House of Commons portcullis
House of Commons
Session 2005 - 06
Publications on the internet
Standing Committee Debates

Draft Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006

The Committee consisted of the following Members:

Chairman: Mrs. Janet Dean
Afriyie, Adam (Windsor) (Con)
Austin, Mr. Ian (Dudley, North) (Lab)
Battle, John (Leeds, West) (Lab)
Blunt, Mr. Crispin (Reigate) (Con)
Bone, Mr. Peter (Wellingborough) (Con)
Chapman, Ben (Wirral, South) (Lab)
Gidley, Sandra (Romsey) (LD)
Gilroy, Linda (Plymouth, Sutton) (Lab/Co-op)
Goodman, Helen (Bishop Auckland) (Lab)
Irranca-Davies, Huw (Ogmore) (Lab)
Michael, Alun (Cardiff, South and Penarth) (Lab/Co-op)
Milton, Anne (Guildford) (Con)
Murrison, Dr. Andrew (Westbury) (Con)
Webb, Steve (Northavon) (LD)
Winterton, Ms Rosie (Minister of State, Department of Health)
Wood, Mike (Batley and Spen) (Lab)
Wright, Mr. Iain (Hartlepool) (Lab)
Mark Etherton, Committee Clerk
† attended the Committee

First Standing Committeeon Delegated Legislation

Monday 19 June 2006

[Mrs. Janet Dean in the Chair]

