Human Fertilisation and Embryology Act 1990

Miscellaneous and General U.K.

[F1 42A Powers to make regulations in relation to standards of quality and safety U.K.

(1) The Secretary of State may by regulations make provision specifying requirements to be met for the purposes of ensuring traceability.

(2) The Secretary of State may by regulations make provision in relation to the notification of serious adverse events and serious adverse reactions (whether to the Authority or such other person as may be specified in the regulations).

(3) The Secretary of State may by regulations make provision specifying requirements to be met for the purposes of verifying that standards of quality and safety equivalent to those required pursuant to this Act apply in relation to imports by tissue establishments of gametes and embryos from third countries.

(4) The Secretary of State may by regulations make provision specifying technical requirements in relation to the following—

(a) the licensing or authorisation of tissue establishments;

(b) the procurement of gametes or embryos;

(c) selection criteria for donors of gametes and embryos;

(d) laboratory tests required for donors;

(e) procedures for the reception of gametes and embryos at the tissue establishment;

(f) the gamete and embryo preparation process;

(g) gamete and embryo processing, storage and distribution.

(5) The provision that may be made in regulations under this section includes provision amending this Act and may modify, or further modify, the provisions of the second, third and fourth Directives as they apply by virtue of this Act.

(6) The Secretary of State may only make regulations under this section in relation to Great Britain.]

Textual Amendments

F1 S. 42A inserted (31.12.2020) by S.I. 2019/482, regs. 1, 2(14) (with reg. 4) (as amended by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 15); 2020 c. 1, Sch. 5 para. 1(1)

43 Keeping and examining gametes and embryos in connection with crime, etc. U.K.

(1) Regulations may provide—

(a) for the keeping and examination of gametes or embryos, in such manner and on such conditions (if any) as may be specified in regulations, in connection with the investigation of, or proceedings for, an offence (wherever committed), or

(b) for the storage of gametes, in such manner and on such conditions (if any) as may be specified in regulations, where they are to be used only for such purposes, other than treatment services, as may be specified in regulations.

(2) Nothing in this Act makes unlawful the keeping or examination of any gametes or embryos in pursuance of regulations made by virtue of this section.

(3) In this section “examination” includes use for the purposes of any test.

Commencement Information

I1 S. 43 wholly in force, s. 43 not in force at Royal Assent see s. 49(2), s. 43(1) in force for certain purposes at 8.7.1991; and s. 43 fully in force at 1.8.1991 see S.I. 1991/1400, art. 2(1)(f)(2)

44 Civil liability to child with disability. U.K.

(1) After section 1 of the M1 Congenital Disabilities (Civil Liability) Act 1976 (civil liability to child born disabled) there is inserted—

“1A Extension of section 1 to cover infertility treatments.

(1) In any case where—

(a) a child carried by a woman as the result of the placing in her of an embryo or of sperm and eggs or her artificial insemination is born disabled,

(b) the disability results from an act or omission in the course of the selection, or the keeping or use outside the body, of the embryo carried by her or of the gametes used to bring about the creation of the embryo, and

(c) a person is under this section answerable to the child in respect of the act or omission,

the child’s disabilities are to be regarded as damage resulting from the wrongful act of that person and actionable accordingly at the suit of the child.

(2) Subject to subsection (3) below and the applied provisions of section 1 of this Act, a person (here referred to as “the defendant”) is answerable to the child if he was liable in tort to one or both of the parents (here referred to as “the parent or parents concerned”) or would, if sued in due time, have been so; and it is no answer that there could not have been such liability because the parent or parents concerned suffered no actionable injury, if there was a breach of legal duty which, accompanied by injury, would have given rise to the liability.

(3) The defendant is not under this section answerable to the child if at the time the embryo, or the sperm and eggs, are placed in the woman or the time of her insemination (as the case may be) either or both of the parents knew the risk of their child being born disabled (that is to say, the particular risk created by the act or omission).

(4) Subsections (5) to (7) of section 1 of this Act apply for the purposes of this section as they apply for the purposes of that but as if references to the parent or the parent affected were references to the parent or parents concerned.”

(2) In section 4 of that Act (interpretation, etc)—

(a) at the end of subsection (2) there is inserted—

“and references to embryos shall be construed in accordance with section 1 of the Human Fertilisation and Embryology Act 1990”,

(b) in subsection (3), after “section 1” there is inserted “1A”, and

(c) in subsection (4), for “either” there is substituted “any”.

Commencement Information

I2 S. 44 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

Marginal Citations

M1 1976 c. 28.

45 Regulations. U.K.

(1) The Secretary of State may make regulations for any purpose for which regulations may be made under this Act.

[F2 (1A) Subsection (1) does not enable the Secretary of State to make regulations by virtue of section 19(6) (which confers regulation-making powers on the Authority).]

