Human Fertilisation and Embryology Act 1990

• (b) does anything which, by virtue of section 3(3) of this Act, cannot be authorised by a licence,

is guilty of an offence and liable on conviction on indictment to imprisonment for a term not exceeding ten years or a fine or both.

• (2) A person who—

• (a) contravenes section 3(1) or (1A) of this Act, otherwise than by doing something which, by virtue of section 3(3) of this Act, cannot be authorised by a licence,

• (aa) contravenes section 3(1B) of this Act,

• (b) keeps ... any gametes in contravention of section 4(1)(a) ... of this Act,

• (ba) uses any gametes in contravention of section 4(1)(b),

• (bb) contravenes section 4(1A) of this Act,

• (c) contravenes section 4(3) of this Act, or

• (d) fails to comply with any directions given by virtue of section 24(5D) of this Act,

is guilty of an offence.

• (2A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) If a person—

• (a) provides any information for the purposes of the grant of a licence, being information which is false or misleading in a material particular, and

• (b) either he knows the information to be false or misleading in a material particular or he provides the information recklessly,

he is guilty of an offence.

• (4) A person guilty of an offence under subsection (2) or (3) above ... is liable—

• (a) on conviction on indictment, to imprisonment for a term not exceeding two years or a fine or both, and

• (b) on summary conviction, to imprisonment for a term not exceeding six months or a fine not exceeding the statutory maximum or both.

• (4A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) A person who discloses any information in contravention of section 33A of this Act is guilty of an offence and liable—

• (a) on conviction on indictment, to imprisonment for a term not exceeding two years or a fine or both, and

• (b) on summary conviction, to imprisonment for a term not exceeding six months or a fine not exceeding the statutory maximum or both.

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) A person who without reasonable excuse fails to comply with a requirement imposed by regulations made by virtue of section 19B(3)(a) or 20B(3)(e) of this Act is guilty of an offence.

• (8) Where a person to whom a licence applies or the holder of the licence gives or receives any money or other benefit, not authorised by directions, in respect of any supply of gametes, embryos or human admixed embryos, he is guilty of an offence.

• (9) A person guilty of an offence under subsection ... (7) or (8) above is liable on summary conviction to imprisonment for a term not exceeding six months or a fine not exceeding level five on the standard scale or both.

• (10) It is a defence for a person (“the defendant”) charged with an offence of doing anything which, under section 3(1) or (1A), 4(1) or 4A(2), cannot be done except in pursuance of a licence to prove—

• (a) that the defendant was acting under the direction of another, and

• (b) that the defendant believed on reasonable grounds—

• (i) that the other person was at the material time the person responsible under a licence, a person designated by virtue of section 17(2)(b) of this Act as a person to whom a licence applied, or a person to whom directions had been given under section 24(5A) to (5D), and

• (ii) that the defendant was authorised by virtue of the licence or directions to do the thing in question.

• (10A) It is a defence for a person (“the defendant”) charged with an offence of doing anything which, under section 3(1A) or (1B) or 4(1A), cannot be done except in pursuance of a licence or a third party agreement to prove—

• (a) that the defendant was acting under the direction of another, and

• (b) that the defendant believed on reasonable grounds—

• (i) that the other person was at the material time the person responsible under a licence, a person designated by virtue of section 17(2)(b) of this Act as a person to whom a licence applied, a person to whom a third party agreement applied, or a person to whom directions had been given under section 24(5A) to (5D), and

• (ii) that the defendant was authorised by virtue of the licence, third party agreement or directions to do the thing in question.

• (11) It is a defence for a person charged with an offence under this Act to prove—

• (a) that at the material time he was a person to whom a licence or third party agreement applied or to whom directions had been given, and

• (b) that he took all such steps as were reasonable and exercised all due diligence to avoid committing the offence.

Consent to prosecution

42

No proceedings for an offence under this Act shall be instituted—

• (a) in England and Wales, except by or with the consent of the Director of Public Prosecutions, and

• (b) in Northern Ireland, except by or with the consent of the Director of Public Prosecutions for Northern Ireland.

Miscellaneous and General

Keeping and examining gametes and embryos in connection with crime, etc

43

• (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.

Civil liability to child with disability

44

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

(1A) (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”.

