Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019

Baroness Manzoor Excerpts

Wednesday 9th January 2019 Grand Committee

Moved by

[Baroness Manzoor]

That the Grand Committee do consider the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019.

[Baroness Manzoor (Con)]

My Lords, I refer the Grand Committee to the comments that I made at the start of the first SI, which also extend to this SI. I beg to move.

[Baroness Thornton (Lab)]

My Lords, the Minister has probably now realised that the Grand Committee is not satisfied with the regulations, and it is highly unlikely that the Grand Committee will be satisfied with these regulations on organs, because they concern the cross-border trafficking of human organs. When I read these regulations, I wondered—and I have already asked the Minister to walk us through this on one occasion—how an organ which is in Spain will find its way to Manchester when a match is found. What new barriers will exist with regard to the regulatory framework, inspection, cost and travel if we crash out of the European Union? When we are talking about organ transplants, lives are at stake. I am therefore extremely concerned that we will find ourselves with people not getting organs that match from other parts of Europe, or indeed with organs in the UK which should be in Ireland. I know that there is a great deal of trafficking of organs from hospitals across the Irish border. There are therefore some serious problems here, but they have been mentioned by many noble Lords in Grand Committee over the last three hours or so. I do not necessarily agree with the noble Lord, Lord Tyler, about unicorns, but on the other hand, these orders made me extremely worried that they are not deliverable. I hope that the Minister might on this occasion be able to convince us that they are.

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[Lord Warner (CB)]

My Lords, I want to comment on this set of regulations but will relate my remarks to all 10. I address my remarks to the three Ministers here, bearing in mind the three hours that we have spent on these regulations so far, as the noble Baroness, Lady Barker, has said. It can be taken as given that most of what I, the noble Lord, Lord Winston, and others said on the previous set of regulations is what we would say on this set of regulations, but I am not going to repeat it. The same considerations apply.

We are not going to get to number nine on the list, and I want to question what the Minister has been saying, and what the Government have been asserting, all the way along, which is that these regulations do not change policy. The Minister has said this a number of times. I know from the speech I am going to make on number nine that it has changed policy, and I shall deploy the arguments to demonstrate that. Unfortunately, the noble Lord, Lord Henley, is not here to hear them, but if I ever get the chance, he will hear them.

I have a terrible feeling that my concerns about item nine apply all the way through this set of regulations. They do change policy and, although this is not the Minister’s fault, the Government have been asserting for month after month that they do not. They do, and they change policy that is set out in primary legislation in some cases. We do not have any alternative, if I may say to the Grand Committee, to continuing to negative—or whatever the verb is—all these sets of regulations. We can go through this process all the way down to item 10 if the Government want us to do that. I am quite prepared to do that to make the point to the Government. I am doing that not as a member of any party—I am the only Cross-Bench Peer in the Room—but because we are discrediting this House by giving an authenticity to these regulations, which I fear would then get tucked away in the cupboards of Whitehall to be produced again when the need arises. I do not want to be associated with giving authenticity to this set of regulations, and would hope that other Members, of different political parties, feel the same way. I want these three Ministers, who have heard this and sat through this very patiently, to go to the Chief Whip and the powers that be in the government party with feedback about the farce being created.

[Baroness Manzoor]

My Lords, for two years, the Government have been implementing a significant programme of work to ensure that the UK will be ready, from day one, in all Brexit scenarios, and I have tried to make that clear throughout the three SIs. For organs, tissues and cells, our priority is to ensure the continuity of supply and to maintain the existing high standards of safety and quality. Organs for transplant and stem cells need to be transported urgently, as has been made clear today, and we are working across government with the health sector to prepare for, and mitigate, any possible disruption which may affect the organs or stem cells imported from the EU. For other less time-sensitive tissues and cells, we are also preparing for possible disruption, and information for tissue establishments will be available through the regulator.

This has been an interesting debate. I for one take very seriously the comments that have been made by noble Lords. I will endeavour to ensure that the Chief Whip is made entirely aware of the comments regarding SI processes and the future. I have already undertaken to do that but it is important to restate the point.

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[Baroness Barker]

Sorry, can I clarify what the Minister has just said? The EU is allowed to export to a third country but it is under no obligation to do so. At the moment we are members of the EU so bodies do not have to have an import licence, but they will. So she is saying that there could be six months in which the EU could choose not to export to us as a third country and in which the organisations in this country will have no power to import. We are potentially talking about at least a six-month gap about which we can do nothing because we will no longer be in the EU.

[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.

[Lord Adonis]

My Lords—

[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.