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Why is this so casual? Why is the researcher not required to check or to get proof of what is being said? If there is no adult at all whom the researcher can claim to be responsible for the incapacitated person, then, according to the amendment, the researcher must take reasonable—there is that word again—steps to find someone or other who will take responsibility. If such a personage does not come easily to mind, the researcher can choose someone else. He is allowed to choose someone who will allege that he is interested in the patient, but surely he can shoo in anyone at all to say that. It is not enough to state that the person must have no connection with the project. He or she, chosen by the researcher, could very easily be the researcher’s husband, wife, friend or aunt or someone working in the same laboratory on another subject. There is no problem there. That colleague would not need to be told the rhyme or reason for the use of the cells, as he would know that already; nor surely would he be likely to stand in his colleague’s way. There is no requirement whatever for him to know anything at all about the patient or the views of the patient; he would just need to say something in front of his fellow researcher.

Sub-paragraph (3) of new paragraph 15G makes it possible, just because there is a supposition that an individual is dead, to permit the use of that person’s cells for what he or she may have regarded as a repugnant purpose. Surely that is also wrong. If we accept that, surely we are saying that a person’s body may be used in any way once he is dead. That has always been opposed. So far as I know, no one has ever said that it would be right to use a cadaver in any way that a person wished, and the thought that we are now asking to do so concerns me greatly. Again, surely it would be wrong to claim that, just because a person who may or may not be dead never said that he did not want his body to be used to create half animal/half human embryos, he would not mind if such a thing were done. Even if that person had agreed that his body parts could be used after death for transplants to help sick people, that is a very long way from agreeing that those parts should be utilised to make animal/human embryos. This is a matter on which many people have strong views, and I claim that they have every right to

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them. In fact, sub-paragraph (1) of new paragraph 15G does not require that the research be medical but simply scientific, and scientific research goes much wider than medical research—far beyond the straightforward pursuit of curing disease.

If I read new paragraph 15G carefully, it suggests that “any” of the conditions listed will be sufficient for the authorisation of research, and I ask the Minister whether that is correct. Will just one of them be sufficient or is it necessary to accept that they are all relevant and applicable?

As I understand it, the whole of Amendment No. 92 has been acknowledged by the Government as interfering with Article 8 of the European Convention on Human Rights. In fact, the present Leader of the House, in an earlier incarnation as a Whip with responsibilities towards this Bill, said:

“If a child is incapable of giving consent to the creation of a human or human-admixed embryo themselves, because they are too young to do so, it would be wrong for any person, including the parents, to make that decision for them, given the significance of creating an embryo using their genetic material”.—[Official Report, 21/1/08; col. 52.]

The noble Baroness the Leader of the House also said that,

I have the greatest respect for the integrity and sincerity of the noble Baroness, Lady Royall, and I have absolutely no doubt that she meant every word that she said. However, since then, the Government’s position has changed. They now claim that, after all, this is justified. But is it? Queen’s Counsel Mr Aidan O’Neill, who has been asked to provide a legal opinion on the matter, agrees with the Government that the use of human cells for the creation of human embryos and/or human admixed embryos does indeed engage the Article 8 rights of the donor. He also agrees with the Government that removing the requirement for consent would interfere with this right. However, his legal opinion is that the provisions before us today in this amendment are not compatible with the convention because they do not give proper weighting to the interests of those whose genetic material is now being used.

The scientific need for these provisions on consent has, so far as I know, never been demonstrated. So far as I am aware, there is not a shred of evidence that creating animal/human creatures will bring about cures or even palliatives to assist sufferers from recognised diseases. If Ministers are serious about adhering to the important human rights convention, they simply cannot pass this part of the Bill. I listened with great care to what was said earlier in the debate on that very matter, but the question which has not been addressed until now is that it may well be in direct contravention of human rights.

Every human being has a right to decide whether he or she supports creating cloned human or animal/human embryos from their cells for research, and he or she

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permits his or her own body to be used in that way. Unless we are ready to deny this right, we cannot allow Amendment No. 92 to pass into law. Removing these consent provisions will return the Bill to the state that it was in when it previously left the House.

