Consultation outcome

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

Updated 20 January 2026

Introduction

In response to the COVID-19 pandemic, multiple regulations were put in place to enable the rollout of the COVID-19 and influenza vaccination programmes and to ensure there was a sufficient vaccination workforce to administer them. These regulations were made by making amendments to the Human Medicines Regulations 2012 (HMRs) through the:

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

Between 5 September and 28 November 2025, the government hosted a 12-week public consultation on amending regulations to support the supply and deployment of vaccines across the UK. These proposals build upon the successes of vaccination programmes during the pandemic, with the intention of developing a vaccination system that is fit for the future. By supporting the safe supply, distribution and administration of a wider range of vaccines, the aim of these changes is to strengthen the vaccination system across all 4 nations of the UK, and to help the health service to implement improvements which will facilitate the shift to prevention as described in the 10 Year Health Plan for England.

This document summarises the responses to that consultation and sets out the government’s response to the feedback received.

The remit of the regulations that were consulted on 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 a manufacturer’s licence being required. R3A has enabled NHS teams in England to work more flexibly, collaboratively and effectively through the mass vaccination centre model or primary care network (PCN) model while maintaining safety through robust governance structures. This has contributed to delivering significant operational benefits. The flexibility provided by R3A has been similarly useful for vaccination programmes in Scotland, Wales and Northern Ireland
• 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. R19 has increased flexibility for vaccines to be moved swiftly and safely between sites in response to need without a wholesale dealer’s licence, helping to reduce vaccine wastage and enabling more timely access to vaccinations
• 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. R247A has helped to ensure there is a sufficient workforce to deliver COVID-19 and influenza vaccines to a large number of people
• 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). R233 (8) has enabled community pharmacies to deliver outreach services tailored to the needs of the populations they serve, increasing access to COVID-19 and influenza vaccines
• 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 manufacturer’s 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. S17 has increased flexibility in delivering COVID-19 and influenza vaccines as part of an OHS through expanding the ‘occupational health vaccinator’ workforce

The provisions in R3A, R19 and R247A proved vital to the success of the COVID-19 and influenza vaccination programmes during the COVID-19 pandemic, and enabled the continued safe and effective deployment of vaccines across the UK to help safeguard public health. R3A, R19 and R247A are time limited provisions which are due to lapse on 1 April 2026. There is a need to agree the future of these provisions beyond this date. R233, regulation 3 and S17 are permanent provisions, but making the proposed amendments would improve the vaccination system and ensure the legislation is able to support ongoing programme delivery.

The consultation proposed:

• allowing R3A (1) and (2) to lapse to reflect our shift from a pandemic scenario to a more targeted approach to recent COVID-19 vaccination campaigns
• retaining R3A (3) and (4) and R19 as permanent legislation to maintain flexibilities in the labelling and movement of vaccines in defined circumstances with appropriate safeguards in place
• replacing R247A with a new permanent provision to help increase the workforce capacity to deliver vaccines at scale and pace
• expanding the scope of provisions in R3A, R19, R233 and the new provision replacing R247A to include any vaccine against an infectious disease caused by a virus or bacteria, providing flexibility for a wider range of vaccination programmes
• amending R233 and regulation 3 to increase flexibility for community pharmacies to deliver vaccination services outside registered premises. This will enable community pharmacies to deliver targeted outreach, improving access to vaccines and helping reduce health inequalities
• expanding the relevant provisions in S17 to cover all vaccinations or immunisations offered as part of an OHS to help improve vaccine access for eligible staff, ensuring better protected workforces in delivering the vital roles they do, within and beyond the health and social care sectors
• aligning the list of professionals who can administer vaccines under an NHS or local authority OHS in S17 with those who can supply medicines under a PGD (part 4 of schedule 16) to provide clarity and consistency
• expanding the scope of the relevant provisions in S17 to include private OHS providers, enabling them to use the ‘occupational health vaccinator’ role and providing parity with the NHS and local authority OHS

The proposed amendments to these regulations are designed to build upon the benefits that the HMRs have provided to date, as well as 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 also increasing the effectiveness of the system’s supply chain and workforce (including health visiting teams and community pharmacists) to improve vaccination uptake.

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, sought 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 the original consultation document.

Overview of consultation activity

Prior to the launch of the public consultation, pre-consultation engagement was undertaken with a broad range of stakeholders involved in the vaccination system across the UK. This engagement developed the government’s proposals to make permanent provisions for R3A, R19 and R247A and to expand the scope of R3A, R19, R247A, R233, regulation 3 and S17. We engaged regularly with the devolved governments in the lead-up to publication to ensure this consultation reflected the context and requirements of all 4 nations.

We raised awareness of, and encouraged participation in, the consultation through the Department of Health and Social Care (DHSC) and Department of Health in Northern Ireland (DoH NI) each directly communicating with key stakeholder organisations. The consultation was also promoted in Wales by NHS Wales and the Welsh Government and in Scotland by Public Health Scotland and the Scottish Government to encourage responses from partners.

We have analysed all the consultation responses and noted specific feedback on the proposals. The government response seeks to address the main points raised. We have also considered all responses relating to how the proposed amendments might impact people differently in relation to protected characteristics.

Informed by the responses received in this public consultation, we have updated the public sector equality duty impact assessment relating to the proposed amendments. This can be found in the ‘Legal duties’ section of this consultation response.

Methodology

The consultation utilised an online survey published on GOV.UK. The survey consisted of 14 closed questions (quantitative) and 15 open-ended (qualitative) questions relating to the proposed amendments of the regulations themselves. There were also questions relating to the demographics of those responding and the potential impact of the proposed amendments. Respondents could choose whether to answer each question, and the open-ended questions were not mandatory. Respondents could also submit written evidence to a dedicated mailbox.

We received 218 responses in total. Of those, 216 responses were received through the consultation platform, and 2 responses were received by email. Of the 2 responses received by email, only 1 addressed the specific questions relating to this consultation, while the other raised points outside the scope of these proposals. We have analysed all responses and considered the feedback received. We considered the quantitative responses (agree, disagree, neither agree nor disagree, don’t know) provided to each closed question as well as the qualitative responses provided in the open-ended questions, where people could share their views in their own words.

Responses to each quantitative question were tallied and summarised as percentages of all 217 responses which addressed the specific proposals. To note, data may have been rounded in line with the UK Statistics Authority’s Code of Practice for Statistics. Due to rounding, percentages may not add up to 100%.

Responses to the qualitative questions were analysed by the DHSC policy team using thematic analysis to code responses into themes. This was then peer reviewed by another member of DHSC policy. DHSC analysts also performed quality assurance including reviewing the methodology and performing spot checks. Where respondents made specific suggestions relating to the legislation itself, these were identified and read in detail. Any key questions were identified and noted for the government response.

Breakdown of respondents

A total of 218 responses were received, one of which raised points outside the scope of the proposals. We have provided a summary of the 217 responses which addressed the specific proposals below:

• 61% of responses were received from individuals sharing their professional views. Of these, 90% indicated that they worked within the NHS or health service delivery
• 4% of responses were received from individuals sharing their personal views
• 34% of responses were received on behalf of organisations. Of these:
  • 55% indicated that their organisation was a public sector body
  • 23% were from businesses
  • 16% were not-for-profit organisations

The UK-wide amendments proposed in this consultation will support vaccination programmes across all 4 nations. Therefore, it was important to get views from across the UK. A breakdown of responses by nation can be found below.

Of individuals sharing their personal or professional views:

• 55% stated that they live in England
• 28% stated that they live in Scotland
• 15% stated that they live in Wales
• 2% stated that they live in Northern Ireland

Of organisations who shared their views:

• 36% stated that they operate or provide services in England only
• 27% stated that they operate or provide services in Scotland only
• 9% stated that they operate or provide services in Wales only
• 4% stated that they operate or provide services in Northern Ireland only
• 23% stated that they operate or provide services across the nations

Analysis and government response

Overall, the majority of responses received were supportive of the proposals outlined in the consultation. We received many positive comments detailing how the flexibilities provided by the regulations have had a positive impact and helped to increase access and efficiency across the system, while effectively using the workforce to safely deliver COVID-19 and influenza vaccinations.

Respondents who stated that they were NHS and health service delivery professionals were broadly supportive of these proposals.

To create a vaccination system that is fit for the future, the consultation set out our proposal to expand the scope of R3A, R19, R233 and the new provision replacing R247A to include any vaccine against an infectious disease caused by a virus or bacteria. The aim is to support the delivery of ongoing national vaccination programmes and enable the health system to rapidly respond to need, including in response to any potential future pandemic. Across multiple questions, we received comments asking for clarity on how these regulations will be used beyond the COVID-19 and influenza vaccination programmes. We do not expect all the amended provisions to be utilised across all eligible vaccination programmes across the 4 nations, but we are enabling their use across any vaccine against an infectious disease caused by a virus or bacteria to provide flexibility and ensure this legislation is adaptable to future requirements.

We wish to note that while the consultation proposal referred to a ‘vaccine-preventable disease’, we have concluded this terminology lacks clarity because a vaccine may not always prevent disease, although it may minimise the effects. Throughout this response, we will therefore use the term ‘vaccine against an infectious disease caused by a virus or bacteria’ as described in the consultation document. The legislative instrument that gives effect to this will reflect the final terminology.

We would also like to note that there were some minor data quality concerns where a response to the initial quantitative question (agree or disagree) did not align with the adjoining qualitative response received from the respondent. This was particularly the case for the questions which proposed allowing R3A (1) and (2) and R247A to lapse.

Overarching themes

The overarching policy objective of the HMRs is to safeguard public health through ensuring the safety and availability of human medicines to patients. The amendments proposed will help safeguard public health, in accordance with section 2 (2) of the Medicines and Medical Devices Act 2021.

Multiple themes were identified during analysis of responses, which we have addressed below.

