Consultation outcome

Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns: consultation response

Updated 25 January 2022

1. Executive summary

The Secretary of State for Health and Social Care in relation to Great Britain, and in conjunction with the Minister of Health in Northern Ireland, in relation to Northern Ireland, held a public consultation on a review of temporary provisions in the Human Medicines Regulations (HMRs) 2012 to support influenza and coronavirus (COVID-19) vaccination campaigns. The consultation ran for 3 weeks from 8 to 29 December 2021.

The consultation sought views on proposals to extend or make permanent a range of provisions that have supported the COVID-19 and influenza vaccination campaigns and are due to lapse on 1 April 2022. These are:

• increasing the vaccinator workforce in the NHS and in occupational health for NHS bodies

• enabling vaccine final preparation, labelling and related activities to take place under NHS arrangements without additional marketing authorisations or manufacturer’s licences being needed

• allowing vaccines to be moved between premises at the end of the supply chain by NHS bodies and the medical services of Her Majesty’s Forces that do not hold wholesale dealer licences

• allowing pharmacies who are running vaccination services to do so from premises other than their registered pharmacy premises

In addition, the consultation asked for views on extending workforce flexibilities to Occupational Health Schemes in the private sector, adding additional professional groups to those who can already vaccinate under Occupational Health Schemes, clinical supervision within vaccine centres and the prospect of extending all of the arrangements to any future pandemic scenario (not just COVID-19 or influenza).

In total there were 125 completed consultation responses received, 84% of which were from individuals and 16% from organisations. The government welcomes the participation of all individuals and organisations who contributed to the consultation. We received responses from a range of people including individual members of the public, NHS and health service delivery bodies, social care, private sector and charity or third sector organisations. There were responses from all UK countries.

The Department of Health and Social Care (DHSC) and its Northern Irish counterparts have analysed the responses and have carefully considered the feedback received. Respondents who stated that they were NHS, health service delivery or social care professionals, were broadly supportive of the proposals and provided commentary and sometimes powerful examples as evidence to support their views. Individuals who did not identify as health service delivery or social care professionals, overwhelmingly disagreed with the majority of the proposals and provided very little evidence relating to the specific consultation questions. Their comments were generally about their views on the COVID-19 pandemic itself. All types of the respondents were broadly in favour of amending the HMRs to require COVID-19 and influenza vaccination activities carried out pursuant to pandemic protocols, to be supervised by a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol (see regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations)). (This provision is currently written into the protocols themselves.)

Where there was no support for the proposals, the most common alternative that respondents wished to see was to allow the provision in question to lapse. Responses to the consultation raised no significant patient safety risks.

Over the summer of 2021, DHSC held initial conversations with external stakeholder organisations to determine their views on how the provisions have been used and the direction they would like to see them take from 1 April 2022. Responses to this informal consultation are summarised at the end of each section in the ‘themes common across responses’ section.

Following the analysis of consultation responses and taking into account the continuing need for mass vaccination, we will prioritise implementation of those provisions that will lapse on 1 April 2022, to enable health services to continue to plan and operate mass COVID-19 and influenza vaccinations.

The next steps for these and the other proposals are as follows:

Tranche 1, to be laid before Parliament in February: an Statutory Instrument (SI) amending those provisions in the HMRs that are currently due to lapse on 1 April 2022, as detailed above. This will give health services the certainty they need to be able to continue to plan and operate mass COVID-19 and influenza vaccination programmes on the same basis as now.

Tranche 2, clinical supervision within vaccine centres: this received broad support and will be taken forward at the next legislative opportunity.

Tranche 3: provisions relating to extending workforce flexibilities to Occupational Health Schemes in the private sector and adding professional groups to those who can already vaccinate under Occupational Health Schemes. Limited evidence was received through this consultation on these provisions. We will undertake further, targeted evidence gathering before making a final decision.

Tranche 4: extension of all of the arrangements to any future pandemic, not limited to COVID-19 or influenza. This will be considered further and subject to further public consultation, as indicated previously.

2. Introduction

The Human Medicines Regulations 2012 (HMRs) set out a comprehensive regime for:

• the authorisation of medicinal products

•  for the manufacture, import, distribution, sale and supply of those products

• for their labelling and advertising

• pharmacovigilance

They also provide for enforcement powers for the authorisation and supervision of medicinal products.

The HMRs were amended in the final quarter of 2020 to add flexibility to some of the normal rules that would ordinarily govern vaccines and their supply to patients, in light of COVID-19. The changes were to facilitate the mass vaccination campaigns that have been taking place against both COVID-19 and seasonal influenza in the UK. Some of the changes were permanent but a number remain in force only until 1 April 2022 to support COVID-19 and seasonal influenza vaccinations.

