Human Fertilisation and Embryology Act 1990 (c. 37)

Activities governed by the Act U.K.

3 Prohibitions in connection with embryos. U.K.

[F1 (1) No person shall bring about the creation of an embryo except in pursuance of a licence.

(1A) No person shall keep or use an embryo except—

(a) in pursuance of a licence, or

(b) in the case of—

(i) the keeping, without storage, of an embryo intended for human application, or

(ii) the processing, without storage, of such an embryo,

in pursuance of a third party agreement.

(1B) No person shall procure or distribute an embryo intended for human application except in pursuance of a licence or a third party agreement.]

[F2 (2) No person shall place in a woman—

(a) an embryo other than a permitted embryo (as defined by section 3ZA), or

(b) any gametes other than permitted eggs or permitted sperm (as so defined).]

(3) A licence cannot authorise—

(a) keeping or using an embryo after the appearance of the primitive streak,

(b) placing an embryo in any animal, [F3 or]

(c) keeping or using an embryo in any circumstances in which regulations prohibit its keeping or use, F4 ...

F4 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) For the purposes of subsection (3)(a) above, the primitive streak is to be taken to have appeared in an embryo not later than the end of the period of 14 days beginning with [F5 the day on which the process of creating the embryo began], not counting any time during which the embryo is stored.

Textual Amendments

F1 S. 3(1)-(1B) substituted (25.5.2007 for certain purposes, otherwise 5.7.2007) for s. 3(1) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 8

F2 S. 3(2) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 3(2), 68(2); S.I. 2009/2232, art. 2(a)

F3 Word in s. 3(3)(b) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 3(3)(a), 68(2); S.I. 2009/2232, art. 2(a)

F4 S. 3(3)(d) and preceding word repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 3(3)(b), 68(2), Sch. 8 Pt. 1; S.I. 2009/2232, art. 2(a)

F5 Words in s. 3(4) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 3(4), 68(2); S.I. 2009/2232, art. 2(a)

Commencement Information

I1 S. 3 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[F6 3ZA Permitted eggs, permitted sperm and permitted embryos U.K.

(1) This section has effect for the interpretation of section 3(2).

(2) A permitted egg is one—

(a) which has been produced by or extracted from the ovaries of a woman, and

(b) whose nuclear or mitochondrial DNA has not been altered.

(3) Permitted sperm are sperm—

(a) which have been produced by or extracted from the testes of a man, and

(b) whose nuclear or mitochondrial DNA has not been altered.

(4) An embryo is a permitted embryo if—

(a) it has been created by the fertilisation of a permitted egg by permitted sperm,

(b) no nuclear or mitochondrial DNA of any cell of the embryo has been altered, and

(c) no cell has been added to it other than by division of the embryo's own cells.

(5) Regulations may provide that—

(a) an egg can be a permitted egg, or

(b) an embryo can be a permitted embryo,

even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease.

(6) In this section—

(a) “woman” and “man” include respectively a girl and a boy (from birth), and

(b) “prescribed” means prescribed by regulations.]

Textual Amendments

F6 S. 3ZA inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 3(5), 68(2); S.I. 2009/2232, art. 2(a)

[F7 3A Prohibition in connection with germ cells. U.K.

(1) No person shall, for the purpose of providing fertility services for any woman, use female germ cells taken or derived from an embryo or a foetus or use embryos created by using such cells.

(2) In this section—

• “female germ cells” means cells of the female germ line and includes such cells at any stage of maturity and accordingly includes eggs; and

• “fertility services” means medical, surgical or obstetric services provided for the purpose of assisting women to carry children.]

Textual Amendments

F7 S. 3A inserted (10.4.1995) by 1994 c. 33, s. 156(2); S.I. 1995/721, art. 2, Sch.

4 Prohibitions in connection with gametes. U.K.

(1) No person shall—

(a) store any gametes, or

[F8 (b) in the course of providing treatment services for any woman, use—

(i) any sperm, other than partner-donated sperm which has been neither processed nor stored,

(ii) the woman's eggs after processing or storage, or

(iii) the eggs of any other woman,] F9 ...

