Legalize / United Kingdom / Public General Act

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

articles Not indexed

Reform history JSON API

A woman gives the person responsible notice under paragraph (a) of subsection (1) of section 44 of that Act (agreed female parenthood conditions) in a case where the woman for whom the treatment services are provided has previously given a notice under paragraph (b) of that subsection referring to her.

7

The woman for whom the treatment services are provided gives the person responsible a notice under paragraph (b) of that subsection in a case where the other woman to whom the notice relates has previously given a notice under paragraph (a) of that subsection.

Request for information as to genetic parentage etc.

Disclosure of information

Power to provide for additional exceptions from section 33A(1)

Conscientious objection.

Amendment of law relating to termination of pregnancy.

Orders

Offences.

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

Civil liability to child with disability.

Regulations.

Notices.

Northern Ireland.

Other terms.

Prohibition in connection with germ cells.

3ZA

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

(2) A permitted egg is one—

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

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

(3) Permitted sperm are sperm—

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

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

(4) An embryo is a permitted embryo if—

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

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

(5) Regulations may provide that—

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

(b) an embryo can be a permitted embryo,

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

(6) In this section—

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

(b) “prescribed” means prescribed by regulations.

4A

(1) No person shall place in a woman—

(a) a human admixed embryo,

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

(2) No person shall—

(a) mix human gametes with animal gametes,

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

except in pursuance of a licence.

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

(a) the appearance of the primitive streak, or

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

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

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

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

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

(i) two human pronuclei,

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

(iii) one human gamete or other human cell,

(b) any other embryo created by using—

(i) human gametes and animal gametes, or

(ii) one human pronucleus and one animal pronucleus,

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

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

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

(7) In subsection (6)—

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

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

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

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

(10) In this section—

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

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

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

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

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

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

8ZA

(1) The Authority must carry out its functions effectively, efficiently and economically.

(2) In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).

8E

(1) The Authority may if it thinks it appropriate to do so provide assistance to any other public authority in the United Kingdom for the purpose of the exercise by that authority of its functions.

(2) Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.

9A

(1) The Authority may delegate a function to a committee, to a member or to staff.

(2) The Authority may establish such committees or sub-committees as it thinks fit (whether to advise the Authority or to exercise a function delegated to it by the Authority).

(3) Subject to any provision made by regulations under section 20A (appeals committees), the members of the committees or sub-committees may include persons who are not members of the Authority.

(4) Subsection (1) has effect subject to any enactment requiring a decision to be taken by members of the Authority or by a committee consisting of members of the Authority.

Conditions of storage licences.

Revocation of licence

18A

(1) The Authority may on application by the holder of the licence vary the licence so as to substitute another person for the person responsible if—

(a) the application is made with the consent of that other person, and

(b) the Authority is satisfied that the other person is a suitable person to supervise the licensed activity.

(2) The Authority may vary a licence on application by—

(a) the person responsible, or

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

(3) The Authority may vary a licence without an application under subsection (2) if it has the power to revoke the licence under section 18(2).

(4) The powers under subsections (2) and (3) do not extend to making the kind of variation mentioned in subsection (1).

(5) The Authority may vary a licence without an application under subsection (2) by—

(a) removing or varying a condition of the licence, or

(b) adding a condition to the licence.

(6) The powers conferred by this section do not extend to the conditions required by sections 12 to 15 of this Act.

19C

(1) Where the Authority—

(a) has reasonable grounds to suspect that there are grounds for revoking a licence, and

(b) is of the opinion that the licence should immediately be suspended,

it may by notice suspend the licence for such period not exceeding three months as may be specified in the notice.

(2) The Authority may continue suspension under subsection (1) by giving a further notice under that subsection.

(3) Notice under subsection (1) shall be given to the person responsible or where the person responsible has died or appears to be unable because of incapacity to discharge the duty under section 17—

(a) to the holder of the licence, or

(b) to some other person to whom the licence applies.

(4) Subject to subsection (5), a licence shall be of no effect while a notice under subsection (1) is in force.

(5) An application may be made under section 18(1) or section 18A(1) or (2) even though a notice under subsection (1) is in force.

Procedure on reconsideration

Directions as to particular matters.

Procedure for approval of code.

Disclosure in interests of justice: congenital disabilities, etc.

Parental orders in favour of gamete donors.

Civil liability to child with disability.

Disclosure of information

Disclosure in interests of justice: congenital disabilities, etc.

Mitochondrial donation

Index.

35A

(1) Regulations may provide for any of the relevant provisions to have effect subject to specified modifications in relation to cases where—

(a) an egg which is a permitted egg for the purposes of section 3(2) by virtue of regulations made under section 3ZA(5), or

(b) an embryo which is a permitted embryo for those purposes by virtue of such regulations,

has been created from material provided by two women.

(2) In this section “the relevant provisions” means—

(a) the following provisions of this Act—

(i) section 13(6C) (information whose provision to prospective parents is required by licence condition),

(ii) section 31 (register of information),

(iii) sections 31ZA to 31ZE (provision of information), and

(iv) Schedule 3 (consents to use or storage of gametes, embryos or human admixed embryos etc.), and

(b) sections 54 and 54A of the Human Fertilisation and Embryology Act 2008 (parental orders).

Fees

Northern Ireland.

35B

(1) The Authority may charge a fee in respect of any of the following—

(a) an application for a licence,

(b) the grant or renewal of a licence,

(d) the exercise by the Authority of any other function conferred on it by or under this Act or by or under any other enactment—

(i) in relation to a licence,

(ii) in relation to premises which are or have been premises to which a licence relates,

(iii) in relation to premises which are or have been relevant third party premises in relation to a licence, or

(iv) in relation to premises which, if an application is granted, will be premises to which a licence relates or relevant third party premises.

(2) The amount of any fee charged by virtue of subsection (1) is to be fixed in accordance with a scheme made by the Authority with the approval of the Secretary of State and the Treasury.

(3) In fixing the amount of any fee to be charged by virtue of that subsection, the Authority may have regard to the costs incurred by it—

(a) in exercising the functions conferred on it by or under this Act (apart from sections 31ZA to 31ZG and 33D), and

(b) in exercising any other function conferred on it by or under any other enactment.

(4) The Authority may also charge such fee as it thinks fit in respect of any of the following—

(a) the giving of notice under section 31ZA(1) or 31ZB(1), or

(b) the provision of information under section 31ZA, 31ZB or 31ZE.

(5) In fixing the amount of any fee to be charged by virtue of subsection (4) the Authority may have regard to the costs incurred by it in exercising the function to which the fee relates.

(6) When exercising its power to charge fees under section 8(2), 31ZF(2)(d) or this section, the Authority may fix different fees for different circumstances.

38A

(1) Schedule 3B (which makes provisions about inspection, entry, search and seizure) has effect.

