Office of Public Sector Information
74.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, there is now an express requirement that the consent must be signed.
75.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.
76.Under the 1990 Act, a consent must specify the purposes for which any gamete or embryos are to be used. The Act 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.
77.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 or embryos. New paragraph 1(1) of Schedule 3 requires this notice to be provided in writing and signed by the person withdrawing consent.
78.Paragraph 7 of Schedule 3 to the Act 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 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 unless 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.
79.This provision allows 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.
80.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 Act makes provision to also apply this condition where a person’s gametes are used for the purpose of non-medical fertility services.
81.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.
82.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.
83.Paragraph 6 of Schedule 3 to the 1990 Act is amended by paragraph 9 of Schedule 3 to the 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. (“Human cells” are defined by new paragraph 22 to exclude reproductive cells).
84.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.
85.New sub-paragraph (3A) is inserted into paragraph 6 to provide that a “relevant person” means:
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 in vitro an embryo which was then used to create embryo A; and
each person whose gametes or human cells were used to create in vitro a human admixed embryo, which was then used to create embryo A.
86.Paragraph 15 of Schedule 3 to the Act inserts paragraph 22 into Schedule 3 to the 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 (as defined) 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.
87.Paragraph 8 of Schedule 3 to the 1990 Act is amended by paragraph 11 of Schedule 3 to the Act to require consent from each “relevant person” to the storage of any embryo. Consent to storage of human cells continues to be regulated under the Human Tissue Act 2004.
88.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.
89.Paragraph 4 of Schedule 3 to the 1990 Act is also amended by paragraph 6 of Schedule 3 to the Act 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.
90.Paragraph 7 of Schedule 3 to the 1990 Act is amended by paragraph 10 of Schedule 3 to the Act 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.
91.
New paragraph 22 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 22 of Schedule 3 also defines human cells as excluding cells of the female or male germ line or cells of an embryo.
92.Paragraphs 22 to 24 of Schedule 7 to the Act 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.
93.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.
94.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.
95.New paragraphs 9 and 10 of Schedule 3 to the 1990 Act will allow the storage of gametes, without written consent, providing a medical practitioner 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.
96.New paragraphs 12 to 14 are inserted into Schedule 3 to the 1990 Act by paragraph 13 of Schedule 3 to the Act 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 section 4 of the Act). Human admixed embryos can be created using embryos, human cells, gametes and other human admixed embryos.
97.Paragraph 12 makes provision equivalent to paragraph 6 of Schedule 3 to the 1990 Act (as amended by the Act) 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.
98.Consent is also required from each “relevant person” in relation to a human admixed embryo for its use in a research project (see paragraph 12(3)). In addition consent from each “relevant person” must be in place before a human admixed embryo is received by any person.
99.New paragraph 13 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.
100.New paragraph 14 defines “relevant person”, for the purposes of new paragraphs 12 and 13, to mean any of the following:
each person whose gametes or human cells were used to bring about the creation of the human admixed embryo (human admixed embryo A);
each person whose gametes or human cells were used to create an embryo in vitro, which was then used to create human admixed embryo A; and
each person whose gametes or human cells were used to create a human admixed embryo in vitro, which was then used to create human admixed embryo A.
101.As for the creation of embryos, new paragraph 22 of Schedule 3 to the 1990 Act, as inserted by paragraph 15 of Schedule 3 to the Act, 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.
102.Paragraph 2 of Schedule 3 to the 1990 Act is amended to make equivalent provision to embryos used to create 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.
103.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.
104.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 89 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 embryo created from it.
105.The Act inserts new paragraphs 20 and 21 into Schedule 3 to the 1990 Act, which provide an exception to the general requirement for an effective consent, found in paragraph 6 of Schedule 3, for the use of a person’s cells to bring about the creation of an embryo or human admixed embryo and for the subsequent storage and use of any resulting embryo. This exception to the requirement for consent only applies to cells stored before the commencement of the consent provisions in the Act. In addition, the exception will only apply if the Authority are satisfied that either:
the licence holder could not reasonably identify the donor;
the donor had died, or was reasonably believed to be dead and consent from a family member or close friend has been obtained working on the basis of a hierarchy established by the Human Tissue Act 2004 (person in a qualifying relationship); or
the donor was not reasonably traceable and if there was reason to believe the donor was dead a person in a qualifying relationship was not reasonably traceable.
