Human Fertilisation and Embryology Act 1990

Disclosure in interests of justice: congenital disabilities, etc.

Amendment of law relating to termination of pregnancy.

Conscientious objection.

Powers of members and employees of Authority.

Power to enter premises.

Offences.

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

Civil liability to child with disability.

Regulations.

Inspection of documents held by an importing licensee

Index.

Northern Ireland.

Short title, commencement, etc.

8B

• (1) Arrangements may be made between the Authority and a government department, a public authority or the holder of a public office (“the other authority”) for—

• (a) any functions of the Authority to be exercised by, or by members of the staff of, the other authority, or

• (b) the provision by the other authority of administrative, professional or technical services to the Authority.

• (2) Arrangements under subsection (1)(a) do not affect responsibility for the carrying-out of the Authority's functions.

• (3) Subsection (1)(a) does not apply to any function of making subordinate legislation (within the meaning of the Interpretation Act 1978).

8C

• (1) This section applies to any function of the Authority other than—

• (a) any function which, by virtue of any enactment, may be exercised only by members of the Authority,

• (b) a function excluded from this section by subsection (2), or

• (c) a function excluded from this section by the Secretary of State by order.

• (2) A function is excluded from this section if—

• (a) it relates to the grant, revocation or variation of any licence,

• (b) it is a power or right of entry, search or seizure into or of any property, or

• (c) it is a function of making subordinate legislation (within the meaning of the Interpretation Act 1978).

• (3) The Authority may make arrangements with any person (“the authorised person”) for the exercise by that person, or by the employees of that person, of any function of the Authority to which this section applies.

• (4) Any arrangements made by the Authority under this section—

• (a) may be revoked at any time by the Authority, and

• (b) do not prevent the Authority from exercising any function to which the arrangements relate.

• (5) Subject to subsection (6), anything done or omitted to be done by or in relation to the authorised person (or an employee of the authorised person) in, or in connection with, the exercise or purported exercise of any function to which the arrangements relate is to be treated for all purposes as done or omitted to be done by or in relation to the Authority.

• (6) Subsection (5) does not apply—

• (a) for the purposes of so much of any contract between the authorised person and the Authority as relates to the exercise of the function, or

• (b) for the purposes of any criminal proceedings brought in respect of anything done or omitted to be done by the authorised person (or any employee of the authorised person).

• (7) Section 38A(2) of this Act (which relates to the keeping of embryos, human admixed embryos and gametes) applies in relation to the authorised person or any employee of the authorised person, when exercising functions of the Authority, as it applies in relation to any member or employee of the Authority exercising functions as member or employee.

8D

• (1) This section applies to—

• (a) the Authority,

• (b) any public authority or other person exercising functions of the Authority by virtue of section 8B,

• (c) any member of staff of any person falling within paragraph (b),

• (d) any person exercising functions of the Authority by virtue of section 8C,

• (e) an employee of any person falling within paragraph (d), or

• (f) any person engaged by the Authority to provide services to the Authority.

• (2) No obligation of confidence is to prevent the disclosure of information by a person to whom this section applies to another such person if the disclosure is necessary or expedient for the purposes of the exercise of any function of the Authority.

19A

• (1) In the case of a decision to grant a licence, the Authority shall give notice of the decision to—

• (a) the applicant, and

• (b) the person who is to be the person responsible.

• (2) In the case of a decision to revoke a licence, the Authority shall give notice of the decision to—

• (a) the person responsible, and

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

• (3) In the case of a decision to vary a licence on application under section 18A(1), the Authority shall give notice of the decision to—

• (a) the holder of the licence, and

• (b) (if different) the person who is to be the person responsible.

• (4) In the case of any other decision to vary a licence, the Authority shall give notice of the decision to—

• (a) the person responsible, and

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

• (5) In the case of a decision to refuse an application for the grant, revocation or variation of a licence, the Authority shall give notice of the decision to the applicant.

• (6) Subject to subsection (7), a notice under subsection (2), (4) or (5) shall include a statement of the reasons for the decision.

• (7) In the case of a notice under subsection (2) or (4), the notice is not required to include a statement of the reasons for the decision if the decision is made on an application under section 18(1) or 18A(2).

