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House of Lords Hansard
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Lords Chamber
28 February 2019
Volume 796

House of Lords

Thursday 28 February 2019

Prayers—read by the Lord Bishop of Oxford.

World Bank: Selection Process for President

Question

Moved by

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To ask Her Majesty’s Government whether they can confirm that nomination by the government of the United States does not constitute grounds for giving a candidate special priority for the position of President of the World Bank; and whether they are committed to an open, merit-based and transparent selection process for that position.

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My Lords, Her Majesty’s Government are committed to the open, merit-based and transparent process for selecting the next World Bank President agreed by the World Bank Board, including the agreed criteria against which candidates should be assessed.

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My Lords, I thank the Minister for his reply. The perpetuation of the de facto monopoly by the USA and Europe of the positions at the head of the IMF and the World Bank undermines confidence in those institutions and in internationalism, and is surely unacceptable in a world that has changed radically since the founding of those institutions seven decades ago.

First, will the Minister now clearly and strongly on behalf of Her Majesty’s Government encourage good candidates from across the world to come forward for nomination, recognising that the past monopoly and the current signalling from Europe in relation to this appointment is a real deterrent? Secondly, will he recognise that the sustainable development goals agreed at the UN in September 2015 and the UN Paris climate agreement of December 2015 are at the core of the World Bank’s agenda and therefore recognise that the absence of commitment to this agenda is a serious weakness in the candidate nominated by the US, a weakness compounded by his lack of experience in managing a financial institution?

Thirdly—

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Too long.

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This is important. Thirdly, when the tenure of Christine Lagarde, who has done an outstanding job as head of the IMF, comes to an end, will the Minister state clearly and strongly that Her Majesty’s Government will not support the perpetuation of Europe’s monopoly of this position and will actively seek good candidates from outside Europe and the USA?

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In answer to the first question, yes, there should be an open process and suitable candidates should come forward. When the noble Lord was at the World Bank, there was an anointing of the US candidate; since 2011, there has been a process, which we welcome. Secondly, we are absolutely unequivocal in standing by our commitments on climate change, which are an integral part of the role of the World Bank and have been shaped in great part by the noble Lord’s work, for which we are all grateful.

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My Lords, irrespective of the outcome of this open and transparent process that the Minister is talking up so much, I have no doubt that the outcome will be Malpass, the US nominee, getting it. However, what are the British Government doing to ensure that we have the fullest representation at the World Bank, with people there to influence its decisions—more than simply the head of the bank?

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Our key representative serving on the executive board is Richard Montgomery, our executive director. I am in regular contact with him, and he makes a great contribution in this area. Of course, the application process is still under way: it is open until 14 March, so other candidates may come forward and we will evaluate them, as we have before.

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My Lords, what will Her Majesty’s Government do if the United States continues to nominate a candidate who, according to many people—including, I suspect, some within the British Government—does not meet the criteria for the post?

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That is the process that is under way at the moment. The only formal candidate to have been nominated currently—Under-Secretary Malpass—is in London today to meet the UK Governor of the World Bank, the Secretary of State for International Development. She is making very clear the importance we attach to the World Bank’s commitments, particularly in relation to climate change.

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My Lords, does my noble friend the Minister agree that the recent announcement that Norway’s sovereign wealth fund, currently valued at around $1 trillion, will shortly increase its stake in Britain—currently 8.5%, which is significant in its own right—is a strong vote of confidence in the UK’s economy post Brexit?

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Absolutely. I am grateful to my noble friend for drawing that to the House’s attention. I am sure that noble Lords will welcome not only that vote of confidence in Britain but Forbes magazine’s assessment of the UK as the top place in the world to invest in and do business in, and its continuing to be the number one location for foreign direct investment in the European Union.

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My Lords, the Government repeatedly say that they are committed to a proactive foreign policy following Brexit, in which we will play a full part in building a constructive, peaceful world based on human rights and the rule of law. Despite whatever the Minister may say in good faith, the perception worldwide is that certain traditional powers see these key posts as a carve-up for them. How is that acceptable, and why is the world not given the opportunity to find the strongest possible candidate, committed to the UN objectives, at such a crucial time?

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These Bretton Woods institutions were set up in 1944-45 on the basis of shareholdings. The United States has a shareholding of 16%; ours is some 3.8%. It is natural for the largest shareholder to represent the money it put on the table to get the Bank off the ground. We should consider their putting forward a candidate a good thing.

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My Lords, if the World Bank is to be the champion of the world’s poor and leave no one behind, is it not important for the President of the World Bank to command the confidence of the world’s poor?

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We attach great importance to the legitimacy of the open, merit-based process that is now in place for making that appointment.

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My Lords, in assessing which candidate will succeed, will the Minister take account of the policies advocated by them? Along with the IMF, the World Bank has had a reputation in recent decades for pursuing a destructive, neoliberal policy, which has recently failed in Georgia, as it has elsewhere. Privatisation, marketisation, small government and cuts in public spending have become a religion, instead of a sensible policy to allow these countries to grow and succeed.

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I do not accept that description of the World Bank’s work. It does an incredible amount for the world’s poor through investing in infrastructure and food—for example, for the Rohingya population. It is absolutely committed to eradicating extreme poverty around the world, which is why we support it.

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My Lords, once the nomination process has closed, will my noble friend let the House know when he expects the shortlist of candidates to be published?

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The nomination process will close on 14 March. The candidates will then be assessed by the executive board of directors and a decision will be made ahead of the spring meetings in Washington between 12 and 14 April.

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My Lords, if the outcome of the shortlist is that the only remaining candidate is someone who appears to deny climate change and to adopt policies meaning that the good work the World Bank has done on sustainable development would be reversed, would the Government be prepared to veto such an appointment in those circumstances?

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The World Bank has undertaken a very major commitment: between 2021 and 2025, a significant increase—some $200 billion—will be devoted to climate change projects. That is fundamental to the work of the World Bank. We have made it clear that we expect that work, which has already been agreed, to be continued under whoever is the president.

Theatre Tickets: London

Question

Asked by

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To ask Her Majesty’s Government whether they have any plans to address the cost of theatre tickets in London and any effect this has on theatregoers.

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My Lords, commercial theatres in London are responsible for setting their own ticketing price structures. Theatres supported by the Arts Council also operate independently of government and have autonomy in setting their prices. However, many theatres in London operate schemes to encourage more people to attend performances through free or discounted tickets and audience numbers have continued to grow.

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My Lords, as the Government are almost certainly aware, West End theatre is thriving at the moment. However, the price of a decent seat in the stalls, for example, has nearly doubled in the past three years. The Government may not be aware that the main beneficiaries of these higher prices are not so much the producers of the plays and musicals, but rather those who control access to theatres: the theatre owners, the ticket sellers and the discredited secondary ticket market. London theatres are already becoming too expensive for many regular theatregoers and I hope that the Government will take this issue very seriously. As we all know, one of the many reasons that people come to London is its theatres, but they are gradually becoming too expensive for anyone to be able to attend the major plays.

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My Lords, the noble Earl has highlighted an issue at the very top of the range. Some of those ticket prices have gone up and I think the average top ticket now costs more than £100. However, there are many examples of theatres making a big effort to offer cheap prices. For example, the Donmar Warehouse offers free tickets to those aged under 25 each month via a ballot, while the Royal Court Theatre has discounted nights. There are many examples of where theatre seats can be obtained for much less than the top prices.

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My Lords, will my noble friend bear in mind that some of us wonder what this has to do with the Government? In saying that, if people do not go to the theatre in London, surely he should be promoting the wonderful provincial opportunities that we have in this country, be they in Manchester, Leeds, York or Newcastle—and indeed, in view of the Question asked by the noble Earl, in Glasgow as well.

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My Lords, I completely agree with my noble friend. That is why the Arts Council spends so much money—an increasing proportion in fact—outside London. We are trying to promote the arts in general outside London and the Arts Council is taking very proactive steps to do that.

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My Lords, has the Minister seen the study by the National Campaign for the Arts which shows that ticket prices in all areas of the arts are rising at a rate well above inflation because of the reliance on earning money from the public through ticket prices? The result is that the demographic has narrowed and attendance overall falls, while regional inequalities are exacerbated. Will the Government now seriously consider increasing public funding to address these concerns?

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The Government spend just under £0.5 billion a year on the arts, along with providing £860 million of tax relief for the creative industries, so we are doing a fairly large amount already. My figures are slightly different. UK Theatre has advised that in real terms—thus taking inflation into account—the overall average price being paid for a ticket has risen by 2% since 2013.

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My Lords, I remind the House of my interests as in the register. I wonder if the Minister agrees with me—I think he does, because he has virtually said it—that it is very misleading to look just at headline ticket prices. It is true that London theatres are expensive if you want the best seats in the stalls on a Saturday night, but it is possible to go to the theatre in London for quite modest sums. I also ask him to confirm that putting on a live performance of any kind, particularly at scale, is extremely expensive and very difficult to achieve, requiring a great variety of skills and talents. The more we support it, the more likely we are to find homes for all our young people who might be looking to those industries for jobs in the future.

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I completely agree with the noble Baroness. As I said, the Arts Council specifically is looking at trying to increase the diversity not only of audiences but of people who work in the industry. For example, we will imminently announce the Youth Performance Partnerships, a scheme for five regional hubs for performance and drama. It will reach up to 10,000 young people over the next three academic years.

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My Lords, I declare my interest as co-chair of the All-Party Parliamentary Group on Ticket Abuse. Given the lead this House has taken in delivering effective consumer protection legislation against unscrupulous ticket touts, will my noble friend the Minister do everything possible to promote face-value exchanges for ticketing to address the continuing blatant disregard of the law by companies such as Viagogo?

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I absolutely agree with my noble friend, and I believe enforcement action has been taken against Viagogo. It is not 100% certain that it has complied with the court order, in which case it will be taken back to court. We take it seriously and, as my noble friend knows, have taken measures to crack down on the worst abuses in secondary ticketing, such as bots.

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My Lords, I pick up on the question from the noble Lord, Lord Kirkhope. So many of these smash hits playing on the London stage and so much of the talent, both front and back of house, come through the regional subsidised sector. However, it is struggling, partly because of local government funding cuts. Can the Minister assure the House that funding to this sector through the Arts Council and theatre tax relief will be protected in the upcoming spending review? I declare an interest as a trustee of the Lowry.

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There are 186 National Portfolio theatres in the country, the vast majority of which are not in London. As for the spending review, we will advocate as hard as we can for the arts.

Islamic Ceremony: Civil Marriage Registration

Question

Asked by

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To ask Her Majesty’s Government, following Resolution 2253 (2019) passed on 22 January by the Parliamentary Assembly of the Council of Europe, what plans they have to review the Marriage Act 1949 to make it a legal requirement for Muslim couples to civilly register their marriage before, or at the same time as, their Islamic ceremony.

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My Lords, we recognise that the noble Baroness, Lady Cox, has brought a number of proposals for reform to the House. We are aware of Resolution 2253 from the Parliamentary Assembly of the Council of Europe. We remain committed to exploring the legal and practical challenges of limited reform relating to the law on marriage and religious weddings, as outlined in the Government’s recently published Integrated Communities Action Plan.

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My Lords, I thank the Minister for his reply and his reference to the fact that I have introduced Private Member’s Bills for eight consecutive years in an attempt to highlight the suffering from gender discrimination in the application of sharia law of many Muslim women, many of whom have come to me desperate, destitute and even suicidal, with no rights following asymmetrical divorce inflicted by their husbands. Therefore, while I welcome Her Majesty’s Government’s commitment to explore the legal and practical challenges of marriage reform, I ask the Minister for an assurance that this legislation will be introduced as a matter of great urgency, as so many women are now suffering in this country in ways that would make the suffragettes turn in their graves.

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My Lords, we share the noble Baroness’s concern that some may feel compelled to accept decisions made informally, such as those made by religious councils. But marriage is a complex area of law and the issues will require careful consideration. We intend to explore those, as I indicated. Where sharia councils exist, for example, they must abide by the law. Where there is a conflict with national law and the court is asked to adjudicate, national law will always prevail.

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My Lords, almost two-thirds of Muslim women married in the UK are not legally married and, as the Prime Minister has acknowledged, after divorce may be subject to penury, so what will the Government do? This is not discriminatory because the independent review suggests only that sharia courts also have a civil component, or at least there is a parallel civil ceremony, that puts Muslim women on the same basis as Jewish and Christian women. A year has passed since the independent review. Why will the Government not protect these very vulnerable Muslim women?

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My Lords, we are concerned that these people should be protected. The decision to go through with what is sometimes termed a nikah ceremony is widespread and unfortunately it does not give rise to a lawful marriage in England and Wales. But, as from April, we are taking forward detailed work to determine the best course of action to address such issues.

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My Lords, recent High Court decisions show that this is an issue that affects religious ceremonies generally, but such ceremonies are marriages under UK criminal law if they are forced marriages. However, a victim of a forced religious marriage can then be left destitute as there are no remedies that follow to get access to the matrimonial property—unfortunately, Parliament left that gap. So can my noble friend please outline when this injustice will be remedied, as it is certainly a barrier to victims of forced marriage coming forward if they face destitution because they cannot get hold of their rightful matrimonial property?

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My Lords, I must make it clear that the offence of forced marriage does not give legal recognition to marriages but is intended to protect victims from this abhorrent practice, regardless of the validity or otherwise of the marriage. Access to financial orders available on divorce depends on whether or not there has been a legally void or dissolved marriage and is governed by an entirely separate legal regime.

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My Lords, marriage is not just some romantic notion of happily ever after—after 25 years of marriage, I have learned that it is much more than that. It gives protections and rights that should be available to all couples regardless of whether or not they are religious. But these Muslim women, who believe that they are legally wed, may not find out that they do not have the protections of the law until far too late. That is why the requirement for a civil ceremony as well, as recommended by the Home Office’s own independent review last year, is so important. Is it not high time now for a fundamental review of the Marriage Act 1949 to recognise all forms of marriage in the 21st century?

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The general proposition that we should recognise all forms of marriage raises issues in itself. Our marriage law actually goes back to Lord Hardwicke’s Act of 1753 rather than just to 1949. It is a complex area that we will consider from the spring onwards and in which we will have to move with care. But we cannot simply recognise all informal types of marriage. We have a basic marriage law in this country based on the place in which it is celebrated and the fact that that place is open to the public and that it should be witnessed. We cannot move away from that. Indeed, to do so would create other issues and problems for ourselves.

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My Lords, we all recognise that this is a very complex issue, as the Minister has said. I pay tribute to the efforts of my noble friend Lady Cox, who has been on this case for years and years. Does the Minister not recognise that literally tens of thousands of women are in a very disadvantaged position? The Government produce one excuse after another but when will they actually take some effective action to end this outrageous situation?

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My Lords, there is a very real issue out there and it has to do with education and information as much as anything else. Many vulnerable people are not aware of what is required for a valid marriage ceremony in England and Wales. Therefore, we must address that issue—I accept that. But simply to move in the direction of recognising, for example, the nikah form of ceremony creates very real difficulties in itself. To take one example, how will you then police the issue of sham marriages?

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My Lords, as one who has attended a number of meetings arranged by the noble Baroness and wishes to salute her courage and persistence, I ask my noble and learned friend on the Front Bench to try to inject a sense of urgency here. It is all very well saying, “We have considered it”, and “We will look at it”. We need action. It is a complicated subject but we need some real urgency here.

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My Lords, following the Government’s Integrated Communities Action Plan, we are going to take forward an analysis of policy objectives in this area and detailed work will be carried out.

Nord Stream 2 Pipeline

Question

Asked by

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To ask Her Majesty’s Government what representations they have made to the government of Germany about the Nord Stream 2 pipeline, following discussions at this year’s Munich Security Conference.

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My Lords, we in the United Kingdom have significant concerns about the Nord Stream 2 pipeline, given its potential impact on European energy security and in particular on Ukraine. We regularly raise our concerns with key partners, including Germany. Both my right honourable friend the Prime Minister and the Minister for Europe have raised this with their German counterparts.

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My Lords, I am delighted that the Government take this position. Last year, we saw solidarity between Europe, the United States and the West in general following the Novichok poisonings in Salisbury. Nobody needs to be in any doubt as to the threats that come from Russia. NATO was set up to face the threats coming from what was then the Soviet Union. Surely Her Majesty’s Government should use NATO as a lever to put pressure on Germany—which, after all, was defended by NATO against the Soviet Union—to ensure that action is taken over the Nord Stream 2 pipeline, which is described by many as an energy weapon giving leverage to Putin.

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As my noble friend may well be aware, Germany is still pursuing and moving forward with Nord Stream 2. The operational challenge at the moment comes from Denmark, which has not yet given approval for the pipeline to be near where Nord Stream 1 is laid. That process continues, and in that regard we continue to work with Denmark as well. On my noble friend’s wider point about NATO, yes, of course it was set up for the purposes of the defence of Europe and the western alliance. I am delighted and proud of the commitment that the United Kingdom makes, as we continue to invest in it. We have asked other European partners, including Germany, to ensure they pay their dues to NATO.

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My Lords, I welcome the response from the Minister but, as the Prime Minister has said on many occasions, we should engage but beware. If this has been raised with the German Government, what has the response been on how this matter is moved forward? We are maintaining sanctions and have condemned Russia for its actions in Crimea and Ukraine. Is it not about time that we heard from the Minister what response we are getting from our allies?

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First and foremost, this is an issue of European security. In that regard, we have been working with the European Union. However, as I have already indicated from the Dispatch Box, Germany is certainly looking to proceed with Nord Stream 2 but there are caveats. Work has been done: for example, the noble Lord, Lord Collins, will be aware of the work done on the gas directive. The whole issue is one of monopoly. Gazprom currently controls a major source of European energy supplies. We believe that is incorrect and that belief is shared by our European partners. The work done on the gas directive will guarantee that once the new pipeline is operational, it can be managed more effectively by European regulation.

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My Lords, noble Lords are surely right to be concerned about the Nord Stream 2 pipeline and the greater reliance on Russia and Gazprom. The Minister mentioned Denmark; the European Commission is seeking to mitigate the effect of it, including legislating so that pipelines cannot be directly owned by gas suppliers. If indeed the UK leaves the EU, how in future might the UK have any influence over such decisions, which affect the whole region?

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The noble Baroness is quite right to raise the work that is being done. We have certainly played our part in strengthening the role of regulation and the gas directive, for the very reason that there should not be a monopolisation. We have seen previous instances where the supplier has used that monopoly on three separate occasions, particularly in Ukraine, as a means to stop supply or curtail it. On the broader issue of what happens once we leave the European Union, I assure her that we continue to have strong relationships with all our European Union partners, and that will continue after we leave the European Union.

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I think my noble friend understands that the real purpose behind Nord Stream 2 is for Russia to make life more uncomfortable for Ukraine, as he said, and in particular for Poland, and to cope with Germany’s disastrous energy policy which is resulting in rising rather than falling carbon emissions and all the difficulties that follow from that. Poland is our friend. Are we being as helpful as we should be to Poland in its situation relating to energy and to its relations with Russia? We need its help and support, and it needs us.

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I agree with my noble friend. I reassure him that we are working with Poland. He is right that it has reservations about this project, as does Denmark. We will continue to work with European partners in this respect. The work that has been done on the gas directive allows greater regulation of supply. As a broader issue, we are concerned. From a UK perspective, this does not impact our energy supply in the way it does Europe’s. Gas supplied from Russia is about 2% of the UK’s overall energy mix. However, the concern is wider for Europe, particularly for Ukraine, and we will continue to work with like-minded partners, including Denmark and Poland.

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My Lords, in the past couple of years there was agreement within NATO and the EU that we would cut reliance on Russian gas. In the debates we have with Germany, how does it justify the fact that it will increase its reliance on Russian gas? As the noble Lord said, this is very much targeted at Ukraine. There are real issues here, and it is contrary to what has been agreed in NATO and the EU.

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I agree with the noble Lord, as I agree with my noble friend. It is quite clear from the UK’s perspective. We are so against this project for the very reasons the noble Lord articulates.

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My Lords, part of the problem is that former Chancellor Schröder is one of the chief lobbyists for this project. Does the Minister not see this in the context of the wishes of Putin’s Russia to undermine the economy of Ukraine, just as we now see in the Kerch Strait?

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I agree with the noble Lord. There would be an impact if Nord Stream 2 goes ahead—current gas supplies run through Ukraine to Slovakia, and then pass back to Ukraine because of the nature of the relationship between Russia and Ukraine—as Ukraine’s economy would lose out because transit fees currently form about 3% of its GDP. I agree with the sentiments being expressed. The points that have been raised are points that we raise with the European Commission and our European partners.

Supply and Appropriation (Anticipation and Adjustments) (No. 2) Bill

First Reading

The Bill was brought from the Commons, endorsed as a money Bill, and read a first time.

Business of the House

Timing of Debates

Moved by

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That the debate on the motion in the name of Lord O’Shaughnessy set down for today shall be limited to 2½ hours.

Motion agreed.

Kimberley Process Certification Scheme (Amendment) (EU Exit) Regulations 2019

Motion to Approve

Moved by

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That the draft Regulations laid before the House on 20 December 2018 be approved.

Relevant document: 14th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee A). Considered in Grand Committee on 13 February.

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My Lords, I was unable to be present when this SI was considered in Grand Committee, and I am very grateful for this opportunity to comment briefly. If the UK is indeed to leave the EU, this is an area in which we must put in place our own arrangements. The Kimberly process is an extremely important certification scheme to address the appalling abuses involving so-called blood diamonds which drive conflict, particularly in Africa. The Kimberley process seeks transparent and fair practice in this sector, and we are rightly signed up to it. I note and share the concerns expressed in Grand Committee by the noble Lord, Lord Collins, about exactly what would happen if we were to leave the EU with no deal. Nevertheless, on behalf of these Benches, we welcome the Government’s continued commitment to the Kimberley process as expressed in this SI. Whether we are in or outside the EU, this commitment is vitally important.

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My Lords, I endorse what the noble Baroness has said, and what my noble friend Lord Collins said in Committee. Can the Minister give us a categorical assurance that there will be no gap when Britain is no longer a signatory and supporter of this scheme? I declare an interest as I was the British Foreign Office Minister who initiated this treaty and Britain’s involvement in it. Britain led the way to get the international treaty, and we got the rest of the European Union signed up to it—initially against resistance from the World Diamond Council but, ultimately, with its support. This is a very important scheme, making sure that conflict diamonds do not enter the international arena illegally and fuel conflict, as they once did in Angola, Sierra Leone and the DRC.

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My Lords, the noble Baroness, Lady Northover, can be excused totally for being unable to be present. In fact, hundreds of us were not able to be present; the only people present were the Minister and my noble friend Lord Collins.

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And someone in the Chair.

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There was someone in the Chair too, yes indeed. This is symptomatic of what is going on at the moment. I believe the noble Lord, Lord Collins, described it in Committee as an “SI stampede”. I have described it on occasion as a veritable tsunami of statutory instruments. I think we were told yesterday that 740 statutory instruments have been laid, but most have not yet gone to the committees, let alone to the Grand Committee and to the House. This is an astonishing situation. As my noble friend Lord Hain said—as did the noble Baroness, Lady Northover—this is a very important statutory instrument. We have important statutory instruments, Lord Speaker—sorry, I mean noble Lords, but maybe one day we will be able to address him properly; we have them simultaneously in Grand Committee and here. How can we possibly carry out our proper duty of scrutiny?