Governance and assurance

Across all questions, there were comments on the need for strong governance arrangements. We would like to stress that there are robust governance processes in place across the vaccination system in the UK to uphold vaccine integrity and ensure patient safety. The HMRs provide the legal mechanisms for vaccine supply, deployment and administration, including patient group directions (PGDs), patient specific directions (PSDs) and, while relevant temporary provisions are in force, national protocols.

A PSD is a written direction from a doctor, dentist or non-medical prescriber for a medicine to be supplied or administered to a named patient after the prescriber has assessed that patient on an individual basis. The prescriber must be satisfied that the person to whom administration is delegated has relevant qualifications, experience, knowledge and skills. A PGD is a written instruction for the sale, supply and/or administration of medicines to groups of individuals who may not be individually identified before presenting for treatment. PGDs can only be used by registered healthcare professionals listed in part 4 of schedule 16 of the HMRs. PGDs can be used for supply or administration of any vaccine with a UK marketing authorisation and must be authorised by a public body as set out in schedule 16 of the HMRs.

National protocols were introduced by R247A in December 2020 to provide the mechanism that enables an expanded workforce to legally and safely deliver COVID-19 and influenza vaccines without the input of a prescriber, using an approved protocol. The national protocol must be authorised by ministers in each of the 4 nations in the UK. Our proposed amendment to replace R247A with a new permanent provision to support the use of an extended workforce to supply and administer vaccinations would replace the use of national protocols with a new legal mechanism covering all vaccines, a vaccine group direction (VGD). A VGD would be developed and authorised by the relevant public health body in each of the UK nations, adapting the robust governance arrangements already in place for PGDs. Further detail on VGDs can be found in ‘Amendments to regulation 247A’ below.

Experience with national protocols for COVID-19 and influenza programmes has demonstrated that non-registered staff can be deployed safely and effectively. However, public health bodies in each of the UK’s 4 nations must ensure that any expansion of this workforce is proportionate. We anticipate that VGDs will enable vaccine providers to utilise this workforce year-round, if appropriate for their delivery model and in a carefully managed way. The decision-making framework for which programmes would enable delegation of vaccination activities through a VGD will be established through robust governance and operational frameworks, supported nationally and complementing those already existing for PGDs.

In addition, other governance arrangements will be in place, including mechanisms to ensure accurate and timely record keeping of vaccinations.

In England, COVID-19 and influenza vaccination sites can use point of care systems to send vital data to national systems to update patients’ GP records when a person is vaccinated, including product and batch details, and the recording of adverse reactions. Providers are able to securely access these systems while away from their registered premises and include the site of vaccination when recording a vaccination. Development work is underway to support the interoperability of records systems to enhance this further and expand to other vaccinations. Similar records systems are used in:

• Scotland, recording through systems such as the vaccination management tool
• Wales, recording through one of the following:
  • the Welsh Immunisation System used by health boards, general practice, community pharmacies and Public Health Wales
  • primary care IT systems
• Northern Ireland, recording through the Vaccination Management System used by primary care, community pharmacies, and health and social care trusts

Training

We received multiple comments on the need for training for staff who will be utilising these provisions.

There are various requirements for healthcare workers involved in vaccination to receive robust training. NHS England’s national service specifications and contracts set out that it is the responsibility of providers to meet this requirement. Providers must ensure that staff have the required experience, skills and training including face to face vaccination administration training where applicable. We expect providers, who are responsible for ensuring healthcare professionals are practically competent in the workplace, to assure their vaccinators are appropriately trained through the use of competency assessors.

The UK Health Security Agency (UKHSA) publishes National minimum standards and core curriculum for immunisation training guidance to commissioners and providers of immunisation services on the minimum level and scope of training that should be provided to those undertaking clinical and non-clinical roles associated with the delivery of vaccination programmes. Therefore, all healthcare staff with a role in delivering vaccination programmes should meet the national minimum standards referenced above. This updated material merged existing training standards which were separate for registered and non-registered healthcare staff. Providers of vaccination services are expected to adopt these minimum standards and have assurance in place to demonstrate core competencies in vaccinations. The update reflects the increasingly complex and varied landscape where healthcare staff from a wide range of occupations now provide vaccinations in many different settings and service areas. This includes a range of less traditional venues adapted to facilitate rapid delivery in response to pandemics and outbreaks, often at huge scale.

Existing UKHSA PGDs and protocols require all those operating under them to be competent in:

• the use of the legal mechanisms
• the delivery of the specific vaccination programme - for example, being familiar with the relevant chapters of the UKHSA Green Book, the handling and storage requirements of the vaccines, and their summary of product characteristics
• any other relevant supporting materials as defined in the PGD or protocol

Wastage

We received multiple comments concerning the importance of reducing vaccine wastage. We recognise that there would be positive by-effects of the proposed amendments on reducing wastage, however the main intention of these proposals, in line with the overarching policy objective of the HMRs, is to maintain patient safety while increasing access to vaccines to support uptake and increasing effectiveness within the vaccination system.

Partners in the system are working together to minimise wastage. UKHSA is responsible for the procurement, storage and distribution of COVID-19 vaccines. UKHSA seeks to minimise wastage by ensuring that volumes of COVID-19 vaccine are procured in line with forecasted demand. NHS England works to optimise supply routes which ensure sufficient vaccine is supplied on a timely basis without oversupplying to end users and NHS England’s national and regional teams work closely with vaccination providers to monitor and ensure vaccines are used within the shortest possible timeframe. The delivery model in Scotland means that, where necessary, vaccines can be shared within health boards to meet additional demand and reduce waste. The government is also working with manufacturers to improve the handling characteristics of vaccines procured.

In relation to the provisions in R19, we have discussed further with systems partners, including with the Medicines and Healthcare products Regulatory Agency (MHRA), who are clear that in line with the consultation, provisions in this regulation should only be utilised in exceptional circumstances, where there is an urgent public health need (for a patient to receive the particular medicinal product) and no alternative means of addressing that public health need. While the movement of vaccines between providers could enable better utilisation of stock and reduce vaccine wastage, this would not in and of itself constitute an urgent public health need, therefore R19 would not provide the legal basis for movement of stock to address wastage.

Vaccine safety

Across all questions, a small proportion of respondents disagreed with the proposals because of their concerns around the safety and efficacy of vaccines. We would like to provide reassurance that the safety of all vaccines deployed in the UK remains of the utmost importance to the government. Every vaccine deployed in the UK must first go through rigorous development and testing processes set by the UK’s independent medicines regulator, MHRA. Each vaccine candidate is assessed by teams of scientists and clinicians and only authorised once it has met robust standards of safety, quality and efficacy.

The safety, integrity and efficacy of vaccines is also maintained through a regulated supply chain, where vaccines are transported and supplied in accordance with their marketing authorisation. The proposals in this consultation will support supply chain integrity.

Amendments to regulation 3A

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

Our proposal was to allow R3A (1) and (2) to lapse on 1 April 2026, which aligns with our shift from a pandemic scenario to a more targeted approach for recent COVID-19 vaccination campaigns. 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 in an emergency.

The consultation proposed to retain R3A (3) and (4) as permanent legislation to support the continuation of current and future supply chains within the COVID-19 programme. Our proposal to expand R3A (3) and (4) to cover any vaccine against an infectious disease caused by a virus or bacteria is designed to 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 vaccines.

Question

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

Of the 217 responses to this question:

• 102 respondents (47%) agreed
• 75 respondents (35%) disagreed
• 24 respondents (11%) neither agreed nor disagreed
• 16 respondents (7%) didn’t know

Almost half (47%) of respondents to this question agreed with the proposal to let the provisions under R3A (1) and (2) lapse from 1 April 2026, with 35% disagreeing. There were however a few data quality issues for the responses received to this question, with some respondents either misunderstanding the proposals or providing information contradictory to whether they agreed or disagreed with the proposals.

Of those who provided a qualitative response, many respondents commented that the provisions provided by R3A (1) and (2) are still needed in the vaccination system. Respondents highlighted that R3A (1) and (2) provide workforce benefits through making more effective use of the workforce and reducing workforce pressures, increase efficiency in the vaccination system and support delivery at scale.

Respondents asked for clarity on what “final stage of assembly and preparation of COVID-19 vaccines” means in practice. To clarify, some vaccines used in COVID-19 campaigns are supplied in multi-dose vials instead of pre-filled syringes, which has required final preparations to take place before the vaccine can be administered, including reformulation. R3A (1) and (2) 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. This supported the bulk assembly of COVID-19 vaccines by or under the supervision of a doctor, registered nurse or a pharmacist, as needed during a pandemic scenario to enable vaccine deployment at the scale and pace required. As we transition toward a more targeted approach to COVID-19 vaccinations, we proposed that these provisions are no longer necessary as they facilitate the large-scale preparation of vaccine as needed for a mass vaccination centre.

Before R3A was introduced, 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 initial phases of the COVID-19 vaccination programme.

In response to some comments concerning the impact on staff morale of these changes, we would like to provide reassurance that our proposal to let R3A (1) and (2) lapse is not a reflection of the workforce’s ability to conduct the final stage of assembly and preparation of COVID-19 vaccines. Many comments from respondents to this question emphasised the success of using a wider range of healthcare workers, with adequate training and supervised by a registered healthcare professional, to conduct vaccine assembly and preparation during the pandemic. The proposal to allow these provisions to lapse is simply to reflect that these temporary measures are no longer required and there is not a strong reason for making them permanent.

Some respondents raised concerns about how long it would take for emergency legislation amending the HMRs could be brought into force if similar provisions to R3A (1) and (2) are needed for any potential future pandemic scenarios. We would like to provide reassurance that emergency legislation can be introduced at pace where required. The Medicines and Medical Devices Act 2021 (section 7 (Emergencies)), as the parent act for the HMRs, would enable this emergency legislation to be introduced, under the negative procedure. Statutory instruments made in the negative procedure can be signed by the minister before being laid in Parliament. They will then automatically come into effect as law unless either the House of Commons or House of Lords objects within a fixed period, normally 40 days. Similarly in Northern Ireland, any emergency legislation introduced under the negative resolution procedure can be signed and laid before the Northern Ireland Assembly and would also then automatically come into effect as law unless a Member of the Assembly brought a motion to the Assembly for debate, seeking to strike down the legislation.

