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Grand Committee

Volume 794: debated on Wednesday 9 January 2019

Grand Committee

Wednesday 9 January 2019

Arrangement of Business


Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019.

I am grateful to the Minister for giving way. Could we ask that these are degrouped and that we consider them each individually, please?

I understand the issue that is being raised. Perhaps I may say that the three sets of regulations bring in very similar provisions but have been drafted separately, as they amend different legislation. I am happy to take each statutory instrument separately. However, just to give advance notice, my speech will be the same.

Perhaps I may begin again. We are debating three sets of regulations which are critical in maintaining patient safety for organs, tissues and cells used to treat patients. The regulations have been developed as part of contingency planning and will be needed if we leave the EU with no agreement in place. If the UK reaches a deal with the EU, the department will revoke or amend these instruments to reflect the deal.

The Minister has confirmed that these regulations would have a purpose only if there were no deal, so all the time that she and the excellent five civil servants behind her have put in—and they have done a lot of work—will be unnecessary if a deal is agreed. Is that right?

With all due respect to the noble Lord, of course, as the Government, we have to put in place contingency planning. If the noble Lord will allow me to finish what I am going to say, he will understand what the regulations relate to and the reason we are putting them down.

So the corollary of that is that all the work that she has done, and that of her predecessor, the noble Lord, Lord Shaughnessy—whom we miss; sadly, he is no longer a Minister—and all the work that the civil servants have put in is nugatory: it will be forgotten and wasted if a deal is agreed, which is the Government’s policy. Is that right?

My Lords, I do not know what the deal will be, if it is agreed. All I can do is deal with these SIs. I am not here to talk about the deal or the no-deal. We have done contingency planning as to what would happen to ensure patient safety and organ donations, imports and exports. The SIs relate to that. Perhaps I may continue, if the noble Lord is happy with that answer.

Not really; I am not clear about this. If there is a deal, does it include something that deals with human fertilisation and embryology, which would mean that we do not need this SI? Does a part of the deal negotiated by the Prime Minister—not yet agreed by Parliament but negotiated by the Prime Minister—already cover the substance of this SI, and this SI is relevant only if there is no deal? Is that correct?

Yes, I have confirmed that to the noble Lord already, but we have to make contingency plans. That is why I am standing before the Committee to explain what we are doing.

Perhaps I may begin again in order to provide the context. We are debating three sets of regulations. They are critical in maintaining patient safety for organs, tissues and cells used to treat patients. These regulations have been developed as part of contingency planning, and will be needed if we leave the EU with no agreement, and I am happy to confirm that again to the noble Lord. If the UK reaches a deal with the EU, the department will revoke or amend these instruments to reflect that deal.

My Lords, I am grateful to the Minister for giving way. In view of the fact that the House of Commons voted yesterday against no deal being taken forward—and it is the elected House, we are the subordinate House—does she not think that the right thing to do is to not proceed with these no-deal preparations, but instead to devote the time of the Grand Committee and the House to issues where we can make a difference? Many of us were not able to be present in the Chamber for the opening speeches in the debate on the EU withdrawal deal because of this debate. I might respectfully say that her department would not have to waste all this money and time, and her great devotion to duty, on something which is clearly against the will of the elected House.

My Lords, I understand the point the noble Lord is making, but I disagree with him. This is about contingency planning, and we will move forward in that way. It is right and proper that the Government do this, and any sensible Government would be planning for any eventuality.

I want to get to the end of what I am going to say. Both noble Lords will have the chance to make their contributions then.

Well, they may well get answers if they allow me to finish.

These instruments, which will come into force on exit day, will ensure that UK law on organs, tissues and cells functions effectively after exit day, and maintains the same high standards of safety and quality. The instruments are intended to maintain the current regulatory framework across the UK, so UK organisations such as hospitals, stem cell laboratories, tissue banks and fertility clinics will continue to work to the same high quality and safety standards as they did prior to exit.

I have not given way. I am sorry but I need to finish. I need to make some progress. I have given way on a number of occasions, so forgive me.

The instruments are being made under the European Union (Withdrawal) Act 2018. They make appropriate amendments and revocations to correct deficiencies in UK law and retained EU law. Regardless of one’s views on EU exit, we can all agree that UK patients should have every opportunity to access the life-changing therapies covered by these regulations, such as: organs, including hearts to treat heart failure; stem cells used to treat blood cancers; corneas to restore sight or skin grafts to treat burns; and eggs and sperm to treat infertility.

Some organs, tissues and cells move between the UK and the EU. The proposed amendments are critical to ensuring that this movement can continue if we exit the EU without a deal in March 2019—and I stress again for noble Lords, if we leave without a deal.

A small number of organs are shared with EU and non-EU countries, with fewer than 30 organs on average being imported or exported each year. Tissues and cells are imported from and exported to EU countries less often than they are imported from and exported to countries outside the EU. There are around 5,000 imports of tissues and cells from the EU in a typical year. That includes around 600 imports of stem cells and 3,000 imports of bone products. The UK imports donated sperm, primarily from commercial sperm banks in the USA and Denmark.

To be clear, these instruments are limited to the necessary technical amendments to ensure that the legislation is operative on EU exit day. The instruments confer powers from the European Commission to the Secretary of State and the devolved Administrations to make technical changes. However, no policy changes are made through these regulations and we have no intention of making any at this point. I hope that that reassures noble Lords.

The main changes that these instruments would introduce are as follows. First, in the event of no deal, the UK and the EU will consider each other to be third countries; the regulations redefine the term “third country” to include EU countries and Gibraltar. As a result, licensed establishments will need to make administrative changes to continue to import organs, tissues and cells from EU countries and Gibraltar. For example, establishments may need to put new agreements in place with their EU supplier.

Secondly, the regulations amend a number of references contained in current UK legislation that will no longer be appropriate once the UK withdraws from the EU, such as references to obligations with which the UK must comply as an EU member state. For example, the instruments remove the obligation for UK regulators to share information on serious adverse incidents with the European Commission, as this was meant to be a reciprocal obligation of information sharing and we cannot keep an obligation that can be fulfilled by only one side. However, licensed establishments that exchange organs, tissues and cells with the EU will still have the obligation to report any serious adverse incident that may have affected their quality and safety to the UK regulators within 24 hours. That obligation extends to activities carried out in the EU.

Can the Minister clarify something for me? I may have missed something. Who is the obligation on? Is the obligation on the EU to tell us, us to tell the EU or both?

Yes, it is critical. The obligation applies to both sides within the 24-hour period I mentioned. UK regulators will therefore continue to receive information on serious adverse events.

I want further clarification on that point. Why will the EU be obliged to tell us things if we crash out?

Obviously, our licence and the agreements we have in place will enable that to happen on both sides. We hope that those close partnerships will continue after we exit if we exit with a no-deal agreement.

My Lords, can the Minister tell the Committee whether those licences are already in place? It sounds as though the Minister is expressing an aspiration for those licence agreements to be in place. We are talking about arrangements that will need to be put in place in just two months’ time.

I will come back to that when I speak later.

The UK regulators will therefore continue to receive information on serious adverse events and reactions related to organs, tissues and cells imported from the EU and the national reporting systems that the UK competent authorities operate will not be affected post exit. I hope that that answers the noble Lord’s question.

Is that a fact or a statement of aspiration? I ask that because there is a very important difference. Is the Minister talking about what she hopes will happen or what she can tell the Grand Committee is in fact the case because of licence arrangements with our European partners that are currently in place?

I can say to the noble Lord that if we leave the EU with a no-deal Brexit, licensed establishments are obliged to report all incidents whether they occur in the UK or in any other country. I think that the question the noble Lord is asking is why we would have licences anyway. Why would they talk to each other if we are no longer part of the team? I think that that is what the noble Lord is saying. Because these agreements are already in place, they will continue. There will be a six-month period, if we leave without a deal, to ensure that all the licences with whichever parties they are with are updated and put in place.