Regulations

45

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

• (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 under this Act shall be exercisable by statutory instrument.

• (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.

• (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;

• section 42A;

• section 43;

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

• (5) A statutory instrument containing regulations 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.

Notices

46

• (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 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.

Index

47

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.

Northern Ireland

48

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

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Short title, commencement, etc

49

• (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 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.

SCHEDULE 1

Status and capacity

1

The Authority shall not be regarded as the servant or agent of the Crown, or as enjoying any status, privilege or immunity of the Crown; and its property shall not be regarded as property of, or property held on behalf of, the Crown.

2

The Authority shall have power to do anything which is calculated to facilitate the discharge of its functions, or is incidental or conducive to their discharge, except the power to borrow money.

Expenses

3

The Secretary of State may, with the consent of the Treasury, pay the Authority out of money provided by Parliament such sums as he thinks fit towards its expenses.

Appointment of members

4

• (1) All the members of the Authority (including the chairman and deputy chairman who shall be appointed as such) shall be appointed by the Secretary of State.

• (2) In making appointments the Secretary of State shall have regard to the desirability of ensuring that the proceedings of the Authority, and the discharge of its functions, are informed by the views of both men and women.

• (3) The following persons are disqualified for being appointed as chairman or deputy chairman of the Authority—

• (a) any person who is, or has been, a medical practitioner registered under the Medical Act 1983 (whether fully, provisionally or with limited registration), or under any repealed enactment from which a provision of that Act is derived,

• (b) any person who is, or has been, concerned with keeping or using gametes or embryos outside the body, and

• (c) any person who is, or has been, directly concerned with commissioning or funding any research involving such keeping or use, or who has actively participated in any decision to do so.

• (4) The Secretary of State shall secure that at least one-third but fewer than half of the other members of the Authority fall within sub-paragraph (3)(a), (b) or (c) above, and that at least one member falls within each of paragraphs (a) and (b).

Tenure of office

5

• (1) Subject to the following provisions of this paragraph and paragraphs 5A and 5B, a person shall hold and vacate office as a member of the Authority in accordance with the terms of his appointment.

• (2) A person shall not be appointed as a member of the Authority for more than three years at a time.

• (3) A member may at any time resign his office by giving notice to the Secretary of State.

• (4) A person who ceases to be a member of the Authority shall be eligible for re-appointment (whether or not in the same capacity).

• (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.

• (5) If the Secretary of State is satisfied that a member of the Authority—

• (a) has been absent from meetings of the Authority for six consecutive months or longer without the permission of the Authority, or

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) is unable or unfit to discharge the person's functions as chairman, deputy chairman or other member,

the Secretary of State may remove the member from office as chairman, deputy chairman or other member.

Disqualification of members of Authority for House of Commons and Northern Ireland Assembly

6

In Part II of Schedule 1 to the House of Commons Disqualification Act 1975 and in Part II of Schedule 1 to the Northern Ireland Assembly Disqualification Act 1975 (bodies of which all members are disqualified) the following entry shall be inserted at the appropriate place in alphabetical order—

The Human Fertilisation and Embryology Authority

.

Remuneration and pensions of members

7

• (1) The Authority may—

• (a) pay to the chairman such remuneration, and

• (b) pay or make provision for paying to or in respect of the chairman or any other member such pensions, allowances, fees, expenses or gratuities,

as the Secretary of State may, with the approval of the Treasury, determine.

• (2) Where a person ceases to be a member of the Authority otherwise than on the expiry of his term of office and it appears to the Secretary of State that there are special circumstances which make it right for him to receive compensation, the Authority may make to him a payment of such amount as the Secretary of State may, with the consent of the Treasury, determine.

Staff

8

• (1) The Authority may appoint such employees as it thinks fit, upon such terms and conditions as the Authority, with the approval of the Secretary of State and the consent of the Treasury, may determine.

• (2) The Authority shall secure that any employee whose function is, or whose functions include, the inspection of premises is of such character, and is so qualified by training and experience, as to be a suitable person to perform that function.

• (3) The Authority shall, as regards such of its employees as with the approval of the Secretary of State it may determine, pay to or in respect of them such pensions, allowances or gratuities (including pensions, allowances or gratuities by way of compensation for loss of employment), or provide and maintain for them such pension schemes (whether contributory or not), as may be so determined.

