Human Fertilisation and Embryology (Parental Orders) Regulations 2010

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 under 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.