Perhaps I may ask for some clarification of that. The licences will continue to exist for only six months. Is that what the noble Baroness has just said? I repeat: the licences that we are talking about will continue for only six months.

Perhaps I may revert to that because we are getting into the questions when I would like to move forward. Noble Lords will have a chance to come back to me with questions.

The regulations also modify how some of the requirements in the directives which are referred to in our domestic legislation are to be read post exit. We are talking about the scenarios if there is no deal. This is necessary to ensure that the requirements referred to function properly post exit.

Thirdly, these instruments transfer powers from the Commission to the Secretary of State and the devolved Administrations, where these are within their competence, to allow the Government to respond to emerging threats, changes to quality and safety standards and technological advances. Legislative competence for the donation, processing and use in treatment of human reproductive cells—sperm, eggs and embryos—is reserved to Westminster. Competence in respect of all other human tissues, cells and organs is devolved and the relevant instruments are being made on a UK-wide basis with the consent of the devolved Administrations. NHS Blood and Transplant oversees organ donation and transplantation on a UK-wide basis, and we have UK-wide regulators in this area.

The changes in these instruments were discussed with the UK regulators, the Human Tissue Authority and the Human Fertilisation and Embryology Authority, along with issues of operational implementation. The regulators have been working with their licensed establishments to consider the changes introduced by these instruments and no issues of concern have been raised. The impact of these instruments on businesses and public bodies will be low. Only establishments that import from or export to EU countries will be affected.

I turn now particularly to organs. NHS Blood and Transplant is the UK transplant organisation. NHSBT and the Human Tissue Authority will work together to put any new arrangements in place as needed to allow organ exchange to continue post exit. There is no impact on organ transplant centres. In terms of tissues and cells, licensed establishments that import tissues and cells will need to put new agreements in place so that they can continue to import tissues and cells from EU countries. That is what I have said already in answer to a question put by the noble Lord, Lord Adonis. The instruments give a six-month transition period to give them time to do this, which is what I pointed out previously in response to a question.

I am sorry but I really want to finish. I will then be happy to take any questions.

During this period, imports and exports will continue to take place as long as the regulatory authorities are satisfied that equivalent standards are met—that is on both sides. We estimate that all these establishments will also import tissues and cells from third countries and so will be able to use their existing written agreements as a template. Licensed establishments that export tissues and cells will also need to put new agreements in place. The timings for this will be determined by the requirements in the relevant EU country. Again, we estimate that all these establishments will also export tissues and cells to third countries and so should be able to use their existing written agreements as a template. The UK regulators will continue to advise and support all tissue establishments in preparing for exit day. In addition to ensuring that the regulations are operable, we continue to proportionately prepare for the continued safe supply of organs, tissues and cells across the UK in all potential EU exit outcomes. I beg to move.

Before the Minister sits down and my noble friend makes her speech—which I am much looking forward to—a number of key concerns were raised about these regulations in the House of Commons when they were debated there, which the Minister has not referred to at all. There was the issue of the costs that will be incurred by establishments and how that will be met; the issue of what happens with problems in the ports, because of course a lot of this involves very sensitive movements of materials such as organs and tissues, and no satisfactory answer was given on that; and the issue of licensed establishments applying for new import/export relationships. It would help the Committee enormously if the Minister were able to give us some information on those three crucial issues. Those central issues were raised in the consideration of these regulations by the House of Commons.

My Lords, may I seek clarification? As I understand it, the Grand Committee is currently discussing only the first regulation. The Minister drifted into the other two regulations, which are the responsibility of her department, but have I got it right that we are currently looking only at the first instrument?

Indeed, I intend to address only that regulation. I do not intend to make the same speech about all three orders. My noble friend is quite right about the issues that he has mentioned, and that applies to all these three orders, so I will not go into that detail.

I thank the Minister for introducing this SI, which, as she said, is necessary only if we crash out of the European Union. I say to the Minister—as I said to her colleague the noble Lord, Lord O’Shaughnessy, whenever I have had to deal with these sad statutory instruments—that this is a gross waste of public money and time, and expertise that could be better used elsewhere. I put that on the record again. This set of SIs, and particularly the one about human embryology, deals with hugely important issues for people’s personal lives in different ways, and to get them wrong would therefore be potentially devastating for the people concerned.

On the first regulations, on embryology, the UK currently imports sperm primarily from sperm banks in the USA and Denmark, as the noble Baroness said. How will that traffic in particular be affected by Brexit and these instruments? The regime that we currently have in the European Union obliges us to inspect third country premises. As the UK will no longer be an EEA member, we will become a third country. I ought to explain that to the Committee because, although the Minister alluded to it, that is the truth. That will happen if we crash out at the end of March. I would like the Minister to confirm that that is correct.

We are very fortunate in the UK to have two reputable bodies, the Human Tissue Authority and the very experienced Human Fertilisation and Embryology Authority, which was the first in the world to be dealing with this. It is currently the body that inspects UK premises on behalf of the European Union, which makes sense. So what is going to happen? Who is going to carry out the inspections of all the different premises? And what happens the other way round? Are we entitled to inspect those premises across the European Union that deal with the Human Fertilisation and Embryology Authority? Will this cause delay in the production of embryos and tissues required by the Human Fertilisation and Embryology Authority? After the six-month grace period to comply with EU requirements, will premises involved in these issues then be inspected by EU regulators? I will probably repeat that question on the other two SIs.

I had hoped that when the noble Baroness explained these orders to the Grand Committee, we would find ourselves enlightened, but I find myself even more concerned, and so I am going to leave those remarks on this particular SI where they are and return to human tissues and organs when we reach those.

Since we are faced with no less than 10 significant Brexit-related statutory instruments this afternoon, the first such substantial group—with implications for scrutiny of hundreds to come—and since there are important general issues here, this is my only opportunity to make some general comments and suggestions based on my service on the Delegated Powers and Regulatory Reform Committee. As the Minister has been at pains to emphasise to the Grand Committee, this is contingency planning for no deal, and I note the comments made by both the noble Baroness and other members of the Committee. But that does not relieve the responsibility on the House and on this Committee to ensure the scrutiny is as careful as it can be, and to ensure that if we find ourselves in a different circumstance, we are also prepared for scrutiny of the different issues that may arise. We have no idea what sort of Brexit there is going to be, or whether there is going to be any Brexit at all. I do not expect to contribute to the individual debates on each one of these 10 SIs, because I do not have the expertise of my colleagues here who will be addressing the individual issues. But I am advised that this is the only appropriate opportunity to make some general comments.

I am sure that all three Ministers bringing these Motions before the Grand Committee today will have read carefully—or have been carefully briefed on—the recent report of the Constitution Committee, a well-regarded committee of your Lordships’ House that we all pay huge regard to because of its expertise and experience. The Grand Committee will also be aware of the report entitled The Legislative Process: The Delegation of Powers. It made explicit reference to the critical importance of “effective and timely scrutiny” of Brexit-related secondary legislation, and is so relevant to the 10 instruments in front of us this afternoon—and to this special scrutiny of Brexit SIs—that it would be unthinkable if Ministers were not fully briefed on its recommendations. I do not need to read extracts to the Grand Committee, but will confine myself to key recommendations. That being said, I do not need to read long extracts from the committee’s analysis to this afternoon’s meeting of the Grand Committee; instead, I shall confine myself to key recommendations. In passing, though, I should note that the committee took extensive evidence from a host of authoritative parliamentarians, including senior Ministers, as well as from the Secondary Legislation Select Committee of your Lordships’ House and the Delegated Powers and Regulatory Reform Committee, on which I serve.