This is being pushed through because one woman is so adamant and determined to have her own way and treats both Houses of Parliament like rubber stamps. She appears more like an elected dictator than a Prime Minister in a Cabinet Government in a parliamentary democracy. It is getting totally out of hand.

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My Lords, before the Minister rises, how can I resist making a contribution? The debate in Grand Committee lasted for some considerable time despite there being only the two of us; we were able to debate the issue in quite a lot of depth. One point raised, which the Minister ought to address today, is that we may await the consent of the other nations to join the convention: is there a potential gap, if we fall out of the EU, in not being a full member of the convention?

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I think we are at risk of having as long a debate as we did in Grand Committee. I am glad to see that the diamonds issue is creating a lot of interest in your Lordships’ House, in contrast to that day in Grand Committee.

I welcome and thank the noble Baroness, Lady Northover, for her support of the Government’s position. We are agreed, irrespective of the differences and questions that have been raised, about the importance of continuing the Kimberley process. As the noble Lord, Lord Hain, himself has said—I acknowledge that he was instrumental in starting this process—successive Governments have continued with our membership because, plainly and simply, it is the right thing to do. Certainly the Government’s planning and programme is a reflection of the fact that there should be no gap. When we leave the EU, there should be a continuation of our membership of the Kimberley process, and appropriate programmes have been set up to ensure that that happens.

I cannot leave this Dispatch Box without responding to the noble Lord, Lord Foulkes, who raised the issue of the Prime Minister. The Prime Minister is leading our country at perhaps one of the most challenging times that our history has faced, certainly in my lifetime. What is needed right now is a good deal to allow us to leave the EU. The more time that we spend debating SIs and prolonging the process through unnecessary debate, the more that we will not achieve that end. What is required now is for the whole country, this House and the other place to get behind the deal, do the deal and get behind the Prime Minister, who is leading our country in most challenging times. I say to the noble Lord that I know the Prime Minister; I have known her for 27 years. She is a lady of principle and passion, and she is showing both.

Motion agreed.

Fertilisers and Ammonium Nitrate Material (Amendment) (EU Exit) Regulations 2019

Motion to Approve

Moved by

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That the draft Regulations laid before the House on 16 January be approved.

Considered in Grand Committee on 20 February.

Motion agreed.

Aquatic Animal Health and Alien Species in Aquaculture (Amendment) (Northern Ireland) (EU Exit) Regulations 2019

Equine (Records, Identification and Movement) (Amendment) (EU Exit) Regulations 2019

Aquatic Animal Health and Plant Health (Legislative Functions) (EU Exit) Regulations 2019

Animals (Legislative Functions) (EU Exit) Regulations 2019

Motions to Approve

Moved by

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That the draft Regulations laid before the House on 10, 15, 17 and 21 January be approved.

Relevant document: 14th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee B). Considered in Grand Committee on 20 February.

Motions agreed.

Terrorism Act 2000 (Proscribed Organisations) (Amendment) Order 2019

Motion to Approve

Moved by

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That the draft Order laid before the House on 25 February be approved.

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My Lords, your Lordships will want to be aware that on 25 February we also laid a name-change order under Section 3(6) of the Terrorism Act 2000, recognising aliases of two already proscribed organisations: the Revolutionary Peoples’ Liberation Party/Front, otherwise known as DHKP-C, and Daesh. That order came into effect on Tuesday. It will ensure that our proscription of those groups remains up to date and that they are not able to evade the consequences of proscription in the UK by operating under alternative names.

The threat level in the UK, which is set by the independent Joint Terrorism Analysis Centre, remains at severe. This means that a terrorist attack in our country is highly likely and could occur without warning. While we can never entirely eliminate the threat from terrorism, we are determined to do all that we can to minimise the threat to the UK and our interests abroad, and to disrupt those who would engage in it. We recognise that terrorism is a global threat that is best tackled in partnership, so it is also important that we demonstrate our support for other members of the international community in their efforts to tackle terrorism whenever and wherever it occurs.

Proscription is an important part of the Government’s strategy to tackle terrorist organisations and those who support them. The order before the House today would amend Schedule 2 to the Terrorism Act 2000 to extend the existing proscription of Hezbollah to cover the group in its entirety. It would also add two further groups to the list of proscribed terrorist organisations. The first is Jamaat Nusrat al-Islam wal-Muslimin or JNIM. This would include its aliases Nusrat al-Islam and Nusrat al-Islam wal-Muslimeen, or NIM, and its media arm az-Zallaqa. The second group is Ansaroul Islam, including its alias Ansaroul Islam Lil Irchad Wal Jihad.

This is the 23rd proscription order under the 2000 Act. Proscription sends a strong message that terrorist activity is not tolerated wherever it happens. Under Section 3 of the Terrorism Act 2000, the Home Secretary has the power to proscribe an organisation if he believes it is concerned in terrorism. If the statutory test is met, the Home Secretary may then exercise his discretion to proscribe the organisation. The Home Secretary takes into account a number of factors in considering whether to exercise this discretion, and these include: the nature and scale of the organisation’s activity; the extent of the organisation’s presence in the UK; and the need to support other members of the international community in tackling terrorism.

The effect of proscription is that a listed organisation is outlawed and is unable to operate in the UK, specifically as a result of a number of criminal offences applying to activity in support of it. It is a criminal offence for a person to be a member of a proscribed organisation, to invite, provide or recklessly express support for it, or to arrange a meeting in support of it. It is also an offence to wear or display in public, or to publish images of, clothing or articles such as flags in circumstances which arouse reasonable suspicion that an individual is a member or supporter of a proscribed organisation.

The Counter-Terrorism and Border Security Act 2019 recently updated these powers, adding the publication of images offence and extending extraterritorial jurisdiction, so that UK nationals and residents can be prosecuted in the UK courts for certain proscription offences committed overseas. This will ensure that we can take action where, for example, a foreign fighter located with a terrorist group in another country reaches back to individuals in the UK via the internet, seeking to build support for that organisation.

Proscription sends a strong message to deter fundraising and recruitment for proscribed organisations. The assets of a proscribed organisation can also become subject to seizure as terrorist assets. Proscription can also support other disruptions of terrorist activity—for example, the use of immigration powers such as exclusion from the UK, in a case where the excluded individual is linked to a proscribed organisation and their presence in the UK would not be in the public interest.

Given its wide-ranging impact, the Home Secretary will exercise the power to proscribe only after thoroughly reviewing the available evidence. This includes information taken from both open sources and sensitive intelligence, as well as advice that reflects consultation across Government, with the intelligence and law enforcement agencies, as well as relevant Whitehall departments. The cross-government proscription review group supports the Home Secretary in this decision-making process. The Home Secretary’s decision to proscribe is taken only after great care and consideration of each case but, given the impact that the power can have, it is appropriate that proscriptions must be approved by both Houses before they can come into force.

Having carefully considered all the evidence, the Home Secretary believes that Hezbollah in its entirety, JNIM and Ansaroul Islam are currently concerned in terrorism. Noble Lords will appreciate that I cannot comment on specific intelligence. However, I can provide a summary of each group’s activities in turn. First, this order extends the proscription of Hezbollah’s military wing to cover the group in its entirety.

I am sure noble Lords are aware that Hezbollah was established during the Lebanese civil war, following the Israeli invasion of Lebanon in 1982. It is committed to armed resistance to the State of Israel, and aims to seize all Palestinian territories and Jerusalem from Israel. It supports terrorism in Iraq and the Palestinian territories, and has a lengthy history of involvement in terrorism elsewhere in the world including in Europe. Currently it is most active in Syria where, since 2012, it has helped to prolong the brutal conflict and the suffering of the Syrian people. In 2016, Hezbollah helped besiege Aleppo, stopping humanitarian aid reaching parts of the city for six months and putting thousands at risk of mass starvation. Its actions continue to destabilise the fragile Middle East.

Hezbollah, as a political entity in Lebanon, has won votes in legitimate elections and forms part of the Lebanese Government. It also has the largest non-state military force in the country. Successive UK Governments have long held the view that elements of Hezbollah have been involved in conducting and supporting terrorism, and, as a result, proscribed Hezbollah’s External Security Organisation in 2001. In 2008, the proscription was extended to include the whole of Hezbollah’s military apparatus—namely, the Jihad Council and all the units reporting to it. Hezbollah’s military wing is also designated in the UK under the Terrorist Asset-Freezing etc. Act 2010 and by our EU partners under the EU asset freezing regime. The US, Canada, the Netherlands and many partners in the region already designate Hezbollah in its entirety as a terrorist organisation.

There have long been calls in this country to proscribe the whole of the group, and it has been argued that the distinction between the political and military wings is an artificial one. Indeed, the group itself has laughed off the suggestion that there is such a distinction. The Government have continued to call on Hezbollah to end its status as an armed group, in line with our commitment to strengthening Lebanon’s stability, security and prosperity. However, it has not listened, and indeed its behaviour has escalated.

In the light of Hezbollah’s increasingly destabilising behaviour in the region over recent years and the links between its political and military wings, we have concluded that the distinction between the two is now untenable. We assess that the group in its entirety is concerned in terrorism, and we now believe that it is right to proscribe the entire organisation.

The second group that this order proscribes is Jamaat Nusrat al-Islam wal-Muslimin, also known as Nusrat al-Islam and Nusrat al-Islam wal-Muslimeen. This includes its media arm, az-Zallaqa. JNIM, as it is called, was established in March 2017 as a federation of al-Qaeda-aligned groups in Mali, including the AQ-Maghreb Sahel branch, Ansar al-Dine, the Macina Liberation Front and al-Murabitun. JNIM’s area of operations includes northern and central Mali, northern Burkina Faso and western Niger. JNIM aims to eradicate state and western presence from these areas and to institute governance in accordance with a strict Salafist interpretation of sharia law.

The group has been responsible for attacks on western interests in the region and across wider west Africa, as well as the kidnap of western nationals for ransom. It is also designated by the US and the UN. JNIM attacks are typically claimed via az-Zallaqa, the group’s media foundation. Examples of attacks include, on 18 June 2017, a firearms and improvised explosive device, otherwise known as an IED, attack on Le Campement resort in Bamako, in which three civilians and two military personnel were killed; on 2 March 2018, a vehicle-borne improvised explosive device, otherwise known as a VBIED, and firearms attacks on the French embassy and the Burkinabe Chief of Defence HQ in Ouagadougou in Burkina Faso; on 14 April 2018, a VBIED and firearms attack on the Timbuktu camp of the French-led counter-insurgency operation in the Sahel, Operation Barkhane, and the United Nations Multidimensional Integrated Stabilization Mission in Mali. On 22 April 2018, there was a further indirect fire attack on the Timbuktu campi; on 28 June 2018, a VBIED attack on the G5 Sahel force HQ at Sévaré, in the Mopti region of the Sahel; and on 29 July 2018, a VBIED attack on a Malian army and Operation Barkhane convoy in the Gao region in Mali.

The final group to be proscribed, Ansaroul Islam, is also known as Ansaroul Islam Lil Irchad Wal Jihad. Its overarching aim is to establish dominance over the historic Fulani kingdom of Djelgoodji, situated in northern Burkina Faso and central Mali, and to implement its own strict interpretation of sharia. The group announced its existence on 16 December 2016 and claimed responsibility for an attack on an army outpost in Nassoumbou in Burkina Faso, which killed at least 12 soldiers. The group seeks to eradicate Burkinabe state presence from the country’s northern regions. It does so through attacks on government institutions and civilians linked to them, including police stations, schools and civic officials. Typical methodologies include small arms fire and IEDs. Further, the predominantly ethnic Fulani organisation will frequently target other ethnic groups, leading to substantial internal displacement of persons. Ansaroul Islam is highly likely supported by the federation of al-Qaeda groups in Mali, JNIM.

In conclusion, it is right that we proscribe Hezbollah in its entirety, and that we add these two further groups—JNIM and Ansaroul Islam, as well as their aliases—to the list of proscribed organisations. Subject to the agreement of this House and the House of Commons, the order will come into force tomorrow. I beg to move.

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One of the few joys of being in the Opposition is that, unlike the Minister, I do not have to repeat the names of organisations and locations. I thank the Minister for her explanation of the purpose and meaning of this order. It was discussed in the Commons on Tuesday, following which it was approved without a Division. We did not oppose it, and that will be our position today in your Lordships’ House.

Ever since the Terrorism Act 2000, no proscription order brought forward by any Government has been opposed by the official Opposition, and that is not about to change. Seventy-four international terrorist organisations are now proscribed under the Act. As the Minister said, it is intended that this order will come into effect tomorrow. The Minister referred to the organisations and groupings that will be proscribed under the order. Two have been established in the last two years or so, and carry out their attacks and atrocities in specific areas of Africa. The third is Hezbollah, which has been around for rather longer, nearly 40 years. The then Labour Government proscribed Hezbollah’s External Security Organisation in 2001, and its whole military apparatus, including the Jihad Council, was proscribed in 2008.

In her letter of 25 February, the Minister said:

“Hezbollah, as a political entity in Lebanon has won votes in legitimate elections, and forms part of the Lebanese Government. It has the largest non-state military force in the country”.

The effect of this order is to proscribe the political as well as the military wing of Hezbollah, and thus proscribe the organisation in its entirety.

I have a few questions to raise with the Government about the order, and about what has led to it being brought forward today. Just 13 months ago, in a Commons debate, the Security Minister was resisting arguments for proscribing Hezbollah in its entirety—resisting what the Government are seeking to do through this order today.

The Security Minister—he is still the Security Minister—said in that debate:

“Hezbollah also represents Lebanon’s Shi’a community and, over time, has gained significant support from that community. Hezbollah provides social and political functions in Lebanon. As a major political group and the largest non-state military force in the country, Hezbollah clearly plays an important role in Lebanon … I have heard from many Members today that Hezbollah’s military and political wings are indivisible, joined at the hip and centrally led. That is not … the view of every country. Australia, New Zealand and the EU take a different view”.

He went on, just 13 months ago, to say that,

“it is difficult to separate Hezbollah from the state of Lebanon. Hezbollah is in the Parliament and the Government, and that represents a different challenge from that which we find with many other terrorist groups”.—[Official Report, Commons, 25/2/18; cols. 507-8.]

Do the Government still subscribe to the comments I have just quoted, made by the Security Minister just 13 months ago? What has changed over the last 13 months to lead the Government to adopt the approach they now propose in relation to the political wing of Hezbollah, which we will not be opposing, but which the Government were arguing against in January of last year?

In the debate in the Commons on Tuesday, the Home Secretary said:

“I can say that Hezbollah has been reported in many open sources as being linked to or claiming responsibility for many atrocities. These include a suicide bomb attack on a Buenos Aires Jewish community centre in 1994 that left 85 people dead and hundreds injured. The bloodshed came just two years after an attack on the Israeli embassy in that same city, which killed 29 people. Hezbollah’s involvement in the Syrian war since 2012 continues to prolong the conflict and the brutal repression of the Syrian people. In 2016, it helped besiege Aleppo, stopping humanitarian aid reaching parts of the city for six months, putting thousands at risk of mass starvation. Its actions continue to destabilise the fragile middle east”.—[Official Report, Commons, 26/2/19; col. 283.]

I am sure nobody would wish to do anything other than condemn the specific acts referred to by the Home Secretary last Tuesday, but the point is that all those acts he referred to were known about when the Security Minister was arguing, 13 months ago, against proscribing the political wing as well as the military wing of Hezbollah. Again, what has happened over the last 13 months to lead to the Government changing their stance?

In her letter to me of 25 February the Minister wrote:

“Hezbollah itself has publicly denied a distinction between its military and political wings”.

I think, though, that I am right in saying that that was known at the time of the debate in the Commons in January of last year, when the Security Minister was arguing against proscribing the political as well as the military wing of Hezbollah.

At the end of the debate in the Commons last Tuesday, in response to questions about why the Government had changed their stance, the Home Secretary said:

“I will give four reasons”.

It would be helpful if the Minister could repeat those four reasons, since it seemed to me that he gave only two. He said:

“First, there is secret intelligence. I think the House will understand why we cannot share it … there has been a step change in the activity of Hezbollah, particularly in Syria”.—[Official Report, Commons, 26/2/19; col. 304.]

The second, I think, was that the proscription review group had expressed the view that Hezbollah in its entirety met the definition of a terrorist organisation in the 2000 Act. Does that mean the proscription review group was not of that view at the time of the debate in January 2018, when the Security Minister argued against the course of action the Government are now proposing—namely, that the political as well as the military wing of Hezbollah should be proscribed? If so, what is it, at least in general terms, that has led the proscription review group to change its view of 13 months ago?

The Home Secretary also said that both the Foreign and Commonwealth Office and the Department for International Development have looked again at the work they do in Lebanon. They are clear that they can continue that work and support the legitimate Government of Lebanon and its people. What exactly does that mean in practice? One of the Conservative contributors to the debate on this order in the Commons on Tuesday said that he thought Hezbollah provided,

“13 out of the 68 Members of Parliament in the governing coalition”.

That Conservative contributor went on to say that there were,

“important development objectives, particularly in the south of Lebanon where Hezbollah has the core of its support from the poorer Shi’a communities in the Lebanon”.—[Official Report, Commons, 26/2/19; col. 294.]

If the FCO and DfID think that they can continue their work in Lebanon—and the Minister for Security laid some stress in the debate 13 months ago on how the stronger the state of Lebanon is, the weaker Hezbollah will be—does it mean that they will be having, or continuing to have, contact with members of the political wing of Hezbollah in Lebanon, even though this order proscribes Hezbollah in its entirety, including its political wing?

One change since the debate in January 2018 is not a new Minister of Security, but a new Home Secretary. Maybe that is an important, though not decisive, reason behind the change in the Government’s stance. This order will be passed by your Lordships’ House, and I stress again that we are not opposing it, but I would like some answers on the record from the Government to the questions I have asked and the points I have made, because I do not think the questions addressed in the letter of 25 February sent to me by the Minister on behalf of the Government were in relation to Hezbollah.

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My Lords, I also thank the Minister for explaining this order. I completely agree with the words of the noble Lord, Lord Rosser, on the Government appearing to fail to answer the question, “Why now?”

If somebody is demonstrating on the streets of London and there is only one flag—there are not separate flags for the military and political wings of Hezbollah—I understand that it might be difficult to prosecute them when half the organisation is proscribed and the other half is not. But the questions remains, as the noble Lord, Lord Rosser, said: what has changed since January last year when the Government supported the political wing of Hezbollah being kept separate? Indeed, the Minister talked about how important it is that we support the international effort to tackle terrorism. While the US, Canada, the Netherlands and Israel all designate the whole of Hezbollah a terrorist organisation, as the noble Lord said, the European Union and Australia designate only the military wing as terrorist. What has happened?

Our other concerns are around changes that have happened very recently under the Counter-Terrorism and Border Security Act, which we opposed. It extends the existing offence of supporting a proscribed organisation to include recklessly expressing support for it, rather than intentionally inviting support, with a maximum sentence of 10 years in prison. It also extends extraterritorial jurisdiction for these offences, so British citizens and residents who express support for Hezbollah, wear clothing related to it or wave its flags in other countries can be prosecuted in the UK. This raises a serious concern: someone who does something supportive of the political wing of Hezbollah—including recklessly expressing support for it—in a country where it is not proscribed, such as in Australia, or Lebanon itself, could still be prosecuted in the UK.

In the debate on the then Counter-Terrorism and Border Security Bill, the noble Lord, Lord Anderson of Ipswich—former Independent Reviewer of Terrorism Legislation—said that he was concerned that, while he was in post,

“at least 14 of the 74 organisations proscribed under the Terrorism Act 2000 … are not concerned in terrorism and therefore do not meet the minimum statutory condition for proscription”.—[Official Report, 17/12/18; cols. 1642.]

The Minister will recall the debate, when concern was expressed that organisations were being proscribed for political reasons rather than because they fulfilled the statutory requirements for being proscribed.

Of course, one can speculate about what has changed. The noble Lord, Lord Rosser, talked about a change of Home Secretary. He may not welcome my commenting that political capital has been made from the leader of the Opposition, Jeremy Corbyn, having previously been a supporter of Hezbollah. Of course, the Labour Party is facing considerable issues regarding anti-Semitism, and the concerns of the Jewish community about Hezbollah are well known. But I am sure that these have nothing to do with the timing of the whole of Hezbollah being proscribed on this occasion.

We have serious concerns about the whole process, which we expressed in debates on the then Counter-Terrorism and Border Security Bill. However, like the formal Opposition, we will not oppose this order; we simply wish to place on the record our concerns about the process.

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It is welcome but belated that this order should be passed. While we have listened to the reservations expressed by the Labour Party and the Lib Dems, it remains the fact, as I am sure they will agree, that if more has come out about a situation, and maybe we were misled or not given the full facts a while ago, it is right to take that step now.

Imagine, if you can, an organisation that marched through London and actively promoted an ideology that—forgive my words—black people should be killed and their lands restored to colonialist oppressors. You would have no doubt or hesitation about banning it. Well, a group called National Action did just that, and it was recently banned—so this is not a new move. That organisation said that non-whites and “sub-humans”—which it implied was the right word—should not be tolerated.

The Mayor of London supports this ban. We should be tough on terrorism and the causes of terrorism. There is no division between the political and military wings of Hezbollah. In fact, little stickers saying “We are the political wing” have been put on the flags carried by these people as they march, precisely in order to exploit that. They have said, “Each of us is a combat soldier. The story of ‘military wing’ and ‘political wing’ is the work of the British”.

The right to peaceful protest, which we uphold, does not extend to the violent and the threatening and the racist. Countries with which we have close relations, including Canada, Holland, France, New Zealand and even Bahrain, all ban Hezbollah. This of course will not stop the necessary co-operation with the Lebanon Government.

The organisation that I hope we will ban today fights for Assad. This is not just a Jewish issue, as has been implied. The beliefs that this organisation expresses are a harbinger of what is to come if you are western. The anti-Semitism is the tip of the iceberg. The organisation expresses a group of beliefs that everything western is wrong, everything white is wrong, everything that might be stigmatised as colonialist is wrong, and war must be fought to bring everyone to heel.

Hezbollah has said:

“Until Israel ceases to exist and the last Jew in the world has been eliminated,”

it will continue to fight. It has said:

“If Jews all gather in Israel it will save us the trouble of going after them worldwide”.

We cannot possibly go along with allowing such an organisation to march through London.

Hezbollah is a partner to Iran, for which cause it engages in money laundering, arms sales and drugs smuggling. It is implicated in the Yemen disaster. It has prolonged the Syrian conflict. It has carried out attacks all over Europe. Classifying Hezbollah as “terrorist” would stop it using our banks to transfer money around the world. What it does fits precisely Section 3(5) of the Terrorism Act 2000. It has been involved in Iranian-directed bombings that have killed more than 1,000 UK and US servicemen in Iraq and Afghanistan. What has changed in the last year is increasing revelation of this and increasing fear. It is by no means a partisan move. I hope that this House will wholeheartedly support the Motion.