Question

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

Of the 217 responses to this question:

• 157 respondents (72%) agreed
• 18 respondents (8%) disagreed
• 26 respondents (12%) neither agreed nor disagreed
• 16 respondents (7%) didn’t know

Many respondents who provided comments stated general support for this proposal, with respondents acknowledging it was a pragmatic long-term solution that maintains patient safety in line with MHRA requirements. Respondents noted that provisions under R3A (3) and (4) have increased operational efficiency across the vaccine system as well as ensured supply chain resilience. Respondents also highlighted the positive impacts of R3A (3) and (4) on reducing vaccine wastage, through accurate shelf-life labelling following product thawing, mitigating the quality risks associated with frozen vaccines.

While some respondents acknowledged that effective governance is in place, a few other respondents highlighted safety concerns for patients and workforce. We would like to highlight the strong governance and safeguards included in the provisions under R3A (3) and (4).

Some respondents highlighted the need for clarity on which professionals are permitted to re-label vaccines to reflect changes in shelf life from product thawing. Those permitted to re-label vaccines under these proposals will be all individuals, organisations or companies who are holders of a wholesale dealer’s licence, but who do not hold a manufacturer’s licence.

Respondents also suggested specific additional training for permit holders of wholesale dealers’ licences (who do not hold manufacturers’ licences) would be beneficial. We expect that any activity involving the thawing of frozen product will be in line with the information provided by the manufacturer in the instructions for their product and aligned to the principles of good manufacturing practice.

Question

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

Of the 217 responses to this question:

• 157 respondents (72%) agreed
• 28 respondents (13%) disagreed
• 22 respondents (10%) neither agreed nor disagreed
• 10 respondents (5%) didn’t know

Many respondents who provided comments set out that expanding R3A (3) and (4) to any vaccine against an infectious disease caused by a virus or bacteria will enable more efficient use of a capable vaccinator workforce, reducing overall workforce pressures. Respondents also highlighted that the increased flexibilities resulting from the expanded scope of R3A (3) and (4) can improve vaccine access and uptake against a wider range of diseases. This will support the shift from sickness to prevention as described in the 10 Year Health Plan for England.

Some respondents noted the specific benefits of the provisions in enabling vaccination programmes that are reliant on mRNA technologies to be operationally feasible. This is because mRNA vaccines are regularly delivered to UKHSA either frozen or at ultra-low temperatures (depending on the vaccine characteristics) before being thawed and re-labelled for use as and when required. The flexibility delivered by this proposal will help facilitate rapid and safe deployment of newer vaccine technologies, supporting development of future vaccine supply chains and contributing to the UK’s position in vaccine innovation on the world stage.

Some respondents flagged concerns relating to the increased risks associated with the relabelling of non-COVID-19 vaccines, considering the proposal to expand these provisions to other vaccination programmes unnecessary. To mitigate these risks, strong governance structures will be put in place, and any activity will be undertaken in alignment with the existing principles of good manufacturing practice. As an example, for COVID-19 vaccines in England, the expectation is that a single regulated organisation (with a wholesale dealer’s licence) will be undertaking the thawing and application of the post-thaw expiry label before providers received the final product. This reduces the risk associated with multiple providers (unfamiliar with post-thaw expiry labelling) having to undertake this activity upon receipt of stock. For products where a post-thaw expiry label is required, we expect similar processes to occur.

As the consultation responses were broadly supportive of our proposals on R3A, we intend to:

• allow R3A (1) and (2) to lapse on 1 April 2026
• retain R3A (3) and (4) as permanent legislation with an expanded scope for any vaccine against an infectious disease caused by a virus or bacteria

Allowing R3A (1) and (2) to lapse reflects the fact that we are no longer operating in a pandemic scenario, although we continue to offer COVID-19 vaccination to those at greatest risk. Retaining R3A (3) and (4) with an expanded scope will help future-proof the regulations and support the UK to implement vaccine technologies which require ultra-low temperature storage conditions in the supply chain.

Amendments to regulation 19

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.

The consultation proposed to retain the provisions under R19 (4A) to (4C) as permanent legislation with appropriate safeguards and governance built in to continue to enable the health system to work effectively and collaboratively to safely ensure vaccines can be rapidly deployed in response to need. The consultation also proposed to expand these provisions to cover any vaccine against an infectious disease caused by a virus or bacteria, with appropriate safeguards in place, to enable the system to respond as quickly as required.

Across all questions relating to R19, we received several comments highlighting reducing vaccine wastage as a significant positive impact of R19. While we acknowledge that our proposed amendments would have positive by-effects on reducing vaccine wastage, our priority when designing amendments to R19 is to support the development of a health system that can respond to need, and the associated public health benefits this will bring.

Question

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?

Of the 217 responses to this question:

• 164 respondents (76%) agreed
• 21 respondents (10%) disagreed
• 21 respondents (10%) neither agreed nor disagreed
• 11 respondents (5%) didn’t know

About three-quarters (76%) of respondents agreed with the proposal to retain the provisions under R19 (4A) to (4C) as permanent legislation to support distribution, when necessary, while 10% disagreed. A similar pattern of responses was observed for this question compared to the proposal to retain R3A (3) and (4) as permanent legislation.

Many respondents provided strong support for the proposal, highlighting multiple benefits of retaining R19 as permanent legislation including, but not limited to:

• reducing wastage
• improving health system ability to respond to need
• increasing efficiency
• improving vaccine access

Several responses agreed in principle with our proposal, but desired further clarification in legislation on the exceptional circumstances in which providers can operate under R19 to move vaccines between end sites. We have provided clarity on the preconditions in our analysis of the question ‘Do you agree or disagree that the legislation should set out preconditions and safeguards to regulate the use of R19 (4A) to (4C)?’ below.

Where respondents disagreed, their main concerns related to increased safety risks and robust governance and assurance processes. We would like to stress that there are robust governance processes in place across the vaccination system in the UK to uphold vaccine integrity and ensure patient safety. The HMRs provide the legal mechanisms for vaccine supply, deployment and administration. In amending R19, we will also ensure that the draft regulations include conditions that require that local and national decision makers are content that exceptional circumstances have been met before the provision can be utilised. This will minimise misuse of the provisions and strengthen the governance and assurance processes associated with the movement of stock.

Question

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

Of the 217 responses to this question:

• 164 respondents (76%) agreed
• 27 respondents (12%) disagreed
• 19 respondents (9%) neither agreed nor disagreed
• 7 respondents (3%) didn’t know

There is strong support for this proposal, with many respondents highlighting the benefits relating to reducing vaccine wastage in expanding the scope of the provision to any vaccine against an infectious disease caused by a virus or bacteria. Comments provided by respondents indicated broad support for the expansion of scope, citing the public health benefits and potential improvements to the vaccination system.

Some respondents stated that R19 is not necessary for vaccination programmes beyond COVID-19 and influenza. In line with other respondents, and following discussions with our expert group, we have concluded that expanding R19 to any vaccine against an infectious disease caused by a virus or bacteria will enable the health system to respond to exceptional circumstances impacting other vaccination programmes, as well as make the legislation more agile for future requirements.

A small number of respondents held concerns over the potential misuse of the provisions, risking vaccine integrity and patient safety. To mitigate this issue, we have proposed including preconditions and safeguards in the legislation itself and have tested that with respondents in the following question.

Question

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

Of the 217 responses to this question:

• 170 respondents (78%) agreed
• 9 respondents (4%) disagreed
• 28 respondents (13%) neither agreed nor disagreed
• 10 respondents (5%) didn’t know

There was strong support for the proposal to include preconditions and safeguards in the legislation for R19, with several respondents noting that preconditions would reduce potential misuse of the regulation. Many respondents highlighted the importance of ensuring suitable governance and accountability processes are in place to maintain the safety, integrity and effectiveness of vaccines. A few respondents emphasised the need to ensure any conditions for exceptionality are proportionate.

Following the consultation outcome, we have engaged system partners across the 4 nations to agree on the specific preconditions to be included in R19.

We have concluded that R19 should only be used where 2 conditions (A and B) are met.

Condition A is that the body making arrangements to supply the vaccine agree with the transfer between the providers and the distribution occurs in exceptional circumstances. The exceptional circumstances are such that the provider distributing the medicinal product and the provider receiving the product (who is to administer the product) agree that all the following are applicable:

• there is an urgent public health need for a patient to have the vaccine administered to them on a particular occasion
• there is no alternative method of the patient receiving the vaccine without undue delay
• there is no suitable alternative medicinal product that the patient could receive without undue delay

This will ensure vaccines are only moved between providers where it is clinically essential.

Condition B is that the vaccine remains in its manufacturer’s original outer packaging as complete original packs and it is stored and transported in accordance with the terms of its marketing authorisations. This will uphold vaccine integrity and ensure patient safety.

Based on the consultation responses received regarding R19, we intend to retain R19 (4A) to (4C) as permanent legislation with appropriate preconditions and safeguards set out in legislation and an expanded scope to any vaccine against an infectious disease caused by a virus or bacteria. This will enable the health system to ensure vaccines can be rapidly deployed in response to urgent public health needs, supporting development of a vaccination system fit for the future.

Amendments to 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.

We propose replacing R247A with a new permanent provision which would introduce a new legal mechanism to support the use of an extended workforce to administer vaccinations. The proposed provision would introduce a VGD to make permanent the ongoing use of non-registered healthcare workers under the supervision of a specified registered healthcare professional in parts of the vaccination process. Our proposal would also expand the use of these VGDs beyond COVID-19 and influenza to all national vaccination programmes, providing protection against an infectious disease caused by a virus or bacteria, to support workforce delivery capacity.

