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Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Volume 807: debated on Monday 2 November 2020

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020.

My Lords, these regulations are critical in giving effect to the Ireland/Northern Ireland protocol for the safety and quality of blood, organs, tissues and cells, including reproductive cells.

I will give a brief moment of context. In January, the European Union (Withdrawal Agreement) Act 2020 was agreed by this House. It brings into domestic law the withdrawal agreement between the UK and the EU. Included in the withdrawal agreement is the protocol on Ireland/Northern Ireland, commonly referred to as the Northern Ireland protocol.

On 20 May 2020, we set out our approach to implementing the Northern Ireland protocol as part of meeting our obligations under the withdrawal agreement. We are committed to meeting these obligations, all the while recognising the unique status of Northern Ireland within the UK and the importance of upholding the Belfast, or Good Friday, agreement.

These SIs covering donated blood, organs, tissues and cells support the vital role that these materials play in life-changing treatments for UK patients—whether it is blood transfusions to treat major blood loss, heart transplants to treat heart failure, stem cells to treat blood cancer, or eggs and sperm to treat infertility, patients rely on these treatments every day. Last year in the UK, there were 3,760 deceased organ transplants, approximately 1,100 people benefited from UK-donated stem cells and approximately 13% of IVF cycles used donor eggs or sperm. Many people would not be alive today if it were not for the generosity of donors.

The UK’s current high safety and quality standards for blood, organs, tissues and cells are derived from EU law. The application of these standards makes Britain one of the most progressive regulatory environments in the world.

Last year, in preparation for the UK leaving the EU, the Government made four statutory instruments to fix shortcomings in the current law caused by EU exit. These were made on a UK-wide basis and come into effect on 1 January 2021. These 2019 statutory instruments maintain the current safety and quality standards across the UK.

So let me explain for a moment what these regulations do. The Northern Ireland protocol requires Northern Ireland to remain aligned with the EU blood, organs and tissues and cells directives for as long as the protocol is in force, including any future changes to the directives. These four instruments will come into force on 1 January 2021 and will ensure that Northern Ireland continues to be aligned with the directives after the end of the transition period. There are five ways in which they do this.

First, the regulations ensure that the safety and quality standards will remain the same across the UK from 1 January 2021. These standards are currently aligned with EU directives. Secondly, the UK regulators for blood, organs, tissues, and cells will continue to act as the competent authorities for Northern Ireland in respect of the EU. This means that the Medicines and Healthcare products Regulatory Agency, the Human Tissue Authority and the Human Fertilisation and Embryology Authority will continue to meet the same EU obligations for Northern Ireland as they do now.

Thirdly, these instruments amend the definition of “third country” for imports into Northern Ireland to ensure that we meet the terms of the Northern Ireland protocol, but also meet our commitment to unfettered access. This means that from 1 January 2021, when establishments in Northern Ireland receive blood, organs, tissues and cells from Great Britain, they will need to treat them the same as those received from outside the EU. In accordance with our commitment to unfettered access for goods moving from Northern Ireland to Great Britain, there will be no changes to the requirements when sending blood, organs, tissues and cells from Northern Ireland to Great Britain. The movement of blood, organs, tissues and cells around the UK is critical for patient treatment, and we are committed to ensuring that this movement can continue from 1 January 2021.

Fourthly, these instruments will require tissue establishments in Northern Ireland to continue using the single European code for traceability purposes, as they do now. Fifthly, the 2019 statutory instruments introduced some limited regulation-making powers into UK law for each of the UK nations. The EU withdrawal agreement Act 2018 contains the powers needed to make changes in relation to the safety and quality of blood, organs, tissues and cells for Northern Ireland to ensure future alignment with any changes to the directives. Therefore, the powers in the 2019 statutory instruments are no longer needed for Northern Ireland, and consequently these regulations limit those regulation-making powers to Great Britain.

Let me be clear: the fact that Northern Ireland will remain subject to EU law in this area does not mean that the UK as a whole will be prevented from making changes to the safety and quality regime in this area. The EU directives in this area set minimum standards of safety and quality. They allow member states to go further if they wish. If the UK as a whole wished to move forward and change the safety and quality standards, this could be done. They are a floor, not a ceiling.

