Consultation outcome

Amendments to regulations 3A, 19 and 247A of the Human Medicines Regulations 2012 to support the ongoing delivery of COVID-19 and influenza vaccination

Updated 30 October 2023

Executive summary

The Human Medicines Regulations 2012 (HMRs) were amended by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 to provide greater flexibilities for the movement and supply of certain type of vaccines, in light of the COVID-19 pandemic.

The aim of this proposal is to ensure that the flexibilities established by those regulations are maintained for a further time-limited period to support the continuing supply, distribution and administration of COVID-19 and influenza vaccines as we transition out of the pandemic.

This consultation focuses on 3 provisions in the HMRs:

• regulation 3A (R3A)
• regulation 19 (R19)
• regulation 247A (R247A))

These regulations:

• enable trained healthcare professionals or staff under the supervision of healthcare professions 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)
• allow COVID-19 and influenza vaccines to be moved between premises at the end of the supply chain, by providers operating under NHS arrangements and the medical services of His Majesty’s Forces, that do not hold wholesale dealer licences (R19)
• enable 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)

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, and in conjunction with the Department of Health Northern Ireland in relation to Northern Ireland (pursuant to section 45(1) of the Medicines and Medical Devices Act 2021), is seeking views on the proposal to amend these 3 existing provisions so that they remain in place until 1 April 2026.

Introduction

The COVID-19 and influenza vaccination programmes have saved tens of thousands of lives across the UK. It is important that we continue to ensure the most vulnerable are protected through a targeted vaccination offer for those most at risk.

As part of the response to the COVID-19 pandemic, amendments to the HMRs were laid in Parliament on 16 October 2020 to provide regulatory flexibility to support the rollout of the COVID-19 vaccination campaign and upscale the influenza vaccination programme in the UK, while protecting public safety. These amendments followed a public consultation held from 28 August to 18 September 2020. This proposal concerns 3 of the amendments made to R3A, R19 and R247A.

Regulations 3A and 19

Amendments to R3A allow for the final stage preparation of the COVID-19 vaccines to be carried out by suitably qualified healthcare professionals without the need for manufacturing licences or marketing authorisations. 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 and the medical services of His Majesty’s Forces without the need for a wholesaler dealer’s licence. Both regulations included a sunset provision of 21 March 2022, which was extended by further amendment to the HMRs to 1 April 2024 following consultation in 2021.

Both R3A and R19 have brought significant operational benefits. R3A has allowed the labelling of COVID-19 vaccines with a new shelf life after thawing; and allowed preparation or reconstitution by the addition of the recommended diluent, without the need for a manufacturers’ licence or marketing authorisations.

This additional flexibility has meant that NHS teams have been able to use the skills and expertise of their staff in appropriate areas much more effectively, enabling safer systems of working, particularly at larger sites. At the same time, GP practices have entered into collaboration agreements to enable them to collaborate within a primary care network (PCN) grouping. COVID-19 vaccinations are not available in pre-filled syringes and so they continue to require preparation before administration to patients. The PCN grouping model relies on this regulation to allow healthcare professionals to prepare and assemble COVID-19 vaccines for patients, regardless of location or where the patients are registered.

R19 has improved collaboration across the system, enabling safe and appropriate vaccine movement between GP practices within a PCN grouping to support delivery of the NHS COVID-19 and influenza vaccination programmes and provision in places where they could be used best and/or had the greatest need.

There is a continuing requirement to deliver COVID-19 and influenza vaccines at pace and at scale, both now and in the future, while maintaining public safety. Vaccines have proven to be the best line of defence against the COVID-19 pandemic and for the prevention of severe illnesses arising from seasonal influenza, helping to reduce unplanned hospital admissions, a key factor in NHS resilience. As a result, we are keen to extend the current temporary provisions in R3A and R19, while working in parallel with system partners to agree a permanent approach.

Regulation 247A

As part of a number of amendments to the HMRs to support the deployment of COVID-19 and influenza vaccines, 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. It was recognised that due to the need to rapidly rollout the programme at scale as soon as a COVID-19 vaccine became available, an alternative legal mechanism to administer vaccines using an expanded workforce was required, given the capacity constraints on those who were at the time able to prescribe or administer vaccines.