(2) Nothing in this Act makes it unlawful for a member or employee of the Authority to keep any embryo, human admixed embryo or gametes in pursuance of that person's functions as such.

Civil liability to child with disability.

Regulations.

Power to make consequential provision

45A

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

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

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

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

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

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

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

(6) In this section—

“enactment” means—an Act of Parliament (other than this Act),an Act of the Scottish Parliament,a Measure or Act of the National Assembly for Wales, orNorthern Ireland legislation,whenever passed or made;

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

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

45B

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

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

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

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

Short title, commencement, etc.

4A

(1) A person (“P”) is disqualified for being appointed as chairman, deputy chairman, or as any other member of the Authority if—

(a) P is the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order, or a debt relief restrictions order or interim debt relief restrictions order under Schedule 4ZB of the Insolvency Act 1986,

(b) a bankruptcy order has been made against P by a court in Northern Ireland, P's estate has been sequestered by a court in Scotland, or under the law of Northern Ireland or Scotland, P has made a composition or arrangement with, or granted a trust deed for, P's creditors, or

(c) in the last five years P has been convicted in the United Kingdom, the Channel Islands or the Isle of Man of an offence and has had a qualifying sentence passed on P.

(2) Where P is disqualified under sub-paragraph (1)(b) because a bankruptcy order has been made against P or P's estate has been sequestered, the disqualification ceases—

(a) on P obtaining a discharge, or

(b) if the bankruptcy order is annulled or the sequestration of P's estate is recalled or reduced, on the date of that event.

(3) Where P is disqualified under sub-paragraph (1)(b) because of P having made a composition or arrangement with, or granted a trust deed for, P's creditors, the disqualification ceases—

(a) at the end of the period of five years beginning with the date on which the terms of the deed of composition or arrangement or trust deed are fulfilled, or

(b) if, before then, P pays P's debts in full, on the date on which the payment is completed.

(4) For the purposes of sub-paragraph (1)(c), the date of conviction is to be taken to be the ordinary date on which the period allowed for making an appeal or application expires or, if an appeal or application is made, the date on which the appeal or application is finally disposed of or abandoned or fails by reason of its non-prosecution.

(5) In sub-paragraph (1)(c), the reference to a qualifying sentence is to a sentence of imprisonment for a period of not less than three months (whether suspended or not) without the option of a fine.

Embryo testing

1ZA

(1) A licence under paragraph 1 cannot authorise the testing of an embryo, except for one or more of the following purposes—

(a) establishing whether the embryo has a gene, chromosome or mitochondrion abnormality that may affect its capacity to result in a live birth,

(b) in a case where there is a particular risk that the embryo may have any gene, chromosome or mitochondrion abnormality, establishing whether it has that abnormality or any other gene, chromosome or mitochondrion abnormality,

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

(ii) a gender-related serious illness, or

(iii) any other gender-related serious medical condition,

establishing the sex of the embryo,

(d) in a case where a person (“the sibling”) who is the child of the persons whose gametes are used to bring about the creation of the embryo (or of either of those persons) suffers from a serious medical condition which could be treated by umbilical cord blood stem cells, bone marrow or other tissue of any resulting child, establishing whether the tissue of any resulting child would be compatible with that of the sibling, and

(e) in a case where uncertainty has arisen as to whether the embryo is one of those whose creation was brought about by using the gametes of particular persons, establishing whether it is.

(2) A licence under paragraph 1 cannot authorise the testing of embryos for the purpose mentioned in sub-paragraph (1)(b) unless the Authority is satisfied—

(a) in relation to the abnormality of which there is a particular risk, and

(b) in relation to any other abnormality for which testing is to be authorised under sub-paragraph (1)(b),

that there is a significant risk that a person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition.

(3) For the purposes of sub-paragraph (1)(c), a physical or mental disability, illness or other medical condition is gender-related if the Authority is satisfied that—

(a) it affects only one sex, or

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

(4) In sub-paragraph (1)(d) the reference to “other tissue” of the resulting child does not include a reference to any whole organ of the child.

Sex selection

1ZB

(1) A licence under paragraph 1 cannot authorise any practice designed to secure that any resulting child will be of one sex rather than the other.

(2) Sub-paragraph (1) does not prevent the authorisation of any testing of embryos that is capable of being authorised under paragraph 1ZA.

(3) Sub-paragraph (1) does not prevent the authorisation of any other practices designed to secure that any resulting child will be of one sex rather than the other in a case where there is a particular risk that a woman will give birth to a child who will have or develop—

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

(b) a gender-related serious illness, or

(4) For the purposes of sub-paragraph (3), a physical or mental disability, illness or other medical condition is gender-related if the Authority is satisfied that—

(a) it affects only one sex, or

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

Power to amend paragraphs 1ZA and 1ZB

1ZC

(1) Regulations may make any amendment of paragraph 1ZA (embryo testing).

(2) Regulations under this paragraph which amend paragraph 1ZA may make any amendment of sub-paragraphs (2) to (4) of paragraph 1ZB (sex selection) which appears to the Secretary of State to be necessary or expedient in consequence of the amendment of paragraph 1ZA.

(3) Regulations under this paragraph may not enable the authorisation of—

(a) the testing of embryos for the purpose of establishing their sex, or

(b) other practices falling within paragraph 1ZB(1),

except on grounds relating to the health of any resulting child.

(4) For the purposes of this paragraph, “amend” includes add to and repeal, and references to “amendment” are to be read accordingly.

Purposes for which activities may be licensed under paragraph 3

3A

(1) A licence under paragraph 3 cannot authorise any activity unless the activity appears to the Authority—

(a) to be necessary or desirable for any of the purposes specified in sub-paragraph (2) (“the principal purposes”),

(b) to be necessary or desirable for the purpose of providing knowledge that, in the view of the Authority, may be capable of being applied for the purposes specified in sub-paragraph (2)(a) or (b), or

(2) The principal purposes are—

(a) increasing knowledge about serious disease or other serious medical conditions,

(b) developing treatments for serious disease or other serious medical conditions,

(c) increasing knowledge about the causes of any congenital disease or congenital medical condition that does not fall within paragraph (a),

(d) promoting advances in the treatment of infertility,

(e) increasing knowledge about the causes of miscarriage,

(f) developing more effective techniques of contraception,

(g) developing methods for detecting the presence of gene, chromosome or mitochondrion abnormalities in embryos before implantation, or

(h) increasing knowledge about the development of embryos.

4A

(1) This paragraph applies where—

(a) a permitted embryo, the creation of which was brought about in vitro, is in storage,

(b) it was created for use in providing treatment services,

(c) before it is used in providing treatment services, one of the persons whose gametes were used to bring about its creation (“P”) gives the person keeping the embryo notice withdrawing P's consent to the storage of the embryo, and

(d) the embryo was not to be used in providing treatment services to P alone.

