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Clause 15: Conditions of storage licences

122.     Clause 15 amends section 14 of the 1990 Act. Section 14, as amended, continues to provide for various conditions to apply to storage licences. Clause 15 amends the statutory conditions attached to storage licences and amends the maximum statutory storage limit for embryos to bring it into line with the ten-year limit applicable to the storage of gametes.

123.     Currently, there is a five-year storage period. After this has expired, the Human Fertilisation and Embryology (Statutory Storage Periods for Embryos) Regulations 1996 (SI 1996/375) allow embryos to be kept in storage, for an additional five years, only if the couple are still considered to be infertile and the embryos are kept solely for their own treatment. Removing both the five-year break point and the restriction on storage for personal use will allow couples to opt for a full ten-year storage period at the outset and give them the opportunity, if they no longer wish to use the embryos themselves, to donate them for the treatment of others or for research. Couples will be able to take up this option at any point during the ten-year period.

124.     Section 14 is also amended to apply a ten-year statutory storage period to human admixed embryos.

Clause 16: Grant of licence

125.     This clause amends section 16 of the 1990 Act. It removes from section 16 of the 1990 Act the requirement for a licence application to be in a particular form and for an initial and an additional fee to be paid. Fees will be set in accordance with a scheme made by the HFEA under new section 35B of the 1990 Act set out at clause 27.

Clause 17: The person responsible

126.     Clause 17 repeals the definition of "nominal licensee" from the 1990 Act. The term "nominal licensee" is no longer used because it does not adequately reflect the responsibilities of a licence holder.

Clause 18: Revocation and variation of licence

127.     Clause 18 provides that the HFEA may revoke or vary any licence on application by the person responsible or the licence holder (if different). The HFEA may also revoke or vary a licence of its own volition where certain conditions are satisfied. The power to vary a licence does not include the power to vary the mandatory conditions that are by virtue of sections 12 to 15 of the 1990 Act included in every licence.

Clause 19: Procedure for refusal, variation or revocation of licence

128.     Clause 19 makes a number of small amendments to the procedures in the 1990 Act for notifying licensing decisions to interested parties. The HFEA will provide the applicant with notice of its proposed decision and the reasons for the decision. Once a person has been given notice they will then have the right to make representations about the proposed decision. If the HFEA proceeds with the decision, then section 20 (inserted by clause 21 of the Bill) provides that the applicant may apply for reconsideration of the decision.

Clause 20: Power to suspend licence

129.     This clause inserts new section 19C substituting section 22 of the 1990 Act concerning the Authority's powers to suspend a licence. Any period of suspension is restricted to a maximum of 3 months although this may be renewed. Appeals against a decision to suspend may be made to an appeals committee constituted under regulations made by the Secretary of State in the same way as other licensing decisions (see new section 20A of the 1990 Act).

Clause 21: Reconsideration and appeals

130.     Clause 21 substitutes sections 20 and 21 of, and inserts new sections 20A and 20B into, the 1990 Act.

131.     Substituted section 20 sets out the rights of appeal against licensing decisions of the HFEA.

132.     New section 20A provides that the HFEA must maintain one or more appeals committees. The constitution of appeals committees will be set out in regulations made by the Secretary of State. The regulations may also provide for advisors to be appointed to appeals committees so that the committees can receive specialist scientific, legal and other advice.

133.     New section 20B provides that reconsideration of licensing decisions and suspension notices will be by way of a fresh decision. It provides for regulations to make provision about the procedure to be followed. Those regulations may in particular make provision about: the right of the appellant and the HFEA to appear before the committee; the consideration of written representations by the committee; the giving and admissibility of evidence and the production of documents; the taking of decisions by the committee and the notification of those decisions.

134.     New section 21 provides that a further appeal may be made to the High Court (or, in Scotland, the Court of Session) by a person aggrieved by the appeals committee's decision, but only on a point of law.

Clause 22: Directions

135.     Section 24 of the 1990 Act provides for directions to be given in respect of various matters. Clause 22 makes several amendments to this section, some of which concern the directions which may be given in respect of human admixed embryos and others which make updated provision concerning what is to happen when a licence is varied or ceases to have effect.

