Grand Committee
(10 months, 2 weeks ago)
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Arrangement of Business
(10 months, 2 weeks ago)
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The Deputy Chairman of Committees (Lord Ashton of Hyde) (Con)
My Lords, if there is a Division in the Chamber while we are sitting, this Committee will adjourn as soon as the Division Bells are rung and resume after 10 minutes.
Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023
(10 months, 2 weeks ago)
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Lord Markham
That the Grand Committee do consider the Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
My Lords, I am grateful to be here today to debate these important regulations. Before I begin, I draw the attention of noble Lords to my entry in the register of interests regarding my shareholding in a company which conducts private sector health screening.
To discuss this SI effectively, I must first set out some context. The provisions in the instrument concern in vitro diagnostic—IVD—devices. These are medical devices that test samples taken from the human body to monitor a person’s overall health or to treat and prevent diseases. Examples of IVD devices include blood tests to detect HIV or hepatitis, tests for cancer biomarkers and more commonly known tests such as pregnancy tests. The Medicines and Healthcare products Regulatory Agency—MHRA—is the UK regulator for medical devices, including IVD devices.
This SI is necessary first and foremost because it enables the MHRA effectively to enforce regulations in Northern Ireland, protecting patient safety. Without this SI, the MHRA will lack important powers equivalent to those in place across the rest of the UK.
Secondly, the SI is particularly beneficial given that life sciences and medical technology are major growth sectors in Northern Ireland, and this Government are committed to making Northern Ireland thrive. The SI will unblock UK-wide clinical studies of medical devices and IVD devices that include Northern Ireland locations. Northern Ireland has a unique regulatory position under the Windsor Framework, including access to the EU single market. By providing for a stable regulatory environment in Northern Ireland, this SI will further enable the whole of the UK to remain an attractive market for research and development of medical technologies.
In May 2022, the EU replaced its regulatory framework for IVD devices with a new regulation, the EU in vitro diagnostic regulation, which I will refer to as the EU IVDR. The EU IVDR has automatically applied in Northern Ireland since 2022 under the terms of the Windsor Framework. The Command Paper published last week reaffirms our commitment to unfettered access. This SI facilitates consistency in the operation of device regulations in Northern Ireland and GB, where beneficial to Northern Ireland, and reflects the unfettered access of Northern Ireland IVD devices to the GB market.
I will now take a moment to summarise the key provisions this instrument introduces. The SI lays down proportionate penalties and gives the MHRA powers to serve compliance notices for breaches of the EU IVDR in Northern Ireland. Although the MHRA previously had the necessary tools to respond to safety concerns, the statutory instrument further strengthens this toolkit. It gives the MHRA powers to designate and monitor notified bodies in relation to the EU IVDR and charge fees related to these activities. Notified bodies in the UK can carry out the technical conformity assessment of IVD devices for EU regulatory compliance, allowing the manufacturer to affix the “CE” and “UK(NI)” marks for placing their devices on the market across the UK.
Sponsors of performance studies for new IVD devices in Northern Ireland will need to apply to an ethics committee in the UK for an ethical review and hold sufficient insurance to meet any potential financial liability in the event of injury or death from participation in the study. The instrument also creates an arbitration procedure for refused performance study applications. It allows studies of IVD devices and clinical investigations of medical devices taking place in both Northern Ireland and Great Britain to require only a contact person to be established in Northern Ireland, rather than a legal representative, supported by a sponsor or legal representative established in Great Britain. This reduces the burden on businesses and makes it straightforward for studies and investigations to include sites across the whole of the UK. It will enable more studies and investigations to go ahead in Northern Ireland.
The SI allows a coronavirus test that complies with the EU IVDR and the new EU common specifications to be placed on the Northern Ireland market without needing to obtain separate approval from the MHRA, as is the current UK requirement. This will reduce burdens and avoid duplication of costs for Northern Ireland businesses wanting to place Covid tests on the market across the whole UK.
The SI includes specific provisions to ensure unfettered access of qualifying Northern Ireland IVD devices to the Great Britain market with no additional barriers or burdens to Northern Ireland traders. This product-specific legislation sits alongside general protections for Northern Ireland’s unfettered access to the rest of the UK under the United Kingdom Internal Market Act 2020.
These provisions allow us to honour our current commitments under the Windsor Framework and will strengthen the regulation of IVD devices in Northern Ireland, to the benefit of patients and businesses. For these reasons, I am content to bring forward this legislation today. I commend these regulations to the Committee.
Baroness Finlay of Llandaff (CB)
My Lords, I should declare that my son is a cardiologist and founder of Rhythm AI and Echopoint Medical—I think those medical devices do not completely fall within the scope of this, but I declare it anyway just in case.
It is notable that the medical devices road map from the MHRA, which set a future regulatory framework for devices and was published on 9 January, talks about four statutory instruments. Does this form part of those four? Are others due to come, and if so, when?
Despite the Government’s warm words about us being an attractive market, the problem is that the UK is becoming an increasingly less attractive market because our application-to-approval time has extended beyond that of other countries such as the US and Australia and, I think, Japan. Clinical trials in general are not being brought to the UK. During the pandemic, we showed that MHRA approval could allow us to be the fastest in the world with vaccine development and, more recently, with treatment of sickle cell disease. However, low numbers of patients are now enrolled in studies. For the life sciences to develop, trial and test new technologies, they need to be able to do so rapidly. How will the MHRA have adequate workforce to deal with an increased workload from Northern Ireland? Has that been factored in?
How will the risk assessment be set? It is important to recognise that some developments will fail and fall by the wayside. A realistic risk assessment recognises that a whole population needs to be studied. That is best done with post-market surveillance, which is key to evaluating the implementation of any new technology in the real world.
There is a view that our regulations have become tighter, making it too hard and burdensome for device development to be brought to the NHS; as the UK market is small, we need to make it particularly attractive for innovation. The eventual market, being small, would allow us to keep our innovations and market them abroad once they had gone through full approval processes. What steps are in place for mutual recognition agreements to be taken forward?
A paper from Birmingham Health Partners, Alternative Routes to Market for Medical Devices, suggests there are three routes. I gather that Switzerland has now undertaken to adopt the Food and Drug Administration approval systems from the US, registering the file—for us, it could be registered with the MHRA—with a post-market surveillance plan in place. Of course, the initial safety standards must be met, but it is in the real world that benefits and risks are revealed.
For our deficits and gaps in the NHS, there are problems that we need to solve by pulling new technology and diagnostics in. But the golden age of innovation will happen only if there is fast approval to evaluate, with good surveillance so that those innovations with problems are rapidly dropped and those with promise and better patient outcomes continue to be developed. This innovation has to happen across primary and community care as well as hospital specialty services. It requires the recognition of intrinsic risk by adjusting the risk threshold, including that not to innovate is also a risk.
The public understands the need to innovate. In the related areas of clinical trials, which I think is an important but salutary comparator, we have dropped from being fourth in the world to being 10th in the world, which is much to the loss of our NHS and our patients, as well as, obviously, innovation business. Our time for the regulatory review is greater, so we are slower than many other countries. How will these regulations strip out unnecessary processes and bureaucracy and speed up processes to make us attractive to innovators? Northern Ireland being in the unique position that it is now in could be a very important market for innovation, with its fast and easy access and attractions for those developing in vitro devices.
Lord Allan of Hallam (LD)
My Lords, I was grateful to the Minister for his description of in vitro devices, which is not necessarily obvious from the regulations. I hope that he can confirm that the “in vitro” bit is misleading; we are talking about lots of tests that are done in plastic and no longer glass, so it is a Latin hangover. I think that I am right in thinking that this applies to everything, whether it is a stick test or whatever device it is; it applies to any kind of diagnostic test.
