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Human Fertilisation and Embryology Act 1990

Type Public General Act

Publication 1990-11-01

Last updated 2024-11-28

State In force

Department Statute Law Database

Source legislation.gov.uk

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Principal terms used

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

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(1) In this Act (except in section 4A or in the term “human admixed embryo”)—

(a) embryo means a live human embryo and does not include a human admixed embryo (as defined by section 4A(6)), and

(b) references to an embryo include an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo.

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

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

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

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

(4) In this Act (except in section 4A)—

(a) references to eggs are to live human eggs, including cells of the female germ line at any stage of maturity, but (except in subsection (1)(b)) not including eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo,

(b) references to sperm are to live human sperm, including cells of the male germ line at any stage of maturity, and

(5) For the purposes of this Act, sperm is to be treated as partner-donated sperm if the donor of the sperm and the recipient of the sperm declare that they have an intimate physical relationship.

(6) If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may provide that in this Act (except in section 4A) “embryo”, “eggs”, “sperm” or “gametes” includes things specified in the regulations which would not otherwise fall within the definition.

(7) Regulations made by virtue of subsection (6) may not provide for anything containing any nuclear or mitochondrial DNA that is not human to be treated as an embryo or as eggs, sperm or gametes.

The person responsible.

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(1) In this Act—

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

“basic partner treatment services” means treatment services that are provided for a woman and a man together without using—the gametes of any other person, orembryos created outside the woman's body,

“competent authority”, in relation to an EEA state ..., means an authority designated in accordance with the law of that state or territory as responsible for implementing the requirements of the first, second, third and fourth Directives,

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

“distribution”, in relation to gametes or embryos intended for human application, means transportation or delivery to any person in or outside the United Kingdom for human application, and related terms are to be interpreted accordingly,

“human application” means use in a human recipient,

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

“non-medical fertility services” means any services that are provided, in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services,

“nuclear DNA”, in relation to an embryo, includes DNA in the pronucleus of the embryo,

“processing”, in relation to gametes or embryos intended for human application, means any operation involved in their preparation, manipulation or packaging, and related terms are to be interpreted accordingly,

“procurement”, in relation to gametes or embryos intended for human application, means any process by which they are made available, and related terms are to be interpreted accordingly,

“serious adverse event” means—any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of gametes or embryos intended for human application and which, in relation to a donor of gametes or a person who receives treatment services or non-medical fertility services—might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions, ormight result in, or prolong, hospitalisation or illness, orany type of gametes or embryo misidentification or mix-up,

“serious adverse reaction” means an unintended response, including a communicable disease, in a donor of gametes intended for human application or a person who receives treatment services or non-medical fertility services, which may be associated with the procurement or human application of gametes or embryos and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or illness,

“store”, in relation to gametes, embryos or human admixed embryos, means preserve, whether by cryopreservation or in any other way, and “storage” and “stored” are to be interpreted accordingly,

“tissue establishment” means a tissue bank or a unit of a hospital or another body which procures, tests, processes, preserves, stores or distributes human gametes or embryos,

“traceability” means the ability—to identify and locate gametes and embryos during any step from procurement to use for human application or disposal,to identify the donor and recipient of particular gametes or embryos,to identify any person who has carried out any activity in relation to particular gametes or embryos, andto identify and locate all relevant data relating to products and materials coming into contact with particular gametes or embryos and which can affect their quality or safety,

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

(2) References in this Act to keeping, in relation to embryos, gametes or human admixed embryos , include keeping while preserved in storage.

(2A) For the purposes of this Act, a person who, from any premises, controls the provision of services for transporting gametes or embryos to any person in or outside the United Kingdom for human application is to be taken to distribute gametes or embryos on those premises.

(2B) Any reference in this Act to a requirement of a provision of the first, second, third or fourth Directive—

(a) in the application of this Act in relation to Great Britain, is to be read as a reference to a requirement which that provision would require to be imposed if the provision formed part of the law of England and Wales or Scotland, and

(b) in the application of this Act in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed.

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

Activities governed by the Act

Prohibitions in connection with embryos

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

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

(a) in pursuance of a licence, or

(b) in the case of—

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

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

in pursuance of a third party agreement.

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

(2) No person shall place in a woman—

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

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

(3) A licence cannot authorise—

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

(b) placing an embryo in any animal, or

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

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

Prohibitions in connection with gametes

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(1) No person shall—

(a) store any gametes, or

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

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

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

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

except in pursuance of a licence.

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

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

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

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

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

The Human Fertilisation and Embryology Authority, its functions and procedure

The Human Fertilisation and Embryology Authority

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(1) There shall be a body corporate called the Human Fertilisation and Embryology Authority.

(2) The Authority shall consist of—

(a) a chairman and deputy chairman, and

(b) such number of other members as the Secretary of State appoints.

(3) Schedule 1 to this Act (which deals with the membership of the Authority, etc.) shall have effect.

Accounts and audit

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(1) The Authority shall keep proper accounts and proper records in relation to the accounts and shall prepare for each accounting year a statement of accounts.

(2) The annual statement of accounts shall comply with any direction given by the Secretary of State, with the approval of the Treasury, as to the information to be contained in the statement, the way in which the information is to be presented or the methods and principles according to which the statement is to be prepared.

(3) Not later than five months after the end of an accounting year, the Authority shall send a copy of the statement of accounts for that year to the Secretary of State and to the Comptroller and Auditor General.

(4) The Comptroller and Auditor General shall examine, certify and report on every statement of accounts received by him under subsection (3) above and shall lay a copy of the statement and of his report before each House of Parliament.

(5) The Secretary of State and the Comptroller and Auditor General may inspect any records relating to the accounts.

(6) In this section “accounting year” means the period beginning with the day when the Authority is established and ending with the following 31st March, or any later period of twelve months ending with the 31st March.

Reports to Secretary of State

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(1) The Authority shall prepare—

(a) a report for the period beginning with the 1 August preceding the relevant commencement date (or if that date is a 1 August, beginning with that date) and ending with the next 31 March, and

(b) a report for each succeeding period of 12 months ending with 31 March.

(1A) In subsection (1)(a) “the relevant commencement date” means the day on which paragraph 3 of Schedule 7 to the Human Fertilisation and Embryology Act 2008 comes into force.

(1B) The Authority shall send each report to the Secretary of State as soon as practicable after the end of the period for which it is prepared.

(2) A report prepared under this section for any period shall deal with the activities of the Authority in the period and the activities the Authority proposes to undertake in the succeeding period of twelve months.

(3) The Secretary of State shall lay before each House of Parliament a copy of every report received by him under this section.

General functions of the Authority

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(1) The Authority shall—

(a) keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters,

(b) publicise the services provided to the public by the Authority or provided in pursuance of licences,

(c) provide, to such extent as it considers appropriate, advice and information for persons to whom licences apply or who are receiving treatment services or providing gametes or embryos for use for the purposes of activities governed by this Act, or may wish to do so, ...

(ca) maintain a statement of the general principles which it considers should be followed—

(i) in the carrying-on of activities governed by this Act, and

(ii) in the carrying-out of its functions in relation to such activities,

(cb) promote, in relation to activities governed by this Act, compliance with—

(i) requirements imposed by or under this Act, and

(ii) the code of practice under section 25 of this Act, and

(d) perform such other functions as may be specified in regulations.

