That the Grand Committee do report to the House that it has considered the Human Fertilisation and Embryology (Parental Orders) Regulations 2010.

Relevant documents: 7th Report from the Joint Committee on Statutory Instruments.

My Lords, I shall speak also to the Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010 and the Human Fertilisation and Embryology (Parental Orders) (Consequential, Transitional and Saving Provisions) Order 2010. These statutory instruments are necessary in order to implement provisions that were the subject of debate during the passage of what became the Human Fertilisation and Embryology Act 2008.

I shall begin with the disclosure of information for research purposes regulations, which are made under Section 33(D) of the 1990 Act, as amended by the 2008 Act. Before going on to discuss the regulations, I should like to draw the Committee’s attention to two numbering errors in the printed regulations. In Regulation 4, paragraph (6) is numbered in error: paragraph (7) should be numbered (6), paragraph (8) should be numbered (7) and so on to the end of that regulation. The last sentence in Regulation 6 is numbered paragraph (2) in error. I apologise for these mistakes, which will be amended in the final version of the regulations.

The regulations provide for the Human Fertilisation and Embryology Authority—the HFEA—to authorise the disclosure and use of certain identifying information contained in its register for medical or other research purposes. The regulations set out the process whereby research establishments make applications to the HFEA for authorisation and make provision for the revocation and suspension of authorisations by the HFEA when the research establishment has failed to protect the information disclosed to it. Finally, they make provision for the authority to be assisted by an oversight committee, which will help ensure the governance of the regime created by the regulations.

The register maintained by the HFEA records every IVF and donor insemination treatment cycle carried out in the UK since August 1991. It is one of the most comprehensive databases in the world and contains more than 800,000 entries. It has long been recognised that the register has the potential to be of significant use to researchers, enabling more extensive research on different treatments, their effectiveness and any long-term implications. This may include, for example, whether the ovarian stimulatory drugs taken during IVF treatment have any causal links to the development of ovarian cancer in some patients.

Since the 2008 Act came into force on 1 October 2009, patients and their partners can consent to disclosure and can vary or withdraw that consent at any time. This is good news for future researchers, but the real value of the HFEA register for current research is the wealth of data already on it. The 2008 Act therefore introduced a regulation-making power to allow identifying information to be released for research purposes, under certain conditions, without consent. The authorisation process for such a release is set out in the disclosure of information for research purposes regulations. Under the regulations, researchers applying to the HFEA to be given access to identifying information held on its register will need to demonstrate the project meets strict criteria, including that it is not reasonably practical to obtain the information other than under these regulations. The HFEA can refuse to grant authorisation, including when it is satisfied that the research project is not necessary or expedient in the interests of the public or improving patient care.

While parents can choose to give consent to disclosure of identifying information about children who have already been born, they cannot give prospective consent about a child that might never exist. This could compromise research relating to children born as a result of treatment services. The Government do not want researchers and clinics to have to chase former patients to ascertain their wishes. We also do not want new parents to have to consider such matters when they have far more pressing concerns. We have therefore extended the authorisation process created by these regulations to apply to data about children recorded on the register at any time on or after 1 August 1991. The authorisation criteria will be exactly the same as for historic data.

The regulations do not apply to all the information held on the register. Information on the donation and use in treatment of donated gametes and embryos is excluded. This information is especially sensitive and it would be unacceptable to release it without the knowledge of those involved. The regulations were the subject of two public consultations, between January and March 2009 and between October and December. While I hope that people would be prepared to assist with important research, individuals are entitled to withhold their identifying information if they wish. The Government will work with the HFEA, patient groups and others to publicise the purpose and effect of the regulations.

I turn to the Human Fertilisation and Embryology (Parental Orders) (Consequential, Transitional and Saving Provisions) Order 2010, which is made under Section 55 of the 2008 Act. The order is made by applying, with modifications, the adoption legalisation specified in the 2008 Act.