(2) The person keeping the embryo must as soon as possible take all reasonable steps to notify each interested person in relation to the embryo of P's withdrawal of consent.

(3) For the purposes of sub-paragraph (2), a person is an interested person in relation to an embryo if the embryo was to be used in providing treatment services to that person.

(4) Storage of the embryo remains lawful until—

(a) the end of the period of 12 months beginning with the day on which the notice mentioned in sub-paragraph (1) was received from P, or

(b) if, before the end of that period, the person keeping the embryo receives a notice from each person notified of P's withdrawal under sub-paragraph (2) stating that the person consents to the destruction of the embryo, the time at which the last of those notices is received.

(5) The reference in sub-paragraph (1)(a) to a permitted embryo is to be read in accordance with section 3ZA.

9

(1) The gametes of a person (“C”) may be kept in storage without C's consent if the following conditions are met.

(2) Condition A is that the gametes are lawfully taken from or provided by C before C attains the age of 18 years.

(3) Condition B is that, before the gametes are first stored, a registered medical practitioner certifies in writing that C is expected to undergo medical treatment and that in the opinion of the registered medical practitioner—

(a) the treatment is likely to cause a significant impairment of C's fertility, and

(b) the storage of the gametes is in C's best interests.

(4) Condition C is that, at the time when the gametes are first stored, either—

(a) C has not attained the age of 16 years and is not competent to deal with the issue of consent to the storage of the gametes, or

(b) C has attained that age but, although not lacking capacity to consent to the storage of the gametes, is not competent to deal with the issue of consent to their storage.

(5) Condition D is that C has not, since becoming competent to deal with the issue of consent to the storage of the gametes—

(a) given consent under this Schedule to the storage of the gametes, or

(b) given written notice to the person keeping the gametes that C does not wish them to continue to be stored.

(6) In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications—

(a) for sub-paragraph (4), substitute—

(4) Condition C is that, at the time when the gametes are first stored, C does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the storage of the gametes.

, and

(b) in sub-paragraph (5), for “becoming competent to deal with the issue of consent to the storage of the gametes” substitute “ acquiring such capacity ”.

10

(1) The gametes of a person (“P”) may be kept in storage without P's consent if the following conditions are met.

(2) Condition A is that the gametes are lawfully taken from or provided by P after P has attained the age of 16 years.

(3) Condition B is that, before the gametes are first stored, a registered medical practitioner certifies in writing that P is expected to undergo medical treatment and that in the opinion of the registered medical practitioner—

(a) the treatment is likely to cause a significant impairment of P's fertility,

(b) P lacks capacity to consent to the storage of the gametes,

(d) the storage of the gametes is in P's best interests.

(4) Condition C is that, at the time when the gametes are first stored, P lacks capacity to consent to their storage.

(5) Condition D is that P has not subsequently, at a time when P has capacity to give a consent under this Schedule—

(a) given consent to the storage of the gametes, or

(b) given written notice to the person keeping the gametes that P does not wish them to continue to be stored.

(6) In relation to Scotland—

(a) references in sub-paragraphs (3) and (4) to P lacking capacity to consent are to be read as references to P being incapable, within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000, of giving such consent,

(b) the references in sub-paragraphs (3) and (5) to P having capacity are to be read as references to P not being so incapable, and

11

A person's gametes must not be kept in storage by virtue of paragraph 9 or 10 after the person's death.

Creation, use and storage of human admixed embryos

12

(1) A person's gametes or human cells must not be used to bring about the creation of any human admixed embryo in vitro unless there is an effective consent by that person to any human admixed embryo, the creation of which may be brought about with the use of those gametes or human cells, being used for the purposes of any project of research.

(2) A human admixed embryo the creation of which was brought about in vitro must not be received by any person unless there is an effective consent by each relevant person in relation to the human admixed embryo to the use of the human admixed embryo for the purposes of any project of research.

(3) A human admixed embryo the creation of which was brought about in vitro must not be used for the purposes of a project of research unless—

(a) there is an effective consent by each relevant person in relation to the human admixed embryo to the use of the human admixed embryo for that purpose, and

(b) the human admixed embryo is used in accordance with those consents.

(4) If the Authority is satisfied that the parental consent conditions in paragraph 15 are met in relation to the proposed use under a licence of the human cells of a person who has not attained the age of 18 years (“C”), the Authority may in the licence authorise the application of sub-paragraph (5) in relation to C.

(5) Where the licence authorises the application of this sub-paragraph, the effective consent of a person having parental responsibility for C—

(a) to the use of C's human cells to bring about the creation of a human admixed embryo in vitro for use for the purposes of a project of research, or

(b) to the use for those purposes of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C's human cells,

is to be treated for the purposes of sub-paragraphs (1) to (3) as the effective consent of C.

(6) If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraphs (1) to (3) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (5) ceases to apply in relation to C.

(7) Sub-paragraphs (1) to (3) have effect subject to paragraphs 16 and 20.

13

(1) A human admixed embryo the creation of which was brought about in vitro must not be kept in storage unless—

(a) there is an effective consent by each relevant person in relation to the human admixed embryo to the storage of the human admixed embryo, and

(b) the human admixed embryo is stored in accordance with those consents.

(2) Where a licence authorises the application of paragraph 12(5) in relation to a person who has not attained the age of 18 years (“C”), the effective consent of a person having parental responsibility for C to the storage of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C's human cells is to be treated for the purposes of sub-paragraph (1) as the effective consent of C.

(3) If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraph (1) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (2) ceases to apply in relation to C.

(4) Sub-paragraph (1) has effect subject to paragraphs 16 and 20.

14

For the purposes of paragraphs 12 and 13, each of the following is a relevant person in relation to a human admixed embryo the creation of which was brought about in vitro (“human admixed embryo A”)—

(a) each person whose gametes or human cells were used to bring about the creation of human admixed embryo A,

(b) each person whose gametes or human cells were used to bring about the creation of any embryo, the creation of which was brought about in vitro, which was used to bring about the creation of human admixed embryo A, and

(c) each person whose gametes or human cells were used to bring about the creation of any other human admixed embryo, the creation of which was brought about in vitro, which was used to bring about the creation of human admixed embryo A.

15

(1) In relation to a person who has not attained the age of 18 years (“C”), the parental consent conditions referred to in paragraphs 6(3A) and 12(4) are as follows.

(2) Condition A is that C suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

(3) Condition B is that either—

(a) C is not competent to deal with the issue of consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or

(b) C has attained the age of 16 years but lacks capacity to consent to such use of C's human cells.

(4) Condition C is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about—

(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or

(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

(5) Condition D is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who—

(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or

(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

(6) In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications—

(a) for sub-paragraph (3) substitute—

(3) Condition B is that C does not have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.