(2) The power to make regulations [F3 under this Act] shall be exercisable by statutory instrument.

[F4 (3) The power to make regulations under this Act may be exercised—

(a) either in relation to all cases to which the power extends, or in relation to those cases subject to specified exceptions, or in relation to any specified cases or classes of case, and

(b) so as to make, as respects the cases in relation to which it is exercised—

(i) the full provision to which the power extends or any less provision (whether by way of exception or otherwise);

(ii) the same provision for all cases in relation to which the power is exercised, or different provision as respects the same case or class of case for different purposes;

(iii) any such provision either unconditionally, or subject to any specified condition.

(3A) Any power of the Secretary of State or the Authority to make regulations under this Act includes power to make such transitional, incidental or supplemental provision as the Secretary of State or the Authority considers appropriate.]

[F5 (4) The Secretary of State shall not make regulations by virtue of any of the provisions specified in subsection (4A) unless a draft has been laid before and approved by a resolution of each House of Parliament.

(4A) Those provisions are—

• section 1(6);

• section 3(3)(c);

• section 3ZA(5);

• section 4(2) or (3);

• section 4A(5) or (11);

• section 20A(3);

• section 20B(2);

• section 24(4B);

• section 31ZA(2)(a);

• section 33C;

• section 33D;

• section 35A;

• [F6 section 42A;]

• section 43;

• paragraph 1(1)(g), 1ZC or 3A(1)(c) of Schedule 2.]

(5) A statutory instrument containing regulations [F7 made by the Secretary of State] shall, if made without a draft having been approved by resolution of each House of Parliament, be subject to annulment in pursuance of a resolution of either House of Parliament.

(6) In this Act “regulations” means regulations under this section.

Textual Amendments

F2 S. 45(1A) inserted (6.4.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 30(2), 68(2); S.I. 2009/479, art. 5(f)(h) (with art. 7 Sch.)

F3 Words in s. 45(2) inserted (6.4.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 30(3), 68(2); S.I. 2009/479, art. 5(f)(h) (with art. 7 Sch.)

F4 S. 45(3)(3A) substituted for s. 45(3) (6.4.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 30(4), 68(2); S.I. 2009/479, art. 5(f)(h) (with art. 7 Sch.)

F5 S. 45(4)(4A) substituted for s. 45(4) (6.4.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 30(5), 68(2); S.I. 2009/479, art. 5(f)(h) (with art. 7 Sch.)

F6 Words in s. 45(4A) inserted (31.12.2020) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/482), regs. 1, 2(15) (with reg. 4); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in s. 45(5) inserted (6.4.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 30(6), 68(2); S.I. 2009/479, art. 5(f)(h) (with art. 7 Sch.)

Commencement Information

I3 S. 45 fully in force at 8.7.1991 see s. 49(2) and S.I. 1991/1400, art. 2(1)(g)

[F8 45A Power to make consequential provision U.K.

(1) The Secretary of State may by order make such provision modifying any provision made by or under any enactment as the Secretary of State considers necessary or expedient in consequence of any provision made by regulations under any of the relevant provisions of this Act.

(2) For the purposes of subsection (1), “the relevant provisions of this Act” are—

(a) section 1(6) (power to include things within the meaning of “embryo” and “gametes” etc.);

(b) section 4A(11) (power to amend definition of “human admixed embryo” and other terms).

(3) Before making an order under this section containing provision which would, if included in an Act of the Scottish Parliament, be within the legislative competence of that Parliament, the Secretary of State must consult the Scottish Ministers.

(4) Before making an order under this section containing provision which would be within the legislative competence of the National Assembly for Wales if it were included in [F9 an Act of the Assembly], the Secretary of State must consult the Welsh Ministers.

(5) Before making an order under this section containing provision which would if included in an Act of the Northern Ireland Assembly, be within the legislative competence of that Assembly, the Secretary of State must consult the Department of Health, Social Services and Public Safety.

(6) In this section—

• “enactment” means—

  (a)

  an Act of Parliament (other than this Act),

  (b)

  an Act of the Scottish Parliament,

  (c)

  a Measure or Act of the National Assembly for Wales, or

  (d)

  Northern Ireland legislation,

  whenever passed or made;

• “modify” includes amend, add to, revoke or repeal;

• “the Assembly Act provisions” has the meaning given by section 103(8) of the Government of Wales Act 2006.]

Textual Amendments

F8 S. 45A inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 31, 68(2); S.I. 2009/2232, art. 2(o)

F9 Words in s. 45A(4) substituted (1.4.2018) by Wales Act 2017 (c. 4), s. 71(4), Sch. 6 para. 52 (with Sch. 7 paras. 1, 6); S.I. 2017/1179, reg. 3(r)

[F10 45B Orders U.K.