A lot of preparatory work has already taken place. The regulators for the relevant sectors are working with licensed establishments across the UK to help ensure they are ready for any changes that will arise from 1 January 2021. They are supporting establishments to put any necessary import licences and agreements in place, preventing any disruption in the supply of blood, organs, tissues and cells. These changes affect only a very small number of establishments in Northern Ireland: one blood establishment, one transplant centre, two licensed tissue establishments and four fertility clinics. There will be some minor administrative costs for establishments in Great Britain moving blood, organs, tissues and cells to Northern Ireland.

Regarding the DAs, legislative competence for the donation, processing and use in treatment of human reproductive cells remains reserved to Westminster. Competence in respect of all other human tissues and cells, blood and organs is devolved, and the relevant instruments are being made on a UK-wide basis with the consent of the devolved Administrations. Work is under way to put in place a common frame- work between the UK Government and the devolved Administrations, to support co-ordinated decision-making on the safety and quality of blood, organs, tissues and cells after the end of the transition period.

To conclude, these regulations are vital to the Government’s preparations for the end of the transition period. It is essential that they are made to allow the UK to fulfil its obligations under the Northern Ireland protocol. The UK already has high standards for the safety and quality of blood, organs, tissues and cells. These instruments ensure the UK will continue to work to these high standards after the transition period; that blood, organs, tissues and cells will continue to be able to be moved around the UK; and that we have a platform to build the regulatory regime even further. I beg to move.

My Lords, I thank the Minister for introducing and explaining so carefully the statutory instruments. Clearly, as he said, they are very important. The key statement he made, which is repeated in paragraph 7.7 of the Explanatory Memorandum, is:

“Neither the 2019 SIs, nor the 2020 SIs make changes to the safety and quality standards, which will remain the same across the UK from 1 January 2021.”

However, for Northern Ireland, these standards are expressed by reference to EU legislation, whereas for Great Britain they are not; although, at the moment, the substance is the same in both cases. So I ask the Minister: what are the implications of any future change made in EU directives or in UK law? Since we may not stay aligned with the EU, there must be some inevitability, at that stage, of that arising. Will that not then lead to a confusing situation in future where UK regulators are responsible for overseeing different laws in separate parts of the UK? If that is the case, and given that this is a hugely sensitive area, will this inhibit the movement of tissues and organs between Ireland and Great Britain? The Minister mentioned such movement, but will he clarify how much movement there is at the moment?

I would also like to ask the Minister about the six-month transition period from exit day to allow establishments time to put the necessary arrangements into place for importing and exporting tissues and cells with the EU? Is he confident that that is sufficient time for those establishments?

I refer to our recent debate on the Human Tissue Act during the passage of the Medicines and Medical Devices Bill. As the Minister knows from our debate, it is our view at least that the Human Tissue Act does not require appropriate consent for imported human tissue, and, in addition, imported human tissue for use in medical research does not require traceability. Of course, this is very relevant in the case of China and the shocking use of organs of prisoners and minority groups for commercial exportation. I readily acknowledge that we are currently in discussion with the Minister’s department about a suitable amendment to deal with this, but will any such amendment agreed in the Medicines and Medical Devices Bill apply also to Northern Ireland?

I am sure the noble Lord, Lord Alton, will speak in some detail on this, but, as I have the opportunity, I would like also to talk about human tissue. As the Minister will know, we have been concerned about the view of the WHO on the practices in China, as it is based upon a self-assessment by China itself. This has been the subject of correspondence between the Government and the World Health Organization. The Minister, the noble Lord, Lord Ahmad, has now turned down a freedom of information request from the noble Lord, Lord Alton, and I want to express my disappointment. This is so important that the Government really ought to publish the correspondence. Having said that, I am very grateful for the opportunity to debate these regulations.

I too thank the Minister for presenting the statutory instruments. I will speak in particular to the blood safety and quality regulations. These are clearly very important and, as we get closer to the date by which a deal was meant to have been arrived at and there is not one, they become even more important, particularly given the shelf life of blood.