It is a serious misuse of Parliament to curtail debate and proper investigation into this vital matter, but that is what is happening at the moment. I was shocked to hear that so strict was the curtailment that MPs in another place were given no time at all to debate on the Floor of the House the amendments dealing with consent. I earnestly hope that the Government have put no Whip on their Members and that they do not troop into the Lobby to vote against this amendment without having listened to the arguments, but I fear that such a Whip is in existence. If human rights mean anything to the Government, they must not allow them to be trampled on to please one section of scientists, however well intentioned.

Finally, so little time has been available for public knowledge to be disseminated about this debate that so far very few comments have had time to surface. However, I want to quote Professor David Jones, who is the director of the Centre for Bioethics and Emerging Technologies—which are very important in this context—St Mary’s University College. He says that this is retrospective legislation, allowing the use of tissues that were not donated for that purpose. I do not think that we have touched on his concern. He says that it would be very counterproductive to allow the most controversial kind of research without the safeguards of effective consent. How can people trust scientists, if their cells can be used without their consent for research to which they are strongly opposed?

If effective consent is not restored to the Bill, there is a real danger that public confidence in tissue banking will be undermined, to the great detriment of scientific research. I have no wish whatever to halt or harm scientific research. I do, however, deeply care about the rights of human beings. I beg to move.

8.30 pm

Lord Neill of Bladen: My Lords, I support the amendment put forward by the noble Baroness, Lady Knight. I want to concentrate on one single point: the human rights convention and Article 8 thereof. We are looking at three categories of cases; parents giving consent on behalf of children, consent where an adult lacks capacity and the use of existing cell lines. A Minister told us on 21 January that it was not possible to allow consent in all those cases as that would all be contrary to Article 8 of the human rights convention.

The noble Baroness, Lady Knight, has referred to what the noble Baroness, Lady Royall of Blaisdon, said then. When the Minister dealt with existing cells—stuff that is already in the archive—she said:

“In essence, the Bill sets out a framework which ensures that, if a person’s gametes or cells are used to create an embryo, effective consent is in place beforehand. In the case of cell lines, even though the original cells may have been taken from the donor with their consent to research in general, the use of their genetic material to create cloned embryos or human admixed embryos is exceptional, and requires its own express consent. To provide otherwise would be incompatible with the convention rights. We have done a lot of work on this issue. It would also be incompatible with the Human Rights Act”.—[Official Report, 21/1/08; cols. 46-7.]



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Later—and the noble Baroness, Lady Knight, has also referred to this—the Minister dealt with the other two cases, of children and adults, saying:

“No one can give consent on behalf of an adult who lacks capacity, and, for the same reasons, I do not believe that a child’s cells should be used to create embryos or human-admixed embryos without that child’s own consent.

If a child is incapable of giving consent to the creation of a human or human-admixed embryo themselves, because they are too young to do so, it would be wrong for any person, including the parents, to make that decision for them, given the significance of creating an embryo using their genetic material”.

The noble Baroness, Lady Royall, then referred to the powerful arguments put forward by the noble Lord, Lord Patel, and by my noble friend Lord Walton of Detchant, but she concluded that,

That position came on 21 January this year from a Minister speaking on behalf of the Government. Ten days later came the first sign of the U-turn, in a letter from the noble Lord, Lord Darzi. Making no reference whatever to the passages that I have just read, he sent a letter to all those, including myself, who spoke in the debate at the earlier stage of the Bill. The letter dealt entirely with the use of existing cells. The hour is late, but the noble Lord, Lord Darzi, made it clear that, since the debate on 21 January, the science community had been arguing why that valuable archive was a tool that they really wanted to use. From their point of view, I entirely understand what they were seeking to achieve.

In his letter, the noble Lord began by saying that,

so, there was more factual evidence. He continued:

“A compelling case has been made that the requirement for express consent could, in certain circumstances, impose a significant burden on research in this field. On this basis the Government takes the view that it would be possible to make an exception to the requirement for express consent, provided that stringent safeguards are in place. We would expect that such an exception would focus on situations where the inability to continue using existing cells would have significant adverse effects on research, where such research would be in the public interest. The detail of such safeguards to ensure compliance with Article 8 requires further consideration”.

