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57. Currently as a matter of policy, the HFEA does not allow sex selection except for medical reasons. This position is maintained in the Bill. Paragraph 1ZB deals more generally with practices of sex selection for example sperm sorting, and precludes them from being authorised by a licence other than where there is a particular risk that a woman will give birth to a child who will have or will develop a gender-related serious physical or mental disability, serious illness or other serious medical condition (see paragraph 52 of these notes). Paragraph 1ZB does not prevent any embryo testing practices that may be permitted under paragraph 1ZA.
58. Paragraph 1ZC provides regulation-making powers to amend new paragraph 1ZA (embryo testing), and to make consequential amendments of the new paragraph 1ZB (sex selection). However, regulations may not authorise testing embryos to establish their sex or other practices of sex selection, except on grounds relating to the health of any resulting child.
59. Paragraph 4 of Schedule 2 to the Bill is intended to prevent sex selection in the context of the provision of non-medical fertility services. A licence cannot authorise the procurement or distribution of sperm to which any process has been applied which is designed to result in a child of a specific sex.
60. Under paragraph 3 of Schedule 2 to the 1990 Act, a research licence may authorise the creation, keeping and use of human embryos for the purposes of a project of research. Paragraph 6 of Schedule 2 to the Bill substitutes new paragraphs 3 and 3A for the existing provision.
Purposes for which embryo research may be undertaken
61. A research licence may not authorise any activity unless the HFEA considers it to be necessary or desirable for one of the specified research purposes.
62. The list of permitted research purposes was extended by the Human Fertilisation and Embryology (Research Purposes) Regulations (SI 2001/188) ("the 2001 Regulations"), which allowed embryos to be created and used for research into stem cell therapies and the treatment of serious disease. New paragraph 3A brings together all the research purposes currently listed in the 1990 Act and the 2001 Regulations. It also makes three significant changes to the previous position on licensable research using embryos.
63. The list of purposes for which research may be licensed has been expanded in new paragraph 3A(2)(a) to include research which is undertaken to increase knowledge, not only about serious diseases, but also about other serious medical conditions. This includes conditions such as neural trauma or other tissue damage, which would not be considered to be diseases and therefore would not previously have been permitted.
64. New paragraph 3A(2)(b) allows for research into the development of treatments for other serious medical conditions, as well as for serious disease. Research may lead to an understanding of how to change stem cells into particular tissues, which may have the potential to regenerate or repair tissue damage caused by disease or trauma.
65. New paragraph 3A(1)(b) extends an existing provision, giving the HFEA power to not only issue licences where it is necessary or desirable for one of the principal purposes, but also where the research will increase knowledge about serious disease or other serious medical conditions, or develop treatments for them.
66. The 2001 Regulations are superseded by these provisions and are therefore revoked by Part 2 of Schedule 8 to the Bill.
Genetic modification of cells
67. Currently, paragraph 3(4) of Schedule 2 to the 1990 Act prohibits alteration of the genetic structure of the cell of an embryo, except in such circumstances as may be specified in regulations. No such regulations have in fact been made. This prohibition is not included in the re-enacted paragraph 3, therefore research involving the genetic modification of embryos may now be authorised under a research licence.
Human admixed embryos
68. Paragraph 3(2) of Schedule 2 to the 1990 Act, as inserted by paragraph 6 of Schedule 2 to the Bill, continues to allow the mixing of sperm with the egg of a hamster, or other animal specified in directions, for the purposes of research into the normality or fertility of sperm. Any resulting human admixed embryo must be destroyed as soon as the research is complete and no later than the two-cell stage.
69. New paragraph 3(3) enables licences to be issued to create, keep and use human admixed embryos defined under new section 4A(5)(a) to (d) as inserted by clause 4 for the purposes of a project of research specified in the licence.
70. Where regulations under section 4A(5)(e) provide for any other thing to be treated as a human admixed embryo, paragraph 3(5) provides a further regulation-making power to allow such human admixed embryos to be created and kept and used for the purposes of a project of research.
71. New paragraph 3(6) provides that no research licence can be granted unless the proposed use of embryos or human admixed embryos is necessary for the purposes of the research.
