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Human Fertilisation and Embryology Act 2008

Type Public General Act

Publication 2008-11-13

Last updated 2022-01-27

State In force

Department Statute Law Database

Source legislation.gov.uk

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(2) Where the sperm of a man, or an embryo the creation of which was brought about with his sperm, was used after his death, he is not, subject to section 39, to be treated as the father of the child.

(3) Subsection (2) applies whether W was in the United Kingdom or elsewhere at the time of the placing in her of the embryo or of the sperm and eggs or of her artificial insemination.

Cases in which woman to be other parent

Woman in civil partnership at time of treatment

42

(1) If at the time of the placing in her of the embryo or the sperm and eggs or of her artificial insemination, W was a party to a civil partnership with another woman or a marriage with another woman, then subject to section 45(2) to (4), the other party to the civil partnership or marriage is to be treated as a parent of the child unless it is shown that she did not consent to the placing in W of the embryo or the sperm and eggs or to her artificial insemination (as the case may be).

(2) This section applies whether W was in the United Kingdom or elsewhere at the time mentioned in subsection (1).

Treatment provided to woman who agrees that second woman to be parent

43

If no man is treated by virtue of section 35 as the father of the child and no woman is treated by virtue of section 42 as a parent of the child but—

(a) the embryo or the sperm and eggs were placed in W, or W was artificially inseminated, in the course of treatment services provided in the United Kingdom by a person to whom a licence applies,

(b) at the time when the embryo or the sperm and eggs were placed in W, or W was artificially inseminated, the agreed female parenthood conditions (as set out in section 44) were met in relation to another woman, in relation to treatment provided to W under that licence, and

then, subject to section 45(2) to (4), the other woman is to be treated as a parent of the child.

The agreed female parenthood conditions

44

(1) The agreed female parenthood conditions referred to in section 43(b) are met in relation to another woman (“P”) in relation to treatment provided to W under a licence if, but only if,—

(a) P has given the person responsible a notice stating that P consents to P being treated as a parent of any child resulting from treatment provided to W under the licence,

(b) W has given the person responsible a notice stating that W agrees to P being so treated,

(c) neither W nor P has, since giving notice under paragraph (a) or (b), given the person responsible notice of the withdrawal of P's or W's consent to P being so treated,

(d) W has not, since the giving of the notice under paragraph (b), given the person responsible—

(i) a further notice under that paragraph stating that W consents to a woman other than P being treated as a parent of any resulting child, or

(ii) a notice under section 37(1)(b) stating that W consents to a man being treated as the father of any resulting child, and

(e) W and P are not within prohibited degrees of relationship in relation to each other.

(2) A notice under subsection (1)(a), (b) or (c) must be in writing and must be signed by the person giving it.

(3) A notice under subsection (1)(a), (b) or (c) by a person (“S”) who is unable to sign because of illness, injury or physical disability is to be taken to comply with the requirement of subsection (2) as to signature if it is signed at the direction of S, in the presence of S and in the presence of at least one witness who attests the signature.

Further provision relating to sections 42 and 43

45

(1) Where a woman is treated by virtue of section 42 or 43 as a parent of the child, no man is to be treated as the father of the child.

(2) In England and Wales and Northern Ireland, sections 42 and 43 do not affect any presumption, applying by virtue of the rules of common law or section A1(2) of the Legitimacy Act 1976 or section 2(1)(a) of the Family Law Act (Northern Ireland) 2001, that a child is the legitimate child of the parties to a marriage or civil partnership.

(3) In Scotland, sections 42 and 43 do not apply in relation to any child who, by virtue of any enactment or other rule of law, is treated as the child of the parties to a marriage or civil partnership.

(4) Sections 42 and 43 do not apply to any child to the extent that the child is treated by virtue of adoption as not being the woman's child.

Embryo transferred after death of civil partner or intended female parent

46

(1) If—

(a) the child has been carried by W as the result of the placing in her of an embryo,

(b) the embryo was created at a time when W was a party to a civil partnership with a woman or a marriage with a woman,

(d) the other party to the civil partnership or marriage consented in writing (and did not withdraw the consent)—

(i) to the placing of the embryo in W after the death of the other party, and

(ii) to being treated for the purpose mentioned in subsection (4) as the parent of any resulting child,

(e) W has elected in writing not later than the end of the period of 42 days from the day on which the child was born for the other party to the civil partnership or marriage to be treated for the purpose mentioned in subsection (4) as the parent of the child, and

(f) no one else is to be treated—

(i) as the father of the child by virtue of section 35 or 36 or by virtue of section 45(2) or (3), or

(ii) as a parent of the child by virtue of section 42 or 43 or by virtue of adoption,

then the other party to the civil partnership or marriage is to be treated for the purpose mentioned in subsection (4) as a parent of the child.

(2) If—

(a) the child has been carried by W as the result of the placing in her of an embryo,

(b) the embryo was not created at a time when W was a party to a marriage or a civil partnership, but was created in the course of treatment services provided to W in the United Kingdom by a person to whom a licence applies,

(i) to the placing of the embryo in W after the death of the other woman, and

(ii) to being treated for the purpose mentioned in subsection (4) as the parent of any resulting child,

(d) the other woman died before the placing of the embryo in W,

(e) immediately before the other woman's death, the agreed female parenthood conditions set out in section 44 were met in relation to the other woman in relation to treatment proposed to be provided to W in the United Kingdom by a person to whom a licence applies,

(f) W has elected in writing not later than the end of the period of 42 days from the day on which the child was born for the other woman to be treated for the purpose mentioned in subsection (4) as the parent of the child, and

(g) no one else is to be treated—

(i) as the father of the child by virtue of section 35 or 36 or by virtue of section 45(2) or (3), or

(ii) as a parent of the child by virtue of section 42 or 43 or by virtue of adoption,

then the other woman is to be treated for the purpose mentioned in subsection (4) as a parent of the child.

(3) Subsections (1) and (2) apply whether W was in the United Kingdom or elsewhere at the time of the placing in her of the embryo.

(4) The purpose referred to in subsections (1) and (2) is the purpose of enabling the deceased woman's particulars to be entered as the particulars of the child's other parent in a relevant register of births.

(5) In the application of subsections (1) and (2) to Scotland, for any reference to a period of 42 days there is substituted a reference to a period of 21 days.

Woman not to be other parent merely because of egg donation

47

A woman is not to be treated as the parent of a child whom she is not carrying and has not carried, except where she is so treated—

(a) by virtue of section 42 or 43, or

(b) by virtue of section 46 (for the purpose mentioned in subsection (4) of that section), or

Effect of sections 33 to 47

48

(1) Where by virtue of section 33, 35, 36, 42 or 43 a person is to be treated as the mother, father or parent of a child, that person is to be treated in law as the mother, father or parent (as the case may be) of the child for all purposes.

(2) Where by virtue of section 33, 38, 41, 45 or 47 a person is not to be treated as a parent of the child, that person is to be treated in law as not being a parent of the child for any purpose.

(3) Where section 39(1) or 40(1) or (2) applies, the deceased man—

(a) is to be treated in law as the father of the child for the purpose mentioned in section 39(3) or 40(4), but

(b) is to be treated in law as not being the father of the child for any other purpose.

(4) Where section 46(1) or (2) applies, the deceased woman—

(a) is to be treated in law as a parent of the child for the purpose mentioned in section 46(4), but

(b) is to be treated in law as not being a parent of the child for any other purpose.

(5) Where any of subsections (1) to (4) has effect, references to any relationship between two people in any enactment, deed or other instrument or document (whenever passed or made) are to be read accordingly.

(6) In relation to England and Wales and Northern Ireland, a child who—

(a) has a parent by virtue of section 42, or

(b) has a parent by virtue of section 43 who is at any time during the period beginning with the time mentioned in section 43(b) and ending with the time of the child's birth a party to a marriage or civil partnership with the child's mother,

is the legitimate child of the child's parents.

(7) In relation to England and Wales and Northern Ireland, nothing in the provisions of section 33(1) or sections 35 to 47, read with this section—

(a) affects the succession to any dignity or title of honour or renders any person capable of succeeding to or transmitting a right to succeed to any such dignity or title, or

(b) affects the devolution of any property limited (expressly or not) to devolve (as nearly as the law permits) along with any dignity or title of honour.

