Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019
Debate between Lord Adonis and Baroness Manzoor(5 years, 11 months ago)
Grand CommitteeRead Full debate Read Hansard Text
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
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 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 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.
Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
Debate between Lord Adonis and Baroness Manzoor(5 years, 11 months ago)
Grand CommitteeRead Full debate Read Hansard Text
Baroness Manzoor
To be very clear, the six-month period relates to imports. It is important to point that out. After the six months, there will be advice from the regulators as to what the new import agreements will be and what more needs to be put in place during the six-month transition period. There has to be consultation and there have to be agreements, and that is the whole point: we want to put these SIs in place so that we have contingency planning regarding the agreements.
A number of noble Lords raised the issue of ports and airports. I have already given the answer and there is not very much that I can add to it. The Government are making plans to mitigate any delays at borders. As I have said, where there is a priority need, we will endeavour to do our very best to ensure that there are no delays. On the other interesting ideas that were put forward, any of those various forms of transportation are at the disposal of the Government in any scenario should they wish to use them.
Lord Adonis
Do I take it that the Minister is saying that the RAF and the Royal Navy may be put at the disposal of the NHS to deal with this no-deal contingency planning? I took that to be the meaning of the words that she has just said.
Baroness Manzoor
No, just to be clear, I could not possibly agree to that or let the noble Lord draw that conclusion from my comments. What I am saying is that the Government will use whatever means they have at their disposal to ensure that priority needs are met where they can be and where it is necessary to do so.
Lord Adonis
My Lords, the Government have the RAF and the Royal Navy at their disposal, and the Minister just said that they would use whatever means were at their disposal. They clearly have those services at their disposal, so why would they not use them in these extreme circumstances?
Baroness Manzoor
My Lords, I know the noble Lord is pushing me to answer that question but there is nothing that I can add to the answer that I have already given.
On the impact assessments, I want to make clear once again—this relates to all three SIs, as does everything that I have said—that these instruments are limited in what they do by the powers under which they are made under the European Union (Withdrawal) Act. Those powers were debated and approved by Parliament, and an impact assessment was carried out in relation to that. There is nothing that I can add to that.
I have probably not added to the satisfaction of the noble Lord, Lord Adonis—
Baroness Manzoor
Research is also outside the scope of these SIs. The noble Lord has tremendous experience in this area, which we appreciate and value. We have a fantastic NHS based on world-leading research, working with our partners across the EU. That is right, but these SIs are not about that. These are matters for greater minds than mine to think about if we exit the EU. However, as far as these SIs are concerned, we want to maintain what we have at the moment. They cover a contingency plan to ensure that we have agreements in place. However, I understand the ethical issues and the points being made by the noble Lord, Lord Winston, regarding scientific research and close working collaborations, but I am not in a position to talk about them because they are not pertinent to the SIs we are discussing today.
Lord Adonis
The Minister has not answered my question about the processes that will be put in place for licensed establishments to apply for new import-export relationships. Can she tell the Grand Committee more about those because these establishments are keen to know what will happen? When will the processes be published in the no-deal scenario? When will the Government know what arrangements will apply, given the huge importance of import-export relationships both for the treatment of patients and, as my noble friend Lord Winston rightly said, for the conduct of research?
Baroness Manzoor
My Lords, I responded to that question on two occasions. I will repeat for the noble Lord that all the processes currently in place will remain; there will not be anything new. These regulations do not bring in anything new and they do not change anything. They seek simply to put continuation plans in place should there be a no-deal Brexit. All the regulators support them.
Lord Adonis
My Lords, I do not find that answer satisfactory. Is the Minister saying that they will not need any new import-export arrangements? My understanding is that they will. That does not affect the point that the Minister hopes that there will be no change. We are talking about a legal issue to do with the licensing arrangements. My understanding is that the existing licensing arrangements will not continue in the case of no deal, so when will establishments be informed about how they can apply and what the process will be for new and updated licences? I understand that the Minister is not in a position to tell the Grand Committee now, but I hope that she may be able to respond when we come to the third statutory instrument in this group because the same issues arise there. Perhaps she will be better briefed between the second and the third instrument so that she can reply next time.
Baroness Manzoor
I am happy to respond. I hope that I am not repeating the same points, but they are important. Clearly, the noble Lord is finally beginning to understand that there will not be any new licences. Importers already have the licences they need; we will need to look only at new agreements. There is lots of information on the regulator’s website to enable organisations that deal with these different categories of issues to contact the regulator. However, at the moment we do not see that as an issue, because many of those already have templates of the agreements they use for non-EU countries. I beg to move.
Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
Debate between Lord Adonis and Baroness Manzoor(5 years, 11 months ago)
Grand CommitteeRead Full debate Read Hansard Text
Baroness Manzoor
No, my Lords, we are not talking about a gap. We are actually talking about the continuation of what we have in place at the moment. That is why we are making these contingency plans.
Baroness Manzoor
No, I am sorry, we have discussed these issues. Many of the same issues are coming up on all three SIs.
Lord Adonis
The Minister has not answered the points. That is why we keep raising them. If she provides inadequate answers, I am afraid they remain inadequate.
Baroness Manzoor
I am afraid that is the only answer I can give, even if it is not one that the noble Lord, Lord Adonis, feels is adequate. If there are issues that I feel I need to write to noble Lords about, I will do so, but I think I have given the best answer that is available to me.
The noble Baroness, Lady Barker, raised an important point regarding traceability. The requirement to ensure the traceability of tissues and cells, including reproductive cells, will remain. UK-licensed establishments were already using systems to ensure traceability from donor to receiver of tissues and cells before the introduction of the single European code, and in most cases the code was added to the existing system. After exit, UK-licensed establishments will be able to use the same IT systems that they are using now if they want to. The code will be removed and establishments will use the traceability system that was in place before the introduction of the single European code.
The noble Baroness asked about the powers and the instruments in relation to the Secretary of State. The Secretary of State can make changes to deal with new safety issues, and that is what the SIs will enable to happen. If the Government decided to do that, though, they would need to make new regulations which would have to have parliamentary scrutiny at that point, so he cannot do it just like that.
I restate that all the points that I have made relating to all three SIs go across the board for all of them. I hope noble Lords will appreciate that I have done my best to answer as many of the points as I could, if not all of them. I cannot go any further in terms of processes of statutory instruments and what the Committee can or cannot do, nor can I comment on the wider EU Brexit deal.
I thank all noble Lords who have taken part in this excellent debate. I believe in the scrutiny of legislation, and noble Lords have certainly carried that out with gusto today. I beg to move.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
The Question is that the Grand Committee do consider the draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019.
Student Loans: Interest Rates
Debate between Lord Adonis and Baroness Manzoor(7 years, 3 months ago)
Lords ChamberRead Full debate Read Hansard Text Read Debate Ministerial Extracts