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My Lords, I strongly support the Government on this order.

There can be little doubt that Hezbollah has completely taken over control of Lebanon. It is certainly in the Parliament but it is also in the military—it is everywhere—and Lebanon and its Government can do little without Hezbollah. The deputy secretary-general of Hezbollah, Naim Qassem, has repeatedly said that the political and the military wings are as one—they are not distinct. There is little doubt too that Hezbollah is funded and supported by Iran and represents an outpost of that country, with its Shia expansionist policies, and that those policies are not only anti-Israel and anti-Zionist but anti-Semitic; wherever Jews exist, one just needs to see the sorts of terrorist attacks Hezbollah has made on Jewish installations around the world. It is not just Jews—they have attacked and killed British troops in Syria, as well as the poor Syrians.

It is not only Israel that has worries in the Middle East; Saudi Arabia, Jordan and Egypt are all extremely worried about Hezbollah’s activities, and we have a good example in Yemen, where it has a role too. Its interests have nothing to do with the plight of Palestinians. They are just pawns in their game, and if a peaceful resolution and a two-state solution eventually emerge, which we would all like to see, it will not stop Iran and Hezbollah in their anti-Semitic activities.

Against this background, it is impossible to believe that the so-called political wing of Hezbollah was unaware of what goes on. How can the political wing not be pulling the strings with Iran to produce 150,000 or more missiles and rockets in southern Lebanon, and digging six tunnels under the border with Israel? How can that possibly be thought of as a purely defensive action? Both wings are as one, both should be proscribed, and I hope we agree.

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I refer the House to my registered interests. I commend the Government on this important decision—it is the right one, and long overdue.

On 22 June 2017, after the al-Quds rally, where those yellow flags with the AK-47 were on the streets of London, I said in your Lordships’ House that separating Hezbollah into its military and political wings is an untenable and artificial exercise. The US, Canada, the Arab League and the Gulf Cooperation Council designate Hezbollah in its entirety—what do we know better than them? I asked whether it was not time that the UK demonstrated its commitment to combating extremism by joining our allies in proscribing Hezbollah in its entirety. I also wrote to the Home Secretary in those terms at the time. Some noble Lords talked about Australia; I noted in the press only today that the Australian Foreign Minister in London was interested in following what we are trying to do here today.

What has changed? Of course, I do not speak for the Government themselves. That question was asked by the Labour and Liberal Democrat Front-Bench spokesmen during the debate in the other place on Tuesday, and today in your Lordships’ House. However, those asking the question were all seeking an answer from the Government about the behaviour of Hezbollah. What had it done—what terror atrocities had it masterminded to change the Government’s position and proscribe it in full?

Hezbollah has always been consistent and has not changed at all. It does not recognise the artificial exercise of a division between the military and political; it never has. When Members ask what has changed, they seem to want to discover a smoking gun. It is apparent that some would have preferred to continue to separate the so-called two distinct parts of Hezbollah, appeasing Hezbollah as if it was our friend. Very few of us would call Hezbollah our friend.

Over the years, the main reason given for this ludicrous position was to maintain our relationship with and support for the Lebanese Government and to be able to continue to provide the necessary aid to Lebanon, because, as has been said, Hezbollah had members elected to the Lebanese Government. That was the reason given, but I assert that it was an excuse to do nothing, not a reason. Many other countries that have proscribed Hezbollah in full have connections with and work with the Lebanese Government without any problem whatever. It was an excuse, not a reason.

As an aside, my response to Hezbollah’s role in Lebanon is very clear and was mentioned by the noble Lord, Lord Turnberg. It does indeed play a significant role in Lebanon: it has 150,000 rockets and missiles embedded in south Lebanon, facing Israel.

There is a simple and clear answer to the question, “What has changed?” In my view, the change is as refreshing as it is important. The change is in the Home Secretary, the Foreign Secretary and the Defence Secretary. We have Ministers of integrity, with the courage to ask questions and seek explanations on advice they receive.

Sometimes, policy can drift and we can find ourselves in a time warp where policy remains unchanged as if we are in a fantasy land, rather than facing up to reality. Our policy on proscribing Hezbollah was in such a time warp, until the change was made by Sajid Javid, Jeremy Hunt and Gavin Williamson. They should be praised for making this important change. This legislation is important as it shows the rest of the world that the UK is a safe country to do business with and supports the global economy by mitigating terrorist risks. In our constant fight against terror, they have ensured that our Government are in the right place. This gives me great hope for Britain’s future post Brexit as a world leader in a turbulent and dangerous world.

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My Lords, although I agree in principle with the order proscribing Hezbollah for precisely the reason that the noble Lord just spelled out—Hezbollah does not make a distinction between the political and military arms of its organisation—I should like to insert a tiny protection for freedom of expression. I think it is true to say that once one proscribes the political arm of any organisation, one tends to relegate the debate to more violent areas rather than encourage those disagreements to be discussed around the table.

I will cite one small example: a case brought by the American Civil Liberties Union in the early 1980s or late 1970s. It concerned a small town outside Chicago, Illinois called Skokie, in which lived a number of people who were Holocaust survivors. A neo-Nazi group decided that it wanted to demonstrate in that town, which was of course highly offensive and provocative. The ACLU took the case to the Supreme Court, which ruled that the march should go ahead simply because it was entirely possible for those survivors of the Holocaust to avoid the march by closing their curtains, shutting their doors, going away for the day or whatever it might be. The reasoning behind that was that if one were to prevent the march going ahead, it might well force the marchers, rather than staging a political demonstration, to become more violent.

I say this because we must be mindful in this day and age that there are enormous and horrendous threats to free speech. We ignore them at our peril.

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My Lords, one does not often hear these words from the Opposition Benches, but I congratulate the Government, particularly the Home Secretary, on doing the right thing about Hezbollah.

There is no division of Hezbollah. Nasrallah has explicitly said time and again, “We do not have a military wing and a political wing”. He must get quite frustrated with the British Government for not understanding that, but he keeps repeating it. It is true; Hezbollah is one. Due to my professional past, I am the last person to criticise the Foreign Office but I feel that it is to blame for our Government not taking the correct, logical and obvious position of proscribing the whole of Hezbollah. I can see that an ambassador in Lebanon might find it difficult if the Government with whom he is trying to co-operate include terrorists.

We seem to have paid a very high price in not proscribing Hezbollah for so many years out of diplomatic convenience. There is no doubt about it: you can have perfectly normal relations with the Lebanese Government without the problem of Hezbollah being in the Government and being proscribed. The heavy price referred to by the noble Baroness, Lady Deech, included Hezbollah flags flying on the streets of London time and again in 2017 and 2018 during demonstrations. They flew under the excuse that they were for the political, not the proscribed, wing. That is unacceptable on our part.

Hezbollah is not just anti-Israel. It is deeply anti-Semitic and makes no pretence about that. The noble Baroness, Lady Deech, quoted Nasrallah as saying that it is very useful if all the Jews gather in Israel because then Hezbollah does not have to go round the world looking for Jews to kill. His deputy has also said that God imprinted blasphemy on the Jews’ hearts. That is an extreme anti-Semitic point, even for some of the anti-Semites we know about in Britain. We must accept that it is an unacceptable, nasty, anti-Semitic, dangerous terrorist organisation that threatens all our democracies, not just those in the Middle East. It is high time that it was proscribed and I congratulate the Government on doing so.

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I also agree that the decision to proscribe Hezbollah in its entirety has logic and merit. It not only commits terrorist acts; as the noble Baroness just said, it wants to destroy not only Israel but Jews. It is wholly anti-Semitic. Like the Home Secretary, I was at last night’s Community Security Trust dinner, where everyone was aware of the rising incidence of anti-Semitic hate crime. That is a huge concern for not only the Jewish community but all of us.

Treating the two wings of Hezbollah as distinct has always been artificial. Noble Lords have described Hezbollah’s boldness and consistency in declaring itself one single entity. That raises the question of timing. I agree with my noble friend Lord Paddick and the noble Lord, Lord Rosser, that the Government owe us a rather better explanation than we have had so far.

The noble Lord, Lord Polak, said that it was due to the change of personnel. If I recall his precise words, he said that the present Home Secretary, Defence Secretary and Foreign Secretary all have integrity. Does that imply that the Conservative Secretaries of the past nine years did not have integrity? That is quite a strange argument. After all, all those posts have been filled by the same party for the past nine years. It is true that just 13 months ago the Security Minister said:

“Hezbollah is anti-Semitic and wishes the destruction of … Israel”,

but he resisted the argument that the political and military wings of Hezbollah were indivisible, joined at the hip and centrally led. He said:

“Ministers do not make up proscription decisions over a cup of coffee. We make them on the recommendations submitted to us by our law enforcement agencies, security services … and intelligence services”.—[Official Report, Commons, 25/1/18; cols. 507-8.]

It is therefore fair to ask how that advice has changed.

To me, it would be a viable argument to say that it is because of the rising incidence of anti-Semitic hate crime against people and property, such as the destruction of headstones in cemeteries. Appalling things are going on both against the person and against property. In that context, it is totally unacceptable that the Metropolitan Police is unable to take action against demonstrators proclaiming their support for Hezbollah, waving the flag and putting stickers on it saying, “We are the political wing so you cannot touch us”. I would be interested to hear the argument from the Government: “It is unacceptable that on the streets of London fear should be put into the Jewish community and all of us who want to see decency and an absence of prejudice and discrimination”. But we have not heard that argument from the Government and they are being coy by not telling us what has changed. So, if I have to fall back on the argument of the noble Lord, Lord Polak, that it is because of a change of personnel, that raises interesting questions about the attitude of the holders of those offices over the past nine years.

Lastly, I want to ask how Brexit is going to affect European co-operation in counterterrorism and things such as asset freezing. Every form of Brexit will damage that co-operation, but a no-deal Brexit will damage it even more. We are to have a mega-SI from the Home Office shortly. I attended the briefing meeting kindly held by the Minister on Tuesday. However, although we have been hearing discussions about whether or not no deal is being ruled out, I have just seen a clip of the Leader of the House of Commons, Andrea Leadsom, who this morning is still protesting that she has total support for a no-deal Brexit. That would have a catastrophic effect on our co-operation across the European Union in exchanging vital data, working with Europol, extradition and the exchange of evidence to bring people to trial, and a whole range of counterterrorism co-operation, as well as the freezing of assets. How is the Government’s attitude to Brexit—any kind of Brexit, let alone a no-deal Brexit, which the Prime Minister and the Leader of the House of Commons are refusing to rule out absolutely—consistent with an apparent stance of wanting to do everything in our power to counter terrorist organisations? That really does not quite add up.

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My Lords, I strongly welcome the announcement this week by the Home Secretary that the UK will proscribe Hezbollah in its entirety. Does my noble friend agree that this will send a clear message that no terror group will be given a free pass to operate on British soil?

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My Lords, I declare an interest as a member of Labour Friends of Israel and the chair of the APPG for Kurds in Iran. I have also recently been to Syria, to the Kurdish side, to witness its fight against Daesh, or ISIS. Last year, I mentioned in the House the terrible betrayal of the Kurds that the Government have participated in, in acquiescing to the Turkish demand to invade and occupy Afrin.

I have huge respect for all who have spoken, but I dispute the claim by the noble Lord, Lord Polak, that Hezbollah has not changed. There has been a remarkable journey over the last 20 years: it has joined the political and democratic process; it is the largest single party in Lebanon and got 300,000 votes, which is 100,000 more than any other party; and it has played a key role in brokering a broad-based coalition Government there. It has not been mentioned today, but Hezbollah played a significant role in restoring the synagogue in Beirut. Unfortunately, the number of Jews in Beirut is smaller than the number of Peers here, but none the less it has restored the synagogue to pristine condition, and that is something we should hear.

I found it very odd to hear the Minister say that Hezbollah was prolonging the suffering of the Syrian people. I say to the Minister that it is Daesh, or ISIS, that is prolonging the suffering of the Syrian people. It is a remarkable thing to describe a group that resisted Daesh and fought against ISIS—our principal enemy and genuinely a terrorist organisation—as prolonging that suffering. In a small way, we should all feel some gratitude for that. We can all understand in our historical consciousness—beginning with the Israeli invasion in 1982 and the occupation that lasted for somewhere between 12 and 18 years—why there might be some resistance to that and some feeling that it was wrong. Hezbollah essentially began as Khomeini’s shock troops in the Bekaa valley and the Jabal Amel, but it transferred its allegiance from Khomeini and Khamenei to Sistani in Najaf. There has been a very significant shift in its religious allegiances.

Palmerston said that our interests are eternal and our allies are temporary. I subscribe to that view of foreign policy. In Iraq, as well as in Lebanon, the Arab Shia have tried to underwrite some form of democratic Government. They are to be distinguished very much from Iran, which is Persian. Our Foreign Office used to have an understanding of that but has somehow lost it; it should retain some historical understanding. We should develop some form of independent foreign policy that does not just follow the United States, which is extremely pro-Saudi and pro-Sunni, and therefore hostile to Hezbollah.

We need to recognise that Hezbollah has made this journey towards democracy and towards preserving the territorial integrity of the Lebanese state. As the Minister mentioned, Hezbollah represents the Shia community—but not just the Shia community; it also has votes from the Sunni community and from the Christians. I am not suggesting to the House that Hezbollah is like the Lib Dems; it is obviously more successful and slightly more significant than that. I do not doubt that there are very bad people in its midst, but it is a political party that represents the largest plurality in Lebanese politics and has committed itself to democracy and pluralism in its deeds. We should always look at the deeds rather than focus exclusively on incendiary words. I ask the House to reflect that maybe it would be foolish to block conversation and possible negotiation with Hezbollah.

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My Lords, I welcome the Government’s response this week in joining our allies America, together with Canada and the Netherlands, in proscribing Hezbollah. That sends a strong message that the UK Government totally abhor terrorism in any form. Classifying Hezbollah as a terrorist organisation will significantly constrain its ability to operate in Britain, and severely erode its ability to raise funds here, use British banks—as the noble Baroness, Lady Deech, alluded to earlier—and to transfer funds around the globe. Finally, it is right to judge Hezbollah by the totality of its actions.

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My Lords, I want to say a word about Africa, because, interesting as this debate on Hezbollah has been, the order also concerns west Africa. The Minister tiptoed very skilfully through the acronyms, so I thought I would take a minute to ask her a question. I used to know towns such as Timbuktu and Bamako in Mali quite well when I visited on behalf of Christian Aid.

I imagine that the motivation for proscribing these organisations is simple—relations of Daesh are living there and the world is a small place, especially as far as terrorism goes, and it crosses frontiers. The noble Baroness, Lady Ludford, referred to Brexit. I do not want to go that far but I am particularly interested in whether the order is shared with our fellow European members. As the Minister well knows, we are part of a joint mission. British troops are involved. Sometimes there are casualties and it is much nearer to home than we realise. I know that the joint mission will go ahead after Brexit, but I would be grateful to hear whether this is part of joint thinking, unlike with Hezbollah, where there have been differences.

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My Lords, I want to put on record my deep appreciation to my noble friend Lord Rosser for the speech that he made at the beginning of this debate. It was penetrating and analytical, and it is absolutely essential to the cause to which we all subscribe that he gets a full and explicit reply from the Government. I have been a Defence Minister and a Foreign Office Minister, and I totally understand that when we operate in this kind of context there are things that have to be confidential. But that makes it doubly important to be as explicit and transparent as we can possibly be in the support of the case that we pursue. If there have been, in a short period of time, the changes that have been described in this debate, it is absolutely, inescapably obvious that we have to give a very good account for why this has happened.

One good thing about this debate is that it has aired the issues a little more widely. It would be totally naive to imagine that the issue of anti-Semitism is simply about Jewish people. I personally believe that the total unacceptability of anti-Semitism is because it is about people. But not to understand that it has sinister—I use that word quite deliberately—implications would be very naive. It is obviously about other political objectives as well. To refuse to face that fact will not help at all.

The one crucial point that I want to make is this. I know that I have made it before, but I will go on making it until my dying day. We are ultimately in a battle for hearts and minds. It is in the sphere of hearts and minds that we will build lasting security, not by administrative arrangements or containment operations. It is by winning people’s conviction, understanding and appreciation of why the values about which we like to talk in this House are so indispensable to the future of humanity. That is the issue: hearts and minds.

That is why, when we are introducing anti-terrorism legislation, it is terribly important that all the time right in the forefront of the minds of those charged with the responsibility of coming to a conclusion are the words and thoughts: what are our values? What will be the down cost of this? What will play into the hands of extremists, as they exploit genuine anxieties and doubts amongst young people but not only young people? That is the issue that must not be ignored. What is the counterproductivity of what is being proposed?

It is a very difficult balance and a very difficult decision, but I urge that we always keep that concern about counterproductivity very much in mind in our deliberations.

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My Lords, it is a great honour to follow the noble Lord, Lord Judd, whom I have known and admired for a good few years. I am delighted to say that he has lost none of his firebrand qualities. He articulated what the Labour Front Bench and the Liberal Democrat Front Bench were saying in shades of blancmange—as a kind of procedural thing, that somehow we have to make sure the procedures are right. I kind of understand that, when the issue is very difficult and you would like to say “Let’s ban them” but you do not want to do that, you hide behind a load of procedures.

Essentially, this is a subjective decision for the Minister to make. The Minister receives advice, weighs that advice and has to come to a conclusion. There will be no magic moment at which the Minister says, “This is the advice that has changed”. If noble Lords on the Opposition Benches do not like this order, they should vote against it. They should not say that they will not oppose it but that they think in their hearts that they should oppose it, or that they would like to oppose it but it would look bad with some members of their party. It is important to decide on the issue.

Much has been said about my honourable friend the Security Minister, whom I have known for a good few years. In a brief gap in the proceedings of this House, I took the opportunity to go into the Gallery of another place and watch the proceedings. Having had the opportunity to watch the Minister in his previous speech, when I watched him on the Front Bench his body language looked much more relaxed on this occasion than it did on the previous one. I have no doubt that this is the right decision. I argued with my party, and I pay tribute to my right honourable friend the Home Secretary for coming to this decision.

If the House will allow me, I also pay tribute to my noble friend Lord Polak, who has been a champion of this over a number of years and has kept this issue in the minds of both Houses of Parliament. He deserves considerable credit for arriving at this decision.

The strange thing is that the difference between the military wing and the political wing is an entirely separate western construction. It does not exist in the minds of Hezbollah. We know that those who chair the grand jihad council and the Shia council are one and the same people. They do not see any distinction. It has been a convenient device for us to talk to them. The Minister made an immensely important point: Hezbollah is not just against Israel; it is against the Jewish people.

We heard the noble Baroness, Lady Deech, quoting Hassan Nasrallah; perhaps for reasons of delicacy she did not read out the quotation in full. I will do so:

“The Jews are a cancer which is liable to spread at any moment … If they all gather in Israel, it will save us the trouble of going after them worldwide”.

That is pretty unambiguous.

It is not a question of saying that, if we help the political wing, we will somehow help the military wing; they are the same person. The military wing does not decide to go around bombing various people and trying to organise the deaths of British soldiers or citizens elsewhere, while the political wing discusses the price of tickets at the theatre in Lebanon; they are one and the same people, and we need to recognise that.

We also need to recognise one other thing. The noble Baroness, Lady Ludford, commented very reasonably on this and made an interesting pitch, perhaps offering her services as a spin doctor to No. 10. The point is that our population—and our British Jewish citizens—need to feel safe; it is about their ability to go out without facing these flags of hate or the chanting, about feeling safe in the United Kingdom. It is important to set down the message that this country will have no place for anti-Semitism. You cannot have that view if you allow an organisation like this to move freely.

We must also remember that the issue is not just about security concerns; a substantial part of this organisation is funded by the smuggling of drugs. It is a main player in the trafficking of drugs throughout the world. We have seen arrests in France and in the United States. It is not a single part of our community only that is affected, but the whole community. Our streets will be perhaps just that little bit safer by removing from this organisation a convenience that, frankly, we should never have granted it.

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My Lords, I would like to congratulate the Government—my right honourable friends in the Home Office and Foreign Office, my noble friend the Minister and her department—for this decision and for bringing forward this legislation. I am delighted that the Opposition is not opposing it, but I must express disappointment that it is not actually in support.

Hezbollah is a radical Shia Islamist terror group backed by Iran, which seeks to impose its totalitarian ideology, with violence, on other Muslims. It wants to drive out western influences from the Muslim world. The organisation itself says, as we have heard from many noble Lords in this debate, that there is no distinction between its military and its political wings. It poses a threat not only to Israel and Jews—and I declare an interest—but to other citizens in the Middle East, of all religions, as well as here in Europe and elsewhere in the West. It has also been established, as my noble friend Lord Pickles rightly said, that Hezbollah is involved in drug trafficking and money laundering, and trafficks large amounts of cocaine through Europe and the US, as was uncovered in 2016 by the US Drug Enforcement Administration, Europol and Eurojust.

So I hope the Minister will agree that proscription will help to restrict Hezbollah’s ability to undertake such criminal activities in our own country, which pose huge threats to British citizens, and that banning the entirety of Hezbollah, as well as Ansaroul Islam and JNIM in the Sahel region of Africa, further demonstrates this Government’s determination to stand up against terrorism and groups dedicated to opposing our western civilisation, values and way of life.

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My Lords, I thank all noble Lords who have spoken in this debate. I start with Brexit, which for once is irrelevant to this debate. Matters of national security and intelligence-sharing were in place between states before the EU ever existed, and I know they will continue after it.

One of the major questions asked was: why now? Why did we resist proscription 13 months ago and what has changed? Proscription is a very significant step to take and, as my noble friend Lord Pickles says, it is a decision by the Home Secretary. We keep our response to terrorism under review and it is entirely appropriate that we take all available opportunities to strengthen the UK’s response to both domestic and international threats. Proscribing organisations is just part of that response.

The UK has continued to call on Hezbollah to end its armed status. It has not listened and in fact, contrary to what the noble Lord, Lord Glasman, says, its behaviour has escalated. The links between the senior leaders of the political and military wings and the group’s destabilising role in the region mean that the distinction between the wings is now simply untenable, as noble Lords have said. As the noble Lord, Lord Turnberg, my noble friend Lord Polak and the noble Baroness, Lady Ramsay of Cartvale, said, Hezbollah has itself publicly denied a distinction between its military and political wings. To answer noble Lords’ point, the UK has had a no-contact policy with any part of the organisation for a number of years.

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I have been listening to this debate quite closely. What happens in the event that a Member of the Lebanese Parliament—Lebanon is a member of the IPU—comes to the United Kingdom as part of a delegation? Would there be any difficulties for that person in entering the UK?

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There might well be. As a member of a proscribed organisation, they may well have great difficulty in getting into this country. I will come to the point about democratic elections shortly. We now assess that the group in its entirety is concerned in terrorism, although I know that noble Lords, particularly the noble Lord, Lord Rosser, on the Front Bench, will understand that I cannot go into the details of current intelligence.