• (4) If an employee of the Authority—

• (a) is a participant in any pension scheme applicable to that employment, and

• (b) becomes a member of the Authority,

he may, if the Secretary of State so determines, be treated for the purposes of the pension scheme as if his service as a member of the Authority were service as employee of the Authority, whether or not any benefits are to be payable to or in respect of him by virtue of paragraph 7 above.

Proceedings

9

• (1) Subject to any provision of this Act, the Authority may regulate its own proceedings, and make such arrangements as it thinks appropriate for the discharge of its functions.

• (2) The Authority may pay to the members of any committee or sub-committee such fees and allowances as the Secretary of State may, with the consent of the Treasury, determine.

10

• (1) A member of the Authority who is in any way directly or indirectly interested in a licence granted or proposed to be granted by the Authority shall, as soon as possible after the relevant circumstances have come to his knowledge, disclose the nature of his interest to the Authority.

• (2) Any disclosure under sub-paragraph (1) above shall be recorded by the Authority.

• (3) Except in such circumstances (if any) as may be determined by the Authority under paragraph 9(1) above, the member shall not participate after the disclosure in any deliberation or decision of the Authority ... with respect to the licence, and if he does so the deliberation or decision shall be of no effect.

11

The validity of any proceedings of the Authority, or of any committee or sub-committee, shall not be affected by any vacancy among the members or by any defect in the appointment of a member.

Instruments

12

The fixing of the seal of the Authority shall be authenticated by the signature of the chairman or deputy chairman of the Authority or some other member of the Authority authorised by the Authority to act for that purpose.

13

A document purporting to be duly executed under the seal of the Authority, or to be signed on the Authority’s behalf, shall be received in evidence and shall be deemed to be so executed or signed unless the contrary is proved.

Investigation by Parliamentary Commissioner

14

The Authority shall be subject to investigation by the Parliamentary Commissioner and accordingly, in Schedule 2 to the Parliamentary Commissioner Act 1967 (which lists the authorities subject to investigation under that Act), the following entry shall be inserted at the appropriate place in alphabetical order—

Human Fertilisation and Embryology Authority

.

SCHEDULE 2

Licences for treatment

1

• (1) A licence under this paragraph may authorise any of the following in the course of providing treatment services—

• (a) bringing about the creation of embryos in vitro,

• (b) procuring, keeping, testing, processing or distributing embryos,

• (c) procuring, testing, processing, distributing or using gametes

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

• (d) other practices designed to secure that embryos are in a suitable condition to be placed in a woman ... ,

• (e) placing any permitted embryo in a woman,

• (f) mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of testing the fertility or normality of the sperm, but only where anything which forms is destroyed when the test is complete and, in any event, not later than the two cell stage, and

• (g) such other practices, apart from practices falling within section 4A(2), as may be specified in, or determined in accordance with, regulations.

• (2) 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 and may authorise the performance of any of the activities referred to in sub-paragraph (1) above in such manner as may be so specified.

• (3) A licence under this paragraph cannot authorise any activity unless it appears to the Authority to be necessary or desirable for the purpose of providing treatment services.

• (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.

• (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) A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.

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

Licences for storage

2

• (1) A licence under this paragraph or paragraph 1 or 3 of this Schedule may authorise the storage of gametes or embryos or both.

• (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).

• (2) Subject to the provisions of this Act, a licence authorising such storage as is mentioned in sub-paragraph (1) or (1A) may be granted subject to such conditions as may be specified in the licence and may authorise storage in such manner as may be so specified.

• (3) A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.

Licences for research

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.

General

4

• (1) A licence under this Schedule can only authorise activities to be carried on—

• (a) on premises specified in the licence or, in the case of activities to which section 3(1A)(b) or (1B) or 4(1A) applies, on relevant third party premises, and

• (b) under the supervision of an individual designated in the licence.

• (1A) A licence which authorises activities falling within paragraph 1 or 1A above may not also authorise activities falling within paragraph 3 above.

• (2) A licence cannot—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) apply to more than one project of research,

• (c) authorise activities to be carried on under the supervision of more than one individual, or

• (d) apply to premises of the person who holds the licence in different places.