(b) in sub-paragraph (5)(a), for “have capacity to consent” substitute “ are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent ”, and

(c) in sub-paragraph (5)(b), for “are competent to deal with the issue of” substitute “ have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to ”.

Adults lacking capacity: exemption relating to use of human cells etc.

16

(1) If, in relation to the proposed use under a licence of the human cells of a person who has attained the age of 18 years (“P”), the Authority is satisfied—

(a) that the conditions in paragraph 17 are met,

(b) that paragraphs (1) to (4) of paragraph 18 have been complied with, and

the Authority may in the licence authorise the application of this paragraph in relation to P.

(2) Where a licence authorises the application of this paragraph, this Schedule does not require the consent of P—

(a) to the use (whether during P's life or after P's death) of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research,

(b) to the storage or the use for those purposes (whether during P's life or after P's death) of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of P's human cells.

(3) This paragraph has effect subject to paragraph 19.

17

(1) The conditions referred to in paragraph 16(1)(a) are as follows.

(2) Condition A is that P suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

(3) Condition B is that P lacks capacity to consent to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.

(4) Condition C is that the person responsible under the licence has no reason to believe that P had refused such consent at a time when P had that capacity.

(5) Condition D is that it appears unlikely that P will at some time have that capacity.

(6) Condition E is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about—

(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or

(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

(7) Condition F is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who—

(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or

(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

(8) In this paragraph and paragraph 18 references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

(9) In relation to Scotland—

(a) references in sub-paragraphs (3) to (5) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent, and

(b) sub-paragraph (7) is to be read with the following modifications—

(i) in paragraph (a), for “have capacity to consent” substitute “ are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent ”, and

(ii) in paragraph (b), for “are competent to deal with the issue of” substitute “ have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to ”.

Consulting carers etc. in case of adult lacking capacity

18

(1) This paragraph applies in relation to a person who has attained the age of 18 years (“P”) where the person responsible under the licence (“R”) wishes to use P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, in a case where P lacks capacity to consent to their use.

(2) R must take reasonable steps to identify a person who—

(a) otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P's welfare, and

(b) is prepared to be consulted by R under this paragraph of this Schedule.

(3) If R is unable to identify such a person R must nominate a person who—

(a) is prepared to be consulted by R under this paragraph of this Schedule, but

(b) has no connection with the project.

(4) R must provide the person identified under sub-paragraph (2) or nominated under sub-paragraph (3) (“F”) with information about the proposed use of human cells to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project and ask F what, in F's opinion, P's wishes and feelings about the use of P's human cells for that purpose would be likely to be if P had capacity in relation to the matter.

(5) The condition referred to in paragraph 16(1)(c) is that, on being consulted, F has not advised R that in F's opinion P's wishes and feelings would be likely to lead P to decline to consent to the use of P's human cells for that purpose.

(6) In relation to Scotland, the references in sub-paragraphs (1) and (4) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Effect of acquiring capacity

19

(1) Paragraph 16 does not apply to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo if, at a time before the human cells are used for that purpose, P—

(a) has capacity to consent to their use, and

(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

(2) Paragraph 16 does not apply to the storage or use of an embryo or human admixed embryo whose creation in vitro was brought about with the use of P's human cells if, at a time before the embryo or human admixed embryo is used for the purposes of the project of research, P—

(a) has capacity to consent to the storage or use, and

(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

(3) In relation to Scotland, the references in sub-paragraphs (1)(a) and (2)(a) to P having capacity to consent are to be read as references to P not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Use of cells or cell lines in existence before relevant commencement date

20

(1) Where a licence authorises the application of this paragraph in relation to qualifying cells, this Schedule does not require the consent of a person (“P”)—

(a) to the use of qualifying cells of P to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or

(b) to the storage or the use for those purposes of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of qualifying cells of P.

(2) “Qualifying cells” are human cells which—

(a) were lawfully stored for research purposes immediately before the commencement date, or

(b) are derived from human cells which were lawfully stored for those purposes at that time.

(3) The “commencement date” is the date on which paragraph 9(2)(a) of Schedule 3 to the Human Fertilisation and Embryology Act 2008 (requirement for consent to use of human cells to create an embryo) comes into force.

Conditions for grant of exemption in paragraph 20

21

(1) A licence may not authorise the application of paragraph 20 unless the Authority is satisfied—

(a) that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are—

(i) human cells in respect of which there is an effective consent to their use to bring about the creation in vitro of embryos or human admixed embryos for use for those purposes, or

(ii) human cells which by virtue of paragraph 16 can be used without such consent, and

(b) that any of the following conditions is met in relation to each of the persons whose human cells are qualifying cells which are to be used for the purposes of the project of research.

(2) Condition A is that—

(a) it is not reasonably possible for the person responsible under the licence (“R”) to identify the person falling within sub-paragraph (1)(b) (“P”), and

(b) where any information that relates to P (without identifying P or enabling P to be identified) is available to R, that information does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(3) Condition B is that—

(a) the person falling within sub-paragraph (1)(b) (“P”) is dead or the person responsible under the licence (“R”) believes on reasonable grounds that P is dead,

(b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, and

(c) a person who stood in a qualifying relationship to P immediately before P died (or is believed to have died) has given consent in writing to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(4) Condition C is that—

(a) the person responsible under the licence (“R”) has taken all reasonable steps to contact—

(i) the person falling within sub-paragraph (1)(b) (“P”), or

(ii) in a case where P is dead or R believes on reasonable grounds that P is dead, persons who could give consent for the purposes of sub-paragraph (3)(c),

but has been unable to do so, and

(b) the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

(5) The HTA consent provisions apply in relation to consent for the purposes of sub-paragraph (3)(c) as they apply in relation to consent for the purposes of section 3(6)(c) of the Human Tissue Act 2004; and for the purposes of this sub-paragraph the HTA consent provisions are to be treated as if they extended to Scotland.

(6) In sub-paragraph (5) “the HTA consent provisions” means subsections (4), (5), (6), (7) and (8)(a) and (b) of section 27 of the Human Tissue Act 2004.

(7) In this paragraph references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

(8) Paragraphs 1 to 4 of this Schedule do not apply in relation to a consent given for the purposes of sub-paragraph (3)(c).

Interpretation

22

(1) In this Schedule references to human cells are to human cells which are not—

(a) cells of the female or male germ line, or

(b) cells of an embryo.