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 by 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.

My Lords, I, too, thank the noble Baroness, Lady Thornton, for the customarily thorough way in which she introduced these two sets of regulations. Before I turn to the detail, I should like to thank the staff from the department for their extremely helpful explanations. When presented with both sets of regulations at the same time, it was rather difficult to see one’s way clearly through them. As in many aspects of the law in this field, many of the principles with which we are dealing are long established. However, it is the implementation of those principles in a very technical way that makes these statutory instruments appear to be much more complex than they are in many cases.

I shall start with the regulations which apply to disclosure of information for research. The noble Baroness is right that in our very detailed passionate and heated debates on the Human Fertilisation and Embryology Act, or Bill as it then was, there was agreement that, on balance, it would be to the betterment of humanity if there were potential to conduct research using the database held by the Human Fertilisation and Embryology Authority. It was also agreed, without dissent, that information relating to donors and donor-conceived children was of a different order and had to be subject to much more stringent protection. Nevertheless, it was agreed that principally for the purpose of longitudinal research into the effects of embryology and the development of certain conditions, it would be preferable to let researchers have very limited access.

My recollections from the passage of the Act relate to the data held on the register. My understanding is that the register is a register of treatment; it is not a complete register of births that have resulted from treatment. I remember that when we talked at considerable length about issues relating to birth certificates and the rights of donor-conceived people to find out who their biological parents are, the briefings that we received from the HFEA pointed out that, because of the limited nature of the register, it is not possible to say that there is a complete register of all donors. For example, donors may have moved and the HFEA does not track the lives of donors after the point at which their information has been stored. It is therefore important to establish what we are talking about at the base level.

That plays directly into the point that was made about consent by the noble Earl, Lord Howe. We are now talking about information that goes back over a very long time, to 1991. I agree with the noble Earl about a campaign to raise awareness about the change to the use of the register for research into possible medical conditions. We should not assume that people who have been involved in IVF treatment or donation would automatically wish to be part of that, but they might if they knew about it. I, too, wanted to ask why the department had ruled out the mounting of a campaign.

Following on from that, I also wanted to ask about periods of authorisation for research. From Regulation 10, I understand that such authorisation would be for a period of five years. I am not the noble Lord, Lord Winston, but is it not the case that research programmes in this field can be quite lengthy and take a considerable amount of time? Therefore, can periods of authorisation be renewed and is there any limit on that renewal?

I also wanted to talk about the destruction of information. The regulations are, in many ways, rightly prescriptive about what research institutions must do and cannot do with information. They are very prescriptive about the penalties for mishandling information. In Regulation 18, which deals with the destruction of information, I see that there is no penalty for the failure to destroy information. The HFEA might therefore be powerless in such circumstances and that might be an omission.

Finally, I note in Regulation 21 the proposal to create an oversight committee. In an area as technical and sensitive as this that is probably a good thing. I see from the first three paragraphs of that regulation that the role of the oversight committee will be principally about the monitoring and granting of authorisations, the processing of disclosable information and looking at the annual reports of research establishments. Then there is a catch-all paragraph, to,

“consider such other matters relating to these Regulations as the Authority or the Committee may determine”.

Can the Minister indicate the sort of things that that paragraph would be intended to cover and the sorts of things that it would not?

I happen to believe that the HFEA does a difficult job extremely well, but the organisation is frequently subjected to criticism, not all of it fair or informed. Part of the protection that we as Parliament owe the HFEA is to be quite clear about what its remit is and is not.

I welcome the parental orders regulations. As I was reading them, I was thinking about the discussions that the House had not only on the HFE Bill but going back to the Adoption and Children Act 2002. We discussed the importance of parental orders for families in which there is a clear and settled intent to create a family and for whom it is in the best interests of children to have a process that is swifter and lighter-touch than the full adoption process which involves going through a court. We should welcome that. I note that most of the order simply replicates parts of the law on adoption that have already been agreed by both Houses of Parliament and, therefore, should not detain us long.