SCHEDULE 3

Consent

1

• (1) A consent under this Schedule, any renewal of consent, 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”), any renewal of consent by 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—

• (a) “effective consent” means a consent under this Schedule which has not been withdrawn;

• (b) references to renewal of consent are to renewal of consent to the storage of any gametes or embryo under paragraph 11A or 11C.

2

• (1) A consent to the use of any embryo must specify one or more of the following purposes—

• (a) use in providing treatment services to the person giving consent, or that person and another specified person together,

• (b) use in providing treatment services to persons not including the person giving consent,

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

• (c) use for the purposes of any project of research,

and may specify conditions subject to which the embryo may be so used.

• (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.

• (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 period for which, by virtue of section 14(3), the gametes, embryo or human admixed embryo may be stored under the licence),

• (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.

• (3) A consent under this Schedule must provide for such other matters as the Authority may specify in directions.

• (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.

Procedure for giving consent

3

• (1) Before a person gives or renews consent under this Schedule—

• (a) he must be given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and

• (b) he must be provided with such relevant information as is proper.

• (2) Before a person gives consent under this Schedule he must be informed of the effect of paragraph 4 and, if relevant, paragraph 4A below.

Variation and withdrawal of consent

4

• (1) The terms of any consent under this Schedule may from time to time be varied, and the consent may be withdrawn, by notice given by the person who gave the consent to the person keeping the gametes, human cells, embryo or human admixed embryo to which the consent is relevant.

• (2) Subject to sub-paragraph (3), the terms of any consent to the use of any embryo cannot be varied, and such consent cannot be withdrawn, once the embryo has been used—

• (a) in providing treatment services,

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

• (b) for the purposes of any project of research.

• (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.

Use of gametes for treatment of others

5

• (1) A person’s gametes must not be used for the purposes of treatment services or non-medical fertility services unless there is an effective consent by that person to their being so used and they are used in accordance with the terms of the consent.

• (2) A person’s gametes must not be received for use for those purposes unless there is an effective consent by that person to their being so used.

• (3) This paragraph does not apply to the use of a person’s gametes for the purpose of that person, or that person and another together, receiving treatment services.

In vitro fertilisation and subsequent use of embryo

6

• (1) A person’s gametes or human cells must not be used to bring about the creation of any embryoin vitro unless there is an effective consent by that person to any embryo, the creation of which may be brought about with the use of those gametes or human cells, being used for one or more of the purposes mentioned in paragraph 2(1)(a), (b) and (c) above.

• (2) An 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 embryo to the use for one or more of the purposes mentioned in paragraph 2(1)(a), (b), (ba) and (c) above of the embryo.

• (3) An embryo the creation of which was brought about in vitro must not be used for any purpose unless there is an effective consent by each relevant person in relation to the embryo to the use for that purpose of the embryo and the embryo is used in accordance with those consents.

• (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.

• (4) Any consent required by this paragraph is in addition to any consent that may be required by paragraph 5 above.

Embryos obtained by lavage, etc.

7

• (1) An embryo taken from a woman must not be used for any purpose unless there is an effective consent by her to the use of the embryo for that purpose and it is used in accordance with the consent.

• (2) An embryo taken from a woman must not be received by any person for use for any purpose unless there is an effective consent by her to the use of the embryo for that purpose.

• (3) Sub-paragraphs (1) and (2) do not apply to the use, for the purpose of providing a woman with treatment services, of an embryo taken from her.

• (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.

Storage of gametes and embryos

8

• (1) A person’s gametes must not be kept in storage unless there is an effective consent by that person to their storage and they are stored in accordance with the consent.

• (2) An embryo the creation of which was brought about in vitro must not be kept in storage unless there is an effective consent, by each relevant person in relation to the embryo, to the storage of the embryo and the embryo is stored in accordance with those consents.

• (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.

• (3) An embryo taken from a woman must not be kept in storage unless there is an effective consent by her to its storage and it is stored in accordance with the consent.

• (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.

SCHEDULE 4

Family Law Reform Act 1969 (c. 46. )

1

In section 25 of the Family Law Reform Act 1969 (interpretation), at the end of the definition of “excluded” there is added “ to section 27 of the Family Law Reform Act 1987 and to sections 27 to 29 of the Human Fertilisation and Embryology Act 1990 ”.