19B

• (1) Directions may make provision about—

• (a) the form and content of applications under this Act, and

• (b) the information to be supplied with such an application.

• (2) The Secretary of State may by regulations make other provision about applications under this Act.

• (3) Such regulations may, in particular, make provision about procedure in relation to the determination of applications under this Act and may, in particular, include—

• (a) provision for requiring persons to give evidence or to produce documents;

• (b) provision about the admissibility of evidence.

20A

• (1) The Authority shall maintain one or more committees to carry out its functions in pursuance of notices under section 20.

• (2) A committee under subsection (1) is referred to in this Act as an appeals committee.

• (3) Regulations shall make provision about the membership and proceedings of appeals committees.

• (4) Regulations under subsection (3) may, in particular, provide—

• (a) for the membership of an appeals committee to be made up wholly or partly of persons who are not members of the Authority, and

• (b) for the appointment of any person to advise an appeals committee on prescribed matters.

• (5) For the purposes of subsection (4) “prescribed” means prescribed by regulations under subsection (3).

Procedure on reconsideration

20B

• (1) Reconsideration shall be by way of a fresh decision.

• (2) Regulations shall make provision about the procedure in relation to reconsideration.

• (3) Regulations under subsection (2) may, in particular, make provision—

• (a) entitling a person by whom reconsideration is required, (“the appellant”) to require that the appellant or the appellant's representative be given an opportunity to appear before and be heard by the appeals committee dealing with the matter,

• (b) entitling the person who made the decision which is the subject of reconsideration to appear at any meeting at which such an opportunity is given, and to be heard in person or by a representative,

• (c) requiring the appeals committee dealing with the matter to consider any written representations received from the appellant or the person who made the decision which is the subject of reconsideration,

• (d) preventing any person who made the decision which is the subject of reconsideration from sitting as a member of the appeals committee dealing with the matter,

• (e) requiring persons to give evidence or to produce documents,

• (f) concerning the admissibility of evidence, and

• (g) requiring the appellant and any prescribed person to be given notice of the decision on reconsideration and a statement of reasons for the appeals committee's decision.

• (4) Regulations under subsection (2) may, in particular, make different provision about the procedure on reconsideration depending upon whether the reconsideration is in pursuance of a notice under section 20(3) or a notice under section 20(5).

• (5) Such regulations may, in particular, make provision—

• (a) in relation to cases where a person requires reconsideration of a decision to suspend a licence and reconsideration of a decision to continue the suspension of that licence, and

• (b) in relation to cases where reconsideration of a decision is required under section 20(2) by only one of two persons by whom it could have been required.

• (6) In this section—

• (a) “prescribed” means prescribed by regulations under subsection (2), and

• (b) “reconsideration” means reconsideration in pursuance of a notice under section 20.

Directions: general.

Directions as to particular matters.

Code of practice.

Procedure for approval of code.

Meaning of “mother”.

Meaning of “father”.

Inspection, entry, search and seizure

Parental orders in favour of gamete donors.

Register of information

31ZA

• (1) A person who has attained the age of 16 (“the applicant”) may by notice to the Authority require the Authority to comply with a request under subsection (2).

• (2) The applicant may request the Authority to give the applicant notice stating whether or not the information contained in the register shows that a person (“the donor”) other than a parent of the applicant would or might, but for the relevant statutory provisions, be the parent of the applicant, and if it does show that—

• (a) giving the applicant so much of that information as relates to the donor as the Authority is required by regulations to give (but no other information), or

• (b) stating whether or not that information shows that there are other persons of whom the donor is not the parent but would or might, but for the relevant statutory provisions, be the parent and if so—

• (i) the number of those other persons,

• (ii) the sex of each of them, and

• (iii) the year of birth of each of them.

• (3) The Authority shall comply with a request under subsection (2) if—

• (a) the information contained in the register shows that the applicant is a relevant individual, and

• (b) the applicant has been given a suitable opportunity to receive proper counselling about the implications of compliance with the request.

• (4) Where a request is made under subsection (2)(a) and the applicant has not attained the age of 18 when the applicant gives notice to the Authority under subsection (1), regulations cannot require the Authority to give the applicant any information which identifies the donor.