I will follow on from what the noble Lord, Lord Hunt, said. Standards in Northern Ireland are linked to the EU and will continue to be linked to the EU under the agreement. For Great Britain, divergence can take place. I note that the Minister said it was a floor and not a ceiling, but sometimes the floor can fall in, even with small changes—for example, on the storage of blood. So how will the Government ensure that divergence does not mean that standards will change before they come before Parliament and are passed into law, which could mean that the supply of blood becomes slower than is operationally required?

I note that 6.5% of plasma is imported from the EU to the UK. Can the Minister confirm what arrangements have been made to ensure that that plasma will continue to be available to those in GB—and speedily? If we go to a no-deal arrangement, what arrangements are there and what discussions have been had with the EU with regard to our position on getting this supply of plasma? Will it change if we are a third country? I seek exactly the same assurances on the supply of blood for patients with rare diseases who require imported blood and blood components. What arrangements have been made to ensure that the supply and standards remain the same over a period of time?

If the EU brings in new technical updates, what processes for Great Britain will be in place and how will they be linked to future EU standards? What proactive work will take place, or will we have to reactively change if the EU changes its standards and is seen to diverge?

It is clear that the arrangements on this seem certain—but only if the GB Government decide not to diverge at any point. I want assurances in particular on that, but also with regard to supply. In the House of Commons debate at the time of the 2019 regulations, the Under-Secretary of State at the Department of Health and Social Care stated very clearly that the fast-tracking of shipments at ports and alternative routes were being prepared. Have those now been prepared and, if they have, what arrangements are in place for the fast-tracking of shipments at ports and alternative routes for the supply of blood into the UK, Northern Ireland and GB?

My Lords, I am likewise very grateful to my noble friend the Minister for his very clear explanation of the purpose of these regulations. I wish to speak only to the first set, relating to blood safety and quality.

As the Minister quite rightly explained, the purpose of the regulations is to enable the protocol to be applied and therefore for the regulations in Northern Ireland to continue to be those prescribed by EU law, rather than those under UK law. So the issues, as noble Lords have already said, including the noble Lord, Lord Hunt of Kings Heath, are very much around what will happen if there is some degree of divergence in the future.

My point is that I do not regard this as an unlikely prospect: I fear that it is a quite likely—and perhaps even an imminent—prospect. I say this because it is just over a year since the European Commission published its working document, Evaluation of the Union Legislation on Blood, Tissues and Cells. My expectation is that, probably this month, an inception impact assessment will be published by the European Commission, and its working plan says that it expects to publish a legislative proposal in the third quarter of next year—so this is not a speculative prospect.

It may not occur because the United Kingdom chooses to have different regulations. Notwithstanding my noble friend’s optimistic scenario, it is not simply a question of whether the United Kingdom chooses to have higher standards of regulation. Divergence does not necessarily mean that one jurisdiction has high standards and one has low standards; they have different standards.

Let me give some examples of where this might arise. The first relates to advanced therapy medicinal products; here, I am talking about gene therapies and somatic cell therapies. It is clear from the European Commission’s work on what it terms “strategic value chains” that one of the nine areas it has identified is personalised medicines. We know from discussions in the European Parliament in relation to these matters, and from the way in which the Commission has responded to them, that it does not simply regard this as strategic but also regards Europe’s own legislation on the governance of gene therapies as potentially differing from where it is now—and it may well be different from the way in which we choose to govern gene therapies in this country. So we may diverge in that respect.

Secondly, the noble Lord, Lord Scriven, referred to plasma and plasma products. The European Union is dealing with substantial excess, and rising, demand for plasma and plasma products. There is a serious deficiency in supply in the European Union, much of which is presently met from the United States. It may well be that the European Union adopts measures the purpose of which is to increase supply within it. That may have implications for the supply of plasma products heading out of the EU to non-EU member states. Of course, for these purposes, the United Kingdom will become a non-EU member state, so we may have divergence in that respect.

This is not confined to the European Union. On 30 October, the US Food and Drug Administration published a list of 230 sensitive products in this area, five of which relate to plasma and plasma products. There are rising demands for products in this area and international constraints on supply. I will not repeat him but the noble Lord, Lord Hunt, asked a perfectly reasonable question about the ability of the HTA to be a competent authority for two different jurisdictions, and whether my noble friend the Minister is happy that the HTA can exercise both roles.