Social Security Act 1975 (c. 14. )

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Social Security (Northern Ireland) Act 1975 (c. 15. )

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adoption Act 1976 (c. 36. )

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Family Law Reform (Northern Ireland) Order 1977 (S.I. 1977/1250 (N.I. 17))

5

In Article 13 of the Family Law Reform (Northern Ireland) Order 1977 (interpretation), at the end of the definition of “excluded” there is added “ and to sections 27 to 29 of the Human Fertilisation and Embryology Act 1990 ”.

Adoption (Scotland) Act 1978 (c. 28. )

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

7

In Article 15 of the Adoption (Northern Ireland) Order 1987 (adoption by one person), in paragraph (3)(a) (conditions for making an adoption order on the application of one parent), after “found” there is inserted “ or, by virtue of section 28 of the Human Fertilisation and Embryology Act 1990, there is no other parent ”.

Human Organ Transplants Act 1989 (c. 31. )

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Human Organ Transplants (Northern Ireland) Order 1989

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Meaning of “embryo”, “gamete” and associated expressions.

1A

In this Act—

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

• “the second Directive” means Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, as amended by Commission Directive 2012/39/EU, ...

• “the third Directive” means—in the application of this Act in relation to Great Britain, Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (“the 2006 Directive”), as it had effect immediately before 29 April 2015 (which is the date on which the amendments made by Commission Directive 2015/565/EU came into force), andin the application of this Act in relation to Northern Ireland, the 2006 Directive as amended by Commission Directive 2015/565/EU,

• “the fourth Directive” means Commission Directive 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.

Prohibitions in connection with gametes.

2A

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

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

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

• (1A) For the purposes of subsection (1), as it applies in relation to Great Britain, Article 24 of the first Directive is to be read subject to the modifications set out in paragraph 11A(8) of Schedule 3A.

• (2) In this Act—

• “relevant third party premises”, in relation to a licence, means any premises (other than premises to which the licence relates)—on which a third party procures, tests, processes or distributes gametes or embryos on behalf of any person in connection with activities carried out by that person under a licence, orfrom which a third party provides any goods or services which may affect the quality or safety of gametes or embryos to any person in connection with activities carried out by that person under a licence;

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

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

• (a) the third party,

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

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

Prohibitions in connection with embryos.

Reports to Secretary of State.

3A

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

• (2) In this section—

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

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

Duties of the Authority in relation to the Single European Code: Northern Ireland

Accounts and audit.

Conditions of licences: human application

Inspection of third country premises etc.: Northern Ireland

8A

The Authority must, in relation to Northern Ireland, communicate to the competent authorities of EEA states, and to the European Commission, such information in relation to serious adverse events and serious adverse reactions as is necessary for the purpose of enabling appropriate action to be taken, including where necessary the withdrawal from use of gametes and embryos that are intended for human application but are known or suspected to be unsuitable for such application.

Procedure on reconsideration

Code of practice.

Code of practice.

Procedure for approval of code.

13A

• (1) The following shall be conditions of every licence under paragraph 1A of Schedule 2.

• (2) The requirements of section 13(2) to (4) and (7) shall be complied with.

• (3) A woman shall not be provided with any non-medical fertility services involving the use of sperm other than partner-donated sperm unless the woman being provided with the services has been given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and has been provided with such relevant information as is proper.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Meaning of “father”.

14A

• (1) This section applies to—

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

• (b) every licence under paragraph 2 of that Schedule, so far as authorising storage of gametes or embryos intended for human application, and

• (c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.

• (2) A licence to which this section applies may not authorise the storage, procurement, testing, processing or distribution of gametes or embryos unless it contains the conditions required by Schedule 3A.

• (3) In relation to any gametes or embryos imported into Northern Ireland from an EEA State, compliance with the requirements of the laws or other measures adopted in the relevant state or territory for the purpose of implementing the first, second and third Directives shall be taken to be compliance with the conditions required by Schedule 3A.

• (4) Subsection (3) shall not apply to any licence conditions imposed by the Authority which amount to more stringent protective measures for the purposes of Article 4(2) of the first Directive.

Conditions of research licences.

15A

• (1) The Authority shall investigate serious adverse events and serious adverse reactions and take appropriate control measures.