• (5) Regulations cannot require the Authority to give any information as to the identity of a person whose gametes have been used or from whom an embryo has been taken if a person to whom a licence applied was provided with the information at a time when the Authority could not have been required to give information of the kind in question.

• (6) The Authority need not comply with a request made under subsection (2)(b) by any applicant if it considers that special circumstances exist which increase the likelihood that compliance with the request would enable the applicant—

• (a) to identify the donor, in a case where the Authority is not required by regulations under subsection (2)(a) to give the applicant information which identifies the donor, or

• (b) to identify any person about whom information is given under subsection (2)(b).

• (7) In this section—

• “relevant individual” has the same meaning as in section 31;

• “the relevant statutory provisions” means sections 27 to 29 of this Act and sections 33 to 47 of the Human Fertilisation and Embryology Act 2008.

31ZB

• (1) Subject to subsection (4), a person (“the applicant”) may by notice to the Authority require the Authority to comply with a request under subsection (2).

• (2) The applicant may request the Authority to give the applicant notice stating whether or not information contained in the register shows that, but for the relevant statutory provisions, the applicant would or might be related to a person specified in the request (“the specified person”) as—

• (a) a person whom the applicant proposes to marry,

• (b) a person with whom the applicant proposes to enter into a civil partnership, or

• (c) a person with whom the applicant is in an intimate physical relationship or with whom the applicant proposes to enter into an intimate physical relationship.

• (3) Subject to subsection (5), the Authority shall comply with a request under subsection (2) if—

• (a) the information contained in the register shows that the applicant is a relevant individual,

• (b) the Authority receives notice in writing from the specified person consenting to the request being made and that notice has not been withdrawn, and

• (c) the applicant and the specified person have each been given a suitable opportunity to receive proper counselling about the implications of compliance with the request.

• (4) A request may not be made under subsection (2)(c) by a person who has not attained the age of 16.

• (5) Where a request is made under subsection (2)(c) and the specified person has not attained the age of 16 when the applicant gives notice to the Authority under subsection (1), the Authority must not comply with the request.

• (6) Where the Authority is required under subsection (3) to comply with a request under subsection (2), the Authority must take all reasonable steps to give the applicant and the specified person notice stating whether or not the information contained in the register shows that, but for the relevant statutory provisions, the applicant and the specified person would or might be related.

• (7) In this section—

• “relevant individual” has the same meaning as in section 31;

• “the relevant statutory provisions” has the same meaning as in section 31ZA.

31ZC

• (1) Where—

• (a) the Authority has received from a person (“the applicant”) a notice containing a request under subsection (2)(a) of section 31ZA, and

• (b) compliance by the Authority with its duty under that section has involved or will involve giving the applicant information relating to a person other than the parent of the applicant who would or might, but for the relevant statutory provisions, be a parent of the applicant (“the donor”),

the Authority may notify the donor that a request under section 31ZA(2)(a) has been made, but may not disclose the identity of the applicant or any information relating to the applicant.

• (2) In this section “the relevant statutory provisions” has the same meaning as in section 31ZA.

31ZD

• (1) This section applies where a person (“the donor”) has consented under Schedule 3 (whether before or after the coming into force of this section) to—

• (a) the use of the donor's gametes, or an embryo the creation of which was brought about using the donor's gametes, for the purposes of treatment services provided under a licence, or

• (b) the use of the donor's gametes for the purposes of non-medical fertility services provided under a licence.

• (2) In subsection (1)—

• (a) “treatment services” do not include treatment services provided to the donor, or to the donor and another person together, and

• (b) “non-medical fertility services” do not include any services involving partner-donated sperm.

• (3) The donor may by notice request the appropriate person to give the donor notice stating—

• (a) the number of persons of whom the donor is not a parent but would or might, but for the relevant statutory provisions, be a parent by virtue of the use of the gametes or embryos to which the consent relates,

• (b) the sex of each of those persons, and

• (c) the year of birth of each of those persons.

• (4) Subject to subsections (5) to (7), the appropriate person shall notify the donor whether the appropriate person holds the information mentioned in subsection (3) and, if the appropriate person does so, shall comply with the request.