Question

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

Of the 217 responses to this question:

• 128 respondents (59%) agreed
• 69 respondents (32%) disagreed
• 14 respondents (6%) neither agreed nor disagreed
• 6 respondents (3%) didn’t know

Over half (59%) of respondents agreed with the proposal to let R247A lapse from 1 April 2026, and less than a third (32%) disagreed. However, across both groups it was clear that there was a want for a legal mechanism to be in place to support the use of non-registered workers.

We would like to take this opportunity to firstly recognise how instrumental non-registered healthcare workers have been to the successful delivery of COVID-19 and influenza vaccination programmes to date. This was reflected in the consultation responses, with many respondents highlighting how R247A enabled more effective use of the workforce and reduced workforce pressures, as well as noting the capability of the workforce. Several respondents emphasised the safe and successful use of the non-registered healthcare workforce in enabling alternative models of vaccine delivery to be tested, identifying successful models and upskilling non-registered workers to competently deliver vaccinations.

Of the respondents who agreed with letting R247A lapse and who provided a qualitative response, most said they strongly supported the continued use of an extended workforce. These respondents generally only supported letting R247A lapse if an alternative legal mechanism such as the one proposed in this consultation is introduced.

Similarly, around a third of those who disagreed, and almost all respondents who did not state a clear position, said they do not want R247A to lapse without an alternative legal mechanism in place. Both groups emphasised that any new legal mechanism must be simple, robust and supported by strong safeguards and governance measures. Requirements include a clear training package and strict supervision requirements supported by the replacement legal mechanism.

Organisations that supported allowing R247A to lapse also agreed it should be replaced with a new legal mechanism. These organisations recognised that while the national protocol was vital for enabling COVID-19 and influenza vaccination, it had drawbacks, including:

• the need for ministerial approval (which they thought was burdensome)
• ambiguity in roles and responsibilities
• poor alignment with other regulations

Respondents felt the new legal mechanism proposed in this consultation would address these issues. They stressed the need for a new robust, well-designed permanent provision (not created in an emergency) and highlighted the importance of having this in place by 1 April 2026 to protect delivery of the spring COVID-19 vaccination programme.

A small number of respondents wanted R247A to lapse without replacement, citing concerns about adequate training and supervision for the unregistered workforce. Similarly, a few respondents who wanted to keep R247A highlighted their concerns about shifting delivery away from primary care settings and about the competence of the non-registered workforce to support other vaccines beyond COVID-19 and influenza.

The following 2 questions under R247A set out how we plan to address these concerns, including training and expertise for an expanded workforce and the safeguards we propose to ensure safe vaccine administration.

Question

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?

Of the 217 responses to this question:

• 171 respondents (79%) agreed
• 34 respondents (16%) disagreed
• 8 respondents (4%) neither agreed nor disagreed
• 4 respondents (2%) didn’t know

There was strong support for this proposal with most respondents providing positive comments in support of introducing a new permanent provision, with many of these respondents recognising both the workforce benefits and public health benefits of using an extended workforce. Many respondents noted how the provisions under R247A enabled vaccine delivery at the scale and pace required during the pandemic.

In relation to the workforce, many respondents explained how vital non-registered healthcare workers were in enabling millions of COVID-19 vaccine doses to be delivered during the pandemic following adequate training. These respondents suggested that, with appropriate training, this competent cohort of staff would be able to support vaccinations for school-age children and older adults under the clinical supervision of registered healthcare professionals, ensuring the UK has the workforce capacity needed to deliver these programmes.

Across responses from organisations, there was broad support, conditional on the basis that a VGD is utilised for nationally commissioned vaccination programmes and the development of the VGD is undertaken at a national level by each nation’s health protection agency. Several organisations welcomed the ability within the provision to make local decisions around the use of an extended workforce, particularly in supporting the use of registrant-only service delivery via PGDs where the use of a VGD is not felt to be warranted.

Highlighting similar concerns to those flagged in the previous question, several respondents raised concerns about the competency of the non-registered healthcare workforce, suggesting that using non-registrants dilutes the quality of care received by an individual during a vaccination. Even those who were supportive were clear that the legislation needs to be underpinned by clear governance, competency frameworks and robust training to protect patient safety and maintain clinical standards. Some respondents also flagged that training needs to cover the move to VGDs and how these relate to existing provision via PGDs and national protocols. They felt this would help prevent confusion and avoid scenarios where workforce groups continue practices permitted under previous protocols, creating clinical governance gaps.

VGDs will permit registered healthcare professionals (listed in schedule 16 of the HMRs) to clinically assess, obtain informed consent and administer vaccinations to individuals without the need for them to be prescribed. VGDs will allow some tasks within the vaccination process, such as vaccine preparation, administration and record keeping, to be delegated to suitably trained registered and non-registered healthcare workers. Each VGD will specifically state which tasks can be delegated and to whom and this may vary between VGDs for different vaccination programmes.

UKHSA, as the organisation producing VGDs in England, will ensure VGDs clearly define who can undertake different aspects of the vaccination activity. VGDs will be developed using robust mechanisms adapted from the existing processes for publishing national vaccination PGD templates, overseen by their Medicines Governance Committee. We expect organisational authorisation to follow the same processes as for PGDs, with the commissioner being responsible for this. Providers will need to ensure that practitioner authorisation occurs before the staff member undertakes vaccination activity as part of service delivery, which will follow a similar process to PGDs.

In England, the NHS Specialist Pharmacy Service (SPS) will issue guidance on VGDs as they do for PGDs. This will include clarity on the circumstances in which delegation of certain aspects of vaccination activity can occur.

In Scotland, governance around the use of VGDs would sit with the Scottish Vaccination and Immunisation Programme, which includes representation from NHS Education for Scotland colleagues. NHS Education for Scotland provides national, quality assured education materials which boards then use as part of their own local training methodology. Alongside working to national minimum standards and with proficiency assessment, healthcare support workers will continue to work under supervision of a registrant at all times. Scotland anticipates that specialist clinical colleagues will agree a framework for considering whether a VGD should be produced, before one is taken to the clinical governance group that would approve this approach. Boards would progress the use of any VGD through their own clinical and educational governance requirements.

In Wales, the authoring and evaluation of VGDs will continue to be led by NHS professionals using effective governance mechanisms that have safely enabled delivery of national vaccination programmes under PGDs and national protocols.

In Northern Ireland, development of regional VGDs will continue to be led by the Department of Health’s Strategic Planning and Performance Group and the Public Health Agency, utilising the robust governance mechanisms already in place for PGDs and national protocols.

A specific concern was raised by a few respondents who disagreed with the proposal and questioned the capability of non-registered workers to manage potential adverse events that might occur following vaccinations. It should be noted, however, that some of those who responded in support of this workforce highlighted that this issue was not unique to the vaccination system and that non-registered workers had experience of responding to allergic reactions in other circumstances, citing the ambulance service as an example where this has been conducted effectively.

To provide reassurance, all staff operating a VGD will be required to undergo suitable training in line with UKHSA’s minimum standards and core curriculum for immunisation training and to demonstrate competency against these standards. Currently, online training packages are provided by the UKHSA. New vaccinators are also required to 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. This training includes how to deal with possible adverse reactions to a vaccine. Training is not a one-off event and after initial training, individuals are required to maintain their competence through regular updates at least annually and more frequently if changes to programmes occur.

Vaccines are prescription only medicines (POMs) and consent to receive these has to be obtained by specified registered healthcare professionals. This includes explaining the possible risks and benefits involved with having the vaccination. It will remain the responsibility of the registered healthcare professional operating under the VGD to ensure they have gained informed consent before vaccine administration is delegated. While it is outside the scope of healthcare support workers and other non-registrants to seek informed consent to receive a vaccine, they should seek agreement to administer a vaccine for which informed consent has been gained by a specified registered healthcare professional.

In relation to public health, many respondents commented on the importance of providing the flexibility for the capacity of the vaccinator workforce to increase in response to patient demand. Some respondents emphasised how this provision would improve the resilience of the health system as well as enable the health system to deliver more consistent access to vaccines and uptake across demographic groups. Several respondents based in Scotland emphasised how their delivery models would be severely impacted if R247A lapses without a new permanent replacement, leading to significant financial and operational challenges in delivering ongoing vaccination programmes.

Case study: utilisation of the extended workforce in Scotland

In Scotland, following the introduction of R247A, most NHS boards utilised non-registrants to support the rollout of the COVID-19 vaccination (and in parallel influenza) programme in mass vaccination, high throughput clinic settings. This approach, influenced by the Scottish Vaccine Transformation Programme, has supported the delivery of a timely, sustainable, cost-effective, patient-centric and safe vaccination service across the board. This is an important component in ensuring Scotland has a confident and competent workforce who are operating at the top of their licence. This supports delivery of an important outcome of Scotland’s 5-year Vaccination and Immunisation Framework and Delivery Plan, which is to:

Ensure greater flexibility in delivery mechanisms in a joined-up way by integrated teams, working across the system and organisations, to improve patient experience, deliver value for money, and safeguard long-term financial sustainability.

A few respondents queried the need for expanding these provisions beyond COVID-19 and influenza vaccination programmes. We have seen the benefits of enabling the safe delivery of vaccinations using qualified, assessed and supervised non-registered healthcare workers to facilitate more efficient use of the healthcare workforce. Expanding the provisions means that the non-registered workforce, employed as vaccinators, could work year-round (under appropriate supervision), rather than just supporting on seasonal programmes. This will strengthen the workforce capacity as well as freeing up valuable clinical resource and time for service improvements and other clinical priorities. Public health agencies in all 4 nations will identify which programmes are appropriate for a VGD to be in place.