• (2) In investigating any serious adverse event or serious adverse reaction, the Authority shall, where it is appropriate to do so, arrange for—

• (a) any premises to which a licence relates and any relevant third party premises to be inspected on its behalf, and

• (b) a report on the inspection to be made to it.

• (3) If the Authority, in relation to Northern Ireland, receives a request from a competent authority in an EEA state to carry out an inspection in relation to a serious adverse event or serious adverse reaction, the Authority must arrange for such an inspection to be carried out, for a report to be made of the inspection and for appropriate control measures to be taken.

Temporary suspension of licence.

The person responsible.

Revocation and variation of licence.

Procedure for refusal, variation or revocation of licence.

Appeal to Authority against determinations of licence committee.

Temporary suspension of licence.

Directions: general.

Directions as to particular matters.

Code of practice.

Procedure for approval of code.

Meaning of “mother”.

Effect of sections 27 and 28.

Parental orders in favour of gamete donors.

31A

• (1) The Authority shall keep a register recording the grant, suspension or revocation of—

• (a) every licence under paragraph 1 or 2 of Schedule 2 authorising activities in relation to gametes or embryos intended for use for human application, ...

• (b) every licence under paragraph 1A of Schedule 2, and

• (c) every licence under paragraph 3 of Schedule 2 authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.

• (2) The register shall specify, in relation to each such licence—

• (a) the activities authorised,

• (b) the address of the premises to which the licence relates,

• (c) the name of the person responsible and the name of the holder of the licence (if different), and

• (d) any variations made.

• (3) The Authority shall make such of the information included in the register as it considers appropriate available to the public in such manner as it considers appropriate.

31B

• (1) The Authority shall keep a register containing information provided to it under this Act about any serious adverse event or serious adverse reaction.

• (2) The Authority shall make such of the information included in the register as it considers appropriate available to the public in such manner as it considers appropriate.

Information to be provided to Registrar General.

Restrictions on disclosure of information.

Disclosure in interests of justice: congenital disabilities, etc.

Amendment of Surrogacy Arrangements Act 1985.

Conscientious objection.

Powers of members and employees of Authority.

Power to enter premises.

Offences.

Consent to prosecution.

Civil liability to child with disability.

Regulations.

Notices.

Index.

Northern Ireland.

Short title, commencement, etc.

Licences for non-medical fertility services

1A

• (1) A licence under this paragraph may authorise any of the following in the course of providing non-medical fertility services—

• (a) procuring sperm, and

• (b) distributing sperm.

• (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.

• (2) 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 and may authorise the performance of any of the activities referred to in sub-paragraph (1) above in such manner as may be so specified.

• (3) A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.

SCHEDULE 3A

Traceability system

1

Licence conditions shall require that all persons to whom a licence applies adopt such systems as the Authority considers appropriate to secure compliance with the requirements of Article 8 of the first Directive (traceability) and Article 9 of the third Directive (traceability).

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Serious adverse events and serious adverse reactions : Great Britain

3

In relation to Great Britain, licence conditions shall require such—

• (a) systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and

• (b) accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,

to be in place as the Authority considers appropriate.

Third party agreements and termination of licensed activities

4

For the purpose of securing compliance with the requirements of Articles 21(5) (tissue and cell storage conditions) and 24 (relations between tissue establishments and third parties) of the first Directive, licence conditions shall specify the requirements that must be met in relation to the termination of storage activities authorised by the licence and in relation to third party agreements.

Requirements for procurement of gametes and embryos

5

Licence conditions shall require all persons to whom a licence applies who are authorised to procure gametes or embryos, or both, to comply with the requirements (including as to staff training, written agreements with staff, standard operating procedures, and appropriate facilities and equipment) laid down in Article 2 (requirements for the procurement of human tissues and cells) of the second Directive.

Selection criteria and laboratory tests required for donors of reproductive cells

6

In relation to partner-donated sperm which is not , or partner-donated eggs which are not, intended to be used without processing or storage, licence conditions shall require compliance with the selection criteria for donors and the requirements for laboratory tests laid down in section 2 (partner donation (not direct use)) of Annex III (selection criteria and laboratory tests required for donors of reproductive cells) to the second Directive.