• (5) The appropriate person need not comply with a request under subsection (3) if the appropriate person considers that special circumstances exist which increase the likelihood that compliance with the request would enable the donor to identify any of the persons falling within paragraphs (a) to (c) of subsection (3).

• (6) In the case of a donor who consented as described in subsection (1)(a), the Authority need not comply with a request made to it under subsection (3) where the person who held the licence referred to in subsection (1)(a) continues to hold a licence under paragraph 1 of Schedule 2, unless the donor has previously made a request under subsection (3) to the person responsible and the person responsible—

• (a) has notified the donor that the information concerned is not held, or

• (b) has failed to comply with the request within a reasonable period.

• (7) In the case of a donor who consented as described in subsection (1)(b), the Authority need not comply with a request made to it under subsection (3) where the person who held the licence referred to in subsection (1)(b) continues to hold a licence under paragraph 1A of Schedule 2, unless the donor has previously made a request under subsection (3) to the person responsible and the person responsible—

• (a) has notified the donor that the information concerned is not held, or

• (b) has failed to comply with the request within a reasonable period.

• (8) In this section “the appropriate person” means—

• (a) in the case of a donor who consented as described in paragraph (a) of subsection (1)—

• (i) where the person who held the licence referred to in that paragraph continues to hold a licence under paragraph 1 of Schedule 2, the person responsible, or

• (ii) the Authority, and

• (b) in the case of a donor who consented as described in paragraph (b) of subsection (1)—

• (i) where the person who held the licence referred to in that paragraph continues to hold a licence under paragraph 1A of Schedule 2, the person responsible, or

• (ii) the Authority.

• (9) In this section “the relevant statutory provisions” has the same meaning as in section 31ZA.

31ZE

• (1) For the purposes of this section two relevant individuals are donor-conceived genetic siblings of each other if a person (“the donor”) who is not the parent of either of them would or might, but for the relevant statutory provisions, be the parent of both of them.

• (2) Where—

• (a) the information on the register shows that a relevant individual (“A”) is the donor-conceived genetic sibling of another relevant individual (“B”),

• (b) A has provided information to the Authority (“the agreed information”) which consists of or includes information which enables A to be identified with the request that it should be disclosed to—

• (i) any donor-conceived genetic sibling of A, or

• (ii) such siblings of A of a specified description which includes B, and

• (c) the conditions in subsection (3) are satisfied,

then, subject to subsection (4), the Authority shall disclose the agreed information to B.

• (3) The conditions referred to in subsection (2)(c) are—

• (a) that each of A and B has attained the age of 18,

• (b) that B has requested the disclosure to B of information about any donor-conceived genetic sibling of B, and

• (c) that each of A and B has been given a suitable opportunity to receive proper counselling about the implications of disclosure under subsection (2).

• (4) The Authority need not disclose any information under subsection (2) if it considers that the disclosure of information will lead to A or B identifying the donor unless—

• (a) the donor has consented to the donor's identity being disclosed to A or B, or

• (b) were A or B to make a request under section 31ZA(2)(a), the Authority would be required by regulations under that provision to give A or B information which would identify the donor.

• (5) In this section—

• “relevant individual” has the same meaning as in section 31;

• “the relevant statutory provisions” has the same meaning as in section 31ZA.

31ZF

• (1) In this section and section 31ZG, a “voluntary contact register” means a register of persons who have expressed their wish to receive information about any person to whom they are genetically related as a consequence of the provision to any person of treatment services in the United Kingdom before 1 August 1991.

• (2) The Authority may—

• (a) set up a voluntary contact register in such manner as it thinks fit,

• (b) keep a voluntary contact register in such manner as it thinks fit,

• (c) determine criteria for eligibility for inclusion on the register and the particulars that may be included,

• (d) charge a fee to persons who wish their particulars to be entered on the register,

• (e) arrange for samples of the DNA of such persons to be analysed at their request,

• (f) make such arrangements as it thinks fit for the disclosure of information on the register between persons who appear to the Authority to be genetically related, and

• (g) impose such conditions as it thinks fit to prevent a person (“A”) from disclosing information to a person to whom A is genetically related (“B”) where that information would identify any person who is genetically related to both A and B.

