Date Laid: 10 November 2021
Parliamentary procedure: affirmative
This instrument extends the requirement for mandatory COVID-19 vaccination to anyone working in the NHS on a regulated activity in the health and social care sector who will have direct, face to face contact with a service user. In our 10th Report on the preceding Care Homes Regulations, we said that if the Department of Health and Social Care (DHSC) decided to extend its mandatory vaccination policy, we would expect to see a more effectively argued case for it: unfortunately, the Explanatory Memorandum (EM) accompanying this instrument is just as superficial.
DHSC has published other documents in relation to this instrument but useful information is scattered between them and much of it, particularly the “Impact Statement”, is very broad brush. The Statement is no substitute for the required Impact Assessment (IA), which should have been integral to the policy development process. An IA should include both detailed consideration of the costs and benefits of the policy chosen and allow it to be compared with rejected alternative solutions.
Our many concerns include:
1.These Regulations are drawn to the special attention of the House on the grounds that the explanatory material laid in support provides insufficient information to gain a clear understanding about the instrument’s policy objective and intended implementation.
2.This instrument would make it mandatory for anyone in England working for the NHS in a “regulated activity” to be fully vaccinated against coronavirus unless subject to medical exemption. An equivalent requirement is also applied to anyone “employed or otherwise engaged” for the purposes of a “regulated activity” by a “registered person” within the health and social care sector. This includes care provided in a “service user’s” own home.
3.In relation to care and nursing homes, the same rules apply as set out in the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 (“the Care Homes Regulations), principally that the registered person must not let a person other than a service user or his or her family enter the premises unless they can provide evidence that they have been vaccinated with the complete course of an authorised vaccine. This is subject to a short list of exceptions, which these Regulations extend to include anyone participating in an authorised clinical trial or who may have received different vaccines (listed in Schedule 4), as long as they have had a top up dose of an authorised type at least 21 days before commencing work.
4.In relation to other regulated activities, which cover a very wide range of medical and social care services, the same requirements for full vaccination against coronavirus apply (including the new exceptions) unless the person is medically exempt or “will not have direct, face to face contact with a service user”.
5.One innovation is a provision for newly employed workers: they may start work providing they have had one dose of an authorised vaccine at least 21 days previously or have been vaccinated with “other” vaccines. They must, however, have met the legislation’s conditions, generally a requirement for a top up dose of an authorised vaccine, within 10 weeks if they are to continue to be deployed.
6.These provisions are due to come into effect 12 weeks after these draft Regulations are made but the Government have announced that the intended start date is to be 1 April 2022. The Secretary of State will be required to report annually to Parliament on the operation of these Regulations.
7.We are disappointed that the Explanatory Memorandum (EM) lacks all practical detail. Its content is minimal, giving only a high-level overview of the policy without giving an adequate description of how the legislation will apply in the real world or what its consequences may be.
8.Paragraph 7.2 of the EM gives the current levels of COVID-19 vaccine uptake in NHS England. As with the EM accompanying the Care Homes Regulations, the EM for this instrument fails to address some fundamental points: while high levels of vaccination among NHS staff are desirable to protect vulnerable patients, there is no explanation of why the current level of 92% is insufficient, whether a 100% vaccination rate is feasible, and why local action is not possible to deal with facilities falling below the 80% minimum staff vaccination rate advocated by the Scientific Advisory Group for Emergencies (SAGE). The EM repeatedly states that there is a strong case for making vaccination mandatory in these settings but fails to provide an evidence-based argument.
9.The press release issued by the Department of Health and Social Care (DHSC) includes more figures than the EM. For example, it states that 103,000 NHS trust workers and 105,000 domiciliary care workers are not yet fully vaccinated which tells us the size of the issue being dealt with. DHSC has published several other documents relevant to the instrument but the EM references them only obliquely and provides no links to access the documents. To gain an understanding of the issues involved, we have had to trawl:
10.An EM should set out the case for an instrument’s underlying policy and describe its intended effect. It should be a freestanding, comprehensive explanation, and it should not be necessary to conduct extensive research into other documents in order to achieve an understanding of what an instrument does: we regard this EM as an example of poor practice.
11.Searching through these other documents has provided us with some understanding of what is intended, but the instrument contains a number of terms which are not defined or explained.