7

Subject to paragraph 7A, in relation to donations of gametes or embryos other than partner-donated sperm , partner-donated eggs or partner-created embryos, licence conditions shall require compliance with the selection criteria for donors and the requirements for laboratory tests laid down in section 3 (donations other than by partners) of Annex III to the second Directive.

8

Licence conditions shall require that the laboratory tests required by sections 2 and 3 of Annex III to the second Directive to be carried out for the purpose of selecting gametes or embryos for donation, meet the requirements of section 4 (general requirements to be met for determining biological markers) of Annex III to the second Directive.

Donation and procurement procedures and reception at the tissue establishment

9

In relation to—

• (a) donation and procurement procedures, and

• (b) the reception of gametes and embryos at the premises to which a licence relates or at relevant third party premises,

licence conditions shall require compliance with the requirements of Article 15(3) (selection, evaluation and procurement) and Article 19(4) to (6) (tissue and cell reception) of the first Directive and with the requirements laid down in the provisions of the second Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.

Requirements for holding a licence under paragraph 1, 1A or 2 of Schedule 2

10

Licence conditions shall require compliance with the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.

Requirements for holding a licence for gametes and embryo preparation processes

11

In respect of gametes and embryos preparation processes, licence conditions shall require compliance with—

• (a) the requirements of Article 20(2) and (3) (tissue and cell processing) and Article 21(2) to (4) of the first Directive, and

• (b) the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.

	Relevant provisions of the third Directive
Reception of gametes and embryos at the tissue establishment	Annex II, Part A
Processing of gametes and embryos (validation, documentation and evaluation of critical procedures)	Annex II, Part B
Storage and release of gametes and embryos (criteria to be complied with, including standard operating procedure)	Annex II, Part C
Distribution and recall of gametes and embryos (criteria to be complied with, including procedures to be adopted)	Annex II, Part D
Final labelling of gametes and embryo containers for distribution (information to be shown on container label or in accompanying documentation)	Annex II, Part E
External labelling of the shipping container (information to be shown on label on shipping container)	Annex II, Part F

Interpretation of this Schedule

12

In this Schedule—

• “HIV” means human immunodeficiency virus, type 1 and type 2;

• “partner-created embryos” means embryos created using the gametes of a man and a woman who declare that they have an intimate physical relationship;

• “partner-donated eggs” means eggs donated between a woman and a woman who declare that they have an intimate physical relationship;

• “RNA” means ribonucleic acid.

Family Law Reform (Northern Ireland) Order 1977 (S. I. 1977/1250 (N. I. 17))

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

Human Organ Transplants (Northern Ireland) Order 1989 (S.I. 1989/2408 (N.I. 21)

Editorial notes

[^c271605]: Act modified (temp.) by S.I. 1991/1400, art.3 Act modified by S.I. 1991/1400, art. 4(3) Act referred to (S.) (1.4.1997) by S.I. 1997/291, rules 2.45-2.59 (Ch. 2 Pt. VI)

[^c271606]: S. 1 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1830971]: S. 1(1) applied (1.4.2005 for certain purposes, 20.10.2005 for certain further purposes, 7.4.2006 for certain further purposes, 31.7.2006 for certain further purposes and 1.9.2006 otherwise) by Human Tissue Act 2004 (c. 30), s. 54(6) (with transitional provisions in s. 58); S.I 2005/919, {art. 3}, Sch. (with transitional provisions in art. 2); S.I. 2005/2792, art. 2(d); S.I. 2006/404, art. 3(3), Sch. (subject to art. 4); S.I. 2006/1997, art. 2(1)(2), 3(1)(2), Sch. (subject to arts. 4, 7, 8) (as that S.I. is amended by S.I. 2006/2169, art. 2)

[^c1830973]: S. 1(4) applied (1.4.2005 for certain purposes, 20.10.2005 for certain further purposes, 7.4.2006 for certain further purposes, 31.7.2006 for certain further purposes and 1.9.2006 otherwise) by Human Tissue Act 2004 (c. 30), s. 54(6) (with transitional provisions in s. 58); S.I 2005/919, {art. 3}, Sch. (with transitional provisions in art. 2); S.I. 2005/2792, art. 2(d); S.I. 2006/404, art. 3(3), Sch. (subject to art. 4); S.I. 2006/1997, art. 2(1)(2), 3(1)(2), Sch. (subject to arts. 4, 7, 8) (as that S.I. is amended by S.I. 2006/2169, art. 2)

