Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
Debate between Lord Deben and Baroness Manzoor(5 years, 11 months ago)
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Baroness Manzoor
I am sorry but I will be firm on this. All noble Lords have had ample opportunity to speak. I wish to move on. If I have not addressed the noble Lord’s point, perhaps we can come back to it.
I want to thank the noble Baroness, Lady Thornton, for her words. We know that this is a sensitive, delicate and important issue, and indeed the noble Lord, Lord Winston, has highlighted its importance as well. It is vital that we have consistency in maintaining our contingency plan so that we can ensure that the service which is currently being provided continues and that we have effective agreements in place. I should say to the noble Baroness, Lady Thornton, that in either a deal or a no-deal situation, the changes to UK legislation will not affect the availability, safety or quality of organs, tissue and cells as the current standards will be maintained. The current arrangements support the free movement of organs, tissue and cells across the EU. The UK and the countries of the EU would consider each other as third countries after exit day, as the noble Baroness rightly said. The relevant EU directives and UK legislation allow for agreements to be made to receive organs, tissue and cells from countries outside the EU provided that they meet equivalent standards of quality and safety. This means that the agreements for sharing organs, tissue and cells with EU countries can continue to be made.
My noble friend Lord Deben and other noble Lords raised the issue of the cost for establishments of tissue and cells. The estimates are that 12 out of 135 tissue establishments will need to put new agreements in place. Many already have templates that they can use quickly and effectively because we look at organs, tissue and cells across the world, not only in the EU. That is precisely why we expect the costs to be small.
My noble friend and others also raised wider issues as regards exiting the EU. As he rightly pointed out, I am afraid that those are not within the remit of these SIs. Quite rightly, my noble friend asked me whether the changes are deliverable. The changes are minimal and they are deliverable. The operational changes have been discussed with the regulators, which consider that the changes we are advocating can be made. There is no large-scale transportation risk that we are aware of.
Lord Deben
My noble friend has not answered my point and this is a debate. The question I want to ask her is this. I accept that there are no large-scale transportation issues, but there are transportation issues. My question is how we will prioritise those things that need to be prioritised in circumstances in which no aeroplane would be flying because the insurance system does not enable it to do so. What are we going to do with that? Who is in charge of making sure that we have naval or air cover to deal with it? That is a proper question for my noble friend in these circumstances.
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.