Human Fertilisation and Embryology Act 1990 (c. 37)

Licence conditions U.K.

12 General conditions. U.K.

[F1 (1)] The following shall be conditions of every licence granted under this Act—

(a) [F2 except to the extent that the activities authorised by the licence fall within paragraph (aa), that those activities] shall be carried on only on the premises to which the licence relates and under the supervision of the person responsible,

[F3 (aa) that any activities to which section 3(1A)(b) or (1B) or 4(1A) applies shall be carried on only on the premises to which the licence relates or on relevant third party premises,]

(b) that any member or employee of the Authority, on production, if so required, of a document identifying the person as such, shall at all reasonable times be permitted to enter those premises and inspect them (which includes inspecting any equipment or records and observing any activity),

(c) [F4 except in relation to the use of gametes in the course of providing basic partner treatment services F5 ... ,] that the provisions of Schedule 3 to this Act shall be complied with,

(d) that proper records shall be maintained in such form as the Authority may specify in directions,

(e) that no money or other benefit shall be given or received in respect of any supply of gametes[F6 , embryos or human admixed embryos] unless authorised by directions,

(f) that, where gametes[F7 , embryos or human admixed embryos] are supplied to a person to whom another licence applies, that person shall also be provided with such information as the Authority may specify in directions, and

(g) that the Authority shall be provided, in such form and at such intervals as it may specify in directions, with such copies of or extracts from the records, or such other information, as the directions may specify.

[F8 (2) Subsection (3) applies to—

(a) every licence under paragraph 1 or 1A of Schedule 2, F9 ...

(b) every licence under paragraph 2 of that Schedule, so far as authorising the storage of gametes or embryos intended for human application[F10 , and

(c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.]

(3) It shall be a condition of every licence to which this subsection applies that—

(a) such information as is necessary to facilitate the traceability of gametes and embryos, and

(b) any information relating to the quality or safety of gametes or embryos,

shall be recorded and provided to the Authority upon request.]

Textual Amendments

F1 S. 12 renumbered as s. 12(1) (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 13(2)

F2 Words in s. 12(1)(a) substituted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 13(3)(a)

F3 S. 12(1)(aa) inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 13(3)(b)

F4 Words in s. 12(1)(c) inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 13(3)(c)

F5 Words in s. 12(1)(c) repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 12(2)(a), 68(2), Sch. 8 Pt. 1; S.I. 2009/2232, art. 2(c)

F6 Words in s. 12(1)(e) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 12(2)(b), 68(2); S.I. 2009/2232, art. 2(c)

F7 Words in s. 12(1)(f) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 12(2)(b), 68(2); S.I. 2009/2232, art. 2(c)

F8 S. 12(2)(3) inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 13(4)

F9 Word in s. 12(2)(a) repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 12(3)(a), 68(2), Sch. 8 Pt. 1; S.I. 2009/2232, art. 2(c)

F10 S. 12(2)(c) and word inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 12(3)(b), 68(2); S.I. 2009/2232, art. 2(c)

Commencement Information

I1 S. 12 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

13 Conditions of licences for treatment. U.K.

(1) The following shall be conditions of every licence under paragraph 1 of Schedule 2 to this Act.

(2) Such information shall be recorded as the Authority may specify in directions about the following—

(a) the persons for whom services are provided in pursuance of the licence,

(b) the services provided for them,

(c) the persons whose gametes are kept or used for the purposes of services provided in pursuance of the licence or whose gametes have been used in bringing about the creation of embryos so kept or used,

(d) any child appearing to the person responsible to have been born as a result of treatment in pursuance of the licence,

(e) any mixing of egg and sperm and any taking of an embryo from a woman or other acquisition of an embryo, and

(f) such other matters as the Authority may specify in directions.

(3) The records maintained in pursuance of the licence shall include any information recorded in pursuance of subsection (2) above and any consent of a person whose consent is required under Schedule 3 to this Act.

(4) No information shall be removed from any records maintained in pursuance of the licence before the expiry of such period as may be specified in directions for records of the class in question.

(5) A woman shall not be provided with treatment services F11 ... 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 [F12 supportive parenting]), and of any other child who may be affected by the birth.