That was the first hint of a change. It was followed up in paragraph 16 of his letter, which dealt specifically with the human rights situation. The noble Lord wrote:

“In considering whether the interference can be justified and proportionate to a legitimate aim the Government considered the concerns of the scientific community. Specifically the issue is whether the issue can be justified on the basis of ‘the protection of health’ under Article 8(2)”.

We can see what has happened: the evidence from the scientists has come in, showing a “scientific need”—a term the noble Lord used in the early part of his letter—and that is transmogrified and put forward here in altered garb as the protection of health under Article 8(2).

That is how matters stood. Then we had the amendments in the other place, on which the noble Baroness, Lady Knight, has commented at length. I shall not go into the detail of that. The noble Lord,

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Lord Darzi, then wrote another undated latter, which we received just before today’s hearing. That letter does not mention Article 8 at all, but the Minister referred to the Explanatory Notes to the Commons Amendments—and, “scientific need” comes back into the picture in paragraph 57. It states:

“Although removing the requirement for consent would interfere with this right”—

the Article 8 right—

The term “public health”, which is used in paragraph 2 of Article 8, is not used at all but “scientific need” is. No argument is advanced at any point as to why all the hard work done before 21 January, which put the Minister in a position to say, “This is not possible under the convention”, has been turned around to become very possible; an escape route has been found through the reference to health.

If matters stood there one would be complaining about why we have had no straightforward explanation from the Government as to why they held the original opinion, and why they have now changed it. Are we to understand that they did not originally consider the possible exceptions to the basic provision of Article 8.2? Anyone advising on whether the article applies will look at the exceptions. However, the matter does not stop there. We have received an opinion, to which the noble Baroness, Lady Knight, referred, although I do not know how widely it has been circulated because I received it only yesterday. The opinion is that of a well known Queen’s Counsel, a Scottish silk who works in Edinburgh, whose work I have come across in other contexts, but I have never met him. He is a highly professional and skilled lawyer. He concludes, at paragraph 3.9 of his opinion:

“In sum it seems to me that the provisions dispensing with or substituting consent if passed could well be the subject to successful challenge for their incompatibility with the requirements of the European Convention on Human Rights”.

In particular, he focuses on the charter of rights, which your Lordships will recall from the many days that we spent discussing the treaty of Lisbon and its adjunct, the charter of rights. It is a familiar text to us all. Article 1 of the Charter of Fundamental Rights states:

“Human dignity is inviolable. It must be respected and protected”.

Article 3 on the,

“Right to the integrity of the person”,

states:

“Everyone has the right to respect for his or her physical and mental integrity ... In the fields of medicine and biology, the following must be respected in particular ... the free and informed consent of the person concerned, according to the procedures laid down by law”.

In addition, there is another convention, which the UK attended but did not sign, although 34 member states of the Council of Europe did, called the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine—also known as the Oviedo convention. It opened for signatures in 1997 and has now come into force as between the

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signatories. Some 23 nations have ratified the convention among the 34 which signed. The UK has not signed, as well as other countries, including Germany, Russia and one or two others. Most countries have signed. The provisions that matter are Articles 1, 2, 5 and 6. Article 1 states:

“Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine”.

Article 2, “Primacy of the human being”, is important. It states:

“The interests and welfare of the human being shall prevail over the sole interest of society or science”.

The human being, the individual, prevails over the interests of science.

Article 5, the “General rule”, states:

“An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time”,

which is contrary to the Government’s proposals. Article 6 on,

“Protection of persons not able to consent”,

states:

“Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit”.

In other words, all of those provisions are aimed at protecting the rights of the individual and are a direct objection to the proposal now being made. They add weight to my first contention that we do not know why the Government have changed their mind on the scope of Article 8. We have now received the opinion and provisions that I referred to, which we need to consider calmly, and send the matter back to the other place.

Lord Walton of Detchant: My Lords, in speaking to this amendment, so skilfully moved by the noble Baroness, Lady Knight of Collingtree, I must declare two interests: first, many years ago, I was president of the General Medical Council; secondly, I am now an honorary life president of the Muscular Dystrophy Campaign. When I was president of the GMC, we struggled for years with the problem of informed consent. However, there is no question but that the medical profession accepts that the principle of informed consent lies at the core of medical practice. It is absolutely right that a doctor may recommend to a patient the appropriate treatment for his condition but it is up to the patient, having fully appreciated the circumstances relating to the treatment recommended, whether he should accept such treatment. Therefore, he must give his informed consent. Within the law and within medical practice, he is fully entitled, if he so wishes, to refuse that consent, even if it results in death.

