Grand Committee
Space Industry (Licence Exemption for Military Activities of Allies) Regulations 2025
Baroness Blake of Leeds
That the Grand Committee do consider the Space Industry (Licence Exemption for Military Activities of Allies) Regulations 2025.
Relevant document: 13th Report from the Secondary Legislation Scrutiny Committee
Baroness in Waiting/Government Whip (Baroness Blake of Leeds) (Lab)
My Lords, missile defence is a critical thread in our tapestry of national security. The threats we face, highlighted by Russia’s reckless targeting of Dnipro with a ballistic missile, underline the need to be prepared. We test and train regularly with our allies, and our next missile defence testing and training exercise, codenamed Exercise Formidable Shield, is in May 2025.
Formidable Shield is a US-led exercise, hosted by the UK Government, at the MoD’s Outer Hebrides air weapon range, on behalf of NATO and our other defence partners. It is one of the most advanced and comprehensive missile defence training exercises in the world. It involves the UK and allied forces conducting live-fire drills, missile defence tests and real-world scenario-based training.
These activities are critical to the defence and security of the UK and the strength of our military alliances. First, they enhance interoperability. Exercise Formidable Shield will bring 10 nations together, each with distinct systems, targets and technologies. It will allow us to align these different systems and work in concert effectively in real-world operations, so that the UK and our allies can respond quickly and cohesively to any threats.
Secondly, Formidable Shield improves our collective missile defence capabilities, and our ability to adapt to evolving ballistic missile and other threats. This is why the live-fire element of Exercise Formidable Shield is particularly valuable.
Thirdly, Exercise Formidable Shield reinforces strategic deterrence, which is vital in maintaining stability and preventing conflicts escalating. The exercise sends a strong message to our adversaries that the UK, NATO and its allies are prepared to defend ourselves and our territories against any form of aggression.
In order to replicate operational conditions for these exercises, the UK and allied nations need to operate ever more sophisticated defence missiles, capable of climbing above the stratosphere. This would bring them within the scope of the licensing regime within the Space Industry Act 2018 and its associated secondary legislation. The Space Industry Act 2018 was never intended to regulate military activity. It was passed into law to ensure the safety and appropriate governance of the commercial spaceflight industry and is regulated by the Civil Aviation Authority.
The Government seek licensing exemptions under the Space Industry Act and associated secondary legislation for allied armed forces activities. This exemption is very narrow. It allows only allied armed forces, their operatives and international military organisations, such as NATO, to fire sub-orbital—that is, non-orbiting—uncrewed rockets from MoD sites or platforms, with MoD permission and under the control of the MoD’s regulator. To clarify the SLSC report, this exemption will not cover activities from UK spaceports, only MoD sites.
The exemption would bring multinational exercises into line with sovereign ones. Similar stratospheric tests conducted solely by the MoD are not affected by the Space Industry Act 2018 and its accompanying licensing regime on the basis that, as a matter of statutory interpretation, the Act must not bind the Crown. Exercises above the stratosphere, which would be exempt under this instrument, would be under the expert supervision of the defence regulator, which has monitored military activities for decades, including MoD rocket launches above the stratosphere. Unlike the civilian authorities, the defence regulator has the infrastructure and expertise to oversee the safety of these exercises properly. The amendments the Government seek would avoid putting an increased and new burden on civil authorities.
This instrument will apply to England, Wales, Scotland and Northern Ireland. It is subject to the affirmative procedure, as set out under Section 68(6) of the Space Industry Act 2018.
To conclude, the UK’s missile defence capability is a critical component of national and global security but, like all defence capabilities, to be effective it must be constantly maintained, updated, exercised and tested. Exercise Formidable Shield, planned for May 2025, is the next essential opportunity to conduct live-fire drills, missile defence tests and real-world scenario-based training. An enormous amount of military planning has gone into it from all the nations involved, and the Government seek appropriate regulatory certainty by the end of February in order to get maximum value from the exercise.
Approving this exemption in a timely manner will send a clear signal that the UK Parliament is united on the defence of our national security, united against our adversaries and united in its support for NATO. I hope that noble Lords will join me in supporting these measures. I beg to move.
Baroness Smith of Newnham (LD)
My Lords, it would be easy simply to stand up and thank the Minister for introducing this statutory instrument clearly, and it goes without saying that it should have the support of the opposition parties, in particular for the reasons that she outlined at the end—to demonstrate that we stand united with our NATO allies on a cross-party basis—but I have a few comments to make.
On the Liberal Democrat Benches, we considered whether somebody on the defence side or the transport side should respond, but the sad circumstance is that today my noble friend Lady Pidgeon is in Cardiff for the funeral of our late lamented friend Baroness Randerson, so it was agreed that, almost regardless of the subject matter, I would take the business today. In doing so, I pay tribute to Baroness Randerson, who would in many ways have been the perfect person to lead on this because her interests were in transport but she also had a real interest in the international.
With those words of introduction, I came to this statutory instrument rather cold. When we take part in the Armed Forces Parliamentary Scheme, we are very much told that air, sea, land, cyber and space are so important for defence. It is very clear that we need to ensure that space is safe, so we absolutely support the principle of the statutory instrument. In particular, as the Minister said, it is vital that Exercise Formidable Shield can take place, but a few questions come up.