(1) The power to make an order under section 8C(1)(c) or 45A of this Act shall be exercisable by statutory instrument.

(2) The power to make an order under section 8C(1)(c) or 45A of this Act includes power to make such transitional, incidental or supplemental provision as the Secretary of State considers appropriate.

(3) A statutory instrument containing an order made by the Secretary of State by virtue of section 8C(1)(c) shall be subject to annulment in pursuance of a resolution of either House of Parliament.

(4) The Secretary of State shall not make an order by virtue of section 45A unless a draft has been laid before and approved by a resolution of each House of Parliament.]

Textual Amendments

F10 S. 45B inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 32, 68(2); S.I. 2009/2232, art. 2(p)

46 Notices. U.K.

(1) This section has effect in relation to any notice required or authorised by this Act to be given to or served on any person.

(2) The notice may be given to or served on the person—

(a) by delivering it to the person,

(b) by leaving it at the person’s proper address, or

(c) by sending it by post to the person at that address.

(3) The notice may—

(a) in the case of a body corporate, be given to or served on the secretary or clerk of the body,

(b) in the case of a partnership, be given to or served on any partner, and

(c) in the case of an unincorporated association other than a partnership, be given to or served on any member of the governing body of the association.

(4) For the purposes of this section and section 7 of the M2 Interpretation Act 1978 (service of documents by post) in its application to this section, the proper address of any person is the person’s last known address and also—

(a) in the case of a body corporate, its secretary or its clerk, the address of its registered or principal office, and

(b) in the case of an unincorporated association or a member of its governing body, its principal office.

(5) Where a person has notified the Authority of an address or a new address at which notices may be given to or served on him under this Act, that address shall also be his proper address for the purposes mentioned in subsection (4) above or, as the case may be, his proper address for those purposes in substitution for that previously notified.

Commencement Information

I4 S. 46 fully in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

Marginal Citations

M2 1978 c. 30.

47 Index. U.K.

The expressions listed in the left-hand column below are respectively defined or (as the case may be) are to be interpreted in accordance with the provisions of this Act listed in the right-hand column in relation to those expressions.

Activities governed by this Act	Section 4(5)
[F11 Appeals committee]	[F11 Section 20A(2)]
Authority	Section 2(1)
[F12 Basic partner treatment services	Section 2(1)]
Carry, in relation to a child	Section 2(3)
F13 . . .	F13 . . .
Directions	Section 2(1)
[F14 Distribution, in relation to gametes or embryos intended for human application	Section 2(1)]
Embryo [F15 (except in section 4A or in the term “human admixed embryo”)]	Section 1
[F16 First Directive	Section 1A]
[F17 Fourth Directive	Section 1A]
Gametes, eggs or sperm [F18 (except in section 4A)]	Section 1
[F11 Human admixed embryo]	[F11 Section 4A(6)]
[F19 Human application	Section 2(1)]
[F17 Importing licensee	Section 2B(2]
Keeping, in relation to embryos or gametes	Section 2(2)
Licence	Section 2(1)
F20 . . .	F20 . . .
F20 . . .	F20 . . .
[F21 Non-medical fertility services	Section 2(1)]
[F11 Nuclear DNA (in relation to an embryo)]	[F11 Section 2(1)]
[F22 Partner-donated sperm	Section 1(5)]
Person responsible	Section 17(1)
Person to whom a licence applies	Section 17(2)
[F23 Person to whom a third party agreement applies	Section 2A(3)]
[F24 Processing, in relation to gametes or embryos intended for human application	Section 2(1)]
[F25 Procurement, in relation to gametes or embryos intended for human application	Section 2(1)]
[F17 Qualifying gametes or embryos	Section 2B(3)]
[F26 Relevant third party premises, in relation to a licence	Section 2A(2)]
[F27 Second Directive	Section 1A]
[F28 Serious adverse event	Section 2(1)]
[F29 Serious adverse reaction	Section 2(1)]
F30 . . .	F30 . . .
Store, and similar expressions, in relation to embryos[F31 , human admixed embryos] or gametes	[F32 Section 2(1)]
[F17 Third country	Section 2B(4)]
[F17 Third country premises	Section 2B(5)]
[F17 Third country supplier	Section 2B(6)]
[F33 Third Directive	Section 1A]
[F34 Third party	Section 2A(2)]
[F35 Third party agreement	Section 2A(1)]
[F36 Tissue establishment	Section 2(1)]
[F37 Traceability	Section 2(1)]
Treatment services	Section 2(1)

Textual Amendments

F11 Words in s. 47 inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 13(d); S.I. 2009/2232, art. 2(y)

F12 S. 47 Table: entry 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, 28(2)(b)