Action was needed to determine if the provisions should be made permanent, extended for a further limited period or allowed to lapse. The Secretary of State in relation to Great Britain, and in conjunction with the Minister of Health in Northern Ireland, in relation to Northern Ireland, sought views on these proposals via a public consultation which ran from 8 to 29 December 2021. The proposals are about:

• increasing the vaccinator workforce in the NHS and in occupational health for NHS bodies

• enabling vaccine final preparation, labelling and related activities to take place under NHS arrangements without additional marketing authorisations or manufacturer’s licences being needed

• allowing vaccines to be moved between premises at the end of the supply chain by NHS bodies and the medical services of Her Majesty’s Forces that do not hold wholesale dealer licences

• allowing pharmacies who are running vaccination services to do so from premises other than their registered pharmacy premises

The consultation also asked for views on extending workforce flexibilities to Occupational Health Schemes in the private sector, adding professional groups to those who can already vaccinate under Occupational Health Schemes, clinical supervision within vaccine centres and in the interests of pandemic preparedness, the prospect of extending all of the arrangements to any future pandemic scenario (not just COVID-19 or influenza).

We understand that the NHS has used the full range of options already available to them as provided by the HMRs, to deliver COVID-19 and influenza vaccines safely and effectively at the pace and scale required. The suggested changes to the HMRs will help to ensure that that NHS continues to have the added flexibility it requires to operate any necessary mass vaccination programmes for COVID-19 and influenza from 1 April 2022.

Over the summer of 2021, DHSC held initial conversations with external stakeholder organisations to determine their views on how the provisions have been used and the direction they would like to see them take from 1 April 2022. Responses to the informal consultation are summarised at the end of each section in the ‘themes common across responses’ section.

The following section of this document discusses the analysis of the consultation responses in detail.

3. Summary and evaluation of responses

3.1 Approach to analysis

DHSC and their Northern Irish counterparts have analysed the responses and considered the feedback received. In doing so, we looked at the responses given to each of the questions posed as well as the information responders provided in the ‘free text’ sections of the consultation response survey, where people could share their views in their own words.

Key themes or topics in the responses were identified across each of the 9 questions asked by the consultation.

3.2 Overview of respondents

A total of 125 responses were received. There were 123 completed responses to the consultation received through the GOV.UK page. In addition, there were 2 responses received via email and 0 responses received by post.

84% of responses were from individuals. 16% were on behalf of organisations

Of those who responded on behalf of organisations, these were split into NHS or health service delivery 75%, private sector 8%, social care 6%, other public sector 3%, charity or third sector 3%, retired 3% and student 3%.^{[footnote 1]}

32% of respondents stated that they were responding as a health care professional.

3.3 Themes common across responses

There was only one true theme across the consultation responses - individuals commenting on wider COVID-19 issues including vaccination policy. The types of comment received, however, are not directly related to the questions being posed in the consultation document. Examples include:

Quotes from respondents

The pandemic is over. Deaths are very low compared to other causes of death. Very few groups are seriously affected. Life must go back to normal. There is no justification for continuing any emergency precautions and measures because it’s not an emergency anymore.

Prove that Sars Cov 2 exists and that this hasn’t been planned for decades.

Cancer treatments, elective surgeries and mental health must be put at the forefront of the health system we are paying for.

They are totally unnecessary as you know… Vaccines do not work as you know…Less vaccines less illness and death.

We do not intend, therefore, to respond further to these points in this document as the comments are out of scope but further information about these issues is available from the UK Health Security Agency and the British Society for Immunology.

All other points mentioned below arguing against the proposals were raised by only a handful of respondents.

Several individuals raised concerns about which staff groups should be vaccinating the public and whether they have adequate training and qualifications but no evidence to indicate what would constitute adequate training was provided.

There appeared to be a lack of awareness about operating department practitioners and the provision currently in regulations which allows them to undertake vaccination activities for COVID-19 and influenza in occupational health services in the NHS and in local authorities. When we asked if there was any operational need to add any other professions to the list of those who can supply and administer in relation to COVID-19 and influenza under an Occupational Health Scheme, a few comments made it clear that some people were not aware that operating department practitioners were already able to do this.

Quotes from respondents

Operating Department Practitioners are registered with the HCPC but are currently excluded from this activity. Their role involves the administration of drugs and they are vital in acute settings for the role out of the vaccine programme.

AHPs who are already working in a clinical setting, who are used to handling and checking numerous drugs especially ODPs would be most appropriate.

Pharmacy Technicians were mentioned as a group that some respondents would like to see able to undertake this activity, and to a lesser extent, wider Allied Health Professional (AHP) groupings with relevant experience. Others suggested that perhaps anyone listed in relevant legislation, able to utilise a Patient Group Direction (PGD), should be able to undertake this activity.

Some respondents commented that they would require more detail about the proposals before they were able to make an informed decision and reply to the consultation appropriately.

The use of a flexible workforce relieving the burden on particular staff groups was mentioned fairly frequently and many respondents went on to say what a positive experience they have had using the provisions in practice.

Regarding the use of the provisions for all future pandemics, some respondents thought provisions should be temporary only as different pandemics would likely require different responses.

4. Consideration of responses to individual consultation questions

4.1 Expanding the workforce

Provisions were made to expand the workforce eligible to administer vaccines, to ensure that the UK is legally able to make the most of the workforce available to administer COVID-19 and influenza vaccines. The temporary provisions enabling additional healthcare professional groups to vaccinate health and social care workers in occupational health services and the public under PGDs.