[F13 (6) A woman shall not be provided with treatment services of a kind specified in Part 1 of Schedule 3ZA unless she and any man or woman who is to be treated together with her have been given a suitable opportunity to receive proper counselling about the implications of her being provided with treatment services of that kind, and have been provided with such relevant information as is proper.

(6A) A woman shall not be provided with treatment services after the happening of any event falling within any paragraph of Part 2 of Schedule 3ZA unless (before or after the event) she and the intended second parent have been given a suitable opportunity to receive proper counselling about the implications of the woman being provided with treatment services after the happening of that event, and have been provided with such relevant information as is proper.

(6B) The reference in subsection (6A) to the intended second parent is a reference to—

(a) any man as respects whom the agreed fatherhood conditions in section 37 of the Human Fertilisation and Embryology Act 2008 (“the 2008 Act”) are for the time being satisfied in relation to treatment provided to the woman mentioned in subsection (6A), and

(b) any woman as respects whom the agreed female parenthood conditions in section 44 of the 2008 Act are for the time being satisfied in relation to treatment provided to the woman mentioned in subsection (6A).

(6C) In the case of treatment services falling within paragraph 1 of Schedule 3ZA (use of gametes of a person not receiving those services) or paragraph 3 of that Schedule (use of embryo taken from a woman not receiving those services), the information provided by virtue of subsection (6) or (6A) must include such information as is proper about—

(a) the importance of informing any resulting child at an early age that the child results from the gametes of a person who is not a parent of the child, and

(b) suitable methods of informing such a child of that fact.

(6D) Where the person responsible receives from a person (“X”) notice under section 37(1)(c) or 44(1)(c) of the 2008 Act of X's withdrawal of consent to X being treated as the parent of any child resulting from the provision of treatment services to a woman (“W”), the person responsible—

(a) must notify W in writing of the receipt of the notice from X, and

(b) no person to whom the licence applies may place an embryo or sperm and eggs in W, or artificially inseminate W, until W has been so notified.

(6E) Where the person responsible receives from a woman (“W”) who has previously given notice under section 37(1)(b) or 44(1)(b) of the 2008 Act that she consents to another person (“X”) being treated as a parent of any child resulting from the provision of treatment services to W—

(a) notice under section 37(1)(c) or 44(1)(c) of the 2008 Act of the withdrawal of W's consent, or

(b) a notice under section 37(1)(b) or 44(1)(b) of the 2008 Act in respect of a person other than X,

the person responsible must take reasonable steps to notify X in writing of the receipt of the notice mentioned in paragraph (a) or (b).]

(7) Suitable procedures shall be maintained—

(a) for determining the persons providing gametes or from whom embryos are taken for use in pursuance of the licence, and

(b) for the purpose of securing that consideration is given to the use of practices not requiring the authority of a licence as well as those requiring such authority.

[F14 (8) Subsections (9) and (10) apply in determining any of the following—

(a) the persons who are to provide gametes for use in pursuance of the licence in a case where consent is required under paragraph 5 of Schedule 3 for the use in question;

(b) the woman from whom an embryo is to be taken for use in pursuance of the licence, in a case where her consent is required under paragraph 7 of Schedule 3 for the use of the embryo;

(c) which of two or more embryos to place in a woman.

(9) Persons or embryos that are known to have a gene, chromosome or mitochondrion abnormality involving a significant risk that a person with the abnormality will have or develop—

(a) a serious physical or mental disability,

(b) a serious illness, or

(c) any other serious medical condition,

must not be preferred to those that are not known to have such an abnormality.

(10) Embryos that are known to be of a particular sex and to carry a particular risk, compared with embryos of that sex in general, that any resulting child will have or develop—

(a) a gender-related serious physical or mental disability,

(b) a gender-related serious illness, or

(c) any other gender-related serious medical condition,

must not be preferred to those that are not known to carry such a risk.

(11) For the purposes of subsection (10), a physical or mental disability, illness or other medical condition is gender-related if—

(a) it affects only one sex, or

(b) it affects one sex significantly more than the other.

(12) No embryo appropriated for the purpose mentioned in paragraph 1(1)(ca) of Schedule 2 (training in embryological techniques) shall be kept or used for the provision of treatment services.

(13) The person responsible shall comply with any requirement imposed on that person by section 31ZD.]