I turn to a number of those very important regulations in the context of this SI. The first is a recommendation in paragraph 106:

“There is no provision for amending statutory instruments and we are not proposing one. However, this means that Parliament’s only options when presented with an inappropriate or defective statutory instrument are to accept it or reject it. This places a greater onus on the Government to respond to the concerns raised by parliamentarians, and to withdraw and re-lay statutory instruments where appropriate”.

Because this is contingency planning, these may very well be precisely the circumstances that we are addressing here with these instruments today. I am sure that all Members here will be listening carefully to Ministers when they respond to our concerns, because this is not the constitutional equivalent of a fait accompli.

My Lords, the noble Lord is making a very effective speech. Does he not think that having 10 of these very important statutory instruments scheduled for one meeting of the Grand Committee is, frankly, insulting to the House in the expectation that the Government are holding as to the amount of scrutiny that we will give to each of these extremely important orders?

Looking around the Room, I can see some very experienced Members of your Lordships’ House. I am sure that we will deal with these instruments in a very effective way, as it is our responsibility collectively to give them the attention that they deserve. Despite the fact that, as the Minister has made clear, this may well be a wasted exercise, we still have to do it properly.

I turn to another recommendation from the Constitution Committee in paragraph 110:

“If the Government uses delegated powers to propose secondary legislation which makes technical provision within the boundaries of the policy and has previously been agreed in primary legislation, Parliament is unlikely to wish to block statutory instruments. However, we are concerned, and this report has shown, that these boundaries are not always respected and that ministers may seek to use statutory instruments to give effect to significant policy decisions. Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable”.

We in your Lordships’ House all have a responsibility to ensure that the work that we do here is done with meticulous care. Here is an example: this instrument is the beginning of a whole sequence, a flood, of SIs coming before your Lordships’ House—we are told there are going to be hundreds—and each time we have one before us we have to make a careful assessment of whether it is necessary, quite apart from whether it is effective. As the Minister has already said, the instrument before us is simply in case there is a no-deal outcome. The Government have made it so clear over recent weeks that that is not their favoured outcome—they keep telling us what dire consequences there would be for the country if it happened—that it may well be asked whether we are spending our time profitably in this circumstance, so that is particularly appropriate to this section of our discussion today.

I hope the noble Lord will forgive me; he is much more experienced than I am about the consideration of statutory instruments. The House of Commons Procedure Committee produced its sixth report of the Session on 4 July last year on the scrutiny of delegated legislation under the European Union (Withdrawal) Act, which is of course precisely what we are engaged in here. It said in paragraph 56:

“We estimate that the latest day on which an instrument subject to negative resolution can be laid so that praying time expires on 29 March 2019 is Monday 18 February 2019. The latest day on which a proposed negative can be laid before Parliament so that the period for consideration expires before 18 February 2019”—

which was what the Government had then said was their aspiration—

“is Friday 25 January 2019”.

That is respectively three weeks and six weeks from the present date. Does the noble Lord, with his great experience of these matters, think it credible that these hundreds of instruments which apparently are going to be needed to implement the no deal could conceivably be laid in time for these procedures to be conducted by either Friday 25 January or Monday 18 February?

Friday 25 January is even sooner than the noble Lord said, I think. Not for the first time, the noble Lord has jumped ahead of my speech for me. I shall come back to this point later because I share his concern. I served in the other place on the Procedure Committee and I have the greatest respect for the very professional way it looks at matters of procedure. I have to say, though—and this comes out very fully in the report of our Constitution Committee—that I do not have the same respect for the extent to which it scrutinises secondary legislation, which lays an additional responsibility on your Lordships’ House to do this with extreme care. So I shall come back to the point about the timetabling that the noble Lord has referred to.

Yesterday in the Chamber, in Committee on the Financial Services (Implementation of Legislation) Bill, there was a succession of exchanges between my noble friend Lady Bowles of Berkhamsted and the noble Lord, Lord Bates—who is here; he is always here at exactly the right moment, as we all know from previous experience—on this very relevant issue. Indeed, the advice of the Delegated Powers and Regulatory Reform Committee was referred to on a number of occasions so I pay tribute to the noble Lord, Lord Bates, because he undertook, at col. 2144, to come back to the concerns of the Committee on Report. I hope he might be prepared to extend the discussions he is undertaking to set in motion beyond the Members who took part in the debate yesterday to include those of us who serve on the Delegated Powers Committee, and to consider more generally the issues that were raised by it.

The Constitution Committee recommends in paragraph 111:

“The Government already has a mechanism to remedy faults in statutory instruments which are identified by parliamentary scrutiny. SIs subject to the affirmative procedure are made only when signed by a minister after parliamentary debates have taken place; until they are signed, they can be withdrawn, revised and re-laid. SIs subject to the negative procedure come into force on the date specified on the instrument, but the Government already has the power to lay a second SI to revoke and replace the first”.

That is particularly relevant to the SI before us because it is highly likely that in its present form, it will not be as effective or possibly even as necessary as the Minister is now saying, because, as she admits, this is all contingency planning for an outcome that the House of Commons has already said it does not wish to see and the Government keep telling us is such a dire consequence that we should be blackmailed into accepting some other outcome. On all sides, the circumstances are likely to change and in those circumstances this SI may be totally obsolete and an anachronism, or it may need to be revised. But in such circumstances it is the responsibility of the Government to come back to your Lordships’ House with a new proposition.

My Lords, I am grateful to the noble Lord for giving way again. Of course, a big issue is what happens if the Grand Committee is not persuaded that we should agree these regulations this afternoon. It is certainly my opinion, and I think it may be the opinion of some of my noble friends, that we should not do so at the end of this debate. I am unfamiliar with the procedures of the House—this will be important; I think it will also impact on many other statutory instruments—as to what will happen in that event. My understanding is that the Grand Committee has to agree proposals by unanimity because it cannot vote, so if we do not agree on approving this statutory instrument, does it automatically go to the House itself? I assume that that would be the acceptable procedure. Is there a guarantee that we would then get to debate it properly and fully and get the fuller explanation and the revisions which may be necessary, as the noble Lord has just set out, in a full debate in the Chamber itself?

My Lords, I am getting worried the noble Lord seems to be able to read my mind. I am no expert on that particular issue, because it is unusual, but I think he is technically correct. We cannot vote within the Grand Committee, so it has to go back to the Floor of the House. Time has to be found for that, but we have very little time before the projected, but totally unrealistic, date of 29 March.

I revert back to the Constitution Committee’s recommendation, which is a timely reminder for all of us—especially Ministers and their departments—that it is totally unacceptable for Parliament to be forced to approve a defective SI. The mechanisms are there to make sure that does not happen, with no excuses of time pressure, complexity or expediency. How often we hear that argument in present circumstances: “Oh, but it is expedient”. Is it really expedient? Is this particular instrument before the Grand Committee expedient? We are told it is only to be used in extreme circumstances which everybody says they want to avoid.

We have a responsibility, and have to ensure that the eventual legislative product avoids defects. Incidentally, there are several potential incidents of Henry VIII powers in the 10 orders with us this afternoon. It is always difficult to see precisely whether Henry VIII is raising his head, if I may use that expression. There are some such powers there, and that should give us cause for concern.

At the end of this SI, and of some of the others we are coming to later, there is a statement to the effect that:

“A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sectors is foreseen”.

I have read speedily the Explanatory Memorandum for this particular order. I cannot see any persuasive argument for why it is not possible that there could be a significant impact. Who makes that decision? What are the criteria for deciding whether something does or does not have a potential significant impact? We are right to question the extent to which this particular SI is in order.

I turn to recommendation 112 from the Constitution Committee’s recent report. It states:

“However, for these processes to work, the Government must take account of the scrutiny of statutory instruments and respond promptly to remedy any deficiencies. Where it does not do so, in exceptional circumstances Parliament may use its existing powers to block such instruments. The Government should recognise that parliamentary defeat on a statutory instrument need not be considered momentous nor fatal. It does not prevent the Government subsequently tabling a revised SI having listened to and acted on parliamentarians’ concerns”.