(8) In relation to Scotland—

(a) those provisions do not apply to any title, coat of arms, honour or dignity transmissible on the death of its holder or affect the succession to any such title, coat of arms or dignity or its devolution, and

(b) where the terms of any deed provide that any property or interest in property is to devolve along with a title, coat of arms, honour or dignity, nothing in those provisions is to prevent that property or interest from so devolving.

References to parties to marriage or civil partnership

Meaning of references to parties to a marriage

49

(1) The references in sections 35 to 47 to the parties to a marriage at any time there referred to—

(a) are to the parties to a marriage subsisting at that time, unless a judicial separation was then in force, but

(b) include the parties to a void marriage if either or both of them reasonably believed at that time that the marriage was valid; and for the purposes of those sections it is to be presumed, unless the contrary is shown, that one of them reasonably believed at that time that the marriage was valid.

(2) In subsection (1)(a) “judicial separation” includes a legal separation obtained in a country outside the British Islands and recognised in the United Kingdom.

Meaning of references to parties to a civil partnership

50

(1) The references in sections 35 to 47 to the parties to a civil partnership at any time there referred to—

(a) are to the parties to a civil partnership subsisting at that time, unless a separation order was then in force, but

(b) include the parties to a void civil partnership if either or both of them reasonably believed at that time that the civil partnership was valid; and for the purposes of those sections it is to be presumed, unless the contrary is shown, that one of them reasonably believed at that time that the civil partnership was valid.

(2) The reference in section 48(6)(b) to a civil partnership includes a reference to a void civil partnership if either or both of the parties reasonably believed at the time when they registered as civil partners of each other that the civil partnership was valid; and for this purpose it is to be presumed, unless the contrary is shown, that one of them reasonably believed at that time that the civil partnership was valid.

(3) In subsection (1)(a), “separation order” means—

(a) a separation order under section 37(1)(d) or 161(1)(d) of the Civil Partnership Act 2004 (c. 33),

(b) a decree of separation under section 120(2) of that Act, or

Further provision about registration by virtue of section 39, 40 or 46

Meaning of “relevant register of births”

51

For the purposes of this Part a “relevant register of births”, in relation to a birth, is whichever of the following is relevant—

(a) a register of live-births or still-births kept under the Births and Deaths Registration Act 1953 (c. 20),

(b) a register of births or still-births kept under the Registration of Births, Deaths and Marriages (Scotland) Act 1965 (c. 49), or

(c) a register of live-births or still-births kept under the Births and Deaths Registration (Northern Ireland) Order 1976 (S.I. 1976/1041 (N.I. 14)).

52

(1) The requirement under section 39(1), 40(1) or (2) or 46(1) or (2) as to the making of an election (which requires an election to be made either on or before the day on which the child was born or within the period of 42 or, as the case may be, 21 days from that day) is nevertheless to be treated as satisfied if the required election is made after the end of that period but with the consent of the Registrar General under subsection (2).

(2) The Registrar General may at any time consent to the making of an election after the end of the period mentioned in subsection (1) if, on an application made to him in accordance with such requirements as he may specify, he is satisfied that there is a compelling reason for giving his consent to the making of such an election.

(3) In this section “the Registrar General” means the Registrar General for England and Wales, the Registrar General of Births, Deaths and Marriages for Scotland or (as the case may be) the Registrar General for Northern Ireland.

Interpretation of references to father etc. where woman is other parent

Interpretation of references to father etc.

53

(1) Subsections (2) and (3) have effect, subject to subsections (4) and (6), for the interpretation of any enactment, deed or any other instrument or document (whenever passed or made).

(2) Any reference (however expressed) to the father of a child who has a parent by virtue of section 42 or 43 is to be read as a reference to the woman who is a parent of the child by virtue of that section.

(3) Any reference (however expressed) to evidence of paternity is, in relation to a woman who is a parent by virtue of section 42 or 43, to be read as a reference to evidence of parentage.

(4) This section does not affect the interpretation of the enactments specified in subsection (5) (which make express provision for the case where a child has a parent by virtue of section 42 or 43).

(5) Those enactments are—

(a) the Legitimacy Act (Northern Ireland) 1928 (c. 5 (N.I.)),

(b) the Schedule to the Population (Statistics) Act 1938 (c. 12),

(d) the Registration of Births, Deaths and Marriages (Special Provisions) Act 1957 (c. 58),

(e) Part 2 of the Registration of Births, Deaths and Marriages (Scotland) Act 1965 (c. 49),

(f) the Congenital Disabilities (Civil Liability) Act 1976 (c. 28),

(g) the Legitimacy Act 1976 (c. 31),

(h) the Births and Deaths Registration (Northern Ireland) Order 1976 (S.I. 1976/1041 (N.I. 14)),

(i) the British Nationality Act 1981 (c. 61),

(j) the Family Law Reform Act 1987 (c. 42),

(k) Parts 1 and 2 of the Children Act 1989 (c. 41),

(l) Part 1 of the Children (Scotland) Act 1995 (c. 36),

(m) section 1 of the Criminal Law (Consolidation) (Scotland) Act 1995 (c. 39), and

(n) Parts 2, 3 and 14 of the Children (Northern Ireland) Order 1995 (S.I. 1995/755 (N.I. 2)).

(6) This section does not affect the interpretation of references that fall to be read in accordance with section 1(2)(a) or (b) of the Family Law Reform Act 1987 or Article 155(2)(a) or (b) of the Children (Northern Ireland) Order 1995 (references to a person whose father and mother were, or were not, married to each other at the time of the person's birth).

Parental orders

54

(1) On an application made by two people (“the applicants”), the court may make an order providing for a child to be treated in law as the child of the applicants if—

(a) the child has been carried by a woman who is not one of the applicants, as a result of the placing in her of an embryo or sperm and eggs or her artificial insemination,

(b) the gametes of at least one of the applicants were used to bring about the creation of the embryo, and

(2) The applicants must be—

(a) husband and wife,

(b) civil partners of each other, or

(c) two persons who are living as partners in an enduring family relationship and are not within prohibited degrees of relationship in relation to each other.

(3) Except in a case falling within subsection (11), the applicants must apply for the order during the period of 6 months beginning with the day on which the child is born.

(4) At the time of the application and the making of the order—

(a) the child's home must be with the applicants, and

(b) either or both of the applicants must be domiciled in the United Kingdom or in the Channel Islands or the Isle of Man.

(5) At the time of the making of the order both the applicants must have attained the age of 18.

(6) The court must be satisfied that both—

(a) the woman who carried the child, and

(b) any other person who is a parent of the child but is not one of the applicants (including any man who is the father by virtue of section 35 or 36 or any woman who is a parent by virtue of section 42 or 43),

have freely, and with full understanding of what is involved, agreed unconditionally to the making of the order.

(7) Subsection (6) does not require the agreement of a person who cannot be found or is incapable of giving agreement; and the agreement of the woman who carried the child is ineffective for the purpose of that subsection if given by her less than six weeks after the child's birth.

(8) The court must be satisfied that no money or other benefit (other than for expenses reasonably incurred) has been given or received by either of the applicants for or in consideration of—

(a) the making of the order,

(b) any agreement required by subsection (6),

(d) the making of arrangements with a view to the making of the order,

unless authorised by the court.

(8A) An order relating to the child must not previously have been made under this section or section 54A, unless the order has been quashed or an appeal against the order has been allowed.

(9) For the purposes of an application under this section—

(a) in relation to England and Wales —

(i) “the court” means the High Court or the family court, and

(ii) proceedings on the application are to be “family proceedings” for the purposes of the Children Act 1989,

(b) in relation to Scotland, “the court” means the Court of Session or the sheriff court of the sheriffdom within which the child is, and

(10) Subsection (1)(a) applies whether the woman was in the United Kingdom or elsewhere at the time of the placing in her of the embryo or the sperm and eggs or her artificial insemination.

(11) An application which—

(a) relates to a child born before the coming into force of this section, and

(b) is made by two persons who, throughout the period applicable under subsection (2) of section 30 of the 1990 Act, were not eligible to apply for an order under that section in relation to the child as husband and wife,

may be made within the period of six months beginning with the day on which this section comes into force.