(2) References in this Schedule to an embryo or a human admixed embryo which was used to bring about the creation of an embryo (“embryo A”) or a human admixed embryo (“human admixed embryo A”) include an embryo or, as the case may be, a human admixed embryo which was used to bring about the creation of—

(a) an embryo or human admixed embryo which was used to bring about the creation of embryo A or human admixed embryo A, and

(b) the predecessor of that embryo or human admixed embryo mentioned in paragraph (a), and

(3) References in this Schedule to an embryo or a human admixed embryo whose creation may be brought about using an embryo or a human admixed embryo are to be read in accordance with sub-paragraph (2).

(4) References in this Schedule (however expressed) to the use of human cells to bring about the creation of an embryo or a human admixed embryo include the use of human cells to alter the embryo or, as the case may be, the human admixed embryo.

(5) References in this Schedule to parental responsibility are—

(a) in relation to England and Wales, to be read in accordance with the Children Act 1989,

(b) in relation to Northern Ireland, to be read in accordance with the Children (Northern Ireland) Order 1995, and

(c) in relation to Scotland, to be read as references to parental responsibilities and parental rights within the meaning of the Children (Scotland) Act 1995.

(6) References in this Schedule to capacity are, in relation to England and Wales, to be read in accordance with the Mental Capacity Act 2005.

(7) References in this Schedule to the age of 18 years are, in relation to Scotland, to be read as references to the age of 16 years.

SCHEDULE 3B

Inspection of statutory records

1

(1) A duly authorised person may require a person to produce for inspection any records which the person is required to keep by, or by virtue of, this Act.

(2) Where records which a person is so required to keep are stored in any electronic form, the power under sub-paragraph (1) includes power to require the records to be made available for inspection—

(a) in a visible and legible form, or

(b) in a form from which they can be readily produced in a visible and legible form.

(3) A duly authorised person may inspect and take copies of any records produced for inspection in pursuance of a requirement under this paragraph.

Arranging inspections

2

(1) Where a person—

(a) makes an enquiry to the Authority which concerns the making of a relevant application by that person, or

(b) has made a relevant application to the Authority which the Authority has not yet considered,

the Authority may arrange for a duly authorised person to inspect any of the premises mentioned in sub-paragraph (3).

(2) For the purposes of sub-paragraph (1) a “relevant application” means—

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

(b) an application for authorisation for a person to carry on any such activity on premises where the person is not then authorised to carry it on.

(3) The premises referred to in sub-paragraph (1) are—

(a) the premises where any activity referred to in sub-paragraph (2) is to be carried on;

(b) any premises that will be relevant third party premises for the purposes of any application.

(4) The power in sub-paragraph (1) is exercisable for purposes of the Authority's functions in relation to licences and third party agreements.

Entry and inspection of premises

3

(1) A duly authorised person may at any reasonable time enter and inspect any premises to which a licence relates or relevant third party premises.

(2) The power in sub-paragraph (1) is exercisable for purposes of the Authority's functions in relation to licences and third party agreements.

4

(1) Subject to sub-paragraph (2), the Authority shall arrange for any premises to which a licence relates to be inspected under paragraph 3 by a duly authorised person at intervals not exceeding two years.

(2) The Authority need not comply with sub-paragraph (1) where the premises in question have been inspected in pursuance of paragraph 2 or 3 at any point within the previous two years.

Entry and search in connection with suspected offence

5

(1) If a justice of the peace is satisfied on sworn information or, in Northern Ireland, on a complaint on oath that there are reasonable grounds for believing—

(a) that an offence under this Act is being, or has been committed on any premises, and

(b) that any of the conditions in sub-paragraph (2) is met in relation to the premises,

the justice of the peace may by signed warrant authorise a duly authorised person, together with any constables, to enter the premises, if need be by force, and search them.

(2) The conditions referred to are—

(a) that entry to the premises has been, or is likely to be, refused and notice of the intention to apply for a warrant under this paragraph has been given to the occupier;

(b) that the premises are unoccupied;

(d) that an application for admission to the premises or the giving of notice of the intention to apply for a warrant under this paragraph would defeat the object of entry.

(3) A warrant under this paragraph shall continue in force until the end of the period of 31 days beginning with the day on which it is issued.

(4) In relation to Scotland—

(a) any reference in sub-paragraph (1) to a justice of the peace includes a reference to a sheriff, and

(b) the reference in that sub-paragraph to “on sworn information” is to be read as a reference to “by evidence on oath”.

Execution of warrants

6

(1) Entry and search under a warrant under paragraph 5 is unlawful if any of sub-paragraphs (2) to (4) and (6) is not complied with.

(2) Entry and search shall be at a reasonable time unless the person executing the warrant thinks that the purpose of the search may be frustrated on an entry at a reasonable time.

(3) If the occupier of the premises to which the warrant relates is present when the person executing the warrant seeks to enter them, the person executing the warrant shall—

(a) produce the warrant to the occupier, and

(b) give the occupier—

(i) a copy of the warrant, and

(ii) an appropriate statement.

(4) If the occupier of the premises to which the warrant relates is not present when the person executing the warrant seeks to enter them, but some other person is present who appears to the person executing the warrant to be in charge of the premises, the person executing the warrant shall—

(a) produce the warrant to that other person,

(b) give that other person—

(i) a copy of the warrant, and

(ii) an appropriate statement, and

(5) In sub-paragraphs (3)(b)(ii) and (4)(b)(ii), the references to an appropriate statement are to a statement in writing containing such information relating to the powers of the person executing the warrant and the rights and obligations of the person to whom the statement is given as may be prescribed by regulations made by the Secretary of State.

(6) If the premises to which the warrant relates are unoccupied, the person executing the warrant shall leave a copy of it in a prominent place on the premises.

(7) Where the premises in relation to which a warrant under paragraph 5 is executed are unoccupied or the occupier is temporarily absent, the person executing the warrant shall when leaving the premises, leave them as effectively secured as the person found them.

Seizure in the course of inspection or search

7

(1) A duly authorised person entering and inspecting premises under paragraph 3 may seize anything on the premises which the duly authorised person has reasonable grounds to believe may be required for—

(a) the purposes of the Authority's functions relating to the grant, revocation, variation or suspension of licences, or

(b) the purpose of taking appropriate control measures in the event of a serious adverse event or serious adverse reaction.

(2) A duly authorised person entering or searching premises under a warrant under paragraph 5 may seize anything on the premises which the duly authorised person has reasonable grounds to believe may be required for the purpose of being used in evidence in any proceedings for an offence under this Act.

(3) Where a person has power under sub-paragraph (1) or (2) to seize anything, that person may take such steps as appear to be necessary for preserving that thing or preventing interference with it.

(4) The power under sub-paragraph (1) or (2) includes power to retain anything seized in exercise of the power for so long as it may be required for the purpose for which it was seized.

(5) Where by virtue of sub-paragraph (1) or (2) a person (“P”) seizes anything, P shall leave on the premises from which the thing was seized a statement giving particulars of what P has seized and stating that P has seized it.