However, I have two questions for the Minister. In cases of civil partnerships or long-term, but unmarried, heterosexual couples, I presume that these orders will come into force only when they are enacted and therefore apply to children who receive a parental order after the passage of these regulations. Is it therefore right to assume that families who are in this position at the moment would have had to go through a process under the Adoption and Children Act? I ask that to go to the question asked by the noble Earl, Lord Howe. I assume that if families in this country have had children under surrogacy arrangements with surrogates abroad—anywhere, not just America—they would have had to go through an inter-country adoption process and, therefore, the children would be adopted, perhaps though a fast-track route. Can the Minister confirm that I am right and there is not a group of children in limbo waiting for the passage of these orders?

I rise to speak from the Back Benches to press on two points that have already been extremely well covered from the Front Bench by my noble friend Lord Howe. They relate to the options available to the Department of Health. I know that my concerns are shared by the noble Lord, Lord Alton of Liverpool, who cannot be here this afternoon as he is entertaining an important overseas delegation to Parliament.

Given the important shift that is taking place, we all recognise that research into the long-term effects on people born using assisted reproduction techniques is vital. There is growing evidence that there are long-term risks associated with various assisted reproduction procedures; for example, changes in embryo culture can have a remarkable impact on later development. It is therefore vital that information is collected, but it needs to be obtained in an ethical way. I am sure that the Government are concerned about this. The regulations have various safeguards. For example, if someone has expressed a wish not to have information disclosed for research, that wish will not be overridden. However, information could still, in certain circumstances, be disclosed without the person’s knowledge or active consent. Will the Minister give a little more information about the circumstances in which that important disclosure of information might occur?

In relation to the options available, I again echo the comments that have already been made. In respect of option two, which has the advantage of not compromising the issue of consent, but which the department rejected on the basis of cost, could the Minister say what cost-benefit analysis was undertaken by the department to arrive at that conclusion? What assumptions were made to feed into that system?

My Lords, we have had an instructive, constructive and useful discussion about the regulations and the order. I hope I can answer all the questions that have been raised.

All three noble Lords who contributed raised the issue of the public awareness campaign. I should explain that the key issue about the expense of the campaign was that it would be expensive in terms of effectiveness, not because it was costly. If it had been costly but we thought it would be effective, we would have gone ahead with it. After reading through the documentation, the issue for us was to find the most effective way of dealing with the matter other than through a public awareness campaign that could not be targeted at particular groups but would address the whole country. It might involve media adverts, including television and radio. It could cost anything up to several million pounds but the likely outcome could not be certain. In promoting the effect of the regulations, including the option to withhold identifying information from disclosure, we decided that it would be best to have a targeted campaign—which would involve discussions with patient groups, research bodies and other researchers—and to raise awareness in that way rather than through a wide-ranging advertising campaign. There are, of course, many groups involved in these issues.

The noble Lord, Lord Bates, asked about the circumstances in which information would be released, as did other noble Lords. An application for research would normally be successful only where the research bodies applying to the HFEA had demonstrated that the project was both necessary and expedient in the public interest and in the interests of improving patient care. They must be able to demonstrate that the aims of the project cannot be achieved by other means—this is very important—such as the use of anonymised data or partial data sets where consent can be obtained, and that it is not practicable to obtain consent to the disclosure from the person or persons to whom the information relates. The regulations go into some detail and there are many hoops through which researchers must jump before they are allowed to access this information.

The noble Baroness, Lady Barker, the noble Earl and the noble Lord, Lord Bates, raised the issue of penalties for failure. There is no power in the regulations to create offences. None the less, the research establishment has to be granted approval and would be expected to have high standards. It would also be subject to the penalties applicable to any breach of the Data Protection Act which would still cover this information. So not only would the establishment have its research disrupted and permission withdrawn, it would also be subject to the legalities of the Data Protection Act.