Parental orders: supplementary provision

55

(1) The Secretary of State may by regulations provide—

(a) for any provision of the enactments about adoption to have effect, with such modifications (if any) as may be specified in the regulations, in relation to orders under section 54 or 54A, and applications for such orders, as it has effect in relation to adoption, and applications for adoption orders, and

(b) for references in any enactment to adoption, an adopted child or an adoptive relationship to be read (respectively) as references to the effect of an order under section 54 or 54A, a child to whom such an order applies and a relationship arising by virtue of the enactments about adoption, as applied by the regulations, and for similar expressions in connection with adoption to be read accordingly.

(2) The regulations may include such incidental or supplemental provision as appears to the Secretary of State to be necessary or desirable in consequence of any provision made by virtue of subsection (1)(a) or (b).

(3) In this section “the enactments about adoption” means—

(a) the Adoption (Scotland) Act 1978 (c. 28),

(b) the Adoption and Children Act 2002 (c. 38),

(d) the Adoption (Northern Ireland) Order 1987 (S.I. 1987/2203 (N.I. 22)).

Amendments of enactments

Amendments relating to parenthood in cases involving assisted reproduction

56

Schedule 6 contains amendments related to the provisions of this Part.

General

Repeals and transitional provision relating to Part 2

57

(1) Sections 33 to 48 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 their artificial insemination (as the case may be), after the commencement of those sections.

(2) Sections 27 to 29 of the 1990 Act (which relate to status) do not have effect in relation to children carried by women as a result of the placing in them of embryos or of sperm and eggs, or their artificial insemination (as the case may be), after the commencement of sections 33 to 48.

(3) Section 30 of the 1990 Act (parental orders in favour of gamete donors) ceases to have effect.

(4) Subsection (3) does not affect the validity of any order made under section 30 of the 1990 Act before the coming into force of that subsection.

Interpretation of Part 2

58

(1) In this Part “enactment” means an enactment contained in, or in an instrument made under—

(a) an Act of Parliament,

(b) an Act of the Scottish Parliament,

(d) Northern Ireland legislation.

(2) For the purposes of this Part, two persons are within prohibited degrees of relationship if one is the other's parent, grandparent, sister, brother, aunt or uncle; and in this subsection references to relationships—

(a) are to relationships of the full blood or half blood or, in the case of an adopted person, such of those relationships as would subsist but for adoption, and

(b) include the relationship of a child with his adoptive, or former adoptive, parents,

but do not include any other adoptive relationships.

(3) Other expressions used in this Part and in the 1990 Act have the same meaning in this Part as in that Act.

Part 3 — Miscellaneous and General

Miscellaneous

Surrogacy arrangements

59

(1) The Surrogacy Arrangements Act 1985 (c. 49) is amended as follows.

(2) In section 1 (meaning of various terms), after subsection (7) insert—

(7A) “Non-profit making body” means a body of persons whose activities are not carried on for profit.

(3) In section 2 (negotiating surrogacy arrangements on a commercial basis), in subsection (1)—

(a) in paragraph (a) omit “or take part in”, and

(b) after paragraph (a) insert—

(aa) take part in any negotiations with a view to the making of a surrogacy arrangement,

(4) After subsection (2) insert—

(2A) A non-profit making body does not contravene subsection (1) merely because— (a) the body does an act falling within subsection (1)(a) or (c) in respect of which any reasonable payment is at any time received by it or another, or (b) it does an act falling within subsection (1)(a) or (c) with a view to any reasonable payment being received by it or another in respect of facilitating the making of any surrogacy arrangement. (2B) A person who knowingly causes a non-profit making body to do an act falling within subsection (1)(a) or (c) does not contravene subsection (1) merely because— (a) any reasonable payment is at any time received by the body or another in respect of the body doing the act, or (b) the body does the act with a view to any reasonable payment being received by it or another person in respect of the body facilitating the making of any surrogacy arrangement. (2C) Any reference in subsection (2A) or (2B) to a reasonable payment in respect of the doing of an act by a non-profit making body is a reference to a payment not exceeding the body's costs reasonably attributable to the doing of the act.

(5) After subsection (5) of that section insert—

(5A) A non-profit making body is not guilty of an offence under subsection (5), in respect of the receipt of any payment described in that subsection, merely because a person acting on behalf of the body takes part in facilitating the making of a surrogacy arrangement.

(6) After subsection (8) of that section insert—

(8A) A person is not guilty of an offence under subsection (7) if— (a) the body of persons referred to in that subsection is a non-profit making body, and (b) the only activity of that body which falls within subsection (8) is facilitating the making of surrogacy arrangements in the United Kingdom. (8B) In subsection (8A)(b) “facilitating the making of surrogacy arrangements” is to be construed in accordance with subsection (8).

(7) In section 3 (advertisements about surrogacy), after subsection (1) insert—

(1A) This section does not apply to any advertisement placed by, or on behalf of, a non-profit making body if the advertisement relates only to the doing by the body of acts that would not contravene section 2(1) even if done on a commercial basis (within the meaning of section 2).

Exclusion of embryos from definition of “organism” in Part 6 of the EPA 1990

60

(1) Section 106 of the Environmental Protection Act 1990 (c. 43) (meaning of “genetically modified organisms” etc.) is amended as follows.

(2) In subsection (2), for “or human embryos” substitute “ , human embryos or human admixed embryos ”.

(3) After subsection (3) insert—

(3A) For the purposes of subsection (2) above— (a) “human embryo” means an embryo within the meaning given in the provisions of the Human Fertilisation and Embryology Act 1990 (apart from section 4A) by virtue of section 1(1) and (6) of that Act, and (b) “human admixed embryo” has the same meaning as it has in that Act by virtue of section 4A(6) and (11) of that Act.

General

Orders and regulations: general provisions

61

(1) Any power of the Secretary of State to make an order or regulations under this Act is exercisable by statutory instrument.

(2) Any power of the Secretary of State to make an order or 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.

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

Orders and regulations: parliamentary control

62

(1) Orders made by the Secretary of State under this Act are subject to annulment in pursuance of a resolution of either House of Parliament.

(2) Subsection (1) does not apply to—

(a) an order to which subsection (3) applies, or

(b) an order under section 68 (commencement).

(3) No order under section 64 (power to make consequential and transitional provision etc.) which includes provision made by virtue of subsection (2) of that section may be made unless a draft of the order has been laid before, and approved by a resolution of, each House of Parliament.

(4) No regulations under section 55 (parental orders: supplementary provision) may be made unless a draft of the regulations has been laid before, and approved by a resolution of, each House of Parliament.

Meaning of “the 1990 Act”

63

In this Act, “the 1990 Act” means the Human Fertilisation and Embryology Act 1990 (c. 37).

Power to make consequential and transitional provision etc.

64

(1) The Secretary of State may by order make—

(a) any supplementary, incidental or consequential provision, and

(b) any transitional or saving provision,

that the Secretary of State considers necessary or expedient for the purposes of, in consequence of, or for giving full effect to, any provision of this Act.

(2) An order under this section may modify—

(a) any enactment passed or made before the passing of this Act, and

(b) any enactment passed or made before the end of the Session in which this Act is passed.

(3) An order under this section which modifies an enactment in consequence of any provision of Part 2 may modify subsection (5) of section 53 (interpretation of references to father etc.).

(4) An order under this section may provide for any provision of this Act which comes into force before any other provision comes into force to have effect, until that other provision has come into force, with specified modifications.

(5) 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.

(6) 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 an Act of the Assembly, the Secretary of State must consult the Welsh Ministers.

(7) 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.

(8) Nothing in this section limits the power under section 61 to include transitional or saving provision in a commencement order under section 68(2).

(9) The modifications that may be made by virtue of subsection (2) are in addition to those that are made by any other provision of this Act.

(10) In this section—

“enactment” means an enactment contained in, or in an instrument made under—an Act of Parliament,an Act of the Scottish Parliament,a Measure of the National Assembly for Wales, orNorthern Ireland legislation;

“modify” includes amend, add to, revoke or repeal, and references to “modifications” are to be read accordingly;

“the Assembly Act provisions” has the meaning given by section 103(8) of the Government of Wales Act 2006 (c. 32).

