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

Baroness Manzoor Excerpts

Wednesday 9th January 2019 Grand Committee

Moved by

[Baroness Manzoor]

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

[Baroness Manzoor (Con)]

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

[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.

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[Baroness Thornton]

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.

[Baroness Manzoor]

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.

[Lord Tyler]

My Lords—

[Baroness Manzoor]

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

[Lord Tyler]

This is a specific point.

[Baroness Manzoor]

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

[Lord Tyler]

It is a very simple question.

[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.

[Baroness Barker]

You cannot guarantee that.

[Baroness Manzoor]

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.

[Baroness Barker]

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.

[Baroness Manzoor]

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.

[Lord Adonis]

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.

[Baroness Manzoor]

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.

[Lord Adonis]

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?

[Baroness Manzoor]

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—

[Lord Tyler]

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

[Baroness Manzoor]

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

[Lord Tyler]

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

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[Baroness Manzoor]

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, who have agreed them.

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

[Lord Tyler]

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?

[Baroness Manzoor]

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.

[Lord Warner]

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?

[Baroness Manzoor]

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.

[Lord Winston]

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.

[Baroness Manzoor]

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.

[Lord Winston]

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

[Baroness Manzoor]

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.

[Lord Adonis]

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?

[Baroness Manzoor]

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.

[Lord Adonis]

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.

[Baroness Manzoor]

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.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

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”.