Consultation outcome

Amendments to the Human Medicines Regulations 2012 to support the ongoing delivery of COVID-19 and influenza vaccination: consultation response

Updated 30 October 2023

Introduction

As part of the response to the COVID-19 pandemic, a number of regulations were put in place to enable COVID-19 and influenza vaccines to be safely deployed at speed and scale, and to ensure that there is sufficient workforce to administer the vaccines. These regulations were made by making amendments to the Human Medicines Regulations 2012 (HMRs) through the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020. 

Two of the regulations that were put in place at the start of the pandemic - regulation 3A (R3A) and regulation 19 (R19) - are due to lapse on 1 April 2024, while regulation 247A (R247A) is only permitted for use during a pandemic. As such, there is a need to consider whether these regulations should be amended in order to maintain the existing provisions.

Between 7 August and 18 September 2023, the government hosted a public consultation on proposed amendments to R3A, R19 and R247A of the HMRs. This document summarises the responses to that consultation and sets out the government’s response to the issues raised.

The 3 regulations (R3A, R19 and R247A) under consultation relate to:

• enabling trained healthcare professionals or staff under the supervision of healthcare professionals to conduct the final stage of assembly, preparation and labelling of COVID-19 vaccines without additional marketing authorisations or manufacturer’s licences being required (R3A)
• allowing COVID-19 and influenza vaccines to be moved between premises 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 wholesale dealer’s licences (R19)
• enabling the use of an extended workforce who are legally and safely able to administer a COVID-19 or influenza vaccine without the input of a prescriber, using an approved protocol (R247A)

All 3 amendments have brought significant benefits:

• R3A has allowed the labelling of COVID-19 vaccines with a new shelf life after thawing, and allowed delegated preparation or reconstitution by the addition of the recommended diluent, without the need for a manufacturer’s licence or marketing authorisations
• R19 has enabled safe and appropriate vaccine movement between vaccination providers without the need for a wholesale dealer’s licence. This has supported the delivery of the NHS COVID-19 and influenza vaccination programmes, and put provision in places where vaccinations could be best used and/or had the greatest need
• R247A provided the mechanism that expanded the workforce who are legally and safely able to administer a COVID-19 or influenza vaccine without the input of a prescriber, using an approved protocol. Through the introduction of a new type of national protocol, R247A allowed non-registered healthcare workers and those who are registered healthcare professionals who cannot ordinarily administer medicines or vaccines without the input of a prescriber to safely administer a COVID-19 or influenza vaccine

R3A and R19 have sunset provisions, which mean they will be repealed on 1 April 2024 unless extended, while R247A is only permitted for use during a pandemic. The consultation therefore proposed to temporarily extend these regulations until 1 April 2026 while a permanent solution is developed. For R247A, this involves removing condition A from the regulation, which requires there to be a pandemic in order for medicinal products used for vaccination or immunisation against COVID-19 or influenza to be administered under a national protocol.

The proposed amendments to R3A and R19 will allow for continued flexibility for vaccine administration and support collaboration across the system. The proposed amendment to R247A will ensure that the current workforce administering COVID-19 and influenza vaccines, under an approved national protocol, may continue to do so in order to provide sufficient workforce as we transition out of a pandemic.

Extending the provisions will ensure that the flexibilities established by these regulations are maintained, thereby supporting the continued safe and effective deployment of COVID-19 and influenza vaccines to the pace and scale required, both now and in the future, while maintaining public safety. It also allows the government to work with system partners to undertake a fuller consideration of longer-term mechanisms that can be deployed to better support the delivery and administration of COVID-19 and influenza vaccines. Where alternative mechanisms are agreed to be beneficial, these will be subject to consultation ahead of any potential implementation.

Overview of consultation activity

Prior to the launch of the public consultation, pre-consultation engagement was undertaken with a broad range of stakeholders who are involved in the distribution, preparation and administration of COVID-19 and influenza vaccines. This engagement outlined the government’s intention to consult on extending R3A, R19 and R247A until 1 April 2026, and to amend R247A to allow for its use outside of a pandemic. There was also regular engagement with the devolved administrations in the lead-up to publication to ensure that the consultation reflected the context and requirements of each of the 4 nations.