Minor and consequential amendments

65

Schedule 7 contains minor and consequential amendments.

Repeals and revocations

66

Schedule 8 contains repeals and revocations.

Extent

67

(1) Subject to the following provisions, this Act extends to England and Wales, Scotland and Northern Ireland.

(2) Any amendment or repeal made by this Act has the same extent as the enactment to which it relates (ignoring extent by virtue of an Order in Council).

(3) Subsection (2) is subject to paragraph 1(2) of Schedule 6.

(4) Her Majesty may by Order in Council provide for any of the provisions of this Act to extend, with or without modifications, to the Bailiwick of Guernsey.

(5) Subsection (4) does not authorise the extension to the Bailiwick of Guernsey of a provision of this Act so far as the provision amends an enactment that does not itself extend there and is not itself capable of being extended there in exercise of a power conferred on Her Majesty in Council.

(6) Subsection (4) does not apply in relation to the extension to the Bailiwick of Guernsey of a provision which extends there by virtue of subsection (2).

(7) Subsection (3) of section 61 applies to the power to make an Order in Council under this section as it applies to any power of the Secretary of State to make an order under this Act, but as if the references in that subsection to the Secretary of State were references to Her Majesty in Council.

Commencement

68

(1) The following provisions of this Act come into force on the day on which this Act is passed—

sections 61 to 64;

section 67, this section and section 69.

(2) The remaining provisions of this Act come into force in accordance with provision made by the Secretary of State by order.

Short title

69

This Act may be cited as the Human Fertilisation and Embryology Act 2008.

SCHEDULE 1

1

Schedule 1 to the 1990 Act (supplementary provision about Authority) is amended as follows.

2

After paragraph 4 (appointment of members) insert—

(4A) (1) A person (“P”) is disqualified for being appointed as chairman, deputy chairman, or as any other member of the Authority if— (a) P is the subject of a bankruptcy restrictions order or interim order, (b) a bankruptcy order has been made against P by a court in Northern Ireland, P's estate has been sequestered by a court in Scotland, or under the law of Northern Ireland or Scotland, P has made a composition or arrangement with, or granted a trust deed for, P's creditors, or (c) in the last five years P has been convicted in the United Kingdom, the Channel Islands or the Isle of Man of an offence and has had a qualifying sentence passed on P. (2) Where P is disqualified under sub-paragraph (1)(b) because a bankruptcy order has been made against P or P's estate has been sequestered, the disqualification ceases— (a) on P obtaining a discharge, or (b) if the bankruptcy order is annulled or the sequestration of P's estate is recalled or reduced, on the date of that event. (3) Where P is disqualified under sub-paragraph (1)(b) because of P having made a composition or arrangement with, or granted a trust deed for, P's creditors, the disqualification ceases— (a) at the end of the period of five years beginning with the date on which the terms of the deed of composition or arrangement or trust deed are fulfilled, or (b) if, before then, P pays P's debts in full, on the date on which the payment is completed. (4) For the purposes of sub-paragraph (1)(c), the date of conviction is to be taken to be the ordinary date on which the period allowed for making an appeal or application expires or, if an appeal or application is made, the date on which the appeal or application is finally disposed of or abandoned or fails by reason of its non-prosecution. (5) In sub-paragraph (1)(c), the reference to a qualifying sentence is to a sentence of imprisonment for a period of not less than three months (whether suspended or not) without the option of a fine.

3

In paragraph 5—

(a) after sub-paragraph (4), insert—

(4A) A person holding office as chairman, deputy chairman or other member of the Authority is to cease to hold that office if the person becomes disqualified for appointment to it.

, and

(b) in sub-paragraph (5)—

(i) omit paragraph (b) and the word “or” immediately after it,

(ii) in paragraph (c) for “functions of a member” substitute “ person's functions as chairman, deputy chairman or other member ”, and

(iii) in the full-out words, for the words from “declare” to the end substitute “ remove the member from office as chairman, deputy chairman or other member ”.

SCHEDULE 2

Introductory

1

Schedule 2 to the 1990 Act (activities for which licences may be granted) is amended as follows.

Licences for treatment

2

(1) Paragraph 1 (licences for treatment) is amended as follows.

(2) In sub-paragraph (1)—

(a) after paragraph (c) insert—

(ca) using embryos for the purpose of training persons in embryo biopsy, embryo storage or other embryological techniques,

(b) in paragraph (d), omit the words from “or” onwards,

(d) in paragraph (g), after “practices” insert “ , apart from practices falling within section 4A(2), ”.

(3) For sub-paragraph (4) substitute—

(4) A licence under this paragraph cannot authorise altering the nuclear or mitochondrial DNA of a cell while it forms part of an embryo, except for the purpose of creating something that will by virtue of regulations under section 3ZA(5) be a permitted embryo.

(4) After sub-paragraph (4) insert—

(4A) A licence under this paragraph cannot authorise the use of embryos for the purpose mentioned in sub-paragraph (1)(ca) unless the Authority is satisfied that the proposed use of embryos is necessary for that purpose.

(5) At the end insert—

(6) In this paragraph, references to a permitted embryo are to be read in accordance with section 3ZA.

Embryo testing and sex selection

3

After paragraph 1 insert—

(1ZA) (1) A licence under paragraph 1 cannot authorise the testing of an embryo, except for one or more of the following purposes— (a) establishing whether the embryo has a gene, chromosome or mitochondrion abnormality that may affect its capacity to result in a live birth, (b) in a case where there is a particular risk that the embryo may have any gene, chromosome or mitochondrion abnormality, establishing whether it has that abnormality or any other gene, chromosome or mitochondrion abnormality, (c) in a case where there is a particular risk that any resulting child will have or develop— (i) a gender-related serious physical or mental disability, (ii) a gender-related serious illness, or (iii) any other gender-related serious medical condition, establishing the sex of the embryo, (d) in a case where a person (“the sibling”) who is the child of the persons whose gametes are used to bring about the creation of the embryo (or of either of those persons) suffers from a serious medical condition which could be treated by umbilical cord blood stem cells, bone marrow or other tissue of any resulting child, establishing whether the tissue of any resulting child would be compatible with that of the sibling, and (e) in a case where uncertainty has arisen as to whether the embryo is one of those whose creation was brought about by using the gametes of particular persons, establishing whether it is. (2) A licence under paragraph 1 cannot authorise the testing of embryos for the purpose mentioned in sub-paragraph (1)(b) unless the Authority is satisfied— (a) in relation to the abnormality of which there is a particular risk, and (b) in relation to any other abnormality for which testing is to be authorised under sub-paragraph (1)(b), that there is a significant risk that a person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition. (3) For the purposes of sub-paragraph (1)(c), a physical or mental disability, illness or other medical condition is gender-related if the Authority is satisfied that— (a) it affects only one sex, or (b) it affects one sex significantly more than the other. (4) In sub-paragraph (1)(d) the reference to “other tissue” of the resulting child does not include a reference to any whole organ of the child. (1ZB) (1) A licence under paragraph 1 cannot authorise any practice designed to secure that any resulting child will be of one sex rather than the other. (2) Sub-paragraph (1) does not prevent the authorisation of any testing of embryos that is capable of being authorised under paragraph 1ZA. (3) Sub-paragraph (1) does not prevent the authorisation of any other practices designed to secure that any resulting child will be of one sex rather than the other in a case where there is a particular risk that a woman will give birth to a child who 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. (4) For the purposes of sub-paragraph (3), a physical or mental disability, illness or other medical condition is gender-related if the Authority is satisfied that— (a) it affects only one sex, or (b) it affects one sex significantly more than the other. (1ZC) (1) Regulations may make any amendment of paragraph 1ZA (embryo testing). (2) Regulations under this paragraph which amend paragraph 1ZA may make any amendment of sub-paragraphs (2) to (4) of paragraph 1ZB (sex selection) which appears to the Secretary of State to be necessary or expedient in consequence of the amendment of paragraph 1ZA. (3) Regulations under this paragraph may not enable the authorisation of— (a) the testing of embryos for the purpose of establishing their sex, or (b) other practices falling within paragraph 1ZB(1), except on grounds relating to the health of any resulting child. (4) For the purposes of this paragraph, “amend” includes add to and repeal, and references to “amendment” are to be read accordingly.