72. New paragraphs 3(7), (9) and (10) of Schedule 2 to the 1990 Act deal with time limits and conditions applying to research licences.
Licences for storage (of human admixed embryos)
73. Under paragraph 2 of Schedule 2 to the 1990 Act, a storage licence may authorise the storage of gametes or embryos, or both. Paragraph 5 of Schedule 2 to the Bill inserts new sub-paragraph (1A) into paragraph 2 of Schedule 2 to the 1990 Act allowing the storage of human admixed embryos (regardless of whether the licence holder is already licensed to store embryos or gametes). Any such licence would be subject to the same conditions and time limits under paragraph 2(2) and (3) of Schedule 2 to the 1990 Act as licences to store embryos and gametes.
Clause 12: General conditions of licences
74. Section 12 sets out general conditions that apply to every licence granted under the 1990 Act. The 2007 Regulations amended section 12 to except non-medical fertility services from the ambit of Schedule 3 to the 1990 Act. Neither the remit of the EU Directive or the powers under which it was implemented allowed for the consent provisions in Schedule 3 to the 1990 Act about the use and storage of gametes and embryos to be applied in the case of persons providing gametes for the purpose of the provision of non-medical fertility services. This clause amends section 12 of the 1990 Act to rectify that situation.
75. Clause 12 also amends section 12 to ensure that no money or other benefit can be given or received for the supply of human admixed embryos (unless authorised by directions) and that if human admixed embryos are supplied to a person to whom another licence applies they must be provided with any information that the HFEA may specify in conditions. These amendments ensure that any research licence granted in connection with a human admixed embryo will be subject to the same relevant licence conditions as for embryos or gametes.
Clause 13: Consent to use or storage of gametes, embryos and human admixed embryos etc
76. Clause 13 introduces Schedule 3 to the Bill which amends Schedule 3 to the 1990 Act, relating to consent to store or use embryos or gametes to create an embryo in vitro.
Formalities of consent
77. Schedule 3 to the 1990 Act states that consent for the storage and use of gametes and embryos is required in writing. This requirement for written consent is retained, but the Bill also provides that the consent must be signed.
78. People who have suffered an injury resulting in a condition such as quadriplegia or a similar condition may lack the physical ability to sign the consent form although they have the capacity to consent. New paragraph 1(2) of Schedule 3 to the 1990 Act will allow a physically incapacitated person, who is unable to write and therefore give consent in writing, to direct another to sign on their behalf, in the presence of a witness.
Purpose of consent
79. Under the 1990 Act, consent must specify the purposes for which any gamete or embryos are to be used. The Bill amends paragraph 2(1) of Schedule 3 so that, in addition to being able to consent to the use of embryos for treatment or research, a person may now also specify that an embryo can be used in the training of embryologists.
Variation and withdrawal of consent
80. Paragraph 4 of Schedule 3 to the 1990 Act requires that a person withdrawing their consent to the storage and/or use of gametes or embryos gives notice of this to the establishment holding the gametes/embryos. New paragraph 1(1) of Schedule 3 requires this notice to be provided in writing and signed by the person withdrawing consent.
81. Paragraph 7 of Schedule 3 to the Bill inserts new paragraph 4A to Schedule 3 into the 1990 Act and introduces a "cooling off period" where one person in a couple seeking fertility treatment withdraws their consent to the storage of an embryo or, where donated gametes are used, where the gamete donor withdraws consent. This provision does not alter the existing requirement that the consent of both parties is required to store the embryos but it is intended to provide a year-long "cooling off" period during which the embryos will not be destroyed until all interested persons (see paragraph 4A(3)) consent. There is also to be a "cooling off" period where a single woman seeks fertility treatment and the gamete donor or donors withdraw consent.
82. This provision will allow embryos to remain lawfully stored while the parties, if they wish, attempt to reach a private resolution on the future of the embryos. If the interested persons do not agree to the embryos being removed from storage or simply do not respond to the notification, the embryos will remain in storage until the one year period expires after which they would be allowed to perish.
Non-medical fertility services
83. Paragraph 5 of Schedule 3 to the 1990 Act provides that a person's gametes must not be used for the purpose of treatment services unless there is an effective consent. The Bill provides for this condition also to apply where a person's gametes are used for the purpose of non-medical fertility services.
