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Dr. Andrew Murrison (Westbury) (Con): Notwithstanding the Minister's remarks and those of the hon. Member for Erewash (Liz Blackman), does she accept that, in the minds of the general public, a clear distinction exists between blocks and slides and whole organs, and that that needs to be reflected in the Bill?

Ms Winterton: Yes, a certain amount of discussion has taken place, as the hon. Gentleman knows, about the definition of tissue and organs. It was felt that defining that too closely could cause confusion. We believe that our approach, and the guidance that will be issued by the Human Tissue Authority, will make that clear.

In implementing Sir Liam's recommendations and in making other changes, we have worked closely with professional and family support groups. I want to mention particularly the members of the national committee on organ retention, PITY 2—Parents who have Interred their Young twice; other support groups, including the Relatives Reference Group in Northern Ireland; and, as I said earlier, the tireless work of Mrs. Elaine Isaacs. I also thank the members and president of the Royal College of Pathologists, who recognised the need for change and have taken clear and positive steps forward. With their help and that of others, we have already achieved a lot.

In April 2001, we established the Retained Organs Commission, which has provided advocacy, overseen the return of organs and tissue to families and given guidance to trusts. It has carried out admirably the most difficult of tasks in the most difficult of circumstances,

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and I pay tribute to the chair and members of the commission for their dedication and commitment. We have published guidance and consent forms for post-mortems. We have given advice that clarifies the law as it currently stands. We have set in train a programme of work that includes providing information and support to bereaved families. We are supporting further training and development for health professionals so that the practices and principles that underlie the Bill can be taken up fully in future practice. Parallel work is being undertaken in Northern Ireland, and in Wales we have focused on the establishment of a network of trust co-ordinators to facilitate all aspects of change in anticipation of the Bill.

The underlying principle of the changes is informed consent. Much has already been done, but the chief medical officer recommended that there should be a comprehensive review of the law relating to the whole area of the use of human tissue, from the living as well as the deceased, and its use for transplantation, research and other purposes, such as donation for teaching and education.

Mr. Tam Dalyell (Linlithgow) (Lab): What is the time scale of this review? When are we likely to have any guidance on the question of presumed consent?

Ms Winterton: The review to which I refer is the review that the chief medical officer asked us to conduct. That has now been completed, and its form is within the Human Tissue Bill that we are considering today. With regard to the issue of presumed consent, clearly, that has been given serious consideration. The principle of this Bill, however, is informed consent.

We have looked closely at the experience of other countries with presumed consent, and while there may be a legal framework of presumed consent, the practice in all countries—Spain is highlighted as a country in which presumed consent is considered to have led to increased rates of organ donation—is that relatives are asked for their permission for organ donation to go ahead. If they object, that permission is not given. It is also necessary to approach relatives for health screening purposes, in case anything in the recent history of an individual could lead to infection if an organ were given to another person.

The evidence that has emerged is that the structures that are set in place are what enable organ donation to happen: for example, having nurses or others who can approach relatives at critical points to secure organ donation. We have used the example of places such as Spain in our transplant framework, we have set in train those structures in this country, and we are already seeing improvements in organ donation rates. All the evidence is that that is the way to improve organ donation, and not through a system of presumed consent.

Mr. Desmond Swayne (New Forest, West) (Con): The Minister rightly stresses the importance of informed consent. What measures is she taking to ensure that more people give that consent? We could do much more to increase the number of people on the donor register. And what can be done to give effect to consent? Many

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organs are wasted because action is not taken quickly enough following deaths. Current common law does not allow some forms of elective ventilation; perhaps, in certain circumstances, they could be granted legislative approval.

Ms Winterton: We aim to have 16 million people on the register by 2010. Moreover, the Bill contains measures allowing organs to be preserved so that relatives can be approached within a specific period, and others providing that the wishes of those who have indicated that they want their organs to be donated must be respected. We must deal with the practicalities, however, and relatives will always be asked for information about a person's recent social history. We cannot claim that the Bill will solve everything, but it does contain provisions relating to the issues raised by the hon. Gentleman.

Mr. Kenneth Clarke (Rushcliffe) (Con): Surely the Spanish experience shows that a system of presumed consent can be operated in an entirely sensitive way, and that families can be consulted and their wishes considered, but on a different basis from that which obtains here. The Spanish system assumes at the outset that there are no strong objections, which has resulted in a rate of cadaver donations more than twice as high as ours. The change was not drastic, but it has proved to be very significant. Meanwhile, we are left with one of the worst records in western Europe: we have a serious shortage of organ donors and donations.

Ms Winterton: The right hon. and learned Gentleman assumes that the legal framework in Spain has brought about the current position there. The former director of the National Organ Commission in Spain has clearly stated that the increase in the number of donations has been achieved not by anything to do with presumed consent, but by the structures that we are replicating here.

The right hon. and learned Gentleman should also bear in mind that following outrage among some families about practices that had taken place, France returned to a system of informed consent. Some people felt that consent might have been presumed but not verified, which caused enormous distress. We strongly favour the principles of informed consent underlying the Bill, combined with the other measures that I have described.

Dr. Evan Harris (Oxford, West and Abingdon) (LD): I hope the Minister will accept that there is some debate about her recitation of history in the context of France, and also that there is a genuine argument to be had about presumed consent and opting in versus opting out. Many professionals believe the evidence suggests that it is a significant factor.

The system proposed by, among others, the British Medical Association, is used in Belgium, where there is strong evidence that it has made a difference. It does involve relatives being asked for the social history, so it is a straw dog otherwise, and strong objections are taken into account under that system of presumed consent.

Ms Winterton: As I have said, relatives' objections are always taken into account and are rarely overridden.

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We are talking about the rights of individuals, not just those of the state. The state does not own a human body; nor do doctors or scientists. It is up to individuals to choose whether to make this important gift, for it is a gift. We must respect their wishes. We must give them as much information as possible about the benefits of organ donation, but ultimately it is a matter of individual choice. We must empower people to make that choice, but we do not feel that it is for the state to dictate, or to presume that it has a right to someone's body if that person does not want to proceed.

As I have said, there was considerable uncertainty about the law, and we conducted a great deal of consultation. In July 2002, jointly with the National Assembly for Wales, we published the consultation document "Human Bodies, Human Choices". We published the results of our consultation with a wide range of interested groups and individuals in April 2003, and presented broad legislative proposals in September. We then held a further round of stakeholder meetings with families, clinicians, researchers, heads of royal colleges and anatomic and other organisations including the BMA, the Retained Organs Commission, the Wellcome Trust, UK Transplant, the Human Genetics Commission and the National Assembly's organ retention advisory group.

Mr. Lansley: The Minister will know that in April 2003 her predecessor, responding to a debate in the House, undertook that a draft Bill would be published before the summer recess. Notwithstanding the Minister's belief that the Bill clarifies the law, it has not been clarified as much as many people—including members of the organisations she just mentioned—hoped it would be. Pre-legislative scrutiny is designed expressly for that purpose. Why was a draft Bill not published for pre-legislative scrutiny, as was intended?

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