Clause 23: Code of practice

136.     Section 25 of the 1990 Act requires the HFEA to maintain a code of practice giving guidance about the conduct of licensable activities. In particular the code must provide guidance to clinics about the account to be taken of the welfare of children who may be born as a result of treatment services (including a child's need for a father) and of other children who may be affected by such births.

137.     Clause 23(2) amends section 25(2) of the 1990 Act to replace the reference to "a child's need for a father" with a reference to "a child's need for supportive parenting".

138.     Clause 23 also inserts new section 25(2A) into the 1990 Act to require the HFEA to provide guidance in the code about the giving of a suitable opportunity to receive proper counselling and the provision of such relevant information as is proper, as required by the licence conditions for clinics under new section 13(6) and (6A) of the 1990 Act.

Clause 24: Register of information

139.     Section 31 of the 1990 Act requires the HFEA to keep a register of information obtained by it which relates to the provision of treatment services, or the keeping or use of any gametes or an embryo taken from a woman, or the procurement or distribution of sperm for certain purposes. It also requires the HFEA to keep a register of information obtained by it about people born as a result of treatment services.

140.     Section 31 makes provision for people conceived as a result of donated gametes since the 1990 Act came into effect to require the HFEA to provide them with certain information.

141.     Donor-conceived people are able to find out whether, but for the provisions of the Act which determine parenthood in relation to people born as a result of certain treatment services (sections 27 to 29 of the Act), they would be related to the person they intend to marry and at age 18 they are able to find out whether the register shows that they were, or may have been, conceived using donor gametes. If so, they are able to obtain such information which is held on the register as is specified in regulations made under section 31(4).

142.     The Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004 (SI 2004/1511) specify the information which the HFEA must provide if a request is made by a donor-conceived person. Where information was provided by a donor before 1 April 2005, certain specified non-identifying information must be provided to the donor-conceived person. Where identifying information was provided by a donor after 31 March 2005 then certain identifying and non-identifying information must be provided. Those who ask for information from the register must be given an opportunity to receive counselling.

143.     Donors who made their donation before 31 March 2005 but after the 1990 Act came into force, can opt to re-register as identifiable, and identifying information about them could then be released if a request was made by a person conceived as a result of their donation.

144.     Clause 24 of the Bill replaces section 31 with new sections 31 to 31ZG. New section 31 re-enacts the parts of the amended section 31 which deal with the register so that the HFEA must continue to keep a register of the information referred to above and must also record such information which it obtains after the Bill comes into effect.

145.     New section 31ZA re-enacts the existing provisions of section 31 of the 1990 Act which enable a donor-conceived person ("the applicant") to obtain information about their donor. However, the donor-conceived person will now be able to request this information from age 16. Only non-identifying information can be disclosed whilst the donor-conceived person is under 18.

146.     In new section 31ZA(2)(b) there is a further provision, that a donor-conceived person is entitled to information, at age 16, and on request, about the number, sex and year of birth of their donor-conceived half-siblings who were conceived using gametes of the same donor but are not the donor's legal children.

147.     The HFEA has a discretion not to comply with a request for information about the genetic half-siblings if it is aware of special circumstances which increase the likelihood that the applicant would be able to identify the donor (in a case where the applicant does not have a right to obtain information about the donor's identity) or any such genetic half-sibling.

148.     New section 31ZB enables a donor-conceived person to find out whether they are related to someone they propose to marry, enter a civil partnership or intimate physical relationship with or with whom they are having an intimate physical relationship. The consent of the person they are in or intend to enter into the relevant relationship with will need to be given to the HFEA. There is no age limit in relation to applications under this section by donor-conceived people who are intending to marry or enter a civil partnership. This is in line with the current provision in section 31. In order to make an application as a person who is in or is intending to enter into an intimate physical relationship, the donor conceived person must be aged 16 or over.

