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Clause 12: General conditions of licences
73. 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.
74. Clause 12 also amends section 12 to ensure that no money or other benefit can be given or received for the supply of inter-species embryos (unless authorised by directions) and that if inter-species 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 an inter-species 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 inter-species embryos etc
75. 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
76. 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.
Physical incapacity
77. 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
78. 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
79. 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 will specify that this notice must be provided in writing and signed by the person withdrawing consent.
80. Paragraph 7 of Schedule 3 to the Bill inserts new paragraph 4A to Schedule 3 to 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.
81. 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
82. 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 makes provision to also apply this condition where a person's gametes are used for the purpose of non-medical fertility services.
Consent to use of human cells
83. Current provision under paragraphs 6 and 8 of Schedule 3 to the 1990 Act require the consent of any gamete donor before an embryo can be created in vitro using their gametes for one of the purposes listed in paragraph 2(1). Consent must also be obtained from a gamete donor to storage of their gametes, and any embryo created using their gametes.
84. 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 interspecies embryos.
85. Paragraph 6 of Schedule 3 to the 1990 Act is amended by paragraph 9 of Schedule 3 to the Bill 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.
86. 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.
87. New sub-paragraph (3A) is inserted into paragraph 6 to provide that a "relevant person" includes
- each person whose gametes or human cells were used to bring about the creation of the embryo (embryo A);
- each person whose gametes or human cells were used to create an embryo in vitro, which was then used to create embryo A; and
- each person whose gametes or human cells were used to create an inter-species embryo in vitro, which was then used to create embryo A.
88. Paragraph 14 of Schedule 3 to the Bill inserts paragraph 16 into Schedule 3 to the Bill and provides that references to an embryo or inter-species embryo used to create an embryo include all predecessor embryos or inter-species 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 inter-species embryos.
89. 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.
90. 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 inter-species embryo created using a person's cells or gametes). Consent can be withdrawn or varied either in relation to a specific embryo or generally.
91. 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 inter-species 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.
92. 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 an inter-species embryo in vitro.
93. 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 inter-species embryos, in the same way that they apply to human cells or gametes used to create embryos or inter-species 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.
94. Paragraphs 18 - 20 of Schedule 7 to the Bill amend the Human Tissue Act 2004 to ensure that consent must be obtained under the 1990 Act (as amended) for the use of human cells to create or alter an embryo or inter-species embryo.
Cases where consent not required for storage
95. 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 simply be too young to be considered competent to consent to storage of their gametes.
96. 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.
97. 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 inter-species embryos
98. New paragraphs 13 - 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 inter-species embryos (as defined under new section 4A (5) of the 1990 Act, inserted by Clause 4 of the Bill). Inter-species embryos can be created using embryos, human cell, gametes and other inter-species embryos.
99. Paragraph 13 achieves equivalent provision 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 an inter-species embryo in vitro for the purpose of a research project.
100. Consent is also required from each "relevant person" in relation to an inter-species embryo for its use in a research project (see paragraph 13(3)). In addition consent from each "relevant person" must be in place before an inter-species embryo is received by any person
101. 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 an inter-species embryo.
102. New paragraph 15 defines "relevant person" to include:
- each person whose gametes or human cells were used to bring about the creation of the inter-species embryo (inter-species embryo A);
- each person whose gametes or human cells were used to create an embryo in vitro, which was then used to create inter-species embryo A; and
- each person whose gametes or human cells were used to create an inter-species embryo in vitro, which was then used to create inter-species embryo A.
103. 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 inter-species embryo used to create an inter-species embryo include all predecessor embryos or inter-species embryos. This creates a chain of consent, so that a person must consent to their gametes or human cells being used to create an inter-species embryo and their consent is then required to the subsequent use of that inter-species embryo to create other embryos or interspecies embryos.
104. Paragraph 2 of Schedule 3 to the 1990 Act is amended to make equivalent provision to embryos for inter-species embryos. These amendments ensure that the consent to use of any inter-species 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 inter-species embryo if the person who has consented dies or loses capacity. Conditions can also be attached to storage of the inter-species embryo.