(2) The Authority may, if it thinks fit, charge a fee for any advice provided under subsection (1)(c).

Disclosure in interests of justice.

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(1) The Authority shall maintain one or more committees to discharge the Authority’s functions relating to the grant, variation, suspension and revocation of licences, and a committee discharging those functions is referred to in this Act as a “licence committee”.

(2) The Authority may provide for the discharge of any of its other functions by committees or by members or employees of the Authority.

(3) A committee (other than a licence committee) may appoint sub-committees.

(4) Persons, committees or sub-committees discharging functions of the Authority shall do so in accordance with any general directions of the Authority.

(5) A licence committee shall consist of such number of persons as may be specified in or determined in accordance with regulations, all being members of the Authority, and shall include at least one person who is not authorised to carry on or participate in any activity under the authority of a licence and would not be so authorised if outstanding applications were granted.

(6) A committee (other than a licence committee) or a sub-committee may include a minority of persons who are not members of the Authority.

(7) Subject to subsection (10) below, a licence committee, before considering an application for authority—

(a) for a person to carry on an activity governed by this Act which he is not then authorised to carry on, or

(b) for a person to carry on any such activity on premises where he is not then authorised to carry it on,

shall arrange for the premises where the activity is to be carried on to be inspected on its behalf, and for a report on the inspection to be made to it.

(7A) Before considering such an application, the licence committee may also arrange for—

(a) any premises that will be relevant third party premises for the purposes of the application to be inspected on its behalf, and

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

(8) A licence committee shall arrange for any premises to which a licence relates to be inspected on its behalf at intervals not exceeding two years, and for a report on the inspection to be made to it.

(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10) A licence committee need not comply with subsection (7) above where the premises in question have been inspected in pursuance of that subsection or subsection (8) above at some time during the period of two years ending with the date of the application, and the licence committee considers that a further inspection is not necessary.

(10A) A licence committee may arrange for any relevant third party premises to be inspected on its behalf and for a report on the inspection to be made to it.

(11) An inspection in pursuance of subsection (7), (7A), (8) or (10A) above may be carried out by a person who is not a member of a licence committee.

Licensing procedure

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Scope of licences

Licences for treatment, storage and research

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(1) The Authority may grant the following and no other licences—

(a) licences under paragraph 1 of Schedule 2 to this Act authorising activities in the course of providing treatment services,

(aa) licences under paragraph 1A of that Schedule authorising activities in the course of providing non-medical fertility services,

(b) licences under that Schedule authorising the storage of gametes, embryos or human admixed embryos, and

(2) Paragraph 4 of that Schedule has effect in the case of all licences.

Licence conditions

General conditions

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(1) The following shall be conditions of every licence granted under this Act—

(a) except to the extent that the activities authorised by the licence fall within paragraph (aa), that those activities shall be carried on only on the premises to which the licence relates and under the supervision of the person responsible,

(aa) that any activities to which section 3(1A)(b) or (1B) or 4(1A) applies shall be carried on only on the premises to which the licence relates or on relevant third party premises,

(b) that any member or employee of the Authority, on production, if so required, of a document identifying the person as such, shall at all reasonable times be permitted to enter those premises and inspect them (which includes inspecting any equipment or records and observing any activity),

(c) except in relation to the use of gametes in the course of providing basic partner treatment services ... , that the provisions of Schedule 3 to this Act shall be complied with,

(d) that proper records shall be maintained in such form as the Authority may specify in directions,

(e) that no money or other benefit shall be given or received in respect of any supply of gametes, embryos or human admixed embryos unless authorised by directions,

(f) that, where gametes, embryos or human admixed embryos are supplied to a person to whom another licence applies, that person shall also be provided with such information as the Authority may specify in directions, and

(g) that the Authority shall be provided, in such form and at such intervals as it may specify in directions, with such copies of or extracts from the records, or such other information, as the directions may specify.

(2) Subsection (3) 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 the 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.

(3) It shall be a condition of every licence to which this subsection applies that—

(a) such information as is necessary to facilitate the traceability of gametes and embryos, and

(b) any information relating to the quality or safety of gametes or embryos,

shall be recorded and provided to the Authority upon request.

Conditions of licences for treatment

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(1) The following shall be conditions of every licence under paragraph 1 of Schedule 2 to this Act.

(2) Such information shall be recorded as the Authority may specify in directions about the following—

(a) the persons for whom services are provided in pursuance of the licence,

(b) the services provided for them,

(c) the persons whose gametes are kept or used for the purposes of services provided in pursuance of the licence or whose gametes have been used in bringing about the creation of embryos so kept or used,

(d) any child appearing to the person responsible to have been born as a result of treatment in pursuance of the licence,

(e) any mixing of egg and sperm and any taking of an embryo from a woman or other acquisition of an embryo, and

(f) such other matters as the Authority may specify in directions.

(3) The records maintained in pursuance of the licence shall include any information recorded in pursuance of subsection (2) above and any consent of a person whose consent is required under Schedule 3 to this Act.

(4) No information shall be removed from any records maintained in pursuance of the licence before the expiry of such period as may be specified in directions for records of the class in question.

(5) A woman shall not be provided with treatment services ... unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth.

(6) A woman shall not be provided with treatment services of a kind specified in Part 1 of Schedule 3ZA unless she and any man or woman who is to be treated together with her have been given a suitable opportunity to receive proper counselling about the implications of her being provided with treatment services of that kind, and have been provided with such relevant information as is proper.

(6A) A woman shall not be provided with treatment services after the happening of any event falling within any paragraph of Part 2 of Schedule 3ZA unless (before or after the event) she and the intended second parent have been given a suitable opportunity to receive proper counselling about the implications of the woman being provided with treatment services after the happening of that event, and have been provided with such relevant information as is proper.

(6B) The reference in subsection (6A) to the intended second parent is a reference to—

(a) any man as respects whom the agreed fatherhood conditions in section 37 of the Human Fertilisation and Embryology Act 2008 (“the 2008 Act”) are for the time being satisfied in relation to treatment provided to the woman mentioned in subsection (6A), and

(b) any woman as respects whom the agreed female parenthood conditions in section 44 of the 2008 Act are for the time being satisfied in relation to treatment provided to the woman mentioned in subsection (6A).

(6C) In the case of treatment services falling within paragraph 1 of Schedule 3ZA (use of gametes of a person not receiving those services) or paragraph 3 of that Schedule (use of embryo taken from a woman not receiving those services), the information provided by virtue of subsection (6) or (6A) must include such information as is proper about—

(a) the importance of informing any resulting child at an early age that the child results from the gametes of a person who is not a parent of the child, and

(b) suitable methods of informing such a child of that fact.

(6D) Where the person responsible receives from a person (“X”) notice under section 37(1)(c) or 44(1)(c) of the 2008 Act of X's withdrawal of consent to X being treated as the parent of any child resulting from the provision of treatment services to a woman (“W”), the person responsible—

(a) must notify W in writing of the receipt of the notice from X, and

(b) no person to whom the licence applies may place an embryo or sperm and eggs in W, or artificially inseminate W, until W has been so notified.