On the regulations, I shall offer a one-sentence Brexit whinge, which is just to say: “Oven-ready, ha ha ha!” Looking at these regulations, we are now in legislative spaghetti territory, where to do something quite small and simple requires pages and pages of legislation to enact it. We are in a very messy regulatory situation, and it is only going to multiply over time. That was the first point that I wanted to raise.
It would be helpful if the Minister could say, for the health area for which he is responsible, the extent to which the Government have assessed how far there will now be divergence between Northern Ireland and Great Britain in the relevant health areas. There are two different scenarios. In one, the UK stands still, but the EU moves on, which is effectively what has happened here: the EU has updated its law, and we are now having to respond, because it will apply in Northern Ireland. So even if we do nothing, there will be change, and we should be reasonably capable of extrapolating that by looking at past behaviour and the EU’s legislative programme. Of course, the other scenario is where we actively diverge from the EU.
I hope that, in both scenarios, the Minister will be able to confirm that there is somebody—or a team somewhere in DHSC—who has all this mapped out. It may not have been possible before Brexit, when we were still living in la-la land—but, since we have had the experience of the retained EU law Bill, where the number of laws that we found tripled from the first exercise to the current iteration, it is important for businesses out there that we understand how much retained EU law there is in the health area, how much of it will be relevant and how much will require this kind of statutory instrument to ensure that we can respect both the Northern Ireland and the Great Britain settlement.
I am also curious: the Minister referred to the fact that the EU’s updated law was implemented as a regulation, which of course applies directly, rather than a directive, which needs transposition. He said that it applied from May 2022, but we are regulating only now. I am genuinely curious as to what happened in the intervening period. Is it the case that if somebody had been selling non-conforming devices, they would get away with it for that period because the law did not catch up? I am curious to hear what the Government’s intention is. Presumably, this scenario is going to be repeated: there will be new bits of EU law and we have to follow on and make sure that they are implemented for Northern Ireland. I am genuinely interested in the Minister’s comments on the Government’s strategy: are they concerned at all that there may be these gaps, or is it something we just have to live with now?
Baroness Merron (Lab)
My Lords, I also thank the Minister for setting out the provisions in the regulations and for trying to unravel the many pages before us. This seems to be one of those innocuous measures that are needed just because that is where we are, but I very much take on board the comments of the noble Lord, Lord Allan, which are worth wider government consideration.
Clearly, these regulations are needed to support the implementation of new EU regulations that came into operation in Northern Ireland in May last year. They are important in that we have to secure continuity of supply and trade in medical devices within the UK and the EU, and the draft regulations affect a diverse range of equipment and systems to examine specimens in vitro, including items such as blood grouping reagents, pregnancy test kits and hepatitis B test kits, to give just a few examples.
As the noble Baroness, Lady Finlay, said, it is important that we support innovation. The medtech sector provides a huge contribution to our health service and our vibrant life sciences sector, from catching killer diseases early all the way through to preventing infections. The products we are talking about are found in doctors’ surgeries, hospitals and our own homes. They are part of our daily lives. We certainly know from the pandemic how difficult it can be to replace them if supply is disrupted, so we are here to ensure that supply disruption does not happen.
As has been said, the Explanatory Memorandum sets out that these regulations should affect only some 19 businesses in Northern Ireland and cost less than £5 million to implement, but it is important to acknowledge and put on record that they are a valuable part of the UK medtech ecosystem. On these Benches, we certainly support the regulations, which we believe will secure unfettered access to the British market for Northern Ireland businesses and ensure continuity of supply.
I also have a few questions that I hope will be helpful for the Minister. It is welcome that the previous fee structure is being retained to reduce disruption for Northern Ireland operators, but could he say what assessment has been made of any impact on the MHRA’s responsibilities as a regulator? Could he also confirm that it will be resourced to fulfil those responsibilities?
Previously, Ministers have talked about future realignment of regulations on medical devices following our departure from the EU, including consideration of alternate routes to the British market. Can the Minister say a bit more about what opportunities there might be in this area? What is the timeline for the future regulatory regime that the Government want to bring into force? As the Government have not yet set out their proposals, is there a timeline for doing so?
I note that medical devices did not receive attention in the Windsor deal, which was understandably disappointing to some suppliers, which cited the complexity of navigating the current system. Is the Minister considering adding other product classes, such as other devices, to its scope? Will he also clarify the status of devices on which a conformity assessment has been performed by a UK notified body? Following on from the questions from the noble Lord, Lord Allan, in this regard, will it be possible to place devices bearing a “CE” conformity mark, as well as the EU Northern Ireland mark, on to the EU market? Is it the case that no UK notified body has been appointed? If that is the case, when will this be dealt with and what is the delay down to?
In summary, we are pleased to support these amendments to the regulations to secure continuity of supply for the critical medtech sector. I look forward to hearing the Minister’s response.
Lord Markham (Con)
I thank noble Lords for their contributions and the spirit in which they were made in terms of helpfulness and trying to make the market as open and productive as possible.
I shall try to answer the questions in turn. To the noble Baroness, Lady Finlay, I say, yes, this is part of the four SIs.
On the noble Baroness’s whole question about making the UK market attractive to innovation, that is exactly what this is all about. On her point about clinical trials, my understanding is that there was a period when we slipped down the league on timings. I am told that a lot of that was because we were trying to prioritise Covid issues but, as I understand it today, we are now back within the timeframes. While we slipped down to 10th place in the league, the understanding from recent business coming in is that we think that we are making our way back up into the champions league spots, for want of a better phrase. I am assured that we have seen quite an improvement in the time taken in clinical trials.
On the noble Baroness’s question about what this means for the MHRA—the noble Baroness, Lady Merron, asked a similar question—we do not believe that this should have a significant impact. At the same time, I am totally with the sentiment that we do not want the MHRA to be a bottleneck, not just in this area but generally because speed to market is important here. In the last Budget, we agreed quite an increase in the MHRA’s budget, exactly so that it is able to pass such things through more quickly.
On the points about mutual recognition, it is absolutely our direction of travel. We are looking to do that with other authorities. Again—this also goes to the question of the noble Lord, Lord Allan—we are recognising the “CE” marks until 2030. That is probably a good example of mutual recognition.
Lord Allan of Hallam (LD)
The “CE” mark recognition is an example of one-way recognition, not mutual recognition, because it does not go the other way.
Lord Markham (Con)
Absolutely. Clearly, we would like it both ways, for obvious reasons. There are a number of areas where we are still being open about our rules—not just to the EU but to other countries as well, with the hope that there is some reciprocation down the line. That is definitely the intention. Talking to the regulators, I know that the situation is crazy. We know that the Australian, Canadian or Singapore regulators are top-notch, so we should be satisfied with their work in many cases. The feeling often is that stage one towards that recognition is that, while we might have slightly different standards, recognising that where they have conducted tests, rather than reconducting those tests, we should at least recognise that each other has done the tests correctly. We should take that data and that should speed things up.
In answer to the question of the noble Lord, Lord Allan, we are talking about any type of diagnostic test—
Baroness Finlay of Llandaff (CB)
May I intervene before the Minister moves off the subject of mutual recognition? Perhaps I may clarify whether he envisages this being similar to the Orbis project for drug approval recognition, particularly regarding oncology and cancer drugs, where FDA approval is recognised. There are different levels, so that things can come through to clinical application quickly. What is the position as regards us recognising FDA approval for development? Do the Government intend for that to be adopted by the MHRA, rather than devices having to go through all of our processes as well? Will we recognise the FDA system, with increased focus on post-marketing surveillance?
