Skip to main content

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

Volume 794: debated on Wednesday 9 January 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”.