R247A introduced a new type of national protocol, which must be authorised by ministers in each of the 4 nations of the UK, that allows the classes of persons designated in the national protocol to safely administer a COVID-19 or influenza vaccine. 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, operating department practitioners) and non-registered healthcare workers (such as assistant practitioners, healthcare assistants or maternity support workers).

In practice, the national protocol model has become a key tool to support the programmes of mass vaccination against COVID-19 and influenza, in particular, where administration takes place at mass vaccination centres and the various roles are split between a number of different people (namely: patient assessment, advice and informed consent, vaccine preparation, vaccine administration and record keeping). Additionally, as eligibility for influenza vaccination was expanded for autumn 2020, provisions were built into R247A to enable an expanded workforce to be eligible to administer influenza vaccination during pandemics. This ensured the workforce comprised enough people to deliver the additional vaccinations, especially during the periods when the 2 programmes overlapped.

Under R247A, the first national protocol for the COVID-19 vaccination programme was issued on 18 December 2020 in England for the first COVID-19 vaccine deployed in the UK. Since then, national protocols have been approved by ministers and issued for multiple COVID-19 and inactivated influenza vaccines for the national COVID-19 and influenza vaccination programmes.

The continued use of this mechanism to enable optimisation of the expanded workforce is essential to ensure the NHS across the UK can have certainty in its workforce plans, while maintaining capacity and flexibility as we transition out of the pandemic.

Policy objective

The overarching policy objective is to enable the continued deployment of safe and effective COVID-19 and influenza vaccines to the pace and scale required both now and in the future, while maintaining public safety. If the provisions provided for under R3A and R19 lapse (which will happen if we do nothing), and/or if the provisions in R247A are unable to be drawn on due to the ending of the pandemic, certain NHS vaccination activities would need to cease. This is likely to negatively impact on provision and uptake of these vaccinations.

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. R247A is only permitted for use during a pandemic, and we temporarily wish to expand the provision while a permanent solution is found. R3A and R19 have sunset provisions which mean they will be repealed on 1 April 2024 unless extended.

What we’re consulting on

Amendments to regulation 3A

R3A has allowed all professionally justified acts of preparation and assembly of a coronavirus vaccine to be undertaken by or under the supervision of a doctor, nurse, or pharmacist at any location, without precipitating the need for a manufacturer’s licence or marketing authorisation – provided those acts are done under NHS arrangements or arrangements as part of the medical services of His Majesty’s Forces.

It also allows for authorised medicinal products used for the reformulation of COVID-19 vaccines (for example, diluents) to be re-assembled at the end of the medicines supply chain without the resultant products needing marketing authorisations in order to be supplied.

The flexibility provided by this provision continues to play an important role in the COVID-19 vaccination programme due to the supply chain arrangements and the way in which the vaccinations are packaged. COVID-19 vaccinations are still not available as a pre-filled syringe and so each vaccine administered continues to require final stage preparation before administration to patients.

These flexibilities have allowed for the safe assembly and preparation of COVID-19 vaccines at the pace and scale required within the programme, with over 151 million doses administered in the UK. It has allowed for the labelling of COVID-19 vaccines with a new shelf life after thawing; and allowed preparation, or reconstitution, by the addition of the recommended diluent without the need for a manufacturers’ licence. This has enabled offsite administration of vaccines in care homes and other locations using mobile delivery models, supporting efforts to vaccinate hard to reach and vulnerable communities.

Since the start of the pandemic, GP practices have also entered into collaboration agreements under the COVID-19 vaccination enhanced service to enable them to prepare and assemble COVID-19 vaccines within a PCN grouping. The PCN grouping model relies on this regulation to allow healthcare professionals to prepare and assemble COVID-19 vaccines for patients, regardless of location or where the patients are registered. These flexibilities have meant NHS teams have been able to work more efficiently and allowed NHS staff to focus on their areas of speciality, enabling safer systems of working, particularly at larger sites.

While COVID-19 related deaths and hospitalisations have declined, COVID-19 has not gone away, and vaccinations continue to play an important role in protecting the most vulnerable. The flexibilities within the provision continue to be important for the COVID-19 vaccination programme. We therefore propose to extend these provisions until 1 April 2026 and in parallel we will continue to work with system partners to develop longer term and permanent proposals, to be consulted on at a later date.