The consultation asked for:

• views on proposals to make permanent the provisions which have enabled an expanded workforce to lawfully administer COVID-19 and influenza vaccines and/or immunisation medicines under NHS and local authority Occupational Health Schemes, so that additional healthcare professionals in the occupational health workforce (midwives, registered nursing associates (England only), operating department practitioners, paramedics, physiotherapists and pharmacists) are able to continue to administer these vaccines

• whether there was any operational need for other healthcare professions to be added to the list of those who are able to supply and administer in relation to COVID-19 and influenza under an Occupational Health Scheme

• views on whether there was a need for new changes to extend these provisions to the private sector

Do you agree or disagree that the provisions which expand the workforce for NHS bodies or local authorities operating an Occupational Health Scheme in relation to coronavirus and influenza vaccination and/or immunisation be retained permanently?

Respondents	Agree	Disagree	I don’t know	Not answered
All groups	39%	57%	4%	0%
NHS, health service delivery and social care professionals	79%	17%	4%	0%

Feedback from responses

Respondents who stated that they were NHS, health service delivery or social care professionals were broadly supportive of these proposals - 79% of those who responded in this category being in favour of the proposal. Of the NHS, health service delivery and social care professionals who disagreed with the proposal, 22% of them would like to see it temporarily extended to 1 April 2024 and 67% would like to see the provision lapse. 11% did not express a preference.

A large number of the general public who responded shared views and comments which did not directly relate to the specific question being asked, nor did they include any supportive evidence to back up any points they made. 85% of this group disagreed with the proposal, 95% of them wanted to see the provision lapse on 1 April 2022 and 3% of them wanted to see the provision temporarily extended to 1 April 2024. 2% of them didn’t state their preference for an alternative.

Several responses to the consultation mentioned how useful the flexibility is in enabling them to effectively deliver Occupational Health Service vaccination Schemes.

A number of respondents expressed the view that only doctors or nurses should be able to inject patients, however, this view does not reflect modern day to day NHS clinical practice. There was no evidence provided in consultation responses that suggested that there were safety concerns regarding making this provision, which has been in use for the last year, permanent.

Quotes from respondents

The provisions which expand the workforce have supported rapid and widespread roll out of the vaccination campaigns and they should be retained.

There are ongoing pressures on Occupational Health in the NHS (recognised in the NHS Growing Occupational Health Programme), short staffing within the speciality and in the NHS as a whole. The widened workforce has afforded greater flexibility in providing the covid and flu vaccines to our staff.

Feedback from our pre-consultation engagement with particular interested parties ahead of the public consultation, highlighted that stakeholders were very positive about how this amendment had been used in practice, commenting that it had brought added flexibility to the delivery of their Occupational Health Schemes, utilising additional workforce across health and social care to improve the reach and uptake of the vaccination campaign. All that answered this question were in favour of retaining the amendment permanently.

Quotes from informal consultation respondents

The flexibility enabled the COVID-19 vaccination programme to offer vaccinations from a variety of providers such as Hospital Hubs, Vaccination Centres, PCN Groupings and Community Pharmacy Contractors to those who were eligible for vaccination based on their employment, for example those who worked in health or social care” and “without this flexibility the vaccination of those vulnerable to COVID-19 would have been delayed.

Is there any operational need to add any other professions to the list of those who can supply and administer in relation to COVID-19 and influenza under an Occupational Health Scheme?

Respondents	Yes	No	I don’t know
All groups	22%	60%	18%
NHS, health service delivery and social care professionals	45%	31%	24%

Feedback from responses

As you can see from the table above 22% of all respondents and 45% of NHS, health service delivery and social care professionals want to see other professions added to the list of those who can supply and administer in relation to COVID-19 and influenza under an Occupational Health Scheme.

In summary, there were several respondents who called for a variety of different staff groups to be added to this provision, for example Anaesthesia Associates, Pharmacy Technicians, other AHP groupings with appropriate experience and a couple that called for all those able to vaccinate under PGDs to be able to vaccinate under an NHS or Local Authority Occupational Health Scheme.

As outlined above in the ‘themes’ section, from reading some of the responses it is clear that there is doubt about the status of operating department practitioners (ODPs), as these are currently allowed (until current provisions cease to have effect on 1 April 2022) to act as occupational health vaccinators in the NHS and Local Authorities.

A few respondents asked for this staff group to be added.

Quotes from respondents

Other AHPs may be able to support mass vaccination and preventative medicine in future.

Pharmacy technicians are registered professionals and are being used to undertake new roles, adding them to the range of staff who can vaccinate would increase the pool who could be called upon.

We suggest that the occupational health vaccinators list is expanded to include all those registered healthcare professionals currently listed in the PGD legislation.

Should the changes be extended to Occupational Health Schemes concerned with coronavirus and influenza vaccination and/or immunisation centres operating in the private sector as well those operating in the NHS and local authorities?

