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The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 were laid before both Houses on 22 June 2021. The regulations are subject to the draft affirmative procedure. They were approved by the House of Commons on 13 July 2021 by 319 votes to 246. The regulations are due to be considered by the House of Lords on 20 July 2021.

The Government has said in the regulation’s explanatory memorandum that the purpose of the regulations is to reduce the spread of coronavirus in care homes to protect residents who are vulnerable to the disease. The regulations would require that “the registered person for nursing and personal care” in a care home in England must ensure that no one enters the care home unless they can provide evidence that they have been fully vaccinated by an authorised vaccine against coronavirus, subject to certain exceptions. The House of Lords Secondary Legislation Scrutiny Committee has noted that:

Care home residents, their family and friends, and emergency services are exempt, but the regulations cover a wide range of people including staff, tradespeople and service providers who might routinely need to enter a care home.

Baroness Wheeler (Labour) has tabled the following amendment to the motion to approve the regulations in the House of Lords:

Baroness Wheeler to move, as an amendment to the above motion [to approve the regulations], at the end to insert “but that this House regrets that the regulations do not include any information about how the legislation will operate and that this will be left to guidance that will not be available until the end of July; further regrets that a full impact assessment has not been published including analysis of the number of current staff who may not comply and the potential impact on care homes if care home staff become ineligible for work because they are not fully vaccinated or medically exempt; notes that the Secondary Legislation Scrutiny Committee recommended that the debate on the instrument should be deferred until the operational guidance and full impact assessment has been published; and calls on Her Majesty’s Government to provide stronger supporting evidence for permanently requiring staff to have received both doses of the vaccine or, if they have not, to be banned from entering their workplace”.

Purpose of the regulations

The explanatory memorandum cites advice from the Scientific Advisory Group for Emergencies (SAGE) Social Care Working Group that vaccine rates of 80% in staff and 90% in residents in each care home setting would be needed to provide a minimum level of protection against coronavirus outbreaks. The explanatory memorandum states that “only 65% of care homes in England are currently meeting this dual threshold, and the proportion is only 44% of care homes in London”.  It also states that the Government was delivering a targeted programme of work to support vaccine uptake amongst adult social care workers, including an “extensive communications programme”. Despite the Government’s actions “vaccine uptake amongst care home workers is not consistently at the level we know from SAGE advice is needed to minimise the risk of outbreak”.

In a press release on the policy, the then Secretary of State for Health and Social Care, Matt Hancock, said that vaccination had saved lives but the Government needed to continue to reduce risk:

Vaccines save lives and while staff and residents in care homes have been prioritised and the majority are now vaccinated we need to do everything we can to keep reducing the risk.

Through our consultation we have listened to the experiences and concerns of providers and people living and working in care homes to help shape our approach.

We have a responsibility to do all we can to safeguard those receiving care including in the NHS and so will be consulting further on whether to extend to other health and social care workers.

This is the right thing to do and a vitally important step to continue protecting care homes now and in the future. I’d urge anyone working in care homes to get their jab as soon as possible.

The explanatory memorandum states that under the Health and Social Care Act 2008 (the 2008 act), the Care Quality Commission (CQC) was established and given responsibility for “maintaining a registration system for providers of health and adult social care who carry out regulated activities”. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 were made under the 2008 act and prescribe the kinds of activities that are regulated activities for the purposes of the 2008 act. The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 would make amendments to the 2014 regulations.

The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 (the regulations) would require that “the registered person for nursing and personal care” in a care home must ensure that no one enters the care home unless they can provide evidence that they have been fully vaccinated by an authorised vaccine against coronavirus or that another exemption applies to them. People would only be able to enter a CQC registered care home in England if they met one of the following requirements:

  • the person is a service user of the regulated activity in the premises used by the registered person;
  • the person has provided the registered person with evidence that satisfies the registered person they have been vaccinated with the complete course of an authorised vaccine;
  • the person has provided the registered person with evidence that satisfies the registered person that for clinical reasons they should not be vaccinated;
  • it is reasonably necessary for the person to provide emergency assistance in the premises;
  • it is reasonably necessary for the person to provide urgent maintenance assistance to the premises;
  • the person is a member of the emergency services in execution of their duties;
  • that a person is a friend or relative of the service user visiting the service user.
  • the person is visiting a dying service user;
  • it is reasonably necessary for the person to provide comfort or support to a service user in relation to a service user’s bereavement following the death of a relative or friend; or
  • the person is under the age of 18.

The regulations include a review provision. This would require the secretary of state to review the operation and effect of the regulations. They would have to publish a report within one year after the date on which the regulations came into force and within each successive one-year period.