105. 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 inter-species embryo or to the use and storage of any inter-species embryo created using a person's cells or gametes (or using an embryo or inter-species embryo created using their cells or gametes). Consent can be withdrawn or varied in relation to a specific inter-species embryo or generally.
106. 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 inter-species embryo. This ability to withdraw or vary consent in relation to an inter-species embryo is subject to the same limitation as for embryos set out at paragraph 91 above. This means once the initial inter-species embryo has been used for research purposes consent cannot be withdrawn or varied in relation to any further embryos or inter-species embryo created from it.
107. The amendments at paragraphs 92, 93 and 94 above also make provision in relation to inter-species embryos (as detailed).
Clause 14: Conditions of licence for treatment
108. This clause amends section 13 of the 1990 Act which relates to conditions of licences for treatment.
Embryo testing
109. 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. This would prevent similar situations to cases, outside the UK, where positive selection of deaf donors in order deliberately to result in a deaf child have been reported.
Welfare of the Child
110. Currently, section 13(5) of the 1990 Act requires that:
"A woman shall not be provided with 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."
111. 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."
112. Clause 14(2)(b) of the Bill removes the reference to a child's need for a father from the licence condition to be imposed under section 13(5) of the 1990 Act. Clause 23 makes the same amendment to section 25(2) which concerns the guidance to be given about that condition. Section 13(5) will continue to require licence holders to consider the welfare of a child who may be born as a result of treatment (and any other child who might be affected) and will therefore 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. It will therefore comprise 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 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 donor insemination, clinics are required to offer counselling 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 if 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) is introduced to require that any woman and any partner of that woman who is receiving treatment with her, must be given a suitable opportunity to receive counselling before treatment is provided. The new section 13(6A) requires a suitable offer of counselling to be provided before two people being treated together 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. The new section 13(6C) and (6D) provide that where either partner withdraws consent to agreed fatherhood or parenthood the person responsible for the clinic must notify the other partner. This includes where the woman being treated withdraws her consent for the other partner to be the parent of any resulting child. Where the partner of the woman receiving treatment withdraws their consent, the person responsible shall not place any embryo, sperm or eggs in the woman until she has been notified of it.
120. 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 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 after 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. The concept of two people (who are unmarried and are not civil partners) signing a parenthood agreement where donated embryos or gametes are used will provide a more formal arrangement to replace the current provision that refers to couples being "treated together".
Clause 15: Conditions of storage licences
121. 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.
122. 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.
123. Section 14 is also amended to apply a ten year statutory storage period to inter-species embryos.
Clause 16: Grant of licences
124. 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
125. Clause 17 repeals the definition of "nominal licensee" from the 1990 Act. The term "nominal licensee" is no longer included because it does not adequately reflect the responsibilities of a licence holder.
Clause 18: Revocation and variation of licences
126. Clause 18 provides that the HFEA may revoke any licence or may vary a licence either on application by the licence holder, or the person responsible, or of its own volition. The power to vary a licence does not include the power to vary the mandatory conditions imposed by section 12 and 15 of the 1990 Act on every licence.
Clause 19: Procedure for refusal, variation or revocation of licence
127. 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 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, (introducing by clause 21 of the Bill), provides that the applicant may apply for a reconsideration.
Clause 20: Power to suspend licence
128. This clause introduces 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
129. Clause 21 substitutes sections 20 and 21 of, and introduces new section 20A and 20B in, the 1990 Act.
130. Substituted section 20 sets out the rights of appeal against licensing decisions of the HFEA.
131. 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.
132. 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 include provisions concerning the right of the appellant and the Authority to appear before the committee, for the committee to consider written representations, requirements concerning evidence and the production of documents; and requirements concerning decisions of the committee.
133. New section 21 provides that a further appeal may be made by to the High Court by a person aggrieved by the appeals committee's decision, but only on a point of law.
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