Respondents	Yes	No	I don’t know
All groups	32%	58%	10%
NHS, health service delivery and social care professionals	59%	24%	18%

Feedback from responses

Only a handful of respondents shared their comments on this question so there is very little detail to consider here other than the statistics above. These show that taken as a whole, the majority of respondents disagreed (58%) with extending this provision to the private sector, whereas the majority of NHS, health service delivery and social care professionals agreed (59%) with extending the provision to the private sector. 82% of individuals who are not NHS, health service delivery or social care professionals disagreed with extending the provision.

Quotes from respondents

As a private sector operator of NHS COVID-19 and influenza vaccination services, we believe it is fairest to treat us in line with public sector providers of such services.

We support this to ensure parity between NHS and private providers (who are often commissioned to provide NHS services especially in the out-of-hospital setting).

All health services should work together for the public good especially in times of crisis when vaccination is vaccination and all capacity counts.   It is logical and consistent therefore to extend these changes to centres operating the private sector.

4.2 Parenteral administration of prescription only medicines under a Patient Group Direction by NHS bodies and local authorities

The consultation proposed making the provision for parenteral (given by injection or infusion) administration of prescription only medicines under a PDG by NHS bodies and local authorities permanent.

PGDs can be issued under regulation 229 (exemption for supply by NHS bodies and local authorities) of the HMRs by a number of specified NHS bodies, or bodies exercising public health functions. This enables medicines to be given to patients without a prescription by a registered healthcare professional who is qualified and authorised locally to work under that PGD. As a result of the 2020 changes, a registered health professional from a profession which is able to supply or administer medicines under a PGD, is able to administer a parenteral medicine under PGDs issued in accordance with regulation 229.  Prior to the changes, only an appropriate practitioner (as defined in Regulation 214 of the HMRs) or a person acting in accordance with the directions of an appropriate practitioner, could do this under PGDs issued by specified NHS bodies, or bodies exercising public health functions. 

Without this flexibility there would have been significantly fewer professionals able to administer injectable vaccines leading to vaccine wastage, slower pace of administration of vaccines and/or more prescribers would have been diverted into the vaccination programme, creating an additional drain on healthcare capacity. This provision also aligns administration under PGDs by NHS bodies and local authorities with administration under PGDs for use in general practice.

Regulation 5(a) and 5(b) of the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (SI 2020/1594) made these changes to Regulation 229 of the HMRs.

Do you agree or disagree that this provision to enable parenteral administration of medicines under a PGD should be made permanent for COVID-19, influenza and any future pandemic disease?

Respondents	Agree	Disagree	I don’t know
All groups	37%	52%	11%
NHS, health service delivery and social care professionals	76%	20%	4%

Feedback from responses

52% of all respondents did not want to see the provision to enable parenteral administration of medicines under a PGD for COVID-19, influenza and any future pandemic disease made permanent. However, 76% of NHS, health service delivery and social care professionals did want to see the provision made permanent.

Of the NHS, health service delivery and social care professionals who did not want to see the provision made permanent, 67% of them would allow it to lapse and 22% of them would like to see it temporarily extended to 1 April 2024. 11% of them did not express their preference. Of the non-NHS, health service delivery and social care professionals who did not want to see the provision made permanent, 94% of them wanted to allow the provision to lapse and 4% of them wanted to see it temporarily extended. 2% did not express a preference.

Quotes from respondents

…the regulatory flexibilities in the round have allowed us to (as of 17 December 2021):  Recruit over 300 people to support our COVID-19 and flu vaccination services since we first established them in January 2021. Provide 50,000 flu vaccine doses. Provide 1.2m COVID-19 vaccine doses. Given this experience, we believe such flexibilities are an important contingency measure to have available for the future, and that they should be made permanent.

This has always worked well for GP practices, although protocols would work best in pharmacy settings.

The responses to our engagement with particular interested parties, ahead of the public consultation, were positive about this added flexibility and the ability to administer parenterally under a PGD. All respondents who answered this question were in favour of retaining the provision. A case for making it permanent was made, citing that this would aid understanding and long-term planning for organisations operating in health and social care.

Quotes from informal consultation respondents

This flexibility would be useful to retain, to potentially allowed trained individuals to administer medicines under a written instruction, for example in patients own homes (including residential homes).

4.3 National pandemic vaccination protocols and clinical supervision

The consultation proposed that an amendment is made to the national pandemic vaccination protocols provision in the HMRs that would require a clinical supervisor, who must be a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol, to be supervising at all times when vaccinations are taking place under such a protocol.

The changes made to the HMRs in 2020 introduced a new type of national protocol – new regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations). These require the approval by the Secretary of State and ministers in each of the devolved administrations. Under these protocols, those who are registered healthcare professionals who do not normally administer injectable vaccines, and people who are not registered healthcare professionals, are legally allowed to administer the COVID-19 or influenza vaccine.

Pandemic protocols under 247A have provided the flexibility to set out the training and competence requirements of vaccinators, clear roles and responsibilities for all stages in the process of preparing and administering the vaccines, and the clinical considerations they must follow. They provide that measures are taken to ensure patient safety, including but not limited to clinical treatment of any potential reaction to the administered vaccine, such as anaphylactic shock.

