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Dr. Evan Harris (Oxford, West and Abingdon) (LD): I want to ask the Minister about something in the first part of her remarks. Is she confident that Lords amendment No. 6 is narrow enough in scope to refer only to a person's specific treatment needs? Some people will argue that it is wide enough, especially given its reference to "scientific or medical information", to include purposes that might be considered research. Although that might benefit someone later, there does not have to be a specific individual whose needs must be considered immediately. Is the amendment narrow, or could it be applied more widely?

Ms Winterton: The aim of the amendments and the clauses that have been referred to is simple. We want to be able to determine whether something is likely to affect the person involved directly—whether, as I said, a person might be liable to contract a disease. The provision may therefore be called a mixture of research and treatment: research in the sense that it is about what might happen in the future, and treatment in the sense that it deals with what a person might receive in the meantime to prevent a possible illness in the future.

Asking whether the provision covers research or something that would lead to treatment is therefore rather like asking how many angels can dance on the head of a pin, but I shall be happy to help further if the hon. Gentleman wants to pursue the matter.

Dr. Harris: I will have another stab at this, and I may try and raise it later if I catch your eye, Mr. Deputy Speaker. Lords amendment No.6 talks about

but says nothing about the need to identify that person at the time. As a result, some people may try to use the provision to get the HTA, as opposed to the High Court, to waive the requirement for consent in the case of a non-responder. I make no judgment about that one way or the other, but the requirement would not be waived when there was a person—or a future embryo, or a family— in a clinic who needed the treatment. The Government have rejected previous amendments that would have given the HTA power to use the information for research purposes.
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Ms Winterton: That is dealt with separately. This amendment concerns a specific individual making an application because it would directly benefit him or her. If a person is worried that a particular condition may develop, that person must be able to get information about a relative. That is different from a researcher trying to do research, which is dealt with elsewhere.

The Government recognise that extending the "missing persons" order under clause 7(1) and schedule 5(9) to "non-responders" may result in an increase in the number of applications to waive consent to use tissue in these situations. It is clear, however, that the numbers will still be small. There are 18 genetics centres in England, for example, and we might anticipate that each might have a couple of cases a year. We consider that it should remain an exceptional circumstance, but to save any potential burden on, and cost to, the NHS and to make it easier for both professionals and patients, we consider it appropriate for such applications to be made to the Human Tissue Authority rather than to the High Court.

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The Government consider that, taken together, this group of amendments provides a pragmatic solution to a situation that, while not common, could damage the interests of certain patients. We cannot countenance overriding a clear refusal of consent, but we have now provided for two sets of circumstances in which it may not be possible to get consent to use tissue to benefit another person. That will allow, in particular, genetic information from one person to be used to benefit the health care of a relative.

Dr. Andrew Murrison (Westbury) (Con): The amendments relate to clause 7, which was introduced late in our consideration of the Bill and in response to representations made by researchers, principally geneticists. The group is titled,

In a sense, that strikes at the heart of the Bill, because it is all about consent. Therefore, we need to tread a little warily. That said, the Opposition believe that the change is a pragmatic move that will strike the difficult balance between putting consent at the heart of everything we do medically and ensuring that researchers, especially in genetics, are not disadvantaged in the work that they do on behalf of us all.

I am sure that the Human Tissue Authority will be careful in drawing up codes of practice and guidance on the need to be assiduous in obtaining consent. We agree that the default position introduced by clause 7—that the authority may dispense with the need for consent if no response is received—implies that some effort has been made to ensure that the person concerned does not object to the use of their tissue. I suspect that some cases will emerge every year, given the sensitive nature of the issues surrounding genetics and DNA, in which people do object for a variety of reasons, some that we can imagine but others that we cannot. After all, genetics is a rapidly evolving science and will no doubt in future provide information about people that we are not presently aware of. For example, some religious groups may take exception to the use of tissue for this purpose and wish to object. In the case of objection, it would be
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inappropriate for the authority to have any powers to override. We must be sure that we give people every opportunity to object to the use of tissue and it is clear that we need, as a matter of some urgency, codes of practice from the authority that will clarify those points.

I have expressed the only concern that we have about the amendments. Broadly speaking, we welcome them, although it is a shame that they have been introduced at this late stage. We are concerned that some of the wording may be confusing, especially with regard to what is relevant directly to a person's condition and what might be relevant later. However, with that in mind, we will give the amendments a fair wind.

