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Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
09 January 2019
Volume 794

Considered in Grand Committee

Moved by

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That the Grand Committee do consider the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019.

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My Lords, I have nothing further to add to what I said at the start of the previous SI. I beg to move.

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My Lords, I will not repeat the remarks I made on the previous statutory instrument about the cost, the waste of time and expertise, and so on of the exercise that we are going through. Instead, I will make a few points about this particular order.

European Union safeguards on public health set high standards for the quality and safety of human cells and tissue. I thank the Brexit Health Alliance for its briefing on this subject, because it and I agree that the continuation of the UK’s alignment with these standards is in the interests of citizens on both sides of the European Union/UK border. I do not know what is going to happen next, so I will not speculate. It is clear that it is in the interests of citizens that we get this right. In the UK, we have the Human Tissue Authority, an experienced regulatory body which, one assumes, will continue to be resourced and to work to the same safety standards as before exit.

The issues I raised concerning embryology cross over to the issue of human tissue, and are about inspectors, the safety of premises, the cost and how tissues will cross borders when the UK becomes a third country. I can see from the regulations and the Explanatory Note what the Government think will happen to tissues and organs, but perhaps the Minister could walk us through what will actually happen. Will tissue that is needed in the UK from, say, Spain be able to reach the person who requires it without let, hindrance or regulation? That—and I will say the same on the next SI on organ donation—seems to be the crux of this issue for the ordinary person: whether or not these regulations will allow that traffic to take place with the same ease as today. If it cannot and does not, then these regulations will not work.

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My Lords, the Minister has been put in an impossible position, not by this Committee, but by the Government. We should apologise to the Minister for the fact that we have only her to address in this matter, when we are trying to address the Government. It is no good avoiding the fact that these are part of contingency measures which are themselves entirely unacceptable, because they are not going to work.

The whole process we are concerned with, and to which I deeply object, is to try to shore up an entirely fictitious position. If the Government had really believed, right at the beginning, that there was to be no deal, they would not have proposed a series of measures which were about having a deal. They would have been organising themselves for what would happen if there were no deal. I am applying this particularly to the second of the SIs we are discussing. It is not my noble friend’s fault, and of course she is going to say that it is not within her competence, which I understand, and I admire her considerably. After all, she is my Whip and she keeps me under considerable control, as is noticeable. It is not fair that the Government have put all Ministers into the position in which they have to argue the unarguable. They have to argue the impossible.

Let us look at the issues here. The argument is that if we left the European Union without a deal, we would need legislation in place to ensure that life would continue as normal—but it ain’t gonna continue as normal if we do not have a deal. That is what the Committee has such difficulty in dealing with. What happens if we cannot import or export because there is no possibility of getting through the ports? The Minister said that we will use planes but, if I may say so, the plane situation would be worse because the international agreements on insurance for aeroplanes would collapse immediately and there is no mechanism to put them back into place.

My noble friend is in a difficult position because so far, her right honourable friend the Secretary of State for Transport has not shown fingertip co-ordination or ability on this matter. Not being able to organise a traffic jam when the issue is one of avoiding traffic jams is one of the most mysterious situations of my political life. I have been involved in politics since the age of 17 and I was a Minister for 16 years; I have never known a situation in which it has been so difficult for the revising Chamber, let alone the legislating one, to come to terms with an issue.

I will say a few things to my noble friend. First, this simply does not work, not because of my noble friend’s competence, but because of the Government’s competence in trying to deal with no deal. That is why the House of Commons rightly said that we cannot have no deal. Secondly, it is extremely dangerous to have such discussions based on the principle that they will not be needed, which seems to be behind all this and why we are allowing this measure to go through. The noble Baroness, Lady Thornton, might be but nobody else at the table is prepared to face the issue that this might be real, not a fantasy.

Thirdly, the fantasy that we may or may not be having is costing at least £4 billion, so anybody who talks to me about a Brexit dividend or anything else really must start to be more sensible. Again, my noble friend will say that this matter is not within her competence but it is reasonable for me to tell her that it is not good enough just to say that the costs are minimal. We must know what the costs are. I have never known such a circumstance. Every time we ask the Government about the cost of anything to do with Brexit, the answer is, “We don’t know”—or, worse still, “It is minimal”. I do not know what “minimal” means. For some people, thousands of pounds is minimal; for many a National Health Service operation, thousands of pounds are what they do not have, so it is not minimal but serious. My noble friend must give us confidence that she will go away and insist, as a Minister, that she is given the costs because we need to know how much this will cost. In my view, “minimal” is not a satisfactory answer.

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My Lords, the noble Lord makes an extremely powerful argument about the basis on which this no-deal planning is taking place. As a distinguished former Member of the House of Commons, can he give us his reflections on how that basis has been affected by yesterday’s debate and votes in the House of Commons, including a specific vote against no deal—the whole basis on which we are considering these statutory instruments this afternoon? I ask that particularly in the light of remarks made by Yvette Cooper, who moved the amendment approved by the Commons yesterday. She said that,

“I have heard some say that they want the imminent threat of no deal to persuade people to back the Prime Minister’s deal, if not now, then later. But brinkmanship in Parliament is not the way to resolve this and get the best deal for the country. This is too serious for us to play a massive Brexit game of chicken”.—[Official Report, Commons, 8/1/19; col. 263.]