The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020/1125 and, in Northern Ireland, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020/349 inserted Regulation 247A to the HMRs to allow for new COVID-19 and influenza protocols.

The 247A pandemic protocol has been the preferred mechanism to enable the roll out of COVID-19 vaccinations during the pandemic. It allows the end-to-end vaccination process to be separated and for non-registered staff to support registered staff in the administration process. It also enables vaccinations to take place at pace using workforce models, based on the Royal College of General Practitioners’ Delivering Mass Vaccinations During COVID-19, A Logistical Guide for General Practice (July 2020).

In practice, the pandemic protocols have all included a requirement for a clinical supervisor, who must be a registered doctor, nurse or pharmacist, trained and competent in all aspects of the protocol, to be present and take overall responsibility for provision of vaccination under the protocol at all times and be identifiable to service users. Within regulation 247A itself, there is no express requirement that a clinical supervisor (by reference to specific healthcare professionals) must oversee all elements of supply under the protocol.

Do you agree or disagree that the HMRs (Regulation 247A) should be permanently amended to require coronavirus and influenza vaccination activities carried out pursuant to pandemic protocols to be supervised by a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol?

Respondents	Agree	Disagree	I don’t know
All groups	51%	38%	11%
NHS, health service delivery and social care professionals	64%	30%	6%

Feedback from responses

As you can see from the table above, the majority of all respondents (51%) and the majority of NHS, health service delivery and social care professionals (64%) agree that the HMRs should be permanently amended to require coronavirus and influenza vaccination activities carried out pursuant to pandemic protocols to be supervised by a registered doctor, nurse or pharmacist trained who is competent in all aspects of the protocol.

There were, however, some strong views that supervision was not needed to be made a legislative requirement for the above scenario, as long as vaccinators were appropriately trained. A couple of comments also called for more clarity over what ‘supervision’ actually means in practice.

Quotes from respondents

As long as a clinical professional who is registered has had the appropriate training to administer and supply medications they should not require supervision by a registered nurse or doctor or pharmacist, some of these professions are aligned to doctors and nurses such as ODP advanced clinical practitioner and therefore would not require the supervision of a nurse.

We do not agree that supervision by a doctor, nurse or pharmacist is needed as long as sufficient training given in managing severe allergic reactions.  Independent prescribers and trained clinicians should not need supervision and requiring this rather than leaving it to local decision-making (based on skill sets available) could severely restrict capacity and flexible deployment to meet needs.  It is also doubtful whether in pandemic situations this would be feasible given other capacity pressures.

4.4 Provisions for wholesale dealing and end stage preparation of vaccines

Situations arose during public health COVID-19 and influenza vaccination programmes where there were more vaccines than were needed in one healthcare organisation and too few in another separate healthcare organisation. The supply from one to the other would be classed as a wholesale distribution supply and, therefore, normally subject to having a wholesale dealer licence (see regulation 18 of the HMRs). If such a licence is not held by the organisation (for example 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 patients cannot access the vaccine that is necessary for public health protection and vaccines are wasted.

It is essential that we have the flexibility that vaccines can continue 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 and avoid wastage. The same considerations also apply to medicines to treat COVID-19 and influenza.

The consultation therefore proposed the further temporary extension (until 1 April 2024) of the provisions to change the rules that require holding of wholesaler dealer licences. This will allow for COVID-19 and influenza vaccinations to continue to be moved under NHS authorised arrangements between premises at the end of the supply chain by NHS bodies and the medical services of Her Majesty’s Forces that do not hold wholesale dealer licences (see regulation 19(4A) of the HMRs).

The amendments introduced in late 2020 also make changes to the rules around the requirement to have a wholesale dealer licence in the context of protocols under regulation 247 (exemption for supply in the event or anticipation of pandemic disease) (see regulation 19(4B) of the HMRs). Both these temporary changes provide that the supply of the products must be under ‘relevant arrangements’. These are defined as either arrangements for the provision of services as part of the NHS or armed forces health service (see regulation 19(4C)). The detail of these arrangements would need to be set out in the NHS (or armed services) arrangements for the provision of the vaccines and treatments, but further guidance would also be provided centrally. Guidance around maintaining safety and product integrity is required, but these will be product specific.

Throughout the COVID-19 vaccination campaign, on many occasions mutual aid has been used to rebalance the system between vaccine providers and to redistribute vaccines to the places where they could be used best and/or had the greatest need. The programme would have struggled without this flexibility if wholesale dealer licences were required at every point.

Under normal circumstances, the requirement for wholesaler dealer licences is an important safeguard. At this point in the COVID-19 pandemic response it is proposed that this flexibility is retained for a further period as mass vaccination campaigns continue, and we therefore propose to retain these provisions until 1 April 2024 for the benefit to public health.

Regulation 4 of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020/1125 amended regulation 19 of the HMRs to provide for this, ceasing to have effect on 1 April 2022.