The noble Baroness, Lady Ludford, asked if this action was to stop the intimidation of Jews—for example, by the flying of flags on London streets on al-Quds Day. Actually, it is not; the Government keep our response to terrorism under review, and we believe that now is the time to proscribe the entire organisation due to its increasingly destabilising behaviour over recent years. As for what happens on the next al-Quds Day, clearly the order will provide the police with an additional tool—it will be a criminal offence for a person to display a Hezbollah flag in circumstances that arouse reasonable suspicion that they are a member or supporter of Hezbollah—but the operational approach taken to the management of such public demonstrations will of course be a matter for the police.

The noble Lord, Lord Glasman, made a point about Hezbollah now having democratic seats in the Government. I acknowledged that in my opening statement. I could provide a long reel of its historical activity, but more recently it was involved in the siege of eastern Aleppo and, therefore, was partly responsible for preventing the delivery of humanitarian aid to the city’s approximately 275,000 people between 7 July 2016 and the end of the siege in December 2016. During that time, the UN reported there was a risk of mass starvation—noble Lords will have seen the pictures on television—if that humanitarian aid did not reach eastern Aleppo. The subsequent evacuation from those areas of civilians and fighters was also hindered by Hezbollah. That is very recent.

We remain steadfast in our commitment to Lebanon’s stability, security and prosperity, and we will continue to work with the Lebanese Government. Much of that may seem to contradict what I have just said, but it is important to state these things. The noble Lord, Lord Rosser, asked about the impact of DfID delivery in Lebanon as a result of proscription. We absolutely remain committed to the stability of Lebanon. It is important to say that DfID does not provide any direct assistance to Hezbollah, or to any of the ministries or the institutions that it leads. We ended support to Hezbollah-majority municipalities following the elections in May 2016. DfID requires all its partners to abide by strict UK counterterrorism legislation, and we recently undertook a comprehensive review of all UK government programmes in Lebanon to ensure that we were compliant. As a result of this process, we have strengthened some of our checks and controls, and the majority of our programmes in Lebanon will be unaffected.

I have said that there has been a policy of no contact with any part of Hezbollah since 2010. The proscription clearly will not change that but, in any event, it is not illegal to hold a meeting with a proscribed organisation that is benign or for a legitimate purpose. It is only attending or organising a meeting intended to support or further the activities of the organisation that, as noble Lords would expect, is unlawful.

A number of noble Lords asked about the proscription review group. It is a cross-government group that supports the Home Secretary in his or her decision-making. It makes recommendations and provides advice to the Home Secretary on issues relating to the implementation of the proscription regime, including the case for proscription, name-change orders and consideration of deproscription applications. Membership of that group may vary in accordance with what is being decided, but noble Lords understand that.

The noble Baroness asked about FCO influence on a proscription decision. Clearly the decision-making process of the proscription review group will bring together relevant departments and agencies to come together a collective recommendation.

The noble Lord, Lord Rosser, asked if the proscription review group has changed its assessment of Hezbollah’s involvement in terrorism. The Government are clear that Hezbollah has had a long-standing involvement in terrorism. Proscription is a two-stage test; if an organisation is concerned in terrorism, the Home Secretary has discretion to proscribe it. As I have said, we have continued to call on Hezbollah to disarm, but it has continued its destabilising activities in the region. The Home Secretary has now decided to exercise his discretion to proscribe the entire organisation, which we are clear is involved in terrorism.

I thought I would comment on the remarks of my noble friend Lord Pickles, the noble Baroness, Lady Deech, who I do not think is in her place, and the noble Baroness, Lady Ramsay of Cartvale, as what they said about the intentions of Hezbollah was very powerful. The comments about gathering in Israel so as effectively to get them all at once are disgusting and have no place in our society. Hezbollah do not just want to destroy Israel; it wants to destroy all Jews, and we have to do something about that.

The noble Baroness, Lady D’Souza, made a point about free speech. We are very lucky that we have free speech in this country, and we recognise that proscription will have an impact on it. However, although inviting support for any proscribed group is unlawful, the Government fully support the right of community groups or anyone in the UK to debate and discuss issues pertinent to them and the right to protest, as long as those activities are within the law. We have a long tradition of freedom of speech and assembly, and we will not restrict anyone’s freedom of speech as long as they act within the law and do not promote hatred and division.

The noble Lord, Lord Paddick, talked about points that the noble Lord, Lord Anderson, had made about deproscription reviews being an affront to the rule of law. I reiterate that organisations are proscribed because they are concerned with terrorism. We think that we exercise the proscription power proportionately, but we consider it right to take a cautious approach when considering removing groups from the list of proscribed terrorist organisations. We have made it clear, as I did during the passage of the counter-terrorism Bill, that the Government will seriously consider any information that casts doubt on any proscription, including in the absence of an application.

I conclude by referring to the comments of the noble Earl, Lord Sandwich, about informing other EU countries of the proscription and encouraging them to engage in similar action. We consult member states that have a direct interest in whatever group is at issue. We inform them of the proscription and a parliamentary agreement is secured in this House and the other place. We always consider whether to pursue EU listings of the groups concerned, although obviously different processes and tests apply.

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On the EU side of things, can the Minister tell us what the attitude of the French Government is towards these questions? France is our closest security partner and it would be very relevant to know its views.

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I am sure the noble Lord will understand that I cannot talk about intelligence discussions with other states at the Dispatch Box. Of course, we have very close security ties with France. We have assisted it when it has had terrorist attacks, and I have no doubt that discussions with France will be ongoing.

Motion agreed.

Safety of Medicines and Medical Devices

Motion to Take Note

Moved by

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That this House takes note of the steps being taken to improve the safety of medicines and medical devices.

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My Lords, I am delighted to be able to lead this debate today. I thank all noble Lords who will speak in it and wish the noble Lord, Lord Carrington, the best of luck in delivering his maiden speech—an auspicious occasion that we are all looking forward to.

I also express my gratitude to all those who have provided briefing for today’s debate: In-FACT, Sling The Mesh, The Royal College of Surgeons, the Nuffield Council on Bioethics and others. We are deeply fortunate in this country to have well-informed patient groups, professional organisations, charities, trade bodies and others. Their knowledge provides an indispensable contribution to our national conversation. The same is true of our superb House of Lords Library, which has produced a typically comprehensive and incisive briefing, for which I am grateful.

The reason for this debate stems from my time as a Health Minister, when I had responsibility for medicine and medical device regulation, and for promoting innovation in the NHS. That experience introduced me to the amazing benefits that come from life-changing and life-saving new therapies, but also exposed me to the dreadful harm that can occur—however rarely—as a consequence of the innovations on which we all rely. There is an innate tension between innovation and safety, and that is the principal idea I wish to explore today: how to balance that risk and encourage innovation—especially for those most in need of hope and help—but also act faster, be more agile and more compassionate when things go wrong.

We all have reasons to be grateful for the medical innovations that have become available through the NHS over its 70-year history, many of which were pioneered in this country. From mass vaccination programmes to joint replacement surgery, from organ transplantation to the creation of monoclonal antibodies —the medical and life science research community in the UK has saved and improved the lives of hundreds millions of people around the world. It is a record of which we should be immensely proud, and which the Government are supporting through the Life Science Industrial Strategy.

Our regulatory system can also be seen as a strength. As a Minister, I spent time with many European colleagues, who were always complimentary about the quality of medical regulation in this country, led by the MHRA, CQC and other bodies. They were right to be so, but the experience of the last two years—and the fact that we are having this debate—shows me that we can and must do better.

As I mentioned in responding to her superb maiden speech, my noble friend gave me some excellent and wise advice in 2017, when I joined her as a colleague in the department. She told me to watch my postbag, because it could provide warning signals about problems in the system. How right she was. Among the many letters I had from MPs and noble Lords raising concerns about problems associated with medicines and medical devices, there was a steady stream on two particular areas, which I want to focus on today: mesh, a device often used in a variety of procedures to fix prolapses, incontinence, hernias and other related conditions; and sodium valproate, a highly effective medicine used largely to treat people with severe epilepsy.

It is one thing to read about the problems suffered by patients when medicines and devices cause harm, but it is another thing entirely to meet in person those affected. I have had that opportunity on many occasions, and some of the stories I have heard have been truly heart-wrenching. I will never forget meeting for the first time two remarkable women to discuss the issues associated with sodium valproate. They are here as my guests today: Janet Williams and Emma Murphy of In-FACT, supported by their friend and fellow campaigner Mikey Argy. I was horrified to hear that, despite the risk of the drug’s teratogenic effects—that babies exposed to it in utero ran an unacceptably high risk of developing a range of physical and mental impairments—being known since the 1970s, thousands of women, already vulnerable because of their epilepsy, were still being exposed every year.

I was deeply impressed by the quiet but iron determination of these two women, whose own children have been significantly affected by valproate, and their commitment to reducing risks of other women in this situation. Following that meeting, I worked closely over two years with In-FACT, the APPG and the MHRA—I pay tribute to Dr June Raine and Sarah Morgan for their work—and the heads of the relevant Royal Colleges and other learned societies, to try to do something about this issue. We made a number significant policy changes, including mandating pregnancy prevention programmes for women of child-bearing potential on valproate, and insisting that “do not take in pregnancy” images ought to be put on every prescribed pack.

Change is happening, but despite everyone’s good intentions, the pace is glacial. According to In-FACT, around 30,000 women nationally are prescribed valproate, which is roughly the same as in 2015. While the number of in utero exposures is falling, during a recent valproate stakeholder network meeting, the MHRA stated that some 200 babies have been affected by valproate since April 2018, which was when the pregnancy prevention programme came in. Professor Thangaratinam, professor of maternal and perinatal health, stated in evidence to the Cumberlege review team that every year 350 to 400 women prescribed valproate get pregnant—this for a drug that has a perhaps 50% risk of harming the baby in some way.

I also very clearly remember, following an Oral Question from the noble Lord, Lord Hunt, who I am delighted is speaking after me today, meeting a large group of women whose lives had been ruined by mesh. Some were confined to wheelchairs and all had suffered or were suffering considerable pain as a result of what they had been told at the time was a minor and uncomplicated procedure: the insertion of synthetic mesh. I had several further meetings with affected women and parliamentary campaigners on this issue, and I take this opportunity to thank Kath Sansom and the Sling The Mesh campaign for highlighting the human costs of some of these mesh procedures and for working constructively to change the policy and the regulatory environment to reduce the risks to women.

Again, change has happened—the number of procedures involving mesh is falling and certain categories of use are now effectively banned—but the health system has been too reactive in dealing with a problem that has been apparent for at least 15 years. Faced with the anguish and determination of these women, it was obvious that the Government had to do more. I had also been dealing with the results of the Commission on Human Medicines inquiry into the historic Primodos case, where again a number of families, led by the redoubtable Marie Lyon and her husband, were convinced that their children had been adversely affected by this hormone-based contraceptive.

These cases—Primodos, mesh and valproate—were very different in many ways, but it was also clear, in dealing with these and other issues, that they had critical factors in common. First, our methodology for discovering and verifying adverse events needs to improve. While the UK has one of the best pharmacovigilance regimes in the world, it is still dependent on old-fashioned ideas, such as the voluntary yellow card scheme. Furthermore, the process for regulating devices is not always as rigorous as that for medicines.

Secondly, as must have been obvious from my speech so far, all three cases largely affected women. Of course, women are the greatest users of health services, a fact intimately linked to the fact that they give birth, so we would expect more adverse events to be experienced by them, but there is much more to it than that. In all these cases, I heard women reporting patronising and often patriarchal attitudes from a largely male medical workforce administering a pat on the head, sometimes literally, and telling them that the pain was all in their minds.

Thirdly, and related to the previous point, all these women had been campaigning for years to have their voices heard, their pain and suffering recognised, and it had often fallen on deaf ears. In this respect, the parallels with scandals like the one at Mid-Staffordshire could be seen: a system that too often turns its back when criticised, rather than offering a compassionate and understanding face that seeks to help those affected and prevent the problems occurring for others. It was this insight—that there were common themes that warranted further explanation—that led to my suggesting to the then Health Secretary, Jeremy Hunt, whose abiding principle was that patient safety should always come first, that we needed an independent review into our medicine and medical device safety regime. I was delighted when he and the Prime Minister supported the proposal, and even happier when my noble friend Lady Cumberlege was appointed to lead it. It is fantastic that she is able to speak in the debate today. The work she is doing is so important, and I believe that the way she has engaged patient groups around the country through her review has been truly exemplary. She has already made a big difference, because it was on her recommendation that a pause was instigated on certain mesh procedures in England.

Up to now I have focused on areas where patients have been put at unnecessary risk and provided with inadequate information, and where the system has been too slow to respond. It is certainly my belief that, for medical products with wide usage, where patients expect to live long and broadly healthy lives, we need to do better, but the tension between innovation and safety can manifest itself very differently for people whose outlook is poor. In these cases, the boundary between risk and reward can fall in a very different place. Last January, we in this House were privileged to bear witness to one of the most extraordinary speeches in living memory from our friend, the much loved and much missed Baroness Jowell. I had the honour of responding for the Government to the debate she initiated on improving cancer outcomes. The noble and courageous lady raised many important ideas that day. One of the most significant was that when you do not have long to live, you have little to lose by trying experimental therapies that, in ordinary circumstances, no clinician would dream of giving a patient.

This insight was, of course, also behind my noble friend Lord Saatchi’s Medical Innovation Bill, considered some years ago and inspired by the tragic experience of his own late wife. In these situations, when sadly and frankly the prospects are grim, it is right that the balance between risk and benefit is flexible. In our efforts to improve the safety of medicines and medical devices in general, we must not prevent those willing to take great risks to extend their lives from doing so—quite the opposite. The regulatory regime we need to create must be able to draw a much more sophisticated distinction between the balance of safety and innovation, so that it is dependent on the needs of each individual patient.

There are some really encouraging developments in this area. Next week I will visit Professor Colin Watts and his team at the University of Birmingham. Together with the Brain Tumour Charity they have created BRAIN-MATRIX, a clinical trials platform for people with brain tumours that is the first of its kind. It not only allows patients with a very poor prognosis to access experimental therapies, but also uses adaptive techniques and other methodological innovations to make sure that outcome data is gleaned from every intervention and used to improve each patient’s course of treatment, as well as that of those who will follow them.

I strongly encourage my noble friend the Minister to look at what is happening in Birmingham, and other similar approaches such as Precision Panc, because they have the potential to offer a new way to make sure that patients with these dreadful diseases can quickly access experimental therapies in an ethically acceptable way that generates better treatments for all.

I will conclude by making a few suggestions for how things might change. The current system can be bewildering for patients who do not know where to turn when things go wrong. I think that we need a new national office of patient safety—a compassionate, patient-facing agency that is the first port of call when harm is suffered, that can provide the analytical rigour needed to look at cases on their merits, and that can provide a single focal point for action among the many professional and product regulators that operate in the system.

I am sure that my noble friend the Minister will rightly want to see the results of the Cumberlege review before fully setting out the Government’s own plans, but I am keen to know her thoughts on this proposal. Can she also use the opportunity of this debate to reassure the House—and the many interested patient groups—that the department is fully behind the review and will look at its recommendations later this year with an open and constructive mind?

But we do not have to wait for my noble friend’s review to conclude before we act. It is imperative that the Government support the MHRA and other agencies to use technology and other innovations to improve post-licensing surveillance of medicines and medical devices. This should include using the upcoming EU medical device regulation, the NHS’s own “scan for safety” system and the application of machine learning to the NHS’s unique data resource. It must also include new registries for high-risk devices, such as the one the Government have already committed to for mesh. Can my noble friend the Minister inform the House how the department intends to move forward on this agenda?

For families affected by valproate, does my noble friend agree with me that the ambition should be to limit in utero exposure to as near zero as possible, and to make sure that every eligible woman should be on a pregnancy prevention plan and able to make an informed choice about whether to have a baby?

For women affected by mesh, as well as further strengthening the regulatory regime, will my noble friend ensure that there is a properly funded and staffed national network of expert removal centres and surgical teams who can try to repair some of the damage that has been done?

As medicine evolves and becomes more personalised, and as patients become better informed and more active in managing their own care, the balance between innovation and safety needs to evolve as well. I hope I have set out some of the questions we need to answer as we make these changes, and eagerly anticipate the contributions of noble Lords, including my noble friend the Minister, as we collectively seek to achieve the highest standards of patient safety, care and innovation in our NHS. I beg to move.

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My Lords, I am very grateful to the noble Lord, Lord O’Shaughnessy, for initiating this debate. I remind the House of my health interests as set out in the register, specifically my membership of the GMC and presidency of GS1 UK and the Health Care Supplies Association.

The noble Lord has focused on the review of the noble Baroness, Lady Cumberlege. I will concentrate on surgical mesh, but I recognise that the review has a much wider significance, assessing the actions of relevant authorities over the years when safety concerns have been raised. On surgical mesh, what is so striking is how long it has taken to get any action. The excellent campaign group Sling The Mesh, led by Kath Sansom, has fought a sustained campaign to draw attention to the problems that we have heard about, with many women left in permanent pain, unable to walk or work and feeling totally neglected by the National Health Service.

Not only have these problems been known about for years, they have been recognised in a series of official reviews. As far back as 2012, the Department of Health reported that, while surgery for stress urinary incontinence and pelvic organ prolapse using mesh can be effective for most women, a small percentage will suffer significant side-effects. The department established a working group between 2014 and 2017—for three years—that came to no hard conclusions at all. At the time of the publication of the final report, the MHRA said that it was committed to addressing the serious concerns of patients, but that it was not aware of a robust body of evidence that would lead to the conclusion that mesh was unsafe if used as intended.

In a Statement that the noble Lord repeated to the House in February last year, he referred to advice from the Chief Medical Officer that experts here and abroad had said that, when the treatment is used appropriately,

“many women gain benefit from this intervention, hence a full ban is not the right answer in the light of the current evidence available”.—[Official Report, Commons, 21/2/18; col.164.]

Even after the early findings of the noble Baroness, Lady Cumberlege, the Government instituted a pause, but significantly not a ban, on the use of vaginally inserted mesh to treat prolapse, and on the use of tape or slings to treat stress urinary incontinence.

So we have had a series of reviews. All have recognised the problem, although there is disagreement about its scale. However, they have all tended to recognise the benefits of the procedures and have resisted the ban called for by campaigners. This ambivalent approach has been very frustrating, and I wonder whether the ambivalence lies behind the very poor way in which the NHS has treated those women for whom mesh has been a total disaster. They feel abandoned by the National Health Service and, frankly, the service seems to be in denial about the problem. There are no support mechanisms and precious few opportunities to have the operations reversed—nowhere near the kind of approach that the noble Lord, Lord O’Shaughnessy, has called for today.

This continues. I do not know whether noble Lords have looked at the draft consultation by NICE that it has yet to finalise. I was struck in particular by section 1.10, entitled “Managing Complications Associated with Mesh Surgery”. It states that the decision to remove mesh for any indication needs to be made in the context of an explanation to women that such surgery may not relieve symptoms and may have significant complications, including organ injury, worsening pain, and urinary, bowel and sexual dysfunction. So this leaves a woman damaged by having mesh inserted with little prospect of amelioration at all.

I received an email this morning from a woman member of Sling The Mesh. She is currently in Germany for a non-mesh hernia repair, following two removals of an incontinence mesh. Why did she have to go abroad and pay for it herself, and why is the NHS so hopelessly inadequate in dealing with the issue?

The issue is not confined to vaginal mesh. Last week I met a senior lawyer in Birmingham who spoke to me about his experiences following a hernia mesh implant in 2011 that left him in constant pain. Before the mesh implant operation, he was very active and ran half-marathons. Now, sadly, because of his pain, his mobility has been greatly reduced and he struggles to sit at his desk for any significant time. His life has changed for the worse. Again, the response from the NHS has been wholly inadequate.

I am uncertain whether the problems are caused by poor diagnosis and poor clinical performance, or whether a certain percentage of patients can expect to suffer harm from the intervention. Alongside the challenge the noble Lord raised about the balance between risk, safety and innovation, this raises moral and ethical questions as much as regulatory ones. The question is whether it is right that these operations should continue when we know that, on one hand, many patients will benefit, and on the other, it seems inescapable at the moment that a number of women will suffer. There is disagreement about the percentage but some campaigners think that it is as high as 10%. If this was a medicine, of course it would not receive approval, based on that balance between risk and benefit. However, a device is different, and the regulatory system approaches it in a different way.

I do not know the answer to that—I hope the noble Baroness, Lady Cumberlege, does. I echo what the noble Lord, Lord O’Shaughnessy, said. It would be a great pity if the Government did not listen very strongly to what she has to say, and I hope that they will consider her recommendations in full. I also hope that she will say something about the need to develop a system of safety culture in the health service. This goes much wider than surgical mesh or the issues that she is looking at for the review. As Ken Lownds, a safety expert, put it to me, our approach to safety compared to other safety-critical sectors has the feel of a cottage industry. That has to change, and I hope that the noble Baroness’s review and this debate will be a catalyst for that.

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My Lords, I also congratulate the noble Lord, Lord O’Shaughnessy, on achieving this debate and on his passionate opening speech. There can be no greater issue in relation to medicines and medical devices, apart from whether they work, than whether they are safe. I hope that the House will not be bored by the fact I agree with him, as I agree with the noble Lord, Lord Hunt. I will focus on similar issues but I also want to talk about the role of community pharmacies in ensuring the safe and cost-effective use of medicines and medical devices.

As we know, sodium valproate is a medicine prescribed for certain kinds of epilepsy and bipolar disease, and we know about the dreadful rates of birth defects in the babies of women taking these medicines during pregnancy. Despite the fact that clinicians were advised to prescribe valproate only to patients who had effective contraception and for whom no other medicine worked, and guidance was given about patient information and consent, questions arise about whether that is happening. In October 2016, a group of epilepsy charities surveyed nearly 3,000 women and reported that 20% of those who were taking sodium valproate were not aware of the risks in pregnancy. The survey was repeated a year later, when it was found that 18% of women taking the drug still did not know the risks, and 28% of women said that they had not been informed of the risks in pregnancy despite the availability of the MHRA toolkit produced in February 2016. More than two-thirds of women taking sodium valproate said that they have not received the toolkit. Philip Lee, the chief executive of Epilepsy Action, is calling for a mandatory discussion of the risks with a health professional for all women with epilepsy on valproate so that they can make informed choices before they conceive. Does the Minister agree with that?

On 30 November 2016, in answer to a question from my right honourable friend Norman Lamb MP in another place, the Minister in her former incarnation said:

“In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies, patient groups and relevant charities to increase awareness of the toolkit among general practitioners, pharmacists and patients. The MHRA’s current priority is working to ensure that women taking valproate are fully aware of the risks in pregnancy”.

Can the Minister now say what percentage of women taking valproate are receiving the MHRA materials? That is absolutely crucial to their informed decision. In addition, what lessons have been learned about how effectively to cascade down information and materials produced centrally? If they are produced centrally, however good they are, they are no use at all unless they get to the patients.

