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All of us are worried about those who might try to circumvent the law. I know that the noble Lord would share my indignation should anyone seek to try and do that. He may well be correct that the definitions of gametes, embryos and cell lines defy our ability to be

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crystal clear, as they have done throughout our proceedings. However, anyone reading this legislation once it has passed, in conjunction with the Hansard reports accompanying it, will be in no doubt at all about what Parliament’s intentions were. I would be nervous about anything that gave anybody literally “a licence” to circumvent procedures. I would be anxious about anything that seemed to dilute our determination to prosecute those who deliberately violated the law. I therefore hope that my noble friend will not feel the need to press this further today.

Baroness Knight of Collingtree: My Lords, one of the many lessons I learnt at the other end of the Corridor, during a very long time as a Member of Parliament, was the danger of using the word “reasonable”. As was frequently pointed out, what is reasonable to one person is not reasonable to another. I can think of at least one Bill that fell at that hurdle because there was no way of being absolutely certain that everyone would accept that something was “reasonable”.

Another thing that worries me about the amendment is that it echoes some of the current problems with certain Members of Parliament saying, “I thought I did adhere to all the rules and laws about money. Oh dear, I didn’t—but I was being perfectly reasonable”. There is real danger in failing to acknowledge that Bills must be clear. We have been taught the lesson time and again even if we have not learnt it. Legislation must mean the same thing to different people. If it does not, it could be translated in a way that is very convenient to some people. I am not saying that I am against the amendment per se. I am just saying that the way in which it is worded will open great difficulties down the line.

Lord Mackay of Clashfern: My Lords, it is true that the thrust of the noble Lord’s amendment is that the basic definitions used in the Bill are lacking in precision. If Parliament is creating criminal offences with considerable penalties, it has a fundamental obligation to ensure that the terms used in the formulation of the offences are sufficiently clear so that anyone with a reasonable knowledge of the area will know whether he or she was transgressing the prohibitions.

Lord Maclennan of Rogart: My Lords, it seems to me that the point that the noble Lord, Lord Patel, was addressing, more than the possibility that the practitioner was ignorant of the scope and definition of the law, was that he or she was ignorant of a complete understanding of what he or she had been doing, as a result of which the actions were overtaken by the law and the applicability of the law was not necessarily understood. However, I may have misunderstood the thrust of his argument. If he was seeking to address the imprecision of the law rather than the inexactitude of the understanding of what the scientist was doing, we would obviously have to address the issue of the definitions in the Bill.

Baroness Barker: My Lords, throughout the Bill’s passage we on this Front Bench have been mindful of the fact that scientists are finding themselves in an

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extremely difficult position. Throughout its passage, they have been subject to unfair and somewhat crude criticism, not least the criticism that they have not sufficiently explained to the rest of us what they do. The evidence in all the briefings we have received is that the scientific community, the medical research charities and so on have gone to great lengths to try to explain to the rest of us things that, by definition, we do not know. It is precisely because scientists need to continue to enjoy the confidence of the general public that we believe that the amendment is misguided. I strongly agree with my noble friend Lady Williams of Crosby that, in other walks of life, ignorance of the law is not a defence. I do not believe that a case has as yet been made suggesting that that should not apply here.

I listened closely to the arguments of the noble Lord, Lord Patel, and I should like to ask him some questions. Can he say what is the likelihood of a researcher finding himself or herself in this position? Is it not the case that local ethics committees would be involved in licensing any research? Does that not therefore decrease the chances of a lone researcher committing the sort of offence outlined? Does he agree that if scientists at the cutting edge of knowledge are to continue to retain the general public’s confidence, only the highest standards will be permissible? Should we therefore not seek in any way to dilute the penalties they face? If they put themselves in a position where there is a lack of clarity, the potential for things to go wrong—badly wrong—is immense.