• (3) The Authority may make arrangements with any person by whom a voluntary contact register is kept before the commencement of this section for the supply by that person to the Authority of the information contained in the register maintained by that person.

31ZG

• (1) The Authority may, instead of keeping a voluntary contact register, give financial assistance to any person who sets up or keeps a voluntary contact register.

• (2) Financial assistance under subsection (1) may be given in any form, and in particular, may be given by way of—

• (a) grants,

• (b) loans,

• (c) guarantees, or

• (d) incurring expenditure for the person assisted.

• (3) Financial assistance under subsection (1) may be given on such terms and conditions as the Authority considers appropriate.

• (4) A person receiving assistance under subsection (1) must comply with the terms and conditions on which it is given, and compliance may be enforced by the Authority.

Disclosure of information

33A

• (1) No person shall disclose any information falling within section 31(2) which the person obtained (whether before or after the coming into force of section 24 of the Human Fertilisation and Embryology Act 2008) in the person's capacity as—

• (a) a member or employee of the Authority,

• (b) any person exercising functions of the Authority by virtue of section 8B or 8C of this Act (including a person exercising such functions by virtue of either of those sections as a member of staff or as an employee),

• (c) any person engaged by the Authority to provide services to the Authority,

• (d) any person employed by, or engaged to provide services to, a person mentioned in paragraph (c),

• (e) a person to whom a licence applies,

• (f) a person to whom a third party agreement applies, or

• (g) a person to whom directions have been given.

• (2) Subsection (1) does not apply where—

• (a) the disclosure is made to a person as a member or employee of the Authority or as a person exercising functions of the Authority as mentioned in subsection (1)(b),

• (b) the disclosure is made to or by a person falling within subsection (1)(c) for the purpose of the provision of services which that person is engaged to provide to the Authority,

• (c) the disclosure is made by a person mentioned in subsection (1)(d) for the purpose of enabling a person falling within subsection (1)(c) to provide services which that person is engaged to provide to the Authority,

• (d) the disclosure is made to a person to whom a licence applies for the purpose of that person's functions as such,

• (e) the disclosure is made to a person to whom a third party agreement applies for the purpose of that person's functions under that agreement,

• (f) the disclosure is made in pursuance of directions given by virtue of section 24,

• (g) the disclosure is made so that no individual can be identified from the information,

• (h) the disclosure is of information other than identifying donor information and is made with the consent required by section 33B,

• (i) the disclosure—

• (i) is made 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 (“P”),

• (ii) is of information falling within section 31(2)(a) which could be disclosed by virtue of paragraph (h) with P's consent or could be disclosed to P by virtue of subsection (5), and

• (iii) is made in circumstances where it is not reasonably practicable to obtain P's consent,

• (j) the disclosure is of information which has been lawfully made available to the public before the disclosure is made,

• (k) the disclosure is made in accordance with sections 31ZA to 31ZE,

• (l) the disclosure is required or authorised to be made—

• (i) under regulations made under section 33D, or

• (ii) in relation to any time before the coming into force of the first regulations under that section, under regulations made under section 251 of the National Health Service Act 2006,

• (m) in relation to Northern Ireland, the disclosure is made by a person acting in the capacity mentioned in subsection (1)(a) or (b) for the purpose of carrying out the Authority's duties under section 8A,

• (n) the disclosure is made by a person acting in the capacity mentioned in subsection (1)(a) or (b) in pursuance of an order of a court under section 34 or 35,

• (o) the disclosure is made by a person acting in the capacity mentioned in subsection (1)(a) or (b) to the Registrar General in pursuance of a request under section 32,

• (p) the disclosure is made by a person acting in the capacity mentioned in subsection (1)(a) or (b) to any body or person discharging a regulatory function for the purpose of assisting that body or person to carry out that function,

• (q) the disclosure is made for the purpose of establishing in any proceedings relating to an application for an order under subsection (1) of section 54 or subsection (1) of section 54A of the Human Fertilisation and Embryology Act 2008 whether the condition specified in paragraph (a) or (b) of that subsection is met,

• (r) the disclosure is made under section 3 of the Access to Health Records Act 1990,

• (s) the disclosure is made under Article 5 of the Access to Health Records (Northern Ireland) Order 1993, or

• (t) the disclosure is made necessarily for—

• (i) the purpose of the investigation of any offence (or suspected offence), or

• (ii) any purpose preliminary to proceedings, or for the purposes of, or in connection with, any proceedings.