This is an important recommendation. It is, of course, the constitutional position, so they could not avoid it. I served on the Joint Committee on Conventions, which reported in 2006. Its recommendations were approved unanimously by both Houses. In particular, at paragraph 228, it states:

“The Government appear to consider that any defeat of an SI by the Lords is a breach of convention. We disagree. It is not incompatible with the role of a revising chamber to reject an SI, since (a) the Lords (rightly or wrongly) cannot exercise its revising role by amending the SI or in any other way (b) the Government can bring the SI forward again immediately, with or without substantive amendment, as described by the Clerk of the Parliaments, and (c) the power to reject SIs gives purpose and leverage to scrutiny by the Joint Committee on SIs, and by the new Lords Committee on the Merits of SIs. The Government’s argument that ‘it is for the Commons, as the source of Ministers’ authority, to withhold or grant their endorsement of Ministers’ actions’ is an argument against having a second chamber at all, and we reject it”.

That was a Labour Government, and I hope the present Ministers would not have made such an absurd proposition.

My Lords, the noble Lord continues to make an extremely powerful argument. Does he not think that after the action of the House in rejecting the former Chancellor George Osborne’s tax credit changes two and a half years ago, and when the Government then promptly withdrew those regulations and did not proceed with them, that actually constituted a very important constitutional precedent for how this House should behave? However, to all intents and purposes, all that your Lordships did was to ask the House of Commons to think again. Because the Government believed that they would not be able to mobilise a majority in the House of Commons they withdrew those regulations. That, I think, was a powerful vindication of the scrutiny role of the House of Lords and dealt with the issue of our rejection being somehow unconstitutional because it was regarded as being favourable. But the reality, of course, is that the Government reintroduced regulations in the House of Commons and could carry them there. They would then come back to us with a renewed majority which would significantly influence how your Lordships behaved. The implication of that is that it would be perfectly reasonable for us to reject statutory instruments the first time in order to test the opinion of the House of Commons as to whether it wished to proceed with them. That is particularly important in the case of these no-deal regulations because it is not clear to your Lordships whether it is in fact the will of the House of Commons that we should proceed with no deal.

My Lords, perhaps I may help the Grand Committee. Noble Lords are not being asked to approve the instruments on behalf of the House. As noble Lords, in particular the noble Lord, Lord Tyler, will know, Motions have to be brought back to the House and if the House then wishes to go to a vote, it can do so. My point today is to set out the arguments for the SIs and the importance of why we need to take this action. However, the SIs will be brought back to the House for approval.

I understand that and I am grateful to the Minister for making the point. However, I think that the point the noble Lord has made is perfectly reasonable.

The noble Lord has been in this House for a long time. I hope that he is not being taken in by what the Minister has said. If we accept what she has said and we let the regulations go through on the nod, they go on to a list and will go through the House on the nod. However, if in the end we object, as I did, to a previous instrument, there has to be a proper debate in the House at an agreed time. That is the important issue.

My Lords, I am very much a newbie so I offer my sincere apologies if I have misunderstood. However, my understanding is that all statutory instruments go back to the House and any Member can get up and ask for a vote. It is not simply a nod from the House. The noble Lord is fully aware of that and I have heard him say so himself in the Chamber.

Perhaps I can help the Grand Committee. I should remind noble Lords that the Motion before them is to consider the regulations. I must emphasise the word “consider”, not to approve them. Whatever happens in the Grand Committee, the Government will need to table an approval Motion in the Chamber where any Member can properly register disagreement and table an amendment to debate the Motion.

I thank the Deputy Chairman for that clarification and I am pleased that his words bear out the point I have just made to the noble Lord.

I want simply to respond to the point made by the noble Lord, Lord Adonis. Technically, of course, the House did not reject that particular statutory instrument. The noble Lord may recall that the Motion was very carefully phrased in order to delay its implementation until certain circumstances had been approved. That same evening, a straight rejection was voted down in the House, so I do not think that that situation is strictly comparable to the one that we now face, with this stream of contingency planning SIs—I emphasise the point that the Minister has made this afternoon. These are speculative SIs, if you like, dealing with situations that all of us now must surely think are unlikely. From what the Minister has said, it appears that the House will be subjected to a whole stream of SIs that may never be required. That is an extraordinary way to treat your Lordships’ House.

Finally, I turn to paragraph 113. As I am sure your Lordships will be glad to hear, this is shorter—

Perhaps I may again interrupt, because I do not feel that we are considering the regulations. Of course, I bow to the much greater experience of the noble Lord on constitutional issues. As I said, I am very much a newbie, relatively speaking. However, neither the Joint Committee on Statutory Instruments nor the Secondary Legislation Scrutiny Committee drew to the House’s attention anything special in the three SIs that we are considering. I bring that to the attention of the Grand Committee. We can spend a lot of time looking at processes and procedures relating to SIs, but perhaps I may put in a small plea. This is about considering the three SIs before us, which are important for contingency planning, and I would like us to move forward, if we can.

I hear what the noble Baroness says, but she is technically not correct. At the moment, we are considering only one. Setting that on the table for a moment, I wanted to—

I hope that the noble Lord, who is making a powerful case, will in no way be dissuaded from applying his full powers of scrutiny to these regulations. It would be totally unacceptable if the Grand Committee were in any way influenced by a Minister into thinking that it should not fulfil its constitutional responsibility to give full consideration to each of these instruments individually, not least because, if this issue is to go to the House for a proper debate, as it appears it will, Members of the House will need to be informed by the debate in the Grand Committee and we should not suppress full consideration of the issues at stake.

My Lords, for the record let me say that I am not for a minute suggesting that we should not have full and proper scrutiny of any legislation, whether in Grand Committee or in the Chamber. I value that. At the moment, however, we are talking about processes regarding SIs and not the regulations before us.

My Lords, it is unfortunate that we have not had an opportunity to have a general discussion in the Chamber about this process; otherwise, I could have made this speech then. The report was published by the Constitution Committee of your Lordships’ House on 20 November last year. It is on process and is extremely important. Had the Government made time for that discussion, we could have approached these issues in a different way.

Finally, let me come to the recommendation in paragraph 113, which says:

“If the Government’s current approach to delegated legislation persists, or the situation deteriorates further, the established constitutional restraint shown by the House of Lords towards secondary legislation may not be sustained”.

That is the Constitution Committee of your Lordships’ House putting down an extremely important warning marker. It is intensely important that the whole process on the stream of SIs coming down the track to us is approached with that in mind. It will be up to your Lordships’ House to decide whether the Government are responding appropriately to these recommendations as they bring forward this avalanche of Brexit-related secondary legislation.

The complacency shown by the Minister on Monday in the Chamber, when challenged by my noble friend Lord Newby and others, does not encourage us to be optimistic. He claimed that 50% of the necessary Brexit SIs had been tabled. He also reported that the number had been reduced to some 600. I understand that this has been achieved by a great deal of amalgamation and compositing. The result is that some very long and indigestible SIs are on the way to us, perhaps with as many as 600 pages, in one case. I am told that the Home Office calls these “portmanteau SIs” because they are so general, and they will be extremely difficult for your Lordships’ House to deal with in an adequate manner.

When my noble friend asked the Minister how many SIs had been passed in both Houses, he was unable to give an answer. He did not know it—I hope he does by now. It is clear from the excellent briefing we had this afternoon from HM Treasury on the financial services legislation—indeed, it is also true of the Explanatory Note for these regulations—that we are doing complex and important work. It is not something that can go through on the nod, as the noble Lord, Lord Adonis, said. Therefore, it is right that we take stock of what exactly is happening.