(6E) Where the person responsible receives from a woman (“W”) who has previously given notice under section 37(1)(b) or 44(1)(b) of the 2008 Act that she consents to another person (“X”) being treated as a parent of any child resulting from the provision of treatment services to W—

(a) notice under section 37(1)(c) or 44(1)(c) of the 2008 Act of the withdrawal of W's consent, or

(b) a notice under section 37(1)(b) or 44(1)(b) of the 2008 Act in respect of a person other than X,

the person responsible must take reasonable steps to notify X in writing of the receipt of the notice mentioned in paragraph (a) or (b).

(7) Suitable procedures shall be maintained—

(a) for determining the persons providing gametes or from whom embryos are taken for use in pursuance of the licence, and

(b) for the purpose of securing that consideration is given to the use of practices not requiring the authority of a licence as well as those requiring such authority.

(8) Subsections (9) and (10) apply in determining any of the following—

(a) the persons who are to provide gametes for use in pursuance of the licence in a case where consent is required under paragraph 5 of Schedule 3 for the use in question;

(b) the woman from whom an embryo is to be taken for use in pursuance of the licence, in a case where her consent is required under paragraph 7 of Schedule 3 for the use of the embryo;

(9) Persons or embryos that are known to have a gene, chromosome or mitochondrion abnormality involving a significant risk that a person with the abnormality will have or develop—

(a) a serious physical or mental disability,

(b) a serious illness, or

must not be preferred to those that are not known to have such an abnormality.

(10) Embryos that are known to be of a particular sex and to carry a particular risk, compared with embryos of that sex in general, that any resulting child will have or develop—

(a) a gender-related serious physical or mental disability,

(b) a gender-related serious illness, or

must not be preferred to those that are not known to carry such a risk.

(11) For the purposes of subsection (10), a physical or mental disability, illness or other medical condition is gender-related if—

(a) it affects only one sex, or

(b) it affects one sex significantly more than the other.

(12) No embryo appropriated for the purpose mentioned in paragraph 1(1)(ca) of Schedule 2 (training in embryological techniques) shall be kept or used for the provision of treatment services.

(13) The person responsible shall comply with any requirement imposed on that person by section 31ZD.

Conditions of storage licences

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(1) The following shall be conditions of every licence authorising the storage of gametes, embryos or human admixed embryos—

(a) that gametes of a person shall be placed in storage only if—

(i) received from that person,

(ii) acquired in circumstances in which by virtue of paragraph 9 or 10 of Schedule 3 that person's consent to the storage is not required, or

(iii) acquired from a person to whom a licence or third party agreement applies,

(aa) that an embryo taken from a woman shall be placed in storage only if—

(i) received from that woman, or

(ii) acquired from a person to whom a licence or third party agreement applies,

(ab) that an embryo the creation of which has been brought about in vitro otherwise than in pursuance of that licence shall be placed in storage only if acquired from a person to whom a licence or third party agreement applies,

(ac) that a human admixed embryo the creation of which has been brought about in vitro otherwise than in pursuance of that licence shall be placed in storage only if acquired from a person to whom a licence under paragraph 2 or 3 of Schedule 2 applies,

(b) that gametes or embryos which are or have been stored shall not be supplied to a person otherwise than in the course of providing treatment services unless that person is a person to whom a licence applies,

(ba) that human admixed embryos shall not be supplied to a person unless that person is a person to whom a licence applies,

(ca) that any gametes, embryos or human admixed embryos that have been kept in storage pursuant to the licence must, once they may no longer lawfully be so kept, be removed from storage and disposed of, and

(d) that such information as the Authority may specify in directions as to the persons whose consent is required under Schedule 3 to this Act, the terms of their consent and the circumstances of the storage and as to such other matters as the Authority may specify in directions shall be included in the records maintained in pursuance of the licence.

(2) No information shall be removed from any records maintained in pursuance of such a licence before the expiry of such period as may be specified in directions for records of the class in question.

(3) The requirements referred to in subsection (1)(c) are as follows—

(a) gametes must not be kept in storage for longer than such period not exceeding 55 years beginning with the day on which they are first placed in storage as the licence may specify;

(b) an embryo must not be kept in storage for treatment purposes for longer than such period not exceeding 55 years beginning with the day on which it is first so kept as the licence may specify;

(c) an embryo that is kept in storage for the research or training purpose but not for treatment purposes must not be so kept for longer than such period not exceeding 10 years beginning with the day on which consent was given under Schedule 3 to the storage of the embryo for that purpose as the licence may specify;

(d) a human admixed embryo must not be kept in storage for longer than such period not exceeding 10 years beginning with the day on which it is first placed in storage as the licence may specify.

(4) Where under Schedule 3 consent is given to the storage of an embryo for the training or research purpose by different persons on different days, the reference in subsection (3)(c) to the day on which consent was given is to be taken as a reference to the last of those days.

(5) For the purposes of this section—

(a) “treatment purposes” are purposes referred to in paragraph 2(1)(a) or (b) of Schedule 3;

(b) the “training purpose” is the purpose referred to in paragraph 2(1)(ba) of that Schedule;

Conditions of research licences

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(1) The following shall be conditions of every licence under paragraph 3 of Schedule 2 to this Act.

(2) The records maintained in pursuance of the licence shall include such information as the Authority may specify in directions about such matters as the Authority may so specify.

(3) No information shall be removed from any records maintained in pursuance of the licence before the expiry of such period as may be specified in directions for records of the class in question.

(4) No embryo appropriated for the purposes of any project of research shall be kept or used otherwise than for the purposes of such a project.

(5) If by virtue of paragraph 20 of Schedule 3 (existing cells or cell lines) qualifying cells, as defined by paragraph 20(2) of that Schedule, of a person (“P”) are used to bring about the creation in vitro of an embryo or human admixed embryo without P's consent, steps shall be taken to ensure that the embryo or human admixed embryo cannot subsequently be attributed to P.

Grant, revocation and suspension of licences

Grant of licence

16

(1) The Authority may on application grant a licence to any person if the requirements of subsection (2) below are met.

(2) The requirements mentioned in subsection (1) above are—

(a) that the application is for a licence designating an individual as the person under whose supervision the activities to be authorised by the licence are to be carried on,

(b) that either that individual is the applicant or—

(i) the application is made with the consent of that individual, and

(ii) the Authority is satisfied that the applicant is a suitable person to hold a licence,

(c) in relation to a licence under paragraph 1 or 1A of Schedule 2 or a licence under paragraph 2 of that Schedule authorising the storage of gametes or embryos intended for human application or a licence under paragraph 3 of that Schedule authorising activities in connection with the derivation from embryos of stem cells that are intended for human application, that the individual—

(i) possesses a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences, awarded on completion of a university course of study, or other course of study recognised in the United Kingdom as equivalent, or is otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications in the field of nursing, and

(ii) has at least two years' practical experience which is directly relevant to the activity to be authorised by the licence,

(ca) in relation to a licence under paragraph 2 of Schedule 2 authorising storage of gametes, embryos or human admixed embryos not intended for human application or a licence under paragraph 3 of that Schedule authorising activities otherwise than in connection with the derivation from embryos of stem cells that are intended for human application, that the Authority is satisfied that the qualifications and experience of that individual are such as are required for the supervision of the activities,

(cb) that the Authority is satisfied that the character of that individual is such as is required for the supervision of the activities and that the individual will discharge the duty under section 17 of this Act.