149.     New section 31ZC gives the HFEA the power to inform a donor of the fact that a donor-conceived person has requested information about him. Donor-conceived people will be able to request identifying information about their donor from 2023 onwards, in relation to donors who donated identifiably from April 2005. This could happen sooner if someone who donated before April 2005 elected to re-register as identifiable, and a person conceived from his or her donation requested identifying information from the HFEA. In practice, the HFEA would try to forewarn the donor before identifying information is given to the donor-conceived applicant. This might not be possible in all cases, for example if the donor has moved and has not updated their address. The HFEA may not disclose identifying information about the donor-conceived person to the donor.

150.     New section 31ZD enables donors (including past donors) to be provided with information on request about the number, sex and year of birth of children born as a result of their donations. They may ask the clinic where they donated or the HFEA (if the clinic has closed or the clinic is not able to, or fails to, provide the information). The information can be withheld from the donor if the HFEA is aware that circumstances exist which would mean that releasing the information would increase the likelihood that the donor would be able to identify a child born as a result of their donation.

151.     New section 31ZE enables donor-conceived people to request and obtain identifying information about their genetic half-siblings who were conceived using gametes from the same donor, where neither is the donor's legal offspring. The half-sibling whose information is being released must consent to the disclosure and both siblings must have had a suitable opportunity to receive counselling. There is also a proviso that the disclosure would not lead to the identification of a donor without the donor's consent unless regulations provide that his or her identity could be released to either of the donor-conceived people on request.

152.     New section 31ZF introduces a power for the HFEA to set up, or keep, a voluntary contact register of people who would like to receive information about any person to whom they are genetically related as a consequence of the provision to any person of assisted conception treatment services in the United Kingdom involving donors before the HFEA's register began on 1 August 1991. New section 31ZG enables the HFEA to fund, on such terms and conditions as the HFEA considers appropriate, another person or body to set up and keep a voluntary register.

153.     If the HFEA keeps a register under new section 31ZF, it may charge a fee to people wishing to join it, arrange for DNA samples of people who join to be analysed, with their consent, and matched with those of others on the register, and make arrangements for information to be disclosed between people who are genetically related. It is intended that the fee charged would recover all or part of the costs of keeping the register. Such a voluntary contact register, UK DonorLink, has been run as a national pilot project since 2004 by After Adoption Yorkshire, a voluntary organisation.

Clause 25: Restrictions on disclosure of information

154.     This clause inserts into the 1990 Act new section 33A which will replace the current section 33. New section 33A retains the prohibition on the disclosure of the information falling within section 31(2) of the 1990 Act.

155.     Section 33 currently distinguishes between information which can be disclosed by the HFEA and information which can be disclosed by licence holders and persons to whom directions have been given. New section 33A places all persons who might hold information which is on the HFEA's register on a similar footing when it comes to lifting the prohibitions on disclosure. Information which has been obtained by any person as a member or an employee of the HFEA, a person to whom a licence applies, including those covered by third party agreements, those to whom directions from the HFEA have been given, and authorised people who are carrying out functions which have been contracted out to them by the HFEA (and their members of staff or employees), may not be disclosed except to the categories of person or in the circumstances specified in new section 33A(2).

156.     Section 33A(2) lifts the prohibition on disclosure which section 33A(1) imposes. Exceptions to the prohibition on disclosure are currently listed in section 33 of the 1990 Act, as amended by the Human Fertilisation and Embryology (Disclosure of Information) Act 1992 and the 2007 Regulations. Most of the current section 33 exceptions are being retained. Some are however being replaced, and additional exceptions have been included in new section 33A(2). For example, now section 33A(2) permits disclosure to other persons or bodies discharging a regulatory function and permits disclosure to authorised people who are performing functions contracted out to them by the HFEA, or under third party agreements, or with the consent of those to whom the information relates (in certain circumstances). Anyone considering whether it is lawful to disclose the relevant information will still need to satisfy themselves that the disclosure would not breach the Data Protection Act 1998 or any confidentiality rights. New section 33B provides a power to make further exceptions to 33A(1).