The noble and gallant Lord, Lord Craig of Radley, has on various occasions pointed out that, if the UK were subject to the sort of attacks that Israel faced from Iran, we would not have been able to defend ourselves in the way that Israel was able to do with its Iron Dome. One of my questions, therefore, is: will the exercise that takes place in May, which, as the Minister said, brings together our NATO allies, be replicated in various ways and places to assist in our securing space? I realise that that may be a defence question on which she may wish to write, but I thought I would raise it here and now.
I also have a couple of other questions. Clearly, the Minister is right that the regulation can be done better by the MoD than by the Civil Aviation Authority, but if actions are being undertaken by our service personnel under the auspices of the MoD and therefore military law, there are various issues at stake and, if something went wrong, we would know whom to hold accountable. With our partners and allies, how will that be dealt with? Are there international agreements that would enable us to ensure that any accidents, errors or misdemeanours could be dealt with in an appropriate way? This is not to suggest that the statutory instrument should not go ahead but rather to understand how matters will be dealt with if there is some flaw in the system that means we might need legal measures.
I also have a query—nothing of great import—that I was slightly wondering about. The statutory instrument refers to the “Crown interest” and “Crown land”, as well as to the “Duchy interest”, which is:
“an interest belonging to His Majesty in right of the Duchy of Lancaster or belonging to the Duchy of Cornwall”.
Does that mean the rights of the Duchy of Cornwall currently, which belongs to the Prince of Wales, or are there Duchy lands that still adhere to His Majesty the King? That is purely a question that puzzled me slightly.
Apart from those few questions, there is nothing else for me to say other than that we wish the statutory instrument well.
Baroness Goldie (Con)
My Lords, first I associate myself with the sentiments expressed by the noble Baroness, Lady Smith, with reference to her friend and colleague Baroness Randerson.
If the noble Baroness, Lady Smith, comes to this cold, I come to the issue out of the deep freeze, but let me do my best. The Minister has helpfully laid out the primary purpose of the draft statutory instrument, by describing the exemptions that the draft instrument creates; of course, these activities, unless exempted, would otherwise be caught by the civilian-focused regulations. Therefore, let me say first that I accept the priority that must be accorded to defence operational flexibility, and I not only support but applaud the Government’s desire to ensure such flexibility is not compromised.
Having said that, while I support the statutory instrument, developments in the space domain are fast-moving and, while protecting our defence capability activity is of course vital, broader questions arise as to how the Government will keep abreast of that fast-moving scene. I have a number of questions, on which I will be very happy if the Minister wishes to write to me. My first question is: welcome though this SI is, how do the Government align this exemption with consistent principles of oversight and accountability, which are central to the overall integrity of space operations?
To minimise risk, do the Government propose to review the operation of this exemption in practice, perhaps after a year, to ensure that there are no unintended and potentially dangerous consequences and that there is transparency about how the exemption is operating? We must be satisfied that the shift of power from civilian regulators, such as the Civil Aviation Authority, to the MoD is not inadvertently reducing accountability unacceptably and potentially sidelining important safety protocols that are in place for good reason. I seek the Minister’s reassurance about that.
Baroness Blake of Leeds (Lab)
I thank noble Lords for those very thoughtful questions, which covered quite a range of activities. I ask them to give me a moment to gather my thoughts.
I thank the noble Baroness, Lady Smith, for her comments about Baroness Randerson. It is my great privilege that the last meeting that I had before Christmas was with Baroness Randerson, as well as my noble friend Lord Hendy, on a great passion of hers: the buses Bill. I hope that we can do her justice in the passage of that Bill through the House because I know just how much it meant to her.
I will take up the generous offers from the noble Baronesses, Lady Goldie and Lady Smith, and will write to them on the more technical issues that they raised.
This is a very important subject. We can sum up its importance by saying, as was expressed in both sets of comments from the noble Baronesses, that the threat we face is advancing, proliferating and converging; it is probably the most acute it has been in over 30 years. The UK employs a broad approach to deterring and defeating air and missile threats, including through NATO. I assure noble Lords that, of course, the UK continually reviews our air and missile defence requirements to ensure that we are adequately defended against the evolving threats that we face. Further developments in these capabilities are being considered in conjunction with the strategic defence review. I hope that that brings some reassurance.
On experience, the MoD has been firing rockets safely from its sites since the 1950s. The MoD and allies would carry the liability, as they were already doing before the Act, for activity in respect of firing allied rockets.
With respect to the Duchy of Cornwall and the Crown Estate, I am grateful for the offer for me to write just to clarify the matters that the noble Baroness raised around those issues.
Regarding the MoD regulations, again allies have been undertaking activity, including firing rockets below the stratosphere, alongside UK military at MoD sites under defence regulation for decades. All activities conducted by foreign allies in the UK need MoD permission and must conform to MoD regulations, be overseen by the MoD regulator and be on MoD sites. I hope that this addresses the concerns.
In terms of the environmental questions that were raised, I will write and hopefully give the reassurance that it goes without saying that those considerations will be taken into account in everything that we do.
I hope that I have addressed the points that were raised. I reinforce my thanks to both parties opposite in their support for this, particularly regarding the time pressures that we are under and in ensuring that we have a very successful operation in May from our site in the Hebrides. We must ensure that the legislation that we bring through enables our defences to outpace the malign ambitions of our adversaries.
Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) (Amendment) Regulations 2024
(1 day, 21 hours ago)
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Lord Leong
That the Grand Committee do consider the Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) (Amendment) Regulations 2024.