Some respondents asked for clarity on the difference between a patient group direction (PGD) and a vaccine group direction (VGD). The primary difference between VGDs and PGDs is that a VGD allows for the separation of the decision to treat by a registered healthcare professional and to provide information and to seek consent to that treatment, from the administration of the vaccine which can be done by a separate individual including non-registered healthcare workers. This is not permissible under a PGD. Separating these tasks in the vaccination process has significant benefits in terms of increasing workforce capacity and efficiency.

Following one specific response, we would also like to make a correction to a statement made in the consultation document where we said:

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 […] is authorised to administer vaccines either under the VDG or under a separate PGD.

This should read: “who […] is authorised to administer vaccines under the VGD”, as the registered healthcare professional is only able to delegate tasks under a VGD. When administering or supplying a medicine under a PGD, the authorised registered healthcare professional working under the PGD must undertake all parts of the PGD process - no part can be delegated to another person whether or not they are a registered healthcare professional.

It was incorrect to mention PGDs in this context. There was also a spelling error in the use of the acronym VGD, and we apologise for any confusion caused by these errors.

Question

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)?

Of the 217 responses to this question:

• 107 respondents (49%) agreed
• 69 respondents (32%) disagreed
• 33 respondents (15%) neither agreed nor disagreed
• 8 respondents (4%) didn’t know

Where respondents agreed that an age condition was needed, there was no consensus on the age for this condition, with different suggestions to exclude babies, infants, under 16 year olds or under 18 year olds from VGDs. Some respondents also suggested that the use of conditions should be widened out to other groups, such as pregnant women and those with certain disabilities.

The rationale from respondents who provided further information in support of an age condition was largely linked to concerns around the complexity of infant and school-age programmes. Respondents spoke of vaccinating infants and young children as requiring specialist clinical knowledge, consent processes and the ability to manage complex needs. Nearly a quarter of respondents providing further information also flagged an age condition being important for maintaining public confidence in immunisation programmes.

Nearly half of all respondents who provided a comment to this question gave a suggestion for how to include an age condition in the legislation, which we have carefully considered. These suggestions varied from applying the VGD to all ages if the workforce is adequately trained and robust safeguards and governance are in place, to specifying the age condition to be in line with the licencing of the vaccine.

Where respondents disagreed that an age condition should be included, those who provided rationale outlined that they believed it was unnecessary and would introduce avoidable complexity. Alternative suggestions were provided including to build appropriate safeguards into the regulation through requiring a national expert body to draft the VGD. It was believed that competence and suitability should be determined by training, assessment and professional standards rather than through an age threshold.

Some respondents flagged that non-registered staff already undertake procedures of comparable complexity, such as taking bloods from infants and children, and can be trained to administer vaccines safely under appropriate governance arrangements. Furthermore, it was suggested that imposing an age condition could risk creating operational barriers, reducing flexibility and undermining efforts to address declining childhood vaccination rates. It was also suggested that it could stifle workforce development and innovation and impede the health system’s ability to rapidly respond to future public health emergencies.

Given the consultation responses, considered alongside the strong agreement to introduce the VGD with a scope to cover any vaccine against an infectious disease caused by a virus or bacteria, we have concluded that the most appropriate permanent solution is for an age condition not to be included in the permanent provision. Instead, where clinically necessary, specific VGDs should include age conditions on a vaccine-by-vaccine basis as agreed by the public health agency producing the VGD, reflecting on the different risks associated with different vaccination programmes. This solution, while not explicitly stating an age condition, will safeguard against any inappropriate use of an extended workforce across the infant and childhood vaccination programmes.

Our conclusion reflects the strong position put forward by a high proportion of respondents, particularly responses on behalf of organisations, and ensures that the new legal provision replacing R247A is agile to respond to future vaccine scenarios. This will increase flexibility and capacity in the system to be able to rapidly respond to potential future epidemics or pandemics which could require vaccinations across all age cohorts or target specific age cohorts. Introducing an age condition in legislation could potentially limit deployment of a future vaccination programme at the potential scale and pace needed, risking public health. As mentioned above, safeguards will be in place in terms of the responsible parties for drafting and approving VGDs, and in the requirement for robust competency assessments, safeguarding training and supervision requirements to further protect the clinical safety of everyone being vaccinated by the extended workforce.

Based on the consultation responses received regarding R247A, we intend to allow R247A to lapse on 1 April 2026 and introduce a new permanent legal mechanism, regulation 235A. This will support the use of an extended workforce to administer any vaccine against an infectious disease caused by a virus or bacteria as directed by a national body developing the VGD and will not include an age condition. This will ensure the UK has the necessary agile and flexible workforce to deliver a wider range of vaccination programmes, including potentially in the event of a future potential public health emergency requiring rapid vaccine deployment.

Amendments to regulation 233 and regulation 3

R233 enables persons lawfully conducting a retail pharmacy business to deliver COVID-19 and influenza vaccination services off the registered premises under a PGD. The consultation proposed to expand R233 to include any vaccine against an infectious disease caused by a virus or bacteria to enable community pharmacies to provide wider outreach vaccination services. This is in line with the shift from hospital to community as described in the 10 Year Health Plan for England.

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 manufacturer’s licence. The consultation proposed allowing R3A (1) and (2) to lapse on 1 April 2026 which would mean that pharmacists would no longer be able to prepare or assemble COVID-19 vaccines away from the registered retail pharmacy or hospital premises. To address this, the consultation proposed making a provision in regulation 3 to enable pharmacists and pharmacy technicians to prepare or assemble medicines for a patient in the course of the patient’s treatment without needing a manufacturer’s licence, subject to the same conditions placed on doctors, dentists, nurses and midwives.

We would note that the consultation was in error in suggesting that pharmacy technicians were able to utilise the exemption in R3A (1). R3A (1) did not permit pharmacy technicians to carry out acts of preparation or assembly, where they were not otherwise able to perform those acts in the course of other authorisations. We will not, therefore, be including a new derogation for pharmacy technicians in regulation 3.

Question

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

Of the 217 responses to this question:

• 147 respondents (68%) agreed
• 37 respondents (17%) disagreed
• 22 respondents (10%) neither agreed nor disagreed
• 11 respondents (5%) didn’t know

Many respondents provided comments highlighting how R233 improves vaccine access and uptake for COVID-19 and influenza vaccines and that expanding the provisions to any vaccine against an infectious disease caused by a virus or bacteria will have similar positive impacts. We received many comments explaining the importance of enabling targeted outreach for vaccination delivery for different communities.

A response sent on behalf of an organisation operating in Wales highlighted the positive impacts for rural communities:

Expanded use of community pharmacy delivery during the pandemic was invaluable in increasing vaccination uptake across rural communities such as [Welsh county]. Provided robust governance and competency frameworks remain in place, extending these provisions to all vaccine-preventable diseases and making these flexibilities permanent would enhance equity of access, increase workforce efficiency and support future preparedness ensuring we retain the agility developed during the pandemic, thus enabling rapid mobilisation of vaccine programmes for any future infectious disease threats.

An organisation operating across the UK highlighted the potential benefits in reducing health inequalities:

We strongly support this proposal which we believe is essential for effective outreach to improve vaccination rates for routine programmes across the life course, as well as COVID-19 and flu. The proposal is fully aligned with the 10 Year Health Plan’s shift to community care. Analysis suggests that community-based access points may help reduce inequalities in adult vaccination uptake, with more flexible delivery models potentially supporting higher participation among groups currently less likely to attend traditional GP-led services.

There were further positive comments from many respondents, highlighting how this provision will increase flexibility and efficiency in the vaccination system. Several respondents noted how this amendment would improve patient choice, in line with ambitions in England’s 10 Year Health Plan, through providing more options of locations to get vaccination as a result of targeted outreach for a wider range of vaccines as enabled by this amendment. These respondents also explained how this amendment will have public health benefits in improving the system’s ability to respond to emerging need. As an example, local providers would be able to deploy pop-up vaccination services to rapidly tackle local outbreaks of infection. Some respondents emphasised how expanding to any vaccine against an infectious disease caused by a virus or bacteria will help future-proof this legislation. 

Several respondents raised concerns relating to governance and assurance in community pharmacies, suggesting that practice was unregulated. The General Pharmaceutical Council in England, Wales and Scotland and the Pharmaceutical Society of Northern Ireland have responsibility for ensuring that the health, safety and wellbeing of users of pharmacy services is maintained through appropriate safeguards. We would also like to reassure respondents that as community pharmacies are already able to deliver COVID-19 and influenza vaccinations off-site, there are existing robust governance processes in place to mitigate any risks. We expect extending this provision to other vaccination programmes to increase vaccine access for patients who are unable to access traditional vaccination services. In addition, where a pharmacy vaccination service has been commissioned, the commissioner of the pharmacy vaccination service has responsibility for ensuring vaccination sites, including those away from registered premises, are appropriate.

Additionally, these respondents highlighted that they were concerned about the accurate recording of vaccinations as a result of incompatible information management systems between different healthcare providers. Specific concerns included the potential to vaccinate individuals who are not eligible for a vaccination and the increased risk of individuals being offered, and taking up the offer of, the same vaccine dose multiple times.

Pharmacy contractors should only vaccinate patients that are eligible to receive the vaccination, by their inclusion in agreed national policy that has been announced and authorised by the commissioner. It is essential that all pharmacies providing vaccination services adhere to the service specification, PGDs, national standards and professional guidance to maintain patient safety and to ensure that the vaccine campaign is as effective as possible. PGDs include information related to the number of doses of the vaccine required, and vaccinators must follow the PGD to ensure patients only receive doses of a vaccine where this is clinically indicated. Community pharmacies can access patient records to support delivery of clinical services, including vaccinations and these systems will be available securely when delivering services away from the registered premises. This will minimise the risks of double vaccination occurring in off-site vaccination services.