• (3) Subsection (1) does not apply to the disclosure of information in so far as—

• (a) the information identifies a person who, but for sections 27 to 29 of this Act or sections 33 to 47 of the Human Fertilisation and Embryology Act 2008, would or might be a parent of a person who instituted proceedings under section 1A of the Congenital Disabilities (Civil Liability) Act 1976, and

• (b) the disclosure is made for the purpose of defending such proceedings, or instituting connected proceedings for compensation against that parent.

• (4) Paragraph (t) of subsection (2), so far as relating to disclosure for the purpose of the investigation of an offence or suspected offence, or for any purpose preliminary to, or in connection with proceedings, does not apply—

• (a) to disclosure of identifying donor information, 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, made by any person acting in a capacity mentioned in any of paragraphs (c) to (g) of subsection (1).

• (5) Subsection (1) does not apply to the disclosure to any individual of information which—

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

• (b) relates only to that individual or, in the case of an individual who is treated together with, or gives a notice under section 37 or 44 of the Human Fertilisation and Embryology Act 2008 in respect of, another, only to that individual and that other.

• (6) In subsection (2)—

• (a) in paragraph (p) “regulatory function” has the same meaning as in section 32 of the Legislative and Regulatory Reform Act 2006, and

• (b) in paragraph (t) references to “proceedings” include any formal procedure for dealing with a complaint.

• (7) In this section “identifying donor information” means 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 for the purposes of treatment services or non-medical fertility services in consequence of which an identifiable individual was, or may have been, born.

Consent required to authorise certain disclosures

33B

• (1) This section has effect for the purposes of section 33A(2)(h).

• (2) Subject to subsection (5), the consent required by this section is the consent of each individual who can be identified from the information.

• (3) Consent in respect of a person who has not attained the age of 18 years (“C”) may be given—

• (a) by C, in a case where C is competent to deal with the issue of consent, or

• (b) by a person having parental responsibility for C, in any other case.

• (4) 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.

• (5) In the case of information which shows that any identifiable individual (“A”) was, or may have been, born in consequence of treatment services, the consent required by this section does not include A's consent if the disclosure is necessarily incidental to the disclosure of information falling within section 31(2)(a).

• (6) The reference in subsection (3) to parental responsibility is—

• (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;

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

33C

• (1) Regulations may provide for additional exceptions from section 33A(1).

• (2) No exception may be made under this section for—

• (a) disclosure of a kind mentioned in paragraph (a) or (b) of subsection (4) of section 33A, or

• (b) disclosure in circumstances in which section 32 of this Act applies of information having the tendency mentioned in subsection (2) of that section, made by any person acting in a capacity mentioned in any of paragraphs (c) to (g) of subsection (1) of section 33A.

33D

• (1) Regulations may—

• (a) make such provision for and in connection with requiring or regulating the processing of protected information for the purposes of medical research as the Secretary of State considers is necessary or expedient in the public interest or in the interests of improving patient care, and

• (b) make such provision for and in connection with requiring or regulating the processing of protected information for the purposes of any other research as the Secretary of State considers is necessary or expedient in the public interest.

• (2) Regulations under subsection (1) may, in particular, make provision—

• (a) for requiring or authorising the disclosure or other processing of protected information to or by persons of any prescribed description subject to compliance with any prescribed conditions (including conditions requiring prescribed undertakings to be obtained from such persons as to the processing of such information),

• (b) for securing that, where prescribed protected information is processed by a person in accordance with the regulations, anything done by that person in so processing the information must be taken to be lawfully done despite any obligation of confidence owed by the person in respect of it,

• (c) for requiring fees of a prescribed amount to be paid to the Authority in prescribed circumstances by persons in relation to the disclosure to those persons of protected information under those regulations,

• (d) for the establishment of one or more bodies to exercise prescribed functions in relation to the processing of protected information under those regulations,

• (e) as to the membership and proceedings of any such body, and

• (f) as to the payment of remuneration and allowances to any member of any such body and the reimbursement of expenses.