106.In each case, there must not be any information available to the person responsible under the licence to suggest that the donor would have objected to the research. In addition, the Authority have to be satisfied there were reasonable grounds for believing that scientific research would be adversely affected to a significant extent if the only cells that could be used were those for which consent had been obtained, (or which fall within the exception to consent for adults lacking capacity, detailed below at paragraph 109).
107.New section 15(5) to the 1990 Act, as inserted by paragraph 7 of Schedule 7 to the Act, makes it a condition of any research licence, which relies on the exception to consent under new paragraph 20 of Schedule 3 to the 1990 Act, that any embryos or human admixed embryos created must be anonymised so that they cannot be linked back to the donor.
108.The Act inserts new paragraph 16 to 19 of Schedule 3 to the 1990 Act. Paragraph 16 provides an exception to the requirement for an effective consent, found in paragraph 6 of Schedule 3, for the use of cells from a person who has attained 18 years of age, to bring about the creation of an embryo or human admixed embryo and for the subsequent storage and use of any resulting embryo. Reliance on this exception is subject to the conditions set out in new paragraphs 17 and 18. The Authority must be satisfied that:
the adult lacks capacity and is unlikely to have capacity again;
the adult suffers from, or is likely to develop a serious disease, serious disability or other serious medical condition;
the proposed embryonic research is intended to increase knowledge about that disease/ disability/ condition or its treatment and care (or similar conditions);
there is no evidence that the adult would have refused to participate at any time they may have had capacity in the past;
there are reasonable grounds for believing research of comparable effectiveness could not be carried out using the cells of a person who could consent themselves;
the licence holder has taken steps to identify a carer for the adult who could be consulted or has nominated someone if a carer could not be found;
the carer or nominee has been consulted as to their opinion of what the adult who lacks capacity’s wishes or feelings would be about the proposed use of their cells – if they indicated they did not think that they would want them to be used then the researcher could not use their cells.
109.New paragraph 19 of Schedule 3 to the 1990 Act provides that if the adult donor acquired capacity they can give notice that their cells are not to be used to create any further embryos, or that any existing embryos may not be used in research.
110.Paragraphs 6 and 8 of Schedule 3 to the 1990 Act are amended by paragraph 9(5) and 11(3) of Schedule 3 to the Act, to allow the use of cells from a child under the age of 18 years (or, in Scotland, 16 years) to create an embryo, and the subsequent use and storage of such embryos, without the child’s consent, if consent is given by a person with parental responsibility and a number of other safeguards are in place (see below). The Act inserts new paragraphs 12(4) and (6) and 13(2) and (3) of Schedule 3 to the 1990 Act to make equivalent provision for the use of a child’s cells to create human admixed embryos and for the use and storage of such embryos. These provisions also ensure that if a child attained the age of 18 or became competent before that time, they would be able to vary or withdraw any consent given by a person with parental responsibility (subject to the usual limits on varying and withdrawing consent set out in paragraph 4 of Schedule 3 to the 1990 Act). These provisions cannot be relied on unless the Authority are satisfied that the “parental consent conditions” set out in new paragraph 15 of the 1990 Act are met. The Authority need to be satisfied that:
The child suffers from or is likely to develop a serious disease, serious disability or any other serious medical condition;
The proposed research is intended to increase knowledge about the disease/ disability/ condition, or its treatment and care (or similar conditions);
There are reasonable grounds for believing research of comparable effectiveness could not be carried out using the cells of a person who could consent themselves.
111.Paragraph 2(2) of Schedule 3 ensures that where consent was given to the use of a child’s cells to create an embryo or human admixed embryo and for the storage of that embryo the consent would have to state what should happen to the embryo if the child dies. In addition any consent by a person to the use of their cells to create an embryo or human admixed embryo is to endure their death, unless otherwise stated.
