Human Fertilisation and Embryology Act 1990

Licence conditions U.K.

12 General conditions. U.K.

The following shall be conditions of every licence granted under this Act—

(a) that the activities authorised by the licence shall be carried on only on the premises to which the licence relates and under the supervision of the person responsible,

(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) 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 or embryos unless authorised by directions,

(f) that, where gametes or 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.

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 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.

(6) A woman shall not be provided with any treatment services involving—

(a) the use of any gametes of any person, if that person’s consent is required under paragraph 5 of Schedule 3 to this Act for the use in question,

(b) the use of any embryo the creation of which was brought about in vitro, or

(c) the use of any embryo taken from a woman, if the consent of the woman from whom it was taken is required under paragraph 7 of that Schedule for the use in question,

unless the woman being treated and, where she is being treated together with a man, the man have been given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and have been provided with such relevant information as is proper.

(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.

Commencement Information

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

Yn ddilys o 25/05/2007

[F1 13A

Conditions of licences for non-medical fertility services

(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.

(4) Donors of sperm, other than partner-donated sperm, shall be provided with such information as the Authority shall specify in directions for the purpose of securing compliance with the requirements of Part A of the Annex to the first Directive (information to be provided on the donation of reproductive cells).]

Textual Amendments

F1 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

14 Conditions of storage licences. U.K.

(1) The following shall be conditions of every licence authorising the storage of gametes or embryos—

(a) that gametes of a person or an embryo taken from a woman shall be placed in storage only if received from that person or woman or acquired from a person to whom a licence applies and 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 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,

(c) that no gametes or 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 five years as the licence may specify.

(5) Regulations may provide that subsection (3) or (4) above shall have effect as if for ten years or, as the case may be, five years 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.

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)

Yn ddilys o 25/05/2007

[F2 14A

Conditions of licences: human application

(1) This section applies to—

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

(b) every licence under paragraph 2 of that Schedule, so far as authorising storage of gametes or embryos 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

F2 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

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.

Commencement Information

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

Yn ddilys o 25/05/2007

[F3 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

F3 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