Textual Amendments

F11 Words in s. 13(5) repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 14(2)(a), 68(2), Sch. 8 Pt. 1; S.I. 2009/2232, art. 2(d)

F12 Words in s. 13(5) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 14(2)(b), 68(2) (with s. 14(6)); S.I. 2009/2232, art. 2(d)

F13 S. 13(6)-(6E) substituted for s. 13(6) (6.4.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 14(3), 68(2); S.I. 2009/479, art. 4(a) (with art. 7 Sch.)

F14 S. 13(8)-(13) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 14(4), 68(2); S.I. 2009/2232, art. 2(d)

Commencement Information

I2 S. 13 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[F15 13A Conditions of licences for non-medical fertility services U.K.

(1) The following shall be conditions of every licence under paragraph 1A of Schedule 2.

(2) The requirements of section 13(2) to (4) and (7) shall be complied with.

(3) A woman shall not be provided with any non-medical fertility services involving the use of sperm other than partner-donated sperm unless the woman being provided with the services has been given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and has been provided with such relevant information as is proper.

F16 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F15 S. 13A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 15

F16 S. 13A(4) repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 5, Sch. 8 Pt. 1; S.I. 2009/2232, art. 2(y)

14 Conditions of storage licences. U.K.

(1) The following shall be conditions of every licence [F17 authorising the storage of gametes, embryos or human admixed embryos]—

[F18 (a) that gametes of a person shall be placed in storage only if—

(i) received from that person,

(ii) acquired in circumstances in which by virtue of paragraph 9 or 10 of Schedule 3 that person's consent to the storage is not required, or

(iii) acquired from a person to whom a licence or third party agreement applies,

(aa) that an embryo taken from a woman shall be placed in storage only if—

(i) received from that woman, or

(ii) acquired from a person to whom a licence or third party agreement applies,

(ab) that an embryo the creation of which has been brought about in vitro otherwise than in pursuance of that licence shall be placed in storage only if acquired from a person to whom a licence or third party agreement applies,

(ac) that a human admixed embryo the creation of which has been brought about in vitro otherwise than in pursuance of that licence shall be placed in storage only if acquired from a person to whom a licence under paragraph 2 or 3 of Schedule 2 applies,]

(b) that gametes or embryos which are or have been stored shall not be supplied to a person otherwise than in the course of providing treatment services unless that person is a person to whom a licence applies,

[F19 (ba) that human admixed embryos shall not be supplied to a person unless that person is a person to whom a licence applies,]

(c) that no gametes[F20 , embryos or human admixed embryos] shall be kept in storage for longer than the statutory storage period and, if stored at the end of the period, shall be allowed to perish, and

(d) that such information as the Authority may specify in directions as to the persons whose consent is required under Schedule 3 to this Act, the terms of their consent and the circumstances of the storage and as to such other matters as the Authority may specify in directions shall be included in the records maintained in pursuance of the licence.

(2) No information shall be removed from any records maintained in pursuance of such a licence before the expiry of such period as may be specified in directions for records of the class in question.

(3) The statutory storage period in respect of gametes is such period not exceeding ten years as the licence may specify.

(4) The statutory storage period in respect of embryos is such period not exceeding [F21 ten years] as the licence may specify.

[F22 (4A) The statutory storage period in respect of human admixed embryos is such period not exceeding ten years as the licence may specify.]

(5) Regulations may provide that subsection (3)[F23 , (4) or (4A)] above shall have effect as if for ten years F24 ... there were substituted—

(a) such shorter period, or

(b) in such circumstances as may be specified in the regulations, such longer period,

as may be specified in the regulations.

Textual Amendments

F17 Words in s. 14(1) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(2)(a), 68(2); S.I. 2009/2232, art. 2(e)

F18 S. 14(1)(a)-(ac) substituted for s. 14(1)(a) (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(2)(b), 68(2); S.I. 2009/2232, art. 2(e)

F19 S. 14(1)(ba) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(2)(c), 68(2); S.I. 2009/2232, art. 2(e)

F20 Words in s. 14(1)(c) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(2)(d), 68(2); S.I. 2009/2232, art. 2(e)

F21 Words in s. 14(4) substituted (6.4.2009 for specified purposes, 1.10.2009 in so far as not already in force) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(3), 68(2); S.I. 2009/479, art. 5(a)(h) (with art. 7 Sch.); S.I. 2009/2232, art. 2(e)