4.30 pm

Lord Walton of Detchant: My Lords, this is an exceptionally complex and very sensitive area. If the noble and learned Lord, Lord Mackay, is right to suggest that the phraseology in legal terms used in the Act is insufficiently precise to define the circumstances that might lead to a breach of the Act being performed by a well-meaning individual carrying out research that he or she believed did not fall within the terms of the Act, then I would be greatly concerned. Equally, I would be greatly concerned if any attempt were made to make holes in the Act by passing an amendment that would make it possible for the unlicensed person to experiment on gametes or human embryos without being subject to the full force of the law.

My reading of the very carefully expressed wording of this amendment, so well proposed by my noble friend Lord Patel, would lead me to believe that the amendment deals solely with the very exceptional circumstance where an individual working with cells who was not licensed under the Act—cells which he or she firmly and sincerely believed were not anything to do with the terms set out in the Act—might be subject to criminal sanctions. I wish to be reassured that the Act as it stands is sufficiently precise for that circumstance not to arise. While I have every reason to feel that the Act must be sufficiently clear to prevent the so-called cowboy from experimenting in this highly sensitive field, at the same time the well-meaning and well-intentioned researcher must not be put in hazard, which was the purpose of the noble Lord’s amendment.

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Lord Jenkin of Roding: My Lords, having listened now for several days to the debates on this Bill, including the debates we had on the question of definitions, I would have thought that any bona fide researcher who was engaged or who contemplated engaging in work involving cells, in the way that the noble Lord, Lord Walton of Detchant, has described, and who was in any doubt at all about whether it came within the Act would be extremely wise to go to the authority and say, “This is what I am proposing to do. Do I need a licence?”.

If the researcher is trying to evade the controls by arguing, perhaps on some technicality, that this did not come within the terms of the Act and is subsequently found to have been in breach, I will not be sorry for him. I think that he would have been able to protect himself and that he should have protected himself. Although I understand the case that has been made by the noble Lord, Lord Patel, and by others that some sort of defence of this sort is necessary, I go back to my early training in the law and say that ignorance of the law is not a defence. It may be an excuse and might have some impact on the penalty but it does not negate the offence.

I shall be interested to hear from the noble Lords, Lord Detchant and Lord Patel, and from the Minister, who I suspect will not like this amendment very much, as to whether or not that is right. Surely the message that we want to send out is, “If in doubt, ask”. Anything that suggests that that is not the wise thing to do is misguided.

Lord Neill of Bladen: My Lords, will the noble Lord, Lord Patel, clarify that he is talking not about research teams and providing a defence for them but about individual criminal liability? If the latter, will he consider the last line of the amendment? I know that I irritate him every time I make a point like this, but the last line of his amendment says,

Will he confirm that he does not mean that?

Baroness Royall of Blaisdon: My Lords, the amendment tabled by the noble Lord, Lord Patel, would add a further defence to the Human Fertilisation and Embryology Act 1990 for a person charged with an offence under the Act. It would allow a defendant to raise the defence that at the material time they believed that what they were doing was not something to which the Act applied. It would not be appropriate for a person working in this field, who may be storing gametes and creating, keeping or using embryos, not to be fully aware of the law and the requirement to hold a licence for such activities, which is set out clearly in the 1990 Act.

This is of course a complex area of the law, and situations may arise where scientists are working within ill defined parameters and experimentation sometimes produces different results from those expected. Indeed, the noble Lord, Lord Patel, outlined areas where specific problems arise. However, like the noble Baroness, Lady Williams, I do not believe that ignorance of the law in these areas should be a valid defence. This is a

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complex area of science, and people working in the field should be even more aware of what activities under the Act can be carried out only in pursuance of a licence. As the noble Lord, Lord Jenkin, said, if anyone is in doubt, they simply have to pick up the phone and consult the HFEA.

For proceedings to be brought to prosecute someone under the 1990 Act, the Crown Prosecution Service must first obtain consent from the Director of Public Prosecutions. This is not a common proceeding for criminal offences, and is reserved for offences where weighing the discretionary factors relevant to the decision to prosecute is likely to be a sensitive and difficult task. This therefore makes it desirable for the Crown Prosecution Service to obtain prior approval for a prosecution. If an offence is committed under the 1990 Act, the facts of the case would be looked at carefully and in detail before any proceedings were brought, as this is such a complex area.