Finally, if I may be forgiven for this question, how are we at this moment discussing these regulations in this Committee to give effect to the protocol, while discussing a Bill this afternoon in the Chamber Clauses 43 and 44 of which seem on the face of it to give the Government the power—indeed, give Ministers the responsibility—potentially to disapply the protocol in relation to regulations in this area? This is an absurd proposition. Perhaps my noble friend would be kind enough to explain how we arrived at this place.

My Lords, in thanking the Minister for introducing these statutory instruments, I am conscious of two things. First, they are procedurally necessary because of the decision to leave the European Union, but inter alia, honour a commitment not to use such transitional arrangements to dilute our commitment to uphold the highest possible standards in relation to the use of organs, tissues, blood and cells. I think that the Government have honoured that commitment. Secondly, I am conscious that it is only a few days since we had a full-blown debate on an amendment to the Medicines and Medical Devices Bill, which is currently in Committee, relating to human organs. The noble Lord, Lord Hunt of Kings Heath, referred to this earlier. Like him, I would like further clarity on the one notable change in the regulations—also touched on by the noble Lord, Lord Lansley, a moment ago. It relates to Northern Ireland, where European Union law will continue to apply while not doing so in the rest of the United Kingdom.

The opportunity for confusion and inconsistency is therefore written into the very DNA of the statutory instruments. It reminds us of what is one of the most troubling and unresolved aspects of the withdrawal agreement. I would be interested to know who within the Northern Ireland Executive has been the point man or woman in discussing the implications of the SI; who has been consulted within the Northern Ireland Assembly and what response has been received; and whether these arrangements have been signed off by the Commission in Brussels and the relevant health authorities in Dublin.

When he comes to reply, I would also be grateful to the Minister if he would return to the questions that I put to him last week concerning the trade and exhibition of body parts. Given that the Human Tissue Act does not require traceability, how is that to be resolved in the context of these statutory instruments or in the legislation being taken through the House? Will that principle now be treated differently in Northern Ireland and Great Britain?

Yesterday I sent the Minister an 87-page report, with 270 footnotes, The Economics of Organ Harvesting in China, published by the Institute to Research the Crimes of Communism. It describes forced organ harvesting as

“one of the most inhumane crimes in the entire history of humanity”.

In harrowing detail, it describes what it calls “the business offer” and details an international spider’s web of companies—including some from the United Kingdom—which have aided and abetted what it describes as primitive barbaric practices. I am grateful to the Minister, whom I had a chance to speak to just before we came into this Committee, for already having had a glance at the report. I hope that he will commit to looking at the report further and say how he intends to take forward an investigation into the companies referred to in it. Will he agree to refer it to the World Health Organization for its consideration?

In that context, and further to the remarks of the noble Lord, Lord Hunt of Kings Heath, I might add that only today the information rights unit at the Foreign, Commonwealth & Development Office has written to me in response to the freedom of information request to which I referred during our debate last week, asking for the correspondence between it and the WHO to be made public. In its response, the unit says:

“Some of the information has been withheld using section 27(1)(b) on International Relations. Section 27 is a qualified exemption and is subject to a public interest test. The application of section 27(1)(b) requires us to consider the public interest test arguments in favour of releasing and withholding information.”

The letter also says:

“The disclosure of information could potentially damage the bilateral relationship between the UK and the World Health Organization. This would reduce the UK Government’s ability to protect and promote UK interests through its relations with the WHO, which would not be in the public interest.”

I would obviously contest that strongly, not least because of the vast amounts of public money that pour from the United Kingdom into the WHO. This sits very uncomfortably with our belief in transparency and open government. Elsewhere, the letter says:

“The disclosure of information detailing our relationship with China could potentially damage the bilateral relationship between the UK and China.”

Why should information pertaining to the forced harvesting of organs and their use in organ tourism be damaging to our relations with China?

Let me conclude. I would be grateful if the Minister could say how in further legislation, whether brought through SIs or within the current Bill, we can demonstrate our determination to stamp out organ tourism that relies on the killing of non-consenting victims, and which then trades in their remains in ways which the United Kingdom should demonstrate to the rest of the world that it will not tolerate.