I turn from one medicine with considerable risks that have not been sufficiently taken into account to others for epilepsy where the risks are very low, as has been proved in other countries, yet their accessibility for patients with epilepsy in this country is not very good. I am talking about cannabis-based medicines, which, despite the change in their regulatory position last year, are still not getting to adults and children with epilepsy and other conditions which could benefit from them. Can the Minister update us on that?

The other issue mentioned by the noble Lord, Lord Hunt, is the use of vaginal mesh for pelvic organ prolapse. He is absolutely right: the NHS was very slow to listen to patients with complications after surgery and options were not available to them. Eventually, the Mesh Oversight Group was set up, which consisted of relevant professionals but, crucially, also included patients. One of its recommendations was addressing the knowledge of GPs, because it is to GPs that women go first. They go to GPs when they first realise that they may have a prolapse but, after the surgery, they go back to the GP when they feel that they have complications. The problem is that GPs do not necessarily realise what the cause might be.

As the noble Lord, Lord Hunt, mentioned, this report has particular focus on women who have developed complications. It is very important that they have access to specialist centres with multidisciplinary teams able to advise them and treat complications. I support the call of the noble Lord, Lord O’Shaughnessy, for those to become specialised commissioned hospital services. The Royal College of Surgeons, in its rather late briefing for this debate, also called for clinical trials and traceability by barcoding for all medical devices for implantation. That is important across a wide range. Can the Minister update us on the progress of those recommendations and tell us what lessons have been learned about patient involvement in policy-making? Finally, can the Minister or the noble Baroness, Lady Cumberlege, tell us about the progress of the Cumberlege review?

Given the shortage of time that GPs have to spend with their patients, community pharmacies have a big role to play in ensuring safe and cost-effective use of medicines. The New Medicine Service provides support to patients who have been newly prescribed medicines for long-term conditions. It is intended to improve medicines adherence and is focused on a small range of conditions. It has been assessed on its effectiveness and come out very well, but pharmacists are now suggesting that the service should be extended into other medical conditions where there is significantly poor adherence to the medicines regime. Is that proven intervention to be extended to other medical conditions?

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My Lords, when the noble Lord, Lord O’Shaughnessy, gave up his position at the Department of Health, many people were dismayed, as he was doing an excellent job. I am so pleased that he is still involved with the health service, and today is an example, as he has brought up the vital matter of safety in the NHS, particularly at this difficult time. I thank him for that. I also congratulate the Minister on taking on the mammoth task of looking after the interests of the NHS and social care.

In the past year, I have taken part in several All-Party Parliamentary Health Group evidence sessions on cancer and other disabling conditions. I found the overriding similarities between them to be late diagnosis of the condition and the problems arising from not having the correct medicines and treatment at the right time. At a recent seminar on safety, one of the main dangers highlighted was fatigue of doctors and nurses, risking them giving patients the wrong dosage or the wrong medicines. I understand how that can happen on a busy ward with a shortage of experienced nurses or during a 12-hour shift.

It is sad that the European Medicines Agency has already left London and gone to Amsterdam. Medicine regulation in the UK will be affected by our departure from the EU. With the EMA having left London, it has already begun. The Royal College of Surgeons is pleased to hear that the Government are considering the establishment of a national medical devices registry. Can the Minister give your Lordships a progress report on that matter?

I am so pleased to hear that NHS Improvement is delivering a new patient safety strategy. So many bodies work for the NHS that it is sometimes difficult to know which is doing what. Will that strategy look at the dangers of counterfeit medicines, many of which are available on the internet? Addiction to medicines is a growing problem.

It is estimated that 52,000 people in the UK die every year from sepsis, a serious complication of an infection. I declare an interest as I had it in the summer; I have been on antibiotics for more than six months. A new rapid test for the early diagnosis of sepsis is being developed by researchers from the University of Strathclyde. The device, which has been tested in a laboratory, may be capable of producing results in two and a half minutes.

In a recent report, NHS Improvement stated:

“Treating pressure damage costs the NHS more than £3.8 million every day”.

It also noted:

“Despite extensive prevention programmes, evidence suggests about … 2,000 patients a month develop pressure ulcers”.

Bruin Biometrics has produced an SEM scanner, which is used to address the problem of pressure ulcers. It is a wireless, hand-held device designed to be an adjunct to clinical assessments; it can alert clinicians to incipient pressure damage not visible at the skin’s surface. It is encouraging that these useful devices are being developed so that prevention can avoid many medical problems.

In August 2018, NHS Improvement issued a patient safety alert after 35 people died from cardiac arrest due to hyperkalaemia, or elevated potassium levels. What support is the Department of Health and Social Care giving providers to ensure that they can comply with requirements to test for and treat that condition? Should not guidelines go out to trusts and GPs? High potassium is a danger to kidney patients because their medication can cause high serum potassium, which is dangerous for the heart and can cause cardiac arrest. On the other hand, low potassium levels can be a danger for people with spinal injuries, so more attention should be paid to potassium levels.

Sodium valproate has been discussed by two noble Lords. It is a drug which has put pregnant women with epilepsy in danger of having children who are autistic. This unfortunate case illustrates the need for clear and honest information along with accurate data. Good communication should be set up between hospitals and GPs, patients and carers, voluntary organisations and public health, and prison health and regulators. All stakeholders should communicate where necessary and should work in harmony, not in isolated silos. What is difficult for patients is when they are given conflicting advice and views. This has been a big issue on the Patients Association helpline. There is much to do, and I look forward to hearing the maiden speech and the Minister’s reply.

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My Lords, my interests are in the Lords’ register. I thank my noble friend for securing this debate. There are few who are better informed on this subject or more knowledgeable and committed than he is, as we have heard today. As has been said, I chair the Independent Medicines and Medical Devices Safety Review. It is focused on how the healthcare system has responded to concerns about medicines and devices raised by patients.

When the review reports later this year, we will make recommendations to improve matters, but in terms of what has happened up to now, three medical interventions are in our scope. The first is Primodos. This drug was withdrawn from the market in 1978 but concerns had been raised years earlier. Babies were born damaged. Those that survived are disabled. The second is sodium valproate. The link between sodium valproate and birth defects has been known for many years, yet women and babies continue to be exposed to the risk. Experts suggest that around 20,000 people have been harmed. For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.

The third intervention is surgical mesh. Many thousands of women have had mesh inserted for incontinence or prolapse. The majority have not reported any problems, but a significant and growing minority have suffered terrible complications, including: excruciating chronic pain, which has been described as feeling like razors inside the body; damage to organs; autoimmune problems; the loss of mobility; the loss of a sex life; and depression and suicidal thoughts. The impact of mesh is not only on the woman herself but on her family. The physical and mental pain has led to the break-up of marriages and partnerships, and many cannot work. If they lose their job, they face losing their home. Children have become their mothers’ carers and some women even face the prospect of their children going into care.

So concerned were we by what we heard about mesh that as an interim measure we recommended a pause in its use until the stringent conditions that we set have been met. That pause has been in place since last summer. I have carried out a number of reviews into health-related matters, but I have to say that this is the most troubling and the most harrowing. The suffering of so many people and their families is heart-breaking. The pain, both physical and emotional, is almost impossible to imagine. My team and I made it our priority to do something that the system has failed to do for all these years: to listen and to learn from what we hear.

We have travelled the length and breadth of the UK. We have met many hundreds of people who have been directly affected, and their families. We have heard from many more by email or phone. I pay tribute to all those we have met. Their courage and dignity in the face of such suffering are truly remarkable. It has been a privilege to meet them. The campaign groups that support them do simply wonderful work. I have been deeply saddened, not just by the personal stories but by the constant reminder that this harm was avoidable. Their lives have been turned upside down, but they did not need to be.

We will continue to listen to those affected. We have also received a huge amount of written evidence, all of which is on our website. We are now in the midst of our oral hearings, taking evidence from regulators, medical colleges, manufacturers, the NHS and others. These evidence sessions are video recorded and available via the review’s website. We are looking not to blame but to ensure that we learn.

Our starting point has been some simple questions. Could and should things have been done differently? Could actions have been taken more quickly? What needs to happen now, and who needs to do it? We have more evidence to hear before we write our report, but there are some emerging themes: the lack of proper warnings about risks; the lack of informed consent; a system whose first inclination is to deny there is a problem or simply to ignore concerns; where concerns are eventually heard, the sluggishness of a proper response; the dismissiveness and arrogance of some—I stress only some—in the medical profession; the byzantine complexity of a regulatory system that few within it, let alone patients and the public, seem to fully understand; the fight for diagnosis and support when things have gone wrong; and the inadequate resources available, whether for follow-up surgery in the case of mesh, or medical, social and educational care in the case of sodium valproate and Primodos.

Most troubling to me is that these issues have come to our attention not because they have been raised by regulators, doctors or the NHS but because of people power. People affected have organised themselves into campaign groups and, with the help of Members of Parliament, push the issue up the agenda until finally someone takes notice. That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.

Of course, no medical procedure is without risk, and innovation is crucial in healthcare; we must not stifle it. But it is vital that an individual is able to make an informed decision, based on a clear and full explanation of the benefits and risks, about a medicine or procedure. It is vital that regulators act with independence and impartiality in approving a medicine or device, that safety comes before commercial interest, and that they listen carefully to patient-reported concerns and act swiftly on them. It is vital that surgeons carry out operations for which they are suitably trained, that they have the right level of experience, that they show compassion and that a comprehensive database exists. When things go wrong and avoidable harm is suffered, the test of a good healthcare system—indeed, of a good society—is our ability to listen, to say sorry, to learn and to provide the right care and redress.

Noble Lords would be forgiven for thinking that these points are a statement of the obvious. A year ago, before I started this review, I would have thought so too. Having heard and seen what happens to people when the system fails, I now know they are not. There is much to be done before we can be assured that the system listens to concerns and responds as we would wish. I am determined that my review plays its part in making that happen, but this is a challenge for all of us in this place and in the healthcare system. Noble Lords taking part in this debate and others in this House possess expertise and experience that will be invaluable in ensuring we have a system fit for the future. I hope my review can draw on that as we continue our work.

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My Lords, the topic of today’s debate is well chosen by the noble Lord, Lord O’Shaughnessy. He is to be commended on his enthusiasm, both as a Minister and as a future Back-Bencher, in raising it. I give my best wishes to the noble Lord, Lord Carrington, in anticipation of his maiden speech. I would like to mention Norman Lamb, the honourable Member in the other place, and his indefatigable leadership of the APPG on Epilepsy.

As a barrister, I have been engaged over the years in many cases involving medicines and medical products with general consequences for those who use them. I have no current professional interest in any such case. However, I am the possessor and user of a pacemaker and had a double hip replacement a few months ago, so noble Lords will forgive me if I show enthusiasm for the topic in question. Improving safety, and not accepting it as a given, is a serious topic. We have to work for it, and I want to concentrate on the problem, the scale and some solutions.

On the problem, since the 1960s, the NHS and the international scope of medicines and medical devices have led to better medical treatment, but that development has had consequences. First, a far greater variety of products is produced and marketed internationally. Secondly, there is a wider impact of adverse consequences from some of those products, causing damaging conditions, both physical and mental. Thirdly, such disabilities and illnesses have a devastating effect on the families involved. This is a problem that will not go away. The greater the expansion of medical knowledge and the more demands that are placed on health services by patients, the bigger the issue will become. At the heart of this, the problem we need to bear in mind—and this is a direct point on epidemiology and causation—is who in our society will own medical big data? Will it be the media giants, the Government or institutions, or is it a public good to be owned by everybody and administered by the full gang? This is a critical aspect of the problem.

On the scale, in introducing the review led by the noble Baroness, Lady Cumberlege, Jeremy Hunt, the then Health Secretary, spoke of the “widespread harm” within the health service that had been occasioned by medicines and medical products. That is the scale domestically. Internationally, similar systems, common suppliers and the international exchange on the marketing front have become ever the greater. The problems are physical and mental. They are not gender specific, although certain of the products mentioned are particularly applicable to mothers and children of either gender; they are not age-specific. Look at the present opioid epidemic in the United States, which could occur in other countries if proper steps are not taken.

Then there are the effects in our country. Thalidomide came to light essentially because you could see what it had caused. The haemophiliac HIV/AIDS disaster came from giving haemophiliacs, mostly children, contaminated blood with the wrong factor 8 composition, leading to them getting HIV/AIDS and often dying of it. We may have forgotten mad cow disease and CJD, and the panic it produced, although the problem appeared to be small numerically.

Lastly, there is causation. How do we prove these cases? Doctors rely on academics and scientists to reassure them about use from what they observe in their own practice, but they need data. Scientists and academics must have data to show that a product is safe, so big data comes back into play. The problem is not going to go away and the scale of it is serious.

On the solution: I say yes to everything that the noble Lord, Lord O’Shaughnessy, and my noble friend Lord Hunt have said. I say yes to changes and to patient safety records, but that should be as well as—not instead of—a national, no-fault compensation fund. It is just outrageous that people who have suffered this kind of problem are driven to go to court. New Zealand and Sweden have their systems, and nobody can say that they do not work, but such a system requires interim payments, final payments and the protection of state benefits. It can be paid for by a levy—I have yet to come across a poor pharmaceutical giant that cannot afford to pay a levy, which is the same as insurance—coupled with government money and, if possible, private donations and an independent agency.

To finish quickly, causation is everything in this regard. Clear and authentic diagnostic pathways that doctors can rely on form an essential first step—the quicker you get to it, the less the problem will be. A retrospective audit process should go backwards, so that older people who develop things late are caught. We need the involvement of families and carers, some of whom are present today as observers, along with reliable management of the scheme, adequate resources, long-term financial planning, integrity and independence.

I will conclude. Because of their bravery and dignity, the people who have suffered—patients and the families who look after them, including children and older people—deserve our respect and admiration. But they demand, in justice and morality, our help through the community and society. In giving it, let us not listen to that bureaucratic homily we always get: “It takes a long time; it involves a lot of money”. On the morning of 12 December 1990, I got a phone call in my chambers. As lead counsel in a haemophiliac case, I was told that the case had been settled. I said, “What do you mean?” I was told that the Prime Minister was going to announce it in Parliament at 2 pm, which he did, and it was settled. It can be done quickly and efficiently. I thank noble Lords for their patience for my enthusiasm.

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My Lords, in 1797 my four times great grandfather, the banker Robert Smith, was introduced to the House of Lords on the recommendation of William Pitt—that is, Pitt the Younger—to King George III. The result was that a goodly proportion of the House walked out because he was the first person in trade to be elected to your Lordships’ House. I can only hope I do not stir the same reaction.

I am really privileged to be here today making my maiden speech. Like others, I have sat quietly for some weeks observing the workings and customs of the House. I cannot say that I am yet confident about every aspect of being a newly minted Peer, although I have received endless help and attention, from the doorkeepers up to the Convenor of the Cross Benches, from the attendants up to Black Rod and, of course, from my mentor, my noble friend Lord Aberdare. I have also received help from Peers from every side of the House.

Furthermore, I am most grateful for the splendid services available to Peers, in particular, for the incomparable Library which magicked up a copy of my father’s first speech in your Lordships’ House. I fear this was not very helpful, as he did not make a maiden speech but instead asked an Oral Question—God forbid! The subject was the use of prisoners of war on farms, as they accounted for 40% of farm labour in 1945. I doubt that that is the solution to current agricultural employment issues. Many noble Lords knew my father, and it is therefore a frightening experience to follow in his huge footprints.

As for myself, because of my father’s political presence, I decided to follow a different career path, which I hope has given me sufficient experience in a number of areas to enable me to contribute to the work of this House. I am a banker by way of background, specialising in the world of investment, both direct and portfolio, and I still pursue this career as an independent adviser. I have lived in Asia and travelled widely. I have also worked in the Middle East and have been involved in Saudi Arabia since 1974. Currently, I sit on boards and have advisory appointments in the United States, Europe, the Middle East and the Far East. At home in England, I am an active farmer and a lover of the arts. I am privileged to be a governor of the Royal Shakespeare Company.

I thank the noble Lord, Lord O’Shaughnessy, for introducing this debate. Although I cannot claim to be an expert in the detailed subject of the safety of medicines and medical devices, I am fairly conversant with the importance of the regulatory aspects of the factors which govern the overall environment in which healthcare is brought to the general public. The patient safety aspect of medicine and medical devices is paramount and is constantly evolving with the assistance of new technology, innovation, data capture and identifying worldwide best practice. I am pleased to note that the independent medicines and medical devices safety review is under way and will bring invaluable recommendations to the Government.

I would, however, like to raise a broader issue which needs to be borne in mind throughout our deliberations, since healthcare accounts for some 10% of gross domestic product. In order to satisfy all patients, the provision of healthcare needs to be driven by innovation, demand, affordability and government regulations. The challenge for regulators worldwide, whether the European Medicines Agency, our own MHRA or, in the US, the Food and Drug Administration is to facilitate innovation without lowering standards. Whether we are in Europe or outside, the same issues arise. Innovation enables new, more efficient medicines and devices to be brought to patients at a more affordable cost. It is important that, while not compromising on safety, regulations do not inadvertently inhibit the all-important innovation.

In a small way, I have been involved in the analysis of a number of healthcare companies, particularly in the United States. Over the years, therefore, I have had cause to study the workings of the US FDA which, for many innovators, was seen as a regulatory roadblock. This has changed since the current commissioner took over; unusually in today’s environment, he is thought of positively on both sides of the US political divide. The FDA is now collaborating with companies in a more proactive way during the development process. It is offering more guidance and engaging in more interactive exchanges with companies prior to filings.

The importance of an innovation-friendly regulator cannot be overstated when the results are new products coming to the healthcare industry at a rapid pace, enabling patients to benefit faster than ever before. This is demonstrated by a 168% rise in drug approvals between 2016 and 2018 in the United States. There has been a similar improvement in the approval of medical devices. The regulation of medical devices differs from that of drugs, but the end goal of both approaches is the same: to ensure patient safety and performance. I would be interested to hear from the Minister whether the MHRA has been following these exciting developments at the FDA, and whether there is a process in place to learn from them.

The purpose of bringing these experiences of the FDA to your Lordships’ attention is to demonstrate the value of adopting best practice in the overall field of healthcare, from innovation to manufacture and delivery to safety. The FDA has its issues, and no doubt follows carefully the work of the EMA and MHRA, but I would urge that, in a field where the overall interests of patients are paramount, we can all learn from each other. Will the Minister please assure us that the principal regulators worldwide are communicating regularly and closely to achieve this essential balance between safety and innovation?

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My Lords, I start by congratulating the noble Lord, Lord Carrington, on a really touching and thoughtful maiden speech. We are all hugely moved by memories of his father, and many here will remember him with great fondness. He was a man who embodied the values of the House: courage, professionalism, public service and, very famously, a strong sense of discretion. From the evidence of his splendid maiden speech, the new Lord Carrington should have no fear of following in his father’s huge footsteps. I am sure he will make a powerful impression on the House, particularly in his chosen fields of finance, the rural economy and the arts.

I thank the noble Lord, Lord O’Shaughnessy, for bringing this important debate to the House. I also thank the Library, which has produced a massive, 20-page blockbuster that tackles this technical subject with huge helpfulness. My main interest in the debate is in the area of drug development and the potential for a more agile approach to drug regulation. I am very grateful to those who have already spoken about medical paternalism and the growing scepticism of patients about medical and scientific authority.

It has been my experience of human nature that, when facing an adverse condition, people are prepared to suspend normal attitudes to risk. My father, the late Lord Bethell, suffered severely from Parkinson’s disease. I remember sitting with him in the office of the eminent Professor Tipu Aziz, a great expert in Parkinson’s. My father had avoided all contact with the medical profession for his entire life as an article of faith, but there was Professor Aziz suggesting that he wanted to drill a very large hole in the top of my father’s head and then inject his brain with an untested dopamine mixture. My father, a cautious man at best, thought this was an incredibly exciting idea and was 100% up for it. He was enormously frustrated when he did not qualify for the pilot. I think that is an indication of the changing attitudes that people have, as my noble friend Lord O’Shaughnessy mentioned, when they face medical adversity.

I must declare an interest as a trustee of the Scar Free Foundation. I shall tell the House another story: last year I visited the Centre for Conflict Wound Research, where I met members of the Casevac Club, which is like a modern-day World War II Guinea Pig Club. They are lending their bodies to medical research. There was an amazing veteran with no legs who had a massive scar across his entire torso. He was having a laser puncture his scar 400 times a second in a lattice formation on one side of his body but not the other, in an excruciatingly painful treatment, in order to get important data on the effectiveness of this new skin-healing process. I felt that this was an incredibly moving metaphor for the determination that some people show and the sacrifice that they are prepared to make for medical science.

My noble friend Lord O’Shaughnessy put it very well when he talked about those who live normal lives who expect a regime of safety. I want to talk about that. No one wants an uncontrolled Wild West approach to medical regulation. In fact, that would be utterly counterproductive to investment; I am aware that under certain circumstances when drugs are tested, early problems might prevent investment in later trials.

I highly recommend the report of the Panel on Monitoring the Social Impact of the AIDS Epidemic. That epidemic is fascinating, as the rulebook was essentially thrown out of the window in the mad dash for a cure, and there was essentially a patient mutiny. There was incredible progress and innovation, but there were also terrible mistakes. There were cul-de-sacs and snake oil, and less fortunate, poorer people did not get access to the right treatments. The financial costs were enormous, and the political pressure and risk tolerance were probably unrepeatable. I think we should try to learn the lessons of that episode.

I am very grateful for a briefing from Professor Derek Alderson, president of the Royal College of Surgeons, who talked me through its recent Commission on the Future of Surgery. Its report speaks about the rising use of medical devices and the urgent need for a unified national medical devices registry to make it easier to keep track of what products are on the market and to measure performance and issues. I instinctively lean away from new regulations and registers, and I am aware of the #WeAreNotWaiting movement, which some noble Lords may have followed. However, given recent experiences, which have been spoken about so touchingly by Members of this House, including the noble Lord, Lord Hunt, and the noble Baroness, Lady Cumberlege, it would be wise to support this measure. I was utterly persuaded by his argument, and I urge the Minister to move forward on these recommendations, as indicated in the words of Jackie Doyle-Price in another place earlier this month.

By way of conclusion, I want to make the case to the Minister for an energetic approach to medicine development and data generation that allows for early and progressive patient access to medicine. The European Parliament has handily called this “adaptive pathways”. For me, that phrase encapsulates a really good mixture of three essential ingredients: a thorough, data-driven approach to evaluation; a compassionate attitude to the natural human desire for cures; and a pragmatic recognition that patient feedback is an essential component of the research process. I am excited by the results of the European Medicines Agency pilot and by the UK’s accelerated access review, but my heart sank when I read about the slow pace of change. I urge the Minister to exert her considerable persuasive powers to put a red-hot fire under this process.

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My Lords, I thank the noble Lord, Lord O’Shaughnessy, for tabling this debate and for his continuing interest in the issue. As a relatively new Member, I welcome the noble Lord, Lord Carrington, and congratulate him on his maiden speech.