Lord Markham (Con)
I am probably not qualified to speak specifically about the Orbis project read-across but, at the general level, that is definitely the direction of travel, if you speak to the MHRA. As I said, there are almost two levels to it. The complete level is where you just take it lock, stock and barrel. That is the slightly harder one, but at least the preliminary step towards that is recognising when they have done a batch of tests. I know from a previous life—during Covid, for instance, when a lot of tests were about—that you have to do a number of samples, test them against a control group and see where they come out against that. Those were internationally recognised tests, so if the US, Canada or Australia have done tests on those devices, rather than doing our own tests, let us at least accept them. Those are the two stages of that.
On the point about divergence, this SI tries to make sure that the GB and Northern Ireland markets are as similar as possible. My understanding of how we used to regulate EU “CE” devices was that we would take the “CE” marks and then often tweak them slightly to make them relevant for the domestic market. Apparently, France, Germany and all the countries do that. With this SI, as I mentioned, we are recognising “CE” marks generally until 2030 on a voluntary basis—so, obviously, we can tweak them as much as we like. Northern Ireland generally has to accept those devices because of the Windsor agreement, but it still has that tweaking ability, for want of a better word, that we always used to have when we were in the EU. The idea behind this SI is to allow us to tweak it from both ends—the GB end and the Northern Ireland end—so that it is common, and we have read-across so that the product will work under the “CE” mark in both Northern Ireland and across in GB.
This was explained to me this morning, so my officials can tell me later whether I have been a decent student. For general clarity, as ever, I will happily write this all down, but I hope that makes sense.
Lord Allan of Hallam (LD)
It does; that was a helpful and clear explanation. However, if somebody has tweaked their test for Northern Ireland and they also want to sell to the EU, are they able to do so? For example, can they send it south of the border into the EU? Or would that require an untweaked “CE” mark, and, if so, who gives them that? That is really the heart of it.
Lord Markham (Con)
My understanding of all this—again, I will tell the noble Lord to the best of my knowledge and correct it if I am wrong—is that we always used to tweak it when we were part of the EU. It was generally accepted that we would tweak a bit, and so would France and Germany. That did not stop products being sold across, so I do not believe that they will need to untweak it, for want of a better word. Again, if I am wrong about any of that, I will clarify it.
On the question of what happens between March 2022 and now, I will let the noble Lord know in writing about what happens during that period.
My understanding is that the MHRA is neither a notified body nor an approved body. It does not set “CE” marks or “UKCA” marks itself; it tests them and looks at the conformity, but it does not establish any, for want of a better word.
On the questions raised by the noble Baroness, Lady Merron, that I did not pick up on before, we do not think the fee structure will have much impact on the MHRA.
The noble Baroness also asked what the opportunities are and what kinds of visions will come from this. I freely admit that this is a complicated space. However, one area where I have seen an opportunity is around the precision medicine space. For example, for the next set of cancer treatments, it will be possible to take a sample of the malignant tissue or cells and adjust the messenger RNA to, effectively, get your own body to attack those cells. The problem is that each one of those medicines you produce is individual to you, so it becomes difficult to regulate each individual medicine under the regulatory framework, as it would take ages and destroy the point of the exercise. The MHRA, however, has developed an umbrella mechanism, allowing it to treat all the individual medicines as regulated and approved. That is a major opportunity. My understanding is that the EU has not managed to be quite as fleet of foot, so it is not there yet. That is just one example I have seen; it is very important, as it allows us to charge ahead in terms of the precision medicine space. Moving forward, that will help us establish ourselves in the clinical trials and life sciences fields. I understand the points the noble Lord makes about all the complications due to some of these post-Brexit situations, but, actually, this is one area that is very positive. It will be a huge benefit for us going forward.
On the question asked by the noble Baroness, Lady Merron, about the future vision, I think it is sensible to agree a baseline based upon what we see in reputable countries with standards—such as Canada and Australia —making it as easy as possible to regulate. It would not be ideal if that meant we had to do it just one way, as we would prefer to do it both ways. However, it would still make us attractive as it would be possible to do clinical trials for our products here and know that it will work. However, where we can forge ahead in areas such as precision medicine, where you need tailored and expert help, let us really try and do that. So I think there are some really exciting possibilities.
I hope that gives a flavour of our vision and how we are trying to progress matters in this space. I realise I have not answered every question, but it has been quite a useful debate. I have definitely found it useful to tease out the details. If I may, I will go back to my notes.
I trust that I have provided sufficient answers to the questions and, as I said, I will write to follow up. I hope and trust that I have demonstrated the necessity of these regulations to honour our current commitments under the Windsor Framework agreement. With that, I commend this instrument to the Committee.
European Organization for Astronomical Research in the Southern Hemisphere and the European Space Agency (Immunities and Privileges) (Amendment) Order 2023
(10 months, 2 weeks ago)
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Lord Ahmad of Wimbledon
That the Grand Committee do consider the European Organization for Astronomical Research in the Southern Hemisphere and the European Space Agency (Immunities and Privileges) (Amendment) Order 2023.
Relevant document: 8th Report from the Secondary Legislation Scrutiny Committee
The Minister of State, Foreign, Commonwealth and Development Office (Lord Ahmad of Wimbledon) (Con)
My Lords, this order will allow the European Space Agency’s senior officials to fulfil their roles in the UK by bringing the headquarters agreement the UK signed with the agency in 2013 into domestic law. It will enable the smooth operations of the agency’s facility at the Harwell Science and Innovation Campus in Oxfordshire. It will also foster closer collaboration between the agency and the UK Government and support the development of the space industry, stimulated by the facility at Harwell. The order was laid in draft before Parliament on 18 December, in accordance with the International Organisations Act 1968. It is subject to the affirmative procedure and will be made once it is approved by both Houses.
The purpose of this order is to amend the European Space Agency (Immunities and Privileges) Order 1978. This will be achieved through an amendment to the 2018 order, which sought to amend the 1978 order but did so incorrectly. I apologise to the Committee for that mistake and, indeed, the delay, which, although exceptional, in the sense that it was not something we would expect to happen, is nevertheless unacceptable. This order has been subject to multiple reviews internally and was discussed with the counsel to the Joint Committee on Statutory Instruments before it was cleared and laid.
The order amends the 2018 order clearly and coherently, and in doing so creates a stand-alone article for the head of the Harwell centre and high-ranking staff in the 1978 order. In doing so, it will correctly reflect the privileges and immunities set out in the 2013 headquarters agreement. This agreement provides for the establishment and operation of a facility by the agency at Harwell.
To be clear, the 2018 order failed to correctly provide the agency’s head of the Harwell centre and up to seven high-ranking staff with the
“immunity from suit and legal process”
and the “inviolability” of their residences in the UK under the International Organisations Act, thus failing to correctly implement the terms of the headquarters agreement into UK domestic law. Because of these errors, neither the headquarters agreement nor the 2018 order were brought into force. In practice, this means that the head of the Harwell centre and the seven high-ranking staff members were underprotected. Their privileges and immunities were equivalent to the functional immunities provided to European Space Agency officials under Article 16 of the 1978 order. I assure noble Lords that no negative consequences have been identified as a result.
This order corrects those omissions and affords the head of the Harwell centre and up to seven high-ranking staff members the same privileges and immunities which a head of a diplomatic mission and diplomatic agents of a diplomatic mission established in the UK are entitled to. This change is a prerequisite for the 2013 headquarters agreement to enter into force. Additionally, the 1978 order has been amended also to include an exemption from the legal suit and process immunity in the case of a motor traffic offence or damage caused by a motor vehicle.