I thank my noble friend Lord Bethell for setting out these regulations so clearly. I strongly support all four sets of regulations; as he has said, they are vital to honour the withdrawal agreement. Indeed, that withdrawal agreement is at the base of the regulations we are considering. They essentially ensure that for the purposes of the quality and safety of organs intended for transplant, human tissue, blood and blood products, gametes, embryos and reproductive cells, Northern Ireland is still treated as if it were part of the EU and still a member state. Great Britain—England, Wales and Scotland—is to be treated as a non-member state. Current EU law will therefore remain in place in Northern Ireland, and Great Britain is a third-party state as far as Northern Ireland is concerned.

Initially, this will perhaps not create any day-to-day problems because there will be no initial divergence. However, paragraph 7.13 of the Explanatory Memorandum to these regulations sets out clearly that Northern Ireland establishments will consider Great Britain the same as a non-EU member state, and that Northern Ireland will ensure that there are “equivalent standards” for blood and blood products—those words are used—and for organ issues. Again, it provides for equivalent safety and quality standards. That perhaps is the answer: the standards could be divergent, but they must be equivalent, so there cannot be too much divergence from the norm. That is reassuring.

I do not have an issue with the purpose of these recognitions—I have no problem with that at all; it is a matter of practical common sense. I was briefly a Minister in Northern Ireland, and I saw that the invisible border meant that in practice, ambulances from one side of the border that were near the border would help out when needed on the other side. That was very sensible—it was pragmatic, practical common sense and it happened on a daily basis. However, the withdrawal agreement provided for the situation that we are dealing with here. Like my noble friend Lord Lansley, I ask: why, then, it is then a problem in relation to the United Kingdom internal market legislation? It does not make sense. What we are doing here is sensible and was foreseen—indeed, it was foreseen elsewhere. So why is it a problem with, as it were, the “mothership” legislation? I do not know whether the Minister will feel able to answer that, but it is a real issue for me.

As I say, I have no problem with this legislation at all, which seems very sensible for these purposes. It is a matter of geographic reality rather than anything else. I suspect that the problem is the same in relation to energy regulations that may well be coming forward. For these purposes, once again, if there is a problem with supplying energy on one side of the border because of a failure of supply, the first place one looks is the other side of the border: that is geographic reality and common sense. These matters are being dealt with pragmatically and sensibly, so why are we proposing to breach international law in relation to a broader front? It does not make sense. So I will be very grateful if the Minister feels able to deal with that issue, and I hope that he will. However, the regulations themselves are sensible and I certainly support them.

My Lords, I intend to focus my remarks on the human tissue and organ transplant regulations and, in particular, on the issues of timeliness and trust.

I have a particular interest in both of these issues. Back in 1995, I gave my consent in Brussels for organs from my deceased husband to be removed for transplantation. I was happy to do so and received considerable comfort from the fact that, even after his death, he could do some good for other human beings somewhere in Europe. I mention this because, at the time, we and Belgium were both members of the European Union, and the administration and procedure were expedited smoothly and professionally. Since the 2016 referendum, I have been anxious that no barriers should be put in the way of the continued smooth running of this process.

As we have heard, in 2019 a set of regulations was approved to ensure that EU standards would continue during the implementation period, and today we have regulations that take account of the unusual position of Northern Ireland following our exit from the EU. The regulations ensure that, as long as Northern Ireland takes certain steps which have little or no cost, the same standards will apply and no barriers will be put in the way. I am reassured about that—in theory.

However, there are many practical considerations when you are dealing with human tissues that must be delivered in a timely way. The numbers we are dealing with are significant. Between April 2019 and March 2020, 32 organs from deceased donors moved from GB to Northern Ireland, and 126 organs moved in the other direction. As the Minister said, there are two tissue establishments in Northern Ireland, and they will continue to be able to receive tissues and cells from GB, but they will treat GB as a non-EU member state for this purpose.

I understand that Northern Ireland must continue to meet the requirements of EU directives for as long as the protocol is in force. But, as other noble Lords have said, changes to these instruments may be needed if there are changes to the directives. Can the Minister confirm that the Northern Ireland Administration intend to make these changes if they happen, and, if that is the case, what is the British Government’s intention?