F9 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

except in pursuance of a licence.

[F10 (1A) No person shall procure, test, process or distribute any gametes intended for human application except in pursuance of a licence or a third party agreement.]

(2) A licence cannot authorise storing or using gametes in any circumstances in which regulations prohibit their storage or use.

(3) No person shall place sperm and eggs in a woman in any circumstances specified in regulations except in pursuance of a licence.

(4) Regulations made by virtue of subsection (3) above may provide that, in relation to licences only to place sperm and eggs in a woman in such circumstances, sections 12 to 22 of this Act shall have effect with such modifications as may be specified in the regulations.

(5) Activities regulated by this section or section 3 [F11 or 4A] of this Act are referred to in this Act as “activities governed by this Act”.

Textual Amendments

F8 S. 4(1)(b) 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, 9(2)

F9 S. 4(1)(c) and word repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 4(1)(a), 68(2); S.I. 2009/2232, art. 2(a)

F10 S. 4(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, 9(3)

F11 Words in s. 4(5) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 4(1)(b), 68(2); S.I. 2009/2232, art. 2(a)

Commencement Information

I2 S. 4 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[F12 4A Prohibitions in connection with genetic material not of human origin U.K.

(1) No person shall place in a woman—

(a) a human admixed embryo,

(b) any other embryo that is not a human embryo, or

(c) any gametes other than human gametes.

(2) No person shall—

(a) mix human gametes with animal gametes,

(b) bring about the creation of a human admixed embryo, or

(c) keep or use a human admixed embryo,

except in pursuance of a licence.

(3) A licence cannot authorise keeping or using a human admixed embryo after the earliest of the following—

(a) the appearance of the primitive streak, or

(b) the end of the period of 14 days beginning with the day on which the process of creating the human admixed embryo began, but not counting any time during which the human admixed embryo is stored.

(4) A licence cannot authorise placing a human admixed embryo in an animal.

(5) A licence cannot authorise keeping or using a human admixed embryo in any circumstances in which regulations prohibit its keeping or use.

(6) For the purposes of this Act a human admixed embryo is—

(a) an embryo created by replacing the nucleus of an animal egg or of an animal cell, or two animal pronuclei, with—

(i) two human pronuclei,

(ii) one nucleus of a human gamete or of any other human cell, or

(iii) one human gamete or other human cell,

(b) any other embryo created by using—

(i) human gametes and animal gametes, or

(ii) one human pronucleus and one animal pronucleus,

(c) a human embryo that has been altered by the introduction of any sequence of nuclear or mitochondrial DNA of an animal into one or more cells of the embryo,

(d) a human embryo that has been altered by the introduction of one or more animal cells, or

(e) any embryo not falling within paragraphs (a) to (d) which contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal (“animal DNA”) but in which the animal DNA is not predominant.

(7) In subsection (6)—

(a) references to animal cells are to cells of an animal or of an animal embryo, and

(b) references to human cells are to cells of a human or of a human embryo.

(8) For the purposes of this section an “animal” is an animal other than man.

(9) In this section “embryo” means a live embryo, including an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo.

(10) In this section—

(a) references to eggs are to live eggs, including cells of the female germ line at any stage of maturity, but (except in subsection (9)) not including eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo, and

(b) references to gametes are to eggs (as so defined) or to live sperm, including cells of the male germ line at any stage of maturity.

(11) If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may—

(a) amend (but not repeal) paragraphs (a) to (e) of subsection (6);

(b) provide that in this section “embryo”, “eggs” or “gametes” includes things specified in the regulations which would not otherwise fall within the definition.

(12) Regulations made by virtue of subsection (11)(a) may make any amendment of subsection (7) that appears to the Secretary of State to be appropriate in consequence of any amendment of subsection (6).]

Textual Amendments

F12 S. 4A inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 4(2), 68(2); S.I. 2009/2232, art. 2(a)