That was said by the mover of the Motion which the House of Commons approved yesterday. Does he agree that this is a massive Brexit game of chicken and that there is something fundamentally immoral about the Grand Committee playing a Brexit game of chicken in pursuit of a policy which the House of Commons has now specifically disapproved of in terms?

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My Lords, perhaps I might remind the Committee of Standing Order 28 and urge noble Lords to relate their comments closely to the Motion under discussion.

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This is very closely related to the matter under discussion because the issue under discussion at the moment is no-deal planning, along with the whole basis on which that no-deal planning is being conducted. I am sure that the noble Lord will agree.

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I say to the noble Lord, Lord Adonis, that we have a real issue here because it is very hard for the Minister to have to respond to this situation. Again, I apologise to her for the fact that I feel that I have to speak—because we cannot go on, in the politenesses of this House, ignoring the fundamental problem. The fundamental problem is that we are being led up the garden path in two different ways.

The Deputy Chairman of Committees is perfectly right to refer us to the Standing Orders, but this is central to the discussion that we having on this particular SI. The centrality of it is that, first, we are assuming that this could happen, and the second part of it is that we are assuming that the Government have made proper arrangements that if it were to happen, what is in this instrument is relevant and effective. There is actually a third thing, which goes back to the point made by the noble Lord, Lord Adonis, about whether this is legally possible to happen. That, I think, is a question which is beyond the remit of this Committee but is certainly of very great importance.

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Can I ask the noble Lord a question? I would quite like a response from the Deputy Chairman as well. Two separate arguments are flowing here. One is an argument about whether, in the light of the latest Commons vote on no deal, we should even be discussing that. I can sympathise with the Deputy Chairman’s intervention. However, there is a second issue which keeps coming up: are these changes actually deliverable? We keep coming back to that and it is where I think that not just this Minister but Ministers on the other regulations will have to come clean. If we cannot deliver these things, I would suggest to the Deputy Chairman that that is a relevant consideration. If the propositions in these regulations require a delivery mechanism that we in our judgment feel, on the evidence being presented to us, is not going to deliver what is in these regulations, it is the duty of this Committee to say that to the Government loudly and clearly, no matter how uncomfortable that may be for the luckless Minister who has to present them to us.

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It is natural for the noble Lord, Lord Warner, to have put his finger on exactly what I was about to come to as my final point of discussion.

I say to my noble friend that the problem with which we are faced is that this is a statutory instrument that inherently proposes that it could work, that it could be put into operation. The more I look at it, the more it seems quite impossible for the Government to say that it could work. My noble friend has been absolutely honest about this. She has said that she cannot tell what the future will hold. That of course is true for all of us. She has also said that we have her commitment that these things would be prioritised where priority was necessary. That is a commitment which we respect, but the problem with prioritisation is that you have to be able to do it. I do not believe that any of this is in any way deliverable. It is therefore no good us having this sort of fantasy debate.

We are in fairyland, unless that is politically incorrect as a phrase. This is closer to Enid Blyton than anything I have ever been involved in—it is the Faraway Tree, it has nothing to do with reality. When the noble Lord, Lord Winston, makes an intelligent and sensible contribution about some of the problems which occur when you try to transmute something which is to something which is different, so that it is not quite what people may think, actually in a curious way he is being irrelevant. The truth is that none of this is possible. Arguing about whether it is going to be exactly right or not is a further lunacy. We are even further away from it, because we are now introducing rationality into the discussion. That is one thing that clearly cannot be introduced into the entirely irrational basis upon which we are proceeding.

I am the only person sitting on this side, and I know why: nobody can actually go through this exercise without realising what nonsense it all is. What a ridiculous proposal we have before us. Why have we allowed ourselves to get into this position? I am sorry it is my noble friend who is faced with this, but I do not think this House is doing itself any good by conniving in what is manifestly a total nonsense.

I do not believe it is entirely in order to ask people to support the only deal on the tapis. We all have to accept that the deal the Prime Minister has got is the best deal you could get if you wanted a deal like that. It happens to be much worse than where we are, and I certainly would not vote for it if I had the opportunity. I do not think anybody should vote for their constituents to be poorer, because that is what you have to do if you vote for the Prime Minister’s deal. But that is not the point. We have in front of us proposals which cannot be delivered.

I sympathise with my noble friend over the position in which she finds herself, but I hope she and other Ministers—because we will be continuing this discussion today—will go back to the Government and say, “I cannot stand up and defend this stuff any longer, because I am not in the business of defending Enid Blyton. I cannot be asked to do this, it is not fair”. My speech is entirely on the side of the Minister. It is not fair that she should have been put in the position of defending something which is intolerable, because it is not possible. It cannot be delivered. There is no no-deal scenario which does not mean chaos, so there is no point in having legislation which pretends that it will stop a no-deal scenario being chaos. That is inevitable, ineluctable and inextricable from the whole process. Of course, my noble friend will get her SI through—we have a ludicrous system whereby we cannot do things to it—but I ask her to go back to the Government, and she does not even have to tell us if she does, and say that this is not a proper position to put Ministers in, having to argue for what is unarguable, a fairy tale, and an insult to the intelligence of all of us.

