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House of Lords Hansard
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Quality and Safety of Organs Intended for Transplantation (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 Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019.

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My Lords, I refer the Grand Committee to the comments that I made at the start of the first SI, which also extend to this SI. I beg to move.

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My Lords, the Minister has probably now realised that the Grand Committee is not satisfied with the regulations, and it is highly unlikely that the Grand Committee will be satisfied with these regulations on organs, because they concern the cross-border trafficking of human organs. When I read these regulations, I wondered—and I have already asked the Minister to walk us through this on one occasion—how an organ which is in Spain will find its way to Manchester when a match is found. What new barriers will exist with regard to the regulatory framework, inspection, cost and travel if we crash out of the European Union? When we are talking about organ transplants, lives are at stake. I am therefore extremely concerned that we will find ourselves with people not getting organs that match from other parts of Europe, or indeed with organs in the UK which should be in Ireland. I know that there is a great deal of trafficking of organs from hospitals across the Irish border. There are therefore some serious problems here, but they have been mentioned by many noble Lords in Grand Committee over the last three hours or so. I do not necessarily agree with the noble Lord, Lord Tyler, about unicorns, but on the other hand, these orders made me extremely worried that they are not deliverable. I hope that the Minister might on this occasion be able to convince us that they are.

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My noble friend knows an awful lot more about House of Lords procedure than I do, so I seek her advice. If I were in the other place, as I was for 26 years, I would know exactly what to do. I would ask the Chair, Speaker or whoever was responsible whether it is really in order for us to consider going ahead with something that will involve more expenditure by the Department of Health and its excellent officials, who are sitting behind the Minister, given that the House of Commons decided against a no-deal Brexit yesterday. In other words, we are doing something that seems ultra vires: working on the basis of no deal, which is now not just unlikely but, pray, certain not to take place because of yesterday’s decision. How can we challenge this? How can we stop going ahead with the farce of considering these statutory instruments when we are aware of a decision taken in the other place? Should it be raised with the Clerk of the Parliaments?

I would love our present Deputy Chairman of Committees to rule on that because she is a wise woman and would rule wisely but, sadly, she does not have the power to do so. She knows, as do others, that I have raised many times on the Floor of the House the matter of giving more powers to the Speaker and, following on from that, to the Chairman of Committees, but I have got nowhere. I want to ask my long-standing friend and experienced parliamentarian, the noble Baroness, Lady Thornton, whether there is any way for us to put the Minister out of her misery and abandon both these statutory instruments and those that the noble Lord, Lord Bates—poor him—will have to struggle to deal with. How can we do that?

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My noble friend tempts me to step outside my pay grade. That is not my job.

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They do not pay you for that.

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That is true. I forgot that bit.

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You should be.

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It is not my job to say whether our discussions are ultra vires. The Constitution Committee might usefully address that issue at some point, but this Committee has already made its views quite clear to the Government during the debate on the previous two statutory instruments. I am happy to say that this matter is the Committee’s responsibility.

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My Lords, does my noble friend share our concern that although we have made our views known to the Government, we have had no response? The Minister, whom we respect for the great predicament she is in this afternoon, has not been able to respond at all to the fundamental question underlying this afternoon’s proceedings of whether there is an adequate legal or moral basis for us to debate these statutory instruments when yesterday, the House of Commons—the supreme, elected body—voted specifically against no-deal preparations precisely because it did not want to see these arrangements, which it described as a Brexit “game of chicken”, put in place. Does my noble friend not think that as the Opposition, it is our job to hold the Government to account? Perhaps this debate must happen in the Chamber—as the Minister said, this is above her pay grade—but we need to be robust in asking why these statutory instruments and no-deal preparations are proceeding, as well as why £4 billion is being spent, in a situation that looks legally dubious and morally bankrupt after the Commons vote last night.

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Along with the noble Lords, Lord Deben and Lord Tyler, and other noble Lords, my noble friend has done rather a good job of ensuring that these issues will be taken to where they belong: the Floor of the House.

