Human Fertilisation and Embryology (Parental Orders) Regulations 2010

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. The first three schedules to the new parental orders order set out the detail of how the adoption legislation for England and Wales, for Scotland and for Northern Ireland has been applied to parental orders. Schedule 4 sets out the references to "adoption", "adoptive child" and "adoptive relationship" in the other legislation which are to be read as including reference to parental orders. In passing the Human Fertilisation and Embryology Act 1990, Parliament accepted that occasionally women are prepared to act as surrogates to help couples unable to have children of their own. Parental orders were introduced by the 1990 Act as a way of transferring parental responsibility from a surrogate and her partner, if she has one, to the intended parents referred to as the "commissioning couple". A parental order is made by the court. It requires agreement between the parties and is therefore based on their freely given and unconditional consent. Eligibility criteria were set out in the 1990 Act, which included the requirement that one or both of the commissioning couple must be the child’s genetic parent. It also specified that the applicants must be a married couple. Since then, around 50 parental orders have been granted by the courts each year. Under current law, where same-sex and unmarried couples enter into a surrogacy arrangement, the only option for them to acquire parental responsibility for a child is adoption. However, the 2008 Act replaces the parental order provision in the 1990 Act to allow same-sex and unmarried couples to apply for parental orders as well as married couples. As I have already outlined, the 2010 parental orders order applies current adoption legislation, with modifications, to parental orders. The order makes the welfare of the child the paramount consideration of the court when deciding whether to grant a parental order. This emphasises the value of the child’s interests and is in line with the approach in adoption cases. The welfare checklist set out in the Adoption and Children Act 2002 is also applied, with modifications, to parental orders. This is designed to support the courts in specifying the matters they should take into account when considering, for example, the particular needs of the child. The order was subject to a three-month public consultation in the autumn of 2009 and the responses received demonstrated broad agreement with the approach taken. The consequential, transitional and saving provisions order revokes the 1994 parental order regulations but saves parts of those regulations for specific purposes. It makes the necessary consequential amendments to other legislation and sets out the transitional arrangements for applications made under the 1990 Act which are not disposed of when the new parental order provisions in the 2008 Act and the regulations come into force. Such applications will continue to be processed under the 1990 Act. I commend both sets of regulations and the order to the Committee.