The Government consider these privileges and immunities both necessary and appropriate to deliver on the interests and commitments that the UK has towards the agency. The privileges and immunities conferred enable its head and high-ranking staff to operate effectively in the UK. They are within the scope of the International Organisations Act and in line with UK precedents.
The agency’s other officials are subject only to official act immunities. By making this amendment, the other provisions of the 2018 order can also be brought into force. These cover entry into the UK, and customs provisions and immunity from legal processes within the scope of official activities. Importantly, the provisions also cover the inviolability of official documents and correspondence; the inviolability of the agency’s premises; statutory meetings; foreign currency exchange; functional immunity for officials; and an immunity waiver.
Lord McNally (LD)
My Lords, that apology was delivered with the sincerity and clarity which one has come to expect from the noble Lord, Lord Ahmad, in dealing with this place. In some ways, I feel rather guilty. I put my name down for this debate because I am interested in the space industry, but I feel a little bit guilty that a Minister who is usually working for us in some of the tightest spots in the world is delivering an apology for a drafting cock-up from some five or six years ago. However, it gives me great pleasure to work together on this with the noble Lord, Lord Ahmad, again. Over 10 years ago, we were together in the coalition Government. Since then, as I said, his contribution, particularly in our foreign affairs in some of the most difficult and dangerous positions for a Minister, has done great credit to this House.
The instrument corrects an error. It will bring the provision of UK domestic law in line with the headquarters agreement. Most of all, as the Explanatory Memorandum says:
“It is important that the European Space Agency … has a solid presence within the United Kingdom with an identity that is aligned with the strengths of the United Kingdom space sector”.
That is really why I wanted to speak. I thought that whoever replied could reaffirm this Government’s commitment to a space programme. There are not many times that I stand to speak in praise of Boris Johnson, but as Prime Minister he certainly gave real leadership to the space programme and real encouragement to the departments working on it. I hope that, in welcoming this order, and playing host to and participating in these organisations, we are reaffirming our commitment to space exploration.
I grew up in the 1950s, reading that famous comic, the Eagle. I draw noble Lords attention to that because the adventures of Dan Dare, who was the great spaceman in that comic, were set in 1985. In the 1950s, it was assumed that we would be flying to Venus and that we would have settlements on the moon and all kinds of things. Yet it is now 50 years since a man walked on the moon. The need to recommit ourselves to space is very important.
The European Organisation for Astronomical Research in the Southern Hemisphere has an establishment in Chile, which is home to the very large telescope, known to its friends as the VLT, and the extremely large telescope, known as the ELT. It is quite simply unparalleled in terrestrial astronomy and totally deserving of our participation. I saw a television documentary on it; it is amazing what they are doing there.
I suppose the first thing we have to convince the Government of is that the European Space Agency is not an EU body, so we are not frightening the horses in this case. It is a major player in space, and it is vital that we continue with its work as part of a national policy to support the future growth and viability of the sector. The UK is the largest destination for space investment after the USA, and it is projected to take up some 10% of the global space market—a market already valued at £400 billion in 2022. Space technology already underpins key functions in communications, navigation, climate and weather forecasting, as well as in financial transactions and services.
As I said, it is 50 years since a man last walked on the moon, but the real exploration of space is only just beginning. The agencies cited in this order will be essential in ensuring that we receive all the benefits of the new space age.
Lord Collins of Highbury (Lab)
My Lords, I thank the Minister for his contribution and his apology, which I too think was well meant. We fully understand the reasons for it. I normally congratulate the Minister on his longevity in post. Of course, this is only the second time he has addressed this statutory instrument; I have had the fortune to address it three times. It is quite a horrendous story that an important protection that we are required to give under international conventions has been so difficult to implement. I ran into the noble Baroness, Lady Goldie, last night; she introduced the original SI, and when she responded the first time it was presented she said that the road had been a difficult one, full of potholes and a lot of stumbling. I think that is true.
The Secondary Legislation Scrutiny Committee said:
“Although that 2018 version was made … it still did not implement all the immunities correctly … the treaty has not been ratified. FCDO told us that the error was identified in mid-2018 but its correction was delayed by the requirement to prioritise other legislation for Brexit, COVID-19, and then sanctions connected with the conflict in the Ukraine. Although FCDO says that there has been no actual detriment to the seven individuals involved, this unfortunate series of events casts doubt on FCDO’s competence in drafting effective legislation.”
I hear what the Minister said about double-checking that, but we need a very clear response from him about the impact this may have. As the Explanatory Memorandum says, the siting of this headquarters and bringing it into the UK has a positive economic effect. It is something that we should be encouraging more of, so when we make this sort of mistake it has an impact, as the Secondary Legislation Scrutiny Committee specified, and we need to address it.
The Explanatory Memorandum says that the presence at Harwell
“is attracting businesses and research organisations to locate near to the cluster to enable them to easily access facilities, services and funding that the cluster offers”.
That is a good thing, and it really is a shame that we have not been able to properly implement those protections for the leadership of that cluster. What is the estimated economic benefit of this facility? How much have we been able to attract in locally to benefit that community?
The Secondary Legislation Scrutiny Committee received assurances from the department that there has been no detriment to the individuals. I find that difficult to understand, but anyway, that is what it says. However, the Explanatory Note says:
“An Impact Assessment has not been prepared for this Order as no, or no significant, impact is foreseen on the private, voluntary or public sectors in the United Kingdom”.
Here we have an organisation whose leadership has been impacted by this. Have they suffered a detriment? The Secondary Legislation Scrutiny Committee said there has been no detriment, but we need to have an assurance that some form of assessment was conducted about the potential impacts on the individuals, the organisation and, as the committee said, on our reputation of being able to facilitate these sorts of arrangements under international conventions.
Obviously, I read the debate on the SI in the other place. My honourable friend Stephen Doughty made it clear that we welcome this statutory instrument, its provisions and the facility in Harwell, so I do not want to pour scorn on this. It is a positive move and a good thing. The Minister said that the Government are taking action to ensure this does not happen again, but there must be some sort of reputational damage to us, particularly if we are to try to be a centre and to bring other international organisations into the United Kingdom. I apologise for being a little bit negative about this, but I accept that the Minister has given an apology and that we are putting something right. That is the most important thing.
Lord Ahmad of Wimbledon (Con)
My Lords, I thank both noble Lords who have spoken in this brief debate for their acknowledgement of the fact that what we have in front of us is a correction rather than a substantive order. I think the intent was very clear. The noble Lord, Lord Collins, talked about 2018, and I will come on to that in a moment, but I begin by thanking the noble Lord, Lord McNally, who, as he stated, I was able to call my noble friend for at least five years of my ministerial career. He is a friend in every sense, and it is a real privilege to be picking up on some of his questions.
I must admit that, as he spoke about the Eagle, I googled it—the wonders of technology; I suppose we live in this kind of era. It provided that kind of insight for that generation. As he was speaking he reminded me of something that happened recently. Over the Christmas period, my younger son, who is only nine, suddenly became a real fan of “Star Wars”. In my time, there were only three films; there are now about 11, and then there are sub-strands. He asked me, “When did you first watch it?” I realised that in 1978 I was the same age he is now, so there was some connection there—although he started his question by saying, “Daddy, when you watched it in the ancient times, did they have this technology?” so I am reminded that things move very quickly in the ever-expanding space that is space. Perhaps in future we will have an FCDO Minister not just for the Commonwealth, south Asia, Middle East and north Africa but for Mars, Venus and who knows what else. We look forward to that.