The noble Lord, Lord Patel, said that the Human Tissue Act had a similar defence and asked why it was not appropriate for the Human Fertilisation and Embryology Bill also to have a similar defence. Although this is a defence under the Human Tissue Act, the activities that require a licence under the Human Fertilisation and Embryology Act 1990 relate to the handling of human embryos and gametes, and the sensitivity of these activities means that it is imperative that scientists are aware of whether their activities require a licence under the Act. The noble Baroness, Lady Barker, mentioned ethics committees. I believe that she is correct that ethics committees also consider applications for licences.

This is a very complex area, but at this time I invite the noble Lord to withdraw his amendment.

Lord Patel: My Lords, I thank the Minister for her response, and thank all noble Lords who have spoken. I particularly welcome the comments made by the noble and learned Lord, Lord Mackay of Clashfern. He has, in his customary manner, hit the nail on the head: the issue is that the imprecision of the definitions may lead to this problem. I fully subscribe to the comment made by some noble Lords that ignorance of the law is no defence. I do not challenge that whatsoever, despite the fact that the law might have been framed in the ignorance of science, which probably is a defence.

The current definitions are widely wide, which is probably wise, because that allows the regulator to consider current technology and foreseeable developments when granting and monitoring the licence. I am not talking about people deliberately setting out to break the law when they carry out research; I am talking about scientists doing bona fide research who accidentally stumble upon something because of science that falls under the Act, and who therefore, though they stop any further experiments, fall guilty of the offence.

Let me give an example. An oocyte that has been activated either by fertilisation or artificially is a reasonable definition of the beginnings of an embryo—so it might be hard to argue against the definition. You could say that it is really at the first mitotic division, as that is when the maternal and paternal DNA first get

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together. But that does not work for a parthenogenetically activated oocyte, as there is no paternal DNA. Where researchers are working on trying to improve or determine the quality of the egg that will lead to success in in vitro fertilisation, the intention of such research is to understand the molecular signals rather than to initiate cell division. However, very occasionally an egg that has been cultured may spontaneously divide. Under the current definition of the Act, those researchers will require a licence. If they stop further research and report it, will they then be liable? Can there be a vexatious litigation against them?

A definition that said that only an embryo at the two-cell, eight-cell or blastocyst stage was acceptable might be hard to defend, as each definition would be a little arbitrary. However, the point at which the embryonic genome becomes active at the four-cell stage in humans, when development no longer relies only on maternal—that is, oocyte-derived —products, would make some sense scientifically. I am merely giving examples of how definitions used in the Act do not conform with the developing science.

In terms of science, the Bill includes the definition of an embryo as an egg undergoing any other process capable of resulting in an embryo. The regulators have previously decided that a parthenote—a dividing unfertilised egg—is an embryo. Important research is being undertaken to understand the process by which eggs divide just before fertilisation. Errors at this stage of reproduction result in fertility failure, miscarriages and abnormalities in the foetus. This research has to be approved by the research ethics committee. That does not currently require an HFEA licence. Centres are carrying out such research on eggs and, as I said, the intention of that research is to understand the molecular signals rather than to initiate cell division. It is not appropriate to require an HFEA licence for all research on live human eggs simply to avoid a rare unplanned and unanticipated event. Such increased bureaucracy will seriously discourage research in the field. It is not my intention to do that.

This was a probing amendment to identify that there are areas where the researchers—scientists working on stem cell lines and not on embryos, for example—fall outside the regulation. In an attempt to understand how these lines differentiate—and this is a true example—those scientists found that adding in some factors took those lines one step forward to differentiation into different cell types. In an attempt to take it another step forward, when they added other factors they found that the lines retracted and they were back to stage one. If they had retracted further and gone back to the blastocyst stage, which could well happen, it would mean the creation of an embryo without a licence. The researchers would have had to stop that research, inform the regulators and take advice. They understand that. They do not intend to break the law. I was probing accidental happenings that fall within the law. I hope that I have made my point and that there will be enough on the record so that scientists who do not deliberately set out to break the law but who accidentally fall into this trap will be helped by this discussion and avoid any vexatious litigation. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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Clause 30 [Regulations under the 1990 Act]:

Lord Darzi of Denham moved Amendments Nos. 138 and 139:

On Question, amendments agreed to.