[^c1969923]: S. 1(5) 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,{4}

[^c271607]: S. 2 wholly in force at 1.8.1991 see s. 49(2), S.I. 1990/2165 and S.I. 1991/1440, art. 2(2)

[^c1969937]: Words in s. 2(1) 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, 6(2)

[^c1969970]: Words in s. 2(2) 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, 6(3)

[^c1969973]: S. 2(2A)(2B) 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, 6(4)

[^c1969979]: S. 1A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 5

[^c1969981]: S. 2A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 7

[^c271609]: S. 3 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1969991]: S. 3(1)-(1B) substituted (25.5.2007 for certain purposes, otherwise 5.7.2007) for s. 3(1) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 8

[^c271611]: S. 4 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1969997]: S. 4(1)(b) substituted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 9(2)

[^c1969999]: S. 4(1A) inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 9(3)

[^c271608]: S. 3A inserted (10.4.1995) by 1994 c. 33, s. 156(2); S.I. 1995/721, art. 2, Sch.

[^c271612]: S. 8 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1970023]: S. 8A 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, 10

[^c271615]: S. 11 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1970040]: S. 11(1)(aa) 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, 12

[^c271616]: S. 12 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1970047]: S. 12 renumbered as s. 12(1) (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, 13(2)

[^c1970049]: Words in s. 12(1)(a) 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, 13(3)(a)

[^c1970053]: S. 12(1)(aa) 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, 13(3)(b)

[^c1970062]: Words in s. 12(1)(c) 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, 13(3)(c)

[^c1970069]: S. 12(2)(3) 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, 13(4)

[^c271617]: S. 13 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c271618]: S. 14 wholly in force; s. 14 not in force at Royal Assent see s. 49(2); s. 14(5) in force for certain purposes at 8.7.1991 and s. 14 fully in force at 1.8.1991 by S.I. 1991/1400, art. 2(1)(a)(2)

[^c271621]: S. 15 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1970090]: S. 13A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 15

[^c1970098]: S. 14A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 17

[^c1970102]: S. 15A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 18

[^c271622]: S. 16 wholly in force; s. 16 not in force at Royal Assent see s. 49(2); s. 16(1)(6) in force for certain purposes at 8.7.1991 and s. 16 fully in force at 1.8.1991 by s.I. 1991/1400, art. 2(1)(b)(c)(2)

[^c1970106]: S. 16(2)(c)-(cb) substituted (25.5.2007 for certain purposes, otherwise 5.7.2007) for s. 16(2)(c) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 19

[^c271623]: S. 17 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1970110]: Word in s. 17(1) omitted (25.5.2007 for certain purposes, otherwise 5.7.2007) by virtue of The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 20

[^c1970114]: S. 17(1)(f)(g) 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, 20

[^c271629]: S. 23 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c271630]: S. 24 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1970155]: Words in s. 24(1) 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, 22(2)

[^c1970157]: Words in s. 24(2) 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, 22(3)

[^c1970161]: Words in s. 24(3) 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, 22(4)

[^c1970163]: S. 24(3A) 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, 22(5)

[^c1970165]: S. 24(4A) 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, 22(6)

[^c1970167]: S. 24(12)-(14) 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, 22(7)

[^c271631]: S. 25 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c271632]: S. 27 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c271633]: S. 27(2) modified (1.11.1994) by S.I. 1994/2804, reg. 3, Sch. 2 para. 6

[^c1830832]: Words in s. 27(2) substituted (30.12.2005) by Adoption and Children Act 2002 (c. 38), ss. 139, 148, Sch. 3 para. 77 (with Sch. 4 para. 6-8); S.I. 2005/2213, art. 2(o)

[^c271634]: S. 28 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[^c1827082]: Words in s. 28(1) inserted (1.12.2003) by Human Fertilisation and Embryology (Deceased Fathers) Act 2003 (c. 24), s. 2(1), {Sch. para. 13)}; S.I. 2003/3095, art. 2

[^c1823654]: S. 28(5)(c) modified (1.11.1994) by S.I. 1994/2804, reg. 3, Sch. 2 para. 6