Human Fertilisation and Embryology Act 1990

Principal terms used U.K.

1 Meaning of “embryo”, “gamete” and associated expressions. U.K.

(1) In this Act, except where otherwise stated—

(a) embryo means a live human embryo where fertilisation is complete, and

(b) references to an embryo include an egg in the process of fertilisation,

and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote.

(2) This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body; and in this Act—

(a) references to embryos the creation of which was brought about in vitro (in their application to those where fertilisation is complete) are to those where fertilisation began outside the human body whether or not it was completed there, and

(b) references to embryos taken from a woman do not include embryos whose creation was brought about in vitro.

(3) This Act, so far as it governs the keeping or use of an embryo, applies only to keeping or using an embryo outside the human body.

(4) References in this Act to gametes, eggs or sperm, except where otherwise stated, are to live human gametes, eggs or sperm but references below in this Act to gametes or eggs do not include eggs in the process of fertilisation.

Modifications etc. (not altering text)

C1 S. 1(1) applied (1.4.2005 for certain purposes, 20.10.2005 for certain further purposes, 7.4.2006 for certain further purposes, 31.7.2006 for certain further purposes and 1.9.2006 otherwise) by Human Tissue Act 2004 (c. 30), s. 54(6) (with transitional provisions in s. 58); S.I 2005/919, {art. 3}, Sch. (with transitional provisions in art. 2); S.I. 2005/2792, art. 2(d); S.I. 2006/404, art. 3(3), Sch. (subject to art. 4); S.I. 2006/1997, art. 2(1)(2), 3(1)(2), Sch. (subject to arts. 4, 7, 8) (as that S.I. is amended by S.I. 2006/2169, art. 2)

C2 S. 1(4) applied (1.4.2005 for certain purposes, 20.10.2005 for certain further purposes, 7.4.2006 for certain further purposes, 31.7.2006 for certain further purposes and 1.9.2006 otherwise) by Human Tissue Act 2004 (c. 30), s. 54(6) (with transitional provisions in s. 58); S.I 2005/919, {art. 3}, Sch. (with transitional provisions in art. 2); S.I. 2005/2792, art. 2(d); S.I. 2006/404, art. 3(3), Sch. (subject to art. 4); S.I. 2006/1997, art. 2(1)(2), 3(1)(2), Sch. (subject to arts. 4, 7, 8) (as that S.I. is amended by S.I. 2006/2169, art. 2)

Commencement Information

I1 S. 1 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 1A

Reference to Directives

In this Act—

• “the first Directive” means Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells,

• “the second Directive” means Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, and

• “the third Directive” means Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.]

Textual Amendments

F1 S. 1A 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, 5

2 Other terms. U.K.

(1) In this Act—

• “the Authority” means the Human Fertilisation and Embryology Authority established under section 5 of this Act,

• “directions” means directions under section 23 of this Act,

• “licence” means a licence under Schedule 2 to this Act and, in relation to a licence, “the person responsible” has the meaning given by section 17 of this Act, and

• “treatment services” means medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children.

(2) References in this Act to keeping, in relation to embryos or gametes, include keeping while preserved, whether preserved by cryopreservation or in any other way; and embryos or gametes so kept are referred to in this Act as “stored” (and “store” and “storage” are to be interpreted accordingly).

(3) For the purposes of this Act, a woman is not to be treated as carrying a child until the embryo has become implanted.

Commencement Information

I2 S. 2 wholly in force at 1.8.1991 see s. 49(2), S.I. 1990/2165 and S.I. 1991/1440, art. 2(2)

Yn ddilys o 25/05/2007

[F2 2A

Third party agreements

(1) For the purposes of this Act, a “third party agreement” is an agreement in writing between a person who holds a licence and another person which is made in accordance with any licence conditions imposed by the Authority for the purpose of securing compliance with the requirements of Article 24 of the first Directive (relations between tissue establishments and third parties) and under which the other person—

(a) procures, tests or processes gametes or embryos (or both), on behalf of the holder of the licence, or

(b) supplies to the holder of the licence any goods or services (including distribution services) which may affect the quality or safety of gametes or embryos.

(2) In this Act—

• “relevant third party premises”, in relation to a licence, means any premises (other than premises to which the licence relates)—

  (a)

  on which a third party procures, tests, processes or distributes gametes or embryos on behalf of any person in connection with activities carried out by that person under a licence, or

  (b)

  from which a third party provides any goods or services which may affect the quality or safety of gametes or embryos to any person in connection with activities carried out by that person under a licence;

• “third party” means a person with whom a person who holds a licence has a third party agreement.

(3) References in this Act to the persons to whom a third party agreement applies are to—

(a) the third party,

(b) any person designated in the third party agreement as a person to whom the agreement applies, and

(c) any person acting under the direction of a third party or of any person so designated.]

Textual Amendments

F2 S. 2A 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, 7