My interest in the human tissue regulation is both personal and general. I have a family member who is currently awaiting a bone marrow transplant and, fortunately, matches have been found in other countries, possibly Northern Ireland. Time is of the essence, so my concern is whether organs and tissues from abroad will reach UK patients in a timely way after the end of the transition phase. If the ports are blocked, the Government have suggested that tissue and medicines—and indeed pharmaceuticals—will be flown in. But look what has happened to the aerospace industry during the pandemic. Will there be enough resource? Will the military be used if there are blockages?

I am also concerned about UK bioscience research. There are about 5,000 imports of tissues and cells from the EU alone in a typical year, so it is essential for UK life sciences that there are no barriers to this work. Can the Minister reassure me?

These SIs are to bring EU regulation into UK law, whether or not we get a deal. It is looking as if we will not. When the 2019 SIs were debated in Grand Committee on 9 January 2019, in Hansard col. 201 the Minister said that such materials would be “prioritised”. However, the problem is that everything will need to be prioritised.

In that debate my noble friend Lady Barker raised the issue of inspection of premises, pointing out that the UK and the EU will each inspect their own premises. But what happens if there is a serious incident on one side or the other? Will this not destroy the trust that is needed for this system to work? It is also essential that the public trust the regulations since, in many cases, such as transplantation, their permission is needed. How will the Minister reassure any member of the public listening to this debate that they can have the confidence to give that consent once we are independently responsible for our own standards? As the noble Lord, Lord Alton, said, confusion and inconsistency can destroy trust.

My Lords, I thank the Minister for introducing these regulations. Indeed, I remember taking part in that debate in January 2019—I am looking at the noble Baroness, Lady Thornton, and clearly she does, too. Although much time has passed, little has changed. We are still facing a situation in which we live under the threat of leaving with no deal and therefore being a third country in terms of EU regulation. These matters are of immense importance. We are, as the noble Lord, Lord Lansley, said, talking about tissues and materials and so on which are in high demand and of which there is not a great surfeit.

It is important now to realise that we are talking in these regulations simply about the circumstances under which we would import such materials from the EU into Northern Ireland and into Great Britain. I will say one thing for Brexit: it has educated the British public in what the United Kingdom is and what Great Britain is and what the differences are between the two. Some of us who were brought up in Scotland have long known the difference.

I understand what the Minister says about these regulations being important in order to enable the current regime, or congruence of regimes, to continue. However, we are still talking about these regulations applying only for a transitional period of six months. The noble Lord, Lord Lansley, is absolutely right that we will face the prospect very shortly of having part of the United Kingdom under a regulatory environment into the terms of which the UK Government have had no input. I happen to think that that is an inevitable part of Brexit, and I am not surprised that that was never put on the side of a bus. None the less, it has important consequences for people in Northern Ireland and for the rest of us in the United Kingdom.

Can the Minister say who will have the responsibility for keeping under review the regulatory burden and costs of operating two different systems within the United Kingdom, and who will be responsible for the long-term monitoring of issues such as the availability of organs and tissues within Great Britain on a long-term basis? My noble friend Lady Walmsley is right: there is a degree of danger here to the supply of these necessary items.

When we debated these regulations in 2019, I did not get a satisfactory answer on inspection of premises and what would be the responsibility of both the British authorities and others to notify serious incidents within 24 hours. Perhaps in his response the Minister might take that up.

I also think that the noble Lord, Lord Lansley, is absolutely right that Clauses 42 and 43 of the United Kingdom Internal Market Bill have no place on our statute book. They certainly have no place in relation to the importation of these materials from the EU.

So politically we are no further on, but perhaps the Minister might be able to enlighten us with a bit more detail than was the case back in January 2019.

Like the noble Baroness, Lady Barker, and others in this Room, I have been involved in the legislation that is the subject of these regulations for, in my case, 20-odd years. I thank the Minister for his explanation of these regulations. If he looks back in the record to last year and the statutory instruments that we were discussing in Grand Committee—I think we might even be amending some of them today—he will see that his noble friend Lady Manzoor was given a particularly hard time by the Committee, because of course we were at the time putting on the statute book regulations just in case we crashed out of the European Union in March last year, and many of us resented the amount of legislative time that we wasted preparing for something which did not then happen.

It is of course important to acknowledge that these regulations are of vital and often life-saving importance, and concern literally matters of life and death.