I acknowledge the insights that the noble Lord provided, and the support of the noble Lord, Lord Collins. As I said in my comments introducing this correction, it is important that, when Governments do not get something right first time around, we acknowledge and correct it.
Carer’s Leave Regulations 2024
(10 months, 2 weeks ago)
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Lord Offord of Garvel
That the Grand Committee do consider the Carer’s Leave Regulations 2024.
Relevant document: 8th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department for Business and Trade and Scotland Office (Lord Offord of Garvel) (Con)
My Lords, I was pleased to note the positive debates last year, when the Carer’s Leave Bill received cross-party support in both Houses. The Carer’s Leave Act, under which these regulations are being brought forward, obtained Royal Assent on 24 May 2023. The Carer’s Leave Regulations were laid on 11 December 2023. I should start by thanking Wendy Chamberlain MP and the noble Lord, Lord Fox, for their work in getting us to this stage. I want again to thank everyone who participated in relation to this significant matter in both Houses last year. I am delighted to be here today for this debate on these draft regulations.
I should also take this opportunity to flag a correction slip in relation to page 2 of the SI. Regulation 5(1), line 1 stated:
“is entitled one week”,
but now reads,
“is entitled to one week”.
The context of these regulations is to recognise the importance of unpaid carers. This Government appreciate the time dedicated by unpaid carers to help those dependants who rely on them for their everyday needs. These regulations will provide valuable additional flexibility to support all unpaid carers who are in employment across the country.
Statistics from the Family Resources Survey 2021-22 show that there are 4.9 million adult informal carers in the UK. Just over half of those are also holding down a job. Around 2.5 million people are trying to balance work with their caring responsibilities, which is a significant proportion of the workforce. We know that an additional leave right is important for them. A survey published by Carers UK in 2022 found that 75% of the unpaid carers who responded worry about continuing to juggle work and care, two-thirds have given up opportunities at work because of caring and a quarter said they needed better support to return to or maintain paid work, while a quarter said they need unpaid carer’s leave to do so.
In addition to the new entitlement to carer’s leave, it is also the case that having flexibility with start and finish times at work, or working from home where this is possible, can make it easier for carers to balance work and their caring needs. The Employment Relations (Flexible Working) Act 2023, which also comes into force in April 2024, will increase the number of requests an employee can make in a 12-month period and reduce the time allowed to administer requests. Separate regulations, also expected to come into force in April 2024, will remove the continuity of service requirement for the right to request flexible working. Therefore, employees will be able to request flexible working arrangements from the first day of their employment. These changes will also support the ability of carers to remain in, and progress in, work.
I turn to the regulations, which will fulfil our 2019 manifesto commitment to introduce one week of leave for unpaid carers. I shall set out briefly what they do. The first key element is that the carer’s leave entitlement will be a day one right for employees, so it will be available from the first day of employment. It can be used for providing care or making arrangements for the provision of care for a dependant with a long-term care need. These definitions have purposefully been kept broad to encompass a range of different care needs and circumstances. Flexibility is key: no two care dependants have the same care needs—and the circumstances of the carer’s employment will be different, too.
Employed carers can take the leave flexibly, from half a day at a time up to a block of one week. This ensures that carers can use their carer’s leave in a proportionate way that suits their needs. For example, they could accompany their dependants to an appointment or visit a potential care home and get back to work on the same day. If necessary, they could care for their dependant for a whole week—for example, if they are recovering from a major medical procedure. These are just examples to illustrate how the leave may be used. In claiming the leave, there will be no evidential requirement to demonstrate how the leave will be used or who it is used for. The purpose of this approach is to remove undue stress for the employee, including any concerns that they may have about providing potentially sensitive information about a third party. It will also minimise the administrative burden for employers and reduce bureaucratic obstacles.
The regulations put in place a minimum notice period requirement, which is similar to the existing annual leave entitlement. This will mean that employed carers must give notice of twice the length of time being requested plus one day, subject to a three-day minimum notice period. Furthermore, the notice can be given in multiple forms, whether that is via email, verbally or through an existing application within the workplace. We also recognise that there may be circumstances in which granting the leave may be difficult for the employer, such as during a busy week for an urgent deadline. The regulations will give employers the power to postpone the leave, but they may not deny it completely. It will be down to the employer and employee to come to an alternative arrangement that works best for both parties. Lastly, employees taking carer’s leave will have the same employment protections associated with other forms of family-related leave, including protection from dismissal or detriment as a result of having taken the leave.
In conclusion, these measures will provide invaluable support to unpaid carers balancing work with their caring responsibilities. Employees and employers are set to benefit from this Act. Employees will receive an extra bit of flexibility. By providing that extra flexibility, employers will be able to retain valuable staff members who would otherwise have struggled to remain in work. The Government are very pleased to have supported the Private Member’s Bill and be delivering these regulations.
Baroness Tyler of Enfield (LD)
My Lords, I rise briefly, primarily to say how delighted I am that this legislation will come into force on 6 April. As the Minister said, there was strong cross-party support for the Bill when it had its passage through the House. I thank those who were involved in drawing up the regulations, as they have done a good job of it. I have been involved in this area for some time now, and in previous attempts to get legislation of this type on the statute book that were not successful, and that is why I am delighted that this one was successful. However, I have not been involved for anywhere near as long as my noble friend—and I think of her very much as my noble friend—the noble Baroness, Lady Pitkeathley, who has tirelessly campaigned in this area for many decades.
This is landmark moment and one we should celebrate. For the very first time, those juggling paid work and unpaid care are going to have dedicated rights in the workplace. It will provide them with more flexibility, and it will make a very real difference to the quality of those carers’ lives. It has been estimated that at least 2 million people will be able to take advantage of the provisions in this legislation, which is going to provide real support to help people, particularly women, to stay in work. I emphasise that point, because we know that it is women who are more likely to be juggling work and care and are more likely to be in part-time than full-time work. Also, we know that women in their 50s are more likely to leave the labour market—more likely than men—to provide unpaid care for family members. I am hoping that this is something that will mean that fewer women will have to leave the labour market.
I have one question for the Minister. Thinking back to our previous debates, I think the provisions of this Act will also apply to parents who have children with a long-term disability. That is an important point. What sort of steps are the Government thinking of taking to make sure that those parents are aware that this applies to them and not only to carers of adults with disabilities or older relatives?
This is an incredibly important milestone. I hope that we can build on this important first step, which will benefit the labour market as well as individuals, so that in future we can move to having a paid leave provision.
Baroness Pitkeathley (Lab)
My Lords, I too thank the Minister and his officials. I declare an interest as vice-president of Carers UK. As my friend the noble Baroness, Lady Tyler has said, I have been working on this issue for many decades. I first put forward the idea of a carer’s leave Bill in 1990. When I am at my most pessimistic, I ask whether all I have achieved in 30-odd years is five days’ unpaid leave for carers. When you look at it like that, it ain’t much—but it is a very important step, as the noble Baroness said. When I am feeling optimistic—mostly, I am a glass-half-full person— I recognise what an important step this is in looking at the needs of working carers. Their need is not only for finance, although many of them are struggling with the cost of living; they need extra money now, so they need to keep on working in their jobs. If they do not, they build up future poverty for themselves for the future, because they cannot contribute to pensions. That causes a problem for society down the line. It is also of tremendous psychological import and benefit to carers to remain in the workplace as long as they can. This will help them do it.
The carers’ movement has always been opportunistic. I see this very much as a stepping stone. We now have unpaid leave—the next step is paid carer’s leave. Believe me, we will not give up on that. This is a very good time to be doing this, as we have elections coming up and manifestos to be written in which we might think about paid carer’s leave.