12.We are told in the EM that the Government intend to publish operational guidance by the end of December 2021. We are also told that “the Code of Practice relating to health care associated infections will be updated to supplement this instrument, providing guidance about compliance with this instrument”, and that the requirement for a top-up dose of an authorised vaccine will be subject to UK Health Security Agency guidance. We regularly raise the concern that unclear definitions in the law may be “interpreted” in guidance to exceed what the legislation actually requires.
13.In supplementary material from DHSC we discovered that the proposed operational guidance is published in draft at the end of the Department’s response to the consultation. The draft guidance answers some of our questions about what evidence of vaccination is acceptable and how the registered person is required to record it. It is disappointing therefore that the EM did not mention the availability of this useful material, and this example provides an illustration of our comments about the EM’s poor quality.
14.Some of the terms used in these Regulations, for example “registered person”, are set out in the Health and Social Care Act 2008 (“the 2008 Act”) and associated regulations, but it would have been helpful if the EM had described who that means in practice–for example, in a hospital, would the checking duties on a registered person be the responsibility of the Board, the head of human resources, or the head of each clinical team?
15.Other terms that are crucial to understanding the scope of this legislation are not in the 2008 Act, and so we asked DHSC for an explanation:
“The definition of direct face to face is the common word understanding of face to face.
The Green Book recommends COVID-19 vaccination for all staff who have frequent face-to-face clinical contact with patients and who are directly involved in patient care in either secondary or primary care/community settings. It also recommends COVID-19 vaccination for non-clinical ancillary staff who may have social contact with patients but are not directly involved in patient care. This group includes receptionists, ward clerks, porters, and cleaners.
DHSC and the NHS will provide further guidance to the sector to help providers identify who is in/out of scope. The intention is to provide sufficient flexibility to local circumstances and we do not believe a prescriptive list of roles would be possible or helpful. If an IT worker employed in the provision of the regulated activity has direct contact with patients–which would be very likely if they are installing equipment on a ward, they would be in scope of the requirements.”
“Otherwise engaged’ is not defined in the Regulations, and should be given its plain, ordinary meaning. It captures those workers that are deployed for the provision of the regulated activity but are not contractually obligated to the registered person. As such, volunteers are in scope of the regulations.”
16.We understand that there is uncertainty amongst some healthcare providers about the meaning of these terms and also that implementing them may be particularly problematic in the community healthcare sector.
17.In the IA for the Care Homes Regulations, DHSC supported the proposal not to permit anyone who is unvaccinated to enter the premises on the grounds that:
“SAGE have advised that while there may be staff on site who never come into contact with service users, co-worker networks have been shown to be an important factor in transmission. This means unvaccinated individuals entering the home remain a potential source of infection and transmission in the home, regardless of whether they provide close care to service users.”
18.The House may wish to press the Minister for an explanation of the apparent inconsistency in DHSC’s policy, whereby under these Regulations non-care home staff who are not in face to face contact with patients are exempted despite SAGE’s suggestion that co-workers may be “an important factor in transmission”.
19.We are also disappointed that the EM is silent on the Government’s decision not to provide an exemption on the ground of religious and other beliefs, which in our 10th Report we described as “an important principle that should have been fully justified in the EM”.
20.The matter is addressed, however, in the Department’s response to the consultation in which it reiterates the view that was given by the Minister in oral evidence to the Committee on the Care Homes Regulations. DHSC says:
“We have considered exemptions for those who refuse the vaccine due to religious beliefs and have decided not to provide this exemption. This type of exemption would be difficult to implement or prove and would likely significantly reduce impact of the policy in achieving its aims of increasing levels of protection for both the workforce and patients. It may also cause tension between those who have been exempted and other workers who have been required to be vaccinated as a condition of deployment.”
21.The Equality Impact Assessment says that DHSC has “no data on the numbers in the social care workforce who follow these religions or hold beliefs that may make them reluctant to take the COVID-19 vaccination”. We appreciate that such an exemption might be difficult to enforce, but DHSC provides no evidence to support the assertions that it would undermine the policy or cause tension among co-workers.
22.The Equality Impact Assessment, which examines the effect of the policy on people who share a “protected characteristic”, does however include the following estimates:
23.It concludes that where these various factors combine, for example in London which has the most diverse workforce (66% black, Asian, and minority ethnic (BAME)) and also the most crowded conditions and highest vaccine hesitancy, the numbers likely to refuse the vaccine are greater and they may elect to leave the workforce as an alternative to taking the vaccine.