F13 S. 47 Table: entry omitted (31.12.2020) by virtue of The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/482), regs. 1, 2(16)(a) (with reg. 4); 2020 c. 1, Sch. 5 para. 1(1)

F14 S. 47 Table: entry 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, 28(2)(b)

F15 Words in s. 47 inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 13(a); S.I. 2009/2232, art. 2(y)

F16 S. 47 Table: entry 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, 28(2)(b)

F17 Words in s. 47 inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Fertilisation and Embryology (Amendment) Regulations 2018 (S.I. 2018/334), regs. 1(3), 5(5)

F18 Words in s. 47 inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 13(b); S.I. 2009/2232, art. 2(y)

F19 S. 47 Table: entry 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, 28(2)(b)

F20 S. 47 entries repealed (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 13(e), Sch. 8 Pt. 1; S.I. 2009/2232, art. 2(y)

F21 S. 47 Table: entry 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, 28(2)(b)

F22 S. 47 Table: entry 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, 28(2)(b)

F23 S. 47 Table: entry 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, 28(2)(b)

F24 S. 47 Table: entry 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, 28(2)(b)

F25 S. 47 Table: entry 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, 28(2)(b)

F26 S. 47 Table: entry 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, 28(2)(b)

F27 S. 47 Table: entry 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, 28(2)(b)

F28 S. 47 Table: entry 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, 28(2)(b)

F29 S. 47 Table: entry 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, 28(2)(b)

F30 S. 47 Table entry omitted (1.7.2022) by virtue of Health and Care Act 2022 (c. 31), s. 186(3), Sch. 17 para. 3 (with Sch. 17 Pt. 2)

F31 Words in s. 47 inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 13(c); S.I. 2009/2232, art. 2(y)

F32 S. 47 Table: words in entry 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, 28(2)(a)

F33 S. 47 Table: entry 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, 28(2)(b)

F34 S. 47 Table: entry 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, 28(2)(b)

F35 S. 47 Table: entry 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, 28(2)(b)

F36 S. 47 Table: entry inserted (31.12.2020) by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/482), regs. 1, 2(16)(b) (with reg. 4); 2020 c. 1, Sch. 5 para. 1(1)

F37 S. 47 Table: entry 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, 28(2)(b)

Commencement Information

I5 S. 47 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

48 Northern Ireland. U.K.

(1) This Act (except [F38 sections 33A(2)(r) and] 37) extends to Northern Ireland.

F39 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F38 Words in s. 48(1) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 14; S.I. 2009/2232, art. 2(y)

F39 S. 48(2) repealed (2.12.1999) by 1998 c. 47, s. 100(2), Sch. 15; S.I. 1999/3209, art. 2, Sch.

Commencement Information

I6 S. 48 wholly in force at 1.11.1994; s. 48 not in force at Royal Assent see s. 49(2); s. 48(1) in force for specified purposes at 1.4.1991, 8.7.1991 and 1.8.1991 by S.I. 1991/1400, art. 2(1)(2); s. 48(2) in force at 1.8.1991 by S.I. 1991/1400, art. 2(1)(2); s. 48(1) in force for specified purposes at 5.7.1994 and 1.11.1994 by S.I. 1994/1776, art. 2(1)(2)

49 Short title, commencement, etc. U.K.

(1) This Act may be cited as the Human Fertilisation and Embryology Act 1990.

(2) This Act shall come into force on such day as the Secretary of State may by order made by statutory instrument appoint and different days may be appointed for different provisions and for different purposes.

(3) Sections 27 to 29 of this Act shall have effect only in relation to children carried by women as a result of the placing in them of embryos or of sperm and eggs, or of their artificial insemination (as the case may be), after the commencement of those sections.

(4) Section 27 of the M3 Family Law Reform Act 1987 (artificial insemination) does not have effect in relation to children carried by women as the result of their artificial insemination after the commencement of sections 27 to 29 of this Act.

(5) Schedule 4 to this Act (which makes minor and consequential amendments) shall have effect.

(6) An order under this section may make such transitional provision as the Secretary of State considers necessary or desirable and, in particular, may provide that where activities are carried on under the supervision of a particular individual, being activities which are carried on under the supervision of that individual at the commencement of sections 3 and 4 of this Act, those activities are to be treated, during such period as may be specified in or determined in accordance with the order, as authorised by a licence (having, in addition to the conditions required by this Act, such conditions as may be so specified or determined) under which that individual is the person responsible.

(7) Her Majesty may by Order in Council direct that any of the provisions of this Act shall extend, with such exceptions, adaptations and modifications (if any) as may be specified in the Order, to any of the Channel Islands.

Subordinate Legislation Made

P1 S. 49(2)(6): power exercised by S.Is: 1990/2165, 1991/480, 1991/1400, 1991/1781, 1994/1776

Marginal Citations

M3 1987 c. 42.