The UK legislation for the safety and quality of blood, organs, tissue and cells, including reproductive cells, is of course based on European law. The European Union (Withdrawal) Act 2018 ensures that EU-derived domestic legislation will continue to have effect after the end of the transition period. In 2019, regulations were introduced to ensure that UK legislation in this area could function effectively after the transition period. However, Northern Ireland will remain subject to relevant EU laws as a result of the Ireland/Northern Ireland protocol. So today we are looking at four statutory instruments that would amend the 2019 regulations and enable Northern Ireland to continue to meet European law.

Like other noble Lords, I have two questions that flow from that. First, what effect will the United Kingdom Internal Market Bill have in this regard? Is it a complete waste of our time discussing these things? Secondly, as the noble Lord, Lord Lansley, and my noble friend Lord Hunt asked, what happens when there is divergence in the regulatory framework between the European Union and Great Britain?

As noble Lords have said, there is one blood establishment in Northern Ireland, and it will of course be able to continue receiving blood and blood components from Great Britain establishments. However, Northern Ireland establishments will treat Great Britain as a non-European Union member state—a third country—for this purpose. What does that mean? In practical language, will this delay or impede the use of blood products?

The provisions for importing blood or blood components from a non-EU member state are set out. The Northern Ireland blood establishment already has the required import authorisations in place, and GB blood establishments currently prepare blood and blood components to meet EU and UK standards, so Northern Ireland blood establishments can continue to receive blood or blood components from Great Britain. There are 10 hospital blood banks in Northern Ireland, which will not, I think, need to take any action as a result of this SI.

On organs for transplant, the NHS Blood and Transplant service will continue to be responsible for organ donation and retrieval in the UK. Between April 2019 and March 2020, as other noble Lords have said, 32 organs from deceased donors moved from Great Britain to Northern Ireland, and 126 organs moved from Northern Ireland to Great Britain. Organs will be able to continue moving from Great Britain to Northern Ireland. However, Northern Ireland-based establishments again will be treating Great Britain as a non-EU member state for these purposes. We are told that these are the same provisions that currently apply to organs moving within the UK, and so the changes made by the 2020 SI will make no difference. However, what of the future? What happens when and if the European Union changes the regulations in this area? How will this be impacted? For tissues and organs, as the noble Baroness, Lady Walmsley, said, time is absolutely of the essence in these matters.

The HFEA says on its website:

“As the regulator of the fertility sector we continue to support clinics during the transition period. We have been communicating regularly with clinics through our Clinic Focus publication and have developed an EU exit webpage for clinics. We believe that fertility clinics are minimising the possibility of disruption of patient treatment.”

Well, I wonder whether that is the case, actually, for fertility treatment between Ireland, Northern Ireland and Great Britain.

The Human Tissue Authority website says that

“establishments that are licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) may require changes to their licence. This applies to establishments in the Human Application sector from 1 January 2021.”

So the HTA is saying that human tissue establishments will need to vary their licence in order to continue their activities post transition. This includes establishments that intend to import or export tissues and cells as the starting material for the manufacture of an advanced therapy medicinal product. That is extremely important. In what way will this take place? Will there be delays? How will it happen?

I will look briefly at sperm banks, and I asked this question last year. The UK currently imports sperm primarily from sperm banks in the USA and Denmark. How will that traffic in particular be affected by these new regulations and instruments? In the regime that we currently have, we will be a third country and no longer a member of the EEA. So I would like to have explained how that will affect the import of sperm from the sperm banks that we use in Denmark.

My Lords, I start by saying a profound thank you for a lively, insightful and patient debate, because I recognise that these issues have been visited before—and the debate only improves in the retelling. I shall try to trot through a number of points in quick order, because the debate has been wide-ranging and taken on a number of issues.

I want to start on the most important one, divergence, which was raised by a number of noble Lords, including the noble Lord, Lord Scriven, my noble friend Lord Lansley and the noble Baroness, Lady Thornton. On the question of divergence and one regulator overseeing different territories, I reassure noble Lords that we are moving towards developing a common UK framework for blood, organs, tissues and cells with the devolved Administrations precisely in order to avoid this problem. This is the mechanism whereby the four nations can work together to ensure that they are all aligned and that companies and individuals in each nation can feel confident that they are in one common legislative framework. Policy issues will continue to be considered on a four-country basis going forward. I reassure noble Lords that officials and Ministers in Northern Ireland will continue to be involved in policy development, as they have been to date.