Licences for non-medical fertility services

4

In paragraph 1A (licences for non-medical fertility services) after sub-paragraph (1) insert—

(1A) A licence under this paragraph cannot authorise the procurement or distribution of sperm to which there has been applied any process designed to secure that any resulting child will be of one sex rather than the other.

Licences for storage

5

In paragraph 2 (licences for storage)—

(a) after sub-paragraph (1) insert—

(1A) A licence under this paragraph or paragraph 3 may authorise the storage of human admixed embryos (whether or not the licence also authorises the storage of gametes or embryos or both).

, and

(b) in sub-paragraph (2), after “such storage” insert “ as is mentioned in sub-paragraph (1) or (1A) ”.

Licences for research

6

For paragraph 3 substitute—

(3) (1) A licence under this paragraph may authorise any of the following— (a) bringing about the creation of embryos in vitro, and (b) keeping or using embryos, for the purposes of a project of research specified in the licence. (2) A licence under this paragraph may authorise mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of developing more effective techniques for determining the fertility or normality of sperm, but only where anything which forms is destroyed when the research is complete and, in any event, no later than the two cell stage. (3) A licence under this paragraph may authorise any of the following— (a) bringing about the creation of human admixed embryos in vitro, and (b) keeping or using human admixed embryos, for the purposes of a project of research specified in the licence. (4) A licence under sub-paragraph (3) may not authorise the activity which may be authorised by a licence under sub-paragraph (2). (5) No licence under this paragraph is to be granted unless the Authority is satisfied that any proposed use of embryos or human admixed embryos is necessary for the purposes of the research. (6) Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence. (7) A licence under this paragraph may authorise the performance of any of the activities referred to in sub-paragraph (1), (2) or (3) in such manner as may be so specified. (8) A licence under this paragraph may be granted for such period not exceeding three years as may be specified in the licence. (9) This paragraph has effect subject to paragraph 3A. (3A) (1) A licence under paragraph 3 cannot authorise any activity unless the activity appears to the Authority— (a) to be necessary or desirable for any of the purposes specified in sub-paragraph (2) (“the principal purposes”), (b) to be necessary or desirable for the purpose of providing knowledge that, in the view of the Authority, may be capable of being applied for the purposes specified in sub-paragraph (2)(a) or (b), or (c) to be necessary or desirable for such other purposes as may be specified in regulations. (2) The principal purposes are— (a) increasing knowledge about serious disease or other serious medical conditions, (b) developing treatments for serious disease or other serious medical conditions, (c) increasing knowledge about the causes of any congenital disease or congenital medical condition that does not fall within paragraph (a), (d) promoting advances in the treatment of infertility, (e) increasing knowledge about the causes of miscarriage, (f) developing more effective techniques of contraception, (g) developing methods for detecting the presence of gene, chromosome or mitochondrion abnormalities in embryos before implantation, or (h) increasing knowledge about the development of embryos.

SCHEDULE 3

Introductory

1

Schedule 3 to the 1990 Act (giving of consent to use or storage of gametes or embryos) is amended as follows.

2

In the title to that Schedule, for “OF GAMETES OR EMBRYOS”, substitute “ OR STORAGE OF GAMETES, EMBRYOS OR HUMAN ADMIXED EMBRYOS ETC ”.

3

For paragraph 1 substitute—

(1) (1) A consent under this Schedule, and any notice under paragraph 4 varying or withdrawing a consent under this Schedule, must be in writing and, subject to sub-paragraph (2), must be signed by the person giving it. (2) A consent under this Schedule by a person who is unable to sign because of illness, injury or physical disability (a “person unable to sign”), and any notice under paragraph 4 by a person unable to sign varying or withdrawing a consent under this Schedule, is to be taken to comply with the requirement of sub-paragraph (1) as to signature if it is signed at the direction of the person unable to sign, in the presence of the person unable to sign and in the presence of at least one witness who attests the signature. (3) In this Schedule “effective consent” means a consent under this Schedule which has not been withdrawn.

4

(1) Paragraph 2 (terms etc. of consent) is amended as follows.

(2) In sub-paragraph (1), for the “or” at the end of paragraph (b) substitute—

(ba) use for the purpose of training persons in embryo biopsy, embryo storage or other embryological techniques, or

(3) After sub-paragraph (1) insert—

(1A) A consent to the use of any human admixed embryo must specify use for the purposes of any project of research and may specify conditions subject to which the human admixed embryo may be so used.

(4) For sub-paragraph (2) substitute—

(2) A consent to the storage of any gametes, any embryo or any human admixed embryo must— (a) specify the maximum period of storage (if less than the statutory storage period), (b) except in a case falling within paragraph (c), state what is to be done with the gametes, embryo or human admixed embryo if the person who gave the consent dies or is unable, because the person lacks capacity to do so, to vary the terms of the consent or to withdraw it, and (c) where the consent is given by virtue of paragraph 8(2A) or 13(2), state what is to be done with the embryo or human admixed embryo if the person to whom the consent relates dies, and may (in any case) specify conditions subject to which the gametes, embryo or human admixed embryo may remain in storage. (2A) A consent to the use of a person's human cells to bring about the creation in vitro of an embryo or human admixed embryo is to be taken unless otherwise stated to include consent to the use of the cells after the person's death. (2B) In relation to Scotland, the reference in sub-paragraph (2)(b) to the person lacking capacity is to be read as a reference to the person— (a) lacking capacity within the meaning of the Age of Legal Capacity (Scotland) Act 1991, or (b) being incapable within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000.

(5) For sub-paragraph (4) substitute—

(4) A consent under this Schedule may apply— (a) to the use or storage of a particular embryo or human admixed embryo, or (b) in the case of a person providing gametes or human cells, to the use or storage of— (i) any embryo or human admixed embryo whose creation may be brought about using those gametes or those cells, and (ii) any embryo or human admixed embryo whose creation may be brought about using such an embryo or human admixed embryo. (5) In the case of a consent falling within sub-paragraph (4)(b), the terms of the consent may be varied, or the consent may be withdrawn, in accordance with this Schedule either generally or in relation to— (a) a particular embryo or particular embryos, or (b) a particular human admixed embryo or particular human admixed embryos.

5

In paragraph 3 (procedure for giving consent), in sub-paragraph (2), after “paragraph 4” insert “ and, if relevant, paragraph 4A ”.

6

(1) Paragraph 4 (variation and withdrawal of consent) is amended as follows.

(2) In sub-paragraph (1), for “or embryo” substitute “ , human cells, embryo or human admixed embryo ”.

(3) In sub-paragraph (2)—

(a) for “The” substitute “ Subject to sub-paragraph (3), the ”, and

(b) for the “or” at the end of paragraph (a) substitute—

(aa) in training persons in embryo biopsy, embryo storage or other embryological techniques, or

(4) After sub-paragraph (2) insert—

(3) Where the terms of any consent to the use of an embryo (“embryo A”) include consent to the use of an embryo or human admixed embryo whose creation may be brought about in vitro using embryo A, that consent to the use of that subsequent embryo or human admixed embryo cannot be varied or withdrawn once embryo A has been used for one or more of the purposes mentioned in sub-paragraph (2)(a) or (b). (4) Subject to sub-paragraph (5), the terms of any consent to the use of any human admixed embryo cannot be varied, and such consent cannot be withdrawn, once the human admixed embryo has been used for the purposes of any project of research. (5) Where the terms of any consent to the use of a human admixed embryo (“human admixed embryo A”) include consent to the use of a human admixed embryo or embryo whose creation may be brought about in vitro using human admixed embryo A, that consent to the use of that subsequent human admixed embryo or embryo cannot be varied or withdrawn once human admixed embryo A has been used for the purposes of any project of research.