Several respondents highlighted the excellent work delivered by access and inequalities outreach teams and mobile vaccination services. These respondents expressed concern that enabling community pharmacies to deliver targeted outreach would mean the end for existing outreach teams and mobile services. Enabling community pharmacies to be potentially contracted and commissioned to deliver targeted outreach services would result in equity with other healthcare providers who are already able to take part in these services. It does not necessarily mean that it would bring about the end for existing outreach teams and mobile services. However, it would broaden the competition for these services if they would be competitively procured. Moreover, some of the existing targeted outreach services for COVID-19 vaccination might be already provided by community pharmacies.

In Northern Ireland, community pharmacies have utilised the skills of suitably trained non-registered pharmacy staff to support the delivery of the COVID-19 and influenza seasonal vaccination programmes using the provisions in R247A. 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 by enabling the use of Public Health Agency (PHA) seasonal vaccinators to support the seasonal vaccination programmes.

Question

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?

Of the 217 responses to this question:

• 132 respondents (61%) agreed
• 36 respondents (17%) disagreed
• 30 respondents (14%) neither agreed nor disagreed
• 19 respondents (9%) didn’t know

A number of respondents who agreed with the proposal highlighted that this agreement was conditional on suitable training and/or supervision being provided to pharmacists and pharmacy technicians or on suitable governance arrangements being in place. We would like to emphasise that pharmacists included in the exemption in regulation 3 would be subject to the same conditions placed on doctors, dentists, nurses and midwives who are all able to prepare or assemble medicines for patients without a manufacturer’s licence. Multiple health organisations provided comments in their response addressing these concerns.

NHS England told us:

[This proposal] will offer parity between pharmacists and other healthcare professionals who already have access to such a provision. Pharmacy professionals are adept at handling medicines, including preparation and assembly, through advanced training in this area.

UKHSA told us:

R233 offers potential benefits however, its implementation must be underpinned by strong governance, training, and infrastructure investment to protect patient safety and maintain confidence in vaccination programmes. […] Before expanding invitations to community pharmacy sectors, commissioners must ensure robust education standards and competency frameworks for all mobilised staff. Without these safeguards, patient safety and programme integrity could be compromised.

Some respondents raised concerns about the competency and training of pharmacists to be able to prepare and assemble medicines for patients, with specific concerns raised on their ability to deal with adverse reactions and anaphylaxis.

Having delivered COVID-19 and influenza vaccinations, some pharmacists may already have suitable and sufficient training to understand vaccine administration, its risks and its benefits, and which patients should be included under a COVID-19 or influenza vaccine PGD or national protocol. This is additional training that pharmacists will have undertaken to expand their scope of practice to allow them to vaccinate against COVID-19 and influenza, from which some of the learning may be transferable to support the delivery of other programmes.

Further programme specific training is required for any additional vaccines they may be required to administer. Service specifications require that all pharmacy contractors delivering NHS vaccination services ensure that vaccinators have undertaken appropriate training. This training must be in line with UKHSA’s National minimum standards and core curriculum for immunisation training guidance and should be reviewed periodically and should include competency assessment to demonstrate compliance with those standards. These standards state that the commissioners, providers and trainers must ensure all those involved in vaccination have high-quality training that, as appropriate to their role and responsibilities, facilitates them, or helps them to support colleagues to “demonstrate competence in recognition and management of anaphylaxis and basic life support” and “demonstrate an understanding of appropriate management of adverse reactions”.

The proposed amendment does not change the training expectations of these staff as these are consistent irrespective of the location of service delivery. Vaccinators must be able to give evidence of immunisation training in line with the minimum standards and core curriculum, including anaphylaxis and basic life support training within the last 12 months. Where vaccinators are expected to recognise and treat anaphylaxis, they must have immediate access to an anaphylaxis pack that includes adrenaline. When dealing with adverse reactions, pharmacists and pharmacy technicians should follow the above and on guidance provided by the Resuscitation Council UK as would be expected of any healthcare professional operating under a PGD. Further guidance on the management of adverse events following immunisation is contained in the Green Book.

Some respondents asked for clarity on the role of pharmacists in preparing or assembling vaccines under the provisions in R233. We do not normally expect pharmacists to be carrying out any assembly at the point of vaccination when delivering services. In some circumstances, they may undertake certain relevant tasks, such as reformulating the vaccine through the addition of diluent. Their principal handling would be drawing up one dose from a multi-dose vial, and they will not be permitted to repackage vaccines into smaller units.

An organisation operating in Scotland who agreed with the proposal told us:

This seems like an essential and forward-thinking amendment given the increasing cohort of prescribing pharmacists across the Community Pharmacy network. This also allows for the clinical role of the Pharmacist to continue to develop as it has done over the recent past without undue legislative barriers.

Based on the consultation responses received regarding regulation 233, we intend to expand R233 to cover any vaccine against an infectious disease caused by a virus or bacteria to enable community pharmacies to provide wider outreach services and support a wider range of national vaccination programmes. Based on the consultation responses received regarding regulation 3, we intend to amend regulation 3 to include pharmacists so they can continue to assemble and prepare vaccines when delivering off-site services, subject to the same conditions placed on doctors, dentists, nurses and midwives. These 2 amendments will support delivery of the 10 Year Health Plan commitment to “give community pharmacy a bigger role in prevention by expanding their role in vaccine delivery”.

Amendments to schedule 17

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

The consultation proposed to 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. This will expand the workforce who are able to deliver vaccinations or immunisations under an OHS and will provide a clear and consistent approach of who can safely administer vaccinations under an OHS, reducing confusion among staff. The consultation also proposed to expand the provisions in S17 to private OHS providers which will increase potential workforce capacity, as private OHS providers are currently limited to vaccine administration by registered nurses. This will enable private OHS providers to deliver large-scale vaccination programmes like the seasonal influenza programme. The consultation also proposed to expand the provision under S17 to cover all vaccinations or immunisations falling under an OHS, which will help support vaccine uptake and ensure healthcare staff are adequately protected in the vital roles they do.

Across all 3 questions, respondents raised concerns about the complexities of delivering occupational health vaccinations. 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 should be in line with UKHSA’s ‘National minimum standards and core curriculum for immunisation training’ as for any other vaccinator. 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.

While the proposed provisions under S17 would enable public and private OHS providers to use an extended workforce as occupational health vaccinators, it would be up to each organisation to determine how they would like to use the provisions. Organisations may choose to use the flexibilities in the vaccinator workforce for large-scale seasonal vaccination programmes which require increased workforce capacity for administration. Organisations may also choose to use the flexibilities to make more efficient use of a more specialised OHS workforce. As an example, this could include using midwives to offer appropriate vaccinations to pregnant employees, where they could provide clinical expertise tailored to the patient and their pregnancy. Regardless of the local determination in how S17 is utilised, organisations will be responsible for ensuring anyone acting as an occupational health vaccinator is fully trained and competent to deliver the vaccinations or immunisations in line with UKHSA’s ‘National minimum standards and core curriculum for immunisation training’. There may be additional training requirements depending on the vaccination or immunisation being delivered, for example where blood testing for immunity is required, and all required training for administration of each medicinal product must be completed.

Question

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?

Of the 217 responses to this question:

• 150 respondents (69%) agreed
• 24 respondents (11%) disagreed
• 25 respondents (12%) neither agreed nor disagreed
• 18 respondents (8%) didn’t know

There was strong support for this proposal with many respondents highlighting the necessity of this provision. Respondents commented on the importance of aligning S17 with part 4 of schedule 16 to reduce confusion over which healthcare professionals can deliver vaccinations under an OHS. Additionally, respondents highlighted how S17 has enabled their healthcare providers to use peer vaccinators and other colleagues to support administration of influenza and COVID-19 vaccinations to healthcare workers, helping to improve vaccine access and uptake and protecting them in their work.

We would like to clarify that aligning the list of healthcare professionals who can operate under S17 to fulfil the occupational health vaccinator role will result in nursing associates (in England) and operating department practitioners (ODPs) no longer being able to work as occupational health vaccinators as they are not currently included in part 4 of schedule 16 of the HMRs. There is a closed public consultation hosted by DHSC and DoH NI, awaiting a government response, which proposes enabling ODPs to supply and operate under PGDs - see Extend medicines responsibilities for allied health professions. If the government proceeds with the proposal to enable ODPs to supply and operate under PGDs, it will include an amendment to part 4 of schedule 16 of the HMRs to include ODPs. If this occurs, this amendment will enable ODPs to act as occupational health vaccinators under S17 again as the list of professionals able to use the provisions in S17 will remain updated to the list of professionals in part 4 of schedule 16.

We acknowledge concerns raised by some respondents that occupational health vaccinations are more complicated than other vaccinations as they require thorough risk assessments relating to job role, disease exposure and any existing health conditions. While the healthcare professionals listed in part 4 of schedule 16 would be able to operate under S17 to deliver vaccinations under an OHS, professionals in these roles will still need to undergo adequate training as required currently in line with UKHSA’s ‘National minimum standards and core curriculum for immunisation training’. Depending on the role being undertaken, it will be down to local determination for what training is needed and competency should be demonstrated against the required elements identified against these minimum standards using the assessment tool which accompanies this guidance. Organisations will be responsible for ensuring any occupational health vaccinator is fully trained and competent to undertake the vaccination, but this training may vary depending on the vaccination (for example, delivering a seasonal influenza campaign compared to a course of hepatitis B vaccination). Where a vaccination or immunisation may require additional tasks, such as blood testing, then all necessary additional training needed to undertake the tasks should be completed and the vaccinator will not be deemed as competent to vaccinate until they have completed all required training.

Question

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

Of the 217 responses to this question:

• 99 respondents (46%) agreed
• 49 respondents (23%) disagreed
• 47 respondents (22%) neither agreed nor disagreed
• 22 respondents (10%) didn’t know

There was moderate support for this proposal with many respondents highlighting the workforce benefits of expanding S17 to include private healthcare providers. Respondents noted that this would enable a more efficient use of the vaccinator workforce as private OHS providers play a key role in supporting vaccine delivery being commissioned by NHS organisations or local authorities to support their health and social care workers. As private OHS providers are currently limited to using registered nurses for administration of vaccines, this limits their capacity to deliver large-scale vaccination programmes like influenza.