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As my name has been mentioned, perhaps your Lordships will allow me to make one observation. Perhaps I should also apologise to the Minister, because we have already crossed swords once earlier today on the issue of folic acid supplementation of flour—which I feel strongly about, because the evidence supports it. I slightly disagree with noble friend Lady Thornton, who makes many useful contributions to debates on health and I respect what she says. In the case of human tissue—I do not know whether the Minister is listening—the issue is not just the treatment of patients. A big problem, to which I vaguely alluded, is that we are still collaborating with scientists in Europe. We share tissues. We share cell cultures. We have been able to transport those, although we may not be able to do so in future. However, we are still processing them with different procedures, which require ethical consent. If one regulation—in Germany, for example—changes in respect of regulation for ethical consent in Britain during the experiment, how does that stand with the current arrangements for Brexit? This is a major problem. The Human Tissue Act is not primarily needed for the treatment of patients; it is much more for the development of medical research, which will improve the treatment and understanding of a whole range of diseases. That is not considered in the regulations. It is a major problem for us, which we need to sort out.

I completely sympathise with the position that the Minister is in. I am talking to her as the Government and not as someone who has to answer these complex questions. The point that I am trying to make is that we should have had more consultation on the regulations, which deal with a complex matter. Many of us have seen the regulations only briefly, so the Grand Committee has not had the chance to look at them in detail. That is also a problem, which is why I wonder whether there is some possibility of withdrawing them for the time being.

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That is right. I intend to cover some of these issues when I speak tomorrow in the major debate.

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My Lords, I will confine myself to considering the regulations. I accept the challenge thrown at us by the noble Lord, Lord Deben, about what we are doing. For my part, I believe that my job is to go through these SIs precisely to establish what is real and what is fictitious in them. There is a grave danger, not least on an important subject such as this, that the general public are being given completely false reassurances. I take the point that the regulations are for a no-deal situation and will last for six months only, but the world does not stop and research does not stop in those six months. I echo the point made by the noble Lord, Lord Winston, that the impact on medical research is tremendously important.

I will make two points. On the inspection of premises, the noble Baroness mentioned in the discussion of the previous regulations reciprocal inspection powers between countries. She said that countries in the EU will continue to inspect their premises and we will inspect ours. In a no-deal situation, why would the EU 27 continue to uphold our inspection processes? They are under no obligation to do so. That has huge consequences, not least for research. I make the observation that if we in the United Kingdom are sitting here content that the EU countries will continue to inspect their own facilities to their own standards, that is a very curious interpretation of taking back control.

Secondly, we are told that the regulations will be in force for six months in a no-deal situation. What if, down the line, it turns out that there has been an adverse incident either here or in the EU? What are the implications of that in a no-deal situation for the protection of patients? Yes, we are in fantasy land, but even in fantasy land we have to start asking real questions. Those are simply two of the many questions that noble Lords are entitled to ask and to which we are entitled to have strong answers.

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My Lords, I was not intending to speak on this set of regulations, but I was taken down memory lane when I saw what was involved because I was the Minister who took the human tissues legislation through this House in 2004. I want to remind the Minister why that legislation was put in place because it is relevant to a question that I want to ask at the end of what I am going to say. It was put in place because medical research was being jeopardised because of patients’ concerns about the safety, storage and use of human tissue of various kinds. It arose against a background of huge concern about the treatment of human tissues of children at Alder Hey Hospital. I can still vividly remember the parents of those children fixing me with a gimlet stare as I took that legislation through the House.

My question to the Minister therefore backs up to some extent the point that the noble Baroness, Lady Barker, has just made: can the Government guarantee that in these regulations there will be an absolute set of safeguards around the use of human tissue during the period after a no-deal Brexit that will not jeopardise all the good will that has been built up since 2004, which has got patients willing to co-operate in the use of human tissue for medical research?

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As the noble Lord asks for a guarantee, could he explain how the Government could make such a guarantee? Surely that is our problem; it is not that the Government would not like to make such a guarantee—I am sure they would—but how could they? Is that not the fundamental problem with which we are faced?

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I think it is, but I am trying to be kind to the Minister after what I suspect has been a rather exhausting and tiresome afternoon for her. This requires the Government to be absolutely sure that the safeguards in place now will not be diluted in any way as far as patients are concerned as a result of these regulations. She and the Government have to be sure, as the noble Baroness, Lady Barker, said, that if there is an incident it will not undo all the good will that has been built up in the last 15 years or so.

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The noble Lord has been a Minister and has had to deal with these issues. Could he give his own reflections to the Grand Committee on the issues to do with disruption at ports and airports that might impact on the extensive research and patient treatment that takes place under these provisions? If there was serious disruption, what impact does he think it would have on the communities affected?

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If the Government cannot guarantee the easy transfer of pieces of material of one kind or another that are vital for medical research, you end up with a loss of public confidence in medical research and the ethical considerations surrounding that. It starts to jeopardise the ability of world-class scientists to do the research that at the end of the day benefits patients across the country and indeed across Europe.