F22 S. 14(4A) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(4), 68(2); S.I. 2009/2232, art. 2(e)

F23 Words in s. 14(5) substituted (6.4.2009 for specified purposes, 1.10.2009 in so far as not already in force) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(5)(a), 68(2); S.I. 2009/479, art. 5(a)(h) (with art. 7 Sch.); S.I. 2009/2232, art. 2(e)

F24 Words in s. 14(5) repealed (6.4.2009 for specified purposes, 1.10.2009 in so far as not already in force) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 15(5)(b), 68(2), Sch. 8 Pt. 1; S.I. 2009/479, art. 5(a)(h) (with art. 7 Sch.); S.I. 2009/2232, art. 2(e)

Modifications etc. (not altering text)

C1 S. 14(3) modified by S.I. 1991/1540, art. 2(1), Sch.

C2 S. 14(4) applied (with modifications) (1.5.1996) by S.I. 1996/375, reg. 2(2)(3)

Commencement Information

I3 S. 14 wholly in force; s. 14 not in force at Royal Assent see s. 49(2); s. 14(5) in force for certain purposes at 8.7.1991 and s. 14 fully in force at 1.8.1991 by S.I. 1991/1400, art. 2(1)(a)(2)

[F25 14A Conditions of licences: human application U.K.

(1) This section applies to—

(a) every licence under paragraph 1 or 1A of Schedule 2, F26 ...

(b) every licence under paragraph 2 of that Schedule, so far as authorising storage of gametes or embryos intended for human application[F27 , and

(c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.]

(2) A licence to which this section applies may not authorise the storage, procurement, testing, processing or distribution of gametes or embryos unless it contains the conditions required by Schedule 3A.

(3) In relation to any gametes or embryos imported into the United Kingdom from an EEA state other than the United Kingdom or from Gibraltar, compliance with the requirements of the laws or other measures adopted in the relevant state or territory for the purpose of implementing the first, second and third Directives shall be taken to be compliance with the conditions required by Schedule 3A.

(4) Subsection (3) shall not apply to any licence conditions imposed by the Authority which amount to more stringent protective measures for the purposes of Article 4(2) of the first Directive.]

Textual Amendments

F25 S. 14A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 17

F26 Word in s. 14A(1)(a) repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 6(a), Sch. 8 Pt. 1; S.I. 2009/2232, art. 2(y)

F27 S. 14A(1)(c) and word inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 6(b); S.I. 2009/2232, art. 2(y)

15 Conditions of research licences. U.K.

(1) The following shall be conditions of every licence under paragraph 3 of Schedule 2 to this Act.

(2) The records maintained in pursuance of the licence shall include such information as the Authority may specify in directions about such matters as the Authority may so specify.

(3) No information shall be removed from any records maintained in pursuance of the licence before the expiry of such period as may be specified in directions for records of the class in question.

(4) No embryo appropriated for the purposes of any project of research shall be kept or used otherwise than for the purposes of such a project.

[F28 (5) If by virtue of paragraph 20 of Schedule 3 (existing cells or cell lines) qualifying cells, as defined by paragraph 20(2) of that Schedule, of a person (“P”) are used to bring about the creation in vitro of an embryo or human admixed embryo without P's consent, steps shall be taken to ensure that the embryo or human admixed embryo cannot subsequently be attributed to P.]

Textual Amendments

F28 S. 15(5) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 7; S.I. 2009/2232, art. 2(y)

Commencement Information

I4 S. 15 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[F29 15A

Duties of the Authority in relation to serious adverse events and serious adverse reactions

(1) The Authority shall investigate serious adverse events and serious adverse reactions and take appropriate control measures.

(2) In investigating any serious adverse event or serious adverse reaction, the Authority shall, where it is appropriate to do so, arrange for—

(a) any premises to which a licence relates and any relevant third party premises to be inspected on its behalf, and

(b) a report on the inspection to be made to it.

(3) If the Authority receives a request from a competent authority in an EEA state other than the United Kingdom or in Gibraltar to carry out an inspection in relation to a serious adverse event or serious adverse reaction, the Authority must arrange for such an inspection to be carried out, for a report to be made of the inspection and for appropriate control measures to be taken.]

Textual Amendments

F29 S. 15A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 18