24.There were nearly 35,000 responses to the consultation with an overall majority of 64% objecting to mandatory vaccination on a range of grounds including religious belief, ethical concerns and civil liberties. Members of the adult social care workforce who responded were almost evenly split. Given the degree of objection and its potential to reduce the sector’s workforce, the House may wish to ask the Minister why these individuals’ views could not be accommodated.
25.DHSC also consulted on a proposal to oblige those working in regulated activities to have a flu vaccination: 65% of respondents rejected the proposal. We note however that, for the flu season 2020–21, 76.8% of frontline care workers took the flu vaccination voluntarily. The Department’s response to the consultation says:
“The government has considered the concerns raised in relation to introducing flu vaccination requirements. The flu programme runs between October and March with most flu vaccinations happening October and January. Due to the need to balance this with the time necessary for health and social care to implement the regulations, the government has decided not to introduce vaccination requirements for flu at this time. The government will keep this under review following this winter and ahead of winter 2022–23.”
26.The House may wish to raise any concerns about the principle of mandatory vaccination with the Minister at this point because these Regulations would appear to set a precedent that DHSC may rely on in the future.
27.DHSC has published an “Impact Statement.” Although it contains some useful information, the Department neither highlights key figures from it nor responds to them in the EM. Since it is not an Impact Assessment (IA), it does not include third-party validation and is not published on the legislation.gov.uk website alongside the Regulations so that all potential readers can find it easily.
28.The earlier Care Home Regulations also used this device of an “Impact Statement”. The formal IA was not made available until some four and a half months after that instrument was laid before Parliament and one day before the legislation came into effect. We regard this as very poor practice.
29.Speaking about these new Regulations, the Minister, Lord Kamall, announced that DHSC would publish a full IA as soon as possible and before Members vote on the proposed legislation. This is not good enough. An IA should be produced alongside the legislation and inform policy development, including explaining other policy options explored and dismissed. It should then be published at the same time as the instrument is laid so that those affected can understand the legislation’s practical implications.
30.We regret that DHSC has not adhered to the well-established government practice of providing detailed impact information in a standardised and validated format at the appropriate time.
31. We regard the Impact Statement provided as a token effort that largely raises issues as bullet points without serious discussion of their broader effects. For example, according to DHSC’s figures, of the 208,000 workers in the sector who are currently unvaccinated, 126,000 workers are expected not to comply, and 46,000 are medically exempt, from this we may deduce that this legislation will result in only 36,000 additional staff being vaccinated. DHSC’s own estimate in the Impact Statement puts this at 54,000 (26%) additional staff vaccinated. The figures are confusing. In either case this seems a disproportionately small result for legislation that is anticipated to cause large costs and disruption to the health and social care sector at the end of the grace period. The House may expect to be provided with some very strong evidence to support this policy choice, and DHSC has signally failed to do so.
32.Vaccination has significant benefits from lives preserved, people ill but not hospitalised with COVID-19, and the NHS workforce losing less staff time through sickness. We are well aware of the societal benefit from extensive vaccination but also note that vaccination reduces but does not eliminate transmission of the disease and other hygiene and testing measures will still need to be relied on.
33.The increase in protection from vaccinating the last 8% of health workers may be marginal, and the requirement’s benefits need to be quantified, so that they can be weighed up against the policy’s negative impacts on the healthcare system. The Impact Statement gives a broad-brush view, and both it and the EM are silent on what contingency plans DHSC is making to cope with expected staff losses when these Regulations take effect.
34.The Impact Statement estimates that 5.4% of the health and social care workforce (126,000 staff) will still be non-compliant by the time these Regulations come into force and £270 million will need to be spent in recruitment and training costs to replace these individuals.
35.More worryingly, it states that the effective capacity of the labour market to respond to this change is unknown, and particularly at the end of the grace period there is “significant workforce capacity risk” to an already stretched healthcare system. It also states that DHSC “cannot be confident that the system, even with additional funding will be able to absorb the loss of capacity without further intervention”, but makes no comment on what intervention might be required. The House may wish to ask the Minister how DHSC plans to provide this capacity and at what cost.
36.This instrument, to extend COVID-19 vaccination requirements to the whole of the health and social care sector, was laid two days before the “pilot” instrument requiring vaccination in the care home sector came into effect. There is little reference to any lessons learned from the initial scheme in the assorted documents published, although the Health Secretary’s statement on the day the new Regulations were laid said that “the number of people working in care homes who have not had at least one dose has fallen from 88,000 to just 32,000 at the start of last month”.