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My Lords, we have had a lengthy debate, but it has been extremely helpful and important, and that was best illustrated during the debate on the previous instrument, in the answer the noble Baroness, Lady Manzoor, gave to my question about the inspection of premises. I made the point that the noble Baroness has repeatedly said that this is about ensuring existing arrangements continue. When I challenged her, she was given instant advice that we were talking only about the question of importing organs and tissue, not exporting. That is brilliant; in effect we are not, in a no-deal scenario, going to continue with an existing arrangement for the EU 28, but will, from that point on, be a third country. Whatever we may wish or hope for, the EU will be under no obligation to treat us under continuing and existing laws. Therefore we will inevitably be at a disadvantage. That was extremely helpful.

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But does that not also underline what my noble friends says: that this is not a change in any way? What we mean is that were there to be a no deal, it is not this that changes but that the world changes, and this does not address that change. Therefore the problem is that because that change is not addressed, it will affect us. It will not be as safe or as possible to ensure we can import necessary organs, not just because there will not be any aeroplanes or because there will be problems with boats, but because there will not be a mechanism on that side; we will have a mechanism here. That is a fact of change. Nothing we say will cover the fact that there is a change to which the Government have no contingency plan at all, because they cannot have it.

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Yes, and specifically, I want to ask the noble Baroness about traceability. In these regulations it says that the UK is planning to introduce its own coding system once it is no longer taking part in the EU Coding Platform. Is it right to assume that we will revert to a traceability system that was in place before the EU Coding Platform was introduced, and will it be of the same standard that we have now? I suspect it will not, and therefore the Government should be clear and say that in the matter of the importing and exporting of organs—which are, let us bear in mind, in short supply across the world—we are going to place ourselves at a disadvantage.

I will ask one other question. It is clearly stated that a number of powers currently belonging to the Commission are being transferred to the Secretary of State. Does the Secretary of State have the capacity to make changes in relation to traceability, notification of adverse events and testing to establish whether tissue sent to the UK is free of infection? How can it can be demonstrated that new techniques used to process cells and tissues are safe and effective? And what is going to be the cost of that to the NHS? I am not holding my breath, but I would say that the evidence of the last three hours suggests that this Government is prepared to take a massive gamble with the health of our population.

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I put a question to the noble Baroness, similar to the one I put to my noble friend. Tomorrow, on the Floor of the House, her compatriot, her fellow Liberal Democrat, the noble Lord, Lord Beith, has a question:

“To ask Her Majesty’s Government what assessment they have made of the Parliamentary time required for the consideration and approval of statutory instruments arising from the United Kingdom’s withdrawal from the European Union”.

Would that be a good opportunity to raise the question about ultra vires?

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My Lords, procedure and process in this House is not one of my specialities, but I understand that my noble friend Lord Beith has put that Question down, precisely because the whole House knows that there is absolutely no way we can sit from now until the planned Brexit day and get through the amount of work. Therefore, a great many matters will be left unexamined, and that is quite dangerous.

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My Lords, I want to comment on this set of regulations but will relate my remarks to all 10. I address my remarks to the three Ministers here, bearing in mind the three hours that we have spent on these regulations so far, as the noble Baroness, Lady Barker, has said. It can be taken as given that most of what I, the noble Lord, Lord Winston, and others said on the previous set of regulations is what we would say on this set of regulations, but I am not going to repeat it. The same considerations apply.

We are not going to get to number nine on the list, and I want to question what the Minister has been saying, and what the Government have been asserting, all the way along, which is that these regulations do not change policy. The Minister has said this a number of times. I know from the speech I am going to make on number nine that it has changed policy, and I shall deploy the arguments to demonstrate that. Unfortunately, the noble Lord, Lord Henley, is not here to hear them, but if I ever get the chance, he will hear them.

I have a terrible feeling that my concerns about item nine apply all the way through this set of regulations. They do change policy and, although this is not the Minister’s fault, the Government have been asserting for month after month that they do not. They do, and they change policy that is set out in primary legislation in some cases. We do not have any alternative, if I may say to the Grand Committee, to continuing to negative—or whatever the verb is—all these sets of regulations. We can go through this process all the way down to item 10 if the Government want us to do that. I am quite prepared to do that to make the point to the Government. I am doing that not as a member of any party—I am the only Cross-Bench Peer in the Room—but because we are discrediting this House by giving an authenticity to these regulations, which I fear would then get tucked away in the cupboards of Whitehall to be produced again when the need arises. I do not want to be associated with giving authenticity to this set of regulations, and would hope that other Members, of different political parties, feel the same way. I want these three Ministers, who have heard this and sat through this very patiently, to go to the Chief Whip and the powers that be in the government party with feedback about the farce being created.