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My Lords, I did not care greatly for the Deputy Chairman’s intervention in reading the Standing Orders out to us. I think your Lordships are well aware of the requirements for us to be relevant in our remarks, and I do not believe that anything has been said in the Grand Committee today that is not relevant to the direct issue of no-deal planning, which is the precise issue involved in each of these regulations. It is not just relevant but it is our duty to point out—in the way that the noble Lord, Lord Deben did in his remarks—the big issues to do with the practicality of these arrangements as well as the legal and moral basis on which they are being taken forward, given that the House of Commons, the primary elected body that establishes law and policy, has directly voted against no-deal preparations as recently as yesterday, in a huge Division after a very controversial debate. When I read to him the remarks of Yvette Cooper, the former Labour Cabinet Minister who moved the amendment endorsed by the House of Commons, I think that it was extremely relevant.

We all have great respect and increasing sympathy for the Minister. She is having to assume responsibility for a Government of which she is a distinguished part but only one part. She is in an invidious position in having to reply, but she has not been able to do so because there is no reply to the fundamental issue of why are we considering these regulations at all when it is unclear whether they can be implemented and when the legal basis for them is so shaky and, in my view, unsustainable because, crucially, it depends on the will of the House of Commons, which only yesterday expressed its will emphatically in a huge Division: that it did not want to see no-deal preparations continue—[Interruption.] I am sorry. My noble friend is making an entrance. I thought it might be another intervention from the Chair.

As each of these orders come up for consideration by the House, we need to point out that the Grand Committee believe that the arrangements being put in place are not practical in the time period envisaged for them—now barely two months—and that we will not be satisfied unless the Government can give us some account. The Minister has not been able to say whether there is a satisfactory legal basis for these arrangements to be brought forward, given the view the House of Commons has now expressed. I would welcome that as the Minister did not respond to those remarks in respect of the previous statutory instrument; I hope that she will in her remarks on this one.

The remarks of my noble friends Lord Winston and Lord Warner are acutely concerning. They have huge expertise in this area and have raised very serious concerns about the impact on patients and research in the event that the Government attempt to go down the course envisaged by these regulations. The Grand Committee would welcome the Minister’s views on these issues. I note that we are not talking about a peripheral issue in respect of the NHS and patients. There are about 5,000 imports of tissues and cells from the EU alone in a typical year. This is not my area of expertise, but that is clearly a huge area of our national life which acutely affects a very large number of individuals. That includes 600 imports of stem cells and 3,000 imports of bone products. The UK imports donated sperm primarily from commercial sperm banks in two places—the United States and Denmark—so one of the two principle areas from which we import is in the European Union and will be directly affected. The Minister may be able to confirm figures I have seen saying that Denmark is the principle location from which we import donated sperm and will be hugely affected.

I come back to the fundamental issue I raised in the last debate, to which the noble Baroness was not able to give a satisfactory answer: what happens in the case of serious disruption. I invite the Minister to say more about the word she used in our last debate: “prioritised”. The Government clearly think that there may be serious disruption or there would not have been the attempted simulation of a lorry jam; Chris Grayling could not even organise a lorry jam that worked but a simulation of a lorry jam was attempted on Monday none the less. The Government would not be attempting simulations of lorry jams if they did not think that a lorry jam would be one of the consequences of no deal. I have worked closely with civil servants for many years. They are very conscientious and they feel, correctly, under a duty to see that proper preparations are made for serious contingencies that might arise in respect of policies put forward.

The Grand Committee and the House should take careful note of the fact that this is not any Project Fear done by me or any fantasies from the noble Lord, Lord Deben. The Government are conducting contingency exercises of lorry jams, which means that the port of Dover is effectively impassable for long periods, and we were told yesterday by the junior Transport Minister, the noble Baroness, Lady Sugg, that the port of Ramsgate is being dredged—we are still trying to find out how this dredging is taking place and what the contracts are—so that further no-deal preparations can be made for after the end of March. We now know what the likely disruption can be at the airports, because many of us were trying to get out of Gatwick before Christmas and the drone completely disrupted all the traffic out of the airport.

There is a fundamental question here. When the Minister says that the Government will seek to prioritise the movement of tissues, cells and donations in the way she described—I take her at her word; I know that she would do her absolute best to see that satisfactory contingency arrangements were put in place—what does prioritisation mean that will give the Grand Committee or the House any confidence that there will not be severe disruption that will imperil research, and quite possibly the lives of people in this country, because it is not possible to import cells and embryos in the way that is envisaged? May I press the Minister more on this to say what those contingency measures are and what she means by prioritisation? In what order will things be prioritised? How will this be prioritised over essential food supplies, for example, or other essential matters that have to go through the ports? Can she tell us more about that?

I also want to press her on whether the military might be used, because of course military aircraft and air bases could be used, and can be used under arrangements that do not involve existing EU arrangements in the event of serious disruption at the airport. Can the Minister therefore say whether the services of the RAF or the Royal Navy could be made available? This is not an unreal issue. I was the Secretary of State for Transport who had to deal with the crisis in 2010 when the Icelandic volcano erupted and 150,000 British citizens were stranded abroad; it was a contingency very much like the sort we are discussing today. My noble friend Lord West and I were closeted in a Cabinet committee and then in COBRA, requisitioning aircraft carriers and RAF ships to ensure that people could be moved across the Channel.

