On 9 November 2021, the Government laid the draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2021 (the draft regulations) before Parliament. It did so under the draft affirmative procedure, which means the regulations must be approved by both Houses before they can be brought into force.

The House of Lords is due to debate three motions relating to the draft regulations on 14 December 2021. The motions would differ in effect if approved.

First, Lord Kamall, Parliamentary Under Secretary of State at the Department of Health and Social Care, has tabled a motion for the House to approve the draft regulations. If agreed, this would mean the House of Lords gives its permission for ministers to bring the regulations into force.

Second, Baroness Noakes (Conservative) has tabled a ‘motion to decline’ the draft regulations on the basis that the Government has not published a “full impact assessment”. If agreed, this would stop the draft regulations from becoming law.

Third, Baroness Thornton (Labour), Shadow Spokesperson for Health in the House of Lords, has tabled a ‘non-fatal regret motion’. If agreed, the motion would amend the Government’s approval motion to formally signal that the House has reservations about the draft regulations. But it would not stop ministers from being able to bring the measure into force. The motion outlines several concerns with the draft regulations:

  • the draft regulations do not explain how the legislation will operate, and that this will be deferred to future guidance;
  • the Department of Health and Social Care (DHSC) has not published a full impact assessment alongside the draft regulations;
  • the draft regulations pose a “significant workforce capacity risk” to the health and social care sectors;
  • the House of Lords Secondary Legislation Scrutiny Committee recommended that the draft regulations be “deferred” until the Government provides a “fuller and clearer statement” of how the related Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 (the care home regulations) had affected the care home workforce; and
  • the Government should provide supporting evidence for permanently requiring frontline National Health Service (NHS) staff to have received two doses of an approved Covid-19 vaccine “as a condition of further deployment”.

Background

Current requirements on care workers

On 22 June 2021, the Government laid the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 before both Houses. The regulations made it a requirement for workers in care homes registered by the Care Quality Commission (CQC) in England to be fully vaccinated against Covid-19, subject to certain exceptions. The Government contended that the purpose of the regulations was to reduce the spread of Covid-19 in care homes and to protect care home residents who were vulnerable to the disease. Both Houses approved the regulations in July 2021, although the House of Lords did so with regret. The regulations later came into force on 11 November 2021. The Government described the four-month gap as a “grace period” for the policy to be implemented.

Further background on these earlier regulations can be found in the following article:

House of Lords Library, ‘Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021’, 16 July 2021

Consultation on vaccine requirements in healthcare and wider social care settings

In June 2021, the Government announced its intention to launch a second consultation on whether to make Covid-19 vaccination a condition of deployment in healthcare and the wider social care sectors in England. The further consultation would also explore whether to make the flu vaccine a requirement for staff working in these sectors.

The Government ran the consultation between 9 September and 22 October 2021. It received over 34,900 responses, including from front line staff, managers and service users.

On 9 November 2021, the Government published its response to the consultation. This noted that 65% of respondents did not support the proposal on mandating staff to have both doses of the Covid-19 vaccine as a condition of deployment. Additionally, the consultation found that a majority of respondents (61% for healthcare settings and 62% for social care settings) did not support flu vaccination requirements. However, despite these responses, the Government announced that it would be introducing regulations to “only allow providers of CQC-regulated activities to deploy individuals who have been vaccinated against Covid-19 to roles where they interact with patients and service users”. This would include front-line workers, non-clinical workers and those not directly involved in patient care, such as receptionists and porters.

The Government also noted that it had “considered the concerns raised” relating to introducing flu vaccination requirements. However, due to the need to balance the flu programme (which runs between October and March) with the “time necessary for health and social care to implement the regulations”, it said it would not be introducing vaccination requirements for flu at the same time. Instead, the Government stated that it would keep this under review ahead of winter 2022/23.

What does the draft instrument do?

The draft regulations would amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 to require health and social care workers who have face-to-face contact with service users, including volunteers, to provide evidence that they have been fully vaccinated against Covid-19. They would need to do so to be deployed to their workplace.

In its draft explanatory memorandum, the DHSC said that the purpose of the draft regulations was to:

  • reduce the spread of Covid-19 in health and social care settings, including an individual’s own home; and
  • protect those receiving care who are vulnerable to the virus and the health and social care workforce.

The DHSC also stated that there would be a 12-week, or 3-month, grace period between the draft regulations being made and them coming into force. This would allow those who had not yet been vaccinated to have both doses. Enforcement of the draft regulations would begin from 1 April 2022, subject to parliamentary approval.

However, the draft regulations permit some exemptions to the requirement. This includes if a person should not be vaccinated for clinical reasons or is a participant in a clinical trial.

