Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 Debate
Full Debate: Read Full DebateLord Adonis
Main Page: Lord Adonis (Labour - Life peer)Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019
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Lord Adonis (Lab)
I am grateful to the Minister for giving way. Could we ask that these are degrouped and that we consider them each individually, please?
Baroness Manzoor
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.
Baroness Manzoor
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.
Lord Adonis
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.
Baroness Manzoor
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.
Baroness Manzoor
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.
Baroness Manzoor
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.
Baroness Manzoor
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.
Baroness Manzoor
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.
Lord Adonis
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.
Baroness Manzoor
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.
Lord Adonis
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?
Baroness Manzoor
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.
Baroness Manzoor
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.
Baroness Manzoor
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.
Lord Adonis
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.
Lord Adonis
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?
Lord Tyler
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.
Lord Adonis
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?
Lord Tyler
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.
Lord Adonis
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?
Lord Tyler
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.
Lord Adonis
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.
Baroness Manzoor
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.
Lord Tyler
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—
Lord Adonis
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.
Baroness Manzoor
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.
Lord Foulkes of Cumnock
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.
Lord Adonis
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.
Lord Foulkes of Cumnock
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.
Baroness Barker
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.
Lord Adonis
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.
Lord Foulkes of Cumnock
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.
Lord Adonis
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.
Noble Lords
Lord Adonis
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.
Baroness Manzoor
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.
Baroness Manzoor
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.
Lord Adonis
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?
Baroness Manzoor
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.
Baroness Manzoor
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.
Baroness Manzoor
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.
Lord Adonis
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?
Baroness Manzoor
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.
Lord Adonis
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.
Baroness Manzoor
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.
The Deputy Chairman of Committees
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.