It may be, as the Minister has been at pains to say, that because this is simply contingency planning for an outcome that the Government do not want or expect to happen, and do not want to have to deal with, all this will turn out to be a largely wasted exercise—in which case, we also have a concern. It is a common perception across the House that the Government have not a hope of delivering properly scrutinised Brexit primary legislation before 29 March. However, as the noble Lord, Lord Adonis, said earlier, they have even less chance of providing proper time for rigorous scrutiny of secondary legislation, where the devil is so often in the detail. The overall timetable is beyond the scope of this debate, but if anyone is under the illusion that it would be responsible for the Prime Minister to charge on towards any form of Brexit by the end of March, they should sit down quietly and just look at the proper scrutiny role that we as Members of your Lordships’ House have to exercise on behalf of the nation.

For the convenience of the Committee, perhaps I should read out something from the Standing Orders:

“Debate must be relevant to the Question before the House”—

I believe that that is what the Minister suggested; it must be relevant to the question that I have put from the Chair—and:

“No Lord is to speak more than once to any Motion”.

My Lords, perhaps this can be my speech, then. The noble Viscount in the Chair was looking at me, but there are other Members of the Committee who might need his admonition even more than I do.

But the noble Viscount was looking at me. He should clarify it to everyone. I will be brief—I have only three points to make, which I hope the Minister will find useful.

If Members were in the House the other day, they would have heard the noble Lord, Lord Callanan, trying to twist things in relation to the number of SIs, where they are and how quickly they are going through. He wants to rush all these things through, and I am worried about that. It is even more worrying now: he is so keen to rush them through that he has turned the heating down in this place. The clerks are having to wear scarves to keep warm and survive. But this is a serious matter.

First, to take up the point made by the noble Lord, Lord Tyler, is it right that we should be dealing with the amendment of primary legislation as an SI in Grand Committee and not in primary legislation on the Floor of the House? It is astonishing. I have never known this to happen before; perhaps the Minister can tell us when this has been dealt with in this way before. As the noble Lord, Lord Tyler, rightly said, because we are dealing with it as an SI, we cannot amend it but can only accept it or reject it, and that makes it very difficult. It may be that my noble friend Lady Thornton on the Front Bench, who is an expert on this, would have liked to put down a number of detailed amendments, but she is not able to do that because of the way we dealing with this.

Me too. With respect, these are very complex areas of medicine and clinical science, and they are changing rapidly with increasing advances. It is clear that the existing legislation, which in some cases dates back to 1990, is no longer entirely fit for purpose. It is therefore important that the House reconsiders this legislation. It is a marvellous opportunity, and we cannot simply do this en bloc. It would be a travesty of what this Committee should be doing.

I am grateful to my noble friend; as he is a world expert on these matters, it is useful to have him in the House and this Committee.

Two things worry me if we move out with no deal. First, will the trafficking of organs—people wanting to make money out of organ trafficking—become more likely? The European Union has brought some order and respectability to this, ensuring that it does not happen as it had done in the past, particularly with some countries which came into the European Union relatively recently.

Secondly—and perhaps my noble friend Lord Winston can help on this—are there increased dangers to health? In this SI we are dealing with stem cells, corneas, heart valves, eggs and sperm, skin grafts, and bone products—very sensitive, important issues. Is there scope for commercialisation in relation to that? Again, this is something we could deal with if we were not just rushing it through.

That is all I wanted to raise. I do not think we should be trying to extend this unduly. I know we do not address the Chairman in this way, but there are genuine concerns. With respect to the noble Baroness, Lady Manzoor, who has been rushed into this at short notice because the noble Lord, Lord O’Shaughnessy, is no longer a Minister, there are very serious questions which so far she has not been able to answer. The only way to deal with this issue properly is for it to go to the Floor of the House, where, in a proper debate, experts such as my noble friend Lord Winston can ask specific questions. It would have been even better if we could have dealt with it by primary legislation; then we could have had some amendment. But I think if we do not do this, we are storing up unforeseen dangers that might cause genuine difficulties, and that concerns me.

I hope that that was not too long and it has dealt with the matter before us.

Before my noble friend sits down, may I ask him an important question? Is he aware there is a specific example of British patients leaving these shores to go to the rest of the EEC for treatments which are not regulated by the Human Fertilisation and Embryology Authority? In some cases, for example, they return from Spain with three embryos re-placed in their uterus and end up having triplets on the National Health Service, often at massive cost. One occurred just last month; the health service probably spent hundreds of thousands of pounds on such babies, after a procedure which would not be allowed by this legislation as we set it up in 1990. That is why this is too complex an aspect of our new relationship with Europe to be discussed without very careful consideration.

I am really grateful to my noble friend, who has dealt with this precisely and with knowledge rather than the broad brush I was using. This shows what an advantage it is to have people such as him in the House and this Grand Committee. It would have been better if he could have dealt with it through primary legislation in a proper, considered way; then we could have dealt with it in Committee, amendments could have been tabled and we could have considered the most appropriate way of dealing with it.

My Lords, before my noble friend sits down, does he not also think it would be advantageous to the Grand Committee and the House for us to have a procedure whereby we could discuss amendments to these regulations rather than having to accept them in full or not at all? This is a big problem that we have been struggling with throughout the consideration of these regulations and our wider consideration of the EU withdrawal arrangements.

I certainly do. I see that my noble friend Lord Tunnicliffe is present. He has much greater experience in the House of Lords than I do, and he reminds me that there is a danger in using what I think he called the nuclear option of moving against statutory instruments because of the implications. If we were able to consider amendments to them and amend them in some way, we would not have that worry; we would be able to deal with them in a more specific, detailed, thoughtful and effective way. This is a difficult issue. A lot of people have become increasingly concerned over the years—and I know that this is not just in the Labour Party; it stretches right across the parties to the Conservatives, the Liberal Democrats, the Greens and others—that more and more statutory instruments are just being pushed through, rather than those matters being dealt with in primary legislation.

The noble Lord, Lord Deben, has said “Hear, hear!” in a very positive way. I remember attending a very interesting world conference on the environment that he chaired brilliantly. He allowed everyone to participate fully, which had not happened under the previous presidency and I think has lapsed under subsequent presidencies. He did it very well indeed, which allowed matters in that area to be considered appropriately. It is good to have endorsement from the other side from someone with such experience.

My Lords, like the noble Baroness, Lady Thornton, I shall confine my remarks primarily to the regulations we are currently discussing. With respect to the general debate that we have had, I will say simply that it is common with statutory instruments that there is a great deal of consultation beforehand with relevant bodies, and that is simply not the case on these. That in turn often leads to a determination of whether or not a statutory instrument is in fact controversial and where it ends up being discussed in your Lordships’ House. Some of the earlier discussion about those statutory instruments that will be put into Grand Committee as opposed to being considered on the Floor of the House might therefore have to be reconsidered, given the deluge of statutory instruments that is clearly coming our way.

Because of that, I have some questions for the Minister. Like the noble Baroness, Lady Thornton, I was unclear about what happens regarding the six-month transition period. I understand that the statutory instrument comes into force if there is no agreement. Is it therefore right to assume that there is then a six-month transitional arrangement that will automatically be overtaken, and that at the end of that six months there will be a completely new set of regulations for this important area of work? It is an important area of work, in which we have led the way in the world. The consequences, not least for the research capacity in this country, are extensive.

Like the noble Baroness, Lady Thornton, I could not determine whether the Minister’s statements were statements of aspiration or fact. It seemed to me that she was trying to convince us that there would continue to be equivalent recognition between ourselves and the EU—but on what basis, if we are not just no longer subject to the same agreements but no longer taking part in the development of policy and science that underlines the developing law in this area?

I have one other question on this SI. The Minister said that legislation governing reproductive cells is a reserved, UK-wide matter, but there are cells that are not reproductive but that are created for the purposes of research into human fertilisation and embryology. Is that a reserved matter or a devolved matter? If it is the latter, what discussions have been had with the devolved Administrations? In Scotland we have world-leading academic and research bodies. In conclusion, and this applies to the whole area of research, I have to say: what a waste of time, money and effort, and what damage we are doing to our world-leading research centres in this country.