We have raised awareness of, and encouraged participation in, the consultation through our Department of Health and Social Care (DHSC) and Department of Health in Northern Ireland (DoHNI) communication channels and targeted communications delivered directly to key stakeholder organisations.

We have analysed the consultation responses and noted specific questions 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. The public sector equality duty is published alongside this government consultation response.

Methodology

The online survey comprised of 8 closed-ended (quantitative) and 8 open-ended (qualitative) questions relating to the amendments of the regulations. We received 219 responses through GOV.UK and one response to the consultation email inbox (hmr.consultation@dhsc.gov.uk).

Responses to each quantitative question were tallied and summarised as percentages of all 220 responses. To note, percentage totals reported will not always add up to 100% due to rounding.

Responses to the qualitative questions were analysed using thematic analysis to code responses into themes. A sample of responses was independently reviewed and coded by 4 reviewers to ensure consensus across the coding before the remainder of the responses were divided between 2 reviewers. These codes were then used to generate themes. Our analysis was also independently reviewed by analysts from within DHSC to ensure accuracy and to provide quality assurance.

While qualitative analysis is not always intended to show exactly how many people held a certain view, we have endeavoured to provide an indication of the weight of opinion in responses by using words such as ‘many’, ‘some’, ‘several’ or ‘a few’.

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 220 responses were received. Of these:

• 81% of responses were received from individuals sharing their views
• 19% were received on behalf of organisations

Of respondents sharing their individual views:

• 40% stated that they work for the NHS or in health service delivery
• 3% stated that they work in government, the civil service or other public sector roles
• 9% stated that they work in the private sector
• 2% stated that they work in charity (third sector)

Analysis and government response

The majority of responses received were supportive of the proposals outlined in this consultation. We received a large number of positive comments around how the regulations have helped to improve the delivery of COVID-19 and influenza vaccinations.

We also received views relating to the future of these provisions. Many respondents agreed that the proposed amendments should be time limited until 1 April 2026, with further work required to develop options for longer-term solutions.

For the majority of questions in the consultation, the nature of responses was broadly the same whether they were provided by an individual or an organisation. Respondents who stated that they were NHS and health service delivery professionals were broadly supportive of these proposals.

Across all questions, a small proportion of respondents disagreed with the proposals because of their concerns around vaccine harms or ineffectiveness. As with all responses, these were considered and are represented below in the summary statistics for each of the quantitative questions in this consultation.

In response to the comments received, we want to emphasise that the safety of all vaccinations deployed in the UK remains of the upmost importance to the government. Every vaccine deployed in the UK must first go through the usual rigorous development and testing processes set by the UK’s independent medicines regulator, the Medicines and Healthcare products Regulatory Authority (MHRA). Each COVID-19 vaccine candidate is assessed by teams of scientists and clinicians, and only authorised once it has met robust standards of safety, quality and efficacy. We hope this offers reassurance to respondents with concerns around safety or potential ineffectiveness of COVID-19 vaccines.

We noted 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. In most instances, the respondent had ‘disagreed’ with the proposal, but their comments expressed support for the proposals.

Further summary details of the responses received to the specific consultation questions are provided below.

Amendments to regulation 3A

Expanded preparation capacity for COVID-19 vaccines

R3A enables trained healthcare professionals or staff under the supervision of healthcare professionals to conduct the final stage of assembly, preparation and labelling of COVID-19 vaccines without requiring additional marketing authorisations or manufacturer’s licences. Our proposal to extend this regulation until 1 April 2026 will enable these capabilities to continue during this period, while a permanent solution is developed.

Do you agree or disagree that the provisions provided in regulation 3A should be extended?

Table 1: number of responses received to the question ‘Do you agree or disagree that the provisions provided in regulation 3A should be extended?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Agree	195	89%
Disagree	20	9%
Don’t know	5	2%
Left blank	0	0%

What you told us in this consultation

89% of respondents to this question agreed that the provisions provided under R3A should be extended, with 9% expressing opposition to extension of the regulation.

