination programmes going forward. This in turn has the potential to further enhance the UK as being a favourable place in which to carry out research relating to human medicines, or manufacture or supply human medicines.

The amendments to these regulations have also demonstrated that the UK has the adaptability to ensure that medicines can be supplied at scale and pace where necessary to protect patients and the public. Provisions, such as those providing flexibilities around wholesale dealing, have shown our ability to safely provide flexibility in the supply and distribution of medicines where that will deliver significant public health benefits. 

Summary

The amendments made to the HMRs to support the rollout of the COVID-19 vaccination programme and upscale the influenza vaccination programme, has brought significant operational benefits in terms of the UK’s ability to deliver vaccines at the pace and scale required. Based on the lessons from the millions of COVID-19 and influenza vaccines delivered since December 2020, the further amendments to these regulations will help ensure we are able to develop a permanent vaccination service that is fit for the future.

The amendments proposed will support patient safety, improve access and the availability of vaccines, and improve the UK’s position on the world stage for vaccine innovation. This will be achieved by:

• expanding and regulating the movement and preparation of vaccinations in defined circumstances (R3A and R19)
• expanding the premises from which community pharmacies can deliver vaccination services to allow them to be commissioned to deliver targeted outreach (R233 and regulation 3)
• expand the use of a flexible workforce for vaccine administration (S17 and the proposed new legal provision replacing R247A)

Overall, these changes should allow us to build upon the successes already seen and offer the public a safe and improved vaccination service across the UK.

Privacy notice

Data controller

The Department of Health and Social Care (DHSC) is the data controller.

What personal data we collect

The online survey will ask respondents if they are responding as an individual or on behalf of an organisation. If someone is responding as an individual, they will be asked about their profession, whether they work in the NHS, and where in the UK they live. If someone is responding on behalf of an organisation, they will be asked which sector their organisation is in and where their organisation operates or provides services (with the option to name the organisation).

From this information, it is not possible to identify individuals.

No personal information will be collected from respondents.

How we use your data (purposes)

DHSC will use your data to understand whether respondents are NHS staff when providing their response. It is also helpful for DHSC, when analysing responses, to understand if there are any regional or national variations in relation to observations or views on the use of these regulations to support COVID-19 and influenza vaccination, so it can explore local issues further if required.

Legal basis for processing personal data

Under Article 6 of the United Kingdom General Data Protection Regulation (UK GDPR), the lawful basis we rely on for processing this personal data is:

• e) the processing is necessary to perform a task in the public interest or for our official functions and the task or function has a clear basis in law

Data processors and other recipients of personal data

All responses to the consultation will be seen by policy leads working on amending the regulation in DHSC.

This consultation is hosted via an online platform owned by SocialOptic, who are a contracted supplier of DHSC. SocialOptic will delete any personal data in line with the retention and disposal periods outlined in this privacy notice, or earlier if instructed to do so by DHSC.

International data transfers and storage locations

Storage of data by DHSC is provided via secure computing infrastructure on services located in the European Economic Area (EEA). Our platforms are subject to extensive security protections and encryption measures.

Storage of data by SocialOptic is provided via secure servers located in the UK.

Retention and disposal policy

DHSC will only retain your personal data for as long as either:

• it is needed for the purposes of the consultation
• the law requires us to

This means that collected data will be held by DHSC for a maximum of 5 years. 

SurveyOptic will securely erase the data held on their system one year after the online survey closes, or when instructed to do so by DHSC if the data has served its intended purpose (whichever happens earlier).

Data retention will be reviewed on an annual basis. Anonymised data may be kept indefinitely. 

How we keep your data secure

DHSC uses appropriate technical, organisational and administrative security measures to protect any information we hold in our records from loss, misuse, unauthorised access, disclosure, alteration and destruction. We have written procedures and policies which are regularly audited and reviewed at a senior level. 

SurveyOptic is Cyber Essentials certified. 

Your rights as a data subject

By law, data subjects have a number of rights, and this processing does not take away or reduce these rights under the UK General Data Protection Regulation and the UK Data Protection Act 2018 applies.

These rights are:

• the right to get copies of information - individuals have the right to ask for a copy of any information about them that is used
• the right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected
• the right to limit how the information is used - individuals have the right to ask for any of the information held about them to be restricted - for example, if they think inaccurate information is being used
• the right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case
• the right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioner’s Office.

Their postal address is:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

We keep this privacy notice under regular review, and we will update it if necessary. All updated versions will be marked by a change note on the consultation page. This privacy notice was last updated on 5 September 2025.