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I hope that my noble friend will be able to answer this question, but I point out that it is rather difficult to answer. Yesterday or the day before, we were informed that we have had to withdraw two cutters from the work being done because of people coming across the Mediterranean. That was the only way that we could stop people coming across from Calais. In other words, we appear to have a very exiguous ability to do these things. I am told that we are only borrowing these cutters for a bit and then they will go back again. I also want to know whether our forces have the ability to provide the prioritisation of which the Minister speaks.

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The noble Lord makes an important point, and we look forward to the Minister’s response in more detail on what these contingency arrangements will be. If she is not in a position to tell us, the advice that was given to the Committee by my noble friend Lord Winston is apposite. If the Government cannot give adequate assurances that these arrangements can in fact be put in place or meet the objectives set by the Government to see that there is no disruption in the vital flow of embryos, tissue and so on, the right thing for them to do is to withdraw this regulation and come back to the House after they have done two things. They need to engage in further consultation—as the noble Baroness, Lady Barker, said, the consultation on these regulations has been exiguous—and the noble Lord, Lord Tyler, said that no impact assessment had taken place at all, because the Government judged that the impact was not serious. It does not appear to be the opinion of the Grand Committee this afternoon that the impact is slight; we think that it could be significant in the sectors we are discussing.

So, our advice to the Minister would be that the best thing for her and the Government to do would be to withdraw these instruments and to do two things. First, to engage in further consultation, and secondly, to engage in more intensive contingency planning, particularly on the issue of how disruption will be coped with. That will give the Grand Committee and the House more confidence that we could agree regulations of this kind because they would be capable of meeting their objectives, which is not the case at the moment.

I will raise one final issue for the Minister to address in her reply. Martyn Day, Member of Parliament for Linlithgow and East Falkirk, in the debate in the House of Commons on these regulations, said:

“We do not know what the exact process will be for licensed establishments to apply for a new import-export relationship”,—[Official Report, Commons, Third Delegated Legislation Committee, 19/12/18; col. 5.]

in the case of a no-deal Brexit. That seems to be a significant issue. Since Jackie Doyle-Price was unable to respond to the point in the House of Commons, could the Minister tell us what the process for licensed establishments to apply for a new import-export relationship will be. On the point the noble Baroness, Lady Barker, raised, in the event that new arrangements are not put in place within six months—the period the Minister set out in her opening remarks—what will happen? This is a vital contingency issue, and these are difficult, complex issues. Will the six months be extended? What arrangements will the Government put in place for that? What will happen to the additional costs? I hope the Minister can respond to all these issues in her reply, which will be important for the further consideration by the House of these matters. The House will look to the debate we have had in Grand Committee to inform its own debate in due course.

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My Lords, I am provoked by the noble Lord, Lord Adonis, to pose a question to the Minister, which I hope will be helpful to him. I endorse what the noble Lord, Lord Deben, said about the invidious position in which she has been placed. I have been mulling over what the noble Lord said about the whole scene in which we are now placed. He described it as Enid Blyton; it is more like the unicorn option that some of the Brexiteers thought they were going to have—some wonderful new era of freedom. It is speculative. So often in both Houses, I have been attacked by Ministers for asking them a hypothetical question. The Grand Committee is being asked a hypothetical question this afternoon, which the Government themselves do not believe in. It is speculative: if this thing, which we do not want to happen, happens, we need this particular order.

I put a specific question to the Minister: if, by some curious chance, are faced with the deal the Prime Minister is seeking to obtain the support of Parliament for, presumably this is a complete waste of time? We have been told so often this afternoon that this is a contingency plan for a situation the Government do not want to happen, and therefore, by definition, if it does not happen, this is a waste of time. Do we then have to have quite separate adjustments to the relationship we have under the Prime Minister’s deal? If so, that is a complete new set of secondary legislation which is going to come before your Lordships’ House. I do not know if that is a more likely prospect than the unicorn prospect—the ridiculous situation that the noble Lord, Lord Deben, described in his powerful speech. However, it has huge implications for the role of this House in looking at the detail of legislation. If we are going to be told that 600 of these SIs are now irrelevant, because the no-deal option, the unicorn option, has fallen off the table, but we now have something else in front of us, that has implications for the role and responsibility of this House. If, as the Minister says, the contingency plan is not required, what is the contingency plan for the Prime Minister’s deal? Is there going to be a completely different set of secondary legislation? It is a simple question, and I hope there will be a simple answer.

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My Lords, I want to make two brief points. First, I want to pick the point made by the noble Lord, Lord Deben. I agree that we have been unfair to the Minister. She has been put in a very difficult position. If I have said or done anything inappropriate, I apologise sincerely to her.

This reminds me of something. My memory is failing a wee bit but I think it was Sir Geoffrey Howe who said that he had put in by the Prime Minister to bat on an impossible wicket, which was bad enough, but before he went in, she broke his bat in two. Unfortunately, I think that the noble Baroness, Lady Manzoor, has been put on an impossible wicket and had her bat broken in two. However, to make up for that, I will ask her an easy question. What is it they say? I will bowl her—

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A googly.

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No, not a googly; the opposite.

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A full toss.