Do you agree or disagree that the provision to enable providers of NHS services and medical services to HM Forces to distribute medicinal products to be used for vaccination or immunisation against coronavirus or influenza without the need for a wholesaler dealer licence should be temporarily extended to 1 April 2024 for COVID-19 and influenza?

Respondents	Agree	Disagree	I don’t know
All groups	41%	55%	4%
NHS, health service delivery and social care professionals	80%	14%	6%

Feedback from responses

55% of all respondents disagreed with this proposed provision whereas 80% of NHS, health service delivery and social care professionals agreed with it. Of the 14% of NHS, health service delivery and social care professionals that disagreed with this proposed provision, 86% of them would like to see the provision lapse and 11% did not answer. Of the 84% of non-NHS, health service delivery and social care professionals that disagreed with the provision, 97% of them would like to see the provision lapse, 3% did not answer.

Comments received on this topic were generally supportive citing reduction of waste and improved access to vaccines.  

Quotes from respondents

The pandemic is still ongoing so is the need for this the temporary provision in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns.

This has helped to reduce waste and also to improve access to the vaccines in areas where supply is limited.

The responses to our engagement with particular interested parties, ahead of the public consultation, were very positive about this provision and there was general support for retaining the amendment for COVID-19. It has proven to be very useful for mutual aid and moving vaccines to the places where they are needed most and/ or to prevent wastage. However, it was acknowledged that this should not be routine and should be limited to specific products and scenarios.

Quotes from informal consultation respondents

On many occasions mutual aid has been used to rebalance the system between vaccine providers and redistribute COVID-19 vaccines to the places where it could be used best/had the greatest need. The programme would have struggled without this flexibility/if Wholesale Dealer Licences were required at every point.

4.5 Easing final preparation of coronavirus vaccines

The public consultation proposed the temporary extension (until 1 April 2024) of existing provisions in the HMRs which relax some of the governance rules on the assembly, preparation and labelling of medicinal products and the need for manufacturers’ licences and marketing authorisations to enable the necessary actions taken by pharmaceutical companies and healthcare professionals to specifically prepare COVID-19 vaccines for administration to the public. These relaxations were under the proviso that the actions were done under NHS arrangements or arrangements as part of the medical services of Her Majesty’s Forces.

In the context of COVID-19, in practice this has allowed labelling with a new shelf life after thawing and preparation or reconstitution by the adding the recommended diluent. This has meant NHS teams have been able to use the skills and expertise of their staff in appropriate areas much more effectively and for various professions to focus on their areas of speciality, enabling safer systems of working, particularly at larger sites. The ability to prepare vaccines for administration flexibly, at a range of sites within a safe system has proven to be very useful. As the vaccination campaign progressed, NHS primary care networks have utilised the Enhanced Service Collaboration Agreement to share vaccines and enable a synergistic approach to delivery. Continuing this flexibility for a further period would be of benefit to public health and we therefore proposed to retain these provisions until 1 April 2024.

Regulation 4 of the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (SI 2020/1549) inserted a new regulation 3A (Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products) into the HMRs to provide for this, which ceases to have effect on 1 April 2022.

Do you agree or disagree that the provisions to enable the preparation of COVID-19 vaccinations without the need for manufacturers’ licences and marketing authorisations (which, among other things, relax the rules on packaging and labelling) should be temporarily extended to 1 April 2024?

Respondents	Agree	Disagree	I don’t know
All groups	33%	59%	7%
NHS, health service delivery and social care professionals	67%	20%	14%

Feedback from responses

59% of all respondents disagreed with this suggested temporary extension of the provisions to enable the preparation of COVID-19 vaccinations without the need for manufacturers’ licences and marketing authorisations (which, among other things, relax the rules on packaging and labelling) whilst 67% of NHS, health service delivery and social care professionals agreed with the suggestion.

Of those NHS, health service delivery and social care professionals who disagreed with the suggested extension, 70% of them would like to see it lapse and 33% didn’t answer. Of those non-NHS, health service delivery and social care professionals who disagreed with the provision, 97% of them wanted to see the provision lapse and 3% didn’t answer.

Quotes from respondents

This just helps with the delivery, supply and administration of these essential drugs in the control of this pandemic.

The pandemic is still ongoing so are variants.  So the need for this temporary measure till April 2024 is very much still needed and warranted.

These provisions have allowed us to be more flexible with our workforce and operations.

The responses to our engagement with particular interested parties, ahead of the public consultation, were positive about this added flexibility. The ability to store, make up and administer vaccines at a range of sites within a safe system has proven to be very useful. In fact, without this provision, these activities could not proceed and would greatly endanger deployment in primary care, where handling of frozen products and disposal of dry ice are significant barriers to use. Most responses supported retaining the provision for COVID-19. However, one response urged caution: suggesting further consultation and that reformulating a vaccine potentially should not be allowed in the long-term.

Quotes from informal consultation respondents

This has allowed teams to use the expertise available much more effectively and for various professions to focus on their areas of speciality, enabling safer systems of working, particularly at larger sites” and “Pop-up and roving vaccination models have been and continue to be used within the COVID-19 vaccination programme – these need to be retained for outreach activity to ensure the vaccine is as accessible as possible.