Draft Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006

4.30 pm
The Minister of State, Department of Health(Ms Rosie Winterton): I beg to move,
That the Committee has considered the draft Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
It is a pleasure to serve under your chairmanship, Mrs. Dean. In considering the regulations we shall return to issues discussed at length in our interesting debates on the Human Tissue Bill. I am sure that Opposition Members are aware of the recommendations and findings of the Select Committee on the Merits of Statutory Instruments, which were mentioned in the House of Lords debates. I shall address in my opening speech some of the issues raised, and I hope that that will assist Opposition members of the Committee.
The regulations are being made under the Human Tissue Act 2004, one of the key objectives of which was to rationalise and update a wide range of legislation and put it together in one Act of Parliament. The law on the retention and use of organs and tissue was reviewed following public concern about events at Bristol royal infirmary and the Royal Liverpool children’s hospital. The review revealed that the law on tissue retention, both from the living and the deceased, was inadequate and that the law on anatomical examination and transplants needed to be updated and brought into a single cohesive framework.
The regulations deal with two important issues: they cover the storage of tissue from incapacitated adults and its use in research, including DNA analysis; and they set out a framework for the approval of the living donation of organs, bone marrow and peripheral blood stem cells. They have been subject to the usual consultation and have been laid before Parliament alongside a further set of regulations and draft codes prepared by the Human Tissue Authority. The codes and regulations will complete the implementation of the 2004 Act.
I shall first explain the proposed deemed consent provisions for incapacitated adults, as set out in regulations 3 to 8, which make up part 2. The concept of consent is the principle that underpins the 2004 Act. Among other things, part 1 of that Act sets out a requirement for consent from those capable of giving it to the storage and use of their tissue for certain purposes, such as research or transplantation. The regulations describe circumstances in which there is to be deemed consent in relation to adults who lack the capacity to consent for themselves. The 2004 Act dealt with general issues of consent in part 1, and created separately in section 45 the new offence of non-consensual analysis of DNA. The regulations correspondingly provide separately for general issues of deemed consent, in regulations 3 and 4, and DNA analysis, in regulations 5 to 7. Those provisions together set out the limited circumstances in which the tissue of people who do not have capacity to consent can be kept and used when consent would otherwise have been required.
The circumstances in which consent will be deemed to have been given were indicated during the passage of the 2004 Act. They are as follows: first, and most simply, when it would be in the best interests of the incapacitated person from whose body the material came. For instance, let us imagine that an incapacitated person—P, for the purposes of debate—is cared for by a family member. It might be in that person’s interests to have their tissue tested for the benefit of that relative, if it would help to identify a genetic disorder and if P’s ongoing care depended on the carer’s continued good health. That type of test would probably involve DNA analysis; the draft regulations would permit such analysis, which would otherwise require consent.
Adam Afriyie (Windsor) (Con): Will the Minister confirm that there is no route by which somebody’s DNA could find its way on to the national DNA database via the regulations?
Ms Winterton: I do not think that there is any way by which such DNA could find its way on to the national database, but I shall seek further clarification. If I am able to confirm that by the end of the debate, I shall certainly return to it. If not, I shall write to the hon. Gentleman afterwards.
Secondly, the regulations will allow tissues to be kept or used for research where that research is authorised under the Medicines for Human Use (Clinical Trials) Regulations 2004. Finally, they will allow for research in circumstances authorised under sections 30 to 33 of the Mental Capacity Act 2005.
The Mental Capacity Act is not expected to be brought into force fully until 2007, so the regulations have a transitional provision allowing the storage and use of tissue for research where the research has ethical approval. Put simply, “ethical approval” means approval under existing research ethics review systems. The transitional arrangement will ensure that legitimate research activities do not fall foul of one piece of legislation, pending implementation of the other.
Adam Afriyie: The Minister mentioned research ethics authorities. Regulation 8 states:
“Research is ethically approved within the meaning of this regulation if approval is given by a research ethics authority”.
What are those research ethics authorities? What bodies are they?
Ms Winterton: The research ethics bodies can vary. Sometimes they will be local; clinicians will have to apply to the local ethics committee to use such material. At other times, committees of experts on certain conditions such as cystic fibrosis would look at the extent of research into that field—I visited somewhere carrying out such research not long ago. Ethics committees ensure that legislation is complied with, that research requirements are met and that our knowledge of conditions such as cystic fibrosis benefits.
Adam Afriyie: I would like clarification on a final point. The Minister mentioned local research ethics authorities. Is she suggesting that a local body, such as the one that she mentioned—the cystic fibrosis group—will have jurisdiction and be able to approve research, on the basis of which it could go ahead?
Ms Winterton: As I have said, the ethics committees tend to ensure that legislation is complied with—for example, when using or storing tissue. They must also be satisfied that proper procedures are in place in order to obtain consent when it is needed. If such consent is not needed—perhaps because that person is incapacitated—they must ensure that the appropriate all-round consent has been obtained before any such research is carried out. That is a safeguard at both local and national level for projects that look into particular conditions.
Sandra Gidley (Romsey) (LD): Will the Minister clarify who will oversee the ethics committees? I dealt with a case a couple of years ago where there was a problem in the ethics committee, as a member of the committee pushed forward some problematic research. Obviously, I do not want to go into the details today. What will stop a very keen doctor who wants material to further his research from trying to push something before an ethics committee that might be inappropriate to the best interests of a patient if they had capacity?
Ms Winterton: The overall system is finally accountable to Ministers. Reviews of the work of ethics committees have been carried out. Obviously, if people think that the wrong decision has been reached or that the proper research has not been properly passed by the ethics committee, complaints can be made. The process involves a group of individuals with a specific task and if a researcher proposed something that people thought was wrong, the ethics committee would consider that in the round. People do not always like the work that is carried out, for various reasons, but the strategic health authorities always have oversight if people think that there is a problem. Clinical trials are accredited by the UK Ethics Committee Authority. So the ethics committees are overseen in a number of ways, eventually leading right up to the Secretary of State.
Mr. Peter Bone (Wellingborough) (Con): So that I can understand, I shall give a practical example. My wife was very poorly with liver cancer, and the NHS did a wonderful job and she recovered. She was asked before her operation whether some of her liver could go towards research, and she consented, although she easily could not have done so. Are we saying that in such a situation, if the patient was incapacitated, it automatically would be said that that piece of liver could go for research?
Ms Winterton: No, we are saying that if the research is in the person’s best interests—such as in my example of an individual’s carer and research such as a DNA test from the incapacitated person—consent can be deemed to have been given. In general, and under the terms of the Mental Capacity Act, in cases such as that of the hon. Gentleman’s wife the ethics committee will stress that as far as possible research material should be taken from those with the capacity to consent. There are some instances in which an ethics committee might say that research could be carried out on people without capacity, but there are clear safeguards about that. Often such instances will be associated with an individual’s condition. Some of the examples that we discussed during consideration of the Act were about what might be appropriate social activities for a person with Alzheimer’s to undertake. There are strict rules on invasive procedures, which should be as minimal as possible. For example, if the person found the taking of blood uncomfortable, it should stop.
These areas can of course be controversial. We received many representations during consideration of the legislation. However, it was obvious that a lot of important research could be done into particular conditions, as long as there were clear rules guiding ethics committees considering how samples were to be taken for research purposes. Those rules should be adhered to on the understanding that the research is necessary and that any tissue would be obtained in the most appropriate way.
John Battle (Leeds, West) (Lab): I generally welcome this legislation because, after what happened, safeguards need to be introduced to make sure that there is no abuse and also that people do not turn against transplants. That is a big issue, which could go the other way, with people saying that they do not want to know about the whole business.
My question is about the process and this particular legislation. My hon. Friend said that it is a transitional and interim piece of legislation, not least because the Human Tissue Act 2004 comes into force before the Mental Capacity Act 2005. The Mental Capacity Act will not come into play until 2007. However, there were plans to have a mental health Bill that would change the Mental Capacity Act, and I am told that that might be brought forward before the summer recess in July. Will my hon. Friend confirm that that is the case? Or will we need to do this all again to redefine the Mental Capacity Act? If so, this will be a very transitional measure.
Contents Continue
House of Commons 
home page Parliament home page House of 
Lords home page search page enquiries ordering index

©Parliamentary copyright 2006
Prepared 20 June 2006