Supplementary provision

8

(1) Power under this Schedule to enter and inspect or search any premises includes power to take such other persons and equipment as the person exercising the power reasonably considers necessary.

(2) Power under this Schedule to inspect or search any premises includes, in particular—

(a) power to inspect any equipment found on the premises,

(b) power to inspect and take copies of any relevant documents or records found on the premises, and

(c) in the case of premises to which a licence relates or premises which are relevant third party premises in relation to a licence, power to observe the carrying-on of the licensed activity on the premises.

(3) Any power under this Schedule to enter, inspect or search premises includes power to require any person to afford such facilities and assistance with respect to matters under that person's control as are necessary to enable the power of entry, inspection or search to be exercised.

(4) In this paragraph “relevant document” means a document relevant for the purposes of ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.

9

(1) A person's right to exercise a power under this Schedule is subject to production of evidence of the person's entitlement to exercise it, if required.

(2) As soon as reasonably practicable after having inspected premises in pursuance of arrangements made under paragraph 2 or after having exercised a power under this Schedule to inspect or search premises, the duly authorised person shall—

(a) prepare a written report of the inspection, or as the case may be, the inspection and search, and

(b) if requested to do so by the appropriate person, give the appropriate person a copy of the report.

(3) In sub-paragraph (2), the “appropriate person” means—

(a) in relation to premises to which a licence relates, the person responsible, or

(b) in relation to any other premises, the occupier.

(4) Sub-paragraph (5) applies in relation to Northern Ireland if the European Commission or a competent authority in an EEA state ... requests the Authority to provide it with a copy of a report or information on—

(a) any inspection under paragraph 1 or 1A of records or documents,

(b) any inspection under paragraph 2 where the person to whom an application for authorisation relates also seeks a direction under section 24(4) authorising that person to import qualifying gametes or embryos into the United Kingdom from a third country, or

(c) any inspection under paragraph 3 of premises to which a licence held by an importing licensee relates or which are relevant third party premises in relation to an importing licensee.

(5) The Authority must give a copy of the report or information to the person requesting it, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

Enforcement

10

A person who—

(a) fails without reasonable excuse to comply with a requirement under paragraph 1(1) or 8(3), or

(b) intentionally obstructs the exercise of any right under this Schedule,

is guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Interpretation

11

In this Schedule—

(a) “duly authorised person”, in the context of any provision, means a person authorised by the Authority to act for the purposes of that provision, and

(b) “licensed activity”, in relation to a licence, means the activity which the licence authorises to be carried on.

Effect of sections 27 and 28.

Parental orders in favour of gamete donors.

Disclosure of information

Disclosure in interests of justice: congenital disabilities, etc.

Mitochondrial donation

Fees

Inspection, entry, search and seizure

Civil liability to child with disability.

Regulations.

Orders

Index.

Short title, commencement, etc.

5A

The Secretary of State may suspend a member from office as chairman, deputy chairman or other member of the Authority if it appears to him that one of the conditions in paragraph 5(5) is or may be satisfied in relation to the member.

5B

(1) This paragraph applies where the Secretary of State decides to suspend a member under paragraph 5A.

(2) The Secretary of State must give notice to the member of the decision and the suspension takes effect on receipt by the member of the notice.

(3) A notice under subsection (2) is treated as being received by the member—

(a) in a case where it is delivered in person or left at the member's proper address, at the time at which it is delivered or left;

(b) in a case where it is sent by post to the member at that address, on the third day after the day on which it was posted.

(4) The initial period of suspension must not exceed 6 months.

(5) The Secretary of State may review the member's suspension at any time.

(6) The Secretary of State must review the member's suspension if requested in writing by the member to do so, but need not carry out a review less than 3 months after the beginning of the initial period of suspension.

(7) Following a review the Secretary of State may—

(a) revoke the suspension, or

(b) suspend the member for another period of not more than 6 months from the expiry of the current period.

(8) The Secretary of State must revoke the suspension if at any time—

(a) he decides that neither of the conditions mentioned in paragraph 5(5) is satisfied, or

(b) he decides that either of those conditions is satisfied but does not remove the member from office as chairman, deputy chairman or other member of the Authority.

2B

(1) This section applies for the purposes of this Act.

(2) “Importing licensee” means a person—

(a) to whom a licence applies, and

(b) who is authorised by directions under section 24(4) to import qualifying gametes or embryos ... from a third country.

(3) “Qualifying gametes or embryos” means gametes or embryos intended for human application.

(4) “Third country” means—

(a) in relation to the import of qualifying gametes or embryos into, or the export of qualifying gametes or embryos from, Great Britain, a country other than the United Kingdom,

(b) in relation to the import of qualifying gametes or embryos into Northern Ireland, a country other than Northern Ireland or an EEA state, and

(c) in relation to the export of qualifying gametes or embryos from Northern Ireland, a country other than the United Kingdom or an EEA state.

(5) Premises are “third country premises” if—

(a) in relation to Great Britain—

(i) they are in a country other than the United Kingdom, and

(ii) they are premises in or from which a third country supplier, or a person providing services to a third country supplier, procures, tests, processes, stores, distributes or exports qualifying gametes or embryos intended for import into Great Britain, and

(b) in relation to Northern Ireland—

(i) they are in a country other than Northern Ireland or an EEA state, and

(ii) they are premises in or from which a third country supplier, or a person providing services to a third country supplier, procures, tests, processes, stores, distributes or exports qualifying gametes or embryos intended for import into Northern Ireland.

(6) “Third country supplier” means—

(a) in relation to qualifying gametes or embryos intended for import into Great Britain, a person in a country other than the United Kingdom who has an agreement with an importing licensee for exporting such gametes or embryos into Great Britain, and

(b) in relation to qualifying gametes or embryos intended for import into Northern Ireland, a person in a country other than Northern Ireland or an EEA state who has an agreement with an importing licensee for exporting such gametes or embryos into Northern Ireland.

8ZB

(1) The Authority in relation to Northern Ireland, must allocate to each holder of a relevant licence, one or more unique numbers as the tissue establishment number or numbers in relation to that licence holder in accordance with Annex VII and paragraph 2(a) of Article 10b of the third Directive.

(2) Any number allocated under subsection (1) must be in the format specified in Annex VII.

(3) In relation to Northern Ireland, the Authority must take steps to enable the information specified in Annex VIII to be recorded in the EU Tissue Establishment Compendium in relation to each holder of a relevant licence.

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

(5) The Authority must take the steps mentioned in subsection (3) to enable the information mentioned in that subsection to be recorded before the end of the period of 10 working days beginning with the day on which the person becomes the holder of a relevant licence.

(6) Subsection (7) applies if the Authority becomes aware that any information recorded under subsection (3) was incorrectly recorded or requires updating.