The legislation will substitute the year 2024 for 2026 in R3A under provision 6.

Question

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

• agree
• disagree
• don’t know

Please explain your answer (maximum 500 words).

Question

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

• agree
• disagree
• don’t know

Please explain your answer (maximum 500 words).

Amendments to regulation 19

Amendments to R19 removed the requirement for providers operating under NHS arrangements across England, Wales, Scotland and Northern Ireland, and the medical services of His Majesty’s Forces, to hold a wholesaler dealer’s licence when moving COVID-19 and influenza vaccines between premises.

These provisions were enabled to facilitate safe and appropriate vaccine movement between GP practices within a PCN grouping to support delivery of the NHS COVID-19 and influenza vaccination programmes and provision in places where they could be used best and/or had the greatest need. Additionally, it has facilitated co-administration to patients. The supply of vaccines from one healthcare organisation to another would normally be classed as a wholesale distribution supply and subject to having a wholesale dealer’s licence under regulation 18 of the HMRs. If such a licence is not held by the organisation because it is not required for normal business, this can lead to problems and delays with moving the vaccines between such service providers, and runs the risk that appropriate vaccination of at-risk groups cannot take place and vaccine that could have been used to facilitate access are wasted.

The flexibility provided by the amendment to R19 has enabled COVID-19 and seasonal influenza vaccines to be moved swiftly and safely within the healthcare system between NHS providers (and between the suppliers of medical services to the armed forces) to meet patient need, improve access and avoid wastage. While the deployment programme is now more mature, and under normal circumstances the requirement for wholesaler dealer licences is an important safeguard, there is a continuing need for these flexibilities to be retained for future campaigns to ensure accessibility and to reduce wastage. We therefore propose to extend the existing provisions until 1 April 2026.

As with R3A and noting that the provision was originally due to lapse in 2022, in parallel, we will continue to work with system partners to develop longer term and permanent proposals, to be consulted on a later date.

The legislation will substitute the year 2024 for 2026 in R19 under provision 4D.

Question

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

• agree
• disagree
• don’t know

Please explain your answer (maximum 500 words).

Question

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

• agree
• disagree
• don’t know

Please explain your answer (maximum 500 words).

Amendments to regulation 247A

Condition A of R247A specifies that medicinal products used for vaccination or immunisation against COVID-19 or influenza can only be supplied under a national protocol when a disease ‘is, or in anticipation of a disease being imminently (a) pandemic, and (b) a serious risk or potentially serious risk to human health’.

Although COVID-19 related deaths and hospitalisations have declined, largely due to the continued effectiveness of vaccines and improved treatments, COVID-19 continues to be recognised as a pandemic which has enabled the continued use of R247A to develop national protocols for the administration of COVID-19 and influenza vaccines. However, it is not clear when COVID-19 might transition from pandemic to endemic status, and this uncertainty causes a significant risk for the NHS across the UK in regard to appropriate workforce planning for future COVID-19 and influenza vaccine programmes.

Recognising that we have transitioned to living with COVID-19 and in anticipation of COVID-19 no longer being nationally and/or internationally considered a pandemic, we are consulting to seek views on amending R247A to remove condition A from the regulation. This is in order to allow the continued use of the national protocol model for COVID-19 and influenza vaccines outside of pandemic status for COVID-19.

Amending R247A to allow the continued use of national protocols, as the legal mechanism for administration of COVID-19 or influenza vaccines, would enable the NHS in all nations to maintain efficient delivery of the vaccination campaigns as the NHS transitions out of the pandemic response with minimal disruption to wider health service delivery.

This amendment to R247A will be time limited, to 1 April 2026, in recognition that this mechanism may not be the most appropriate model for the ongoing use of an expanded workforce outside of pandemic response. During the period in which this amended regulation will operate, it is expected that there will be fuller consideration, and potential introduction (where agreed to be beneficial and subject to consultation) of an alternative longer-term mechanism which can be deployed to better support the use of an extended vaccination workforce.

