Human Fertilisation and Embryology (Special Exemption) Regulations 2009

My Lords, I shall speak to the draft Human Fertilisation and Embryology (Appeals) Regulations, the draft Human Fertilisation and Embryology (Special Exemption) Regulations and the draft Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order. I will describe briefly each set of statutory instruments, starting with the appeals regulations. The Human Fertilisation and Embryology Authority licenses IVF and embryo research centres. The HFEA licensing regime is set out in statute by the Human Fertilisation and Embryology Act 1990, with regulation-making powers to add detail to the licensing system. In 2004, the Government announced a review of the 1990 Act, which resulted, after interesting and valuable debate, in the Human Fertilisation and Embryology Act 2008. The 2008 Act updates and amends the 1990 Act and, as part of this, updates the licensing and appeals regime. The 2008 Act requires regulations to be made to set out the details of the constitution of an appeals committee and the process by which an appeal will be heard. The appeals regulations will replace existing regulations that deal with the current appeals processes. The draft appeals regulations aim to ensure that the committee is as independent from the authority as it can be, and that a clear, robust appeals process is set out. There are requirements under common law and the European Convention on Human Rights for appeals procedures to be impartial and fair, and I believe that these draft regulations set out such a procedure. The draft appeals regulations are in four parts. Part 1 sets out the commencement date for the regulations, and definitions of the terms used. Most provisions in the draft appeals regulations will be commenced on 1 October 2009. However, regulations 4 and 6, and the relevant definitions under regulation 2, will be commenced the day after the draft regulations are made. These provisions relate to the constitution of the committee and the appointment of members, and enable the HFEA to appoint and train members of the appeals committee so that the committee is in place on 1 October. Part 2 of the draft appeals regulations sets out the constitution of the committee. As the appeals process is a legal procedure, the regulations provide that both the chair and deputy chair must be legally qualified. The appeals committee will have seven members and must have a lay majority. A non-lay member—a person with a professional interest—is defined as either a registered medical practitioner, a person concerned with keeping or using gametes or embryos outside the body, or a person who is directly concerned with commissioning or funding any research involving such keeping or use of gametes or embryos. This is the same definition as in the 2008 Act. The quorum of the committee will be three, which includes the chair or deputy chair and at least one person with a professional interest. The committee is prevented from sitting with an even number of members, and voting is by a simple majority. Members are prevented from abstaining to ensure that a tied vote does not arise. This provision was introduced following the consultation process. The draft regulations specify who cannot sit on the committee, including current and former HFEA members and staff, current licence holders and current persons responsible under a licence. This aims to ensure that the committee is as independent as possible. The draft regulations prevent licence holders and "persons responsible" working in a licensed clinic from sitting on the appeals committee, but do not restrict who may be appointed as an adviser to the committee. Therefore, should the committee require advice from persons who are excluded from being members, they may be appointed as advisers. Provision for the committee to appoint advisers is made in Part 3 of the regulations. I am confident that, in enabling the committee to appoint expert advisers, we have the correct balance between the maximum independence and objectivity of the committee and its access to expert advice. Part 4 sets out the procedure by which an appeal is determined. I will draw attention to a typographical error in the regulations. Regulation 21(5) refers back to paragraph (3) of that regulation. It should refer to paragraph (4). This will be amended in the final version of the regulations. Part 4 sets out the detail of what documentation the committee will require and when it must be provided. A determination may either be by reference to the papers or at an actual hearing. The draft regulations introduce case management meetings, which may be at the request of either party, to allow the chair to make preliminary rulings on the admissibility of evidence and points of law. This will streamline the appeals process by enabling early agreements on such matters to be reached. Part 4 goes on to provide for witness evidence and sets out the powers held by the committee to summons witness evidence. This part includes the requirements to ensure that the determination is recorded and made available to both parties. The record will include any advice that the committee receives from an adviser, whether given during the deliberations or the hearing. I now turn to the special exemption regulations. The Human Fertilisation and Embryology Act 1990 prohibits