Many respondents believed R3A had improved the operational delivery of COVID-19 vaccines through a safe and effective framework. This was enabled by:

• providing increased flexibility in the preparation of COVID-19 vaccines (as referenced by 10% of the total 220 respondents)
• increasing efficiency in the system (11% of respondents)
• allowing for delivery at scale (5% of respondents)

Respondents commented that the provisions provided by R3A had played a vital role in the delivery of COVID-19 vaccinations to protect the population, and that the vaccination service would not be able to work as efficiently without this regulation in place.

Several respondents also believed that R3A has helped to improve access to vaccinations (7% of respondents), which continues to be important while COVID-19 remains a threat, particularly for vulnerable individuals. Furthermore, the regulation was considered to play a key role as a means of ensuring we can continue to deliver current and potential future COVID-19 vaccination programmes (10% of respondents) and that we are prepared for possible future emergencies (2% of respondents).

Numerous respondents also commented that regulation 3A has allowed for a more effective use of the workforce (4% of respondents) by helping to upskill individuals and, in turn, reducing wider workforce pressures (4% of respondents). Some responses suggested that, should the proposal to extend not be enacted, the impact would likely be felt across an already-stretched workforce. 

A small number of respondents believed that COVID-19 vaccines should not be treated as an exception (1% of respondents), with some believing that previous processes are important to keep people safe (2% of respondents). We would like to emphasise that numerous processes have been introduced to ensure safety in the use of R3A, including:

• a comprehensive training package for unregistered healthcare workers
• the introduction of robust governance arrangements for all organisations handling prescription-only medicines
• the requirement for supervision by healthcare professionals during the final stage of assembly, preparation and labelling of COVID-19 vaccines

Do you agree or disagree with the proposal to set a time limit on regulation 3A until 1 April 2026?

Table 2: number of responses received to the question ‘Do you agree or disagree with the proposal to set a time limit on regulation 3A until 1 April 2026?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Agree	170	77%
Disagree	40	18%
Don’t know	10	5%
Left blank	0	0%

What you told us in this consultation

77% of respondents agreed with the proposal to set a time limit on R3A until 1 April 2026. 18% disagreed.

Many of the respondents stated that they were in favour of the development of a long-term solution (as referenced by 14% of respondents). Some of these respondents highlighted the need to account for potential changes in context or vaccines – for example, some respondents highlighted that the need for this regulation might change if single-dose vials or pre-filled syringes become available in future.

During the period in which this amended regulation will operate, the government will undertake a fuller consideration, and potential introduction (where agreed to be beneficial and subject to consultation) of an alternative longer-term mechanism to support the preparation of COVID-19 vaccines. Working with system partners, we will ensure consideration is given to any anticipated changes in context, including in relation to the packaging and distribution of vaccines.

Amendments to regulation 19

Flexibility in distribution and collaboration across the system

R19 allows COVID-19 and influenza vaccines to be moved between premises at the end of the supply chain by providers operating under NHS arrangements or suppliers of medical services to His Majesty’s Armed Forces without the need for a wholesale dealer’s licence.

Do you agree or disagree that the provisions provided as part of regulation 19 should be extended?

Table 3: number of responses received to the question ‘Do you agree or disagree that the provisions provided as part of regulation 19 should be extended?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Agree	200	91%
Disagree	15	7%
Don’t know	5	2%
Left blank	0	0%

What you told us in this consultation

A similar pattern of responses was observed for R19 as for R3A. 91% of respondents agreed that the provisions provided under R19 should be extended, while 7% disagreed.

Many respondents told us that R19 has improved the operational delivery of vaccines, with the increased flexibility provided by this regulation resulting in a reduction in wastage (as referenced by 15% of the total 220 respondents) due to vaccines being more easily moved between sites to respond to need. Respondents commented that R19 has safely and effectively enabled vaccines to be delivered at speed (4% of respondents), while achieving a more efficient use of resources (10% of respondents).

Several respondents also commented that R19 enables easier access to COVID-19 and influenza vaccinations for patients (13% of respondents) and increased opportunities for co-administration of these vaccines, which has helped to reduce health inequalities. Furthermore, this regulation was considered by respondents to have allowed for an effective use of healthcare staff (1% of respondents), which reduced the burden on the wider workforce (1% of respondents) and, in turn, the health system (1% of respondents).