To confirm how important this debate is, I note that the Medicines and Healthcare products Regulatory Agency has issued three medical device alerts during February—for a pacemaker, an ophthalmic implant and an orthopaedic implant. This has to give us cause for concern. The helpful briefing paper from the Royal College of Surgeons points out:

“The vast majority of medical devices are manufactured and used to high standards”.

However, it goes on:

“Gaps within the current regulatory process … could be putting patients at risk of serious complications and harm”.

One of the examples the royal college gives is of transvaginal mesh implants. I am pleased that, over the past few years, this issue has been taken more seriously. There was a debate in the other place recently, and Members there reported the harrowing experiences of their constituents. Most importantly, the review of the noble Baroness, Lady Cumberlege, will include this issue and I am pleased to see that she will make a return visit to Glasgow later this year. Her comments today were both moving and reassuring for the future.

Last year in Scotland, a woman who died of multiple organ failure was reported to be the first Scottish woman to have had a mesh implant listed as an antecedent cause of death. For a long time, Scottish women who were experiencing debilitating symptoms following mesh implants felt they were not being listened to or even, in some cases, believed. Women made multiple visits to their GPs, taking time off work or giving up work altogether. Many were becoming more disabled and some needed wheelchairs. Women felt that the lack of treatment, continual pain and, for some, the attitude of doctors caused stress and anxiety, which often led to depression.

These women set up a campaign in Scotland, Hear Our Voice, and took the issue to the petitions committee of the Scottish Parliament. From that, a Scottish independent review was established. The review’s final report was, however, not without controversy. Two of the women who had experienced mesh implant surgery resigned before it was published, because they felt it had been watered down from the draft version. It was a real pity that women who had brought the issue to public, media and political notice then felt let down by the final publication.

The Scottish review made the following recommendations: mesh should not be offered routinely to women with prolapse; reporting of all procedures and adverse events should be mandatory; extra steps should ensure that patients have access to clear, understandable advice to help them make informed choices; all appropriate treatment should be available, subject to informed choice and assessment; there should be improved training for clinical teams; and there should be improved research into the safety and effectiveness of the products. How often do patients have to campaign, sometimes for years, to have their concerns addressed? In the meantime, they are often dismissed by so-called experts as overreacting.

We must be able to have confidence in the independence of research. Just this year, a senior medical consultant and researcher acknowledged that he failed to declare £100,000 received from the manufacturer of a type of vaginal mesh implant that he assessed. There is no evidence that his study was influenced by the support he received but it has added to concerns about the lack of transparency from the manufacturing companies.

Obviously, mesh implants are not the only area of concern; breast implants and hip replacements have also had their problems. The Royal College of Surgeons makes the point that, in contrast to drugs, many surgical innovations are introduced without clinical trials or centrally held data. This has resulted in a lack of information and often a considerable time delay in giving a diagnosis, leaving women experiencing chronic pain and sometimes inappropriate treatment.

Women were not given clear information about the risks involved, so they could not have given adequately informed consent. How could the surgeons have provided that information when they did not have the details of clinical trials? Can the Minister assure us that, for the future, will there be more effective clinical trials and faster and more effective action when adverse reactions are reported, and that the people affected will be given sufficient financial compensation, along the lines mentioned by my noble friend Lord Brennan, so as to take at least one worry off their shoulders?

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My Lords, I join others in congratulating my noble friend Lord Carrington on his very well-judged maiden speech today.

In this welcome debate, my remarks will centre on Primodos—an issue I raised with the noble Lord, Lord O’Shaughnessy, while he was a Minister. Like the noble Lord, I pay tribute to Marie Lyon, who chairs the Association for Children Damaged by Hormone Pregnancy Tests. Assiduously and tenaciously, she has fought for justice for those whom big pharmaceuticals have often treated with irresponsible contempt. She and her husband have travelled down from Wigan today and are watching our debate.

Marie Lyon wishes me to thank the noble Baroness, Lady Cumberlege, and the Independent Medicines and Medical Devices Safety Review for taking the campaigners seriously. She tells me:

“The sensitivity shown to our members by the”,

review,

“team is appreciated and commended. I really do feel that”,

they and,

“Baroness Cumberlege … are committed to discovering the truth about the failures of the Drug Company and the Government Regulators and have a genuine desire to ensure justice is served”.

I add my own thanks to the noble Lord, Lord O’Shaughnessy, for his role in encouraging the establishment of the independent review, and I wholly endorse what he said earlier about the desirability of creating a national office for patient safety.

My interest in Primodos began in 2010, when a gentleman born with severe birth defects asked to see me at my university office in Liverpool. He believed that his disabilities were attributable to Primodos, a hormone-based pregnancy test first marketed in the UK in 1959 and produced by Schering AG, which was subsequently taken over by Bayer AG. Withdrawn from sale in the United Kingdom in 1978, tellingly it was also used in South Korea to abort the child in the womb.

Dr Isabel Gal’s 1960 research at Queen Mary’s Hospital for Children demonstrated a link between the drug and severe birth defects, and a review by the Committee on Safety of Medicines concluded that pregnant women should not use it. However, subsequent court cases failed to provide a conclusive outcome, as did a 2014 review by the Medicines and Healthcare products Regulatory Agency.

On 26 October 2010, I asked the Government several Questions. One was about the dosage of the constituents of Primodos; one asked for any documents that the Government held about its dangers to be placed in the Library; one was about the nature of the disabilities; one was about the help given to those affected; and one requested Ministers to meet the Association for Children Damaged by Hormone Pregnancy Tests.

In his reply at the time, the noble Earl, Lord Howe, said that the regulatory agency had no information on the number of children who are born with disabilities, nor did it have evidence. If there was no evidence, why did they ban the drug? As for meeting the victims:

“The MHRA therefore has no current plans to meet members of the Association for Children Damaged by Hormone Pregnancy Tests, people suspected to have been adversely affected by the drug Primodos, or with the pharmaceutical company, Bayer”.—[Official Report, 26/10/10; col. WA 265.]

Despite further letters and Questions, a 2017 report of an expert working group of the UK Commission on Human Medicines continued to state that there was no causal association. Yet in that same year, Sky News broadcast “The Secret Drug Scandal”, which found that evidence of an association had been destroyed by a UK regulator in the 1970s. I asked the Government for their response and,

“whether they will consider establishing a public inquiry into the alleged failure of the regulator at that time to protect public safety”.

In another Question, I asked whether they would examine why,

“no toxicology or testing was undertaken prior to the drug Primodos being licensed”,

and whether they were aware that,

“Primodos was being used as an abortifacient in some parts of the world whilst being sold in the UK for the purposes of pregnancy testing, and … that there may have been collusion between the drug manufacturer and the regulatory bodies”.

In another, I asked why Primodos had stayed on the market and no tests had been,

“ordered by the Committee for the Safety of Medicines under the Medicines Act 1971”.

In another, I asked them to,

“meet with Marie Lyon and representatives of the Primodos victims support group”,

and in another, asked why they were not funding research in Aberdeen and Cambridge examining the,

“likely effects on the child in the womb”.

Then, in February 2018, the right honourable Jeremy Hunt announced his welcome review to be led by the noble Baroness, Lady Cumberlege. I hope that when the Minister replies, she will tell us when it is likely to report and—perhaps more importantly—who will be responsible for taking forward its recommendations. Among other things, as we heard from the noble Baroness, the review will investigate any association between hormone pregnancy tests and their teratogenic effects, and whether the regulatory bodies could, and should, have acted on concerns sooner—and if they did not, why.

Meanwhile, a team at Oxford, led by Professor Carl Heneghan, the scientist responsible for identifying Thalidomide association, has discovered that pooled data show “a clear association” with several forms of malformation. Professor Neil Vargesson has carried out other work on zebrafish, which revealed anomalies that mirrored the adverse effects on victims of Primodos. Their studies were peer-reviewed and remain in the top percentile of scientific studies.

In the House of Commons, the Prime Minister said:

“Ministers are aware of the new study that has come out … and … that study will be looked at very carefully”.—[Official Report, Commons, 16/1/19; col. 1160.]

I welcome that. However, the raw data that Professor Heneghan needs to complete his review has not been made available. The All-Party Parliamentary Group on Hormone Pregnancy Tests, chaired by Yasmin Qureshi MP, and of which I am vice-chairman, has sent a freedom of information request for the data, but to date has not received a response.

Mrs Lyon has twice emailed the Medicines and Healthcare products Regulatory Agency, but has not received a response. I gave the Minister notice of my intention to raise this question today. This is tardy and unco-operative on the part of that body. I hope the Minister will be able tell us whether more can be done to take that forward.

Severely disabled children, cared for by family members now in their late 70s, are increasingly becoming the responsibility of their siblings. While their health deteriorates, many battle every day to support themselves. Some have died fighting to the very end to reveal the truth about the failures of the drugs company and the regulatory agencies. They have faced the implacable determination of regulatory bodies spending huge amounts of public money on ad hoc scientific reviews to cast doubt on the work of highly reputable scientists. Those who have suffered so grievously deserve much better than this.

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My Lords, I am very pleased to participate in today’s debate and privileged to have heard the maiden speech of the noble Lord, Lord Carrington, who brings the wealth of knowledge of senior Carringtons to this House. The debate is of great importance to all of us here, and serves as one of the most pressing cautionary tales for what might happen if the other place does not pass the withdrawal agreement that will be coming before it in due course.

The safety of medical devices and medicines is not a present issue in the minds of the electorate and does not get the attention it deserves. Part of this is down to the incredible luck we all have to live in a country with an excellent health service which guarantees consistently strong treatment across all of its hospitals and surgeries, with investment decisions taken after thorough consultation and planning. We are particularly lucky to have a national regulator with great depth of expertise in particular fields of treatment and medicines—from toothpaste to gene therapy. It is a great shame that, post-departure, the likelihood of the MHRA receiving commissions from the EMA will considerably diminish. One-third of the income of the MHRA is linked to EMA funding, and unless government support is guaranteed there is a serious and pressing risk that the MHRA will suffer a loss of income and reputation and an outflow of specialists to other European regulatory agencies, taking a sizeable proportion of the UK’s comparative advantage with them.

This is important, as it underpins investment by pharmaceutical firms in our universities and labs. It is natural that they would be keen to be close to the leading researchers and benefit from their expertise throughout the development process. I therefore ask the Minister to confirm ongoing government support for areas of specialist research traditionally funded by the EMA for the MHRA, such that the UK maintains our lead in the areas in which we excel. If this cannot be guaranteed, will the Minister commit to seeking a close continuation of the existing relationship in the next stage of Brexit talks focusing on the future relationship? I also wish to add my approval of the ongoing Cumberlege review. The NHS is funded out of general taxation to serve the population, and it is of paramount importance that the people’s voices are heard as soon as concerns are raised about medicines or medical devices.

Too often in the past we have relied on clinicians raising concerns with NICE or the MHRA and then letting action be taken, even when there has been a substantial degree of concern in the patient community. A great deal can be learned from the mechanisms enshrined in statute in Section 11 of the Enterprise Act. So-called super-complaints allow representative consumer bodies to make a well-researched complaint about some feature of the market, to which the responsible regulator or a Minister must respond within a given timeframe. The principle was extended to financial markets by the Financial Services and Markets Act 2000, and the mechanism operating via both of these statutes has been endorsed by consumers and industry alike as an effective means of ensuring accountability and maintaining high standards. I know, of course, that the yellow card scheme operates in a similar way, but there is no guarantee of a fast-track process for responsible nominated groups operating on behalf of consumers. Having had the advantage of reading some of the submissions made to the review online, I have been impressed with the quality of submissions made to the group and I therefore think that they should be given super-complaint powers.

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My Lords, like others I congratulate the noble Lord, Lord O’Shaughnessy, on securing this debate, and welcome the illuminating contribution from my noble friend Lord Carrington in his maiden speech.

I will focus in this debate on the role of the National Institute for Health and Care Excellence, which is building on its 20 years of experience, and will look forward to what needs to be done. I declare that I am vice-chair of a guideline review group on ME and chronic fatigue syndrome, a review that was precipitated by patient voices and has good patient representation on it. I should also declare that my husband has done a great deal of work on patient and family-reported outcome measures, which may be relevant here.

NICE guidance covers, as we all know, the safety and efficacy of interventional procedures and the managing of specific conditions and medicines in different settings. Its technology appraisals of new pharmaceutical and biopharmaceutical products, procedures, devices and diagnostic agents are recognised around the world. Any device under consideration must have a valid and current certification, which comes from the EU at the moment, and be registered with the Medicines and Healthcare products Regulatory Agency. But the EU certification process itself seems at times to be flawed.

NICE has now gone into formal partnership with the MHRA to try to share intelligence and understanding, and to monitor key issues. However, adverse event reporting is a major problem for them in this work because it relies on clinicians notifying such events, as through the yellow card scheme. As with any voluntary reporting system, reporting is incomplete—sometimes woefully so. There is an inherent bias to report the positive benefits of interventions in research papers and underreport adverse effects. There were 62,000 adverse incidents reported over the last three years, a third of which had serious repercussions. However, this is only a small number compared with those that have happened across Europe.

In recognition of this, NICE rigorously reviews its current guidelines and seeks the sources of adverse events. Unfortunately, safety outcomes are poorly addressed in randomised trials; large numbers of treated patients are needed to reliably detect uncommon yet serious events from sources such as large case series, surveys, registers and individual case reports. Sometimes unpublished evidence is the sole source of such information. There are databases, including the US Food and Drug Administration’s manufacturer and user facility device experience database, called MAUDE. Importantly, this is available to the public and is used by sources in this country.

It is essential that safety information and evidence of harm are collected and rapidly disseminated. NICE’s medicine awareness service, with its network of prescribing associates and monthly digest of important new evidence in medicine, aims to reach out widely. But it must be strengthened, and it must have a database to draw on.

Changes to NHS structures in recent years have made dissemination more difficult because responsibility for the implementation of such guidance does not fall to any single body—hence NICE’s agreement with the four nations, a document on safely introducing new procedures. But we need to do much more to strengthen this. All NHS providers should ensure their governance structures require reporting of outcomes, including adverse events, as well as dissemination of information. Clinicians undertaking any interventional procedure, and the suppliers of devices and equipment, should be routinely asked whether any complications have arisen in the short or longer term rather than just leaving it up to them to decide whether such complications are serious enough to report. Patients must be asked too.

All this data can be entered on a mandatory relevant national register, maintained to a sufficiently high standard to deliver evidence to clinicians for decision-making and for informed funding decisions. The quality of registers at the moment seems to be disappointingly variable. Without efficacy and safety information, problems will continue to go undetected and unpublicised.

I turn briefly to another aspect of the control of medical equipment, which is the problem of purchasing. The review by the noble Lord, Lord Carter, highlighted the wastage of duplication and variable pricing—but price is not the only determinant. I will relate a simple problem that concerns syringes. The bulk buying of cheaper syringes seemed to be a good idea. However, they had to be discarded because the plunger was loose-fitting, which meant that, on injection, the contents of the syringe were bypassed and we did not know how much of the drug had been injected into the patient. Contracting had to revert rapidly to a previous, reliable supplier.

Many pieces of tubing, wiring, cannulae et cetera are used every day in clinical practice. They must be of the highest standard and must not break or fracture inside a patient, because major surgery might be required to remove them. I suggest that the light-touch regulation that we have had in the EU should be replaced by a tighter, more rigorous system, so that things are manufactured to a higher standard and we know where the components have come from.

In the last moments of my speech, I remind the House of a speech by Baroness Jowell, to which the noble Lord, Lord O’Shaughnessy, also referred in his opening remarks. She was inspiring on 25 January last year when she called for adaptive clinical trials and the right of patients to try novel therapies. The parents of Charlie Gard, who had type 2 mitochondrial DNA depletion syndrome, wanted him to try nucleoside therapy, which had been tested on type 1 but not type 2 of the condition. The drug would have been taken orally and dissolved in milk—with the only known side-effect being diarrhoea—at an estimated cost of around £5,000. Charlie died before his first birthday, having been denied the possibility of trying this, and his parents, with whom I have had several conversations, live in their bereavement with the haunting thought, “If only we could have tried it”.

In her speech calling for a new approach to novel therapies, Baroness Jowell said:

“It is about the power of kindness, support for carers, better-informed judgments by patients and doctors, and sharing access across more and better data to develop better treatments”.—[Official Report, 25/1/18; col. 1169.]

Sometimes we must allow people to take risks for the benefits of others, because data is critical. Safety sometimes means that we have to allow carefully assessed risks rather than resort to inactivity, so that we can develop new evaluation processes.

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My Lords, it is a great pleasure to follow the noble Baroness, Lady Finlay of Llandaff; and, while listening to her guidance today, also to recall her enormous contribution to better health standards, made both inside and outside Parliament, not least in her capacity as a past president of the Royal Society of Medicine.

Intervening between Committee and Report on the Healthcare (International Arrangements) Bill, this debate comes at a useful moment. I join others in thanking my noble friend Lord O’Shaughnessy for introducing it. I congratulate the noble Lord, Lord Carrington, on an extremely interesting and well-informed maiden speech.

On the approved safety of medicines and medical devices, I will comment briefly on three aspects: current risks to the United Kingdom following Brexit; necessary expedients to help contain these risks; and, to raise medical safety levels both at home and overseas, initiatives and directions that the UK should pursue in any case.

Several adverse consequences appear to be threatened by Brexit. A recent government impact assessment already concedes that firms will be subjected to further costs arising from duplicate authorisations from the two regulatory bodies, the MHRA and the EMA. These extra costs in turn are also deemed to prevent or delay the availability of certain medicines in the UK.

Then the British Medical Association identifies an erosion of safety standards. That follows if the United Kingdom should fail to negotiate a withdrawal agreement next month. For, as alleged, much of what is now developed for the UK market would then go elsewhere instead, thus undermining the UK’s present access to new medicines; as well as setting back its own industries which produce medicines and medical devices. Additionally, it would become far more difficult for the UK and the EU together to supervise and monitor as competently as they now do. Safety standards would deteriorate as a result.

To seek to redress those unwelcome outcomes, the BMA offers sound advice. This calls for United Kingdom licensing to be consistent with that of the EMA, for a formal agreement between the MHRA and the EMA—a point also made by the noble Lord, Lord Carrington—so that they work closely together over medicine approvals, and for mutual recognition of medical device criteria.

Can the Minister endorse these recommendations? If so, that would give comfort to many who harbour misgivings, such not least deriving from a recent government Statement, which avoids mention of specific post-Brexit measures to uphold standards. Instead, it only comments rather vaguely that the UK and the EU would,

“explore the possibility of cooperation of United Kingdom authorities with”,

EU agencies,

“such as the European Medicines Agency”.

Post Brexit, to enhance medical safety at home and overseas, there are perhaps two relevant and parallel routes: that to be taken by the UK together with the EMA, and that to be directly followed here, thus in any case also benefiting the United Kingdom along with other countries internationally. The Royal College of Surgeons warns that the regulatory system across Europe is insufficiently thorough. Device manufacturers can quite easily shop around notified bodies in various countries until their own product receives approval. Therefore, the RCS advises that all new surgical procedures should be registered, with related data collected within relevant national audits before they are given to patients. Wisely too, the RCS urges the use of barcodes so that anything which might develop a fault in future can be traced to identify when it was used and by which surgeon.

Among various expedients to reduce other deficiencies, does my noble friend the Minister agree that here are two which the MHRA and the EMA together should be encouraged to deploy, and that the Government ought now to give that clear message pre Brexit and straightaway?

The EMA is to be congratulated on its launch of an adapted approach to clinical trials. By augmenting transparency of information its new provision, called the clinical trial regulation, will assist collaboration, information-sharing and decision-making between and within member states. However, the MHRA observes that this measure will not be enforced before the UK leaves the EU. In view of that, can the Minister assure us that the UK will definitely be part of this valuable scheme, nevertheless?

Several UK initiatives already stand to promote medical safety levels. Following much better data technology, the Royal College of General Practitioners correctly draws attention to the opportunity for simplification. To predictable advantage, a whole host of medical databases could be connected together. Equally, and where in the first place based on notes from doctors, reporting drug safety issues would become much more efficient whenever multiple systems are replaced by a single one.

To reflect a theme touched upon by my noble friend Lord O’Shaughnessy, so-called adaptive pathways, already alluded to by my noble friend Lord Bethell, represent the notion of bringing some new medicines to market more quickly than would normally happen otherwise—initially only for those in urgent need, yet where afterwards their results can supplement clinical trials all the same. On the preparedness in general to learn from medical errors and near mistakes, to which my noble friend Lady Cumberlege referred, there may now be, if perhaps belatedly so, a growing realisation that thereby not only will patients receive better treatment but vast sums of money can be saved.

All these are hopeful developments within the UK. However, what is needed is a pulling together of their different strands; and, not least, a proper attempt by the Government to achieve such co-ordination. A draft Bill to try to achieve this started in 2017, but that good intention may have drifted into the sands a bit, with a recent government comment that they will bring forward legislation when parliamentary time allows.

Does my noble friend concur that the introduction of such legislation, or, at any rate, an unequivocal commitment by the Government now, well before Brexit, to help promote essential co-ordination, as outlined, would be of considerable relevance and comfort to all concerned?

If also somewhat belatedly, at least there is too a new willingness to pay proper attention to feedback from patients about medical safety and its perceived inadequacies: a priority implied by the noble Lord, Lord Hunt of Kings Heath, the noble Baroness, Lady Masham of Ilton, and others. As a result, every NHS trust may be expected to appoint a patient safety director at senior level. Be that as it may, a final version of the strategy will not be published for another few weeks. Meanwhile, can the Minister assure us that the Government will give full backing to the proposal so it can still be expedited in the first part of 2019 without unnecessary delay?

In summary, my Lords, medical safety standards have to depend on solid and determined teamwork. To date, the Government may have been too laissez-faire. Instead, as necessary and to a far greater extent, they should now take a much firmer lead in assisting proper co-ordination, to the mutual advantage of all, both here and elsewhere.

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My Lords, the safety of medicines and medical devices is a cause in which we are all invested. I join others in thanking the noble Lord, Lord O’Shaughnessy, for instigating this debate and for his excellent opening speech. I was particularly interested in his account of treatment of cancer in the brain in Birmingham—my brother-in-law is an in-patient there as we speak.

In a context where important pharmaceutical and technical advances are being made, ongoing work must be undertaken to ensure that patient safety is never compromised. I am encouraged by some steps that the Government are taking, such as the independent medicines and medical devices safety review.

There are two key ways to keep people safe. The Government must improve regulatory oversight, and must advocate listening to and responding promptly to patients experiencing adverse effects from unsafe medication or devices. Many noble Lords will have received correspondence about the devastation caused by sodium valproate and the awful effect it has had on babies, now disabled adults. Their mothers took the drug while pregnant. Will the Minister hold a briefing session for interested Peers to update us on progress with that—perhaps when we have finished all the health legislation currently coming down the track? That would be hugely helpful.

The impact of Brexit on medicines and medical device safety has already been covered well by other noble Lords, so I will not spend too much time on the topic. I am worried, however, by the expertise we have lost through the relocation of hundreds of staff of the European Medicines Agency to its new headquarters in Amsterdam.