In a press release announcing the draft regulations published on 9 November 2021, the Secretary of State for Health and Social Care, Sajid Javid, said that the regulations would help “give patients and staff the best possible protection”. The press release also detailed that take-up of the vaccine had been high. It stated that 92.8% of NHS workers had had their first dose and 89.9% had had both doses of the Covid-19 vaccine. In social care, 83.7% of domiciliary care workers had had their first dose and 74.6% had had both doses. Despite this, the DHSC noted that the latest published data showed that over 103,000 NHS trust workers and 105,000 domiciliary care workers had not been reported as fully vaccinated and that the Government was “urging them to take up the offer now”.

The Government did not publish a full impact assessment alongside the draft regulations in early November, instead publishing one on 10 December 2021. On 8 December 2021, the Regulatory Policy Committee (RPC) provided its assessment of the impact assessment. In its report, the RPC rated the impact assessment as “not fit for purpose (red) on both the assessment of the equivalent net direct costs to business (EANDCB) and the small and micro-business assessment (Samba)”. The RPC noted that the impact assessment had been submitted for RPC scrutiny after the draft regulations were laid before Parliament.

What parliamentary scrutiny has there been so far?

On 17 November 2021, the draft regulations were considered by the Joint Committee on Statutory Instruments, which did not raise any concerns.

However, in its report published on 23 November 2021, the House of Lords Secondary Legislation Scrutiny Committee raised several concerns. These were that:

  • The draft regulations “lack[ed] practical detail about how key expressions” such as ‘face-to-face’ “are to be applied”. Instead, the legislation referred to future guidance to “supplement this instrument”.
  • The draft explanatory memorandum made “no reference to any lessons learned from the roll-out of the [earlier] care home regulations” and was also “silent” on what contingency plans the DHSC had made to “cope with expected staff losses” when the draft regulations take effect. The committee argued that staff losses were “likely to be particularly acute” in London.
  • The DHSC provided “no evidence to support its assertion” that implementing an exemption on religious grounds “might be difficult” (as detailed in its equality impact assessment).
  • The DHSC’s estimate anticipated that 126,000 unvaccinated workers would lose their jobs for failing to comply with the requirement. The committee stated that this seemed a “disproportionately small gain” for legislation that was “anticipated to cause £270 million in additional costs and major disruption to the health and care provision at the end of the grace period”. Consequently, the committee said that the House of Lords may expect to be provided with “some very strong evidence to support this policy choice”, which the department had “signally failed to do”.

What reaction has there been to the policy?

Although several medical and care bodies have called for health and social care workers to receive both doses of a Covid-19 vaccine, they have been critical of mandating vaccines for staff.

The British Medical Association (BMA) has said that it is “important that every NHS worker gets vaccinated, other than those who can’t for medical reasons”. However, it has also argued that there is an “important distinction” between believing every healthcare worker should be vaccinated and “advocating for mandatory vaccinations”. In a press release published on its website in October 2021, the BMA warned that mandatory vaccinations came with “legal, ethical and practical implications that must be considered” and that the “threat to staff” who refuse to have the vaccine was “of grave concern”.

Similarly, the Royal College of Nursing (RCN) has said that despite its “fundamental position” being that all of its members should be vaccinated, it had “significant concerns” with the regulations. These included that the requirement would “further marginalise” those who were vaccine-hesitant and would “put further pressure on a hugely depleted workforce by forcing people out of employment”. Consequently, the RCN stated that it would lobby the DHSC to publish “robust evaluation” on the impact of the regulations. This would include on:

  • vaccine uptake;
  • any reduction or change to the care available to residents in social care settings; and
  • staff recruitment and retention.

Additionally, the Royal College of General Practitioners (RCGP) has expressed its opposition to the mandatory vaccination of NHS workers. In a statement on its website, the RCGP said that the policy was “particularly concerning” at a time when “we need as many people as possible working in general practice and across the health and care sectors delivering essential patient care and services”. It also stated that despite the grace period, “we are unlikely to be in a better position with workforce pressures come next April”.

The policy has also been met with scepticism from the Labour Party. In response to an oral statement by Sajid Javid announcing the draft regulations in November 2021, Jonathan Ashworth, then Shadow Secretary of State for Health and Social Care, said that Labour would “look carefully” at the draft regulations and the equality impact assessment. Mr Ashworth also urged Mr Javid to “proceed with caution”, warning that “we simply cannot afford to lose thousands of staff overnight”.

However, the policy has also received some support. In an article for the British Medical Journal, Daniel Sokol, a medical ethicist and barrister, stated that Covid-19 vaccinations should be mandatory for healthcare workers. He argued that the General Medical Council instructs doctors to be “immunised against common serious communicable diseases” unless this may be harmful, and therefore, mandatory vaccines would “add a legal obligation to the existing ethical one”.


Cover image by Simon Torsten on Pixabay.