As with R3A, a small number of respondents believed that COVID-19 vaccines should not be treated as an exception (<1% of respondents) and that the amendments are no longer required (2% of respondents). Some also commented that previous processes are important to keep people safe (1% of respondents). 2% of respondents also cited beliefs around vaccine harms (the government’s response to these comments is included at the beginning of the ‘Analysis and government response’ section above).

While R19 allows vaccines to be moved between premises without the need for a wholesale dealer’s licence, this provision must occur under NHS arrangements or the medical services of His Majesty’s Armed Forces. This process is subject to the same levels of quality and safety assessment by the MHRA as for other vaccines. 4% of respondents emphasised that R19 was a safe and effective means of moving COVID-19 and influenza vaccines between premises.

Do you agree or disagree with the proposals to set a time limit on regulation 19 until 1 April 2026?

Table 4: number of responses received to the question ‘Do you agree or disagree with the proposals to set a time limit on regulation 19 until 1 April 2026?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Agree	177	80%
Disagree	34	15%
Don’t know	9	4%
Left blank	0	0%

What you told us in this consultation

80% of respondents agreed with the proposal to set a time limit on R19 until 1 April 2026. 15% disagreed.

As with R3A, many respondents to this question expressed support for the development of a longer-term solution (as referenced by 13% of respondents) to ensure the benefits afforded by R19 can continue.

Some respondents were supportive of a further or indefinite extension of this regulation (5% of respondents), while others believed it would be important for this regulation to be reviewed again in the future to account for any potential changes (9% of respondents).

Amendments to regulation 247A

Expansion of the workforce

Our proposed amendments to R247A will allow for the continued use of an extended workforce to administer COVID-19 and influenza vaccines for a time-limited period while a permanent solution is developed. Responses to questions relating to this regulation are summarised below.

Do you agree or disagree with the proposal to remove condition A from regulation 247A?

Table 5: number of responses received to the question ‘Do you agree or disagree with the proposal to remove condition A from regulation 247A?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Agree	181	82%
Disagree	32	15%
Don’t know	7	3%
Left blank	0	0%

What you told us in this consultation

82% of respondents agreed with the proposal to remove condition A from R247A. 15% disagreed.

Several respondents told us that R247A had provided a safe and effective mechanism (as referenced by 6% of respondents) that has improved the delivery of COVID-19 and influenza vaccines. A number of respondents commented that the pandemic has demonstrated that an expanded workforce can effectively be trained to safely support vaccination programmes.

Many respondents told us that R247A has played an important role in reducing workforce pressures on registered staff (11% of respondents), with the added flexibility leading to substantial increases in capacity (6% of respondents). Respondents reflected on how the effective use of an extended workforce has not only been essential for the delivery of vaccinations, but it has also released qualified healthcare professionals to deliver other care across the system.

Some respondents stated that R247A has successfully improved access to vaccinations (3% of respondents) and that this remains important to ensure health protection (4% of respondents) and to support the ongoing delivery approach (14% of respondents). A few respondents commented that, if the provisions under R247A were lost, this would adversely impact the extended work that has been undertaken to reduce barriers among ethnic minorities and hard-to-reach groups.

Some respondents made suggestions around extending R247A to other vaccines and medicinal products (1% of respondents). Respondents commented that, since the regulation had proven to be safe and effective, it should apply to other immunisations.

A number of respondents told us that they were supportive of the proposal to allow the continued use of R247A, provided that suitable training (5% of respondents), supervision (2% of respondents) and robust governance structures (2% of respondents) were in place. Some respondents believed that current processes were less robust than previous processes in terms of ensuring safety (5% of respondents), with a few citing concerns around quality of care (3% of respondents) or the procedure for securing informed consent (2% of respondents).

A comprehensive online training package is provided by the UK Health Security Agency (formerly Public Health England). New vaccinators complete this training and then undergo practical training within NHS services, followed by a competency assessment to ensure they can safely administer vaccines to patients under the clinical supervision of an experienced healthcare professional. This training includes how to deal with possible adverse reactions to a vaccine. Specific registered healthcare professionals across NHS England are required to obtain informed consent from patients, as is standard practice. This includes explaining the possible risks involved with having the vaccination.