• (3) Where regulations under subsection (1) require or regulate the processing of protected information for the purposes of medical research, such regulations may enable any approval given under regulations made under section 251 of the National Health Service Act 2006 (control of patient information) to have effect for the purposes of the regulations under subsection (1) in their application to England and Wales.

• (4) Subsections (1) to (3) are subject to subsections (5) to (8).

• (5) Regulations under subsection (1) may not make any provision requiring or authorising the disclosure or other processing, for any purpose, of protected information, where that information is information from which an individual may be identified, if it would be reasonably practicable to achieve that purpose otherwise than pursuant to such regulations, having regard to the cost of and technology available for achieving that purpose.

• (6) Regulations under this section may not make provision for or in connection with the processing of protected information in a manner inconsistent with any provision made by or under the data protection legislation.

• (7) Subsection (6) does not affect the operation of provisions made under subsection (2)(b).

• (8) Before making any regulations under this section the Secretary of State shall consult such bodies appearing to the Secretary of State to represent the interests of those likely to be affected by the regulations as the Secretary of State considers appropriate.

• (9) In this section—

• “the data protection legislation” has the same meaning as in the Data Protection Act 2018 (see section 3 of that Act).

• “prescribed” means prescribed by regulations made by virtue of this section,

• “processing”, in relation to information, means the use, disclosure, or obtaining of the information or the doing of such other things in relation to it as may be prescribed for the purposes of this definition, and

• “protected information” means information falling within section 31(2).

Inspection, entry, search and seizure

Amendment of Surrogacy Arrangements Act 1985.

Powers of members and employees of Authority.

Power to enter premises.

Index.

Offences.

Consent to prosecution.

Civil liability to child with disability.

Regulations.

Notices.

Index.

Short title, commencement, etc.

Short title, commencement, etc.

Application of Statutory Instruments Act 1946

15

The Statutory Instruments Act 1946 applies to any power to make orders or regulations conferred by an Act on the Authority as if the Authority were a Minister of the Crown.

SCHEDULE 3ZA

Part 1 — Kinds of treatment in relation to which counselling must be offered

1

The treatment services involve the use of the gametes of any person and that person's consent is required under paragraph 5 of Schedule 3 for the use in question.

2

The treatment services involve the use of any embryo the creation of which was brought about in vitro.

3

The treatment services involve the use of an embryo taken from a woman and the consent of the woman from whom the embryo was taken was required under paragraph 7 of Schedule 3 for the use in question.

Part 2 — Events in connection with which counselling must be offered

4

A man gives the person responsible a notice under paragraph (a) of subsection (1) of section 37 of the Human Fertilisation and Embryology Act 2008 (agreed fatherhood 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 the man.

5

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 man to whom the notice relates has previously given a notice under paragraph (a) of that subsection.

6

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

• (c) no cell has been added to it other than by division of the embryo's own cells.

• (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

• (c) any gametes other than human gametes.

• (2) No person shall—

• (a) mix human gametes with animal gametes,

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

• (c) keep or use a human admixed embryo,

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

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

Consent required to authorise certain disclosures

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,

• (c) an application for the revocation or variation of a licence, or

• (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.

Consent to prosecution.

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,

• (c) in a case where there is a particular risk that any resulting child will have or develop—

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

• (ii) a gender-related serious illness, or

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

establishing the sex of the embryo,

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

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

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

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

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

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

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

• (a) it affects only one sex, or

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

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

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

• (c) any other gender-related serious medical condition.

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

• (a) it affects only one sex, or

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

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

• (c) to be necessary or desirable for such other purposes as may be specified in regulations.

• (2) The principal purposes are—

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

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

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

• (d) promoting advances in the treatment of infertility,

• (e) increasing knowledge about the causes of miscarriage,

• (f) developing more effective techniques of contraception,

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

• (h) increasing knowledge about the development of embryos.

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.

Cases where consent not required for storage

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,

• (c) P is likely at some time to have that capacity, and

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

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

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

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

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

• (6) In relation to Scotland—

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

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

• (c) that Act applies to the storage of gametes under this paragraph to the extent specified in section 84A of that Act.

11

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

Creation, use and storage of human admixed embryos

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.

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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.

Parental consent conditions

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.