My Lords, I will make some points about the validity of our consideration of this statutory instrument. Like the nine others we are going to consider, it relates to no-deal planning. In respect of the remarks made by the Deputy Chairman of Committees, this is highly relevant to this regulation and all the others because we would not be debating this regulation and all the arrangements that the Minister explained, including very complex new relationships that are going to be necessary with our European partners, if it were not for the fact that the Government are putting in place no-deal planning for what might happen if we crash out of the European Union on 29 March without a treaty.

But there is a big question mark about the validity of that no-deal planning, for two reasons. First, the supposition of all parliamentarians when we served the notice under Article 50 was that there would be a deal. The whole purpose of Article 50 is to set in train negotiations for an exit treaty. The House of Commons has never voted—until yesterday, and I will come to this in a moment because it has a big bearing on our consideration of these statutory instruments—on a proposition that the United Kingdom should leave the European Union with no deal; nor have your Lordships. It is my contention that the whole consideration of these statutory instruments is invalid because it does not follow a clear instruction from the House or any legislative basis for the implementation of no-deal arrangements.

Perhaps my noble friend will speculate on the authority under which money has been spent preparing for no deal. I have raised this with Meg Hillier, chair of the Public Accounts Committee, who tells me that the National Audit Office is looking into this to report to the Public Accounts Committee. I just do not understand how millions and millions of pounds can be spent without any authority on something that is not government policy.

I agree entirely with my noble friend. Every time we debate these issues, the sum allocated by the Treasury for no-deal planning is increased. My noble friend and the Committee may have noticed that it has now been increased to £4 billion. Apparently £2 billion of that is still to be allocated. None of this, as far as I can see, follows instructions from the House of Commons or indeed information given to the House of Commons. The first question to ask the Minister in respect of these regulations is: can she tell the Grand Committee how much the preparatory work for these regulations, and all the consultation which the noble Baroness just referred to, is costing, and what the cost will be to the NHS of having to put in place all these new arrangements, including the new licensing provisions referred to in the regulations? A key issue for the House, when it debates these regulations after our consideration, will be to know what the cost is going to be and whether in fact this is a cost that we think it is reasonable for the public to be bearing.

But the situation seems even more serious. As of yesterday, the House of Commons has debated whether or not it wants no deal to proceed. It had a full debate yesterday evening on the amendment tabled by Nicky Morgan and Yvette Cooper on the specific question of whether or not funds under the Finance (No. 3) Bill, which was presented to your Lordships this afternoon, should be allocated in the event of no deal. There was a long and extremely heated debate on that issue. The House of Commons voted by 303 to 296—which is an extremely large Division, one of the largest there has been in the whole Brexit process—against the Government by a majority of seven in favour of the amendment which would severely limit the ability of the Government to use public funds for implementing a no-deal outcome without the specific authorisation of the House.

We are in an extraordinary constitutional position. We are being asked to approve extremely significant regulations involving us crashing out of the European Union with no deal, which, as my noble friend Lord Winston said, in the specific instance of human embryology and tissues, involves big burdens on the NHS, questions about how new arrangements will work and costs to public authorities. That is all being done on the basis of no specific statutory authorisation and against the clearly expressed will of the House of Commons that this should not proceed in any event. I will make the same remarks in respect of all these regulations, because they apply equally, but this is a big issue and this debate will influence the House when these regulations are referred to it.

On the regulations themselves, I was disappointed at the Minister’s opening remarks. The regulations were debated in the House of Commons on 19 December, when many significant concerns were raised. The Minister in the noble Baroness’s department, Jackie Doyle-Price, said that she would consider further the issues that were raised but was not able to give full responses. We are a revising Chamber. The whole purpose of our sitting is to reflect on the considerations of the House of Commons, to ask further questions and to bring to the attention of this House—and, if necessary, the other place—the issues that were raised. I would like to put to the noble Baroness a whole set of questions that were raised in that debate, in the hope that she can give the House fuller answers, which have not been provided so far.

Four questions stood out. The first was on the costs that will be borne by establishments in making the new arrangements necessary under the no-deal contingency plans. In the debate, many Members of the House of Commons raised the issue of the costs. Jackie Doyle-Price said in response:

“On whether costs need to be reimbursed, it is worth noting that we expect the costs incurred by establishments to be extremely low”.

However, she could not give any figures on what the costs would be and how they would be met. Having looked at the consultation to which the noble Baroness referred, I understand that there is concern in NHS establishments about these costs and how they will be met, given the extremely tight funding envelope within which the NHS is working. Could the noble Baroness tell us more about what the costs will be, how they will be borne and who will meet them? Will part of the £4 billion of contingency planning that the Treasury has announced be given to the NHS to meet the costs of new licensing regimes, additional transportation expense and additional consultation requirements as this whole process goes through? If not, how do the Government expect that these costs will be met?

The second point comes from my own area of expertise, which is transport. What will happen if there are big problems at the ports, given the acute sensitivity of the materials—organs, tissues and so on? How are the Government in any position to give undertakings to Parliament that the services provided at the moment for the transportation of these organs and tissues will continue uninterrupted after 29 March if there is serious congestion at the ports and massive disruption to traffic going from Britain to the continent? The contingency planning on ferries—I see that the noble Lord, Lord Deben, is on to the same point—gives no one any confidence at all that arrangements are in place that could assure NHS patients and the doctors who have to give advice to those patients and put their own arrangements in place that there will be no disruption.

Let me quote the words of Jackie Doyle-Price, the Minister in the House of Commons, as they are significant in the context of the issues that we are discussing. She said:

“We have all heard the concerns about whether things will be able to get into the UK through that entry point. We are working with the Department for Transport to ensure that things such as medical supplies, including organs, can get through if there is traffic congestion. We are making such provisions—contingency plans will be in place”.

She said that, if they succeed,

“it will be business as usual and that, for example”—

this does not make grammatical sense, but this is what the Minister said, so it must be true—

“couriers are escorted so they can navigate traffic more quickly. It is very much on our agenda to ensure that we can enable that to happen”.—[Official Report, Commons, Third Delegated Legislation Committee, 19/12/18; cols. 9-10].

The mind boggles about what arrangements the Secretary of State for Health thinks will be put in place in the few moments that he has when he is not buying all the world’s fridges, as he is at the moment. What does it mean that couriers will be escorted so that they can navigate traffic more quickly? If the M26 and M21 are congested and you cannot move, how will these couriers get through? What special arrangements do the Government intend to put in place to enable that? The noble Lord, Lord Deben, thinks that it may be carrier pigeons.

Will the Department of Health hire a new generation of drones as part of its £4 billion for contingency planning so that if disruption takes place, these vital organs and tissues will get through? I hope that the Minister will tell us more because in the House of Commons, Jackie Doyle-Price was not in a position to give any assurances. A lot has happened since, including the debate in the House on ferry contracts. Such ferries could presumably be one of the contingency arrangements for transporting organs, but it turns out that the contract is with a company that has no ferries and no experience of managing them. What assurance can be given to NHS patients and practitioners that there will be no disruption whatsoever in arrangements as a result of this no-deal planning?

The third important issue, which the Minister also referred to, is devolution and how it has an impact on these arrangements. When I read the debates in the House of Commons on the regulations, it was unclear to me precisely what will be devolved and what will not. What will be central government’s responsibility and what will be the devolved authorities’ responsibility? I hope that the Minister can set that out clearly because it will be of great concern to the devolved authorities. In the House of Commons, Jackie Doyle-Price said:

“Legislative competence for the donation, processing and use in treatment of human reproductive cells—sperm, eggs and embryos—is reserved to Westminster. Competence in respect of all other human tissues, cells and organs is devolved”.—[Official Report, Commons, Third Delegated Legislation Committee, 19/12/18; col. 4.]