157.     New section 33C enables the Secretary of State to make provision, in regulations, requiring or regulating the disclosure of information falling within section 31(2) for research purposes. Information can be disclosed for the purposes of medical research where the Secretary of State considers it necessary or expedient in the public interest or in the interests of improving patient care. Information can be disclosed for other research purposes if the Secretary of State considers it necessary or expedient in the public interest. The regulations may make provision requiring fees of a prescribed amount to be paid to the HFEA by persons in relation to the disclosure of protected information to them under the regulations. It is intended that the fees charged would recover all or part of the costs of providing the information. The research could include follow-up studies on the safety of IVF. The regulations may make provision for disclosure to be lawful despite any duty of confidentiality owed in relation to the information. It is expected that this power would only be used in such circumstances where it would not be possible to obtain consent to the disclosure.

158.     Before making the regulations, the Secretary of State must consult, to the extent that he considers appropriate, such bodies who appear to represent the interests of those who are likely to be affected by the regulations. The regulations may make provision for the establishment of a body which will have the function of considering whether disclosure should be authorised, should the Secretary of State consider this to be the appropriate way forward.

Clause 26: Mitochondrial donation

159.     Clause 3 of the Bill inserts new section 3ZA(5) into the 1990 Act to provide a regulation-making power to enable eggs and/or embryos with altered mitochondrial DNA to be classified as "permitted" eggs or embryos, and thus to be implanted in a woman (see note on clause 3 above).

160.     The provisions of the 1990 Act assume that only one woman's egg has been used to produce a child. New section 35A (inserted by clause 26) provides a further regulation-making power to amend specified sections of the 1990 Act if the power under new section 3ZA(5) is exercised. This enables provision to be made in cases where permitted embryos and/or eggs have been created using material from more than one woman. The relevant sections are set out in section 35A(2).

Clause 27: Fees

161.     This clause sets out the circumstances where the HFEA may charge a fee under the 1990 Act. Fees are to be determined by the HFEA under a scheme determined by the Authority, subject to the approval of the Secretary of State and the Treasury. Different fees may be fixed for different circumstances and, in fixing the fee, the HFEA may have regard to the costs incurred in exercising its functions under the 1990 Act.

162.     Clause 27 also provides a new power for the HFEA to charge fees to recoup the cost of meeting various statutory requests for information from donor-conceived people. In these cases, it is intended that the amount of the fee should only reflect the cost of dealing with applications under the provision concerned.

Clause 28: Inspection, entry, search and seizure

163.      This clause introduces Schedule 5 to the Bill which inserts new Schedule 3B into the 1990 Act. New Schedule 3B replaces the existing sections 39 and 40, which relate to the power to enter, inspect and search premises and to seize items found on premises. Schedule 3B also deals with the obtaining and execution of warrants where an offence is suspected. It also provides that failure to comply with certain requirements under the Schedule, or obstruction of the exercise of any rights under it, is an offence. Clause 28 also provides that it is not unlawful for a member or employee of the HFEA to be in possession of embryos, gametes or human admixed embryos in the course of their employment.

Clause 29: Offences under 1990 Act

164.     Clause 29 relates to offences and penalties described in the 1990 Act, as extended by the Bill. It amends section 41 of the 1990 so as to extend the prohibitions introduced by the Bill including those relating to the creation or use of human admixed embryos without a licence; and sets out the circumstances where a defence can be raised under the 1990 Act. The requirement for consent of the Director of Public Prosecutions remains unchanged.

Clause 31: Power to make consequential provision

165.     New sections 1(6), 4A(5)(e) and 4A(10) of the 1990 Act confer powers to amend the definitions of "embryo", "gametes" and "human admixed embryo" under the 1990 Act by regulations. Clause 31 inserts new section 45A into the 1990 Act to enable consequential changes to other legislation as a result of amending any of these definitions. This includes modifying Acts of Parliament, Acts of the Scottish Parliament, Measures or Acts of the Welsh Assembly and Northern Ireland legislation and any secondary legislation made under them (after consultation with the devolved administrations where appropriate). The power under section 45A is exercisable by order.

Clause 32: Orders under the 1990 Act

166.     Clause 32 inserts new section 45B into the 1990 Act. This states that the power to make an order under new section 45A and section 8C(1)(c) (see clause 8) of the 1990 Act is exercisable by statutory instrument. The negative resolution procedure applies to section 8C(1)(c) but the affirmative procedure is applicable to new section 45A.