7

After paragraph 4 insert—

(4A) (1) This paragraph applies where— (a) a permitted embryo, the creation of which was brought about in vitro, is in storage, (b) it was created for use in providing treatment services, (c) before it is used in providing treatment services, one of the persons whose gametes were used to bring about its creation (“P”) gives the person keeping the embryo notice withdrawing P's consent to the storage of the embryo, and (d) the embryo was not to be used in providing treatment services to P alone. (2) The person keeping the embryo must as soon as possible take all reasonable steps to notify each interested person in relation to the embryo of P's withdrawal of consent. (3) For the purposes of sub-paragraph (2), a person is an interested person in relation to an embryo if the embryo was to be used in providing treatment services to that person. (4) Storage of the embryo remains lawful until— (a) the end of the period of 12 months beginning with the day on which the notice mentioned in sub-paragraph (1) was received from P, or (b) if, before the end of that period, the person keeping the embryo receives a notice from each person notified of P's withdrawal under sub-paragraph (2) stating that the person consents to the destruction of the embryo, the time at which the last of those notices is received. (5) The reference in sub-paragraph (1)(a) to a permitted embryo is to be read in accordance with section 3ZA.

8

In paragraph 5 (use of gametes for treatment of others), in sub-paragraph (1), after “treatment services” insert “ or non-medical fertility services ”.

In vitro fertilisation and subsequent use of embryo

9

(1) Paragraph 6 (in vitro fertilisation and subsequent use of embryo) is amended as follows.

(2) In sub-paragraph (1)—

(a) after “person's gametes” insert “ or human cells ”,

(b) after “to any embryo” insert a comma,

(d) for “paragraph 2(1)” substitute “ paragraph 2(1)(a), (b) and (c) ”.

(3) In sub-paragraph (2)—

(a) for the words from “each person” to “creation of” substitute “ each relevant person in relation to ”, and

(b) for “paragraph 2(1)” substitute “ paragraph 2(1)(a), (b), (ba) and (c) ”.

(4) In sub-paragraph (3), for the words from “person” to “creation of” substitute “ relevant person in relation to ”.

(5) After sub-paragraph (3) insert—

(3A) If the Authority is satisfied that the parental consent conditions in paragraph 15 are met in relation to the proposed use under a licence of the human cells of a person who has not attained the age of 18 years (“C”), the Authority may in the licence authorise the application of sub-paragraph (3B) in relation to C. (3B) Where the licence authorises the application of this sub-paragraph, the effective consent of a person having parental responsibility for C— (a) to the use of C's human cells to bring about the creation of an embryo in vitro for use for the purposes of a project of research, or (b) to the use for those purposes of an embryo in relation to which C is a relevant person by reason only of the use of C's human cells, is to be treated for the purposes of sub-paragraphs (1) to (3) as the effective consent of C. (3C) If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraphs (1) to (3) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (3B) ceases to apply in relation to C. (3D) Sub-paragraphs (1) to (3) have effect subject to paragraphs 16 and 20. (3E) For the purposes of sub-paragraphs (2), (3) and (3B), each of the following is a relevant person in relation to an embryo the creation of which was brought about in vitro (“embryo A”)— (a) each person whose gametes or human cells were used to bring about the creation of embryo A, (b) each person whose gametes or human cells were used to bring about the creation of any other embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A, and (c) each person whose gametes or human cells were used to bring about the creation of any human admixed embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A.

Use of embryos obtained by lavage etc.

10

(1) Paragraph 7 (embryos obtained by lavage etc.) is amended as follows.

(2) In sub-paragraph (3), for “This paragraph does” substitute “ Sub-paragraphs (1) and (2) do ”.

(3) After sub-paragraph (3) insert—

(4) An embryo taken from a woman must not be used to bring about the creation of any embryo in vitro or any human admixed embryo in vitro.

Consents in relation to storage

11

(1) Paragraph 8 (storage of gametes and embryos) is amended as follows.

(2) In sub-paragraph (2), for the words from “person” to “creation of” substitute “ relevant person in relation to ”.

(3) After sub-paragraph (2) insert—

(2A) Where a licence authorises the application of paragraph 6(3B) in relation to a person who has not attained the age of 18 years (“C”), the effective consent of a person having parental responsibility for C to the storage of an embryo in relation to which C is a relevant person by reason only of the use of C's human cells is to be treated for the purposes of sub-paragraph (2) as the effective consent of C. (2B) If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraph (2) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (2A) ceases to apply in relation to C. (2C) For the purposes of sub-paragraphs (2) and (2A), each of the following is a relevant person in relation to an embryo the creation of which was brought about in vitro (“embryo A”)— (a) each person whose gametes or human cells were used to bring about the creation of embryo A, (b) each person whose gametes or human cells were used to bring about the creation of any other embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A, and (c) each person whose gametes or human cells were used to bring about the creation of any human admixed embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A.

(4) After sub-paragraph (3) insert—

(4) Sub-paragraph (1) has effect subject to paragraphs 9 and 10; and sub-paragraph (2) has effect subject to paragraphs 4A(4), 16 and 20.

12

After paragraph 8 insert—

(9) (1) The gametes of a person (“C”) may be kept in storage without C's consent if the following conditions are met. (2) Condition A is that the gametes are lawfully taken from or provided by C before C attains the age of 18 years. (3) Condition B is that, before the gametes are first stored, a registered medical practitioner certifies in writing that C is expected to undergo medical treatment and that in the opinion of the registered medical practitioner— (a) the treatment is likely to cause a significant impairment of C's fertility, and (b) the storage of the gametes is in C's best interests. (4) Condition C is that, at the time when the gametes are first stored, either— (a) C has not attained the age of 16 years and is not competent to deal with the issue of consent to the storage of the gametes, or (b) C has attained that age but, although not lacking capacity to consent to the storage of the gametes, is not competent to deal with the issue of consent to their storage. (5) Condition D is that C has not, since becoming competent to deal with the issue of consent to the storage of the gametes— (a) given consent under this Schedule to the storage of the gametes, or (b) given written notice to the person keeping the gametes that C does not wish them to continue to be stored. (6) In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications— (a) for sub-paragraph (4), substitute— (4) Condition C is that, at the time when the gametes are first stored, C does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the storage of the gametes. (b) in sub-paragraph (5), for “becoming competent to deal with the issue of consent to the storage of the gametes” substitute “ acquiring such capacity ”. (10) (1) The gametes of a person (“P”) may be kept in storage without P's consent if the following conditions are met. (2) Condition A is that the gametes are lawfully taken from or provided by P after P has attained the age of 16 years. (3) Condition B is that, before the gametes are first stored, a registered medical practitioner certifies in writing that P is expected to undergo medical treatment and that in the opinion of the registered medical practitioner— (a) the treatment is likely to cause a significant impairment of P's fertility, (b) P lacks capacity to consent to the storage of the gametes, (c) P is likely at some time to have that capacity, and (d) the storage of the gametes is in P's best interests. (4) Condition C is that, at the time when the gametes are first stored, P lacks capacity to consent to their storage. (5) Condition D is that P has not subsequently, at a time when P has capacity to give a consent under this Schedule— (a) given consent to the storage of the gametes, or (b) given written notice to the person keeping the gametes that P does not wish them to continue to be stored. (6) In relation to Scotland— (a) references in sub-paragraphs (3) and (4) to P lacking capacity to consent are to be read as references to P being incapable, within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000, of giving such consent, (b) the references in sub-paragraphs (3) and (5) to P having capacity are to be read as references to P not being so incapable, and (c) that Act applies to the storage of gametes under this paragraph to the extent specified in section 84A of that Act. (11) A person's gametes must not be kept in storage by virtue of paragraph 9 or 10 after the person's death.