Some respondents also commented that this proposal would have workforce benefits beyond the health and social care sectors. Private OHS providers have an important role in providing vaccinations to other sectors and enabling them to operate under S17 would facilitate more efficient delivery of services and expand national capacity to vaccinate during large-scale campaigns (like seasonal influenza or in pandemic or epidemic scenarios).

A respondent from Northern Ireland commented:

Private occupational health services contribute significantly to workforce vaccination coverage. Extending these provisions, under strict governance and competency requirements, ensures consistency of standards across sectors while supporting wider public health protection.

A public sector body operating in England who agreed with this proposal commented:

Schedule 17 6a is currently restricted to NHS and Local Authority (LA) OHS provision. The inability of private providers to operate under this exemption means that they are unable to fully utilise 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 vaccination programmes such as annual flu vaccinations as they are limited to administration by registered nurses only and may not have a large enough nursing workforce to provide these services. Allowing private OHS providers to utilise the Occupational Health Vaccinator role will support an increase in potential workforce capacity. This will increase provision both for OHS to the private sector and also to the public sector including the NHS, local authorities, emergency services and educational establishments, should this work be commissioned from a private provider.

Many respondents also provided comments explaining their concerns relating to robust governance and assurance processes in private healthcare providers delivering occupational health services, compared to public providers like NHS and local authorities. All occupational health vaccinators will be registered healthcare professionals and already considered suitable to operate under a PGD. They will all be subject to professional regulation and oversight when carrying out service delivery, including vaccinations under an OHS. OHSs themselves are not a regulated activity under the Health and Social Care Act 2008 so are not regulated by the Care Quality Commission (CQC), meaning OHS regulation is voluntary. This is true for all OHS providers whether they are public (NHS and local authority organisations) or private providers. This means that we expect the governance processes and training required to vaccinate to be similar for both public and private OHS providers and given the professional regulation and oversight for all occupational health vaccinators, we want to reassure respondents that there are robust governance and assurance processes in place.

Question

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?

Of the 217 responses to this question:

• 130 respondents (60%) agreed
• 34 respondents (16%) disagreed
• 33 respondents (15%) neither agreed nor disagreed
• 20 respondents (9%) didn’t know

Many respondents who provided comments indicated that this proposal was necessary and demonstrated general support for the expansion to all vaccinations or immunisations offered as part of an OHS.

A response sent on behalf of an organisation who agreed with this proposal told us:

A comprehensive, programme-agnostic scope reflects real-world OHS practice (e.g., hepatitis, tetanus, influenza, travel-related risks), simplifying compliance and improving workforce protection.

Several respondents highlighted that this proposal would improve access to a wider range of vaccines, consequently improving vaccine uptake. This will have public health benefits by supporting the ability of the health system to respond to need. In healthcare providers where a patient is diagnosed with an infectious disease, this would enable rapid vaccination of the healthcare workers exposed to the patient to protect them while they carry out their vital roles. A few respondents noted that this would future-proof the legislation, highlighting the need for a responsive health system able to vaccinate its workforce in the event of a future potential pandemic.

Similar themes as the other questions related to S17 were raised on governance and risk management for vaccinations and immunisations beyond COVID-19 and influenza, which we have addressed earlier in ‘Amendments to schedule 17’.

Based on the consultation responses received regarding S17, we intend to align the definition of an occupational health vaccinator in S17 with the list of professions set out in part 4 of schedule 16 (those who can supply medicines under an OHS) to provide a clear and consistent approach across the vaccination system. We also intend to expand the scope of S17 to include private OHS providers, enabling them to use the occupational health vaccinator role and providing parity with NHS and local authority OHS. We also intend to expand the provisions under S17 to all vaccinations or immunisations covered under an OHS as the occupational health vaccinator role is currently limited to administering COVID-19 and influenza vaccines. These changes will improve vaccine access and uptake for staff within and beyond the health and social care sector, protecting them in the vital roles they do.

Impact of proposals

Question

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

Of the 216 responses to this question:

• 163 respondents (75%) agreed
• 18 respondents (8%) disagreed
• 29 respondents (13%) neither agreed nor disagreed
• 6 respondents (3%) didn’t know

The majority of respondents did not believe that our proposals risk impacting people differently with reference to their protected characteristics. We have carefully considered all comments provided by respondents, including all concerns raised by respondents who disagreed with our statement.

Several comments raised concerns that replacing R247A with a permanent provision that includes an age condition may negatively impact individuals below the age threshold. As we have concluded not to include an age condition following the consultation outcome, this is no longer a risk.

Several comments noted that our proposal to expand R233 to any vaccine against an infectious disease caused by a virus or bacteria will positively impact certain groups, which are more likely to have lower vaccine access and uptake, highlighting the elderly, individuals with disabilities and individuals from ethnic minorities as protected characteristics that will benefit most from the targeted outreach.

A few comments highlighted that replacing R247A with a new permanent provision with an expanded scope to any vaccine against an infectious disease caused by a virus or bacteria may have impacts on the protected characteristics of sex, pregnancy and maternity. One respondent suggested that expanding the use of non-registered healthcare workers in vaccinations may positively impact women, as they believe these staff are primarily women, therefore disproportionately providing more career opportunities to them. Another respondent suggested this proposal may negatively impact individuals experiencing pregnancy and maternity as they believe these individuals are more likely to trust registered healthcare professionals, like midwives and health visitors, rather than non-registered healthcare workers, potentially leading to lower vaccine uptake.

Respondents did not provide any comments raising risks directly relating to R3A, R19 or S17. No comments noted risks directly relating to the proposals being consulted on in relation to the following protected characteristics:

• gender reassignment
• marriage and civil partnership
• religion
• sexual orientation

Following the consultation outcome, an update to the existing public sector equality duty impact assessment of our proposals (in the consultation document) can be found in this government response in the ‘Legal duties’ section under ‘Equality Act 2010’.

Question

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?

Of the 21 responses to this question:

• 15 respondents (71%) agreed
• 0 respondents (0%) disagreed
• 6 respondents (22%) neither agreed nor disagreed or didn’t know

The majority of respondents did not believe the proposals risk impacting people differently with reference where they live geographically in Northern Ireland. Some respondents to this question provided comments which highlighted that the proposals in this consultation will improve vaccine access and uptake across Northern Ireland. Respondents noted that the proposals will strengthen system-wide vaccination capacity, benefitting communities across Northern Ireland. Comments provided emphasised that enabling greater distribution flexibility and off-site vaccinations by community pharmacies will support access to vaccines for all geographic areas. These respondents also noted that these proposals could potentially reduce health inequalities across regions in Northern Ireland and between different demographic groups.

Conclusion and next steps

Given the overall broad level of support expressed in the responses to this consultation, the government is proceeding with the proposed permanent amendments to:

• regulation 3A
• regulation 19
• regulation 233 (8) and regulation 3
• schedule 17

We will proceed with the proposal to replace regulation 247A with a new permanent provision, regulation 235A, but following this consultation outcome, this will not include an age condition.

Regulations 3A, 19 and 233 (8) will be expanded in scope to any vaccine against an infectious disease caused by a virus or bacteria. The new regulation 235A will also apply to any vaccine against an infectious disease caused by a virus or bacteria.

Schedule 17 will be expanded in scope to vaccinations or immunisations under an OHS.

We will be laying legislation under the affirmative procedure to make these amendments in due course. This must be actively approved by both Houses of Parliament before it comes into effect.

These amendments will support the ongoing development of a vaccination system that is fit for the future. Building on the successes of large-scale vaccination programmes during the COVID-19 pandemic, this legislation will support patient safety, improve access and availability of vaccines, and improve the UK’s position on the world stage for vaccine innovation. These changes will enable the health service to implement improvements which will facilitate the shift from sickness to prevention as described in England’s 10 Year Health Plan. Commitments in the 10 Year Health Plan also include restoring trust in vaccinations, harnessing technological advances and ultimately increasing vaccine uptake.

Amendments to regulations 233 (8) and 3 will enable community pharmacies to play a bigger role in prevention, as described in the 10 Year Health Plan, through expanding their role in vaccine delivery and enabling targeted outreach to support reducing health inequalities, where evidence indicates this is clinically appropriate and value for resource.

These amendments will enable delivery of commitments to strengthen the vaccination system across all 4 nations of the UK through:

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

The NHS England vaccination strategy outlines the future approach to the deployment of vaccination services in England, building on the learning from COVID-19 and other programmes, and giving integrated care boards increased responsibility to design local delivery networks that are:

• high-quality
• convenient to access and tailored to the needs of local people
• supplemented by targeted outreach to increase uptake in 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 any infectious disease caused by a virus or bacteria

For Scotland’s 5 Year Vaccination and Immunisation Framework and Delivery Plan, the new permanent provision replacing R247A will support delivery of an essential outcome to ensure greater flexibility in delivery mechanisms in a joined-up way by integrated teams. This provision would enable their non-registrant workforce to be redeployed to other vaccination programmes outside of seasonal influenza and COVID-19, subject to the availability of VGDs from Public Health Scotland, instead of being redeployed to other services.

The National immunisation framework for Wales set out the Welsh vision for the future of immunisation: “high uptake of a sustainably delivered, effective vaccine, at the right time, to reduce mortality and morbidity”. These amendments support activities outlined in the Welsh national immunisation framework as well as supporting future development of vaccination approaches that support health boards, increase vaccination outreach and preserve NHS staff capacity. In practice in Wales, the provisions will work alongside local guidance and ongoing training with practical assessments to ensure vaccine safety remains of the utmost importance.