Consent to use of human cells
84. In Schedule 3 to the 1990 Act as it stands, paragraph 6 requires the consent of any person before their gametes can be used to create an embryo in vitro for one of the purposes listed in paragraph 2(1). Under paragraph 8 of the Schedule as it stands, consent must also be obtained from a gamete donor to storage of their gametes, or of any embryo created using their gametes.
85. New scientific procedures have enabled embryos to be created or altered using human cells. It is also possible to create embryos using other embryos or human admixed embryos.
86. Paragraph 6 of Schedule 3 to the 1990 Act is amended by paragraph 9 of Schedule 3 to the 1990 Act to require an effective consent from a person whose gametes or human cells are used to create an embryo in vitro for use in treatment services (not including implantation) or for a project of research.
87. Consent is also required from each "relevant person" in relation to an embryo for its use for any purpose (see paragraph 6(3)). In addition consent from each "relevant person" must be in place before an embryo is received by any person.
88. New sub-paragraph (3A) is inserted into paragraph 6 to provide that a "relevant person" means:
89. Paragraph 14 of Schedule 3 to the Bill inserts paragraph 16 into Schedule 3 to the 1990 Act and provides that references to an embryo or human admixed embryo used to create an embryo include all predecessor embryos or human admixed embryos. This creates a chain of consent, so that a person must consent to their gametes or human cells being used to create an embryo and their consent is then required to the subsequent use of that embryo to create other embryos or human admixed embryos.
90. Paragraph 8 of Schedule 3 to the 1990 Act is amended by paragraph 11 of Schedule 3 to the Bill to require consent from each "relevant person" to storage of any embryo. Consent to storage of human cells continues to be regulated under the Human Tissue Act 2004.
91. Paragraph 2(4) of Schedule 3 to the 1990 Act is substituted to enable consent to relate to the use or storage of a particular embryo or to the use or storage of any embryo created using human cells or gametes (or using any embryo or human admixed embryo created using a person's cells or gametes). Consent can be withdrawn or varied either in relation to a specific embryo or generally.
92. Paragraph 4 of Schedule 3 to the 1990 Act is also amended by paragraph 6 of Schedule 3 to the Bill to require notice to be given to the person keeping the human cells if the donor wishes to withdraw or vary their consent. This mirrors the existing provision for gametes and embryos. However if the person has consented to any embryo created from their cells or gametes being used to create subsequent embryos or human admixed embryos they will not be able to withdraw their consent once the initial embryo has been used for treatment services (not including implantation in a woman) or research.
93. Paragraph 7 of Schedule 3 to the 1990 Act is amended by paragraph 10 of Schedule 3 to the Bill to prohibit the use of an embryo taken from a woman to create an embryo in vitro or to create a human admixed embryo in vitro.
94. New paragraph 16 of Schedule 3 to the 1990 Act applies the consent provisions contained in Schedule 3 to the use of human cells to alter embryos or human admixed embryos, in the same way that they apply to human cells or gametes used to create embryos or human admixed embryos. This ensures consent is in place for example before human cells could be used to alter a human embryo to create a human chimera. New paragraph 16 of Schedule 3 also clarifies that references to human cells do not include cells of the female or male germ line or cells of an embryo.
95. Paragraphs 19 to 21 of Schedule 7 to the Bill make related amendments of the Human Tissue Act 2004 to ensure that, where consent is required under the 1990 Act (as amended) for the use of human cells to create or alter an embryo or a human admixed embryo, consent under the Human Tissue Act is not also required.
Cases where consent not required for storage
96. Patients who undergo chemotherapy or radiotherapy can be left infertile. Prior to treatment, if time allows, fertility could be preserved by placing gametes in storage. However, in some cases, the patient might not have the capacity to give consent to storage. In the case of childhood cancer, a child may be too young to be considered competent to consent to storage of their gametes.
97. Similarly, people who suffer a serious physical injury, the treatment of which could again result in infertility, would also be able to preserve their fertility by this means. For example, a severe injury may have rendered an adult unable, perhaps because of a coma, to give consent or direct another person to do so on his or her behalf.