(d) that the Authority is satisfied that the premises in respect of which the licence is to be granted and any premises which will be relevant third party premises are suitable for the activities, and

(e) that all the other requirements of this Act in relation to the granting of the licence are satisfied.

(3) The grant of a licence to any person may be by way of renewal of a licence granted to that person, whether on the same or different terms.

(4) Where the Authority is of the opinion that the information provided in the application is insufficient to enable it to determine the application, it need not consider the application until the applicant has provided it with such further information as it may require him to provide.

(5) The Authority shall not grant a licence unless a copy of the conditions to be imposed by the licence has been shown to, and acknowledged in writing by, the applicant and (where different) the person under whose supervision the activities are to be carried on.

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

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The person responsible

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(1) It shall be the duty of the individual under whose supervision the activities authorised by a licence are carried on (referred to in this Act as the “person responsible”) to secure—

(a) that the other persons to whom the licence applies are of such character, and are so qualified by training and experience, as to be suitable persons to participate in the activities authorised by the licence,

(b) that proper equipment is used,

(c) that proper arrangements are made for the keeping of gametes, embryos and human admixed embryos and for the disposal of gametes, embryos or human admixed embryos that have been removed from storage,

(d) that suitable practices are used in the course of the activities, ...

(e) that the conditions of the licence are complied with,

(f) that conditions of third party agreements relating to the procurement, testing, processing or distribution of gametes or embryos are complied with, and

(g) that the Authority is notified and provided with a report analysing the cause and the ensuing outcome of any serious adverse event or serious adverse reaction.

(2) References in this Act to the persons to whom a licence applies are to—

(a) the person responsible,

(b) any person designated in the licence, or in a notice given to the Authority by the person who holds the licence or the person responsible, as a person to whom the licence applies, and

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation and variation of licence

18

(1) The Authority may revoke a licence on application by—

(a) the person responsible, or

(b) the holder of the licence (if different).

(2) The Authority may revoke a licence otherwise than on application under subsection (1) if—

(a) it is satisfied that any information given for the purposes of the application for the licence was in any material respect false or misleading,

(b) it is satisfied that the person responsible has failed to discharge, or is unable because of incapacity to discharge, the duty under section 17,

(c) it is satisfied that the person responsible has failed to comply with directions given in connection with any licence,

(d) it ceases to be satisfied that the premises specified in the licence are suitable for the licensed activity,

(e) it ceases to be satisfied that any premises which are relevant third party premises in relation to a licence are suitable for the activities entrusted to the third party by the person who holds the licence,

(f) it ceases to be satisfied that the holder of the licence is a suitable person to hold the licence,

(g) it ceases to be satisfied that the person responsible is a suitable person to supervise the licensed activity,

(h) the person responsible dies or is convicted of an offence under this Act, ...

(i) it is satisfied that there has been any other material change of circumstances since the licence was granted or

(j) it is not satisfied that any third country premises are suitable for carrying out activities in a manner which secures that qualifying gametes or embryos imported from a third country by the holder of the licence meet standards of quality and safety laid down in this Act.

Procedure for refusal, variation or revocation of licence

19

(1) Before making a decision—

(a) to refuse an application for the grant, revocation or variation of a licence, or

(b) to grant an application for a licence subject to a condition imposed under paragraph 1(2), 1A(2), 2(2) or 3(6) of Schedule 2,

the Authority shall give the applicant notice of the proposed decision and of the reasons for it.

(2) Before making a decision under section 18(2) or 18A(3) or (5) the Authority shall give notice of the proposed decision and of the reasons for it to—

(a) the person responsible, and

(b) the holder of the licence (if different).

(3) Where an application has been made under section 18A(2) to vary a licence, but the Authority considers it appropriate to vary the licence otherwise than in accordance with the application, before so varying the licence the Authority shall give notice of its proposed decision and of the reasons for it to—

(a) the person responsible, and

(b) the holder of the licence (if different).

(4) A person to whom notice is given under subsection (1), (2) or (3) has the right to require the Authority to give him an opportunity to make representations of one of the following kinds about the proposed decision, namely—

(a) oral representations by him, or a person acting on his behalf;

(b) written representations by him.

(5) The right under subsection (4) is exercisable by giving the Authority notice of the exercise of the right before the end of the period of 28 days beginning with the day on which the notice under subsection (1), (2) or (3) was given.

(6) The Authority may by regulations make such additional provision about procedure in relation to the carrying out of functions under sections 18 and 18A and this section as it thinks fit.

Appeal to Authority against determinations of licence committee

20

(1) If an application for the grant, revocation or variation of a licence is refused, the applicant may require the Authority to reconsider the decision.

(2) Where the Authority decides to vary or revoke a licence, any person to whom notice of the decision was required to be given (other than a person who applied for the variation or revocation) may require the Authority to reconsider the decision.

(3) The right under subsections (1) and (2) is exercisable by giving the Authority notice of exercise of the right before the end of the period of 28 days beginning with the day on which notice of the decision concerned was given under section 19A.

(4) If the Authority decides —

(a) to suspend a licence under section 19C(1), or

(b) to continue the suspension of a licence under section 19C(2),

any person to whom notice of the decision was required to be given may require the Authority to reconsider the decision.

(5) The right under subsection (4) is exercisable by giving the Authority notice of exercise of the right before the end of the period of 14 days beginning with the day on which notice of the decision concerned was given under section 19C.

(6) The giving of any notice to the Authority in accordance with subsection (5) shall not affect the continuation in force of the suspension of the licence in respect of which that notice was given.

(7) Subsections (1), (2) and (4) do not apply to a decision on reconsideration.

Appeals to High Court or Court of Session

21

A person aggrieved by a decision on reconsideration in pursuance of a notice under section 20 may appeal to the High Court or, in Scotland, the Court of Session on a point of law.

Temporary suspension of licence

22

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

Directions and guidance

Directions: general

23

(1) The Authority may from time to time give directions for any purpose for which directions may be given under this Act or directions varying or revoking such directions.

(2) A person to whom any requirement contained in directions is applicable shall comply with the requirement.

(3) Anything done by a person in pursuance of directions is to be treated for the purposes of this Act as done in pursuance of a licence.

(4) Where directions are to be given to a particular person, they shall be given by serving notice of the directions on the person.

(5) In any other case, directions may be given—

(a) in respect of any licence (including a licence which has ceased to have effect), by serving notice of the directions on the person—

(i) who is the person responsible or the holder of the licence, if different, or

(ii) who was the person responsible or the holder of the licence, if different,

(b) if the directions appear to the Authority to be general directions or it appears to the Authority that it is not practicable to give notice in pursuance of paragraph (a) above, by publishing the directions in such way as, in the opinion of the Authority, is likely to bring the directions to the attention of the persons to whom they are applicable.

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

Directions as to particular matters

24

(1) If, in the case of any information about persons for whom treatment services, other than basic partner treatment services, were provided, the person responsible does not know that any child was born following the treatment, the period specified in directions by virtue of section 13(4) of this Act shall not expire less than 50 years after the information was first recorded.

(2) In the case of every licence under paragraph 1 or 1A of Schedule 2 to this Act, directions shall require information to be recorded and given to the Authority about each of the matters referred to in section 13(2)(a) to (e) of this Act.