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I will bowl her an easy ball. On page 9 of the statutory instrument, paragraph (6) mentions “appropriate authority” and refers to Wales, Scotland and Northern Ireland. What consultation has taken place with the Welsh Assembly and the Scottish Government? What was their reaction to this proposal? Have they specifically approved this statutory instrument or made any comment on it? It would be useful to know that. In the case of Northern Ireland, where as we know there is no Assembly, who was consulted—senior officials, presumably—and what did they say? I genuinely hope that my question falls within the Minister’s pay grade. I look forward to her answer.

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I am grateful to noble Lords for being here because working on statutory instruments has felt quite lonely at times; this is my third or fourth set. I have become increasingly concerned, as I have shared with some of my colleagues. These three statutory instruments in particular give me enormous cause for concern, borne out by the Committee’s comments during the debate—particularly those of my noble friend Lord Winston. Along with her colleagues, the Minister has some serious problems. As I have said to anyone who would listen in the past few weeks, this is written across different subject areas; patents, which we will discuss later, is one example, as well as food security, which my noble friend Lady Jones has been waxing lyrical about. It is written across every single aspect of our life. In that way, our discussion today is important indeed. I do not envy the Minister.

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I thank noble Lords. The discussion has been constructive. Many issues were raised although, as I said in the previous discussion, many of them are outwith the comments I can make. As I said in the debate on the previous SI, my comments relate to all three of them—noble Lords will forgive me if I do not repeat myself—because this is about contingency planning and the specifications are not that different.

A number of noble Lords, including the noble Lords, Lord Foulkes and Lord Tyler, and my noble friend Lord Deben—forgive me if I have forgotten anyone—asked about what will happen in the case of a deal. Again, I want to make it clear that the SIs will be revoked or amended as necessary, depending on the deal. This is just about contingency planning, nothing more. We want only to maintain safety standards and ensure that these services can be provided where they are needed.

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My Lords—

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I am sorry but I am not going to give way.

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This is a specific point.

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I hope that the noble Lord, Lord Tyler, will forgive me, but I have given way many times.

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It is a very simple question.

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I am sorry but I will be firm on this. All noble Lords have had ample opportunity to speak. I wish to move on. If I have not addressed the noble Lord’s point, perhaps we can come back to it.

I want to thank the noble Baroness, Lady Thornton, for her words. We know that this is a sensitive, delicate and important issue, and indeed the noble Lord, Lord Winston, has highlighted its importance as well. It is vital that we have consistency in maintaining our contingency plan so that we can ensure that the service which is currently being provided continues and that we have effective agreements in place. I should say to the noble Baroness, Lady Thornton, that in either a deal or a no-deal situation, the changes to UK legislation will not affect the availability, safety or quality of organs, tissue and cells as the current standards will be maintained. The current arrangements support the free movement of organs, tissue and cells across the EU. The UK and the countries of the EU would consider each other as third countries after exit day, as the noble Baroness rightly said. The relevant EU directives and UK legislation allow for agreements to be made to receive organs, tissue and cells from countries outside the EU provided that they meet equivalent standards of quality and safety. This means that the agreements for sharing organs, tissue and cells with EU countries can continue to be made.

My noble friend Lord Deben and other noble Lords raised the issue of the cost for establishments of tissue and cells. The estimates are that 12 out of 135 tissue establishments will need to put new agreements in place. Many already have templates that they can use quickly and effectively because we look at organs, tissue and cells across the world, not only in the EU. That is precisely why we expect the costs to be small.

My noble friend and others also raised wider issues as regards exiting the EU. As he rightly pointed out, I am afraid that those are not within the remit of these SIs. Quite rightly, my noble friend asked me whether the changes are deliverable. The changes are minimal and they are deliverable. The operational changes have been discussed with the regulators who consider that the changes we are advocating can be made. There is no large-scale transportation risk that we are aware of.

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My Lords—

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No, I am sorry, I must move on.

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My noble friend has not answered my point and this is a debate. The question I want to ask her is this. I accept that there are no large-scale transportation issues, but there are transportation issues. My question is how we will prioritise those things that need to be prioritised in circumstances in which no aeroplane would be flying because the insurance system does not enable it to do so. What are we going to do with that? Who is in charge of making sure that we have naval or air cover to deal with it? That is a proper question for my noble friend in these circumstances.

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I thank my noble friend for that clarification. My noble friend is right to say that at the moment the regulators have agreements in place and those agreements will continue to run; they will not change. This does not change any of the agreements that are in place.

On the issue of reasons such as strikes or volcanic activity preventing flights, I cannot possibly comment. But what I am saying is that the issue behind this is continuing with the agreements. We have organs that are flown from the EU. That will continue. In the NHS we make life and death decisions about priorities every day. If there is a priority and a patient needs an organ, that patient will receive that organ, and the Government will do everything in their power to ensure that patient safety is not compromised.

The Government have already given that undertaking: we will endeavour to do our very best. I passionately care about patient safety. I passionately care about ensuring that no one is put in any undue danger, as do the Government. I do not agree with much of what my noble friend Lord Deben has said about there perhaps being issues with patients not getting the priority that they need if it is necessary. We will endeavour to do everything in our power to ensure that patients who need life-saving organs or any other tissues that may be necessary get them.