Some respondents told us that R247A has played a key role in enabling unregistered healthcare workers to upskill and develop their NHS career. Respondents commented that this trained, unregistered workforce often use the vaccination sector as the first step to becoming the ‘registered’ workforce of the future.

A small number of respondents did not agree with the proposal to extend R247A as they believed an expanded workforce was no longer required (1% of respondents) and that the current provision should not be the normal way of running services.

At a time when we are continuing to see the emergence of new COVID-19 variants in addition to seasonal flu, there is a continuing requirement to deliver COVID-19 and influenza vaccines at pace and at scale, while maintaining public safety. Maintaining the provisions under 247A will enable us to continue to use an extended workforce, which is essential to ensure the safe and effective administration of vaccines.

A few respondents requested further clarification on the proposal (1% of respondents), including around the definition of unregistered healthcare workers.

R247A introduced a new type of national protocol, which must be authorised by ministers in each of the 4 nations of the United Kingdom, that allows the classes of persons designated in the national protocol to safely administer a COVID-19 or influenza vaccine. This includes those who are:

• registered healthcare professionals who cannot ordinarily administer medicines or vaccines without the input of a prescriber (such as nursing associates, pharmacy technicians or operating department practitioners)
• non-registered healthcare workers (such as assistant practitioners, healthcare assistants or maternity support workers) 

During the period in which this amended regulation will operate, the government will undertake a fuller consideration and potential introduction (where agreed to be beneficial and subject to consultation) of an alternative longer-term mechanism that can be deployed to better support the use of an extended vaccination workforce. Working with experts and system partners, consideration will also be given to the suitability of extending this provision to other immunisations, with any proposed changes also being subject to consultation.

Do you agree or disagree with the proposals to set a time limit on regulation 247A until 1 April 2026?

Table 6: number of responses received to the question ‘Do you agree or disagree with the proposals to set a time limit on regulation 247A until 1 April 2026?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Agree	180	82%
Disagree	30	14%
Don’t know	10	5%
Left blank	0	0%

What you told us in this consultation

As with the previous regulations, many of the respondents agreed with the proposal to set a time limit on regulation 247A, with 82% of respondents agreeing to this question. 14% disagreed.

While some believed that the current model should be made permanent now or have an indefinite extension (as referenced by 5% of respondents), many were in favour of an extension of R247A until 2026 while further consideration is given to potential options for developing a long-term solution (14% of respondents).

Several respondents expressed support for there being a further review of R247A in the future (12% of respondents), with some emphasising the importance of including as many experts as possible in that review process (2% of respondents).

During the period in which this amended regulation will operate, we will undertake a fuller consideration and potential introduction (where agreed to be beneficial and subject to consultation) of an alternative longer-term mechanism that can be deployed to better support the use of an extended vaccination workforce.   

Impact of the proposals

The consultation to amend these regulations also included some questions on the expected impact of the proposals, the responses to which are summarised below.

How confident do you feel that the NHS would have an effective response before 1 April 2026 to support the ongoing delivery of COVID-19 and influenza national vaccination campaigns, if the proposed amendments to regulations 3A, 19 and 247A were not made?

Table 7: number of responses received to the question ‘How confident do you feel that the NHS would have an effective response before 1 April 2026 to support the ongoing delivery of COVID-19 and influenza national vaccination campaigns, if the proposed amendments to regulations 3A, 19 and 247A were not made?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Very confident	10	5%
Confident	15	7%
Slightly confident	20	9%
Somewhat confident	29	13%
Not confident at all	74	34%
Don’t know	21	10%
Left blank	51	23%

What you told us in this consultation

34% of respondents told us they were ‘not confident at all’ that the NHS would have an effective response before 1 April 2026 to support the ongoing delivery of COVID-19 and influenza national vaccination campaigns if the proposed amendments to these regulations were not made. 5% responded that they felt ‘very confident’.

Many respondents cited concerns around the expected negative impact on the workforce if the proposed amendments were not made (as referenced by 16% of respondents), with several citing the existing resource pressures faced by the NHS (13% of respondents). Some respondents told us that any further pressures may be damaging to workforce morale (2% of respondents).

Several respondents told us that failure to make the proposed changes could put ongoing vaccination programmes at risk (12% of respondents), with negative impacts in terms of ensuring access and encouraging uptake among at-risk individuals.