Can the Minister explain why the reserved issues are being reserved and the devolved issues devolved? There does not appear to be any clear rationale for this matter, but it will clearly be significant for the relationship between Parliament, Whitehall and the devolved authorities. We have asked a lot of serious questions about the regulations to which I hope the Minister will be able to give full replies for the benefit of not only the Committee but the House when it debates these important issues.

I thank noble Lords very much. I was not expecting such a lengthy debate but I very much welcome this scrutiny. I want to say from the outset that although I welcome the input from the noble Lord, Lord Tyler, the reality is that I am not in a position to comment on the processes and procedures on SIs, including which SIs come before us. As I have said already, these SIs were considered before coming before the Committee and there will be an option for further discussion of them in the House if noble Lords wish. Indeed, if noble Lords wish to table amendments, that is a matter for them. I cannot say what the process is because I do not know. There was some discussion about primary legislation; this is not primary legislation, of course. We are just considering SIs so I am not in a position to talk about amendments.

That is exactly the point that I and others were making. If it were primary legislation then we could amend it, but because these are SIs there is no arrangement for amendments to be considered either here or on the Floor of the House, which means that the instrument has to be either accepted or rejected. That is a take-it-or-leave-it situation that makes things very difficult in an area that, as we have heard, particularly from my noble friend Lord Winston but from others as well, is so complicated.

Before the Minister responds, I have a relevant point. I have sat here listening interestedly to this debate over the last 40 minutes or so; I am waiting to speak on some later regulations. If the Minister could say that she was willing to take matters away in the light of the comments made in Committee for further consideration by the Government, or to withdraw the regulations while that was happening, it would speed up the consideration of these regulations. I think the Minister might take advice very quickly on that issue because we are going to go through the same issues on regulation after regulation. Unless there is some capacity for the Government to respond to the concerns that are being expressed, not just about this set of regulations but on the others as well, we are going to be here for a very long time.

My Lords, it will be a matter for the Grand Committee in terms of how it wishes to proceed. My role today is to enable the scrutiny of the statutory instruments and give the reasons and the arguments as to why they have been put before the Committee for its consideration. It is above my pay grade to take them away and come back. We are here to deal with these three regulations, and I intend to do so.

I wanted to close off the wider debate because much of the debate has not really been about the content of the regulations but about the impact of SIs generally. As the noble Lord, Lord Tyler, said, he has used this Sitting because he felt that no opportunity had been given to him and others to have the debate on the Floor of the House. Again, that is of course not within my remit, but I have listened to what the noble Lord has said and I am sure the Chief Whip and others will hear it. It is open to him and other noble Lords to talk to the usual channels if they have issues regarding what debates take place and which SIs come forward.

Moving sharply on, a number of noble Lords but particularly the noble Lord, Lord Adonis, asked about cost in relation to this particular regulation, although this applies to all three. We expect the cost to be minimal because clinics that need import licences already have them. We estimate that fertility clinics will need to put 60 to 100 new agreements in place, and they will be able to use their existing agreements as templates for the new ones. We are not expecting any additional transportation costs, to which the noble Lord also alluded, because the clinics already meet transport costs for importing from the EU.

If there is serious disruption, there will be significant additional costs to these establishments. How is she proposing that those costs will be met? Are there any concerns about the impact of such disruption on patients and those engaged in this matter?

I hope the noble Lord feels I have been generous in giving way, but I really do need to make progress. I will answer the questions, but he must allow me to answer them before posing the same questions again.

The noble Lord asked about the impact cost for regulators and businesses, and I have already said these are to be low. He also asked what these costs are exactly. I do not have the figures, but they are expected to be very low, because for fertility clinics, it will be largely business as usual. Those importing from the EU already have import licences. The clinics will need written agreements and the regulator, the HFEA, will consider these at no cost.

I am grateful to the Minister for giving way. This is a specialised area and it is quite understandable that the Minister is not fully apprised of the problems arising here. It is a question not merely of cost but also of ethical approval. For example, even for minor changes in a licence—and they can be minimal, such as a request for a three-month extension to a licence we have asked to be reviewed—it can take months just to get the approval. There are so many changes that need to be made when you do different research and find new things happening. This is a moving area of science. It is not static, and it is not like so much other regulation. Therefore, to take three completely different areas en bloc makes no sense. Each brings its own very different problems. I hope the Minister will recognise that as they need to be debated before they go to the Chamber.

I hear what the noble Lord, Lord Winston, says, but I want to reassure him that these instruments are about continuation of present practices, standards and patient safety. They are not introducing new ethical considerations. We are merely, if there is no deal, putting in place contingency plans so that for sixth months, new agreements can be put in place. The number of those agreements is not going to be significant.

A number of noble Lords raised issues about delays at ports. The noble Lord, Lord Adonis, in particular raised this on a number of occasions. I stress again, in the event of no deal, it is possible there may be delays for freight transiting via Dover, the Eurotunnel, and possibly Holyhead and other ports. The disruption to outbound traffic could have an impact on inbound traffic between EU and UK ports; I concede that. It could also lead to congestion on the road network in Kent, but we are planning for this situation and want to avoid any disruption to the supply of urgent material to hospitals in the region, and any congestion at ports or on the roads. Organs, particularly, are flown already, and that will continue. Where there is urgent need, they will be flown to the appropriate places, and those agreements will continue.

No, I am sorry. I have been more than generous today.

This is about contingency planning, making sure that if there is no deal, these will be activated. I have already addressed the cost to businesses. The noble Lord, Lord Adonis, also asked about import licences of UK establishments, and the noble Baroness, Lady Barker, asked about the six-month transition period. The six-month transition period will allow time for UK licensed establishments to put in place the agreements with EU establishments. We will try to mirror as much as we can but it will give further time. Many of those agreements are in place but that is a further six months. I remind your Lordships that we are talking about a no-deal planning scenario.

The noble Baroness, Lady Thornton, asked whether we will be a third country when we exit. Of course, we will be a third country when we exit the EU. She also asked what I thought was a very important and relevant question about who will inspect the establishments in EU countries. Of course, we want to ensure safety for patient care and that the quality is there. I reassure the Committee that EU regulators already inspect establishments in their own countries before they license them, and this will continue after exit day, so we will be able to rely on the standards in the establishments as we currently do. Regulators in their own countries go and inspect the premises and that will continue to happen, so there will be joint understandings of standards, which will not be diluted. This is a continuation. We are not making new plans.

The noble Baroness, Lady Thornton, also asked about the transport of sperm and embryos. Of course, these travel in special containers and, as I said, they are often flown by air. The containers have the appropriate paperwork, which explains what is inside, and they are not expected to be subject to extra inspections at the border when they come into the UK. That will continue.

In response to questions asked by a number of noble Lords—and this applies to all three SIs—licensed establishments are obliged to report all incidents involving adverse effects, whether these happened in the UK or any other country.

I tried to cover the question of the noble Lord, Lord Tyler. The noble Lord spent a considerable time talking about processes and statutory instruments. All I can say to him is that, whatever the outcome, any reasonable, good Government—or any company or business—must have a contingency plan. This is contingency planning. It would be poor of the Government if we did not take such action. So I do not see it as a waste of money. I see it as prudent and effective planning.

What happens if the instruments are not made? That is a matter for the Grand Committee and, of course, the House. It is such a sensitive area and I am a newbie so I am learning all the time. I say to the noble Lord, Lord Tyler—and I said it at the start—that of course the Government will reflect on what has been said, and we take the issues that the noble Lord and others have raised regarding SIs, processes and procedures very seriously.

Is the Minister prepared to make representations to the Government Chief Whip that time should be permitted as soon as possible for the Constitution Committee report to which I referred, which is so relevant to everything that has been discussed this afternoon, to be discussed on the Floor of the House? If we do not have that opportunity before this stream of Brexit-related SIs comes before us, we will not be able to do our duty as the revising House of this Parliament.