When thinking about new employers who will look through this legislation, we should remember the excellent employers who already do this. Employers for Carers, an organisation convened by Carers UK, has many wonderful examples of employers who already recognise carers without the need for legislation and recognise that a small change in working practices—the kind of flexibility that the Minister mentioned—makes a very big change to carers’ lives. Sometimes just allowing a carers’ group in the workplace will provide a very adequate method of support.
Those employers have recognised that carers are among the most dedicated people in their workforce and that retaining them and enabling them to continue their paid work will save a fortune in recruitment and retention. These employers and the new ones who will come into the fold following this legislation and the regulations will very much be beneficiaries, as carers will be, of this Act. They will understand that making carers the subject of this Act and giving them these extra rights makes sound economic sense. We are not just making a moral case for carers; there is a very sound economic case for keeping 2 million carers in work longer than they would otherwise be. As I always remind your Lordships, carers save the nation £162 billion every year, the cost of another health service, through their unpaid work.
I too was going to raise the issue of parent carers with the Minister, but my friend the noble Baroness, Lady Tyler, has already done it. Do the Government have any plans for an awareness campaign to ensure that carers, who are often isolated, will have the opportunity of working with the voluntary organisations in the field? Carers must be made aware of this new and very welcome right.
Lord Fox (LD)
My Lords, so much of life on these Benches feels a little like pushing water up a hill. If you will excuse me for mixing the medium, this was like pushing an open door; it really has been a delight. I feel very lucky because, as both the previous speakers pointed out, they have been operating in this field for decades whereas I, in a sense, picked this Bill up by luck. My friend, Wendy Chamberlain, in the Commons, won the ballot and chose this Bill to bring forward. As I am representing that particular department, I got the good fortune of sponsoring the Bill. I am very pleased, but also humbled, as I came late to this piece.
This is also, I think, the third Minister we have had during the course of the Bill. This, of course, allows me to repeat all the speeches I made to the previous Ministers as a novelty. The Minister’s explanation of the effects of the Bill were excellent. We all, in our different ways, understand the impact it will have on people’s lives and on employees’ lives.
The point I emphasise, though, is that it creates a conversation that carers can safely have with their employer for the first time on this subject. It means that carers who have been in the workplace can come out as carers in the workplace—because they have previously had to worry about whether it would affect their relationship with their employer. The Bill allows them to have a conversation where they can be safe to have that conversation in the place they are.
The points made about the benefits to the economy and the employer are huge. During the run up to this Bill, we talked to a number of large, medium and small employers that were already doing it voluntarily. They found that the benefits far outweighed the very small expense they had to stump up. Simply having to recruit someone is an extremely expensive exercise. We know there is a shortage of skills anyway, but to lose an employee because they have to stay at home and care for someone is a very expensive loss to a business, if the employee is a long-standing and well-established person.
The point about communication is vital. It is not just about communicating to the carers, who need to know this is available to them; it is also about communicating to the employers that it is now on the statute. I am sure the department has a plan, but it would be interesting to hear something about it, either today or in writing. For example, Make UK, which used to be the EEF, has a strong HR support division. It is one of their businesses and what they do. Part of the service that businesses get from being affiliated to Make UK is HR support, and legal and regulatory support. That organisation should be hit really hard with the information on the Bill—if it has not been already—so that it understands the role of employers in not just allowing it but promoting it across their workforce.
There is still a lot of work to be done in terms of getting the information out there. It should not just be employees demanding it—employers should be fully aware of what is now available. So who is going to be accountable for the communication process? In the end, that is going to be the success, of otherwise, of this measure. If people have to find it out through the ether, there is going to be a very slow take up. I am sure that Carers UK will put it out there, but there is a lot of extra work to do.
Once again, I thank the Government for supporting it. It has been a pleasure to help the Government to meet one of the things in their manifesto, although I doubt I will be making a habit of it. For this one, however, thanks to the Government and His Majesty’s loyal Opposition. Most of all, I thank the campaigners who got us this far. The reason we were able to do this is because it was unpaid; it cut out all of the small print that would have been in the legislation, but it establishes a point. I take the point made by the noble Baroness and I hope, in future, that we will be able to take that and move it forward to a bigger and better thing—but we should not diminish the significance of this particular provision.
Lord Leong (Lab)
My Lords, first, I thank the Minister for setting out these regulations and the correction. Correct me if I am wrong, but is it now two weeks instead of one week?
Lord Leong (Lab)
It is one week—okay.
I thank all noble Lords who have spoken: the noble Lord, Lord Fox, the noble Baroness, Lady Tyler, and my noble friend Lady Pitkeathley, whom I thank for her 30 years of campaigning—I do not think I will last 30 years in this House, but I thank her for her dogged perseverance and congratulate her on getting this on the statute book. We support this instrument to establish a statutory entitlement to carer’s leave from 6 April this year and ensure leave is available for employees caring for a dependant with long-term needs in England, Scotland and Wales.
With the introduction of this additional legislation, we will be providing a little more support, albeit limited and unpaid, to around half of the 4.2 million people across the UK who are trying to square the circle of holding down a job while providing unpaid care for elderly or disabled loved ones. The majority of these carers are women over 50. As my noble friend Lady Blake said at Second Reading, some more enlightened employers already have provisions to support workers who are carers, removing the silent shame that sometimes exists for those who provide care while working.
This instrument ensures that all workers become legally entitled to take unpaid leave for caring responsibilities from day one of their employment for up to one week in any 12-month period. This may be taken in increments of half or full days, so long as eligibility for carer’s leave is met. Employees will not be required to provide evidence in relation to their request, and they will be able to use carer’s leave specifically for foreseen and long-term care needs, rather than solely for emergency caring situations. This should enable better planning for employers and employees alike, with the minimum of bureaucracy. In addition, carer’s leave will be available for a wider range of caring situations, excluding general childcare, which better suits those caring for dependants over 18, who fall outside the scope of parental leave legislation.
I am struck by a sense of déjà vu. Last week, I spoke in this Room in support of another statutory instrument, on which noble Lords were broadly agreed, which supported workers who were pregnant or on maternity or parental leave when their employer was considering redundancies. As in this case, the legislation had come through a Private Member’s Bill from this side of the House. As in this case, we were adding legislation that improved the situation for workers, predominantly women, to protect those affected by particular family responsibilities. Once again, I feel compelled to ask the Minister why the Government seem to place such a low priority on such important legislation, as evidenced by the complete absence of an employment Bill despite more than 20 pledges to introduce one.
The Government seem to recognise the importance to our economy of encouraging the cohort of around 5 million people who could work but are not working back into employment, yet they seem to be relying on Private Members’ Bills to identify the problems and bring forward legislation that recognises the realities of the workforce: that many people have family responsibilities which some employers see as barriers to employment. I am afraid it is simply not good enough for them to point to the fact that we have 33 million people in work when, with a growing and ageing population, we are underutilising the skills and talents of millions. These are people who would be contributing to the economy and to the Exchequer if they were better supported to enter or re-enter the workforce.
To turn back to the instrument before us, is the Minister aware that half of all young carers in the UK are carers for their brothers and sisters? However, the definition of dependant does not include siblings by default, unless they live in the same household or come under some vague definition. Although a broader definition is welcome, the room for interpretation of “reasonably rely on” will inevitably leave gaps or create conflict with employers. What consideration have the Government given to this? Furthermore, has any consideration been given to the unlikely but not impossible case where somebody has more than one dependant? Can the Minister clarify whether the one week of carer’s leave entitlement over 12 months is calculated per employee or per dependant?
