Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019

Baroness Barker Excerpts

Wednesday 9th January 2019 Grand Committee

[Baroness Thornton (Lab)]

That is right. I intend to cover some of these issues when I speak tomorrow in the major debate.

[Baroness Barker (LD)]

My Lords, I will confine myself to considering the regulations. I accept the challenge thrown at us by the noble Lord, Lord Deben, about what we are doing. For my part, I believe that my job is to go through these SIs precisely to establish what is real and what is fictitious in them. There is a grave danger, not least on an important subject such as this, that the general public are being given completely false reassurances. I take the point that the regulations are for a no-deal situation and will last for six months only, but the world does not stop and research does not stop in those six months. I echo the point made by the noble Lord, Lord Winston, that the impact on medical research is tremendously important.

I will make two points. On the inspection of premises, the noble Baroness mentioned in the discussion of the previous regulations reciprocal inspection powers between countries. She said that countries in the EU will continue to inspect their premises and we will inspect ours. In a no-deal situation, why would the EU 27 continue to uphold our inspection processes? They are under no obligation to do so. That has huge consequences, not least for research. I make the observation that if we in the United Kingdom are sitting here content that the EU countries will continue to inspect their own facilities to their own standards, that is a very curious interpretation of taking back control.

Secondly, we are told that the regulations will be in force for six months in a no-deal situation. What if, down the line, it turns out that there has been an adverse incident either here or in the EU? What are the implications of that in a no-deal situation for the protection of patients? Yes, we are in fantasy land, but even in fantasy land we have to start asking real questions. Those are simply two of the many questions that noble Lords are entitled to ask and to which we are entitled to have strong answers.

[Lord Warner]

My Lords, I was not intending to speak on this set of regulations, but I was taken down memory lane when I saw what was involved because I was the Minister who took the human tissues legislation through this House in 2004. I want to remind the Minister why that legislation was put in place because it is relevant to a question that I want to ask at the end of what I am going to say. It was put in place because medical research was being jeopardised because of patients’ concerns about the safety, storage and use of human tissue of various kinds. It arose against a background of huge concern about the treatment of human tissues of children at Alder Hey Hospital. I can still vividly remember the parents of those children fixing me with a gimlet stare as I took that legislation through the House.

My question to the Minister therefore backs up to some extent the point that the noble Baroness, Lady Barker, has just made: can the Government guarantee that in these regulations there will be an absolute set of safeguards around the use of human tissue during the period after a no-deal Brexit that will not jeopardise all the good will that has been built up since 2004, which has got patients willing to co-operate in the use of human tissue for medical research?

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[Baroness Manzoor]

I thank my noble friend for that clarification. My noble friend is right to say that at the moment the regulators have agreements in place and those agreements will continue to run; they will not change. This does not change any of the agreements that are in place.

On the issue of reasons such as strikes or volcanic activity preventing flights, I cannot possibly comment. But what I am saying is that the issue behind this is continuing with the agreements. We have organs that are flown from the EU. That will continue. In the NHS we make life and death decisions about priorities every day. If there is a priority and a patient needs an organ, that patient will receive that organ, and the Government will do everything in their power to ensure that patient safety is not compromised.

The Government have already given that undertaking: we will endeavour to do our very best. I passionately care about patient safety. I passionately care about ensuring that no one is put in any undue danger, as do the Government. I do not agree with much of what my noble friend Lord Deben has said about there perhaps being issues with patients not getting the priority that they need if it is necessary. We will endeavour to do everything in our power to ensure that patients who need life-saving organs or any other tissues that may be necessary get them.

The noble Lord, Lord Winston, spoke about the sharing of tissues and cell cultures. I am sorry to repeat myself. I am trying to choose the things that are pertinent for me to repeat because of their importance. I want to make it clear that these SIs are not related to ethical consent for research. The Human Tissue Act covers domestic consent and EU material is outside the scope of that. As I have already indicated, if the EU makes changes to this in the future, the UK will need to decide whether it wants to make any changes at that time. That will be a matter for Parliament.

The noble Baroness, Lady Barker, asked about the arrangements for the inspection of tissues and cells. I assure her that establishments are required to be contained within the agreements with all third countries, as they currently are. That will continue after we exit the EU. That will not change.

I have already said that these SIs do not relate to medical research but only treatment. I say to the noble Lord, Lord Warner, my noble friend Lord Deben and the noble Baroness, Lady Thornton—who I know cares passionately, as we all do, about the safety and quality of the service and organs—of course we want to make sure that there are safeguards after Brexit. Nothing will change. We want to have higher standards, if possible. The standards and quality will not be diluted.

[Baroness Barker]

You cannot guarantee that.

[Baroness Manzoor]

I am saying that we passionately do not want that to happen. We will endeavour to do everything we can. These SIs are continuing the standards. We are not changing standards. If the EU decides to move away to other areas, it will be for the UK Parliament to look at and discuss that issue and agree how we as a country want to move forward. That will be a decision for Parliament, not for these SIs and certainly not for me.

The noble Baroness, Lady Barker, asked what agreements we will put in place to import tissues in the future. The six-month period is a transition period. The agreements that will be put in place will not just finish after the six months. If there is divergence then that will be a different issue for the regulators and it will have to come back to Parliament, but we will use the agreements that are in place as templates for the sake of consistency, and they will continue to exist after the six-month period concludes.

[Baroness Barker]

I have a point that is germane to all three of these SIs. If there is no deal then there is no agreement and no six-month period because, whatever aspirations the British Government may have, the EU is not bound by this. The Minister is talking about the continuation of arrangements, but they are EU arrangements. If there is no deal, we are no longer a member of the EU. That is the flaw which underlies her arguments on all these instruments.

[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.