Clause 33: Meaning of "mother"

167.     Clause 33 re-enacts section 27 of the 1990 Act. It will remain the case that the woman who carries a child following assisted reproduction anywhere in the world is the child's mother, unless the child is subsequently adopted or parenthood is transferred through a parental order.

Clause 35: Woman married at time of treatment

168.     There is no change to the existing position in relation to a child conceived as a result of treatment with donor sperm by a married woman. Her husband will be treated as the child's father, unless it is shown that he did not consent to his wife's treatment. This provision (and others which operate to determine legal parenthood) is subject to the common law presumption that a child is the legitimate child of a married couple, as to which see the note on clause 38 below.

Clauses 36 and 37: Fatherhood conditions

169.     The provisions of the 1990 Act which enable an unmarried man to be the father of a donor-conceived child if he is "treated together" with the mother in a licensed clinic are replaced by clauses 36 and 37. The new provisions require the couple to be treated in a UK licensed clinic, as before, to ensure there is clear evidence of the parents' intentions about fatherhood. However, for the man to be the father at the time the embryo or gametes have been placed in the woman or at the time she is artificially inseminated, the couple must each have given notice of consent to him being treated as the father. Neither of them must have given notice withdrawing that consent and the woman to be treated must not have given notice of consent to another man or woman being treated as the child's parent. The notices of consent do not necessarily have to be drawn up in the clinic, but they must be provided to the "person responsible" at the clinic. This is the person under whose supervision licensed activities are carried out. If, for example, a woman were to give notice of consent to several people being the father of a child, and corresponding notices were given by the other persons, the latest set provided to the clinic would apply.

170.     After the transfer of the gametes or embryo, neither the man nor the woman can withdraw their consent to the man being treated as the child's father unless the woman does not conceive and a new cycle of treatment has to begin. Changes to the conditions which must be included in all treatment licences, which are made by clause 14(3), will require that, if the man withdraws his consent at an earlier stage, the woman must be told before the treatment proceeds. She will therefore have the opportunity to decide whether she wishes to go ahead in these circumstances. If the woman withdraws her agreement to the man being the father, he must be told as soon as possible but he would not, through these provisions, be able to stop her going ahead if she wished to do so. Notices may not validly be given by two people who are within the prohibited degrees of relationship. This is defined in clause 58(2) to include parents and children, siblings and uncles or aunts and their nephew or nieces. Close relatives of this kind may not jointly be treated as a child's parents.

171.     The Bill will maintain the situation that if an unmarried couple carry out self-insemination with donor sperm at home or elsewhere, not as part of licensed treatment, the male partner would not be the legal parent. He would have to take steps to acquire formal parental responsibility, for example by adopting the child. An unmarried man cannot become a parent where donor sperm is provided under a licence under paragraph 1A of Schedule 2 to the 1990 Act (non-medical fertility services) unless also used in treatment services.

Clause 38: Further provisions relating to sections 35 and 36

172.     Clause 38(1) clarifies that where a person is treated as a child's father under the preceding clauses, no other person is to be treated as the father. A sperm donor, for example, would not have this status. Clause 38(2) and (3) provides that clauses 35 and 36 do not affect the common law presumption that a child is the legitimate child of the parties to a marriage. If, for example, a woman marries between the conception of the donor-conceived child and its birth, it will be presumed that her new husband is the father of the child, even if the agreed fatherhood conditions were satisfied in relation to a different man at the time when the gametes or embryo were transferred. This presumption may, however, be rebutted by evidence (for example a DNA test) showing that the husband is not in fact the child's father. In that case, the provisions of clause 36 would apply and the man in respect of whom the agreed fatherhood conditions were satisfied would be the child's father. There is no parallel presumption at common law for people who enter a civil partnership. So the provisions which would otherwise apply to determine parenthood will not be affected by the mother entering into a civil partnership after the transfer of an embryo or gametes.

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Prepared: 6 February 2008