The regulations would come into force 16 weeks after the day on which they are made. The Government has described this as a “grace period” for implementation of the policy. It stated that this would help providers partially mitigate a likely “short-term cost of dealing with staff absences, if workers chose not to get vaccinated as a result of the policy”. A press release on the policy provided the following explanation of when the grace period would apply:

The new legislation means from October—subject to Parliamentary approval and a subsequent 16-week grace period—anyone working in a CQC-registered care home in England for residents requiring nursing or personal care must have 2 doses of a COVID-19 vaccine unless they have a medical exemption.

The Department of Health and Social Care (DHSC) ran a consultation on making vaccination a condition of deployment in older adult care homes in England between 14 April and 26 May 2021. The DHSC published its response to the consultation on 16 June 2021. The explanatory memorandum to the regulations referenced the consultation stating that “overall, a majority (57%) of respondents did not support the proposal but the responses from the adult social care sector were mixed”. It cited respondents “who highlighted clearly issues with the initial scope of including only CQC registered care homes with at least one older (65+) adult”. The explanatory memorandum also stated there was “significant support” for broadening the policy to “include all those coming into close contact with residents or all those entering care homes in any capacity”. Therefore, the DHSC extended the scope to all CQC-registered care homes in England providing accommodation for nursing or personal care and “to include all persons who enter a care home, regardless of their role”, excluding the exceptions. The explanatory memorandum argued that the consultation together with public health evidence provided “a strong foundation” on which to proceed with the policy.

Impact assessment and guidance

The explanatory memorandum states that the Government “intends to publish operational guidance by the end of July” and that an impact assessment had been prepared and would be made available online:

A full impact assessment has been prepared and will be submitted. Once available it will be laid in Parliament and published alongside the explanatory memorandum on the legislation.gov.uk website.

The House of Lords Secondary Legislation Scrutiny Committee criticised the Government for not yet having published either of these documents. The committee’s report is discussed further below. Following the report, Nadhim Zahawi, Minister for Business and Industry and Minister for COVID Vaccine Deployment at DHSC, gave oral evidence to the committee. In the uncorrected transcript Mr Zahawi said that “we will have that [the impact assessment], I hope, by the end of July”. He also said that he hoped to be able “to do an impact statement before the Lords debate” on the regulations. On guidance, Mr Zahawi said that “because of our experience over the past eight months with the vaccination programme, we want to coproduce guidance with the sector”. He said this would deliver the best operational outcome and that “a lot of work is taking place on the cocreation of the guidance”.

Please see the end of the section on the Secondary Legislation Scrutiny Committee’s report below for an update.

On 13 July 2021, the Regulatory Policy Committee (RPC) published a statement saying that an impact assessment should have been produced and sent to the committee:

The DHSC has not yet submitted an appropriate impact assessment (IA) to the RPC for us to assess and provide an opinion on. As a qualifying regulatory provision, an IA should have been produced by the department, submitted to the RPC for independent scrutiny, seen by ministers and presented to Parliament.

We remain open to the DHSC submitting an appropriate IA for RPC scrutiny to allow us to provide an opinion on whether it is fit for purpose or not fit for purpose.

The RPC is an independent body, sponsored by the Department for Business, Energy and Industrial Strategy. It assesses “the quality of evidence and analysis used to inform regulatory proposals affecting the economy, businesses, civil society, charities and other non-government organisations”.

Secondary Legislation Scrutiny Committee report

The House of Lords Secondary Legislation Scrutiny Committee considered the regulations in its report published on 8 July 2021.

The committee was critical of the explanatory memorandum and a lack of detailed information published by the Government, including the operational guidance and impact assessment:

The explanatory memorandum lacks all practical detail about what evidence is acceptable, and how a “registered person” “may process” that information. The DHSC promises more detail in operational guidance but that will not be available until the end of July. Care home residents, their family and friends, and emergency services are exempt, but the regulations cover a wide range of people including staff, tradespeople and service providers who might routinely need to enter a care home. Although a 16 week grace period is provided to allow for existing staff and others to complete their vaccinations, no analysis is given of the number of current staff and others who may not comply or the potential impact on care homes if they become ineligible for work. We would normally expect that information to be included in the Impact Assessment but that has not been made available either.

The committee argued this information was crucial to the House in understanding the policy and how the regulations would work. It said effective parliamentary scrutiny was therefore “impossible” and recommended that the Lords’ debate on the instrument be deferred until the information was published.

In a press release, the committee said effective scrutiny was made impossible because of:

  • the lack of clarity and practical detail about how the legislation is to operate;
  • the absence of any assessment of the impact on the care home workforce and care homes in general;
  • the confusing analysis of current vaccination levels in the sector; and
  • the absence of any clear explanation of the policy choices made.