(3) In relation to gametes or embryos that are not intended for human application, directions may authorise, in such circumstances and subject to such conditions as may be specified in the directions, the keeping, by or on behalf of a person to whom a licence applies, of gametes or embryos in the course of their carriage to or from any premises.

(3A) In relation to gametes and embryos that are intended for human application, directions may authorise the keeping of gametes or embryos by or on behalf of a person to whom a licence applies, in the course of their carriage—

(a) between premises to which licences relate,

(b) between such premises and relevant third party premises,

(c) in relation to Northern Ireland, between premises referred to in paragraphs (a) and (b) and tissue establishments accredited, designated, authorised or licensed under the laws, or other measures, of an EEA state which implement the first, second and third Directives, or

(d) between premises referred to in paragraphs (a) and (b) and tissue establishments in a third country, pursuant to directions given under subsection (4),

in such circumstances and subject to such conditions as may be specified in the directions.

(3B) Directions may authorise, in such circumstances and subject to such conditions as may be specified in the directions, the keeping, by or on behalf of a person to whom a licence applies, of human admixed embryos in the course of their carriage to or from any premises.

(4) Directions may authorise any person to whom a licence applies to—

(a) receive gametes, embryos or human admixed embryos—

(i) from outside the United Kingdom, and

(ii) in respect of Northern Ireland, from Great Britain, or

(b) send gametes, embryos or human admixed embryos outside the United Kingdom,

in such circumstances and subject to such conditions as may be specified in the directions.

(4ZA) Directions made by virtue of subsection (4) may provide for sections 12 to 14 of this Act to have effect with such modifications as may be specified in the directions.

(4A) In giving any directions under subsection (4) authorising any person to whom a licence applies to export from the United Kingdom to a third country, gametes or embryos intended for human application, the Authority shall—

(a) include directions specifying the measures that persons to whom a licence applies shall take to ensure that all such ... exports meet standards of quality and safety equivalent to those laid down in this Act, and

(b) have regard to ensuring traceability.

(4AA) Directions must, in accordance with paragraph 1 of Schedule 3AA, specify requirements with which any person to whom a licence applies who proposes to make qualifying imports (other than a one-off import) must comply before the Authority gives any directions under subsection (4) authorising the person to make qualifying imports.

(4AB) Directions must, in accordance with paragraph 2 of Schedule 3AA, specify requirements with which any person to whom a licence applies who proposes to make a qualifying import which is a one-off import must comply before the Authority gives any directions under subsection (4) authorising the person to make the import.

(4AC) In giving any directions under subsection (4) authorising any person to whom a licence applies to make any qualifying imports, the Authority must include the directions specified in paragraph 3 of Schedule 3AA.

(4AD) Where the Authority gives any directions under subsection (4) authorising any person to whom a licence applies to make any qualifying imports, it must—

(a) in relation to Great Britain, provide that person with a certificate of authority in such form as the Authority considers appropriate; and

(b) in relation to Northern Ireland, provide that person with a certificate in the form set out in Annex II to the fourth Directive.

(4AE) In subsections (4AA) and (4AB) a reference to a one-off import, in relation to gametes or embryos, is to gametes or embryos imported for the purposes of providing services to a particular person or persons on one occasion only.

(4AF) In subsections (4AA) to (4AD) and Schedule 3AA “qualifying import” means the import ... from a third country of gametes or embryos intended for human application.

(4B) Regulations may make provision requiring or authorising the giving of directions in relation to particular matters which are specified in the regulations and relate to activities falling within section 4A(2) (activities involving genetic material of animal origin).

(5A) Directions may make provision for the purpose of dealing with a situation arising in consequence of—

(a) the variation of a licence, or

(b) a licence ceasing to have effect.

(5B) Directions under subsection (5A)(a) may impose requirements—

(a) on the holder of the licence,

(b) on the person who is the person responsible immediately before or immediately after the variation, or

(5C) Directions under subsection (5A)(b) may impose requirements—

(a) on the person who holds the licence immediately before the licence ceases to have effect,

(b) on the person who is the person responsible at that time, or

(5D) Directions under subsection (5A) may, in particular, require anything kept, or information held, in pursuance of the licence to be transferred in accordance with the directions.

(5E) Where a licence has ceased to have effect by reason of the death or dissolution of its holder, anything subsequently done by a person before directions are given under subsection (5A) shall, if the licence would have been authority for doing it, be treated as authorised by a licence.

(11) Where the Authority proposes to give directions specifying any animal for the purposes of paragraph 1(1)(f) or 3(2) of Schedule 2 to this Act, it shall report the proposal to the Secretary of State; and the directions shall not be given until the Secretary of State has laid a copy of the report before each House of Parliament.

(11A) In relation to Great Britain, directions must specify the systems to be adopted for the identification of gametes and embryos intended for human application which the Authority considers appropriate to facilitate traceability.

(12) In relation to Northern Ireland, directions must specify the systems to be adopted for the identification of gametes and embryos intended for human application which the Authority considers appropriate to secure compliance with the requirements of —

(a) paragraph 1 of Article 25 of the first Directive (coding of information),

(b) paragraph 1 of Article 10 of the third Directive (European coding system), subject to any exemption specified in the directions in accordance with paragraph 3 of that Article,

(d) paragraph 1(a) to (f) and (h) of Article 10b of the third Directive (requirements related to the application of the Single European Code).

(12A) In relation to Northern Ireland, directions must require information to be provided to the Authority which the Authority considers appropriate to secure compliance with the requirements of paragraph 1(g) of Article 10b of the third Directive (European coding system).

(13) The Authority may give directions as to the information to be provided to it and any measures to be taken by the person responsible in the event of—

(a) any occurrence which may adversely influence the quality or safety of gametes or embryos intended for human application,

(b) any adverse incident which may be linked to the quality or safety of gametes or embryos intended for human application, or

(14) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Code of practice

25

(1) The Authority shall maintain a code of practice giving guidance about the proper conduct of activities carried on in pursuance of a licence under this Act and the proper discharge of the functions of the person responsible and other persons to whom the licence applies.

(2) The guidance given by the code shall include guidance for those providing treatment services about the account to be taken of the welfare of children who may be born as a result of treatment services (including a child’s need for supportive parenting), and of other children who may be affected by such births.

(2A) The code shall also give guidance about—

(a) the giving of a suitable opportunity to receive proper counselling, and

(b) the provision of such relevant information as is proper,

in accordance with any condition that is by virtue of section 13(6) or (6A) a condition of a licence under paragraph 1 of Schedule 2.

(3) The code may also give guidance about the use of any technique involving the placing of sperm and eggs in a woman.

(4) The Authority may from time to time revise the whole or any part of the code.

(5) The Authority shall publish the code as for the time being in force.

(6) A failure on the part of any person to observe any provision of the code shall not of itself render the person liable to any proceedings, but—

(a) the Authority shall, in considering whether there has been any failure to comply with any conditions of a licence and, in particular, conditions requiring anything to be “proper” or “suitable”, take account of any relevant provision of the code, and

(b) the Authority may, in considering, where it has power to do so, whether or not to vary or revoke a licence, take into account any observance of or failure to observe the provisions of the code.

Procedure for approval of code

26

(1) The Authority shall send a draft of the proposed first code of practice under section 25 of this Act to the Secretary of State within twelve months of the commencement of section 5 of this Act.