Lord in Waiting/Government Whip (Lord Leong) (Lab)
My Lords, these draft regulations will be made under powers provided by the Product Security and Telecommunications Infrastructure Act 2022. The PSTI regulatory regime is comprised of Part 1 of the 2022 Act together with the Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) Regulations 2023, which I will refer to as the 2023 regulations.
This world-leading regulatory regime came into force on 29 April 2024. It better protects consumers, businesses and the wider economy from the harms associated with cyberattacks on consumer connectable products. The law now requires these products that are made available to customers in the UK to meet baseline cybersecurity requirements. This is a world first, and a world-leading regulatory regime, with many other countries now mandating similar requirements based on the world-leading European Telecommunications Standards Institute standard which the UK helped create.
For instance, manufacturers cannot use universal default or easily guessable default passwords, such as “admin123”; this reduces one of the most commonly exploited vulnerabilities in connectable products. Manufacturers must also ensure that they are transparent about the minimum length of time for which they will provide much-needed security updates that patch these vulnerabilities. They must also publish information on how to report security vulnerabilities directly to them and provide status updates about the reported issues. Importers also have important duties they must comply with, as they play an important role in ensuring that more vulnerable products are not imported into the country. The same applies for distributors, as they are often the last line of defence against non-compliant products making their way to consumers.
Subject to the approval of this Committee, this draft instrument will add three new categories of products to the list of excepted products at Schedule 3 to the 2023 regulations, as well as making a correction to those regulations. In their 2020 call for views for this regime, the Government indicated that products would be excepted from the product security regime if it is deemed inappropriate to include them prior to further investigation, they are already covered by robust legislation or they will be covered by future legislation that is particularly relevant to that product category.
DSIT committed to except certain categories of automotive vehicles on 29 April 2023. The Department for Transport has been working at an international level to agree regulations setting cybersecurity requirements for vehicles. This would allow the cybersecurity of these products to be addressed by requirements that are specific to the sector and their functionality. The Department for Transport intends to mandate UN Regulation 155 on cybersecurity and cybersecurity management systems in Great Britain for all new cars, vans, buses, trucks and motorbikes. Its requirements are more appropriate, as it was created in response to the expanding capability and connectivity of vehicle systems.
A consultation is expected to be published with a proposal to lay, via a negative SI, Article 57 GB approval of assimilated EU Regulation 2018/858 in the first half of this year, with the requirements beginning to take effect from February 2026. Additionally, the automotive industry and its supply chain are already beginning to comply with UN Regulation 155, as it has been mandatory for new types of passenger and goods vehicles in the European Union from July 2022. To avoid dual regulation and unintentionally placing undue burden on the automotive industry and trade, the Government are seeking to except specific vehicle categories from the scope of this regime.
First, through the amendment made by Regulation 4, this draft instrument seeks to except consumer-connectable products that fall in scope of Regulation (EU) 2018/858, Regulation (EU) 168/2013 and Regulation (EU) 167/2013 from the scope of the PSTI product security regulatory regime in Great Britain. The consumer connectable products in scope of these regulations include cars, vans, buses, motorcycles, mopeds, quadbikes and tractors. These products are already excepted from the PSTI product security regulatory regime when they are made available for supply in Northern Ireland, as a result of the Windsor Framework.
Secondly, the amendment made by Regulation 3 will correct a minor error in the current language. Adding “period” ensures that the original intent of the paragraph is preserved.
The UK’s product security regulatory regime is world-leading. It cements our position as a world leader in consumer internet-of-things security. This measure will ensure that the regime works as intended and that the security of vehicles can be addressed through appropriate sector-specific regulations, and it will remove unnecessary burdens from the vehicles sector.
I hope the Committee will recognise the importance of excepting these additional products from the scope of the PSTI product security regulatory regime. I commend the regulations to the Committee.
Lord Clement-Jones (LD)
My Lords, I thank the noble Lord, Lord Leong, for his introduction, but I am slightly baffled by this SI. I looked up whether the Commons had had its debate on it and found that it took place on 21 May 2024. Then I looked at the impact assessment, which seems to be dated 2023. I do not quite know why we are dealing with a historic SI almost a year later. What has happened in the intervening period? The Minister did not mention anything to do with that. Is this some oversight by the department? Has something happened? Was somebody ill and could not deal with this in the House of Lords? It is a rather peculiar situation.
The second rather strange aspect of this is that, when the Automated Vehicles Bill was going through, my noble friend the late Baroness Randerson, who was mentioned by my noble friend Lady Smith—it is rather coincidental that this was one of her big issues: automated vehicles and the data relating to them—raised questions about protection of personal privacy and the national security implications of the data being retained by manufacturers of automated vehicles. She also raised the possibility of a cyberattack that could paralyse traffic over a considerable area. Those concerns were also raised by my honourable friend Wera Hobhouse in the Commons at the same time. I think the noble Lord, Lord Sharpe, might be interested in this: we were assured at that time by Ministers in the previous Government that GDPR was good enough protection in respect of automated vehicles, despite the concerns expressed by my late noble friend Baroness Randerson. Now it turns out, as set out in the Explanatory Memorandum, that special provisions are needed.
Again, this is rather baffling. We seem to be hearing either that we have an administrative problem or that there was a misunderstanding about the intended policy. In some respects, I should be pleased that the Explanatory Memorandum sets out more safeguards, because if we are going to exempt these three areas—in particular, automated vehicles—we need to know that those safeguards will be in place through other mechanisms. I will go through what those might be and put questions to the Minister about them.