The noble Earl and the noble Baroness, Lady Barker, raised the issue of Regulation 8(1)(c) regarding researchers not contacting people on the register and a child not being advised. The HFEA will set out in the authorisation its requirements regarding contacting people as a result of IVF, and it has enormous experience of doing that. We would expect it carefully to regulate this process and to have regard to the concerns identified by the noble Earl. There would have to be a very strong case for there to be direct first-contact by a research team rather than a person known to the patient. This would obviously have to be dealt with with great sensitivity. Such contact would have to be sanctioned by the HFEA to ensure that it was done in a way that has been agreed and was intended. It would be likely only in very specialised circumstances.

The noble Earl raised the matter of the culture media using IVF laboratories not being regulated. I am not sure that the noble Earl put it quite like that, but that was my understanding. Paragraph 10 of Schedule 3(8) to the Human Fertilisation and Embryology Act 1990, as amended, requires the persons responsible at licensed IVF clinics to ensure that all equipment and materials are appropriate for use and do not endanger the safety or quality of gametes and embryos. The Act does not directly regulate the manufacture or import of culture media.

The issue of regulation has been the subject of discussion between the HFEA and the Medicines and Healthcare products Regulatory Agency. In July 2008, the MHRA wrote to the HFEA to say that the European Union’s classification and borderline working group had concluded that culture media was a class 3 medical device, therefore bringing it within the MHRA’s area of interest. As such, the MHRA advised that it accepts the culture media carrying the CE mark as suitable for use in IVF treatment. I will be happy to let the noble Earl have a copy of that letter. It gives an extremely well informed and detailed exposition on the issue and will almost certainly be noted by the people who have an interest in this matter.

The noble Baroness, Lady Barker, asked what information the HFEA register holds. The register records information relating to the provision of treatment services, including IVF, the use of donated gametes or embryos and, where known, the outcome of the treatment cycle. It records the storage and use of donated sperm, eggs and embryos, and the procurement, distribution and use of donated sperm provided by non-medical fertility services for home insemination, such as those which operate through the internet.

The HFEA instructs fertility clinics on the information that they must provide for the register by means of a direction made under Section 24 of the Human Fertilisation and Embryology Act 1990. Outcomes, including births, must be notified to the HFEA, but outcomes may not be known for parents who perhaps return abroad after treatment. To that extent, the register may not be complete.

The issue of periods of renewals was raised by several noble Lords. The period for research would be five years. There are at present no restrictions on the number of renewals but each would require the agreement of the HFEA and would be one of the issues monitored by the committee, as I outlined in my opening remarks.

On the second parental order instrument, the noble Earl, Lord Howe, asked whether the Government intended to review the regulation of surrogacy. The answer is yes. We made a commitment that we would do so during the review of the 1990 Act that led to the 2008 Act. We have not yet, however, committed to a timescale for that review.

The noble Earl asked also about children who may become stateless. It is an important question. The law in the UK does not make provision for the automatic recognition of overseas surrogacy arrangements. However, UK law makes provision for parental orders. It strikes the right balance between the need to ensure the welfare of the child and the rights of the commissioning couple. Commissioning couples, if domiciled in the UK, are subject to UK law. My understanding is that if one had gone through the parental order, as in an adoption, the child would then have UK nationality. Parents who go down this road have to inform themselves in advance of the hurdles that they will have to overcome to achieve a surrogate child through that process.

The noble Baroness, Lady Barker, asked about the adoption of children by same-sex couples. Same-sex and unmarried couples can enter into surrogacy arrangements. However, before the regulations come into force, their child would have to be adopted. We do not think that any children are in limbo as a result of this because the adoption route still exists until the regulations come into force.

I hope that I have covered the points raised during the debate. However, I shall read through my notes and make sure that I write to noble Lords if I have omitted any matter of detail. I thank noble Lords for their comments and questions.

Motion agreed.