Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025

Considered in Grand Committee

17:17:00

Moved by

That the Grand Committee do consider the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025.

My Lords, this SI amends the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, which are due to expire after 31 March this year. It removes that expiry date and amends the five-year period from which the regulations are required to be reviewed. Prior to laying this SI, the principal regulations required review every five years from 1 April 2015. The first post-implementation review was delayed until 2022 due to the pandemic. We therefore wish to conduct the next review in 2028. This SI does not change any existing policy. The 2014 regulations set out the activities that are regulated by the CQC and the fundamental standards with which all health and social care providers registered with it need to comply. This is coming before your Lordships’ Committee because, if we do not amend the 2014 regulations, they will automatically expire and the CQC will have no powers to fulfil the requirements in the 2008 Act. Neither will there be an obligation on providers, which are currently required to register with the CQC, to comply with the fundamental standards set out in the 2014 regulations. I am aware that there may have been an expectation to see further changes following the report by Dr Penny Dash into the CQC’s operational requirements, which uncovered significant failings in the CQC’s internal workings. However, dealing with those operational failings does not require changes to legislation; as we have debated in the Chamber on previous occasions, measures have been put in place by the CQC’s new chief executive, Sir Julian Hartley, to urgently address the failures, including the introduction of new governance at the board level. Noble Lords may also have observed that this SI is silent on provisions relating to the use of restraint and the regulation of medical care at temporary cultural and sporting events, on which we also consulted last year. I can give an assurance that these sensitive areas have not been overlooked and that we are continuing to progress work on finalising these policies. The consultation responses on the proposal to make restrictive practices notifiable to the CQC within 72 hours showed support for the measures but highlighted a number of practical concerns, primarily that the proposed timeline could place an additional burden on staff, with the potential risk of impacting patient care. As the Government said in their response to the consultation, further work is needed to ensure that we have the right definitions, systems and processes in place before proceeding with legislative changes. I can tell the Committee that the Government will lay a statutory instrument to remove the exemption relating to regulation of medical care at temporary and cultural sporting events. With this change, providers of such care will be required to register with the CQC for the first time. I hope that will be helpful in setting out what this SI is, and is not, about. I beg to move.

My Lords, again I thank the Minister for clearly and aptly outlining what the statutory instrument is for. I am not going to go over the reasons for this but, broadly, these Benches support what is happening and understand why the streamlining is required. However, like all streamlining where common sense seems to take the central point, it is worth testing just how common and sensical the requirements are, and whether the Government have thought through some of the consequences—or unintended consequences—of what may happen. Although the intention to maintain regulatory oversight and uphold care standards is obviously commendable, several points warrant further investigation and probing. I hope that the Minister will answer in her normal way; she is usually quite thorough and detailed. The Explanatory Memorandum notes that a post-implementation review conducted in July 2022 had limited responses, providing insufficient evidence to suggest that the 2014 regulations did not meet their original objectives. Could the Minister elaborate on the steps taken to engage stakeholders during this review? What measures will be implemented to ensure that, when statutory instruments are extended in future, more comprehensive stakeholder participation will be sought? The amendment mandates having a review every five years. Given the dynamic nature of health and social care, how will the Government ensure that the regulations are monitored and remain responsive to emerging challenges and innovations within the review period? Removing the expiry date also extends the regulations indefinitely. Have the Government assessed the potential long-term impacts of this permanency on service providers and the CQC’s regulatory capacity? I think the noble Baroness knows why this question is being asked. Although I heard what she said about the operational issues that the CQC is undergoing at the moment, the regulatory changes that we are discussing may have some operational impact on the CQC. In particular at the moment, when the CQC’s backlog is significant and its chief executive has said that it has no idea how it will deal with it—indeed, there are certain things stuck in the computer system that they do not know how to get out—how will the Government ensure in the interim that any application made to the CQC regarding this instrument is dealt with in a timely and safe manner? Finally, on the policy areas that the Minister said were outwith these regulations due to further consultation and the sensitivity required, when will the statutory instrument be laid before Parliament? What is the timescale? Are any interim measures being put in place to ensure that any safety issues or regulatory issues with these sporting events are dealt with before the statutory instrument is laid before Parliament? With those questions, we are, as I say, very supportive of this instrument in a broad sense, but the Minister’s normal detailed response would be welcome.

