- (a)an activity of a kind mentioned in section 1(1)(d) or (f) involves material from the body of a person who—
- (i)is an adult, and
- (ii)lacks capacity to consent to the activity, and
- (b)neither a decision of his to consent to the activity, nor a decision of his not to consent to it, is in force,
§ Mr. Speaker
With this it will be convenient to discuss the following amendments: No. 7, in clause 3, page 3, line 40, after 'alive', insert'and subsection (2A) does not apply'.No. 8, in page 3, line 40, at end insert—'(2A) This subsection applies where the person concerned is alive, but lacks the capacity to give consent.(2B) Where subsection (2A) applies, "appropriate consent" means the consent of a person who stands in a qualifying relationship to him.'.No. 9, in page 4, line 31, at end insert—'(8) For the purposes of this section a person lacks capacity to give consent if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of or a disturbance in the functioning of the mind or brain.'.Government amendments Nos. 99 to 107.
§ Ms Winterton
The Bill was not intended to impact on the common law test of best interests, regarding the activities that can take place in relation to tissue from mentally incapacitated adults. As we have said, such issues—in particular, research—will be dealt with under the forthcoming Mental Capacity Bill. However, we now recognise that, as drafted, the Human Tissue Bill would prevent activities that are currently lawful, where the removal of tissue for a particular purpose—for example, transplantation—is deemed to be in the best interests of the incapacitated individual. The person's best interests would be frustrated, because they cannot give the necessary consent to the subsequent use of the tissue.
The Mental Capacity Bill is unlikely to be enacted before 2007, and the Human Tissue Bill is likely to be enacted in 2005. That gap makes it necessary to amend the Human Tissue Bill, so that it does not have a detrimental effect in the interim on the use of tissue lawfully removed from incapacitated patients. We therefore propose to amend the Bill by taking a power to make regulations setting out what is required before tissue from those who lack capacity can be used for purposes regulated by the Bill. Those purposes will include obtaining information that may be relevant to the diagnosis and treatment of another person, such as a genetic relative, and transplantation. The intention is to use the regulations to provide that, in the case of incapacitated adults, tissue may be used for scheduled purposes, where that would be in the adult's best interests.
The regulations would also allow research using the tissue of incapacitated persons, where participation in the research by the person who lacks capacity is authorised in accordance with the clinical trials regulations, which came into force in May. Such use would be subject to the safeguards set out in those regulations, which include that an ethics committee must approve the research. The regulations will also take account of the outcome of debates on the Mental Capacity Bill later in this Session, and research relating to mentally incapacitated adults will be debated in that context. Indeed, rather than setting down the circumstances in the Bill, regulations are proposed because we do not want to pre-empt the debates that will take place later in the Session.
35 In due course, the Mental Capacity Bill may replace the regulation-making power by amendment. Similar amendments will be made to the provisions dealing with DNA, so the regulations can say when it is lawful to hold material from an adult who lacks capacity with the intention of analysing the DNA. Those apply also to Scotland, where it will be necessary for the regulations to take account of authority under the Adults with Incapacity (Scotland) Act 2000, whether for research or for any other of the purposes that I outlined.
§ Mr. Tam Dalyell (Linlithgow) (Lab)
What is the relationship with the Scottish Department of Health, and which other Departments have been involved in discussions? I am not in any way critical; I should just like to know.
§ Ms Winterton
Particularly with regard to the 2000 Act, the main discussions have taken place with the Department of Health and Community Care in Scotland. I am not entirely sure about the nature of discussions with other Departments.
Because we recognise that allowing the use of tissue from incapacitated persons is a sensitive issue, we have provided that the regulations should be subject to affirmative resolution to allow Parliament to discuss the details. Prior to that, it will be necessary to undertake further discussions with appropriate Departments in Scotland. That will give Parliament the opportunity to discuss details that may not have been debated elsewhere.
I commend the new clause to the House.
§ Dr. Murrison
I am glad that any regulations will be subject to the affirmative resolution procedure, because this area is a minefield. It is a pity that we do not yet have the Mental Capacity Bill; if we did, we would not need to discuss the matter in quite this way. I am deeply worried about Secretaries of State making regulations that affect people in such situations, although I suspect that, mercifully, they would be needed very infrequently. I assume that in drafting the provision, the Minister had specific instances in mind that drove it forward, because she, like me, will have been very cautious about treading in this extremely problematic area.
The Minister referred to the measure's potential interaction with the Medicines for Human Use (Clinical Trials) Regulations 2004. I am not entirely clear about how that will work, and I would be grateful if she expanded on it a little further.
§ Ms Winterton
With regard to the authority that is required before a person who lacks capacity can participate in a clinical trial, the legal representative of that person must give consent to their participation. A legal representative is a person who has a sufficiently close relationship with the person lacking capacity, or, 36 if no such person is available, a doctor or other person nominated by the person's health care provider. The clinical trials regulations set out the detailed information that must be provided and other requirements that must be fulfilled before participation can be authorised. We will look very closely at the requirements under the clinical trials directive to ensure that the regulations fit in with them.
Question put and agreed to. Clause read a Second time, and added to the Bill.