storing gametes and creating, keeping or using a human embryo without a licence from the HFEA. This is a key principle of the 1990 Act and has been retained following the update of the legislation by the Human Fertilisation and Embryology Act 2008. However, there are two exceptions to this principle, which were set out in regulations made in 1991. These regulations will be replaced by the draft Human Fertilisation and Embryology (Special Exemption) Regulations. These draft regulations do not represent a change in government policy. It has been necessary to re-make these regulations in consequence of the provisions of the 2008 Act, which update the definitions of "gametes" and "embryos" in the 1990 Act and which provide for the regulation of human admixed embryos. It was also necessary to make some minor and technical amendments to the drafting of the regulations. The draft Human Fertilisation and Embryology (Special Exemption) Regulations set out the cases in which embryos may be examined or kept, and gametes may be stored, without a licence from the HFEA. There are some circumstances where gametes and embryos may be kept for purposes other than for providing fertility treatment or embryo research; for example, during the course of a criminal investigation into alleged breaches of the Human Fertilisation and Embryology Act or the storage of sperm for teaching purposes. The 1991 regulations were made to set out exceptions to the HFEA licensing requirements in these very specific and limited situations. In drafting the 1991 regulations, the Government wanted to ensure that these regulations could not be used to circumvent the stringent controls set out in the 1990 Act. The same applies to these draft regulations. The first exception relates to the examination and keeping of embryos, and the storing of gametes in the course of the investigation of an offence under the 1990 Act, or in relation to proceedings for such an offence. This exemption applies to gametes or embryos that have been seized by the HFEA or which have been transferred to premises where they are held on the instructions of the authority. The second situation that the regulations provide for is cases where gametes are being stored for use in research. The regulations set out three purposes for which a person may store gametes without a licence from the HFEA. These are where they are stored for the purpose of research on gametes, for the development or testing of pharmaceutical or contraceptive products, or for teaching that requires the use of gametes. However, a storage licence will still be required if certain activities are intended to be carried out, including the use of gametes in treatment services, the mixing of eggs and sperm or bringing about the creation of a human or human admixed embryo. It is important to note that the regulations do not remove any licensing requirement relating to how the gametes are used; they only provide exceptions to the requirement for a storage licence. The regulations do not reflect a change in government policy. They are being re-made in consequence of the provisions in the 2008 Act which update the provisions of the 1990 Act in light of scientific developments, and to make some minor drafting changes. We will continue to keep the regulations under review in light of further developments. As your Lordships may be aware, it was necessary for the Department of Health to withdraw an earlier version of the regulations in order to correct an oversight. We regret that this was necessary but note the Merits Committee’s acknowledgement that the department acted quickly to correct the draft regulations. The 1991 regulations worked. They did what they were supposed to do and we do not see any further reasons for which exceptions should be made. For these important reasons we have not updated the policy in these regulations but simply re-made the regulations with the same exceptions. I shall finally and briefly discuss the consequential and transitional order. The 2008 Act updates the 1990 Act. The draft Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order makes provision to ensure that the changes made by the 2008 Act are reflected in other primary and secondary legislation. The order consists of four articles and four schedules. Article 2 and Schedules 1 and 2 make consequential amendments to reflect the parenthood provisions introduced by the 2008 Act. In particular, the 2008 Act introduced the concept of second female parents, which enabled the female partner of a woman to be registered as the legal parent of a child born following assisted conception treatment with donor sperm in certain circumstances. The amendments in these sections ensure that a woman who is a parent by virtue of new provisions has the same rights and obligations as any other legal parent of a child. Article 3 and Schedule 3 contain consequential amendments to other pieces of secondary legislation. Such amendments are necessary to ensure that the secondary legislation appropriately reflects the updated definitions, terms and provisions in the 2008 Act. Article 4 and Schedule 4 contain transitional and saving provisions. These ensure that the process for the transition to new provisions, as introduced by the 2008 Act, is as clear and straightforward as possible. I commend the regulations to the House. I beg to move.