How will the collection, storage and use of personal data by automated vehicles be regulated to ensure compliance with data protection laws? What specific criteria must be met for a person or body to be authorised as a self-driving entity, particularly concerning data protection? Do they need to obtain a certificate of compliance with data protection legislation from the ICO, for instance? How can the public be reassured that their personal data will be protected? How will the regulations ensure that personal data is protected, not only during vehicle operation but after the ownership of a vehicle has ended? What are these robust personal data practices that need to be in place for companies to be authorised as self-driving entities?
What information about the data for the authorisation of automated vehicles must be provided and to whom? Will the Secretary of State consult the Information Commissioner’s Office before making regulations relating to the provision of personal data in automated vehicles, and will the ICO be including elements to do with personal data and automated vehicles in its annual report to Parliament? How will the Government protect against potential cyberattacks on automated vehicle systems?
Specifically, how do the regulations for consumer connectable products under the Product Security and Telecommunications Infrastructure Act interact with those that apply to automated vehicles and their components? Does this exempt the whole of the automated vehicle or, rather, particular connectable items in automated vehicles that would in fact be covered by the PSTI Act? How will the regulations prevent anti-competitive practices by vehicle manufacturers who might use data to restrict competition between them and independent operators?
The Explanatory Memorandum talks about the CAVPASS programme, which provides some information that is relevant. Currently, however, it does not deal directly with these specific questions regarding data handling in automated vehicles. We are promised, I think, that something is coming down the track in 2025. There is mention of a staged approach to regulations, which suggests that future measures will be introduced. When can we expect more information of the kind that I have raised? Is it not long overdue, given the speed of development of these vehicles? They are already in pilot form and we need to know that our data is secure. We are still left with questions, despite all that. I doubt whether CAVPASS is necessarily going to cover how data is collected in relation to cybersecurity and how they will be protected in that respect.
There are quite a lot of questions here, and it is rather peculiar that we were not in a position to ask these questions at the same time as the House of Commons last May. I am therefore looking forward to what the Minister has to say in reply.
Lord Sharpe of Epsom (Con)
My Lords, I thank the Minister for his explanation. I would say to the noble Lord, Lord Clement-Jones, that something did happen, and that was the general election, which we, unfortunately, lost. That no doubt explains something of the delay.
The noble Lord, Lord Clement-Jones, has asked some pertinent questions. I will keep mine a little more general, because this SI amends the original regulations and broadens the exceptions under Schedule 3. The most notable change concerns the automotive sector, as has been noted, where vehicles were previously exempt from certain cybersecurity provisions.
The new regulations align the UK’s approach with international standards. They recognise the unique nature of vehicle systems and the need for specialised cybersecurity measures. UN Regulation No. 155 on cyber security and cybersecurity management systems, which governs the security of vehicles, is now set to be the primary framework for automotive security. As far as it goes, that would obviously seem eminently sensible, but the noble Lord, Lord Clement-Jones, has highlighted that there are a number of broader, perhaps more philosophical, questions about the direction of travel—that is not a pun—with regard to EVs, self-driving vehicles and vehicle autonomy, which we will have to grapple with at some point in the future. I imagine that this is a subject to which we will return.
My questions are a little more general. The regulations are undoubtedly important for protecting consumers and securing digital infrastructure, but we must consider the broader implications. The automotive sector is rapidly evolving, as has been noted, and the development of automated vehicles holds significant economic and societal potential. However, with innovation comes the risk of regulatory frameworks that struggle to keep pace; that is self-evident. How do we ensure that these cybersecurity measures do not inadvertently stifle technological advancement in areas and sectors such as the automotive sector? How do we end up striking the right balance between securing the technologies and enabling them to flourish?
There is also a question here around consumer awareness; again, this was highlighted by the noble Lord, Lord Clement-Jones. How long would an individual’s data be attached to a particular vehicle, for example, even after it is sold? These regulations require manufacturers to disclose the duration of product security support, but how well are consumers equipped to understand and act on this information? Are we confident that the public are sufficiently informed about the critical nature of cybersecurity? Will the Government commit to taking the necessary steps to help customers and consumers protect their devices and data? It seems to us that this is an area where the education of the public must go beyond the bare minimum. We need to ensure that consumers are not left in the dark about the sorts of security risks that they may face.
We must also consider enforcement. With the proliferation of smart products entering the market at such an unprecedented rate, how will we ensure consistent and effective compliance across such a diverse range of industries, from household appliances to vehicles? As new technologies emerge and evolve, the enforcement mechanisms that are in place today may not be enough. Are we allocating the necessary resources to monitor and enforce these standards effectively? Are the Government allocating additional resources to help those things along? Does the current enforcement mechanism system adequately address the rising complexity and scale of the challenges ahead?
As I said, these are broader, more philosophical questions—I do not expect the Minister to be in a position to answer them and there is no need to write—but these are the sorts of things that we all need to consider as a society. Obviously, that will have political, economic and societal ramifications that we all need to consider, but the Opposition have no objection to these regulations; they make perfect sense for now. I suspect, however, that this is a subject to which we will return.
Lord Leong (Lab)
My Lords, I thank the noble Lords, Lord Clement-Jones and Lord Sharpe, for their contributions.