In the meantime, however, while continuing to operate under R247A, the national protocols for each vaccine campaign will continue to require approval by the Secretary of State and the ministers for each of the devolved administrations. This will ensure that the approval of such protocols for COVID-19 and influenza vaccinations and immunisations are justified at a national level.

How R247A has been used across the nations

The implementation of R247A reflected the feedback from the initial consultation on amendments to the HMRs in 2020, where a number of layers of assurance were built into the amendments around using an expanded workforce and maintaining patient safety. Most importantly, the national protocols include requirements for the supervision of a prescriber or specified registered healthcare professional. Vaccinators are also required to obtain informed consent from patients, as standard practice, and anyone administering a COVID-19 or influenza vaccine is given the time and opportunity to undertake the comprehensive training they need.

It also included the commitment to formally review the operation of R247A following one year of use to evaluate whether there had been any adverse effects on patient safety. The review was published in April 2022 and it highlighted that the regulation was being used widely across the UK and that stakeholders were positive about the impact the regulation was having on their ability to effectively deliver the COVID-19 and influenza vaccine programmes. No adverse consequences for patient safety were identified by those responding to the review.

While certain registered healthcare professionals can operate under patient group directions, delegation is not permitted under patient group directions. The protocol filled these gaps by allowing a registered healthcare professional to assess, seek informed consent and then delegate administration to others, be they registered or non-registered healthcare workers.

Subsequent engagement with each nation has indicated that the regulation is still being utilised to support the COVID-19 and influenza programmes and that all nations’ plans for COVID-19 and influenza programmes would be negatively impacted if they were no longer able to rely on R247A as outlined briefly below.

England

R247A supported the COVID-19 vaccine deployment programme as it enabled use of additional registered healthcare professionals and non-registered healthcare workers to vaccinate without input from a prescriber. This significantly increased the NHS’s capability to respond throughout the pandemic, particularly when using mass vaccination models of delivery. 

Clinical workforce capacity remains a challenge in England. Retaining the use of a tool which facilitates vaccination to occur using an expanded vaccination workforce without input from a prescriber, supports the optimisation of the workforce. Additionally, using national protocols as a mechanism to expand the vaccination workforce has brought significant operational benefits for the NHS in England. The recruitment of 54,758 unregistered paid staff has facilitated the delivery of around 148 million vaccinations to date, and 28,000 of this workforce have been retained into wider careers across the health and social care sector, enabling registered staff to work where they can have most impact and benefit.

Scotland

In Scotland, the ‘Vaccination Transformation Programme’, which is part of a wider transformation of primary care and changes to the GP contract, has concluded and the responsibility for delivering vaccines now sits with health boards, having moved away from the previous GP and/or primary care-led model. This means that Scotland’s delivery model is run by territorial health boards and in some areas still relies on larger vaccination clinics. This model relies on the use of competent level 3 and 4 healthcare support workers supervised by registered healthcare professionals. The use of national protocols under R247A, which allows these healthcare support workers to vaccinate, is essential to ensure that Scotland has the workforce to deliver both the COVID-19 and influenza vaccination programmes.

Level 3 and 4 healthcare support workers represent roughly 44% of the workforce delivering COVID-19 and influenza vaccines in Scotland. However, this share is higher in some territorial health board areas and has been higher during the winter vaccination programmes than the spring programmes. The role played by healthcare support workers is generally highest in larger urban health board areas, which require a high capacity to deliver their vaccination programmes. Health board feedback and data gathered on adverse events, like the formal review of R247A, has not raised any safety concerns with the use of healthcare support workers in the COVID-19 and influenza vaccination programmes.

This has been an innovative approach which has been welcomed by health boards and created capacity for Scotland’s registered healthcare professional workforce to be effectively deployed across the wider health and social care system, using their specific skills and knowledge to affect best patient outcomes.

Wales

Vaccinators working under the national protocol model are extensively deployed as part of the COVID-19 and influenza vaccination programmes in Wales. 45% of vaccinators in Wales are unregistered healthcare professionals working in occupational health. In some locations, at certain times, 75% of the workforce is un-registered healthcare professionals in occupational health.

Appropriately trained and supervised, unregistered health professional immunisers are used as part of a skill-mixed model to improve the efficiency and flexibility of services while reducing pressure.