After 31 January, blood, organs and tissues will keep moving from the UK to Northern Ireland and from Northern Ireland to the UK, and they will keep moving from the UK to the EU and from the EU to the UK.

There may be at an appropriate point in the future an opportunity for the department to review whether the UK’s exit from the EU offers us opportunities to reappraise current regulations to ensure that we continue to protect the nation’s health. When that moment arrives, we will consult, analyse and assess. The regulations put in place the opportunity to do that—but that is for a moment in the future and it is not envisaged in the near future. To reassure the noble Lord, Lord Alton, who asked about the devolved Administrations, Scotland, Wales and Northern Ireland have provided their consent to these statutory instruments and they continue to be closely involved in the development of policy.

The noble Lord, Lord Scriven, asked about the Medicines and Medical Devices Bill. I reassure him that the Bill as drafted would already allow us to strengthen the requirements governing the use of human tissues in the development of medicines, were it deemed necessary and appropriate to do so. For instance, powers under Clauses 1 and 2 would enable us to introduce new requirements to the Human Medicines Regulations 2012 for medicines manufactured using human tissues.

The noble Lord, Lord Scriven, and others asked about the movement of blood and blood components. This is a hugely important issue. Currently, the UK is largely self-sufficient in the supply of blood and blood components. It occasionally exports rare blood cells—fewer than 10 units per year—to the EU and to non-EU countries. However, as the noble Baroness, Lady Thornton, observed, blood components are frequently shared across the four nations, as needed to meet demand, and the regulations will ensure that that flow is not interrupted. The movement of blood, organs, tissues and cells around the UK is absolutely critical for patient treatment. That will continue as it is now. There will be some minor administrative changes for tissue establishments in Northern Ireland to receive tissues and cells from Great Britain, but there will be no change to the requirements for Northern Ireland establishments to send blood, organs and tissues to GB.

The noble Baroness, Lady Thornton, and my noble friend Lord Bourne asked about the United Kingdom Internal Market Bill. As they will know, the Bill has passed Second Reading. Amendments have been tabled to enable safety emergency exclusion functions as intended that can be applied, if required, to Northern Ireland qualifying goods. However, I absolutely reassure noble Lords that we are totally committed to upholding our long-standing track record of high standards on health and food, including in respect of the materials which are the subject of these statutory instruments. We have kept healthcare and social care services out of the scope of the services framework rules, ensuring that there is no disruption to the regulation of health and care services.

My noble friend Lord Lansley was right to point out that it is fast-changing world for blood plasma. This could not be more relevant than it is right now. Covid has shown the international constraints on supply and the potential for huge demand. I reassure him that this is uppermost in our minds and that we will put in place all the regulations necessary to ensure that British access to blood plasma from overseas remains as secure as it is today.

To the noble Lord, Lord Alton, I say personal thanks for the report which he sent me. It includes charges which we take very seriously. We are of course against organ tourism. I noted the powerful points that he made in Committee on the Medicines and Medical Devices Bill last month and look forward to further discussion on Report. I reassure him that my noble friend Lord Ahmad has written to the World Health Organization encouraging it to give careful consideration to the findings of the report of the International Coalition to End Transplant Abuse in China. The Government welcome any work that is rigorous and balanced, and that raises awareness of the human rights situation in China. We continue to monitor this issue closely and to consider carefully all the evidence presented to us.

I note the personal testimony of the noble Baroness, Lady Walmsley. My family has been the beneficiary of organ transplantation, so I completely endorse her concerns. Traffic between Great Britain and Northern Ireland will remain, as it will between GB and the EU. I am glad to confirm that Northern Ireland will align with the EU, but we will find a way to work with Northern Ireland within the UK common framework to ensure that this trade continues. I am reminded that between April 2019 and March 2020, the UK exported 13 organs to the EU and imported 13 organs from it. While these numbers may seem low, they are extremely important to those concerned and it is a priority to ensure that those movements continue. With those thoughts, I commend the regulations.

Motion agreed.