I will first address the question asked by the noble Lord, Lord Clement-Jones: why the delay? As the noble Lord, Lord Sharpe, mentioned, it was a result of the general election. At the same time, we were waiting for the Department for Transport to progress UN regulation No. 155, until such time as we knew that we must take this exception out of the current regulations. That is the reason for the delay, basically; it was also about finding parliamentary time to table these regulations. That is that on the delay.
Lord Clement-Jones (LD)
I am sorry to interrupt the Minister but, frankly, this is the same instrument as the one that was debated last May. Nothing has changed apart from the lack of parliamentary time. We could have done this in September, October or whenever. I forget quite when we had the King’s Speech—in July? We could have done this at any time in the past few months.
Lord Leong (Lab)
This is beyond my pay grade, I am afraid. I will need to ask my leader, the Chief Whip, why we could not allocate any parliamentary time for this legislation.
As far as personal data is concerned, the GDPR is still the lead legislation. I respectfully say to the noble Lord that, for the purposes of today’s regulations, the whole issue of such data is outside the scope of this instrument for now. However, I am sure that we will be talking about personal data in the months and, probably, years to come in other forms of legislation, or even about it being regulated itself.
Lord Clement-Jones (LD)
Out of scope? On the basis that we are being asked to exempt automated vehicles, is it not proper that we ask for reassurance about automated vehicles and the implications for safety, data or whatever else? We are exempting them from these connected product regulations, so we need to be reassured that there are other ways of regulating them other than through these regulations. So this is not out of scope; the debate is about whether we should be exempting them.
Lord Leong (Lab)
I take the point, but the instrument is about the two amendments to the regulations. I take the noble Lord’s point about data. Yes, it is important, and we must preserve the data, but this instrument is not within that scope.
Moving on to cybersecurity within autonomous vehicles, cybersecurity is at the heart of the Government’s priorities for the rollout of all self-driving vehicles. The Automated Vehicles Act 2024 enables an obligation to be placed on those responsible for self-driving vehicles to maintain a vehicle’s software and ensure that appropriate cybersecurity measures are in place throughout its service life.
In response to the point made by the noble Lord, Lord Sharpe, about innovation, the Government are committed to supporting the development and deployment of self-driving vehicles in the UK. Our permissive trialling regime means that self-driving cars, buses and freight vehicles are already on UK roads with safety drivers. The Automated Vehicles Act will pave the way to scale deployments beyond trials. The Act delivers one of the most comprehensive legal frameworks of its kind anywhere in the world for self-driving vehicles, with safety at its core. It sets out clear legal responsibilities, establishes a safety framework and creates the necessary powers to regulate this new industry.
On the point about cybersecurity from the noble Lord, Lord Clement-Jones, the Government take national security extremely seriously and are actively monitoring threats to the UK. The Department for Transport works closely with the transport sector, the National Cyber Security Centre and other government departments to understand and respond to cybersecurity issues associated with connected vehicles. UN regulation No. 155 more comprehensively addresses cybersecurity risks with automotive vehicles and has adequate provisions to deal with the prospect of self-driving vehicles. The PSTI regime is designed for consumer contactable devices or products and is not fully equipped to address the specific needs and complexities of vehicle cybersecurity. UN regulation No. 155, which was developed through international collaboration, provides a more suitable and rigorous framework for ensuring the security of vehicles.
More everyday products than ever are now connected to the internet. The Government have taken action to ensure that UK consumers and businesses purchasing consumer connectable products are better protected from the risks of cyberattack, fraud, or even, in the most serious cases, physical danger. The PSTI product security regulatory regime builds on the ETSI international standard and is the first of its kind in the world to come into force.
The cybersecurity regulatory landscape will continue to evolve. The Government need to be agile to ensure that there is synergy between existing and new laws. Through this draft instrument, the Government are delivering on the commitment in 2021 to except certain categories of automotive vehicles from the scope of the PSTI products security regulatory regime. This is because the Government, via the Department for Transport, are in the process of introducing sector-specific regulations that have been developed at an international level to address the cybersecurity of these products. These requirements, which are specifically tailored to these vehicles and their functionality, will create a more precise regime for the sector. This draft instrument therefore ensures that the automotive industry, which contributed £13.3 billion to the economy in 2022, will not be placed under undue burdens from dual regulations.
Lord Clement-Jones (LD)
My Lords, the Minister has not mentioned the point raised in the Explanatory Memorandum, which was designed, I think, to give us comfort about cybersecurity and data: the Government’s Connected and Automated Vehicles: Process for Assuring Safety and Security—CAVPASS—which I mentioned. I did not hear him give us an assurance that that will be developed during 2025 to ensure the safety and cybersecurity of self-driving vehicles. As well as reiterating that the GDPR is an absolutely splendid way of regulating these automated vehicles, I hope that he will reiterate that this will be produced, because I have had a look at what CAVPASS currently says in the area of data, and it is not very much. After all, these connected regulations from which we are exempting automated vehicles are about safety, data and everything else.
Lord Leong (Lab)
My Lords, the noble Lord makes a very important point. Rather than waiting for my officials to give me a briefing note, I will ensure that I write to him on all the points that he has just mentioned.
Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
(1 day, 21 hours ago)
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Baroness Merron
That the Grand Committee do consider the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024.
Relevant document: 13th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
My Lords, I am grateful for the opportunity to debate these amendments, which represent the most substantial reform of UK clinical trials regulation in over two decades.