Dr. Richard Taylor (Wyre Forest) (Ind): I tabled amendment (a) as a probing amendment. Like the hon. Members for Westbury (Dr. Murrison) and for Oxford, West and Abingdon (Dr. Harris), I was concerned particularly about two phrases in Lords amendment No. 6. The first is

That phrase exactly fits definition of research in the "Oxford English Dictionary" as well as the wider definition of research. The Minister has already clarified that, in this amendment, "research" is meant in the narrow sense of looking specifically at features of the donor that could affect people in the future.

My other query was about the definition of "another person". Could it mean other persons? Unless that is clarified, the wording could open the door to research on a wider circle of people. I would be grateful for absolute clarification of those two slight ambiguities.

While I have the chance, may I say how delighted I am that almost all the changes that we struggled to obtain in Committee have now reached the Bill at this stage?

Dr. Evan Harris: I wish to raise three points with the Minister on this group of amendments and, in particular, Lords amendment No. 6. I have already made the first point in an intervention on the Minister. I asked whether the amendment might be used to obtain permission for research without consent from the authority and not from the High Court, as provided for in clause 7(3). As the hon. Member for Wyre Forest (Dr. Taylor) said, it might be argued that to obtain scientific or medical information to help another person or future person is, by definition, a particular type of research project. The Minister kindly confirmed that we should be reassured—or, in the case of those who might have wished to use the provision to make such applications for permission, disappointed—because it is necessary for a person who would benefit from the information to make the application for permission to obtain it. Where in the amendments is the requirement for an application, or does some other provision in the Bill make it impossible for the application to be initiated unless by a person with specific diagnostic or treatment needs?

Will the authority have to decide applications for the purpose of research? Does the Minister think that it is appropriate that applications for research purposes should be decided by the High Court, as provided for in clause 7(3), rather than the authority? Will that make it
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difficult for any applications to be made, whatever their merits, because of the cost? If the Minister believes—as indicated by the amendments accepted in the other place—that the authority is expert enough to make decisions about dispensing with consent in some cases, why should it be the High Court that makes the decision about dispensing with explicit consent for other applications, such as those for research? I hope that I have made my concerns on that point clear. If not, I would be happy to accept an intervention to clarify them further.

Secondly, I would be grateful if the Minister would clarify the steps she expects will be taken to ensure that the donor from whom the authority is being asked to gain consent for the use of their tissue or genes has not died. The amendment refers to there being "no reason to believe" that the donor has died, which mirrors an amendment we discussed on Report—I think that that is worth returning to—but it talks elsewhere about "reasonable efforts" having been made to get the donor to decide whether to consent. If the donor had died, my understanding is that it would not be possible for that to be done, so one might argue that reasonable efforts ought to be made to establish whether a non-responding donor has died.

I presume that the clause is constructed around the knowledge that the person is not dead, but if it is the case that they are alive and not responding, it is curious that one would even need to mention the condition that there be no reason to believe that the donor had died. I am a little unsure of the circumstances in which that provision might apply and of the steps the Minister believes should be taken. Clearly, those who have died will not respond. I would be interested to know how she envisages certainty being obtained as to which applies.

The third issue relates to lack of capacity, and the Minister will be aware that I have raised that before. I understand that both Houses will debate the matter in the context of the Mental Capacity Bill. However, subsection (d) of amendment No. 6 states that

It is thus clearly the Government's understanding that the Mental Capacity Bill will be used in that case to decide whether consent can be obtained. It is important that we debate that now, because this is the best place to get an idea from the Government now that Bill has been published—it was not when we previously debated this matter—on whether the best interests test is the best way forward.

It is hard to argue on an understanding of best interests that it is ever, narrowly, in someone's best interests to allow their material to be used for someone else's benefit. The Minister can say that best interests include what they would have wanted to do for a member of their family, but it seems to me that it would be better—I make this case again—to avoid the term "best interests" and use the expression "not against the best interests of the person concerned". That is a good example, and shows how using such terminology will not change the actual outcome, but it is a more honest way of saying how we are going to deal with issues of lack of capacity. Otherwise, people might feel that such cases are stretching the term "best interests" further than it need go.
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I would be grateful if the Minister would comment on whether she envisages that it would almost always be the case—even though it is not always the case for a donor with capacity—that the advocate or their substituted decision maker would allow such a decision to be made. I hope that that is clear. Like the hon. Member for Westbury (Dr. Murrison), I welcome the fact that we are debating a series of amendments that have improved the Bill and I am pleased that the Government accepted—albeit in another place—some of the amendments that were pressed, which had their echo during debates that took place in this House.

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