4.6 Supply of coronavirus or influenza vaccines by a pharmacy

In the consultation we proposed making permanent the temporary provisions of the HMRs which allow providers of retail pharmacies who are providing a coronavirus or influenza vaccination or immunisation service under PGD to provide that service away from their registered premises.

Regulation 8 of the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (SI 2020/1594) inserted a new paragraph into regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the HMRs provide for this up until it ceases to have effect on 1 April 2022.

This flexibility has been used on a regular basis by the majority of community pharmacy run COVID-19 vaccination sites, where the main site was located away from their normal registered premises. It has also allowed many hundreds of pharmacies to offer pop-up clinics, in particular supporting groups of patients where bookings were not able to be made on the health service booking system of the relevant country (for various reasons) where there were particular infection clusters or in locations where there were clusters of unvaccinated patients. Additionally, this flexibility has allowed teams to vaccinate residents and carers in care homes.

This flexibility was also used in the 2020 to 2021 seasonal influenza programme to support an increase in vaccinations from the previous year and has been already been used widely in the 2021 to 2022 season.

Do you agree or disagree that the provision which enables providers of retail pharmacies who are providing an immunisation or vaccination service for coronavirus or influenza under PGD to provide that service away from their normal registered premises should be made permanent?

Respondents	Agree	Disagree	I don’t know
All groups	39%	57%	5%
NHS, health service delivery and social care professionals	76%	16%	8%

Feedback from responses

The majority of all respondents disagreed (57%) with this proposed provision whereas the majority of NHS, health service delivery and social care professionals (76%) agreed with it. Of those NHS, health service delivery and social care professionals who disagreed with the suggested provision being made permanent, 63% of them would like to see it lapse, 25% of them would like to see it temporarily extended to 1 April 2024 and 11% of them did not express a preference. Of those non-NHS, health service delivery and social care professionals who disagreed with making this provision permanent, 97% of them wanted to see it lapse and 3% wanted to see it temporarily extended to 1 April 2024.

There was a wide range of comments backed up by detailed evidence which supported making this provision permanent. No patient safety concerns were raised.

Quotes from informal consultation respondents

Would help with the annual influenza programme in order to capture groups with poor uptake.

We operate 10 Covid-19 Vaccination Centres, the ability to offer this offsite has enabled us to safely deliver mass vaccinations.

This will improve efficiency of the vaccination programme and make access more convenient to particular patient groups (e.g. care home residents).

The current relaxation of the Regulations have allowed community pharmacies to successfully set up and provide vaccination services from a number of locations and this has contributed significantly to the national vaccination call to arms.  In these uncertain times, we cannot know when these flexibilities will be required again and therefore …. would again urge DHSC to act pragmatically and make this flexibility permanent.

The responses to our engagement with particular interested parties, ahead of the public consultation, were very positive about this provision, stating that it helped pharmacies to offer pop-up clinics away from their registered premises, where there were particular infection clusters or in locations where there were high levels of unvaccinated patients. All of the stakeholders that answered this question were in favour of retaining the provision permanently.

Quotes from informal consultation respondents

Community pharmacies are often small spaces which do not lend themselves to offering vaccinations at any scale.  In order to effectively offer vaccinations such as ‘flu and COVID at any scale community pharmacies need to have this flexibility.  It ensures they can offer vaccines in an appropriate location where factors affecting the individual being vaccinated (confidentiality, access, parking etc) can be considered.  Additionally it allows the main pharmacy premises to continue its routine work without disruption.

4.7 Extension of these provisions to all future pandemic scenarios

Future pandemics may arise from illnesses other than COVID-19 or influenza but may still lead to a requirement for a mass vaccination campaign. It may therefore be beneficial to enable the provisions discussed in the consultation document to be applicable in all pandemic scenarios. At this stage DHSC was simply seeking views on this approach, in order to help formulate our plans. Any changes to our policy on these provisions specifically would require further future public consultation.

Do you agree or disagree that the provisions listed above should be amended to include all future pandemic scenarios?

Responses	Agree	Disagree	I don’t know
All groups	40%	53%	7%
NHS, health service delivery and social care professionals	80%	14%	6%

Feedback from responses

The majority of all respondents (53%) disagreed with the proposal that the provisions discussed in the consultation document should be amended to include all future pandemics. Conversely, however, 80% of NHS, health service delivery and social care professionals agreed with the proposal.

Quotes from respondents

Yes, it is sensible to be able to react quickly in the event of all future pandemic emergencies.

I can see that we will see many variants of diseases moving forward, and this will be essential part in the maintenance and prevention of unnecessary deaths.

Yes and no, only as temporary extensions to future Pandemics. Not permanent.

All the flexibilities are important contingency measures to have readily available in the event of future pandemics.

5. Next steps

An expanded workforce is required to ensure that the COVID-19 vaccine can continue to be safely deployed at the necessary scale and pace required alongside influenza vaccine and other NHS activities. Capacity to undertake these activities would be severely constrained if the regulations which will cease to have effect on 1 April 2022 are not extended. 