The noble Lord, Lord Winston, spoke about the sharing of tissues and cell cultures. I am sorry to repeat myself. I am trying to choose the things that are pertinent for me to repeat because of their importance. I want to make it clear that these SIs are not related to ethical consent for research. The Human Tissue Act covers domestic consent and EU material is outside the scope of that. As I have already indicated, if the EU makes changes to this in the future, the UK will need to decide whether it wants to make any changes at that time. That will be a matter for Parliament.

The noble Baroness, Lady Barker, asked about the arrangements for the inspection of tissues and cells. I assure her that establishments are required to be contained within the agreements with all third countries, as they currently are. That will continue after we exit the EU. That will not change.

I have already said that these SIs do not relate to medical research but only treatment. I say to the noble Lord, Lord Warner, my noble friend Lord Deben and the noble Baroness, Lady Thornton—who I know cares passionately, as we all do, about the safety and quality of the service and organs—of course we want to make sure that there are safeguards after Brexit. Nothing will change. We want to have higher standards, if possible. The standards and quality will not be diluted.

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You cannot guarantee that.

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I am saying that we passionately do not want that to happen. We will endeavour to do everything we can. These SIs are continuing the standards. We are not changing standards. If the EU decides to move away to other areas, it will be for the UK Parliament to look at and discuss that issue and agree how we as a country want to move forward. That will be a decision for Parliament, not for these SIs and certainly not for me.

The noble Baroness, Lady Barker, asked what agreements we will put in place to import tissues in the future.

The six-month period is a transition period. The agreements that will be put in place will not just finish after the six months. If there is divergence then that will be a different issue for the regulators and it will have to come back to Parliament, but we will use the agreements that are in place as templates for the sake of consistency, and they will continue to exist after the six-month period concludes.

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I have a point that is germane to all three of these SIs. If there is no deal then there is no agreement and no six-month period because, whatever aspirations the British Government may have, the EU is not bound by this. The Minister is talking about the continuation of arrangements, but they are EU arrangements. If there is no deal, we are no longer a member of the EU. That is the flaw which underlies her arguments on all these instruments.

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To be very clear, the six-month period relates to imports. It is important to point that out. After the six months, there will be advice from the regulators as to what the new import agreements will be and what more needs to be put in place during the six-month transition period. There has to be consultation and there have to be agreements, and that is the whole point: we want to put these SIs in place so that we have contingency planning regarding the agreements.

A number of noble Lords raised the issue of ports and airports. I have already given the answer and there is not very much that I can add to it. The Government are making plans to mitigate any delays at borders. As I have said, where there is a priority need, we will endeavour to do our very best to ensure that there are no delays. On the other interesting ideas that were put forward, any of those various forms of transportation are at the disposal of the Government in any scenario should they wish to use them.

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Do I take it that the Minister is saying that the RAF and the Royal Navy may be put at the disposal of the NHS to deal with this no-deal contingency planning? I took that to be the meaning of the words that she has just said.

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No, just to be clear, I could not possibly agree to that or let the noble Lord draw that conclusion from my comments. What I am saying is that the Government will use whatever means they have at their disposal to ensure that priority needs are met where they can be and where it is necessary to do so.

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My Lords, the Government have the RAF and the Royal Navy at their disposal, and the Minister just said that they would use whatever means were at their disposal. They clearly have those services at their disposal, so why would they not use them in these extreme circumstances?

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My Lords, I know the noble Lord is pushing me to answer that question but there is nothing that I can add to the answer that I have already given.

On the impact assessments, I want to make clear once again—this relates to all three SIs, as does everything that I have said—that these instruments are limited in what they do by the powers under which they are made under the European Union (Withdrawal) Act. Those powers were debated and approved by Parliament, and an impact assessment was carried out in relation to that. There is nothing that I can add to that.

I have probably not added to the satisfaction of the noble Lord, Lord Adonis—

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Before the noble Baroness concludes, perhaps I may ask her a very specific question.

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I should like to conclude by making my last point, please.

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The noble Baroness has given way to a number of other Members. Why will she not give way to me?

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Perhaps I may conclude my final point about Scotland. Ministers in Wales and Scotland have given their consent to these SIs, as I said in my opening remarks. Senior officials in Northern Ireland have also given their consent. I recognise that it is not where we want to be, but that consent has been given and the details of the SIs are being discussed with the devolved Administrations, which have agreed them.

I am now happy to take the noble Lord’s question.

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I am grateful to the noble Baroness. She said earlier in response to points made by the noble Lord, Lord Deben, and myself, that should we find ourselves in a deal situation as opposed to a no-deal situation—these are the words the Minister used—the SI could either be revoked or amended. There is a world of difference between the two: revoking is one process, but we cannot amend an SI. A completely new SI would have to be introduced, which reinforces the point I tried to make earlier that we are indulging in an entirely speculative, hypothetical exercise on the basis of the unicorn option being where we end up, as the noble Lord, Lord Deben, made clear earlier. While I understand her and her Government to be saying that the Prime Minister’s deal is what they intend and hope will happen, if it does happen, we have to have a completely different SI. Would she like to make that absolutely clear to the Grand Committee?

