Human Fertilisation and Embryology (Parental Orders) Regulations 2010

My Lords, I thank the Minister for introducing these regulations, which, as she said, cover issues that we debated during the passage of what is now the HFE Act 2008. There was a general agreement then that the particularly restrictive terms of the 1990 Act, which originally prohibited almost all disclosure of identifying information contained in the HFEA database, should be relaxed, subject to appropriate safeguards and conditions, in order to facilitate research. For reasons which I shall explain, I am glad that this conclusion was reached and I welcome the fact that the Government have undertaken two consultation exercises on the issue since the passage of the Act. The regulations before us reflect the feedback from those consultations as far as is possible given that the opinions of consultees will inevitably differ. The first issue that I want to raise was covered in the first consultation: consent. It is a generally accepted principle that, where identifying information is used for research purposes, the consent of the individuals involved should first be obtained. Respondents to the consultation were given three choices: to maintain current policy; to disclose data only with the consent of the person or persons to whom the information relates; or to establish a process to authorise disclosure where consent cannot be practicably obtained. The third of these options has been adopted in relation to those whose names were placed on the register up to 30 September 2009; in other words, the normal principle of explicit consent for the disclosure of identifying information has been retrospectively set aside. It would appear that it has been set aside for reasons of expediency—I think that we need to talk about that. It is perfectly fair to argue that burdening IVF clinics with the task of contacting past patients, even if they were in a position to know their whereabouts, which they might not necessarily have been, would have been unreasonable. However, one idea which the department considered was a publicity campaign to encourage people with personal information on the HFEA register to inform the authority if they were willing to allow identifying information to be released. That idea was rejected, I understand, on grounds of cost and uncertainty of outcome. I would question that. How expensive would such a campaign need to be? It is obvious that there would not be a 100 per cent response rate, but what response rate would be likely to provide a sufficient quantum of data to enable viable research to take place? Bearing in mind the sensitivity of the information in question, I cannot help feeling that this option, which after all is the most ethical, should not have been so swiftly rejected. Perhaps the Minister could comment. I ask that question not least because of paragraph 52 of the impact assessment, which explains that, because some people may object to information being disclosed, the HFEA and patient groups will be asked to ensure that information on the regulations is circulated to stakeholders so that patients can register their objection. It also states that the Government will consider how best to raise public awareness of the regulations so that members of the public can be made aware of their right to withhold identifying information from disclosure. If this is what the Government are contemplating, what practical difference is there between such public awareness exercises and the publicity campaign discussed under option 2? Following on from this is an important issue covered by Regulation 8(1)(c), which I shall quote. It states: ""Where the Authority grants an authorisation, it must impose the conditions that … the research establishment must not contact or request any other person to contact on the research establishment’s behalf any individual who is identified by the disclosable protected information except in the manner and circumstances specified in the authorisation"." I cannot emphasise too strongly how important this provision is. We are dealing here with matters which of their very nature are intensely private. Where a child has been conceived by IVF, the parents may think it is nobody else’s business to be aware of that fact. Indeed, it is by no means unimaginable that the parents will see no need to disclose it to the child and may not wish to do so. I personally know of a case where an IVF-conceived child was not told of the circumstances of her conception until she was well into adulthood. For any member of such a family to be contacted out of the blue by a research establishment with requests to supply information of an often confidential kind is not something that one can contemplate without very careful consideration of the manner in which the approach is made. What conditions will the HFEA put in place to ensure that these matters are handled with due sensitivity? The regulations specify that the disclosable protected information must be used only in accordance with the purposes set out in the authorisation. How will it be possible to police that? For how long may an authorisation be renewed at the end of its initial period of authorisation? On the importance of long-term follow-up research into those born by assisted reproduction, recent meetings of the HFEA Scientific and Clinical Advances Advisory Committee—SCAAC—make sobering reading as regards the harm that may be caused to individuals conceived via IVF as a result of variations in the embryo culture medium. A paper considered by the committee highlights some of the variable factors that could affect the future health of the child. In relation to embryo culture media, it notes that gene expression in the blastocyst is affected by culture conditions and warns that growth factors could block the action of the tumour suppressor gene p53. The medium known as Whitten's medium has been shown to affect the expression of 114 genes, while another medium called KSOM-AA affected the expression of 29 genes. Equally, serum may adversely affect mammalian pre-implantation embryos, causing alterations in metabolism and other abnormal effects. In general, it is stated that IVF increases the risk of genomic imprinting disorders. In passing, it is astonishing to me that, despite clear indications that culture medium components might adversely affect the safety of children born after IVF, the SCAAC warns that there is no legal requirement to carry out clinical testing of the safety of embryo culture media, nor even any requirement for a manufacturer of an embryo culture medium to disclose the ingredients. There is more. The paper to which I referred warns that mouse embryo culture causes raised systolic blood pressure post-natally, and a Dutch study on children born after IVF found an effect on several cardiometabolic activities, with higher systolic and diastolic blood pressures and higher fasting glucose levels than in a control group of children. There is also concern over IVF procedures such as embryo biopsy, which is an essential part of pre-implantation genetic diagnosis, and the creation of saviour siblings. Recent research on mice born after embryo biopsy demonstrated a risk of neurodegenerative disorders and memory decline in adulthood, apparently due to alteration in gene expression of proteins in the brain associated with neurodegenerative diseases, including proteins associated with Alzheimer's, Parkinson's and Huntington's disease. If the results are applicable to children born after embryo biopsy, the mental health in adulthood of saviour siblings and those born following pre-implantation genetic diagnosis is at risk. What all this tells us is that we need to do research and, in doing it, we must look at a wider range of parameters than are normally examined in order to detect many of the types of disorder that could be caused, for example, by epigenetic abnormalities or alterations in gene expression. The follow-up research that has been conducted up to now has largely been based on short-term studies. Something of a longer term nature is needed if we are to understand the full medical and developmental implications of IVF procedures. On the parental orders regulations, I wish to touch on only one issue—that is, the law relating to surrogacy. The Minister will recall from our debates on the HFE Bill two years ago that I drew attention to the differing treatment accorded to children born from surrogacy under English law compared to those born in other jurisdictions. Under English law, the child is considered to be the offspring of the woman who carries and gives birth to him, and only a parental order or adoption order can change that. In other jurisdictions, such as Canada and California, surrogacy contracts have legal effect, by virtue of which the egg donor and carrying mother and her husband relinquish all rights to the child and the child is registered as the child of the commissioning parents. These two approaches are fundamentally at odds with each other. They mean that 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, that child will in effect be 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. During the passage of the 2008 Act, the Government undertook to conduct a review of the law in this whole area, and I should like to ask the Minister how far this review has got and when it is likely to be completed. Until it is, we cannot be fully sure that the provisions of the 2008 Act are fully human-rights compliant.