Clinical trials are vital for developing safe and effective medicines, especially for those with limited treatment options, such as the estimated 3 million people living with cancer in the UK and the 17.5 million people managing long-term conditions. Last week, I saw for myself how innovative UK researchers are transforming cancer diagnosis and treatment. I joined the Science Minister, my noble friend Lord Vallance, at the Royal Marsden to learn about a research initiative that is using cutting-edge AI tools to improve breast cancer detection.
To support innovation, our regulations need to be flexible and proportionate. This legislation will do just that by delivering streamlined and efficient regulations, removing barriers to innovation and creating a patient-focused research environment—something that noble Lords called for during Questions on the Statement repeat that we just dealt with in the Chamber. These reforms will support the development of new life-changing treatments for those in need and strengthen the UK’s position as a global leader in clinical trials.
I turn briefly to why this change is necessary and timely. The reason is that the current legislation is based on the now-repealed EU clinical trials directive, so it therefore no longer aligns with the rapid advancements in medicine and technology. We have the opportunity to create a world-class regulatory environment for clinical trials, if we can deliver a modernised framework that supports the safe development of innovative treatments.
I will outline, for the benefit of the Committee, the key aspects of the reforms. First, on risk-proportionate regulation, regulatory requirements will align with the risk level of a clinical trial. Low-risk trials will receive faster approval through automatic authorisation, without compromising patient safety. The second aspect is that of future-proofing. We have removed duplicative and granular legal requirements in favour of tailored guidance, ensuring flexibility for future innovations and moving beyond a one-size-fits-all approach. On international alignment, the UK will remain aligned to global standards, ensuring that trial data is recognised internationally and strengthening its position as a preferred site for multinational clinical trials. Then there is the important point of cementing the UK as a destination for international clinical trials. Streamlined processes will simplify applications and deliver globally competitive approval timelines. The final change that these regulations deliver is increased transparency. We want to ensure that trusted information about clinical trials is publicly available for the benefit of all.
New legal requirements will thus be introduced to register a clinical trial, and publish a summary of results, including an easy-to-read summary for participants. These changes will build public trust in research by improving access to information about ongoing research and enabling informed decisions.
Of course, these reforms will also bring benefits to the National Health Service. Evidence shows that hospitals that undertake research have better patient care outcomes and improved staff retention. Improved efficiency in conducting clinical trials will therefore enhance research efforts and foster innovation in prevention, diagnosis and treatment across various conditions. Those conducting clinical trials will also benefit from a streamlined and risk-proportionate regulatory framework, reducing delays and admin burdens. These reforms, I am glad to say, will stimulate growth in the UK’s life sciences sector and position the UK as a global hub for clinical trials.
I beg the Committee’s indulgence as I correct an administrative error made in the Explanatory Memorandum. It incorrectly stated that an impact assessment was produced. However, since the projected costs and benefits to business were below £5 million annually, a de minimis assessment was conducted and published instead.
Before I conclude, I re-emphasise that participant safety remains absolutely paramount. While this legislation streamlines processes and removes barriers to innovation, what it does is to prioritise robust oversight of all clinical trials, ensuring that the safety of trial participants is never compromised. By modernising our approach, I believe we can strengthen the UK’s position as that global leader, as well as fostering innovation and having the highest safety standards. These reformed regulations accelerate the delivery of tomorrow’s emerging medicines into today’s reality for patients. I beg to move.
Baroness Bennett of Manor Castle (GP)
I thank the noble Baroness, Lady Merron, for her clear introduction to this statutory instrument, which I broadly welcome. There are some important factors here. I particularly welcome the requirement to register clinical trials and publish a summary of the results within 12 months. It has been widely and long acknowledged, in the research community broadly, that there is an issue where less successful or failed trials, or those that are not seen to have interesting results, are not published. They can be as important, or more important, than the successful ones. The failure to publish them is driven by academic, publishing and promotion imperatives—and, I am afraid, by the profit motive in healthcare, where companies have very much sought to find the successful stories and bury the less successful ones. That is really positive and, if I would say one thing, it would be to encourage the Government to speak more about that, because it is important that people understand it. Given the issues that we have with trust across the board at the moment, I encourage them to highlight that we are actually strengthening and improving regulation.
Lord Scriven (LD)
My Lords, I start by congratulating the Minister; I hear her sniffles. She has been a champion of her brief in having to deal with two statutory instruments, as well as a Statement in the House. I thank her for being here.
As the Minister said, the reforms proposed in this statutory instrument aim to create a more streamlined and flexible regulatory environment for clinical trials in the United Kingdom, while balancing safeguarding the interests of trial participants. The amendments seek to uphold the paramount importance of participant safety, ensuring that their rights and well-being remain central to the regulatory framework. By refining the evaluation and development process for new or improved medicines, these changes aim to expedite the delivery of therapeutic benefits to patients and society at large, and we on these Benches recognise that.
The instrument will formalise the combined review process, which has been piloted since 2018 and become the exclusive route for clinical trial applications. This process offers a single application pathway and co-ordinated regulatory and ethics committee review, ending in a unified UK decision for clinical trials. That would be helpful for practitioners and those seeking to innovate, but there are still points that require clarification, and while the objectives of these amendments are commendable, I seek clarification from the Minister on several aspects.
What measures are in place to ensure that the Medicines and Healthcare products Regulatory Agency and the ethics committees will be adequately resourced to manage the anticipated increase in workload resulting from the streamlined process? If no impact assessment has been made, what working assumptions are the department and NHS England working to regarding the workload that this new process will bring?