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My Lords, of course, if we have a deal, these SIs will not be necessary. Perhaps I may rephrase that. If there is a deal, we do not need these SIs as they relate only to a no-deal scenario. Therefore, it is contingency planning, as I have repeatedly said throughout. Of course, if a deal is reached, new SIs will need to be laid.

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I am trying to understand this. If these deals are revoked at the end of six months, does that not assume that a new set of arrangements, in light of a deal, have been made? Is that what it means, or do they hang around in Whitehall departments for the end of the transition period if there has been no agreement, and they then get brought forward as having passed through Parliament? Excuse my suspicious mind, but I have been a senior civil servant and I have seen things taken out of the cupboard from one Government to another. Is my interpretation correct?

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My Lords, the noble Lord does have a suspicious mind, and perhaps I was not clear. This is contingency planning and the agreements that will be put in place within the six months can continue after the six months. They are not just for six months. If there is a deal, then that is an entirely different matter.

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I hate to draw out proceedings longer than any of us wish to be here, but the Minister regrettably neglected to take on the points about research, which relate to all three SIs. I should not dictate how the Minister should think, but we have an excellent NHS because of its research base and the evidence it uses, unlike nearly any other country. We have promoted that and are desperate to maintain it in these difficult circumstances and the coming years, irrespective of Brexit. The problem is one which she may not have taken on board, intellectually. During the course of an experiment, things change. You realise that you need to do a slightly different procedure from what was originally planned. That requires a new ethical procedure, consideration by an ethics committee and, sometimes, patient consent as well.

Much of this research is done on a collaborative basis between two different nations. Noble Lords will see the problem I am trying to allude to. You may have researchers in, for example, Italy with whom you have been in close collaboration and they do something to the cells that we might receive but for which we have not received ethical consent in this country. It seems that that has not been fleshed out at all in our discussions. However, it is vitally important.

I have to tell the noble Baroness that listening to the debate in this Room is a senior medical researcher who has done excellent work with cell cultures. I do not think that she will be reassured by the discussions she has heard today. This is a serious problem for scientists. I am putting this on the record not because I expect a response—it is not fair to expect that—but so that when this instrument is put before the Chamber of the House of Lords, the issue is looked at seriously. It is fundamental to some of the things we are trying to say in the debate.

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Perhaps I may respond briefly to the noble Lord, Lord Winston. I thought that I had made myself clear, but perhaps not clear enough. Research and clinical trials are outside the remit of these SIs.

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The issue is not about clinical trials; it is about collaborative research.

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Research is also outside the scope of these SIs. The noble Lord has tremendous experience in this area, which we appreciate and value. We have a fantastic NHS based on world-leading research, working with our partners across the EU. That is right, but these SIs are not about that. These are matters for greater minds than mine to think about if we exit the EU. However, as far as these SIs are concerned, we want to maintain what we have at the moment. They cover a contingency plan to ensure that we have agreements in place. However, I understand the ethical issues and the points being made by the noble Lord, Lord Winston, regarding scientific research and close working collaborations, but I am not in a position to talk about them because they are not pertinent to the SIs we are discussing today.

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The Minister has not answered my question about the processes that will be put in place for licensed establishments to apply for new import-export relationships. Can she tell the Grand Committee more about those because these establishments are keen to know what will happen? When will the processes be published in the no-deal scenario? When will the Government know what arrangements will apply, given the huge importance of import-export relationships both for the treatment of patients and, as my noble friend Lord Winston rightly said, for the conduct of research?

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My Lords, I responded to that question on two occasions. I will repeat for the noble Lord that all the processes currently in place will remain; there will not be anything new. These regulations do not bring in anything new and they do not change anything. They seek simply to put continuation plans in place should there be a no-deal Brexit. All the regulators support them.

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My Lords, I do not find that answer satisfactory. Is the Minister saying that they will not need any new import-export arrangements? My understanding is that they will. That does not affect the point that the Minister hopes that there will be no change. We are talking about a legal issue to do with the licensing arrangements. My understanding is that the existing licensing arrangements will not continue in the case of no deal, so when will establishments be informed about how they can apply and what the process will be for new and updated licences? I understand that the Minister is not in a position to tell the Grand Committee now, but I hope that she may be able to respond when we come to the third statutory instrument in this group because the same issues arise there. Perhaps she will be better briefed between the second and the third instrument so that she can reply next time.

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I am happy to respond. I hope that I am not repeating the same points, but they are important. Clearly, the noble Lord is finally beginning to understand that there will not be any new licences. Importers already have the licences they need; we will need to look only at new agreements. There is lots of information on the regulator’s website to enable organisations that deal with these different categories of issues to contact the regulator. However, at the moment we do not see that as an issue, because many of those already have templates of the agreements they use for non-EU countries. I beg to move.

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My Lords, in view of the progress of today’s discussions, it is probably not necessary for me to remind the Grand Committee of the Question I am about to put. However, if any noble Lord feels that they would like to be reminded of exactly what we are doing here, I will happily do so. Without indication of that, I will proceed to put the Question, which is that the Grand Committee do consider the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019. As many as are of that opinion will say “Content”; to the contrary, “Not content”.

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Content.

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Not content.

Motion negatived.