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My Lords, for two years, the Government have been implementing a significant programme of work to ensure that the UK will be ready, from day one, in all Brexit scenarios, and I have tried to make that clear throughout the three SIs. For organs, tissues and cells, our priority is to ensure the continuity of supply and to maintain the existing high standards of safety and quality. Organs for transplant and stem cells need to be transported urgently, as has been made clear today, and we are working across government with the health sector to prepare for, and mitigate, any possible disruption which may affect the organs or stem cells imported from the EU. For other less time-sensitive tissues and cells, we are also preparing for possible disruption, and information for tissue establishments will be available through the regulator.

This has been an interesting debate. I for one take very seriously the comments that have been made by noble Lords. I will endeavour to ensure that the Chief Whip is made entirely aware of the comments regarding SI processes and the future. I have already undertaken to do that but it is important to restate the point.

I move to some of the specific issues that were raised by noble Lords. I again thank the noble Baroness, Lady Thornton, for trying to keep the balance; I appreciate the fact that she tried to bring the debate back to the actual SIs. The EU directives allow EU countries to share organs with third countries, which is of course what we will become if and when we exit the EU, so it will be possible for organs to be shared as they are now in a no-deal scenario. NHS Blood and Transplant is the UK’s organ and donation organisation, and it is talking to EU organisations about making new agreements.

At the moment, licensed establishments do not need a licence to import tissues and cells from the EU. After exit they will, and they will need to put appropriate agreements in place. The six months will allow that to happen while the sharing of cells and tissues continues. All current importers from the EU already hold an import licence so no additional licences will be needed, only agreements.

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Sorry, can I clarify what the Minister has just said? The EU is allowed to export to a third country but it is under no obligation to do so. At the moment we are members of the EU so bodies do not have to have an import licence, but they will. So she is saying that there could be six months in which the EU could choose not to export to us as a third country and in which the organisations in this country will have no power to import. We are potentially talking about at least a six-month gap about which we can do nothing because we will no longer be in the EU.

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No, my Lords, we are not talking about a gap. We are actually talking about the continuation of what we have in place at the moment. That is why we are making these contingency plans.

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My Lords—

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No, I am sorry, we have discussed these issues. Many of the same issues are coming up on all three SIs.

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The Minister has not answered the points. That is why we keep raising them. If she provides inadequate answers, I am afraid they remain inadequate.

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I am afraid that is the only answer I can give, even if it is not one that the noble Lord, Lord Adonis, feels is adequate. If there are issues that I feel I need to write to noble Lords about, I will do so, but I think I have given the best answer that is available to me.

The noble Baroness, Lady Barker, raised an important point regarding traceability. The requirement to ensure the traceability of tissues and cells, including reproductive cells, will remain. UK-licensed establishments were already using systems to ensure traceability from donor to receiver of tissues and cells before the introduction of the single European code, and in most cases the code was added to the existing system. After exit, UK-licensed establishments will be able to use the same IT systems that they are using now if they want to. The code will be removed and establishments will use the traceability system that was in place before the introduction of the single European code.

The noble Baroness asked about the powers and the instruments in relation to the Secretary of State. The Secretary of State can make changes to deal with new safety issues, and that is what the SIs will enable to happen. If the Government decided to do that, though, they would need to make new regulations which would have to have parliamentary scrutiny at that point, so he cannot do it just like that.

I restate that all the points that I have made relating to all three SIs go across the board for all of them. I hope noble Lords will appreciate that I have done my best to answer as many of the points as I could, if not all of them. I cannot go any further in terms of processes of statutory instruments and what the Committee can or cannot do, nor can I comment on the wider EU Brexit deal.

I thank all noble Lords who have taken part in this excellent debate. I believe in the scrutiny of legislation, and noble Lords have certainly carried that out with gusto today. I beg to move.

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The Question is that the Grand Committee do consider the draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019.

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Not content.

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Not content.

Motion negatived.

Committee adjourned at 7.50 pm.