(2) If the Authority proposes to revise the code or, if the Secretary of State does not approve a draft of the proposed first code, to submit a further draft, the Authority shall send a draft of the revised code or, as the case may be, a further draft of the proposed first code to the Secretary of State.

(3) Before preparing any draft, the Authority shall consult such persons as the Secretary of State may require it to consult and such other persons (if any) as it considers appropriate.

(4) If the Secretary of State approves a draft, he shall lay it before Parliament and, if he does not approve it, he shall give reasons to the Authority.

(5) A draft approved by the Secretary of State shall come into force in accordance with directions.

Status

Meaning of “mother”

27

(1) The woman who is carrying or has carried a child as a result of the placing in her of an embryo or of sperm and eggs, and no other woman, is to be treated as the mother of the child.

(2) Subsection (1) above does not apply to any child to the extent that the child is treated by virtue of adoption as not being the woman’s child.

(3) Subsection (1) above 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.

Meaning of “father”

28

(1) Subject to subsections (5A) to (5I) below, this section applies in the case of a child who is being or has been carried by a woman as the result of the placing in her of an embryo or of sperm and eggs or her artificial insemination.

(2) If—

(a) at the time of the placing in her of the embryo or the sperm and eggs or of her insemination, the woman was a party to a marriage, and

(b) the creation of the embryo carried by her was not brought about with the sperm of the other party to the marriage,

then, subject to subsection (5) below, the other party to the marriage shall be treated as the father of the child unless it is shown that he did not consent to the placing in her of the embryo or the sperm and eggs or to her insemination (as the case may be).

(3) If no man is treated, by virtue of subsection (2) above, as the father of the child but—

(a) the embryo or the sperm and eggs were placed in the woman, or she was artificially inseminated, in the course of treatment services provided for her and a man together by a person to whom a licence applies, and

(b) the creation of the embryo carried by her was not brought about with the sperm of that man,

then, subject to subsection (5) below, that man shall be treated as the father of the child.

(4) Where a person is treated as the father of the child by virtue of subsection (2) or (3) above, no other person is to be treated as the father of the child.

(5) Subsections (2) and (3) above do not apply—

(a) in relation to England and Wales and Northern Ireland, to any child who, by virtue of the rules of common law, is treated as the legitimate child of the parties to a marriage,

(b) in relation to Scotland, 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

(5A) If—

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

(b) the creation of the embryo carried by her was brought about by using the sperm of a man after his death, or the creation of the embryo was brought about using the sperm of a man before his death but the embryo was placed in the woman after his death,

(d) the man consented in writing (and did not withdraw the consent)—

(i) to the use of his sperm after his death which brought about the creation of the embryo carried by the woman or (as the case maybe) to the placing in the woman after his death of the embryo which was brought about using his sperm before his death, and

(ii) to being treated for the purpose mentioned in subsection (5I) below as the father of any resulting child,

(e) the woman 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 man to be treated for the purpose mentioned in subsection (5I) below as the father of the child, and

(f) no-one else is to be treated as the father of the child by virtue of subsection (2) or (3) above or by virtue of adoption or the child being treated as mentioned in paragraph (a) or (b) of subsection (5) above,

then the man shall be treated for the purpose mentioned in subsection (5I) below as the father of the child.

(5B) If—

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

(b) the creation of the embryo carried by her was brought about by using the sperm of a man after his death, or the creation of the embryo was brought about using the sperm of a man before his death but the embryo was placed in the woman after his death,

(c) the woman was not a party to a marriage with the man immediately before his death but treatment services were being provided for the woman and the man together before his death either by a person to whom a licence applies or outside the United Kingdom,

(d) the man consented in writing (and did not withdraw the consent)—

(i) to the use of his sperm after his death which brought about the creation of the embryo carried by the woman or (as the case maybe) to the placing in the woman after his death of the embryo which was brought about using his sperm before his death, and

(ii) to being treated for the purpose mentioned in subsection (5I) below as the father of any resulting child,

(e) the woman 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 man to be treated for the purpose mentioned in subsection (5I) below as the father of the child, and

(f) no-one else is to be treated as the father of the child by virtue of subsection (2) or (3) above or by virtue of adoption or the child being treated as mentioned in paragraph (a) or (b) of subsection (5) above,

then the man shall be treated for the purpose mentioned in subsection (5I) below as the father of the child.

(5C) If—

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

(b) the embryo was created at a time when the woman was a party to a marriage,

(d) the other party to the marriage died before the placing of the embryo in the woman,

(e) the other party to the marriage consented in writing (and did not withdraw the consent)—

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

(ii) to being treated for the purpose mentioned in subsection (5I) below as the father of any resulting child,

(f) the woman 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 marriage to be treated for the purpose mentioned in subsection (5I) below as the father of the child,and

(g) no-one else is to be treated as the father of the child by virtue of subsection (2) or (3) above or by virtue of adoption or the child being treated as mentioned in paragraph (a) or (b) of subsection (5) above,

then the other party to the marriage shall be treated for the purpose mentioned in subsection (5I) below as the father of the child.

(5D) If—

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

(b) the embryo was not created at a time when the woman was a party to a marriage but was created in the course of treatment services provided for the woman and a man together either by a person to whom a licence applies or outside the United Kingdom,

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

(e) the man consented in writing (and did not withdraw the consent)—

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

(ii) to being treated for the purpose mentioned in subsection (5I) below as the father of any resulting child,

(f) the woman 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 man to be treated for the purpose mentioned in subsection (5I) below as the father of the child, and

(g) no-one else is to be treated as the father of the child by virtue of subsection (2) or (3) above or by virtue of adoption or the child being treated as mentioned in paragraph (a) or (b) of subsection (5) above,

then the man shall be treated for the purpose mentioned in subsection (5I) below as the father of the child.

(5E) In the application of subsections (5A) to (5D) above to Scotland, for any reference to a period of 42 days there shall be substituted a reference to a period of 21 days.

(5F) The requirement under subsection (5A), (5B), (5C) or (5D) above 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) shall nevertheless 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 (5G) below.

(5G) The Registrar General may at any time consent to the making of an election after the end of the period mentioned in subsection(5F) above 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.

(5H) In subsections (5F) and (5G) above “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 maybe) the Registrar General for Northern Ireland.

(5I) The purpose referred to in subsections (5A) to (5D) above is the purpose of enabling the man’s particulars to be entered as the particulars of the child’s father in (as the case may be) a register of live-births or still-births kept under the Births and Deaths Registration Act 1953 or the Births and Deaths Registration (Northern Ireland) Order 1976 or a register of births or still-births kept under the Registration of Births, Deaths and Marriages (Scotland) Act 1965.

(6) Where—

(a) the sperm of a man who had given such consent as is required by paragraph 5 of Schedule 3 to this Act was used for a purpose for which such consent was required, or

(b) the sperm of a man, or any embryo the creation of which was brought about with his sperm, was used after his death,

he is not , subject to subsections (5A) and (5B) above, to be treated as the father of the child.

(7) The references in subsection (2) above and subsections (5A) to (5D) above to the parties to a marriage at the 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 this subsection it shall be presumed, unless the contrary is shown, that one of them reasonably believed at that time that the marriage was valid.