I note that numerous drug safety reports, and reports of suspected adverse reactions to drugs, previously submitted at the EU level will instead be submitted to the MHRA. I echo the concern of the BMA, which has warned about skills gaps in pharmacovigilance. Can the Minister confirm that there is a recruitment drive to ensure that the MHRA is sufficiently staffed to consider the broad range of medicines and medical devices that require scrutiny in the UK? Moreover, what are the Government doing to ensure that the relationship between the EMA and the MHRA remains strong and convergent post Brexit? Will the Government make stronger assurances than the text of the political declaration that accompanied the withdrawal agreement, which states only that the UK and the EU will,

“explore the possibility of cooperation”,

after the transition period? That is simply not good enough. A weak relationship could harm patients and stifle progress. I look to the Minister for assurance that she is aware of this and taking action.

I am pleased to note the work of the independent medicines and medical devices safety review currently under way, looking into how concerns about surgical mesh were handled, and the devastating effects of Primodos and sodium valproate. A lot of insightful evidence has been submitted so far. The noble Baroness, Lady Cumberlege, is investigating whether the NHS harbours enough of a listening culture. The Epilepsy Society raised this issue in its evidence. In the case of surgical mesh, it seems that there was a degree of gender bias, meaning that women’s pain was not taken seriously. My right honourable friend Norman Lamb MP was vocal on the subject of mesh implants, highlighting the years of life-altering pain experienced by affected women, compounded by the emotional trauma of not being listened to and believed. On the back of all that, he set up the APPG. With the review now one year old, does the Minister know whether affected patients finally feel listened to? The review’s impact must be wide-ranging; it should complement work happening upstream to improve review processes.

Several organisations, including the Royal College of Surgeons, have called for tighter regulation and oversight of devices. Looking forward, new devices may be more complex than those of old but, contrarily, some devices may become simpler. Both require vigorous testing. More importantly, we must build ever more comprehensive mechanisms for both regulation and patient feedback. These systems must speak to each other to ensure that every new medicine and medical device is safe for patients. Technology has a role to play in linking patient experiences with unsafe medicines and medical devices in a clear pattern. Just as John Snow—not that Jon Snow—related the spread of cholera to a single water pump, so we see now, through work to analyse multiple databases on patient and drug experiences, that symptoms can be traced to an inappropriate medicine or a faulty medical device. This is an expanding area of work that must be monitored.

The noble Baroness, Lady Masham, mentioned sepsis. A few weeks ago, the noble Lord, Lord Grade of Yarmouth, told the House about the benefits of a national sepsis register. For medicine safety, the Royal College of General Practitioners has recommended a single system, with some similarities for reporting drug safety issues, which would be linked to GP notes. Will the Government consider this, while being mindful of data privacy? Perhaps it could be cross-referenced with the yellow card scheme, providing a stronger pool of data from which to draw conclusions. Multiple health sector experts, including pharmaceutical companies and health professionals, advocate strengthening knowledge of and access to the yellow card scheme.

Training health workers is a key way to keep patients safe—if the Government will provide funding. This could include broader “driving licence” training for the safe use of particular pieces of medical equipment, as well as the training of other health professionals. An obvious but important example is community pharmacists. We all agree that they play a key role in medical safety, for instance through medicine use reviews, new medicines services and keeping a look out for customers buying strong over-the-counter medications, or who appear to be suffering adverse side effects.

In conclusion, the debate has been excellent. I congratulate the noble Lord, Lord Carrington, on an outstanding maiden speech, and I thank the noble Lord, Lord O’Shaughnessy, for introducing the debate. I look forward to the Minister’s response.

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My Lords, I congratulate the noble Lord, Lord O’Shaughnessy, on initiating this important debate—which, of course, a few weeks ago he would have been answering himself. I declare my interests, which are in the register: my long association with the British Healthcare Trades Association and as a lay member of a clinical commissioning group. I also congratulate the noble Lord, Lord Carrington, on his spirited maiden speech and welcome him to the House. I thank all the organisations which have sent us briefings on this issue, and indeed our own Library. They have been very helpful indeed.

While my sympathies are totally with the mesh campaign, I am not going to refer to it because several noble Lords have spoken about it with enormous passion. My heart is with them but I am going to talk about other issues. In that regard I particularly welcome the contributions of my noble friends Lady Bryan and Lord Hunt. The House is aware that these matters are close to the heart of the noble Lord, Lord O’Shaughnessy, and his record of taking action to deal with issues of safety is to be commended, including the establishment of the commission of inquiry which is being chaired and led so wonderfully by his noble friend Lady Cumberlege. She has given us an up-to-date briefing and, indeed, enormous cause for hope.

This is a good time to reflect on the infrastructure that safeguards the introduction of medicines and devices into the UK as Brexit looms. The noble Earl spoke knowledgeably about this and I am grateful to him for his remarks. Like other noble Lords, I believe that we have a legislative and regulatory structure in the UK which is designed to protect patients and which has been material to the development of Europe-wide regulation from which we have all benefited. Several noble Lords have suggested that it is creaky, which I think is right, and that it has to keep up. That sentiment was well expressed by the noble Baroness, Lady Masham. Following a question posed not so long ago by the noble Baroness, Lady Walmsley, about the protection of patients from counterfeit medicines after the UK has left the EU, it was quite clear from the briefings that arrived in my mailbox that the UK pharmaceutical and biotechnology industry and organisations such as the Association of the British Pharmaceutical Industry and the UK BioIndustry Association are warning that leaving the EU without a deal would increase the risk of counterfeit medicines entering both the UK and EU supply chains.

The first issue that I would like to raise with the Minister is this. She will know that the falsified medicines directive—FMD—was published on 1 July 2011 and the legislation became effective on 8 February this year. It introduces tougher rules to ensure that medicines are safe and that the trade in medicines is rigorously controlled. This directive is being introduced to tackle the counterfeit high-price medicines that are a threat to public health worldwide. Does the Minister agree that a no-deal Brexit is likely to see the UK’s access to EU databases revoked, including the European Medicines Verification System, which is the heart of EU-wide compliance with the falsified medicines directive? Those proposals also present a risk to UK patients as unilaterally revoking FMD legislation in the UK would make the country a target for counterfeiters. Both the bodies involved in this area are very concerned indeed. Post Brexit we need to be assured that keeping fake or fraudulent medicines out of our supply chain is an absolute priority.

In this context, three things are important: making specific reference to the importance of co-operating on the regulation of medicines in the political declaration; making it clear that the UK and the EU will co-operate on protecting citizens from infectious disease and counterfeit medicines; and making it clear that the UK and the EU will agree closer collaboration on science and innovation.

The second issue I wish to raise stems from my support over many years for the British Healthcare Trades Association, which, having been founded in 1917, is one of the UK’s oldest and largest healthcare associations. My connection with the association arises partly because many years ago I met stoma nurses and discussed with them the work they do. I had conversations with them about the design and importance of support for stoma patients. Those conversations led to me getting to know the BHTA and realising that a lot of the devices, innovation and design we have in this country rest with small and medium-sized enterprises, which need our support. The BHTA provides them with the controls and regulatory framework that are so important in their relationship with the NHS and individuals. It deals with class 1 and some class 2 devices.

I also want to ask the Minister about the suppliers of other equipment and devices. The wide availability of medical devices from places such as Argos and through Amazon, and the purchase of apps and other monitoring devices, concern me greatly. Last summer I was sent copies of an Argos leaflet, available in a GP surgery outside London, advertising a whole range of equipment, including monitoring devices available in its stores. There was no suggestion in any of these leaflets that it might be a good idea to get professional advice before forking out on these items. We would want a physio to assess us before using walking aids—sticks and rollators—and to be measured up to make sure that we get the correct ones. A shower stool could be dangerous if you had Parkinson’s or a one-sided weakness or found it hard to stand. You would need an occupational therapist to work out whether you needed a chair with a back or with arms.

While we wish people to take responsibility for preventive care and self-care, and monitoring your own health and progress is to be encouraged, effective self-help is a complex thing. It requires ongoing education and support from health and social care workers. Done well, it is fantastic. I ask the Minister her view of the ease with which people can buy medicines and devices, either online or in places such as Argos. For example, is there any research to inform issues of patient safety, knowledge, usage or whether there are enhanced outcomes in terms of prevention or well-being?

Thirdly, I will briefly mention access to new devices for diabetics. Technology plays a key role in diabetes care, particularly for people with type 1 diabetes but also for people with type 2. Over the last few decades new technologies have transformed that. However, it is a postcode lottery. I ask the Minister: what are the Government doing to ensure that there is fair distribution and access to these very important technologies?

Finally, I think I need to ask the Minister about a recent leak concerning the NHS app, which is designed to be a digital front door, and the fact that it would appear it is not able to connect with any other providers of online GP consultations. The leaked NHS Digital briefing shows that a survey of 32 online consultation suppliers, such as LIVI and Babylon Health, found that none of the technology was able to integrate with the NHS app. This is quite a serious matter, because the NHS Long Term Plan commits to building the app into a single digital front door for patients to,

“provide advice, check symptoms and connect people with healthcare professionals—including through telephone and video consultations”—

all brilliant stuff. This is a serious issue of patient safety. I would like assurance from the Minister, given that she, her predecessor—the noble Lord, Lord O’Shaughnessy—and their boss have embraced this technology with such huge enthusiasm. I hope we are not heading into another technological black hole.

I congratulate all noble Lords on their contributions. This has been an absolutely excellent debate, one that I hope will provide support for those people campaigning on a variety of very important issues around patient safety, and will take the debate forward.

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My Lords, I congratulate my noble friend Lord O’Shaughnessy on securing this debate and on what I know was a very personal commitment to this subject when he was Minister. I also congratulate the noble Lord, Lord Carrington, on a truly excellent maiden speech. We all recognise the significant contribution to the United Kingdom’s public life by his father, the late Lord Carrington, but I do not think the current noble Lord, Lord Carrington, will have any trouble following in his footsteps.

Indeed, I thank all noble Lords who contributed today. It has been a thoughtful and sobering debate on a really important subject. We should be proud of the world-leading role that UK researchers, clinicians, industry and regulators play in medical discovery and innovative treatment. We are the first country to introduce whole-genome sequencing to routine clinical care, the first in the world to approve Kymriah and the first in Europe to approve CAR T-cell therapy. As the noble Baroness, Lady Masham, rightly said, that is so important for patients with rare or hard-to-treat conditions, because it raises the hope of earlier diagnosis and more targeted treatments. That is at the heart of many of the measures in the long-term plan and the life sciences strategy, which is directed at improving the capacity of our life sciences industry and the NHS to improve the quality of care for patients.

As many noble Lords eloquently pointed out, medical innovation flourishes only on a firm foundation of clear and effective regulation and informed consent. That is not only about patient safety but about giving certainty to researchers and innovations. The noble Baroness, Lady Finlay, and my noble friend Lord Bethell movingly reminded us that there is an innate tension in the need to drive forward the frontiers of medical innovation to offer hope to those with rare and hard-to-treat conditions—perhaps it is appropriate that today is Rare Disease Day. But there is also the need in a complex and universal system such as the NHS to have effective and agile safety and consent systems. However, in that context, it is never an excuse for a patient’s voice not to be heard loudly, quickly and effectively when things go wrong and we must never tolerate any form of gender bias, as the noble Baroness, Lady Jolly, said.

We heard today of some of the successes and strengths of our current systems of regulation for both medicines and medical devices, but we also heard about instances where our regulatory and wider systems could go further. I pay tribute to all those patients, some of whom are here today, who have shared their experiences and have gone on with a resolute determination to campaign for change for themselves and on behalf of others, including groups that my predecessor met and worked hard with, such as INFACT and Sling the Mesh. Many of them have met Ministers and Members of this House and have, with great bravery, told their stories, many of which are heartbreaking for them and their families. To them I say: thank you for your courage and dignity. Please know that your voices are heard not only here today but across government and across the system.

Noble Lords have already debated many aspects of the role of the MHRA to be responsible for the regulatory compliance of medicines and devices. As noble Lords will be aware, no medicine or medical device is entirely risk-free. The possibility of a patient suffering an adverse reaction or incident, although limited, can never be eliminated. That is why the MHRA has powers to take action, including removing products and devices from the market or resisting their use if the risk and benefit profile changes as new evidence emerges. We need to ensure that we are capturing that evidence most effectively.

Recent examples of where the MHRA has made use of those powers include recalling some sartan medicines for high blood pressure and issuing new temporary measures for the uterine fibroid drug Esmya. The MHRA also initiated EU action on valproate and will continue to consider what further restrictions are needed to ensure that valproate is not used in pregnancy. I will return to that in more detail a little later.

The noble Baroness, Lady Finlay, is absolutely right that the MHRA and NICE are indeed working more and more closely together on these matters. I have heard her and others’ points about the use of registries to capture evidence more effectively. We need to consider how that would interact with local care health records, however, and whether they are the most appropriate place to capture that information. I will take that point away and consider it carefully.

I particularly thank my noble friend Lord Bethell for his truly eloquent account. I appreciate his impatience for progress on this matter, so I would like to focus for a moment on the system for regulating devices. As the House is aware, medical devices are not brought to the market in the same way as medicines. The regulation of medical devices is instead governed by three EU directives as part of the pan-EU system of conformity assessment, a system that sets out standards for pre and post-market assessment of medical devices, including categories of device and the role of notified bodies and the MHRA.

However, there is no direct authorisation of devices for the UK or EU markets conducted by the MHRA. Medical devices and the wider medical technology sector form an area of very fast technological innovation, as the noble Baroness, Lady Thornton, pointed out. This means that devices are routinely improved and replaced as technology is developed, with a view to improving patient safety and experiences. It also means that there are comparative limitations on the amount of pre-market assessment that can be conducted for devices—unlike for medicines—given that the evidence of their actual use by patients is critical to the overall assessment of their efficacy. This is why manufacturers, notified bodies and the MHRA conduct ongoing post-market surveillance and vigilance to respond to information about the safety of devices when in use, and take appropriate regulatory action to improve them. This includes issuing medical device alerts to the healthcare service and the restricting and recalling of products. The publication of more data and patient feedback is an evolving process, as more experience is gained from the use of medical devices.

While the overall system seeks to establish a balance between continuous innovation in medical technologies and patient safety, I fully accept that it is not easy to achieve. By its nature, the regulation of innovative sectors must respond with continuous improvement, while the sectors’ systems and processes need to be continuously reviewed in the interests of patient safety. This is something that I know the MHRA and others take seriously, and to which I am personally committed. It is why the UK has played a role in arguing for change at European level in recent years, and why the Government intend to fully align the UK with the new EU medical devices regulations and in vitro diagnostic medical devices regulations, which my noble friend Lord Dundee mentioned. We will do this even though we are leaving the EU institutions because we are confident that doing so will drive system-wide improvement, including to the levels of clinical data that are mandated before products can be placed on the market, the scrutiny placed on notified bodies, the level of post-market surveillance conducted and the traceability of medical devices. We think this will improve the safety of medical devices.

This approach will establish a stronger and improved baseline for any future system change that we implement after our departure from the European Union. We will proactively ensure that innovative technology and processes are utilised by the UK healthcare system where this can enhance the role of the MHRA, including in relation to data, as well as increasing patient safety and confidence. My noble friend referenced a strong example of this: the Scan4Safety pilot, which was conducted in six trusts. We hope to roll that out across all acute trusts in England. I am a strong supporter of this, given that I announced the pilot in the first place.

Despite these changes, I know that there are still patients who feel that their concerns or experiences are not adequately heard or considered by the health system, and that the response has not been agile enough. It is an essential principle of patient safety that the regulatory environment gives sufficient voice to concerns reported by patients, families and campaigners, and that it works alongside them to respond in a rapid, open and compassionate way to resolve issues. I offer my firm assurance now that, as a department, we will be neither complacent in our success nor ignorant of the possible opportunities to improve. Just as the landscape of medicines and medical devices is ever-changing, so too must be the regulatory frameworks in which they are marketed, monitored and used within our healthcare system.

It is this commitment to evolve and ensure that the patient voice is central to our healthcare system that led to the Independent Medicines and Medical Devices Safety Review, chaired by my noble friend Lady Cumberlege and introduced by my noble friend Lord O’Shaughnessy. We have already heard much about it, so I will not go into detail. However, it will be critical to improving our understanding and action on listening to and consulting patients in the UK healthcare system to ensure that informed choices can be made. We expect the review to report later in 2019, with my noble friend Lady Cumberlege’s assistance. As we have heard, I know it has been consulting in a detailed and patient-oriented manner across the UK. I specifically thank my noble friend for her great sensitivity and dedication when listening to patient groups and individuals. I have met her and her team and heard first-hand how she has travelled the country to ensure that those who want their story to be heard have had an opportunity to speak in a sensitive and appropriate environment. She has handled her work with great tact and compassion, and I thank her for all her hard work and dedication.

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Hear, hear!

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Without second-guessing her conclusions, we recognise that we need to look beyond regulation and take a system approach to patient experience, enhancing the culture of improvement and using data to identify and drive required change, as my noble friend Lord O’Shaughnessy and the noble Lord, Lord Hunt, rightly pointed out. As part of this, I note my noble friend’s reference to a new national office of patient safety. That will require much more detailed discussion and consideration in the light of the review’s recommendations, but even at this stage it has much to recommend it.

 I shall move on to some of the specific questions about surgical mesh. There has been a detailed debate about it, so I do not want to repeat what has been said. As the noble Lord, Lord Hunt, pointed out, in July 2018 my noble friend Lady Cumberlege recommended that there should be a pause without delay in the use of surgical mesh for stress urinary incontinence. That was supported by the Chief Medical Officer and senior clinicians. It was implemented through a high-vigilance regime of restricted practice and communicated to NHS England trusts. I understand that a similar process is taking place in Wales. I understand the impatience for a full ban, but for some women this may still be the only option for treatment, so it was considered that, while awaiting the outcome of the review, it was the appropriate route to take. The current findings are that the pause has dramatically reduced the number of procedures while we await the findings of the inquiry by my noble friend Lady Cumberlege. This is being kept under very tight scrutiny.

With reference to my noble friend’s specific question on a properly funded and staffed national network of expert mesh removal centres, I can confirm that NHS England has consulted on a service specification. When it is in place, we expect the service specification will cover multidisciplinary team management and complex vaginal mesh removal surgery for women who have complex complications. We are taking extremely seriously the review’s wider interim recommendations and are taking appropriate action in response. We will fully consider the final recommendations on mesh that the review will make later this year. Our primary objective will be to prevent future recurrence of the pain and appalling distress that patients, such as those who have given evidence to the review, experienced. We want to ensure that lessons are learned from their experience that will help us to protect other patients from any further risk of harm.

 Turning to valproate, I have tremendous sympathy for the families affected by its use. The Government’s priority is to ensure that women are aware of the risks of this medicine. I therefore agree with my noble friend that the Government’s ambition should be to limit in-utero exposure to as close to zero as possible. Our current goal is rapidly to reduce and eliminate pregnancies being exposed to valproate. This is being supported by a formal pregnancy prevention programme and annual specialist review, as well as clear valproate labelling and packaging. There is also a communication and awareness campaign for healthcare professionals and patients. In response to the question asked by the noble Baroness, Lady Walmsley, all pharmacies have been provided with materials and there have been repeated communications. The General Pharmaceutical Council has written to all pharmacists to remind them of their professional responsibility in providing information to women, while the Royal Pharmaceutical Society and pharmacy bodies have been very active in communicating with their membership and in auditing practice. I recognise that there are still concerns about performance, but action is being taken. Patient input and engagement with members of the patient group, INFACT—who I know my noble friend has met many times—have been invaluable in the feedback process. It remains the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure that women are aware of the risks and are on a pregnancy prevention programme.

I note the questions posed by noble Lord, Lord Alton, regarding Primodos. They were quite detailed so, if he will allow, I will come back to him in writing.

I hope I have covered the majority of points raised by my noble friends and others in this House. This has been an important debate and I reassure all noble Lords that, as a Government, we are fully committed to a system of regulation for medicines and medical devices which intelligently provides access to new, innovative and world-leading products to improve the lives of millions of patients—especially those with diseases that are rare and hard to treat—while simultaneously protecting UK patients from harm, and ensuring that patient voices are heard loudly and clearly throughout the system if something does go wrong.

I finish by thanking my noble friend Lord O’Shaughnessy and all noble Lords who have participated in the debate this afternoon. It is clear that we are united in our dedication to learning from the experiences of those who have been courageous in speaking out, and in our commitment to protecting and improving the safety of patients who use medicines and medical devices in the UK. I am sure that, if we work together on this matter, we will see not only better medicines, better support and better care for patients but a safer NHS that is more responsive when it needs to be.

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My Lords, it has been a privilege to be part of what has been a superb, incisive and moving debate. I pay tribute to noble Lords for their varied but always excellent contributions. As my noble friend Lady Cumberlege said, the quality of the debate is, in a way, testament to the courage of those who have been affected by medicines and devices when they go wrong—often, as the noble Lord, Lord Hunt, said, in the face of an unresponsive system. It is to them that we must truly pay tribute.

I thank the noble Lord, Lord Carrington, for his excellent speech. He will have found that he got a warmer welcome than his forebear, which I am sure he appreciates. I am struck by something he said: that patient safety is paramount but must be balanced with innovation; not to give someone a potentially effective treatment is also an issue of safety, because they could be harmed. This is what we have been grappling with today.

I am deeply grateful to my noble friend the Minister for her comprehensive answers, not only to my questions but to all those posed by noble Lords. She is quite right to applaud the UK’s record in innovation. How reassuring it was to hear from her about the importance of patient voices being heard, the commitment to an evolving regulatory system and the deep support for my noble friend Lady Cumberlege’s review. I am particularly pleased that she has been able to discuss the service specification for the network of experts on mesh, the commitment on valproate exposure in pregnancy and the comments on Scan4Safety and other matters. I thank her for all that.

I found the speech of my noble friend Lady Cumberlege particularly moving. She has spent time with hundreds of families who have been affected by these issues, and I know this affects her. She has shown great courage and perseverance. I hope she has been reassured by the broad support that her review received in the debate today; we look forward to it with great anticipation.

Noble Lords have covered all topics today. The noble Baronesses, Lady Walmsley and Lady Jolly, and the noble Lord, Lord Brennan, talked about valproate; the noble Lord, Lord Hunt, the noble Baronesses, Lady Walmsley, Lady Jolly and Lady Bryan, talked about mesh; the noble Lord, Lord Alton, talked about Primodos; and my noble friend Lady Cumberlege talked about all three. Of course, we have covered other topics too. There has been support for and discussion of many policy ideas. I hope my noble friend the Minister will go away with lots of suggestions about things that we could do next.

The mesh network was mentioned by the noble Lord, Lord Hunt, and the noble Baroness, Lady Walmsley; the National Patient Safety Office was supported by the noble Lord, Lord Alton; and device registries were mentioned by the noble Baronesses, Lady Masham and Lady Finlay, and the noble Lord, Lord Bethell. As the noble Baroness, Lady Thornton, said, we also need to think about what this means for self-care, as consumers become increasingly involved in their own healthcare. The importance of data was mentioned, to make sure that treatment is more targeted but also for better reporting and mandatory reporting—as mentioned by the noble Lord, Lord Brennan, the noble Baronesses, Lady Bryan, Lady Finlay and Lady Thornton, and the noble Earl, Lord Dundee.