If Wales was not able to use this extended workforce for future campaigns, they would need to undertake recruitment activity to bring in more vaccinators. In the current highly challenging recruitment landscape this could be very difficult to do if relying on only registrants to deliver the campaign and could jeopardise their ability to deliver future COVID-19 and influenza vaccine campaigns.

Wales has outlined a vision to continue to use an expanded vaccination workforce in their national immunisation framework for Wales, where this workforce is identified as a key aspect of ensuring sustainable, fit for the future vaccination services in Wales.

Northern Ireland

In Northern Ireland the vaccination workforce is largely made up of a mixture of registered healthcare professionals as well as a smaller number of unregistered healthcare professionals working in occupational health and under the national protocol model.

A sessional vaccinator workforce was recruited regionally to support primary care and community pharmacy throughout the pandemic to deliver influenza and COVID-19 vaccinations. Those who have been involved have been trained to a high level in order to safely administer COVID-19 vaccinations and are appropriately supervised to undertake this role.

A number of GP practices and pharmacies also trained some of their own non-registered healthcare staff to work under the national protocols and these staff have been invaluable in supporting these vaccination programmes.

Question

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

• agree
• disagree
• don’t know

Please explain your answer (maximum 500 words).

Question

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

• agree
• disagree
• don’t know

Please explain your answer (maximum 500 words).

NHS response if these amendments are not made

The following question is targeted at those who have been involved in the delivery of the COVID-19 and influenza national vaccination programmes and asks you to consider a situation where these regulations lapse or cannot be used.

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?

• very confident
• confident
• somewhat confident
• slightly confident
• not confident at all
• don’t know

Please explain your answer and reflect if your view varies by regulation (maximum 500 words).

Public sector equality duty

In line with the government’s requirement to consider the impact of policy on the protected characteristics, the following question is designed to understand whether you feel the proposal risks impacting people differently or could impact adversely on any of the protect characteristics covered by the public sector equality duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998.

Question

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

• yes
• no
• don’t know

Please explain your answer and reflect if your view varies by regulation (maximum 500 words).

Northern Ireland respondents: equality and rural screening

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

Question

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

• yes
• no
• don’t know

Please explain your answer (maximum 500 words).

How to respond

The department welcomes your views on the proposals and invites responses on the specific questions raised.

Please respond by completing our online survey.

If you have any queries on this consultation, email hmr.consultation@dhsc.gov.uk. 

The consultation is open for a period of 6 weeks. Please submit your responses to the questions by 11:59pm on 18 September 2023.

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

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

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

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

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

Patient safety

The overall aim of the proposed amendments is to enable the deployment of COVID-19 and influenza vaccines at the pace and scale required.

The Human Medicines Regulations 2012, amended by the HMRs have played a key role in protecting public health. Over 151 million COVID-19 vaccine doses have been administered in the UK, which has had a significant impact on reducing hospitalisations and deaths. As well as saving tens of thousands of lives, the COVID-19 vaccines have also significantly reduced the pressure on the NHS and allowed the economy and society to reopen. Influenza vaccine efficacy varies year on year as the influenza virus changes and is difficult to predict. However, vaccination remains the best protection against the serious effects of influenza and the annual national influenza immunisation programme aims to provide protection to those who are most at risk from the complications of influenza.

The proposals outlined in this consultation aim to maximise patient and public health benefits of these vaccines by ensuring their widespread availability. Patient safety is at the heart of any public health vaccination programme and is at the forefront of policies proposed in this consultation.

The implementation of R247A reflected the feedback from the initial consultation on amendments to the HMRs in 2020, where a number of layers of assurance were built into the amends around using an expanded workforce and maintaining patient safety.
Most importantly, R247A requires any protocol to include requirements (where appropriate) for the supervision of a person who administers a vaccination under the protocol. In practice, this means that registered and non-registered staff are only able to administer vaccines in accordance with the supervision requirements set out in the protocols. They are supervised and supported in practice as required. Each nation has ensured those administering a COVID-19 or influenza vaccine have adequate training.

Additionally, R247A included the commitment to formally review the operation of R247A following one year of use to evaluate whether there had been any adverse effects on patient safety. The review was published in April 2022 and stakeholders were positive about the impact of R247A and were not aware of any adverse consequences for patient safety.