37.The Impact Statement on the Care Home Regulations, which was provided just before they were debated on 20 July, suggested that around 7% of staff would no longer be able to operate in care homes after the change in the law. The newly published IA uses that same 7% figure which it equates to 38,000 workers. We note a number of articles now appearing in the press about the effects of the cut-off date on care home staffing, and the IA makes clear that effects will vary significantly from local authority to local authority. We recommend that, before the House debates these Regulations, DHSC should provide a fuller and clearer statement of how the Care Home Regulations have affected the care home workforce.
38.We said in our 10th Report on the Care Homes Regulations that high levels of voluntary vaccination among front line staff weakens DHSC’s arguments for using legislation as leverage, and we would therefore expect any regulations extending the mandatory vaccination policy to be accompanied by a much more detailed and structured justification. Sadly, this EM is just as superficial as the last one.
39.Advice from SAGE and the Joint Committee on Vaccination and Immunisation is alluded to but never presented for scrutiny. The EM offers no information about what the changes mean in practice - that is deferred to future guidance. There is a broad-brush statement of potential effects but no plans offered to deal with anticipated negative consequences when the Regulations take effect on 1 April 2022. DHSC has provided no single coherent statement to explain and justify its intended policy, and this undermines the ability of the House to undertake effective scrutiny.
40.The Secretary of State wrote to the Committee offering, in the absence of an IA, to attend an oral evidence session to answer any questions on this policy or DHSC’s approach. While grateful for his offer, we did not it up. Our decision was based on a point of principle–namely, that clear and comprehensive explanatory material should be laid at the same time as an instrument is laid, so that it is available to all interested parties both inside and outside Parliament.
1 , see SLSC, (Session 2020–21, HL Paper 40) and (Session 2020–21, HL Paper 50).
2 Defined in ss 8 and 9 of the Health and Social Care Act 2008. It includes physical and mental health provision, as well as all forms of personal care and other practical assistance provided for individuals who by reason of age, illness, disability, pregnancy, childbirth, or dependence on alcohol or drugs, may require it.
3 DHSC, ‘Press Release: Government to introduce COVID-19 vaccination as a condition of deployment for all frontline health and social care workers’ (9 November 2021): [accessed 24 November 2021].
4 DHSC, Impact Statement: Making vaccination a condition of deployment in health and wider social care sector (9 November 2021): [accessed 24 November 2021].
5 DHSC, The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021—Vaccination as a Condition of Deployment in Care Homes (20 July 2021): [accessed 24 November 2021].
6 DHSC, Making vaccination a condition of deployment in health and wider social care sector—Government response to public consultation (9 November 2021): [accessed 24 November 2021].
7 DHSC, Making vaccination a condition of deployment in health and wider social care settings— Equality Impact Assessment (9 November 2021): [accessed 24 November 2021].
8 DHSC, ‘Coronavirus (COVID-19) vaccination of people working or deployed in care homes: operational guidance’ (updated 19 October 2021): [accessed 19 November 2021].
9 DHSC, Making vaccination a condition of deployment in health and wider social care sector—Government response to public consultation (9 November 2021) p.58–70: [accessed 24 November 2021].
10 UK Health Security Agency, COVID-19: the green book, chapter 14a, 27 November 2020: 24 November 2021]. [accessed
11 DHSC, The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 Vaccination as a Condition of Deployment in Care Homes (20 July 2021): [accessed 24 November 2021].
12 (Rt Hon. Nadhim Zahawi MP).
13 DHSC, Making vaccination a condition of deployment in health and wider social care settings— Equality Impact Assessment (9 November 2021): [accessed 24 November 2021].
14 DHSC, Making vaccination a condition of deployment in health and wider social care sector—Government response to public consultation, (9 November 2021): [accessed 24 November 2021]
15 Public Health England, Seasonal flu vaccine uptake in healthcare workers: winter 2020 to 2021 (24 June 2021): [accessed 24 November 2021].
16 HL Deb, 10 November 2021, [Lords Chamber].
17 Public Health England, Press Release: One dose of COVID-19 vaccine can cut household transmission by up to half (28 April 2021): [accessed 24 November 2021].
18 HC Deb, 9 November 2021, .
19 Community Care, ‘Mandatory vaccination enforced in care homes amid mounting staff gaps and job loss warnings’: [accessed 19 November 2021].
20 The correspondence is published in Appendix 1 of this Report.