Only a few respondents believed that there would be enough time for the NHS to develop an effective response before 1 April 2026 if the proposed changes were not made (1% of respondents).

While the proposed amendments will be time limited to 1 April 2026, the government will work with the NHS and other key stakeholders ahead of that date to undertake a fuller consideration of potential longer-term mechanisms that can be deployed to support the delivery of COVID-19 and influenza vaccines. Where agreed to be beneficial, any proposed alternative mechanisms will be subject to consultation before potential implementation.

Do you think the proposals risk impacting people differently with reference to their protected characteristics?

Table 8: number of responses received to the question ‘Do you think the proposals risk impacting people differently with reference to their protected characteristics?’^{[footnote 1]}

Response	Total responses received	Percentage of responses received
Yes	29	13%
No	142	65%
Don’t know	39	18%
Left blank	10	5%

What you told us in this consultation

65% of respondents told us they did not think the proposals risked impacting people differently with reference to their protected characteristics. 13% of respondents said the proposals would risk impacting people differently with reference to their protected characteristics. 18% did not know.

A number of respondents told us they were not aware of any adverse impacts relating to the use of these regulations to date (4% of respondents).

Conversely, several respondents highlighted the fact that COVID-19 can have a disproportionate impact on those with certain protected characteristics (for example, age and disability) and that, consequently, ensuring we have effective vaccination programmes is crucial to mitigate against inequalities in health outcomes, and removing barriers to access for those with protected characteristics (7% of respondents). In particular, the extended workforce was considered by respondents to have played a key role in increasing uptake among vulnerable or harder-to-reach individuals - either by reducing physical barriers to access or by contributing to building trust in communities.

Some respondents told us that enacting the proposed amendments would have a positive impact on the workforce and inclusivity, and that R247A supports career development for those in lower NHS bands, where data shows there is more diversity in the workforce. Furthermore, respondents cited data showing that members of the public are more likely to take up healthcare interventions when their healthcare professionals reflect the characteristics of the local population.

13% of respondents believed the proposals did risk impacting people differently. 8 responses provided an explanation, allowing for further qualitative analysis. Of these, a couple of respondents explained they were concerned about the impact on those with protected characteristics if we did not amend these regulations. We also received a couple of comments that related to concerns around general health inequalities linked to protected characteristics, rather than in relation to the impact of the specific proposals in this consultation. There was, however, a potential concern raised around the quality of care for elderly patients in relation to an extended workforce.

The government is committed to continuing to work with the NHS to effectively improve access to COVID-19 and influenza 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. A public sector equality duty impact assessment on the proposed amendments to these regulations is published alongside this consultation response at Annex A.

Do you think the proposals risk impacting people differently with reference to their protected characteristics or where they live in Northern Ireland?

What you told us in this consultation

Due to the low number of consultation responses received from participants in Northern Ireland, we have had to apply statistical disclosure controls and have therefore not included a table summarising the responses to this question.

We did, however, conduct the analysis in line with the methodology set out above and in line with responses from the other nations. This showed that the majority of respondents did not think the proposals risked impacting people differently with reference to their protected characteristics or where they live in Northern Ireland (no comments were received).

Conclusion and next steps

Given the high level of support expressed in the responses to this consultation, the government is proceeding with the proposed amendments to R3A, R19 and R247A of the HMRs, which will maintain existing provisions until 1 April 2026. We will be laying legislation that brings these into force in due course.

Given the positive response to maintain these flexibilities beyond this time frame, the government will undertake a fuller consideration and potential introduction (where agreed to be beneficial and subject to consultation) of alternative longer-term mechanisms to better support flexibility and collaboration across the system, and an extended workforce, to ensure safe and effective delivery of COVID-19 and influenza vaccinations.

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, and potential options for extending some of these provisions to other vaccines and medicinal products in the future.

Where further proposals are agreed to be beneficial, these will be subject to consultation before any proposed changes are introduced.

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.

1. Data may have been rounded in line with DHSC statistics guidance and the UK Statistics Authority’s Code of Practice for Statistics. Due to rounding, totals may not add up to 220 and percentages may not add up to 100%. ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