Clause 31 [Power to make consequential provision]:

Lord Darzi of Denham moved Amendments Nos. 140 and 141:

On Question, amendments agreed to.

4.45 pm

Clause 35 [Woman married at time of treatment]:

Earl Howe moved Amendment No. 141A:

The noble Earl said: My Lords, we come to an issue that has not previously been raised in our debates—surrogacy. Surrogate parenthood is a practice that has grown in popularity in a number of countries around the world in recent years. Canada, Ukraine and California are examples of jurisdictions in which legislation is in place that could be seen as actively encouraging surrogacy. The usual arrangement is that the male partner in a marriage or heterosexual relationship or one partner in a male single-sex relationship will provide the sperm that will fertilise the egg of a donor and the resulting embryo will be implanted into the carrying mother, who is usually described as a “surrogate mother” or “gestational carrier”. In other cases, the female commissioning parent may be the genetic parent; in yet others, both commissioning parents are the genetic parents.

In the three jurisdictions that I mentioned, surrogacy contracts have legal effect. Contracts will be entered into between the egg donor and the commissioning parents, and between the carrying mother and her husband, if she has one, and the commissioning parents, which provide that the child will be delivered into their custody on birth and that the egg donor and carrying mother, and her husband, relinquish all rights. The court then makes an order declaring the commissioning parents to be the legal parents and the child is registered as the child of the commissioning parents.

In English law, contracts of this kind have no force or effect, nor do any orders or registrations that are made pursuant to them. Section 27 of the 1990 Act provides that, if a child is being carried by a woman who has been artificially inseminated or has had introduced into her eggs and sperm or an embryo, that woman is to be treated as the mother for all purposes; no other person is to be regarded as the mother, whether or not she is genetically related to the child,

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and wherever this takes place. That provision gives the carrying woman parental status and parental responsibility, which can be lost only through a parental order or through adoption.

Under Section 28(2), reproduced in this Bill in Clause 35, if a woman who is a party to a marriage is carrying a child as the result of the placing in her of eggs and sperm or an embryo, or by artificial insemination, and the creation of the embryo carried by her was not brought about with the sperm of the other party to the marriage, the other party to the marriage is to be treated as the father of the child unless it is shown that he did not consent to the treatment by which she became pregnant. This is irrespective of the fact that the husband may have consented to his wife carrying the baby under a surrogacy arrangement. The genetic father is to be,

It is clear from the House of Lords debates in 1990 that Section 28(2) was intended to cover the position of conventional donor insemination, when a couple want to create a family for themselves and the sperm donor wishes nothing to do with the child. There was only a passing reference to surrogacy in the debates, when it was said that there would not be many such cases and that the commissioning parents would have to apply to adopt. However, no thought appears to have been given to the international dimension.

In a case such as the one that I described, the effect of Section 28(2) in English law is that the child will always be the child of the carrying mother and of her husband, if she is married. I repeat that this is translated into this Bill in Clause 35. In international law, where there is a court order and registration of the surrogacy arrangement, the child is legally the child of the commissioning parents in the state of origin. Thus, if a child is conceived and born abroad as a result of a surrogacy arrangement, registered as the child of the commissioning parents in that jurisdiction and subsequently brought into this country, significant problems arise. The child will be, in effect, parentless and stateless. In the state of origin he is the child of the commissioning parents, while in our law he is the child of the carrying mother and her husband; the commissioning parents have no status. If the commissioning parents happen to be British, the child would have no right to British citizenship and would technically be an illegal immigrant if brought here. On the other hand, if the child were brought here, it would be impossible for the court to send him back to the state of origin, because the surrogate mother there has no parental rights.

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