(8) This section 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.

(9) In subsection (7)(a) above, “judicial separation” includes a legal separation obtained in a country outside the British Islands and recognised in the United Kingdom.

Effect of sections 27 and 28

29

(1) Where by virtue of section 27 or 28 of this Act a person is to be treated as the mother or father of a child, that person is to be treated in law as the mother or, as the case may be, father of the child for all purposes.

(2) Where by virtue of section 27 or 28 of this Act a person is not to be treated as the mother or father of a child, that person is to be treated in law as not being the mother or, as the case may be, father of the child for any purpose.

(3) Where subsection (1) or (2) above 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.

(3A) Subsections (1) to (3) above do not apply in relation to the treatment in law of a deceased man in a case to which section 28(5A),(5B), (5C) or (5D) of this Act applies.

(3B) Where subsection (5A), (5B), (5C) or (5D) of section 28 of this Act applies, the deceased man—

(a) is to be treated in law as the father of the child for the purpose referred to in that subsection, but

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

(3C) Where subsection (3B) above 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.

(3D) In subsection (3C) above “enactment” includes an enactment comprised in, or in an instrument made under, an Act of the Scottish Parliament or Northern Ireland legislation.

(4) In relation to England and Wales and Northern Ireland, nothing in the provisions of section 27(1) or 28(2) to (4) or (5A) to (5I), read with this section, affects—

(a) 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) 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.

(5) In relation to Scotland—

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

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

Parental orders in favour of gamete donors

30

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Information

The Authority’s register of information

31

(1) The Authority shall keep a register which is to contain any information which falls within subsection (2) and which—

(a) immediately before the coming into force of section 24 of the Human Fertilisation and Embryology Act 2008, was contained in the register kept under this section by the Authority, or

(b) is obtained by the Authority.

(2) Subject to subsection (3), information falls within this subsection if it relates to—

(a) the provision for any identifiable individual of treatment services other than basic partner treatment services,

(b) the procurement or distribution of any sperm, other than sperm which is partner-donated sperm and has not been stored, in the course of providing non-medical fertility services for any identifiable individual,

(d) the use of the gametes of any identifiable individual other than their use for the purpose of basic partner treatment services, or

(e) the use of an embryo taken from any identifiable woman,

or if it shows that any identifiable individual is a relevant individual.

(3) Information does not fall within subsection (2) if it is provided to the Authority for the purposes of any voluntary contact register as defined by section 31ZF(1).

(4) In this section “relevant individual” means an individual who was or may have been born in consequence of—

(a) treatment services, other than basic partner treatment services, or

(b) the procurement or distribution of any sperm (other than partner-donated sperm which has not been stored) in the course of providing non-medical fertility services.

Information to be provided to Registrar General

32

(1) This section applies where a claim is made before the Registrar General that a person is or is not the parent of a child and it is necessary or desirable for the purpose of any function of the Registrar General to determine whether the claim is or may be well-founded.

(2) The Authority shall comply with any request made by the Registrar General by notice to the Authority to disclose whether any information on the register kept in pursuance of section 31 of this Act tends to show that the person may be a parent of the child by virtue of any of the relevant statutory provisions and, if it does, disclose that information.

(2A) In subsection (2) “the relevant statutory provisions” means—

(a) section 28 of this Act, and

(b) sections 35 to 47 of the Human Fertilisation and Embryology Act 2008.

(3) In this section and section 33A of this Act, “the Registrar General” means the Registrar General for England and Wales, the Registrar General of Births, Deaths and Marriages for Scotland or the Registrar General for Northern Ireland, as the case may be.

Restrictions on disclosure of information

33

(1) No person who is or has been a member or employee of the Authority shall disclose any information mentioned in subsection (2) below which he holds or has held as such a member or employee.

(2) The information referred to in subsection (1) above is—

(a) any information contained or required to be contained in the register kept in pursuance of section 31 of this Act, and

(b) any other information obtained by any member or employee of the Authority on terms or in circumstances requiring it to be held in confidence.

(3) Subsection (1) above does not apply to any disclosure of information mentioned in subsection (2)(a) above made—

(a) to a person as a member or employee of the Authority,

(b) to a person to whom a licence applies for the purposes of his functions as such,

(d) in pursuance of an order of a court under section 34 or 35 of this Act,

(e) to the Registrar General in pursuance of a request under section 32 of this Act, or

(f) in accordance with section 31 of this Act.

(4) Subsection (1) above does not apply to any disclosure of information mentioned in subsection (2)(b) above—

(a) made to a person as a member or employee of the Authority,

(b) made with the consent of the person or persons whose confidence would otherwise be protected, or

(5) No person who is or has been a person to whom a licence applies , no person who is or has been a person to whom a third party agreement applies, and no person to whom directions have been given shall disclose any information falling within section 31(2) of this Act which he holds or has held as such a person.

(6) Subsection (5) above does not apply to any disclosure of information made—

(a) to a person as a member or employee of the Authority,

(b) to a person to whom a licence applies for the purposes of his functions as such,

(ba) to a person to whom a third party agreement applies for the purposes of his functions under the third party agreement,

(c) so far as it identifies a person who, but for sections 27 to 29 of this Act, would or might be a parent of a person who instituted proceedings under section 1A of the Congenital Disabilities (Civil Liability) Act 1976, but only for the purpose of defending such proceedings, or instituting connected proceedings for compensation against that parent,

(d) so that no individual to whom the information relates can be identified, . . .

(e) in pursuance of directions given by virtue of section 24(5) or (6) of this Act,

(f) necessarily—

(i) for any purpose preliminary to proceedings, or

(ii) for the purposes of, or in connection with, any proceedings,

(g) for the purpose of establishing, in any proceedings relating to an application for an order under subsection (1) of section 30 of this Act, whether the condition specified in paragraph (a) or (b) of that subsection is met, or

(h) under section 3 of the Access to Health Records Act 1990 (right of access to health records), or

(i) under Article 5 of the Access to Health Records (Northern Ireland) Order 1993 (right of access to health records).

(6A) Paragraph (f) of subsection (6) above, so far as relating to disclosure for the purposes of, or in connection with, any proceedings, does not apply—

(a) to disclosure of information enabling a person to be identified as a person whose gametes were used, in accordance with consent given under paragraph 5 of Schedule 3 to this Act, for the purposes of treatment services in consequence of which an identifiable individual was, or may have been, born, or

(b) to disclosure, in circumstances in which subsection (1) of section 34 of this Act applies, of information relevant to the determination of the question mentioned in that subsection.

(6B) In the case of information relating to the provision of treatment services for any identifiable individual—

(a) where one individual is identifiable, subsection (5) above does not apply to disclosure with the consent of that individual;

(b) where both a woman and a man treated together with her are identifiable, subsection (5) above does not apply—

(i) to disclosure with the consent of them both, or

(ii) if disclosure is made for the purpose of disclosing information about the provision of treatment services for one of them, to disclosure with the consent of that individual.

(6C) For the purposes of subsection (6B) above, consent must be to disclosure to a specific person, except where disclosure is to a person who needs to know—

(a) in connection with the provision of treatment services, or any other description of medical, surgical or obstetric services, for the individual giving the consent,

(b) in connection with the carrying out of an audit of clinical practice, or

(6D) For the purposes of subsection (6B) above, consent to disclosure given at the request of another shall be disregarded unless, before it is given, the person requesting it takes reasonable steps to explain to the individual from whom it is requested the implications of compliance with the request.