I am very happy to give that undertaking. I will ensure the Chief Whip is aware of it, as was my intention, and I am sure he will be. These statutory instruments are important because if they are not made, we may not be able to share organs, tissues and cells with EU countries, and that could jeopardise patient treatment. Regarding a question raised by the noble Lord, Lord Foulkes, I stress again that all three SIs are about maintaining the same high safety standards that we have in the NHS. We are not changing anything. We are just putting in place contingency plans. I know he has come back to me again and again on this particular issue in different ways, but we are not making new legislation, nor are we changing primary legislation. We are just ensuring we have agreements in place should a no-deal exit happen.

The Minister said we are not changing primary legislation. So what does “Part 2: Amendment of primary legislation” mean?

Can I complete what I am saying, because at the moment what we are talking about is maintaining current standards. We are not going to be doing anything new. Any changes to UK law will be a matter for Parliament as a whole, so if we were to change primary legislation on whatever issues there are, it would come to the House.

The issue of amendments also was raised. I cannot say much about it because, as noble Lords are well aware, these are statutory instruments. The noble Lord, Lord Winston, spoke about the issue of fertility treatment outside the Human Fertilisation and Embryology Authority-regulated sector. I bow to his significant experience and wealth of knowledge in this particular area. This is an issue of concern, but while we are in the EU—and it is not solved by leaving the EU—addressing it would mean putting restrictions on the ability of individuals to travel abroad and receive medical treatment, which is well outside the scope of the Human Fertilisation and Embryology Act.

I have spoken regarding consultations. The SIs are not about making policy. They are about maintaining the status quo as far as possible, so there are discussions with the regulator rather than a public consultation, which I think the noble Baroness, Lady Barker, was asking about. There have been no issues raised. The noble Baroness also asked about embryo research and where that will sit. This particular issue is reserved to Westminster.

I have tried to answer as many questions as I can on this specific issue but my generic answers extend to all three SIs. I beg to move.

My Lords, before the noble Baroness sits down, in response to the point about disruption at the ports and what the impact could be on these highly sensitive organs and materials, she asked if I was aware that many of them go by plane. I am well aware of that. It is the main means by which transportation takes place in these cases. However, the issue of disruption at the airports in the case of no deal is every bit as serious as disruption at Dover, and the noble Baroness saying that it was all okay because this would be dealt with by air freight misses the point entirely. We have had debates in the House about this precise issue. What arrangements will be put in place? The European Aviation Safety Agency and all the arrangements by which air traffic takes place in Europe are crucially dependent on our membership of the European Union. At the moment, satisfactory arrangements are not remotely in place for the conduct of air traffic in the event of no deal.

Is the Minister aware that her response on the crucial question which will affect the lives of large numbers of patients has not given the Grand Committee confidence? Can she undertake to come back with a much fuller contingency plan for what will happen in the event of disruption at the airports as well as the ports in respect of embryos, tissues and all the other extremely sensitive products which are at stake here?

My Lords, I understand the question. As I have said, organs and other urgent material already travel by air and the Government will make arrangements for them to be prioritised if there are delays at airports.

Can the noble Baroness say what “prioritised” means in the event that air traffic is not taking place at all because of disruption to the regulatory arrangements in respect of the airports? Are the Government in a position, perhaps by use of the RAF and military aircraft, to ensure that these organs, tissues and so on will be transported and that there will be no disruption? That is a critical matter for the Grand Committee and the House to consider in respect of the contingency arrangements for no deal, which is precisely the matter that we are discussing with these instruments.

My Lords, regarding whether airplanes will fly is well beyond my remit, but I fully expect them to do so irrespective of whether we are in the EU or out.

Perhaps that sounds flippant, but they will still be flying. This is a very serious and crucial matter. We are talking about patient safety and organs. We need to ensure that organs can get from point A to point B. I and the Government have made a commitment that they will be given priority. I do not have a crystal ball and I do not know what will happen; I do not know what will happen next week. What I am saying is that we want to support patient safety and the quality of the service at their current levels.

I think that the Minister is being teased somewhat by my noble friend, but some of that is completely justified. Of course, the truth is that this is a Brexit-blind question because airports can be closed. I can remember dealing with this when I was a Minister and there was an active volcano in Iceland which stopped organs from being flown over from Canada. Perhaps I may offer that little bit of comfort to the Minister and suggest that perhaps she might move this statutory instrument.

Before my noble friend finishes, I should say that I really do not feel that that is a satisfactory point. I hope that I will be forgiven for saying this, but there are numerous examples of where the immediate relationship with Europe is important. Let me take one of those which I do not believe has been considered at all. We are aware that the Human Fertilisation and Embryology Authority undertakes to consider that no more than 10 attempts at sperm donation are made by individual donors, but we have increasingly been importing gametes from outside the United Kingdom because the regulations in this country have rather prevented males wishing, not unreasonably, to donate their sperm. As a consequence, we are importing sperm at an increasing rate and there is a great deal of evidence to show that there is an increasing risk of consanguinity in offspring because more than 10 children are produced as a result of one donor selling their sperm in different countries. That is the sort of thing which does in fact apply to the Brexit situation and it is a problem.

The three statutory instruments before us for discussion are so technical and so demanding that the suggestion which has already been made that we should perhaps withdraw them for the time being and have a proper consultation on what is important in the Brexit issues might be something that we should be thinking about today before accepting them en bloc and before we proceed any further.

I thank the noble Baroness, Lady Thornton, for her intervention; I very much appreciated it. I also thank the noble Lord, Lord Winston, for his suggestion. But as I have already indicated, we are considering the SIs here today, and it will be a matter for the Grand Committee how it chooses to proceed. I say again that we are not talking about changing legislation; rather, it is about maintaining the standards that we currently have. In terms of tracing organs, sperm and cells, the regulators will keep the same standards and provisions of traceability. They will not change. As the noble Lord will know, these agreements are not only in place with the EU; the regulators have agreements with other countries around the world.

I conclude with a clarification. It was either the noble Lord, Lord Adonis, or the noble Lord, Lord Foulkes, who said that we are changing primary legislation. They were right, but only to the extent that it is within the powers in the European Union (Withdrawal) Act. We are amending primary legislation in relation to HFE because the EU directives in this area were implemented by primary legislation. I just wanted to clarify that. I beg to move.

My Lords, the Question is that the Grand Committee do consider the draft Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019.

My Lords, I must remind the Grand Committee that the Motion before it is to consider—I emphasise “consider”—the regulations, not to approve them. Whatever happens here in the Grand Committee, the Government will need to table an approval Motion in the Chamber, where any Member who is concerned can properly register disagreement. I also remind the Grand Committee, as contained in paragraph 3.13 on page 29 of the Companion, that we cannot have a vote in Grand Committee. With that in mind, I put the Question again.

Motion negatived.

I refer the Committee to paragraph 10.17 on page 174 of the Companion:

“Affirmative instruments may be considered in Grand Committee. No referral motion is required. After the debate has been held in Grand Committee each instrument is approved by the House on a separate motion”.

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

Considered in Grand Committee

Moved by

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

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

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.

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.

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?

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.

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.

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.

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.

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.

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.

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.

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?

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?

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.

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?

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.

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.

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.

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.

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, we 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.

My Lords, I want to make two brief points. First, I want to pick up 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 been 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—

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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?

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—

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

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.

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?

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.

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?

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.

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.

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.

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.

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?

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.

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.

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.

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”.

Motion negatived.

Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019.

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.

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.

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?

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.

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.

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.

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.

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 for which the Government have no contingency plan at all, because they cannot have it.

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 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 are prepared to take a massive gamble with the health of our population.

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?

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.

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.

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.

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.

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.

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