The critical point was made that regulation must not inhibit innovation—the right to therapy, which the noble Baroness, Lady Finlay, spoke about—which relates to our attitude to risk and our need for a sophisticated system. After all, as the noble Lord, Lord Brennan, pointed out, as our medical knowledge expands, complications will only grow. We will need a different, better and more sophisticated system for dealing with those complications. As the noble Lord, Lord Bethell, and the noble Earl, Lord Dundee, pointed out, that includes having adaptive pathways so that we can take difficult, experimental treatments and make sure that they are properly targeted. We need to do that in common with our partners in the EU and around the world. That is particularly true for rare diseases, an area where the numbers of people are not big enough to do anything significant in one country but where we can really change treatment if we act together. I warmly endorse the intention that we should have a deep and lasting relationship with the EMA after Brexit, because that is for the good and the safety of patients in our country and across the European Union.

I finish by reflecting on three things that my noble friend Lady Cumberlege said, which are the lessons for today: we need to be better at listening, better at learning and better at caring. We owe patients in this country better on all those fronts, and I am sure that as a result of today’s debate we will do so. I thank all noble Lords for their contributions, as well as all those families and people who have been affected and have kept at us on these topics to make sure that change happens—critically, often not for their own benefit but for the benefit of those who are not yet affected. I thank them all and I commend the Motion to the House.

Motion agreed.

Dartmoor Search and Rescue Team

Question for Short Debate

Asked by

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To ask Her Majesty’s Government what assessment they have made of the contribution to public safety made by the Dartmoor Search and Rescue Team, and of the work carried out by search and rescue services more generally.

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My Lords, I am grateful for the opportunity to introduce a debate on the contribution to public safety made by Dartmoor Search and Rescue and Mountain Rescue England and Wales. I draw the House’s attention to my entries in the register, particularly the fact that I have the honour to be patron of the Tavistock team of the Dartmoor Search and Rescue group, which was the first team formed on Dartmoor and celebrated its 50th anniversary last year. I am always careful to take a compass and mobile telephone with me on my frequent walks on Dartmoor. It would be extremely embarrassing if Dartmoor Search and Rescue was called out to find and rescue its patron.

I am very grateful to the Minister, who kindly came down to Tavistock last Saturday to meet me and other members of the Tavistock team to be briefed on the work done by our team and other members of Mountain Rescue England and Wales. I am grateful to Mike France, chairman and senior executive officer of Mountain Rescue England and Wales, for assisting me in preparing for this debate. Next year he will have served 50 years in mountain rescue. His Royal Highness the Duke of Cambridge is the patron of Mountain Rescue England and Wales and has had some years’ front-line experience in this field.

Mountain Rescue England and Wales is the umbrella organisation for some 48 teams throughout the two countries, organised into two Welsh regions and seven English ones. It has associated organisations: Cave Rescue—I remind the House of the heroic and successful contribution that members of Cave Rescue made in Thailand last year—Mountain Rescue Search Dogs, as most teams have search-dog sections, and two Royal Air Force units. Approximately 3,500 trained volunteers in England and Wales are available for deployment. I am also grateful to Mr Rhodri Davey, chairman of the Tavistock team, for his time last Saturday and for assisting me in preparing for this debate. He has served in mountain rescue for 20 years.

I do not recall a previous debate on these matters, and it is time that we as a House, and the Government, had an opportunity to express our profound gratitude to all the volunteers—all of them unpaid—who serve in mountain rescue throughout England and Wales and the UK, and their partners and families. We as a society owe them a debt of honour, and Parliament and the Government must ensure that they have the necessary resources for their operators to enable them to work safely and effectively. Only the best equipment and training will do. Volunteers and others spend a great deal of time fundraising, and the public generally are supportive, but more is needed as the demand increases.

2018 was one of the busiest years on record for many teams. It was not long ago when the busy teams in England and Wales were recording double-figure call-outs per year. In recent years, these numbers have increased to over 100 call-outs per year. In 2018, one team recorded 212 call-outs. Mountain rescue volunteers drop what they are doing and go into the mountains or moorlands to help someone in difficulty, over and over again. Many of these call-outs are genuine accidents, but some could be avoided with better planning.

I would like to express my gratitude, and I am sure the gratitude of the whole House, to the employers of the many volunteers. People volunteer from all different backgrounds and there is a system of selection to ensure that only those who are suitable can join. It is an egalitarian system, where people are accepted from diverse professions, trades, businesses and all walks of life.

In addition to mountain rescue work, volunteers assist in the following events—and this list is not exclusive: local and major flooding; looking for missing persons in urban as well as rural areas; and giving safety cover at fell races and mountain bike events. The list increases almost annually and the equipment requirements to cover these different jobs add to the cost the teams have to bear. The personnel in Mountain Rescue England and Wales save the country millions of pounds. If we did not have our volunteers, the Armed Forces, the police, the ambulance service and the fire service would all have to be deployed, and these services are stretched as it is.

I put it to the Minister that voluntary rescue services are sustainable and they will continue to offer a free service to the people they rescue. This is part of the ethos and culture of mountain rescue and the people who work in it. Rightly and admirably, they believe that mountain rescue is a free service to their fellow walkers and climbers, regardless of how they got into their predicament. The service is also free to the public if the police, ambulance service or, for that matter, fire service ask for their assistance.

Mountain rescue teams will continue improving their training standards and this includes specialist areas such as dog-handling and medical assistance. Volunteers today are very skilled technically, and this is in addition to their great hill-craft knowledge. Information technology in mountain rescue has changed much in the last few years and has assisted immensely with many rescues. Mountain Rescue England and Wales and the teams work closely with the police, the fire service and the ambulance service, and their relationships with local resilience forums and other organisations, including UK Search and Rescue, have been more strongly co-ordinated and greatly improved. This is down to the efforts of all the volunteers and particularly Mountain Rescue England and Wales, which liaises regularly with the first responders and other organisations.

In 2018, Mountain Rescue England and Wales hosted a meeting with Mountain Rescue Scotland and Mountain Rescue Ireland. They discussed matters formally as Mountain Rescue UK, and had open and frank discussions about their tasks and other matters, including United Kingdom search and rescue. Mountain Rescue England and Wales also had meetings with Lowland Rescue and cave rescue organisations last year. The point is that a great deal of information, experience and expertise is exchanged. This will, again, improve the effectiveness and co-ordination of all the organisations to which I have referred.

Recently, after some lobbying of the Government, the teams have been able to apply for a VAT refund on purchased rescue equipment. Presumably, this is a form of zero rating. Mountain Rescue England and Wales and the teams hope to be able to obtain vehicle excise duty refunds on front-line blue-light vehicles. In addition, they can apply for funding for training through a grant from the Libor fines. Unfortunately, this money will run out in approximately two years’ time.

The money for training has been of immense assistance in upping the effectiveness of the teams throughout England and Wales. As I said earlier, it is only fair for the volunteers to have the best training and the best equipment available. I hope that the Minister will be able to liaise with the Treasury and authorise a Treasury official to come to speak to Mountain Rescue England and Wales, because in approximately two years’ time it will need about £400,000 a year to be able to continue the high standards of training to which every volunteer should be entitled.

Mountain rescue is an essential service and the Government should recognise this by giving tangible support. Mountain Rescue England and Wales has significant overheads, including finance, legal and insurance expenses. The cost of insurance is approximately £256,000 a year, and generous contributions have been made to mountain rescue by GO Outdoors and the JD Foundation. As explained earlier, the demands on the teams increase annually, and it is imperative that the Government and the Treasury understand that, in order to save the Treasury millions of pounds per year, some hundreds of thousands of pounds annually are required to assist.

Mountain Rescue England and Wales is a great organisation with wonderful people working for it and in the teams. Team members will visit schools, scouts and many other youth and adult organisations to explain their role and other matters, particularly the respect that should be paid to the mountains and moors. On Dartmoor, for instance, when the mist comes down, even the most experienced and knowledgeable person is in danger. When the rain is pouring down, a small river can become a deadly torrent. It is in these dangerous circumstances, by day and by night and over long periods of time, that the volunteers in the teams give their time and risk their lives.

The whole House, I am sure, will join me in expressing the gratitude of all of us to Mountain Rescue England and Wales and to all the members of the teams, their partners and their families for their dedication, courage, stamina, altruism and wholehearted commitment.

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My Lords, I am grateful to the noble Lord, Lord Burnett, for giving me the opportunity to speak in this debate. I congratulate him on the excellent work he does as patron of the Tavistock team of Dartmoor Search and Rescue.

My first experience of Dartmoor goes back to the spring of 1966 when, as a young Army officer cadet on our final training exercise, I spent a fortnight on the moor and experienced it at its most severe—snow, rain, fog and bitter cold. A year later, two young officer cadets ran into trouble on Dartmoor. A rescue effort was attempted but difficult terrain and impending darkness, coupled with technical mishaps and human error, ultimately led to failure and the two young cadets, sadly, lost their lives.

As a result of that tragedy, the Dartmoor Rescue Group was founded, and I pay tribute to it for its wonderful work. Its members head off into the wind, the rain and the snow to help, among others, lost school groups, injured walkers, missing children and people with dementia. I have grown to respect their work. They are real lifesavers, and, as the noble Lord, Lord Burnett, said, everybody involved is an unpaid volunteer.

My sister lives close to Dartmoor and I know only too well that Dartmoor’s tors, valleys, rivers and forests can be forbidding and dangerous places, especially in bad weather and after dark. Search and rescue operations can be difficult, and at times dangerous, to both rescuers and those being rescued. As the noble Lord said, teams spend a great deal of time and effort training in a wide range of appropriate skills.

One of the main problems they experience is a lack of awareness by the public of the quickly changing weather conditions of Dartmoor. It is easy to get lost if you are not familiar with the moorland and its conditions. Stories are legion of people setting off in totally inappropriate clothing and footwear. The Dartmoor search and rescue team does a very good job in educating schools, scouts and other community groups. However, most of the problems arise with tourists unaware of the potentially treacherous conditions.

Does my noble friend believe that more can be done to warn the visiting public of the huge risks they run by setting off on to the moor unprepared, potentially risking their own and other people’s lives? The Army, and Armed Forces generally, have learned lessons since the earlier deaths. Their professionalism means that they no longer lose young officer cadets or any other service men or women.

I have one further question for my noble friend. I apologise for not giving her warning, and would be very happy to receive a letter. I understand that the Royal National Lifeboat Institution is trialling drones to help casualties at sea. The RNLI put out an open call to the drone industry back in November, asking companies to look at ways that drones could be integrated into its systems. Does my noble friend believe that drones and their technologies could also help search and rescue capabilities more generally?

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My Lords, I am grateful to be allowed to speak in the gap. I would not like this debate to pass without mentioning the Kent Search and Rescue organisation. I am sure that the noble Lord, Lord Burnett, would be happy to agree that this fits into the wider remit of the debate. It is a lowland rescue organisation. I am grateful to him for having brought this important subject to the House.

I declare an interest as patron of the Kent Search and Rescue organisation. My noble friend Lord Evans of Weardale regrets that he cannot be here—he is its chairman. KSAR is a vibrant and healthy volunteer organisation, which is performing a valuable service for the county on land and water. It is well established and pretty well equipped through its fundraising efforts, with a strong group of volunteers whose numbers continue to grow. It is well organised and bent on having the highest professional standards. It is busy—its aim is to be ready 24/7, 365 days a year. It has had a gusting 1,000 callouts over its time; 200 in the last three years. There is no doubt about the valuable service it provides for its community. Sadly, people going missing is far too prevalent, and that situation seems to be getting worse. I know that what it does is highly prized by the police, fire service and coastguards, with whom it has first-class working relationships. To pick up the point made by the noble Lord, Lord Burnett, the police in Kent admit that this group saves them millions of pounds a year by doing jobs that they simply cannot afford, in terms of capacity or cost.

I pay tribute to the Kent Search and Rescue volunteers, and all volunteers on such activities. I am only too aware, as the past chairman of the RNLI, of how important volunteering is in this area of lifesaving, and how valuable that is to the country at large. I am sure the House would want to pay tribute to such organisations and agree that they deserve wholehearted support and thanks, right across the country, for all the good work they do. By the way, to answer the question asked by the noble Lord, Lord Astor, we are using drones, as is the RNLI. I am most grateful for the opportunity to mention lowland rescue, which of course complements the work done by the excellent mountain rescue organisations.

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I thank the noble Lord, Lord Burnett, for securing this debate. As he said in his speech, he has strong personal links to the Dartmoor Search and Rescue team, as patron of the Tavistock group, and is thus able to speak with considerable authority and first-hand experience about the role it plays and the work it does in contributing to public safety.

The Dartmoor rescue group comprises four teams and is sponsored by a number of organisations, including Devon and Somerset Fire and Rescue, Devon and Cornwall Police and, interestingly, Dartmoor Brewery—whether it provides sustenance before, during or after missions is not entirely clear. The four teams are based in Ashburton, Okehampton, Tavistock and Plymouth. I do not want to digress too much, but movement between those locations would be improved for the group if the railway line between Okehampton and Plymouth was fully reopened.

The Dartmoor rescue group covers the 365 square miles of Dartmoor and beyond, and also works with the Cornwall and Exmoor teams. Group members are all volunteers, as has been said, but they are professionally trained in searching, navigation, casualty care, search dog handling and swift water rescues. The group started in 1968 and last year celebrated its 50th anniversary, when, among other activities, civic leaders throughout Devon joined members of the group for a special celebration. The group is affiliated to the Mountain Rescue Council.

The Cabinet Office, the Home Office and the devolved Administrations are responsible for ensuring the quality of preparedness for civil emergencies at the local government level and across central government. Within this, the police services are responsible for ensuring the response and co-ordination of land search and rescue, and the Cabinet Office is responsible for the framework for UK civil protection in accordance with the Civil Contingencies Act 2004, an Act I remember well since I made my maiden speech at its Second Reading—a maiden speech that had been forgotten even before I had finished delivering it. The tasking of adequate resources to respond to civil aeronautical and maritime search and rescue is the responsibility of the Maritime and Coastguard Agency through Her Majesty’s coastguard. However, search and rescue in this country relies on volunteers and voluntary organisations to save lives at sea and on land.

Such volunteers—I believe the noble Lord, Lord Burnett, gave the figure 3,500—give significant amounts of their time without payment and put their own safety, or indeed lives, at risk. By definition, search and rescue can involve going out in appalling conditions at the drop of a hat, in tough and dangerous terrain, at any time of the day or night, on any day of the year, in any season and for an unknown length of time to save those—to give two examples—who have been caught out by a sudden change in weather conditions and are inadequately prepared or to rescue those who have, either literally or metaphorically, got themselves in a hole and who may be lost, injured or vulnerable.

There were only nine days in 2017 without a mountain rescue call-out in England and Wales. On mountain rescue, the total number of operational hours was just under 100,000, or the equivalent of more than 50 people working full-time hours for a year. In 2017, 20% of incidents were more than four hours in duration and 5% took more than eight hours to complete.

In recent months, there have been a series of television programmes on the work of the lifeboat service, which showed in detail the variety of operations that service embraces and the calculated risks the volunteers undertake to rescue those in difficulty—all too often a difficulty that has arisen from stupidity or thoughtlessness rather than from bad luck or an unforeseen development.

For mountain rescue teams, the summer holidays are the busiest time, though at times of heavy snowfall I understand the teams can be asked to support local agencies by transporting medical staff to work and to patient visits.

The majority of voluntary search and rescue organisations are registered charities which rely heavily on donations and fundraising. During working hours, effective search and rescue response also relies on the willingness of employers to release employees who are search and rescue volunteers.

In the light of comments made by the noble Lord, Lord Burnett, could the Minister say whether the level of financial support from donations and fundraising activities continues to be sufficient to maintain and train effective search and rescue services—including equipment—throughout the country, and whether sufficient volunteers continue to come forward to staff these vital, life-saving operations? Have changes in the nature of employment made it more or less difficult for people in employment to get time off to be search and rescue volunteers during working hours?

I have never personally had to require the services of search and rescue, even though in my younger years I was a keen and regular walker. My wife and I first met over 45 years ago doing the Dales Way walk from Ilkley to Windermere, a walk we decided to repeat in 2017 before we got too old to do it again. From doing walks like that, one can appreciate how easy it is for something to go seriously wrong in challenging conditions. To know that help would be available from search and rescue volunteers is a source of considerable comfort.

I endorse the tributes paid by the noble Lords, Lord Burnett and Lord Astor of Hever, and the noble and gallant Lord, Lord Boyce, to all those search and rescue volunteers who unflinchingly and unfailingly turn out to help and save the lives of so many, at not inconsiderable risk to themselves.

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I join other noble Lords in congratulating the noble Lord, Lord Burnett, on securing this important short debate about the arrangements for search and rescue services both in the local area of Dartmoor and more widely across the UK. I also add my personal thanks to the noble Lord, and to the team of Rhodri Davey, Andy Barton and Paul Hudson, who gave me such a warm welcome and interesting visit last weekend to the Tavistock search and rescue centre.

First, Her Majesty’s Government pay tribute to all our search and rescue teams across the UK, and commend the important contribution that our dedicated search and rescue volunteers and full-time services make to the UK as a whole in rescuing and assisting the many thousands of people who get into difficulty in our wonderful mountains, lowlands, caves and around the beautiful coasts, cliffs and seas of the UK.

The UK is very fortunate to have around 170,000 dedicated search and rescue volunteers who, without expectation of reward, risk their lives daily to assist any person who is in need.

Our search and rescue services are recognised around the world, as mentioned by the noble Lord, Lord Burnett—we can all remember with pride the contribution made by UK cave rescue volunteers to the Thai cave incident in June and July last year, which resulted in the rescue of 12 schoolboys and their teacher in very difficult circumstances, with the world watching their every move.

This rescue embodies the spirit of all the UK search and rescue services, which are always prepared to go the extra mile to help those in need and to save life. We are indeed lucky to have search and rescue volunteer services that include the Royal National Lifeboat Institution and Her Majesty’s Coastguard Rescue Service, plus 60 independent lifeboats, all of which readily respond to distress and emergency calls around our coasts and seas, often battling horrendous conditions and the worst that our weather can throw at them.

Our maritime volunteer services attend more than 20,000 incidents a year, rescuing and assisting in excess of 30,000 people. Tragically, some have paid the ultimate price for this self-sacrifice, as the tragedy of the RNLI Penlee lifeboat “Solomon Browne”, which was lost with all hands in 1981, showed. This House pays tribute to the selfless bravery of her volunteer crew.

Inland we have mountain, lowland and cave rescue teams that provide the backbone of inland search and rescue services within the UK. The contribution to public safety by all our search and rescue services, including Dartmoor Search and Rescue, is considerable. My visit to Tavistock brought home clearly the different ways in which these teams contribute to their communities and to our nation’s safety. As my noble friend Lord Astor of Hever said, the Dartmoor team, like many others, was founded on the back of tragedy.

So there is the tangible contribution, with volunteers from Mountain Rescue England and Wales responding to just under 2,500 callouts, with almost 100,000 volunteering hours providing assistance to public safety. In the last few weeks, rescues have included lowering a pilot 1,300 feet when his glider crashed in a snowstorm, rescuing sheep from a rock face in Cumbria, and going out with armed police to assist when a wild camping trip, combined with recreational drugs, went a bit too wild and the participants needed rescuing.

We are lucky to have 27 mountain rescue teams in Scotland and 15 in Northern Ireland, which attended more than 700 callouts in 2017 and assisted about 600 people, giving a further 22,000 hours of their time to assist those in need.

The noble and gallant Lord, Lord Boyce, mentioned our lowland rescue teams. There are 35 of them and in the last year they contributed 60,000 volunteer hours and responded to just over 1,200 incidents. Often the assistance they provide is to locate vulnerable and elderly people affected by mental health and dementia. This is a critical and much-valued service. As I also mentioned, the 15 cave rescue teams in the UK provide a specialist service to assist lost and missing cavers and members of the public, both within the UK and further afield.

The contribution of our search and rescue services to public safety continues to be outstanding, with over 445,000 hours of volunteer time being committed annually to help people in need. But, as well as the tangible contributions, there are less tangible ones: from the commitment of the volunteers, which all noble Lords mentioned, to the support of their families and—as mentioned by the noble Lord, Lord Rosser—of their employers, to the involvement of their communities, particularly in fundraising. Judging by the strength of the friendships and trust between team members that I witnessed in Tavistock, this is an invaluable asset.

But this commitment is not without a price. The mental health charity Mind has provided mental health support for search and rescue volunteers for four years in England and Wales through the Blue Light programme. Mind research has shown—perhaps this is not surprising—that first responders, emergency services staff and volunteers are more likely to experience a mental health problem than the general workforce but less likely to take time off work as a result. I declare my interest as a former trustee of the Royal Foundation. The foundation is working in partnership with Mind to explore ways to provide some sponsorship of the Blue Light programme and to make available a 24/7 helpline specifically for the search and rescue community.

The noble Lords, Lord Burnett and Lord Rosser, mentioned funding, and in particular the future of Libor funding. The UK search and rescue Libor training partnership is looking at opportunities to use some of the remaining funding to enhance longer-term fundraising opportunities, and the Government are keeping this under close review. I cannot promise the noble Lord a meeting with the Treasury but I will undertake to make sure that details of this debate are shared with it.

My noble friend Lord Astor of Hever asked about the role of drones and technology in enhancing our response. Both Her Majesty’s Coastguard and the RNLI are working together to consider the role of drones to increase the efficiency of search and rescue, obviously to save more lives but also to reduce risk to volunteers. Trials are being considered at the moment. However, I reassure more technophobic noble Lords that search and rescue dogs are still absolutely crucial.

I hope I have covered the questions raised by noble Lords. I spotted only one inaccuracy in your Lordships’ comments, which came from the noble Lord, Lord Rosser: I find it impossible to believe that his maiden speech was anything other than very memorable.

It has been a great pleasure to respond for the Government in this important debate and to recognise not only the terrific work of Dartmoor Search and Rescue but all our search and rescue services and their combined contribution to public safety. I am sure that the House will want to join me in paying tribute to all of them and their volunteers for their courage and skills to save lives in whatever environment.

Draft Domestic Abuse Bill

Message from the Commons

A message was brought from the Commons that they have come to the following resolution to which they desire the agreement of the Lords:

That it is expedient that a Joint Committee of Lords and Commons be appointed to consider and report on the draft Domestic Abuse Bill presented to both Houses on Monday 21 January 2019 (CP 15);

That a Select Committee of six Members be appointed to join with a Committee appointed by the Lords for this purpose.

That the Committee should report on the draft Bill by Friday 17 May 2019.

That the Committee shall have power:

(i) to send for persons, papers and records;

(ii) to sit notwithstanding any adjournment of the House;

(iii) to report from time to time;

(iv) to appoint specialist advisers; and

(v) to adjourn from place to place within the United Kingdom.

That the quorum of the Committee shall be two.

House adjourned at 4.17 pm.