Lord Offord of Garvel (Con)
I thank noble Lords for their observations and questions. The great thing about this topic is that we all have consensus about the way forward and why we are doing this.
A number of points have been raised. To take them in a certain amount of order, to answer the noble Baronesses, Lady Tyler and Lady Pitkeathley, the characteristics of the carers being referred to cover 2 million to 2.5 million people, especially women, and especially older women. When we think about the characteristics of those folks, these are, by definition, some of the most conscientious people we have in our communities and are, on the whole, very good employees. It is interesting how, post Covid, employers have worked out that the most important resource they have is the labour force and that they have to work hard to keep the labour force together. It is interesting that, although this is unpaid leave, a number of employers who advertise themselves as Employers for Carers allow this to take place without it being unpaid. We might see more of that as employers begin to understand that this is a very important part of their workforce.
The noble Baronesses both raised the issue of childcare. This SI does not specifically relate to childcare because many regulations are in place specifically for childcare, but I can confirm that carer’s leave can be used for a child where it falls within the definition—the definition being caring for a child with a disability.
The communication of this is interesting. In preparing for this I came across a number of other child provisions, one of which I did not know about. For example, if you have more than a year’s continuous employment with an employer you are entitled to 18 weeks of unpaid parental leave per child up to the child’s 18th birthday, which could be one week a year. I am not aware that many people know about that. That makes the point really well about comms, which will be a key part of this. The Government need to work with a number of agencies to do that.
To be fair, the Government will be promoting this largely through the business channels, the business stake- holder groups for employers, and then through the voluntary organisations such as Care UK. Picking up on the point made by the noble Baroness, Lady Pitkeathley, about the comms and the awareness campaign, a number of pieces of legislation are coming through on carer’s leave—the one we have today—on flexible working, on redundancy protection, and on parental leave, as mentioned by the noble Lord, Lord Leong. They all need to be promoted as those Private Members’ Bills go through, so that together we are able to present the improvements for employees in the workplace,
I turn to the issue raised by the noble Lord, Lord Fox. I thank him, and particularly his colleague, Wendy Chamberlain MP, in the other place—a very effective MP. This relates to safe conversations and the comms to employers. I am confident that good employers will want to promote this measure but, again, it is down to us to make sure that the awareness campaign is raised and is effective. The economic case mentioned by the noble Baroness, Lady Pitkeathley, can be made. It should not necessarily be the only case but it certainly helps with the arguments.
Finally, turning to the noble Lord, Lord Leong, I guess we understand why there was no employment Bill, putting aside the fact that perhaps Covid got in the way of parliamentary time. Philosophically, also, there is a feeling within the Government that we are in a situation where progressive legislation has been put through by many Governments to get UK labour and employment law into a pretty good place. That is evidenced by the fact that there are a record 33 million people working out of 66 million—a record number for the UK. In particular, the noble Lord highlights that 5 million adults are not in work. They are not classified as unemployed but they are not in work and many of them are long-term sick and have lost the pathway back to work. A lot of effort now needs to go into helping them. There is a lot of talent there, which employers can employ. Therefore, the Government are turning our attention to that. However, as far as the overall programme of employment regulations is concerned, these Private Members’ Bills have come in on specific rifle-shot issues, reflecting, as the noble Baroness, Lady Pitkeathley, said, long-term campaigning from many of the groups involved. They have been very specific in a number of the areas that we mentioned and have, therefore, created improvement to the rights of employees in the UK.
In closing, I thank all noble Lords for participating in the debate. It is a pleasure to be involved in legislation that brings all parties together. I hope that this new leave right will make it easier for carers to balance their work commitments and their caring duties. Finally, I thank again the noble Lord, Lord Fox, for his previous work in taking the Act forward: without that, we would not be here today. This is an important piece of legislation and I commend these regulations to the Committee.
Civil Procedure (Amendment No. 4) Rules 2023
(10 months, 2 weeks ago)
Grand CommitteeRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Lord Stewart of Dirleton
That the Grand Committee do consider the Civil Procedure (Amendment No. 4) Rules 2023.
Relevant document: 8th Report from the Secondary Legislation Scrutiny Committee
The Advocate-General for Scotland (Lord Stewart of Dirleton) (Con)
My Lords, this instrument amends the Civil Procedure Rules 1998 to provide a closed material procedure for court proceedings relating to prevention and investigation measures. I will refer to these as STPIMs —state threat prevention and investigation measures—to distinguish them from the familiar acronym TPIMs, or terrorism prevention and investigation measures. I am pleased to report that the Government have announced the appointment of Jonathan Hall KC as the independent reviewer of state threats legislation. As part of that role, he will have oversight of the STPIM regime.
STPIMs are new measures established under provisions in Part 2 of the National Security Act 2023 which closely replicate the provisions for TPIMs in the Terrorism Prevention and Investigation Measures Act 2011. STPIMs provide a suite of restrictive measures which can be used, where necessary and proportionate, to prevent, restrict and disrupt an individual’s further involvement in state threats activity, where prosecution and other disruptive actions are not possible. STPIMs will be used sparingly and as a measure of last resort to mitigate the immediate threat an individual poses while they continue to be investigated by the authorities.
STPIMs require a specific procedural provision to be workable. This instrument, while not establishing STPIMs, makes that procedural provision to enable their operation. The imposition of STPIMs requires the Secretary of State’s approval and the permission and review of the High Court. It also contains a procedure for appeal by the STPIM subject. This statutory instrument amends the Civil Procedure Rules 1998 to provide the court with a bespoke closed material procedure for proceedings relating to STPIMs. The procedure includes, in particular, application by the Secretary of State for permission to impose measures, directions for a review hearing after the imposition of the STPIM, appeal against the imposition of the measure or any other determination in connection with the STPIM. Both the review hearing and any appeal hearing will be determined on judicial review principles.
These cases will inevitably involve sensitive material. This instrument therefore sets out a procedure to enable sensitive material to be relied on by the Government and for the evidence against the STPIM subject to be tested by the court through a closed procedure which will ensure that it can be adequately protected, in the public interest. This rule change is effected by amending Part 80 of the Civil Procedure Rules, which contains rules relating to TPIM proceedings, so that they cover the equivalent STPIM proceedings.
The Government have committed publicly to provide operational partners with the tools needed to combat state threats. STPIMs are important measures within this toolkit and this instrument is vital in ensuring that they are a usable tool which can be fully defended and justified in our courts through both open and closed proceedings. Given the sensitivity of the evidence, which will be a key component in the reason why an individual cannot be prosecuted and why the use of an STPIM is necessary, it would fundamentally undermine the scheme if closed proceedings, where sensitive intelligence and national security arguments can be made, were not available.
Lord Marks of Henley-on-Thames (LD)
My Lords, in what is plainly a crowded Committee, I shall be brief. The Minister referred to STPIMs. I shall also refer to Part 2 notices, in acknowledgement of the fact that the Explanatory Note uses that phrase, while the Explanatory Memorandum uses the STPIMs formula. I say at the outset that we are delighted to hear that Jonathan Hall KC has been appointed the reviewer of STPIMs. His work in this field is well known and widely admired, and it is very welcome that he is going to take on this burden as well.
The Minister explained the nature of STPIMs and of the conditions on which they are to be implemented, and that this SI in effect amends Part 80 of the CPR to enable rules concerning hearings relating to TPIMs to be applied with all necessary changes to Part 2 notices concerning STPIMs. It is plainly sensible that that should be done. I have read Part 80 and there is no material need for any distinction between the procedures applicable for hearings relating to TPIMs and the new hearings relating to Part 2 notices.