Creation, use and storage of human admixed embryos

13

After paragraph 11 (as inserted by paragraph 12 above) insert—

(12) (1) A person's gametes or human cells must not be used to bring about the creation of any human admixed embryo in vitro unless there is an effective consent by that person to any human admixed embryo, the creation of which may be brought about with the use of those gametes or human cells, being used for the purposes of any project of research. (2) A human admixed embryo the creation of which was brought about in vitro must not be received by any person unless there is an effective consent by each relevant person in relation to the human admixed embryo to the use of the human admixed embryo for the purposes of any project of research. (3) A human admixed embryo the creation of which was brought about in vitro must not be used for the purposes of a project of research unless— (a) there is an effective consent by each relevant person in relation to the human admixed embryo to the use of the human admixed embryo for that purpose, and (b) the human admixed embryo is used in accordance with those consents. (4) If the Authority is satisfied that the parental consent conditions in paragraph 15 are met in relation to the proposed use under a licence of the human cells of a person who has not attained the age of 18 years (“C”), the Authority may in the licence authorise the application of sub-paragraph (5) in relation to C. (5) Where the licence authorises the application of this sub-paragraph, the effective consent of a person having parental responsibility for C— (a) to the use of C's human cells to bring about the creation of a human admixed embryo in vitro for use for the purposes of a project of research, or (b) to the use for those purposes of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C's human cells, is to be treated for the purposes of sub-paragraphs (1) to (3) as the effective consent of C. (6) If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraphs (1) to (3) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (5) ceases to apply in relation to C. (7) Sub-paragraphs (1) to (3) have effect subject to paragraphs 16 and 20. (13) (1) A human admixed embryo the creation of which was brought about in vitro must not be kept in storage unless— (a) there is an effective consent by each relevant person in relation to the human admixed embryo to the storage of the human admixed embryo, and (b) the human admixed embryo is stored in accordance with those consents. (2) Where a licence authorises the application of paragraph 12(5) in relation to a person who has not attained the age of 18 years (“C”), the effective consent of a person having parental responsibility for C to the storage of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C's human cells is to be treated for the purposes of sub-paragraph (1) as the effective consent of C. (3) If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraph (1) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (2) ceases to apply in relation to C. (4) Sub-paragraph (1) has effect subject to paragraphs 16 and 20. (14) For the purposes of paragraphs 12 and 13, each of the following is a relevant person in relation to a human admixed embryo the creation of which was brought about in vitro (“human admixed embryo A”)— (a) each person whose gametes or human cells were used to bring about the creation of human admixed embryo A, (b) each person whose gametes or human cells were used to bring about the creation of any embryo, the creation of which was brought about in vitro, which was used to bring about the creation of human admixed embryo A, and (c) each person whose gametes or human cells were used to bring about the creation of any other human admixed embryo, the creation of which was brought about in vitro, which was used to bring about the creation of human admixed embryo A.

14

After paragraph 14 (as inserted by paragraph 13 above) insert—

(15) (1) In relation to a person who has not attained the age of 18 years (“C”), the parental consent conditions referred to in paragraphs 6(3A) and 12(4) are as follows. (2) Condition A is that C suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition. (3) Condition B is that either— (a) C is not competent to deal with the issue of consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or (b) C has attained the age of 16 years but lacks capacity to consent to such use of C's human cells. (4) Condition C is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about— (a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or (b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition. (5) Condition D is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who— (a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or (b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells. (6) In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications— (a) for sub-paragraph (3) substitute— (3) Condition B is that C does not have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research. (b) in sub-paragraph (5)(a), for “have capacity to consent” substitute “ are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent ”, and (c) in sub-paragraph (5)(b), for “are competent to deal with the issue of” substitute “ have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to ”. (16) (1) If, in relation to the proposed use under a licence of the human cells of a person who has attained the age of 18 years (“P”), the Authority is satisfied— (a) that the conditions in paragraph 17 are met, (b) that paragraphs (1) to (4) of paragraph 18 have been complied with, and (c) that the condition in paragraph 18(5) is met, the Authority may in the licence authorise the application of this paragraph in relation to P. (2) Where a licence authorises the application of this paragraph, this Schedule does not require the consent of P— (a) to the use (whether during P's life or after P's death) of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, (b) to the storage or the use for those purposes (whether during P's life or after P's death) of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of P's human cells. (3) This paragraph has effect subject to paragraph 19. (17) (1) The conditions referred to in paragraph 16(1)(a) are as follows. (2) Condition A is that P suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition. (3) Condition B is that P lacks capacity to consent to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research. (4) Condition C is that the person responsible under the licence has no reason to believe that P had refused such consent at a time when P had that capacity. (5) Condition D is that it appears unlikely that P will at some time have that capacity. (6) Condition E is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about— (a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or (b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition. (7) Condition F is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who— (a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or (b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells. (8) In this paragraph and paragraph 18 references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible. (9) In relation to Scotland— (a) references in sub-paragraphs (3) to (5) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent, and (b) sub-paragraph (7) is to be read with the following modifications— (i) in paragraph (a), for “have capacity to consent” substitute “ are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent ”, and (ii) in paragraph (b), for “are competent to deal with the issue of” substitute “ have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to ”. (18) (1) This paragraph applies in relation to a person who has attained the age of 18 years (“P”) where the person responsible under the licence (“R”) wishes to use P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, in a case where P lacks capacity to consent to their use. (2) R must take reasonable steps to identify a person who— (a) otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P's welfare, and (b) is prepared to be consulted by R under this paragraph of this Schedule. (3) If R is unable to identify such a person R must nominate a person who— (a) is prepared to be consulted by R under this paragraph of this Schedule, but (b) has no connection with the project. (4) R must provide the person identified under sub-paragraph (2) or nominated under sub-paragraph (3) (“F”) with information about the proposed use of human cells to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project and ask F what, in F's opinion, P's wishes and feelings about the use of P's human cells for that purpose would be likely to be if P had capacity in relation to the matter. (5) The condition referred to in paragraph 16(1)(c) is that, on being consulted, F has not advised R that in F's opinion P's wishes and feelings would be likely to lead P to decline to consent to the use of P's human cells for that purpose. (6) In relation to Scotland, the references in sub-paragraphs (1) and (4) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent. (19) (1) Paragraph 16 does not apply to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo if, at a time before the human cells are used for that purpose, P— (a) has capacity to consent to their use, and (b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose. (2) Paragraph 16 does not apply to the storage or use of an embryo or human admixed embryo whose creation in vitro was brought about with the use of P's human cells if, at a time before the embryo or human admixed embryo is used for the purposes of the project of research, P— (a) has capacity to consent to the storage or use, and (b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose. (3) In relation to Scotland, the references in sub-paragraphs (1)(a) and (2)(a) to P having capacity to consent are to be read as references to P not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent. (20) (1) Where a licence authorises the application of this paragraph in relation to qualifying cells, this Schedule does not require the consent of a person (“P”)— (a) to the use of qualifying cells of P to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or (b) to the storage or the use for those purposes of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of qualifying cells of P. (2) “Qualifying cells” are human cells which— (a) were lawfully stored for research purposes immediately before the commencement date, or (b) are derived from human cells which were lawfully stored for those purposes at that time. (3) The “commencement date” is the date on which paragraph 9(2)(a) of Schedule 3 to the Human Fertilisation and Embryology Act 2008 (requirement for consent to use of human cells to create an embryo) comes into force. (21) (1) A licence may not authorise the application of paragraph 20 unless the Authority is satisfied— (a) that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are— (i) human cells in respect of which there is an effective consent to their use to bring about the creation in vitro of embryos or human admixed embryos for use for those purposes, or (ii) human cells which by virtue of paragraph 16 can be used without such consent, and (b) that any of the following conditions is met in relation to each of the persons whose human cells are qualifying cells which are to be used for the purposes of the project of research. (2) Condition A is that— (a) it is not reasonably possible for the person responsible under the licence (“R”) to identify the person falling within sub-paragraph (1)(b) (“P”), and (b) where any information that relates to P (without identifying P or enabling P to be identified) is available to R, that information does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project. (3) Condition B is that— (a) the person falling within sub-paragraph (1)(b) (“P”) is dead or the person responsible under the licence (“R”) believes on reasonable grounds that P is dead, (b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, and (c) a person who stood in a qualifying relationship to P immediately before P died (or is believed to have died) has given consent in writing to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project. (4) Condition C is that— (a) the person responsible under the licence (“R”) has taken all reasonable steps to contact— (i) the person falling within sub-paragraph (1)(b) (“P”), or (ii) in a case where P is dead or R believes on reasonable grounds that P is dead, persons who could give consent for the purposes of sub-paragraph (3)(c), but has been unable to do so, and (b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project. (5) The HTA consent provisions apply in relation to consent for the purposes of sub-paragraph (3)(c) as they apply in relation to consent for the purposes of section 3(6)(c) of the Human Tissue Act 2004; and for the purposes of this sub-paragraph the HTA consent provisions are to be treated as if they extended to Scotland. (6) In sub-paragraph (5) “the HTA consent provisions” means subsections (4), (5), (6), (7) and (8)(a) and (b) of section 27 of the Human Tissue Act 2004. (7) In this paragraph references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible. (8) Paragraphs 1 to 4 of this Schedule do not apply in relation to a consent given for the purposes of sub-paragraph (3)(c).