In Northern Ireland, these provisions will provide a robust legislative framework for the delivery of routine vaccination programmes as well as operational advantages in response to an emergency or pandemic situation. The new permanent provisions replacing R247A will enable community pharmacies to continue to utilise the skills of suitably trained non-registered staff such as pharmacy technicians to support vaccine delivery under VGDs. Community pharmacies play an important role in the delivery of seasonal influenza and COVID-19 vaccination to care home residents, and the amended R233 will support the continued development of vaccination services delivered outside of the pharmacy premises and closer to patients. 

Working with system partners and other experts, consideration will be given to the key themes to emerge from this consultation, including the need to keep these regulations under review in light of any contextual changes.

The government welcomes the participation of all individuals and organisations who contributed to this consultation. All responses were considered in the development of policy and this government response.

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

As set out in the consultation document, 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 from treatment of disease to prevention. Vaccines are a critical part of this.

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

• regulating the movement and preparation of vaccinations in defined circumstances
• regulating the use of a trained and flexible workforce for vaccine administration
• widening the scope of vaccines which community pharmacies are able to deliver off-site

This will help promote access to vaccinations for all those who are eligible, including those with protected characteristics. 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 protect a greater number of people from a greater number of diseases.

Evidence and analysis of impacts

We have carefully considered all responses to the consultation questions asking for views on the impact these proposals will have.

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?

The majority of respondents (75% of the 216 who answered the question on protected characteristics) agreed with the statement that the proposals do not risk impacting people differently with reference to their protected characteristics.

Of the 21 respondents who answered the question on the impact geographically in Northern Ireland, 71% agreed that the proposals did not risk impacting people differently with reference to where they live geographically in Northern Ireland.

Where respondents provided comments, these have been analysed and summarised below in relation to the Equality Act 2010.

Eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the act

As set out previously, the intent of these proposals is to eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the act, by helping promote access to vaccinations to all and by using the skills of the vaccination workforce to ensure vaccines can be administered safely and effectively.

The responses received to the consultation support this position, with many citing the positive impact these proposals will have on facilitating better access to vaccinations and supporting outreach, which should benefit harder to reach communities and help to reduce health inequalities. There were also comments provided on how both the increase in accessibility and the size of the vaccination workforce will have a positive impact on a number of protected characteristics, particularly age, pregnancy and religion.

Despite a largely positive response, a concern was raised by a small number of respondents that a fragmentation of vaccination services could occur which risked impacting different populations who might find accessing their general practice easier such as the elderly, those with disabilities, or certain ethnic minorities. Attitudinal surveys also indicate that some ethnic minority populations prefer to attend GP services. As part of this assessment, we would like to reassure respondents that general practice will still continue to play an important role in delivering vaccinations, and the proposals set out in this consultation are part of a mixed model of delivery that aims to maintain important safety measures, while increasing access to vaccines and effectiveness within the system.

Advance equality of opportunity between people who share a protected characteristic and those who do not

The intent of these proposals is also to advance equality of opportunity between people who share a protected characteristic and those who do not by supporting vaccine uptake for everyone.

The responses received throughout the consultation support this statement, with many citing how the proposals will help to support access and improve uptake for all. Within the question that specifically asked about the impact on protected characteristics, respondents similarly talked about the positive impact on access, and also commented on how increasing efficiency, and widening the workforce and supply routes may help reduce barriers further and support more equitable uptake.

There were however a few concerns raised around pregnancy, and the potential impact on uptake which the proposed amendments to R247A could have. There was comment for example, on how pregnant women may be less inclined to take up vaccinations that are administered by non-registered healthcare professionals because they do not have the same level of expertise or trust in them. Attitudinal survey evidence also supports this, with much of the population indicating that the most trusted sources are registered healthcare professionals.

To mitigate this risk, all vaccinators operating under a VGD must undergo comprehensive training in line with UKHSA’s minimum standards and core curriculum for immunisation training to demonstrate competency against these standards. New vaccinators are also required to 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. This training includes how to deal with possible adverse reactions to a vaccine. Training is not a one-off event and after initial training, individuals are required to maintain their competence through regular updates at least annually and more frequently if changes to vaccination programmes occur. It is also important to note, and as many respondents set out in their returns, that non-registered healthcare workers have already played a pivotal role in safely delivering millions of COVID-19 vaccinations and are already a strong and very capable workforce.

Foster good relations between people who share a protected characteristic and those who do not

The intent of these proposals is also to 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.

Again, many of the responses received to the consultation support this statement. By removing barriers in access to help support increased vaccine uptake among underserved populations, respondents set out how the proposals do not restrict access or create barriers for groups with protected characteristics, and in many cases may enhance access, particularly where expanded workforce or outreach models reduce inequalities.

While there was general support across the proposals, there were some concerns raised around the impact of the proposals under R247A in relation to the protected characteristic of age. This was in relation to the question which asked: “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?”. Some respondents raised that the proposals to include a lower age limit could negatively impact and limit the equitable access to safe, timely and effective interventions. This would be of particular concern in the event of an outbreak, or a potential future epidemic or pandemic where large numbers of the population, of all ages, require vaccination at pace, potentially resulting in a delay in offering clinical services to these individuals.

Given the consultation responses, we have concluded the most appropriate solution is that an age condition should not be included in the permanent provision. Where clinically necessary, specific VGDs will include age conditions on a vaccine-by-vaccine basis as agreed by the clinical experts drafting the VGD, reflecting the different risks associated with each vaccination programme. Therefore, the risk of excluding those within certain age cohorts will be mitigated against by the VGD itself providing information on the appropriate use at all age groups as circumstances demand. While we are not explicitly stating an age condition in the legislation, the governance processes around VGDs will safeguard against any inappropriate use of an extended workforce across all age groups. This position reflects the strong position put forward by a high proportion of respondents, particularly responses on behalf of organisations. This approach also ensures that the new legal provision replacing R247A is agile for any future vaccine scenario, while ensuring appropriate safeguards are in place.

Northern Ireland

In Northern Ireland, section 75 of the Northern Ireland Act 1998 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 or negative impacts on individuals with these protected characteristics, and the responses received to this consultation supports this. Of the 21 respondents who answered the question on the impact geographically in Northern Ireland, 71% agreed that the proposals did not risk impacting people differently with reference to where they live geographically in Northern Ireland. Where people provided comments, they were supportive, with each citing how the proposals will help to improve access and may help reduce geographical disparities by supporting flexibility and outreach services.

Assessment on each of the protected characteristics

As well as the above analysis, following a thorough review of responses received, an assessment of the impact on each of the protected characteristics is set out below:

• disability (attitudinal, physical and social barriers for both visible and hidden disability) - we do not consider that our proposals risk impacting different people adversely with reference to their disability. Improved access and outreach opportunities could have a positive impact on those who share this protected characteristic
• sex (men and women) - we do not consider that our proposals risk impacting different people adversely with reference to their sex
• sexual orientation (heterosexual, homosexual or bisexual) - we do not consider that our proposals risk impacting different people adversely with reference to their sexual orientation
• race (ethnic groups, nationalities, Gypsy, Roma, Travellers, language barriers) - we do not consider that our proposals risk impacting different people adversely with reference to their race. Improved outreach opportunities could have a positive impact by increasing access to vaccinations for those who share this protected characteristic
• age (age ranges, old and young) - we do not consider that our proposals risk impacting different people adversely with reference to their age. Improved access has the potential to benefit all. Age is often one of the key indicators for illness and morbidity from disease so increasing access to vaccinations could have a positive impact on those who share this protected characteristic
• gender reassignment (transgender and transsexual people) - we do not consider that our proposals risk impacting different people adversely with reference to their gender reassignment
• religion or belief (people with different religions, beliefs or no belief) - we do not consider that our proposals risk impacting different people adversely with reference to their religion or belief
• pregnancy and maternity (working arrangements, part time working, infant caring responsibilities) - we do not consider that our proposals risk impacting different people adversely with reference to their pregnancy and maternity other than that previously addressed
• marriage and civil partnership (married couples, civil partnerships) - we do not consider that our proposals risk impacting different people adversely with reference to their marriage or civil partnership status

Conclusion

The government is committed to continuing to work with the NHS to effectively improve access to vaccines as a means of protecting at-risk individuals and reducing inequalities in health outcomes, which data shows can be linked to certain protected characteristics. By supporting continued flexibility and collaboration across the system, and ensuring the provision of an extended workforce, the proposals in this consultation seek to facilitate the delivery of vaccinations with the aim of reducing barriers to access and improving uptake among at-risk individuals.

The analysis of the consultation responses support this, with between 71% to 75% agreement and many responses citing how improving access will help to reduce health inequalities and have a positive impact on those who share protected characteristics. Where concerns have been raised, these have been considered and the mitigations and clarifications set out above to ensure that those with protected characteristics are not negatively impacted. Enabling the use of drugs or medicines used for vaccinating or immunising people against disease is of great benefit to UK patients and the NHS. Many of these diseases will disproportionately impact negatively on people with protected characteristics, therefore maintaining a regulatory framework that safely and efficiently supports vaccination programmes is of particular benefit to these groups.

National Health Service Act 2006

The National Health Service Act 2006 also places 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. The proposed amendments were assessed in line with the following duties in the consultation document (on the amending regulations to support the supply and deployment of vaccines page), where more detail can found in the ‘Legal duties’ section. These assessments are summarised below.

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, help improve access and increase the effectiveness across the health system (including in the vaccination workforce and supply chains), while maintaining important safety measures.

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 services 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 learned some important lessons about how the regulatory framework can help improve the quality of healthcare 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.

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. 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 vaccination 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 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 or risk impacting people differently with reference where they live geographically in Northern Ireland.

Conclusion

Following the consultation outcome, we have concluded that the changes that will be brought into force in due course by legislation are in line with the proposals that were consulted on, with regard to the duties under the National Health Service Act 2006. Therefore, we have not provided any updates to the assessments found in the consultation document, as we have concluded these are comprehensive.