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

Baroness Thornton Excerpts

Wednesday 9th January 2019 Grand Committee

[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 Thornton (Lab)]

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

[Baroness Manzoor]

Both.

[Baroness Thornton]

That is rather important.

[Baroness Manzoor]

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

[Baroness Thornton]

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

[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.

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[Lord Tyler (LD)]

My Lords—

[Baroness Thornton]

My Lords—

[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.

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[The Deputy Chairman of Committees (Viscount Ullswater) (Con)]

The noble Lord is correct.

[Baroness Thornton]

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

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

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

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

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

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[Baroness Manzoor]

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

[Baroness Thornton]

Perhaps we could have some clarification from the Deputy Chairman of Committees.

[The Deputy Chairman of Committees]

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

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[Baroness Manzoor]

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

[Baroness Thornton]

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

[Lord Winston]

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

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