Can the Minister provide detailed guidance on how the risk-based approach will be operationalised to ensure consistency across different types of trials? I note that she talked about international alignment, but how do the Government plan to align these regulatory changes with international standards to facilitate seamless multinational trials? What frameworks will be established to monitor the impact of these regulatory changes on trial efficacy and patient safety, which is really important? How will these findings be reported locally within the NHS? Will they be reported to Parliament at any point?
Finally, can the Minister explain and elaborate on the consultation process undertaken with key stakeholders regarding these changes, including patient groups, industry representatives and academic researchers, in the development of these amendments? Were there any differences that emerged from the stakeholders and how have the Government dealt with them?
In conclusion, while we on these Benches support the intention behind these regulations, it is imperative to ensure that the implementation is robust and effective. I look forward to the Minister’s responses on the matters I have raised—less croaky responses, I hope.
Lord Kamall (Con)
My Lords, I thank the Minister for the laying of this statutory instrument. Like the noble Lord, Lord Scriven, I commend her on her valour and robustness, as well as the speed at which she managed to transport herself from the Chamber to here after the Statement repeat, having prepared for that and having been briefed by her officials.
Like many other noble Lords, we welcome these regulations, which are grounded in the review by my noble friend Lord O’Shaughnessy and the subsequent consultation with stakeholders, including the Medicines and Healthcare products Regulatory Agency and Health Research Authority, aimed at modernising the regulatory framework that governs clinical trials in the UK. We know that the landscape for clinical research in the UK faced significant disruption during the Covid-19 pandemic, but we also know that we learned quite a lot from trying to get vaccines out very quickly in terms of ways to speed up trials and to make sure that we get the right balance between efficiency and processes, as well as making sure that people are safe. We need to make sure that we can boost the volume of clinical trials and boost patient recruitment.
The O’Shaughnessy review identified the need for a more flexible and risk-proportionate approach to clinical trials. One very important point is that, while we cannot eliminate risk altogether, we can manage it. Where there is low risk, we should maybe not be placing so much emphasis on processes as compared with when there is high risk, but I also know that there may always be unintended consequences.
Stakeholders such as the Association of the British Pharmaceutical Industry were vocal in their support for these reforms and had in fact been calling for them. The ABPI 2024 report, The Road to Recovery for UK Industry Clinical Trials, highlighted that the number of pharmaceutical industry trials initiated in the UK increased—it was just over 400—between 2022 and 2023, although that still remained 36% below the 2017 level. We therefore understand the need to bring forward these regulations to make sure that we improve the regulatory environment to further increase clinical trial activity.
I turn to the detail of the regulations. One major change that noble Lords have already alluded to is the consolidation of the regulatory and ethics review process, enabling researchers to submit a single application for both regulatory approval and ethics review. While this change is aimed at improving efficiency—which we completely accept and welcome—there is a concern that any changes from consolidating these processes may put additional pressure on the regulators and ethics committees. The noble Lord, Lord Scriven, referred to that. If the single application process becomes overloaded, we risk delays in review times rather than the acceleration that was intended by these measures in the first place. It is essential that we have the resources and infrastructure in place to handle the increased workload effectively. Can the Minister therefore say how the Government will make sure to avoid that sort of overload? We completely understand why they want to consolidate the processes, but will it add extra pressure and will the resource be there to make sure that they are not overloaded and we do not just end up going back to square one, or even make things worse?
In addition, for low-risk trials, automatic regulatory authorisation will be granted, which will further streamline the approval process and free up resources for the more complex, higher-risk trials. Once again, while this makes sense, we have to be aware of possible unintended consequences or concerns that will be raised. The automatic approval of low-risk trials could, for example, raise concerns over oversight and monitoring. The intention to expedite the approval process for those with lower-risk profiles is laudable, but will there be clear criteria in place to ensure that the appropriate level of scrutiny is maintained, particularly in ensuring patient safety? As I said, while we support the intention, particularly for low-risk trials, we must always be aware of unintended consequences or unforeseen complications. Nevertheless, we completely understand why this is being done, and it is something to be welcomed.
Baroness Merron (Lab)
My Lords, I am most grateful to noble Lords for their time and their constructive contributions. I feel that we are all moving in the same direction, and I appreciate the welcome for these regulations. I also appreciate the understanding that I am not firing on all cylinders, but be warned: I will be at some point.
Noble Lords have heard the details of the amendments, which, as I said in my opening speech, represent the most significant reform of UK clinical trials regulation in more than 20 years. As I said in my opening comments, I am conscious of the fact that I have just come from the Chamber, where we heard questions about this very area. So these regulations do seem very timely. If I miss anything in response, I will of course be very pleased to write to noble Lords.
In delivering a more efficient and adaptable regulatory framework, and in accelerating life-saving treatment through streamlined and future-proof processes, the reforms will put patients at the heart of clinical trial processes, as we well as strengthening the UK’s position.
I turn to some of the key points that noble Lords have raised. On the matter of safety clinical trials of course carry varying levels of risk. No clinical trial is entirely without risk, but the MHRA maintains a rigorous regulatory oversight to safeguard patient safety in all clinical trials, and this legislation does not change that. There will be no compromise on the protection of participants. However, we are removing requirements from the current legislation that simply offer duplication or no additional value when it comes to identifying safety risks. As I and other noble Lords have acknowledged, this is about removing obstacles but ensuring that safety is paramount to ensure that regulators, researchers and participants are all aware of potential risks and can take action to deal with them as appropriate.