98. New paragraphs 9 and 10 of Schedule 3 to the 1990 Act will allow the storage of gametes, without written consent, providing a clinician certifies that the conditions set out in those paragraphs have been met. The gametes cannot be used for any purpose unless the gamete provider becomes competent and consents to such use.
Creation, use and storage of human admixed embryos
99. New paragraphs 13 to 15 are inserted into Schedule 3 to the 1990 Act by paragraph 13 of Schedule 3 to the Bill and introduce consent requirements for the creation, use and storage of human admixed embryos (as defined by new section 4A(5) of the 1990 Act, inserted by clause 4 of the Bill). Human admixed embryos can be created using embryos, human cells, gametes and other human admixed embryos.
100. Paragraph 13 makes provision equivalent to paragraph 6 of Schedule 3 to the 1990 Act (as amended by the Bill) and requires an effective consent before a person's gametes or human cells can be used to create a human admixed embryo in vitro for the purpose of a research project.
101. Consent is also required from each "relevant person" in relation to a human admixed embryo for its use in a research project (see paragraph 13(3)). In addition consent from each "relevant person" must be in place before a human admixed embryo is received by any person.
102. New paragraph 14 of Schedule 3 to the 1990 Act achieves equivalent provision to paragraph 8 of Schedule 3 of the 1990 Act (as amended) and requires consent from each "relevant person" to storage of a human admixed embryo.
103. New paragraph 15 defines "relevant person", for the purposes of new paragraphs 13 and 14, to mean any of the following:
104. As for the creation of embryos, new paragraph 16 of Schedule 3 to the 1990 Act, as inserted by paragraph 14 of Schedule 3 to the Bill, provides that references to an embryo or human admixed embryo used to create a human admixed embryo include all predecessor embryos or human admixed embryos. This creates a chain of consent, so that a person must consent to their gametes or human cells being used to create a human admixed embryo and their consent is then required to the subsequent use of that human admixed embryo to create other embryos or human admixed embryos.
105. Paragraph 2 of Schedule 3 to the 1990 Act is amended to make equivalent provision to embryos for human admixed embryos. These amendments ensure that the consent to use of any human admixed embryo must relate to a research project and enables conditions to be attached to such use. In addition the consent must specify a maximum storage period and state what will happen to the human admixed embryo if the person who has consented dies or loses capacity. Conditions can also be attached to storage of the human admixed embryo.
106. Provision is made under the new paragraph 2(4) of Schedule 3 to the 1990 Act to allow a person to consent to the use or storage of a particular human admixed embryo or to the use and storage of any human admixed embryo created using a person's cells or gametes (or using an embryo or human admixed embryo created using their cells or gametes). Consent can be withdrawn or varied in relation to a specific human admixed embryo or generally.
107. Paragraph 4 of Schedule 3 to the 1990 Act is also amended to enable consent to be withdrawn or varied by notice to the person keeping the human admixed embryo. This ability to withdraw or vary consent in relation to a human admixed embryo is subject to the same limitation as for embryos set out at paragraph 92 above. This means once the initial human admixed embryo has been used for research purposes consent cannot be withdrawn or varied in relation to any further embryos or human admixed embryos created from it.
108. The amendments mentioned in paragraphs 93, 94 and 95 above also make provision in relation to human admixed embryos (as detailed).
Clause 14: Conditions of licences for treatment
109. This clause amends section 13 of the 1990 Act which relates to conditions of licences for treatment.
110. Clause 14(4) contains a provision that relates to the provisions on embryo testing (see note on clause 11). New sections 13(8) to (11) amend the 1990 Act to make it a condition of a treatment licence that embryos that are known to have an abnormality (including a gender-related abnormality) are not to be preferred to embryos not known to have such an abnormality. The same restriction is also applied to the selection of persons as gamete or embryo donors. Outside the UK, the positive selection of deaf donors in order deliberately to result in a deaf child has been reported. This provision would prevent selection for a similar purpose.
Welfare of the Child
111. Currently, section 13(5) of the 1990 Act requires that:
"A woman shall not be provided with treatment services, other than basic partner treatment services, unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father), and of any other child who may be affected by the birth."