The committee drew the regulations to the special attention of the House because it stated the “explanatory material laid in support provides insufficient information to gain a clear understanding about the instrument’s policy objective and intended implementation”.

The committee said that whilst requiring staff to be fully vaccinated may be a way to reduce risk to residents, the DHSC needed to justify this policy choice:

No one can be unaware of the increased risks to those living in residential care homes from Covid-19 and that requiring staff to be fully vaccinated may be the way forward, but the approach of these regulations, in requiring both doses, is much stronger than the advice offered by SAGE: The DHSC needs to justify this policy choice.

Appendix 1 of the committee’s report presents answers given to the committee by the DHSC to a series of questions it asked seeking further information.

The committee also invited Nadhim Zahawi, Minister for Business and Industry and Minister for COVID Vaccine Deployment at DHSC, to an oral evidence session to provide further information. This oral evidence took place on 13 July 2021. An uncorrected transcript of the session has also been published. Mr Zahawi said that he hoped to have the impact assessment by the end of July. He also said that he hoped to be able “to do an impact statement before the Lords debate” on the regulations. On guidance, Mr Zahawi said that “because of our experience over the past eight months with the vaccination programme, we want to coproduce guidance with the sector”. He said this would deliver the best operational outcome and that “a lot of work is taking place on the cocreation of the guidance”.

On 19 July 2021, the committee published a report on its oral evidence session with Nadhim Zahawi. An appendix to the report includes additional material from the DHSC. The report also references submissions the committee had received from the care home sector. The committee said it was grateful to the minister and to the department for the further information and explanations that had been provided. However, the committee said that it remained “unclear about the justification for some of the policy choices underlying these regulations and also the basis on which the department struck a balance between public health benefits and the impact on the rights of individuals”.

The DHSC published a statement of impact on the regulations on 19 July 2021. In its report on the oral evidence session, the Secondary Legislation Scrutiny Committee said that it had been sent “an embargoed copy of [the DHSC’s] impact statement in advance of its publication, but it was received too late to be taken into account in this report”.

Debate in the House of Commons

The House of Commons debated the regulations on 13 July 2021. The Commons approved the regulations on division by 319 votes to 246.

Several MPs criticised the Government for not having published an impact assessment prior to the vote in the Commons.

Speaking for Labour, Rosena Allin-Khan, Shadow Health Minister, argued that to understand vaccine hesitancy amongst some care home staff it “is important to understand the health inequalities that much of the workforce face”. She said that 21% of all care staff came from a minority ethnic background and that several factors had increased distrust in the health system:

Negative experiences of a culturally insensitive health service, the higher rates of death from Covid for people from black and south Asian communities, and a lack of representation of minority groups in vaccine trials and wider health research all serve to build distrust in the health system. These are some of the communities that have been hit the hardest during the pandemic.

Dr Allin-Khan said that the risk of being dismissed “only reinforces the reasons for hesitancy in the first place”. She said that the Labour Government in Wales had not introduced compulsory vaccinations but 88% of care home staff had been double vaccinated. She said the Welsh Government had worked “closely with the care sector to drive take-up”. She also expressed concern that the regulations could lead to staff shortages “in already understaffed care homes” and argued that “forcing carers to choose between losing their job and taking a vaccine that they are afraid of is inhumane”.

Responding to the debate, Helen Whately, Minister of State at the Department of Health and Social Care, said that the “clock is ticking towards winter” and towards a combination of coronavirus and flu. She said the Government would continue to support care workers in taking up the vaccine but expressed concern that time was limited. She said a “huge amount” had been done to raise uptake. Speaking earlier in the debate the minister said the Government had consulted widely on the regulations and that it recognised that some people believed that vaccination should be a choice for workers. However, she said that people with relatives in care homes wanted them to be cared for by fully vaccinated staff:

We have consulted extensively, including with a wide range of valued stakeholders, and used their feedback to inform this legislation. We recognise that some people feel that workers should have freedom of choice about vaccination, while others do it as a duty of care to protect the people most at risk. I know from speaking directly to people who receive care and to those who have relatives living in care homes that, although they might not be sure about requiring all care workers to be vaccinated, they are sure that they, individually, want to be cared for by someone who has been fully vaccinated. Many people have little choice about who cares for them.

Closing the debate, the minister said that the regulations represented what else could be done to protect care home residents:

I say to my hon. Friends that the question before us is: what more can we do to protect those who are vulnerable in care homes? This is what we can do and I commend the regulations to the House.

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This article was updated on 20 July 2021 to include references to new material published by the House of Lords Secondary Legislation Committee and the Department of Health and Social Care.

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