Interpretation

15

After paragraph 21 (as inserted by paragraph 14 above) insert—

(22) (1) In this Schedule references to human cells are to human cells which are not— (a) cells of the female or male germ line, or (b) cells of an embryo. (2) References in this Schedule to an embryo or a human admixed embryo which was used to bring about the creation of an embryo (“embryo A”) or a human admixed embryo (“human admixed embryo A”) include an embryo or, as the case may be, a human admixed embryo which was used to bring about the creation of— (a) an embryo or human admixed embryo which was used to bring about the creation of embryo A or human admixed embryo A, and (b) the predecessor of that embryo or human admixed embryo mentioned in paragraph (a), and (c) the predecessor of that predecessor, and so on. (3) References in this Schedule to an embryo or a human admixed embryo whose creation may be brought about using an embryo or a human admixed embryo are to be read in accordance with sub-paragraph (2). (4) References in this Schedule (however expressed) to the use of human cells to bring about the creation of an embryo or a human admixed embryo include the use of human cells to alter the embryo or, as the case may be, the human admixed embryo. (5) References in this Schedule to parental responsibility are— (a) in relation to England and Wales, to be read in accordance with the Children Act 1989, (b) in relation to Northern Ireland, to be read in accordance with the Children (Northern Ireland) Order 1995, and (c) in relation to Scotland, to be read as references to parental responsibilities and parental rights within the meaning of the Children (Scotland) Act 1995. (6) References in this Schedule to capacity are, in relation to England and Wales, to be read in accordance with the Mental Capacity Act 2005. (7) References in this Schedule to the age of 18 years are, in relation to Scotland, to be read as references to the age of 16 years.

SCHEDULE 4

SCHEDULE 5

SCHEDULE 6

Part 1 — General

Population (Statistics) Act 1938 (c. 12)

1

(1) In the Schedule to the Population (Statistics) Act 1938 (particulars which may be required), in paragraph 1 (which relates to the registration of a birth)—

(a) in paragraph (b), after “child,” insert “ or as a parent of the child by virtue of section 42 or 43 of the Human Fertilisation and Embryology Act 2008, ”, and

(b) in paragraph (c)—

(i) in sub-paragraph (i), after “marriage” insert “ or of their formation of a civil partnership ”, and

(ii) at the beginning of each of sub-paragraphs (ii) and (iii) insert “ where the parents are married, ”.

(2) Sub-paragraph (1)(b)(ii) does not extend to Scotland.

Births and Deaths Registration Act 1953 (c. 20)

2

In section 1 of the Births and Deaths Registration Act 1953 (particulars of births to be registered) after subsection (2) insert—

(3) In the case of a child who has a parent by virtue of section 42 or 43 of the Human Fertilisation and Embryology Act 2008, the reference in subsection (2)(a) to the father of the child is to be read as a reference to the woman who is a parent by virtue of that section.

3

In section 2 of the Births and Deaths Registration Act 1953 (information concerning birth to be given to registrar within 42 days), renumber the existing provision as subsection (1) of the section and at the end insert—

(2) In the case of a child who has a parent by virtue of section 42 or 43 of the Human Fertilisation and Embryology Act 2008, the references in subsection (1) to the father of the child are to be read as references to the woman who is a parent by virtue of that section.

4

In section 9(4) of the Births and Deaths Registration Act 1953 (giving of information to a person other than the registrar), after “that section,” insert “ or under paragraph (b), (c) or (d) of subsection (1B) of that section, ”.

5

(1) Section 10 of the Births and Deaths Registration Act 1953 (registration of father where parents not married) is amended as follows.

(2) For the heading to the section substitute “ Registration of father where parents not married or of second female parent where parents not civil partners ”.

(3) After subsection (1A) insert—

(1B) Notwithstanding anything in the foregoing provisions of this Act and subject to section 10ZA of this Act, in the case of a child to whom section 1(3) of the Family Law Reform Act 1987 does not apply no woman shall as a parent of the child by virtue of section 43 of the Human Fertilisation and Embryology Act 2008 be required to give information concerning the birth of the child, and the registrar shall not enter in the register the name of any woman as a parent of the child by virtue of that section except— (a) at the joint request of the mother and the person stating herself to be the other parent of the child (in which case that person shall sign the register together with the mother); or (b) at the request of the mother on production of— (i) a declaration in the prescribed form made by the mother stating that the person to be registered (“the woman concerned”) is a parent of the child by virtue of section 43 of the Human Fertilisation and Embryology Act 2008; and (ii) a statutory declaration made by the woman concerned stating herself to be a parent of the child by virtue of section 43 of that Act; or (c) at the request of the woman concerned on production of— (i) a declaration in the prescribed form made by the woman concerned stating herself to be a parent of the child by virtue of section 43 of the Human Fertilisation and Embryology Act 2008; and (ii) a statutory declaration made by the mother stating that the woman concerned is a parent of the child by virtue of section 43 of that Act; or (d) at the request of the mother or the woman concerned on production of— (i) a copy of any agreement made between them under section 4ZA(1)(b) of the Children Act 1989 in relation to the child; and (ii) a declaration in the prescribed form by the person making the request stating that the agreement was made in compliance with section 4ZA of that Act and has not been brought to an end by an order of a court; or (e) at the request of the mother or the woman concerned on production of— (i) a certified copy of an order under section 4ZA of the Children Act 1989 giving the woman concerned parental responsibility for the child; and (ii) a declaration in the prescribed form by the person making the request stating that the order has not been brought to an end by an order of a court; or (f) at the request of the mother or the woman concerned on production of— (i) a certified copy of an order under paragraph 1 of Schedule 1 to the Children Act 1989 which requires the woman concerned to make any financial provision for the child and which is not an order falling within paragraph 4(3) of that Schedule; and (ii) a declaration in the prescribed form by the person making the request stating that the order has not been discharged by an order of a court.

(4) After subsection (2) insert—

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Human Fertilisation and Embryology Act 2008

Cases in which woman to be other parent

Woman in civil partnership at time of treatment

42

Treatment provided to woman who agrees that second woman to be parent

43

The agreed female parenthood conditions

44

Further provision relating to sections 42 and 43

45

Embryo transferred after death of civil partner or intended female parent

46

Woman not to be other parent merely because of egg donation

47

Effect of sections 33 to 47

Effect of sections 33 to 47

48

References to parties to marriage or civil partnership

Meaning of references to parties to a marriage

49

Meaning of references to parties to a civil partnership

50

Further provision about registration by virtue of section 39, 40 or 46

Meaning of “relevant register of births”

51

Late election by mother with consent of Registrar General

52

Interpretation of references to father etc. where woman is other parent

Interpretation of references to father etc.

53

Parental orders

Parental orders

54

Parental orders: supplementary provision

55

Amendments of enactments

Amendments relating to parenthood in cases involving assisted reproduction

56

General

Repeals and transitional provision relating to Part 2

57

Interpretation of Part 2

58

Part 3 — Miscellaneous and General

Miscellaneous

Surrogacy arrangements

59

Exclusion of embryos from definition of “organism” in Part 6 of the EPA 1990

60

General

Orders and regulations: general provisions

61

Orders and regulations: parliamentary control

62

Meaning of “the 1990 Act”

63

Power to make consequential and transitional provision etc.

64

Minor and consequential amendments

65

Repeals and revocations

66

Extent

67

Commencement

68

Short title

69

SCHEDULE 1

1

2

3

SCHEDULE 2

Introductory

1

Licences for treatment

2

Embryo testing and sex selection

3

Licences for non-medical fertility services