That said, I have a couple of questions. Broadly speaking, this statutory instrument plainly follows the need for a statutory instrument to introduce a procedure for the new orders. This is the right procedure, so we welcome the statutory instrument to that extent. Of course, in a volatile world and volatile conditions relating to terrorism, I cannot at this stage ask the Minister to predict how often STPIMs will be necessary because we cannot tell, but my questions concern the use of the urgent procedure under Schedule 8 to the National Security Act, which provides that the Secretary of State may impose STPIMs in urgent cases without court permission. The Minister referred to court permission being required in the general case. We hope that that is the general case and that it is only cases of real urgency that will give rise to the imposition of these measures.
The schedule gives power for the Secretary of State to impose the measures without permission if he or she thinks that the urgency of the case so requires. In such a case, the Secretary of State must then refer the case to the court for confirmation of the measures after they have been imposed, first for a directions hearing within seven days and then for substantive review. I therefore ask the Minister to indicate, in so far as he is able to do so, how often he would expect the urgent cases procedure to be used as a proportion of the overall number of STPIMs. That is important in the context of orders that have no warning, effectively, whereas when the application for permission is made the person against whom they are going to be made knows something about them.
I also seek an answer from the Minister, as far as he is able to give it, as to how long he would expect confirmation proceedings to take after the directions hearing. We recognise that closed proceedings will very often be involved and that the use of a special advocate, which is envisaged in the Act and the statutory instrument, carries with it its own complications in respect of the late appointment of a special advocate to represent the interests—in so far as he does so—of the person against whom the measures are to be taken. If the Minister can give us some indication of how he would expect a Secretary of State to approach those issues, and how he would expect a court to respond, it would be helpful. Apart from that, we welcome the instrument.
Lord Ponsonby of Shulbrede (Lab)
My Lords, I thank the noble and learned Lord, Lord Stewart of Dirleton, for introducing this SI. We support it, as we did in the House of Commons. I open by noting the sad irony that the Minister who introduced it in the other place has signalled he will stand down from Parliament in due course. I know he is currently still a Minister, but he is standing down for fears for his personal safety.
Lord Ponsonby of Shulbrede (Lab)
My Lords, when the Minister introduced this SI, he explained the nature of the STPIMs and how they relate to TPIMs and said it is natural that this SI amends the Civil Procedure Rules 1998. Although I have plenty of briefing on the background of the reason for this, I want to reiterate the two questions posed by the noble Lord, Lord Marks, and add a third question of my own.
First, the noble Lord asked how often STPIMs will be necessary. The Minister can probably not put a number on that, but perhaps he will be able to give a figure for the proportion of the overall STPIMs in which the urgent procedure will be necessary and the procedure will be followed without court permission. I am not quite sure whether court permission is provided retrospectively if the urgent procedure is used. Secondly, the noble Lord asked how long after a court direction the proceedings will take place. His questions were really about the management of the proceedings.
I was just recollecting that these proceedings are difficult to explain and understand, although they have been in place for probably 10 years or more and are dealing with some of the most intractable problems that we see in our country, terrorism threats. What should and must underpin this is that there is a fair trial underlying all these proceedings, however complex and difficult they are—that we as the British state, if I can put it like that, and the Government, believe that the underlying process is fair. It is almost a philosophical question for the Minister. How do the Government review the processes, assess what the judges do, and listen to the judges who oversee those processes, to have confidence that the underlying process is fair, even though it is not disclosed to the people who are subject to it?
As I said in my introduction, it casts a slight pall over the whole thing that Mike Freer has announced his intention to resign from Parliament, or not to stand again in due course. We in the Opposition support these measures, but there are fundamental questions which we must continue to ask ourselves. I look forward to the Minister’s response.
Lord Stewart of Dirleton (Con)
My Lords, as the noble Lord, Lord Marks of Henley-on-Thames, pointed out, it is scarcely a packed Committee; none the less, the contributions from the noble Lord and from the noble Lord, Lord Ponsonby of Shulbrede, have been of a thoughtful character and, indeed, merit the label “philosophical”, which the noble Lord, Lord Ponsonby, attached to his closing submission.
I am grateful for those contributions and for the broad indication that, while neither of the noble Lords who spoke began to approach the idea of giving His Majesty’s Government a blank cheque in relation to these provisions, and they demanded further scrutiny, none the less, they are broadly speaking in support of the measures in this statutory instrument.
I shall address the questions that were put to me. The noble Lord, Lord Marks of Henley-on-Thames, asked—and the noble Lord, Lord Ponsonby of Shulbrede, echoed the question—about the frequency with which the urgent procedure will be used. I start from the proposition that, as the Committee is aware and has heard, these provisions relating to STPIMs substantially reflect the provisions relating to TPIMs. To a certain extent we can extrapolate from the use of TPIMs some predictions, although the noble Lord, Lord Marks, accepts that it would be a very difficult task to estimate how many. But we can extrapolate from the TPIM experience something which I hope will address the Committee’s concerns. That allows me to say that we expect that the urgent procedure will be used very rarely. It has not been used in relation to TPIMs since the TPIM Act came into force in 2011. As I say, we would expect that the experience in relation to STPIMs would broadly reflect that.
Identifying a case as being urgent would not be a matter of seeking to avoid scrutiny. An urgent case will be one in which notice is sought; that notice must contain justification for the approach and the matter must be referred immediately to the court, which must consider the case within seven days of the notice being imposed. The court will apply exactly the same principles as if it had been consulted in advance and will have the power to quash the notice, or any of the measures specified in it.
I can advise the Committee that, while the experience of TPIMs has been that none has been overturned altogether, the courts none the less have acted anxiously and vigilantly to observe the manner in which they are to be applied and have adjusted, from time to time, certain of the terms of orders that have been made. The individual has a right to a full, automatic High Court review of the case, and a directions hearing in relation to that must take place within seven days of the court confirming the imposition of measures.
Reference to directions hearings allows me to digress for a moment to offer the Committee an assurance that, while that procedure and this statutory instrument apply to the Civil Procedure Rules applicable to England and Wales, equivalent measures will none the less be introduced by our equivalents in the devolved Administrations in Northern Ireland and Scotland. Communication has been made with the relevant rules bodies in those jurisdictions.
Further questions posed by noble Lords related to the matter of volume. Again, if we can be permitted extrapolation from the TPIM experience, it is anticipated that the volume of these measures will be low and used only as a last resort. As I said on an earlier point, the courts will be able to review all closed material and will have the opportunity to challenge the imposition of an order before it is made. Furthermore, through the automatic review, the court could quash the order or remove specific measures. As I said, it has done so in the context of TPIMs.
In terms of transparency, there will be independent oversight by the independent reviewer of state threat legislation, Jonathan Hall KC, who has accepted that post. He will publish an annual report on the use of these powers.
The noble Lord, Lord Ponsonby of Shulbrede, posed the philosophical question, given the necessary degree of confidentiality that will attach to these measures, about how the Government can be satisfied that the measures are working properly, and that the provisions intended to protect the interests of individuals made subject to these measures, notwithstanding the fact that they will not be placed before those persons or their instructed legal representatives, are effective. I can rely with confidence on the integrity of the legal profession in the jurisdictions of this kingdom and the independence that it has always shown, on the independence of our judiciary, and on the special advocate procedure itself, which confers these responsibilities on counsel. They are usually members of the Bar, but this would potentially be open to those with extended rights of audience as solicitor advocates, with the training and vetting they would receive before appointment.
I can take from the submissions heard by the Committee that it is persuaded that the statutory instrument is necessary for the effective operation of STPIMs, slotting in, as it does, into the Civil Procedure Rules and simply adding provisions referring to the governing Act.