The same principles were adumbrated in the General Medical Council’s advice about medical research. It was made absolutely clear that an individual patient could be involved in medical research only with his fully informed consent. However, the issue arose of

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whether a child who was below the age of valid consent, in other words a child who was not Gillick-competent in terms of law, could give consent. If the child was not, the issue arose as to what would be the proper course of action in relation to such research. Although I wholly appreciate the valid points made by my noble friend Lord Neill, the GMC recommended, and that recommendation still holds, that it would be proper for a parent to give consent on behalf of a child to participate in research if it could be shown that the research in question could lead to developments that would be to the benefit of that child as an individual. I think that that remains at the core of this problem.

8.45 pm

In terms of the amendment tabled by the Government, that would only be possible if the child suffers from a serious medical condition or illness and if the research is linked to that condition—such as muscular dystrophy, spinal muscular atrophy, and so many more conditions which are progressive and potentially fatal. An additional safeguard, which is essential in such cases, is that there must be reasonable grounds for believing that research of comparable effectiveness could not take place with cells from a person who could consent. That is the important issue in relation to research involving children.

Amendments tabled in the Commons addressed the issue of cells from an adult who does not have capacity to give consent. They drew particularly on the Mental Capacity Act 2005 to frame appropriate safeguards, including a requirement to consult carers and a requirement that the adult is suffering from or is likely to develop a serious disease or serious disability about which the proposed research is intended to increase knowledge. Again, the important issue is that the research in question would be likely, ultimately, to be to the benefit of that individual.

The issue of cells or cell lines stored before the legislation is brought into force is one that has been raised for many years. I was much involved in the discussions in your Lordships' House on the Human Tissue Act 2004. It was clearly stated then that archival material stored over some time and derived from an individual for whom it is no longer possible to give or withhold consent, can be used for research purposes. It is now quite clear that where a cell donor cannot be identified or traced or has died since the cells were stored, the requirement for effective consent can reasonably be waived subject to the criterion that, in the view of the Human Fertilisation and Embryology Authority, research would be adversely affected to a significant degree if the cells or cell lines cannot be used. Where the cell donor has died and can be traced, consent would be required from a person such as a close relative as set out in the clear hierarchy modelled on that found in the Human Tissue Act.

I do not believe that the amendment so carefully and explicitly moved by the noble Baroness would be to the benefit of patients at all. I therefore strongly support the amendments tabled by the Government.

Lord Waddington: My Lords, your Lordships will appreciate that there is a very important point to be made before we even get to the merits of this matter. It

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was made to some extent when we discussed the amendment moved by the right reverend Prelate, but this is an even more glaring example of how routine and draconian timetabling of Bills prevents proper discussion by the elected representatives of the people of important measures. That is a shocking state of affairs.

These major changes were discussed for just two hours in the Public Bill Committee and were never discussed at all on the Floor of the House of Commons. An amendment to remove them was never reached; and it was without debate and with the use of a three-line Whip that these new proposals were added to the Bill. If we reject these changes we will be doing a service to the House of Commons, because for the first time there will be an opportunity for the other place to discuss these matters properly. I have heard from far more erudite and informed people than myself on the merits of the proposal, so I shall spare the House my views; but I hope that noble Lords take the point that I have made. It is surely our duty to see that the House of Commons considers these matters properly, which it has not done so far.

Lord Mackay of Clashfern: My Lords, this is a remarkable amendment to have been proposed in the House of Commons in view of the statement that the noble Baroness, Lady Royall, made in this House in January. I have listened carefully to the noble Lord, Lord Walton of Detchant, and I think that he has possibly overlooked the point that, in relation to the children and adults who lack capacity, the amendment does not require that the research should be for their benefit. It is possibly for the benefit of those suffering from the same or a similar condition. That is what the amendment says, not the terms that the GMC thought were appropriate.


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