Following the analysis of consultation responses and taking into account the continuing need for mass vaccination, we will prioritise implementation of those provisions that will lapse on 1 April 2022, to enable health services to continue to plan and operate mass vaccinations.

The next steps for these and the other proposals are as follows:

Tranche 1, to be laid before Parliament in early 2022: those regulations that are currently due to lapse on 1 April 2022, as detailed above. This will give health services the certainty they need to be able to continue to plan and operate mass vaccination programmes on the same basis as now.

Tranche 2, clinical supervision within vaccine centres: this received broad support and will be taken forward at the next legislative opportunity.

Tranche 3: provisions relating to extending workforce flexibilities to Occupational Health Schemes in the private sector and adding professional groups to those who can already vaccinate under Occupational Health Schemes. Limited evidence was received through this consultation on these provisions. We will undertake further targeted evidence gathering before making a final decision.

Tranche 4: extension of all of the arrangements to any future pandemic, not limited to COVID-19 or influenza - this will be considered further and subject to further public consultation, as indicated previously.

More detailed information on the contents of the 4 tranches of provisions is set out below:

5.1 Tranche 1: provisions to be made in legislation to come into force on 1 April 2022

Expanding the workforce

Permanently retain the provisions which expand the workforce for NHS bodies or local authorities operating an Occupational Health Scheme in relation to coronavirus and influenza vaccination and/or immunisation.

Parenteral administration of prescription only medicines under a Patient Group Direction by NHS bodies and local authorities

Permanently retain the provision to enable parenteral administration of medicines under a PGD.

Make provisions for wholesale dealing and end stage preparation of vaccines

Temporarily extend to 1 April 2024 the provision to enable providers of NHS services and medical services to HM Forces to distribute medicinal products to be used for vaccination or immunisation against COVID-19 or influenza without the need for a wholesaler dealer licence.

Easing final preparation of coronavirus vaccines

Temporarily extend to 1 April 2024 the provisions to enable the preparation of COVID-19 vaccinations without the need for manufacturers’ licences and marketing authorisations (which, amongst other things, relax the rules on packaging and labelling).

Supply of coronavirus or influenza vaccines by a pharmacy

Permanently retain the provision which enables providers of retail pharmacies who are providing an immunisation or vaccination service for COVID-19 or influenza under PGD to provide that service away from their normal registered premises.

5.2 Tranche 2: clinical supervision

Creating a permanent statutory obligation for COVID-19 and influenza vaccination activities carried out under pandemic protocols to be supervised by a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol.

5.3 Tranche 3: occupational health schemes in the private sector, and further expansion of the workforce

Adding any other relevant registered healthcare professions to the list of those who can supply and administer vaccinations for COVID-19 and influenza under an Occupational Health Scheme.

Extension to Occupational Health Schemes in the private sector of the wider list of registered healthcare professionals who can supply and administer vaccinations for COVID-19 and influenza.

5.4 Tranche 4: extension of these provisions to all future pandemic scenarios

Applying the following provisions to all future pandemic scenarios:

• permanently retain the provisions which expand the workforce for NHS bodies or local authorities operating an Occupational Health Scheme in relation to vaccination and/or immunisation

• enabling providers of retail pharmacies who are providing an immunisation or vaccination service for coronavirus or influenza under PGD to provide that service away from their normal registered premises

• creating a permanent statutory obligation for vaccination activities carried out under pandemic protocols to be supervised by a registered doctor, nurse or pharmacist trained and competent in all aspects of the protocol

• adding any other relevant registered healthcare professions to the list of those who can supply and administer vaccinations under an Occupational Health Scheme

• extension to Occupational Health Schemes in the private sector of the wider list of registered healthcare professionals who can supply and administer vaccinations

5.5 Assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021

We propose to make the legislative changes using powers in Part 2 of the Medicines and Medical Devices Act 2021 (the Act), which provides powers to make, amongst other things, amendments to the HMRs. Section 2 of the Act provides that patient safety must be the overarching objective of the appropriate authority when making regulations. Section 2 requires that when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to 3 factors:

1. The safety of human medicines and that the benefits of doing so outweigh any risks

2. The availability of human medicines

3. The likelihood of the relevant part of the United Kingdom being seen as a favourable place which to:

• carry out research relating to human medicines

• conduct clinical trials

• manufacture or supply human medicines

As set out in section 2(3) of the Act, where regulations under section 2(1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

The appropriate authority is the Secretary of State for Health and Social Care in relation to GB and, in relation to Northern Ireland, it is the Department of Health in Northern Ireland and the Secretary of State acting jointly. Both parties will make the final decision on making any legislative changes under section 2(1).

We assessed the above proposals against each of the factors set out in section 2 for the public consultation exercise and our assessments have not changed.

5.6 Parliamentary Procedure

The amendments to the HMRs will be made using powers within the Medicines and Medical Devices Act 2021. The SI will be subject to the draft affirmative procedure in both the Northern Ireland Assembly and the Houses of Parliament.

1. Note that due to rounding, figures may not add up to 100%. ↩