112.New paragraphs 22(5) to (7) of Schedule 3 to the 1990 Act set out the meaning of the terms “parental responsibility” and “capacity” in relation to England, Wales, Scotland and Northern Ireland. They also provide for the provisions relating to children to apply, in Scotland, to those under 16 years rather than those under 18.
113.This section amends section 13 of the 1990 Act which relates to conditions of licences for treatment.
114.Section 14(4) contains a provision that relates to the provisions on embryo testing (see note on section 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 assisted reproduction technology being used to select an embryo with a view to increasing the chance of giving birth to a child that had or would develop a serious medical condition, or to select a donor to increase the chance of a child having a serious medical condition.
115.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.”
116.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.
117.Section 14(2)(b) of the Act 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”. Section 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.
118.Section 14(6) makes transitional arrangements so that licences which are in force at the date of commencement of the amendment made by section 14(2)(b) will have effect as if they include the condition relating to consideration of welfare.
119.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.
120.Section 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.
121.Section 14(3) and Schedule 4 to the Act extend the existing requirements under the 1990 Act as to the provision of counselling by fertility clinics. 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 if one of the partners subsequently withdraws their consent, clinics will be required to notify the other partner of this.
122.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.
123.New section 13(6B) applies the new concepts of “agreed fatherhood conditions” and “agreed female parenthood conditions” to subsection (6A) as provided for under sections 35 and 42 of the Act.
124.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 –
the importance of informing any resulting child at an early age that the child was donor conceived; and
suitable methods of informing the child about their conception.
125.The new sections 13(6D) and (6E) provide that where either partner withdraws consent to agreed fatherhood or parenthood, the person responsible (as defined by section 17(1) of the 1990 Act) 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.
126.Schedule 4 to the Act 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 Act.
127.Section 15 amends section 14 of the 1990 Act. Section 14, as amended, continues to provide for various conditions to apply to storage licences. Section 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.
128.Under the 1990 Act as it had effect before the amendments made by this section, embryos could be put into storage for five years. This has been amended to remove the five-year break point and allow couples to opt for a full ten-year storage period at the outset.
129.Section 14 is also amended to apply a ten-year statutory storage period to human admixed embryos.
130.This section 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 section 27.
131.Section 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.
132.Section 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.
133.Section 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 section 21 of the Act) provides that the applicant may apply for reconsideration of the decision.
134.This section inserts new section 19C which replaces the previous section 22 of the 1990 Act and relates to 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 appeals against other licensing decisions (see new section 20A of the 1990 Act).
135.Section 21 substitutes sections 20 and 21, and inserts new section 20A and 20B into, the 1990 Act.
136.Substituted section 20 sets out the rights of appeal against licensing decisions of the HFEA.
137.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, that are subject to the affirmative procedure. The regulations may also provide for the appeals committee to appoint advisors to give specialist scientific, legal and other advice.
138.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.
139.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.
140.Section 24 of the 1990 Act provides for directions to be given in respect of various matters. Section 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.
141.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.
142.Section 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”.
143.Section 23 also inserts new section 25(2A) into the 1990 Act to require the HFEA to provide guidance in the Code of Practice 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.
144.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.
145.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.
146.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).
147.Section 24 of the Act 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 Act comes into effect.
148.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.
149.New section 31ZA(2)(b) enables a donor-conceived person to obtain 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.
150.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.
151.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 with whom they are having or intend to have, a relationship will need to be given to the HFEA. 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.
152.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.
153.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.
154.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.
155.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.
156.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.
157.This section 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.
158.Section 33 of the 1990 Act 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).
159.Section 33A(2) lifts the prohibition on disclosure which section 33A(1) imposes in certain circumstances. Previously the exceptions to the prohibitions have been 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) lifts the prohibition on disclosure where disclosure is to other persons or bodies discharging a regulatory function and or is to a person who is 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 33C provides a regulation-making power to make further exceptions to 33A(1).
160.New section 33D 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. Fees may be charged in accordance with regulations made by the Secretary of State for these purposes. 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. Such 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.
161.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 appropriate.
162.Section 3 of the Act 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 section 3 above).
Human Fertilisation and Embryology Act 2008