(7) The Authority must take steps to enable the information to be corrected or updated —

(a) in the case of a correction or update which the Authority considers to be a significant change to the information recorded under subsection (3), before the end of the period of 10 working days beginning with the day on which the Authority became aware that the information was incorrectly recorded or required updating;

(b) in any other case, as soon as is reasonably practicable.

(8) Subsection (9) applies if the Authority becomes aware that—

(a) any information recorded in the EU Tissue Establishment Compendium in respect of a tissue establishment in a relevant state was incorrectly recorded or requires updating, or

(b) a tissue establishment in a relevant state has not complied with the requirements of the laws or other measures adopted in that state for the purpose of implementing paragraph 1 of Article 10b of the third Directive and the non-compliance is significant.

(9) The Authority must inform the competent authority in the relevant state in question.

(10) If the Authority becomes aware that the information recorded in the EU Tissue and Cell Product Compendium requires updating, it must inform the European Commission and the competent authority in the relevant state.

(11) In this section—

“Annex VII” means Annex VII to the third Directive,

“Annex VIII” means Annex VIII to the third Directive,

“EU Tissue and Cell Product Compendium” and “EU Tissue Establishment Compendium” have the same meaning as in Article 2 of the third Directive,

“relevant licence” means a licence granted under any of the following provisions of Schedule 2—paragraph 1,paragraph 1A,paragraph 2, so far as authorising the storage of gametes or embryos intended for human application,paragraph 3, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application,

“relevant state” means an EEA State,

“working day” means any day other than—a Saturday or Sunday,Christmas Day or Good Friday, ora day which is a bank holiday under the Banking and Financial Dealings Act 1971 in any part of the United Kingdom.

15B

(1) This section applies where—

(a) qualifying gametes or embryos are imported into Northern Ireland from a third country by an importing licensee,

(b) the gametes or embryos are distributed in an EEA state ..., and

(i) arranging for an inspection of any third country premises to be carried out on behalf of the Authority,

(ii) arranging for an inspection of any relevant documents held by a third country supplier to be carried out on behalf of the Authority,

(iii) exercising the Authority’s powers under section 18(2) to revoke a licence held by an importing licensee,

(iv) exercising the Authority’s powers under section 18A(3) to vary a licence held by an importing licensee,

(v) exercising the Authority’s powers under section 19C(1) to suspend a licence held by an importing licensee, and

(vi) other appropriate control measures.

(2) The Authority must carry out the activity in question in subsection (1)(c), unless it considers that it would be inappropriate to do so in the particular circumstances of the case.

(3) Before an inspection of any premises is carried out in pursuance of subsection (2), the Authority must—

(a) make arrangements with the competent authority which made the request under subsection (1) for it to participate in the inspection, or

(b) notify the competent authority which made the request under subsection (1) that the Authority has decided that it is not appropriate for it to participate in the inspection and give reasons for that decision.

(4) For the purposes of ascertaining whether qualifying gametes or embryos imported into Northern Ireland from a third country meet standards of quality and safety equivalent to those laid down in this Act, the Authority may arrange for either or both of the following to be to be carried out on its behalf—

(a) an inspection of any third country premises,

(b) an inspection of any relevant documents held by a third country supplier.

(5) The Authority may arrange for a report to be made on any inspection carried out in pursuance of subsection (2) or (4).

(6) Any inspection carried out on behalf of the Authority in pursuance of subsection (2) or (4) must be carried out by a person authorised by the Authority to act for the purposes of this section.

(7) References in this section to carrying out an inspection of any premises include, in particular—

(a) inspecting any equipment found on the premises,

(b) inspecting and taking copies of any relevant documents or records found on the premises, and

(c) observing the carrying on of any activity relevant to ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.

(8) In this section, “relevant document” means a document relevant for the purposes of ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.

15C

(1) This section applies in relation to Northern Ireland where the European Commission or a competent authority in an EEA state requests the Authority to provide it with—

(a) a copy of a report or information on any inspection of third country premises or relevant documents carried out in pursuance of section 15B(2) or (5),

(b) information on any exercise of the Authority’s powers under section 18(2), 18A(3) or 19C(1) in relation to a licence held by an importing licensee (whether in pursuance of section 15B(2) or otherwise), or

(c) information on any appropriate control measures carried out by the Authority (whether in pursuance of section 15B(2) or otherwise).

(2) The Authority must provide the report or information in question to the person requesting it, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

SCHEDULE 3AA

1

A direction given under section 24(4AA) must require the person to whom the licence applies to—

(a) comply with measures specified in the direction for the purposes of ensuring that any qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act,

(b) provide the Authority with any information specified in the direction for the purposes of securing compliance with the requirements of Parts A to E of Annex I to the fourth Directive (information to be provided by importing tissue establishments),

(c) provide the Authority with any documents specified in the direction for the purposes of securing compliance with the requirements of Part F of Annex I to the fourth Directive (documentation to be provided by importing tissue establishments),

(d) do the following—

(i) make available for inspection any documents specified in the direction for the purposes of securing compliance with the requirements of Parts A and B of Annex III to the fourth Directive (availability and provision of documentation) and,

(ii) if requested by the Authority, provide the Authority with any such documents,

(e) enter into a written agreement with any proposed third country supplier which complies with the requirements specified in the direction for the purposes of securing compliance with the requirements of Article 7(2) and (3) of the fourth Directive (written agreements), and

(f) provide the Authority with a copy of the written agreement mentioned in sub-paragraph (e).

2

A direction given under section 24(4AB) must require the person to whom the licence applies to —

(a) comply with measures specified in the direction for the purposes of ensuring that any qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act,

(b) provide the Authority with any information specified in the direction for the purposes of securing compliance with the requirements of Parts A to E of Annex I to the fourth Directive (information to be provided by importing tissue establishments), and

(i) in relation to Great Britain, with any information or documents specified in the direction for the purposes of demonstrating traceability, and that the import is a one-off import within the meaning given by section 24(4AE),

(ii) in relation to Northern Ireland, with any information or documents specified in the direction for the purposes of securing compliance with the requirements of Articles 5(2) and 7(1) of the fourth Directive (requirements in relation to one-off imports).

3

The following requirements must be specified in directions under section 24(4) authorising any person to whom a licence applies to make any qualifying imports—

(a) a requirement that the person must not make any substantial changes in connection with any qualifying imports made by the person unless the Authority approves those changes in writing,

(b) a requirement that the person must notify the Authority if the person ceases to make qualifying imports,

(i) notify the Authority of any serious adverse events or serious adverse reactions notified to the person by the person’s third country supplier (including events or reactions which that supplier suspects are serious adverse events or reactions), and

(ii) provide any information specified in the direction which the Authority requires for the purposes of securing compliance with the requirements of Article 6(2) of the fourth Directive (updated information), and

(d) a requirement that the person must notify the Authority of any changes in circumstances of the person’s third country supplier of which the person is aware.