112. The HFEA is required by section 25(2) of the 1990 Act to provide guidance on this duty, and does so in its Code of Practice to licence holders. The relevant guidance 2 currently states:
2 HFEA Code of Practice, 7th Edition, G.3.3.3
"Where the child will have no legal father, the treatment centre should assess the prospective mother's ability to meet the child's/children's needs and the ability of other persons within the family or social circle willing to share responsibility for those needs."
Clause 14(2)(b) of the Bill amends the reference to a child's need for a father so that the licence condition to be imposed under section 13(5) of the 1990 Act will refer instead to the child's need for "supportive parenting". Clause 23 makes the same amendment to section 25(2) which concerns the guidance to be given about that licence condition. Section 13(5) as amended will therefore require licence holders, before providing treatment services, to consider the welfare of a child who may be born as a result of the treatment (including the need of that child for supportive parenting) and the welfare of any other child who may be affected by the birth. This will continue to be a matter on which the HFEA must provide guidance.
113. Clause 14(6) makes transitional arrangements so that licences which are in force at the date of commencement of the Bill's provisions will have effect as if they include the condition relating to consideration of welfare, as amended by clause 14(2)(b) of the Bill.
Welfare of the child where basic partner treatment services are provided
114. Basic partner treatment services are treatment services that are provided for a woman and a man together, without using donated gametes, gametes that have been stored, or embryos created outside the woman's body. These include artificial insemination (intrauterine insemination, IUI) using sperm that has been processed but not donated or frozen. These services were brought within the HFEA's remit by the 2007 Regulations.
115. Clause 14(2)(a) applies the requirement to take account of the welfare of the child where basic partner treatment services are provided in the same way that the requirement applies to other treatment services regulated under the 1990 Act.
Requirement to offer counselling
116. Clause 14(3) and Schedule 4 to the Bill extend the existing requirements under the 1990 Act as to the provision of counselling by fertility clinics. Currently, under section 13(6) of the 1990 Act, it is a requirement of all licences for treatment issued by the HFEA that a woman may not be provided with any treatment services involving donated gametes or embryos, or the use of an embryo which has been created in vitro, unless she and any man with whom she is being treated have been provided with relevant information and offered counselling. The new provision will extend this requirement to same sex couples. In addition, it will ensure that, before proceeding with embryo transfer or DI, clinics are required to offer counselling and provide relevant information to couples who have given notice that they consent to the intended mother's partner being treated as the parent of a child who is conceived using donor sperm. Where such notices have been given, but one of the partners subsequently withdraws their consent, clinics will be required to notify the other partner of this.
117. The substituted section 13(6) requires that any woman receiving treatment of certain kinds, and any partner of that woman who is receiving treatment with her, must be given a suitable opportunity to receive counselling and must be provided with relevant information before treatment is provided. The new section 13(6A) requires a suitable offer of counselling to be given and relevant information to be provided before treatment is provided in a case where two people consent to the parenthood of any child that may be born as a result of that treatment.
118. New section 13(6B) applies the new concepts of "agreed fatherhood conditions" and "agreed female parenthood conditions" to subsection (6A) as provided for under clauses 35 and 42 of the Bill.
119. New section 13(6C) provides that where the treatment services provided involve the use of donated gametes, or embryos taken from a woman not receiving services, the information provided under subsection (6) and (6A) must include such information as is proper about -
120. The new section 13(6D) and (6E) provide that where either partner withdraws consent to agreed fatherhood or parenthood the person responsible for the clinic must notify the other partner. This also applies where the woman being treated withdraws her consent for the other partner to be the parent of any resulting child. Where the male or female partner of the woman receiving treatment withdraws his or her consent, the person responsible must not place any embryo, sperm or eggs in the woman until she has been notified of the withdrawal of consent.
121. Schedule 4 to the Bill inserts a new Schedule 3ZA into the 1990 Act. Part 1 specifies treatment involving the use of donated gametes or embryos taken from a woman not receiving services and the use of embryos created in vitro as the kinds of treatment in relation to which clinics must offer counselling in accordance with licence conditions imposed under section 13(6). Part 2 defines the events in connection with which counselling must be offered in accordance with licence conditions imposed under section 13(6A) - that is, the giving of notices of consent to parenthood. These provisions take account of the new provisions about parenthood in Part 2 of the Bill.
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