Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019

Lord Deben Excerpts

Wednesday 9th January 2019 Grand Committee

[Baroness Thornton (Lab)]

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 instrutment.

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.

[Lord Deben (Con)]

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.

--- Later in debate ---

[Lord Adonis]

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.

[Lord Deben]

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.

[Lord Warner (CB)]

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.

[Lord Deben]

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.

[Lord Winston (Lab)]

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.

--- Later in debate ---

[Lord Warner]

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?

[Lord Deben]

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?

[Lord Warner]

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.

--- Later in debate ---

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.

[Lord Deben]

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.

[Lord Adonis]

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.

--- Later in debate ---

[Baroness Manzoor]

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, which consider that the changes we are advocating can be made. There is no large-scale transportation risk that we are aware of.

[Lord Deben]

My Lords—

[Baroness Manzoor]

No, I am sorry, I must move on.

[Lord Deben]

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.

[Baroness Manzoor]

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.