4

In this Schedule—

“changes of circumstances” means any changes in circumstances of the description specified in the direction in question in accordance with the provision made in Article 6(3) of the fourth Directive (notification of revocation of third country’s authorisation),

“substantial changes” means changes of the description specified in the direction in question in accordance with the provision as to the meaning of substantial changes made in Article 3(3) of the fourth Directive (requirements where substantial changes made to import activities).

1A

(1) This paragraph applies in relation to Northern Ireland where—

(a) qualifying gametes or embryos are imported from a third country by an importing licensee,

(b) the gametes or embryos are distributed in an EEA state ..., and

(c) the competent authority in that state ... requests the Authority to arrange for an inspection of any relevant documents held by an importing licensee to be carried out.

(2) The Authority must arrange for an inspection of the documents in question to be carried out by a duly authorised person, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

(3) Where relevant documents are stored in any electronic form, a duly authorised person may require an importing licensee to make the documents available for inspection—

(a) in a visible and legible form, or

(b) in a form from which they can be readily produced in a visible and legible form.

(4) A duly authorised person may take copies of any relevant documents inspected in pursuance of a requirement under this paragraph.

(5) In this paragraph “relevant document” means a document relevant for the purposes of ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.

4A

(1) This paragraph applies in relation to Northern Ireland where—

(a) any activity governed by this Act is carried out in relation to qualifying gametes or embryos imported from a third country on any premises--

(i) to which a licence held by an importing licensee relates, or

(ii) which are relevant third party premises in relation to an importing licensee,

(b) the gametes or embryos are distributed in an EEA state ..., and

(c) the competent authority in that state ... requests the Authority to arrange for an inspection of the premises to be carried out.

(2) The Authority must arrange for an inspection of the premises in question to be carried out under paragraph 3 by a duly authorised person, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

(3) Before an inspection of any premises is carried out in pursuance of sub-paragraph (2) the Authority must—

(a) make arrangements with the requesting authority for it to participate in the inspection, or

(b) notify the requesting authority that the Authority has decided that it is not appropriate for the requesting authority to participate in the inspection and give reasons for that decision.

(4) In this paragraph, “requesting authority” means the competent authority which made the request under sub-paragraph (1) for the Authority to arrange for the inspection to be carried out.

Inspection of documents held by an importing licensee

Procedure for approval of code.

Meaning of “mother”.

Meaning of “father”.

Effect of sections 27 and 28.

Parental orders in favour of gamete donors.

Disclosure of information

Mitochondrial donation

Fees

42A

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

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

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

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

(a) the licensing or authorisation of tissue establishments;

(b) the procurement of gametes or embryos;

(d) laboratory tests required for donors;

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

(f) the gamete and embryo preparation process;

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

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

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

Civil liability to child with disability.

Orders

Index.

Short title, commencement, etc.

A1

For the purposes of this Act, as it applies in relation to Great Britain, the first, second and third Directives are to be read subject to the modifications set out in paragraphs 11A to 11C.

Serious adverse events and serious adverse reactions: Northern Ireland

3A

In relation to Northern Ireland, 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 are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.

Modifications to the first, second and third Directives

11A

(1) The modifications to the first Directive are as follows.

(2) Article 8 is to be read as if—

(a) in paragraph 1—

(i) the reference to Member States were a reference to the Authority;

(ii) for “on their territory” there were substituted “in Great Britain”;

(b) paragraphs 2, 3 5 and 6 were omitted.

(3) Article 14 is to be read as if—

(a) in paragraph 1—

(i) the reference to Member States were a reference to the Authority;

(ii) for “within the scope of this Directive” there were substituted “ in accordance with the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 2, the reference to Member States were a reference to the Authority;

(i) the first reference to Member States were a reference to the Authority;

(ii) “in Member States” were omitted.

(4) Article 15 is to be read as if paragraphs 1, 2 and 4 were omitted.

(5) Article 19(5) is to be read as if the words “in accordance with Article 8” were omitted.

(6) Article 20 is to be read as if in paragraph 1, the reference to Article 28(h) were a reference to the requirements of Annex 2 to the third Directive listed in paragraph 11 of this Schedule.

(7) Article 21 is to be read as if—

(a) in paragraph 4, for “laid down in this Directive” there were substituted “ of the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 5—

(i) the first reference to Member States were a reference to the Authority;

(ii) the reference to a tissue establishment accredited, designated, authorised or licensed in accordance with Article 6 were a reference to a tissue establishment authorised or licensed in accordance with the provisions of this Act;

(iii) for the words “Member States' legislation” there were substituted “ legislation ”.

(8) Article 24 is to be read as if—

(a) in paragraph 2, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 5, the reference to the competent authority or authorities were a reference to the Authority.

(9) The Annex is to be read as if—

(a) in paragraph B.1, for “legislation in force in Member States” there were substituted “ requirements of Schedule 3 to the Human Fertilisation and Embryology Act 1990 ”;

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.

Human Fertilisation and Embryology Act 1990

7

Request for information as to genetic parentage etc.

Disclosure of information

Power to provide for additional exceptions from section 33A(1)

Conscientious objection.

Amendment of law relating to termination of pregnancy.

Orders

Offences.

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

Civil liability to child with disability.

Regulations.

Notices.

Northern Ireland.

Other terms.

Prohibition in connection with germ cells.

3ZA

4A

8ZA

8E

9A

Conditions of storage licences.

Revocation of licence

Revocation of licence

18A

19C

Procedure on reconsideration

Directions as to particular matters.

Procedure for approval of code.

Disclosure in interests of justice: congenital disabilities, etc.

Parental orders in favour of gamete donors.

Civil liability to child with disability.

Disclosure of information

Consent required to authorise certain disclosures

Disclosure in interests of justice: congenital disabilities, etc.

Mitochondrial donation

Index.

35A

Fees

Northern Ireland.

35B

38A

Consent to prosecution.

Civil liability to child with disability.

Regulations.

Power to make consequential provision

45A

45B

Short title, commencement, etc.

4A

Embryo testing

1ZA

Sex selection

1ZB

Power to amend paragraphs 1ZA and 1ZB

1ZC

Purposes for which activities may be licensed under paragraph 3

3A

4A

Cases where consent not required for storage

9

10

11

Creation, use and storage of human admixed embryos

12

13

14

Parental consent conditions

15

Adults lacking capacity: exemption relating to use of human cells etc.

16

Consent to use of human cells etc. not required: adult lacking capacity

17

Consulting carers etc. in case of adult lacking capacity

18

Effect of acquiring capacity

19

Use of cells or cell lines in existence before relevant commencement date

20

Conditions for grant of exemption in paragraph 20