I very much welcome the removal of unnecessary administrative burdens; I am sure that all noble Lords do. By increasing the opportunities in the UK to access innovative medicines at an earlier stage, we will expand patient access to new therapies and reinforce the reputation of the NHS as a world-leading platform for health and life sciences.
The noble Lord, Lord Kamall, and the noble Baroness, Lady Bennett rightly highlighted the matters of transparency and public trust. I am very glad to see the new transparency requirements because, for the first time, there will be a legal requirement for sponsors to register a clinical trial, publish a summary of results and offer to provide participants with an easy-to-understand summary of what the research has found. Clear guidance is being produced to ensure that the summary for participants is accurate, tailored and appropriate for the audience, which includes translation into different languages and an awareness of suitable formats, as highlighted by the noble Baroness, Lady Bennett.
A recent study commissioned by the HRA highlighted the importance of transparency, with 69% of respondents stating that they would have greater confidence in research if participants were informed of the outcomes. These measures will therefore foster greater trust and engagement with clinical research, and I certainly welcome that.
The noble Lord, Lord Kamall, asked about the protection of pharmaceutical companies’ legitimate interests in protecting commercially sensitive information, and asked what safeguards are in place. I can assure him that we absolutely respect and understand the need for commercial confidentiality. The new regulations will permit research sponsors to request deferrals for registration and the publication of results, including offering to share these with participants where this is necessary to protect commercially confidential information. Deferrals could be granted for up to 30 months, with the possibility of further deferrals, where justified, up to a maximum of 10 years. I hope that these provisions will safeguard the very legitimate interests of companies, while also maintaining the overall goal of transparency, to which we are all committed.
We recognise the scale and the vibrancy of the UK’s life sciences industry, particularly those conducting clinical trials. Throughout the development of the reforms, we have engaged with the clinical trial community and received widespread support across key stakeholders, including businesses, academics and charities. The public consultation generated over 2,000 responses and demonstrated a strong appetite from the research community for updating and improving clinical trial regulations. We will continue working closely with the research community to produce guidance that supports the smooth implementation of these new regulations.
Noble Lords were very helpful in raising a number of considerations. The noble Lord, Lord Kamall, asked about the criteria for automatic authorisation and for information about low-risk trials. The criteria have been designed to ensure that sufficient scientific evidence already exists regarding the safety of the product and the methodology that has been used in the clinical trial—essentially, that we can be assured that the medicine is safe. The evidence must have been reviewed previously and approved by the MHRA or, where applicable, by regulatory authorities in the EU, the EEA or the USA. Additionally, the legislation defines the criteria for a clinical trial to be eligible for automatic authorisation. I hope that this is helpful to the noble Lord, as his point is very valid.
On the matter of implementation, raised by the noble Lord, Lord Scriven, particularly regarding guidance on risk proportionality, guidance will be published in advance of the regulations coming into force. This will ensure that researchers and those undertaking clinical trials understand the changes and have time to prepare. We are working with stakeholders across the sector and taking views into account to ensure that the guidance is as clear and helpful as possible. The guidance will be promoted by a wide range of channels to ensure that it reaches stakeholders across the research and clinical trial participant community. This is vital as we bring in this legislation.
The noble Lord, Lord Scriven, also raised a point relating to the performance of the MHRA. Since September 2023, all regulatory assessments for clinical trial initial applications and substantial amendments to protocols have been completed within the current statutory timescales of 30 days and 35 days, respectively. The latest performance information about the MHRA regarding clinical trials assessment shows strong consistency and, I am glad to say, no backlogs. The updated legislation will introduce key measures to make it easier and faster for applicants to gain approval. Noble Lords have acknowledged the need to ensure that the UK remains a prime destination for clinical trials.
The noble Baroness, Lady Bennett, raised questions about automatic authorisation. I understand why noble Lords are raising these matters. This is new territory and noble Lords need to be reassured. There are clear criteria embedded in the legislation to ensure that only appropriate clinical trials can use this automatic authorisation route. The criteria are based upon the MHRA stakeholders who were consulted on their extensive experience of clinical trials and the participant safety risks associated with them. I can give the reassurance that, where there is a significant safety concern with the product, clinical trials will not be eligible for automatic authorisation and must undergo full regulatory assessment.
The noble Lord, Lord Scriven, mentioned stakeholder engagement. Following the public consultation, a number of policies were adapted to ensure that the regulations did not have any unintended consequences, as the noble Lord, Lord Kamall, said. Let me give one example. The feedback indicated that patient and public involvement would be best addressed in guidance rather than in legal requirements, in order to give that flexibility and to enable it to be kept up to date.
The noble Baroness, Lady Bennett, mentioned the environmental impact at the stage of clinical trials. I will be pleased to write to her on that point.
As I believe this debate has shown, we are in agreement that, by improving the clinical trial regulatory framework, these changes will expand patient access to cutting-edge therapies, boost the UK’s life sciences sector and reinforce the reputation of the NHS as a leader in health research. On this basis, I hope that noble Lords will feel able to support these vital regulatory changes.
Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025
(1 day, 21 hours ago)
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Baroness Merron
That the Grand Committee do consider the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
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.
Lord Scriven (LD)
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.
Lord Kamall (Con)
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.
Baroness Merron (Lab)
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.
Lord Scriven (LD)
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?
Baroness Merron (Lab)
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.