(6E) In the case of information which relates to the provision of treatment services for any identifiable individual, subsection (5) above does not apply to disclosure in an emergency, that is to say, to disclosure made—

(a) by a person who is satisfied that it is necessary to make the disclosure to avert an imminent danger to the health of an individual with whose consent the information could be disclosed under subsection (6B) above, and

(b) in circumstances where it is not reasonably practicable to obtain that individual’s consent.

(6F) In the case of information which shows that any identifiable individual was, or may have been, born in consequence of treatment services, subsection (5) above does not apply to any disclosure which is necessarily incidental to disclosure under subsection (6B) or (6E) above.

(6G) Regulations may provide for additional exceptions from subsection (5) above, but no exception may be made under this subsection—

(a) for disclosure of a kind mentioned in paragraph (a) or (b) of subsection (6A) above, or

(b) for disclosure, in circumstances in which section 32 of this Act applies, of information having the tendency mentioned in subsection (2) of that section.

(7) This section does not apply to the disclosure to any individual of information which—

(a) falls within section 31(2) of this Act by virtue of paragraphs (a) to (bb) of that subsection, and

(b) relates only to that individual or, in the case of an individual treated together with another, only to that individual and that other.

(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disclosure in interests of justice

34

(1) Where in any proceedings before a court the question whether a person is or is not the parent of a child by virtue of sections 27 to 29 of this Act or sections 33 to 47 of the Human Fertilisation and Embryology Act 2008 falls to be determined, the court may on the application of any party to the proceedings make an order requiring the Authority—

(a) to disclose whether or not any information relevant to that question is contained in the register kept in pursuance of section 31 of this Act, and

(b) if it is, to disclose so much of it as is specified in the order,

but such an order may not require the Authority to disclose any information falling within section 31(2)(c) to (e) of this Act.

(2) The court must not make an order under subsection (1) above unless it is satisfied that the interests of justice require it to do so, taking into account—

(a) any representations made by any individual who may be affected by the disclosure, and

(b) the welfare of the child, if under 18 years old, and of any other person under that age who may be affected by the disclosure.

(3) If the proceedings before the court are civil proceedings, it—

(a) may direct that the whole or any part of the proceedings on the application for an order under subsection (2) above shall be heard in camera, and

(b) if it makes such an order, may then or later direct that the whole or any part of any later stage of the proceedings shall be heard in camera.

(4) An application for a direction under subsection (3) above shall be heard in camera unless the court otherwise directs.

Disclosure in interests of justice: congenital disabilities, etc

35

(1) Where for the purpose of instituting proceedings under section 1 of the Congenital Disabilities (Civil Liability) Act 1976 (civil liability to child born disabled) it is necessary to identify a person who would or might be the parent of a child but for the relevant statutory provisions, the court may, on the application of the child, make an order requiring the Authority to disclose any information contained in the register kept in pursuance of section 31 of this Act identifying that person.

(2) Where, for the purposes of any action for damages in Scotland (including any such action which is likely to be brought) in which the damages claimed consist of or include damages or solatium in respect of personal injury (including any disease and any impairment of physical or mental condition), it is necessary to identify a person who would or might be the parent of a child but for the relevant statutory provisions, the court may, on the application of any party to the action or, if the proceedings have not been commenced, the prospective pursuer, make an order requiring the Authority to disclose any information contained in the register kept in pursuance of section 31 of this Act identifying that person.

(2A) In subsections (1) and (2) “the relevant statutory provisions” means—

(a) sections 27 to 29 of this Act, and

(b) sections 33 to 47 of the Human Fertilisation and Embryology Act 2008.

(3) Subsections (2) to (4) of section 34 of this Act apply for the purposes of this section as they apply for the purposes of that.

(4) After section 4(4) of the Congenital Disabilities (Civil Liability) Act 1976 there is inserted—

(4A) In any case where 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, any reference in section 1 of this Act to a parent includes a reference to a person who would be a parent but for sections 27 to 29 of the Human Fertilisation and Embryology Act 1990.

Surrogacy

Amendment of Surrogacy Arrangements Act 1985

36

(1) After section 1 of the Surrogacy Arrangements Act 1985 there is inserted—

(1A) No surrogacy arrangement is enforceable by or against any of the persons making it.

(2) In section 1 of that Act (meaning of “surrogate mother”, etc.)—

(a) in subsection (6), for “or, as the case may be, embryo insertion” there is substituted “or of the placing in her of an embryo, of an egg in the process of fertilisation or of sperm and eggs, as the case may be,”, and

(b) in subsection (9), the words from “and whether” to the end are repealed.

Abortion

Amendment of law relating to termination of pregnancy

37

(1) For paragraphs (a) and (b) of section 1(1) of the Abortion Act 1967 (grounds for medical termination of pregnancy) there is substituted—

(a) that the pregnancy has not exceeded its twenty-fourth week and that the continuance of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman or any existing children of her family; or (b) that the termination is necessary to prevent grave permanent injury to the physical or mental health of the pregnant woman; or (c) that the continuance of the pregnancy would involve risk to the life of the pregnant woman, greater than if the pregnancy were terminated; or (d) that there is a substantial risk that if the child were born it would suffer from such physical or mental abnormalities as to be seriously handicapped.

(2) In section 1(2) of that Act, after “(a)” there is inserted “or (b)”.

(3) After section 1(3) of that Act there is inserted—

(3A) The power under subsection (3) of this section to approve a place includes power, in relation to treatment consisting primarily in the use of such medicines as may be specified in the approval and carried out in such manner as may be so specified, to approve a class of places.

(4) For section 5(1) of that Act (effect on Infant Life (Preservation) Act 1929) there is substituted—

(1) No offence under the Infant Life (Preservation) Act 1929 shall be committed by a registered medical practitioner who terminates a pregnancy in accordance with the provisions of this Act.

(5) In section 5(2) of that Act, for the words from “the miscarriage” to the end there is substituted

a woman’s miscarriage (or, in the case of a woman carrying more than one foetus, her miscarriage of any foetus) is unlawfully done unless authorised by section 1 of this Act and, in the case of a woman carrying more than one foetus, anything done with intent to procure her miscarriage of any foetus is authorised by that section if— (a) the ground for termination of the pregnancy specified in subsection (1)(d) of that section applies in relation to any foetus and the thing is done for the purpose of procuring the miscarriage of that foetus, or (b) any of the other grounds for termination of the pregnancy specified in that section applies

Conscientious objection

38

(1) No person who has a conscientious objection to participating in any activity governed by this Act shall be under any duty, however arising, to do so.

(2) In any legal proceedings the burden of proof of conscientious objection shall rest on the person claiming to rely on it.

(3) In any proceedings before a court in Scotland, a statement on oath by any person to the effect that he has a conscientious objection to participating in a particular activity governed by this Act shall be sufficient evidence of that fact for the purpose of discharging the burden of proof imposed by subsection (2) above.

Enforcement

Powers of members and employees of Authority

39

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

Power to enter premises

40

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

Offences

41

(1) A person who—

(a) contravenes section 3(2), 3A or 4A(1) or (2) of this Act, or

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