Removing the condition in which the national protocol model can be used does not impact the safety framework and training that is involved for the workforce administering a vaccine under a protocol.

We also believe that proposals to extend provisions relating to wholesale dealing, end-stage vaccine preparation and off-premises vaccine supply by retail pharmacies, have supported swift and safe distribution of COVID-19 and influenza vaccines, and will be critical to maintaining the ongoing public health benefits.

We have also considered environmental safety and impact of the proposals on the wider environment. Relaxing the rules on holding of wholesaler dealer licences has allowed for vaccines to be moved swiftly and safely directly to where they are most required, thereby meeting patient need and avoiding wastage.

Availability

The proposals outlined are intended to enable the supply and increase the availability of vaccines to the public and healthcare professionals. The proposed provisions will ensure the continued timely access to vaccines that the public need for COVID-19 and influenza. The proposed provisions also support the long-term necessity of public vaccinations as we continue to manage COVID-19 and influenza infections into next year and beyond.

The flexibility offered by R247A has been a key enabler in delivering the COVID-19 and influenza vaccination programmes allowing large volumes of vaccines to be delivered through a range of vaccine delivery models, leading to higher programme efficiency, ultimately to the benefit of individuals. The ability to optimise and expand the workforce using an alternative legal mechanism for administration of the vaccines has been instrumental in the success of the programme ensuring vaccines were available to more people and within a shorter timeframe than would have otherwise been possible. To allow the continued use of the national protocol model will ensure that capacity in the workforce is maintained to efficiently deliver future COVID-19 and influenza programmes.

Favourability

These regulations have helped the UK to be seen as a favourable place to supply medicines with the swift and safe distribution of COVID-19 and influenza vaccines, as well as ensuring that there is appropriately trained staff to administer these vaccines.

They have demonstrated that the UK has the adaptability to ensure that medicines can be supplied at scale and pace where necessary to protect patients and the public. Provisions, such as those providing flexibilities around wholesale dealing, have shown our ability to provide flexibility in the supply and distribution of medicines where that will deliver significant public health benefits. They have shown that the UK can and will make changes to ease the introduction of innovative safe treatments for its population.

Summary

The national protocol model has brought significant operational benefits to the COVID-19 and influenza vaccination programmes in terms of ability to deliver vaccines at the pace and scale required without significant impact to the wider provision of health services. Thousands of additional staff have been recruited and trained across the UK to deliver the vaccines, many of whom have been retained into wider careers across the health and social care sector helping to close workforce gaps elsewhere in the NHS and wider sector. Utilising this workforce has reduced pressures for general practice to deliver vaccinations and optimised use of professional resources available, particularly to support COVID-19 recovery, across the United Kingdom. Amendments to R3A and R19 have similarly supported the success of the vaccine deployment programme, provided additional flexibilities, while also protecting patient safety.

The proposal builds on these successes, ensuring there is an appropriately trained workforce available, and regulatory flexibility to efficiently deliver the COVID-19 and influenza vaccine programmes until April 2026, or until a permanent approach is agreed.

Privacy notice

Summary of policy

This consultation sets out the proposal to make an amendment to the Human Medicines Regulations 2012, specifically R3A, R19 and R247A for a time-limited period until April 2026 to support the continuing supply, distribution and administration of COVID-19 and influenza vaccines as we transition out of the pandemic.
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. R247A is only permitted for use during a pandemic, and we temporarily wish to expand the provision while a permanent solution is found. R3A and R19 have sunset provisions which mean they will be repealed on 1 April 2024 unless extended.

Data controller

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

What personal data we collect

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

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No personal information will be collected from respondents.

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The consultation sets out a proposal to continue to use the flexibilities established by R3A, R19 and R247A of the HMRs until April 2026 to support the continuing supply, distribution and administration of COVID-19 and influenza vaccines as we transition out of the pandemic. It is therefore useful to DHSC to understand whether respondents are NHS staff when providing their response. It is also helpful for DHSC, when analysing responses, to understand if there are any regional or national variations in relation to observations or views on the use of these regulations to support COVID-19 and influenza vaccination, so it can explore local issues further if required.

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Changes to this policy

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