My Lords, I once again thank the Minister for the statutory instrument before us. We understand the reason for it: making sure, in particular, that this continues to be in effect after March this year, and setting the next review for 2028. Maybe that is where some of the questions arise—the noble Lord, Lord Scriven, alluded to some of these concerns. We have just finished debating an SI on adapting for innovation—particularly in relation to speeding up clinical trials, which is to be welcomed. It showed that we need to be flexible with the emergence of new technology, knowledge and capabilities in health and social care. But, like the noble Lord, Lord Scriven, we wonder about a five-year review cycle, which may not allow for sufficient flexibility, given some of the fast-paced developments in healthcare. We have seen massive strides in digital health and mental health services. In our debate earlier in the Chamber, we asked about the use of AI in analysing data that the NHS already has. Will five years be too long to wait? Could it slow down the adoption or reviews, if you like, of some of these new technologies? Could the delay in reviewing regulations lead to some important issues being unaddressed for far too long? There may be new awareness of some emerging patient safety risks, for example. I just wonder: how do we get the right balance? I understand why the Government have extended this for five years, but we want to make sure that, within those five years, the Government, the NHS, the regulations and the CQC are flexible enough to take account of innovations. The absence of interim mechanisms for addressing pressing issues during this review period could also foster a sense of regulatory stagnation. There may well be a case where providers and stakeholders feel that concerns are not being acted on quickly enough, especially as challenges arise before that next review. Although we understand the need for a stable framework, we want to understand how to get the balance between stability and responsiveness right. Could that delay necessary regulatory adjustments? The other point here is extending the scope of the regulations to all patients being assessed or treated for a mental health disorder in a mental health unit. Obviously, this coincides with the debate that noble Lords are having on the Mental Health Bill. In this case, it extends beyond only those with learning disabilities and autism. This expansion is generally welcomed, but, once again, it raises questions—which were raised on the last SI—about resources and capacity. I know that the Minister has heard this a number of times, particularly during the passage of the Mental Health Bill. Will there be sufficient support for providers so that they can meet these expanded requirements? How will the Government monitor and address any challenges that may arise from this broader scope? Fortunately, the Minister pre-empted one of the questions that I was going to ask about the regulations’ provisions on temporary healthcare settings, particularly at large sporting and cultural events. We understand the need to remove those regulations, but what thought has been given to the unintended consequences of doing so? I am generally supportive of removing regulations, but I understand why we need them: to make sure that enough account is taken of safety but also that someone is held responsible and there is some accountability when things go wrong.

17:30:00

On the whole, we welcome this instrument, but we want to understand whether there is flexibility within the five years and whether there have been any unintended consequences from the removal of the regulations. This is an important step towards ensuring the continuity of the regulatory framework, but we want to get the right balance between flexibility and being innovative and nimble to respond to changes in the landscape. I look forward to the Minister’s response.

I thank noble Lords for their thoughtful contributions and questions. The summary of the noble Lord, Lord Kamall, of what we are looking for is exactly right. It is all about balance: we need efficiency and speed, but it has to be right. I certainly share that view. As I set out in my opening remarks, the dual purpose of this SI is to remove the expiry date of the 2014 regs and to amend the five-year period from which they should be reviewed. As I mentioned, this is to ensure that health and care providers will continue to be required to register with the CQC and comply with the fundamental standards set out in the 2014 regulations after 31 March this year, and also, as we all agree, to ensure that services will continue to be required to provide a safe and high-quality standard of care. I turn to the points raised by noble Lords. If I find, on review, that I have not adequately answered or have inadvertently missed any questions, I will of course write with the requisite information. The noble Lord, Lord Scriven, referred to the post-implementation review of the 2014 regs. That review ran from May to July 2022, and there were 86 responses. Interestingly, there was insufficient evidence in the responses to suggest whether the objectives of the 2014 regulations remain appropriate and whether there is an alternative system of regulation that would impose less regulation on the health and social care sector. I think we can safely say that it was not conclusive in pointing us in a particular direction. The noble Lord, Lord Scriven, also asked when the statutory instrument to remove the exemption relating to the regulation of medical care at temporary cultural and sporting events will be laid. I can say to him that it will be in the summer. The noble Lord, Lord Scriven, also raised the question of the performance of the CQC, which I completely understand. He asked what is happening, how we are dealing with the backlog of registrations and what is our assessment of its long-term impact on regulatory capacity. I understand that. I re-emphasise that the chief executive of the CQC has commissioned an independent review to look specifically at the CQC’s technology. That will help reduce the backlog, which can be tracked back to 2023, when there were a number of difficulties that now need to be resolved. I absolutely agree that the backlog in registrations is a problem particularly for small providers trying to set up a new care home or service. That problem can mean lost revenues and investment, and that has a knock-on impact on capacity, which we very much need to expand.

It is really helpful that the Minister says that, but a review in itself does not solve the problem. Have the Government given the CQC a timescale, not just regarding a review but for when they expect the operational difficulties to have been addressed? It is important for those who are registering to understand that. What is the timescale, not for the review but for dealing with the consequences of the backlog?

The noble Lord has raised this with me in the Chamber and in a Parliamentary Question, if I am not mistaken. While I cannot be specific, as I have mentioned before, the fortnightly meetings with CQC—after which a report also goes to the Secretary of State—are an example of focus which, I hope, give some sense of the pace and intensity in putting this right. The CQC not being fit for purpose is an unsustainable situation which is causing great difficulty. When I can update your Lordships’ House about timelines, I will be very pleased to do so. The noble Lord, Lord Kamall, asked about interim plans being in place. This is kept under review. We are working with the CQC on its recovery and will review whether further changes are needed. There is nothing to stop us from reviewing regulations in the interim. Five years is the statutory requirement, but it does not mean that we cannot act sooner. It is a point well made about time. Similarly, the noble Lord asked whether the reviews being every five years would slow down the adoption of technology. The intention is that it would absolutely not. The reason for keeping the regulations under review is that that would not be regarded as getting the right balance which we all seek. Regarding capacity issues to meet the expanding requirement, we are very conscious of the consequences. The Government will work with the CQC, NHSE and its partners on a workable mechanism for notifying restraint within 72 hours, which was the point raised. With that, I thank noble Lords for their contributions. Perhaps I can assure them that, in some ways, this is for me a work in progress, on many sides. We will continue to do that.

Motion agreed.

Committee adjourned at 5.38 pm.