Skip to main content

Code of Practice

Here you can read our most up-to-date Code of Practice, the rules by which we regulate fertility clinics. The Code is broken down into the various areas where we have regulatory power and is supported by other documents which deal with issues such as data sharing and confidentiality, which are also available on this page.

33. Mitochondrial donation (version 3.0)

Human Fertilisation and Embryology Act 1990 (as amended)

3 Prohibitions in connection with embryos

  1. 1 No person shall bring about the creation of an embryo except in pursuance of a licence.
    1. 1A No person shall keep or use an embryo except--
      1. a in pursuance of a licence, or
      2. b in the case of--
        1. i the keeping, without storage, of an embryo intended for human application, or
        2. ii the processing, without storage, of such an embryo,
      3. in pursuance of a third party agreement.
    2. 1B No person shall procure or distribute an embryo intended for human application except in pursuance of a licence or a third party agreement.]
  2. 2 No person shall place in a woman--
    1. a an embryo other than a permitted embryo (as defined by section 3ZA), or
    2. b any gametes other than permitted eggs or permitted sperm (as so defined).]
  3. 3 A licence cannot authorise--
    1. a keeping or using an embryo after the appearance of the primitive streak,
    2. b placing an embryo in any animal, [or]
    3. c keeping or using an embryo in any circumstances in which regulations prohibit its keeping or use, . . .
    4. d . . ..
  4. 4 For the purposes of subsection (3)(a) above, the primitive streak is to be taken to have appeared in an embryo not later than the end of the period of 14 days beginning with [the day on which the process of creating the embryo began], not counting any time during which the embryo is stored.
  5. 3ZA Permitted eggs, permitted sperm and permitted embryos
    1. 1 This section has effect for the interpretation of section 3(2).
    2. 2 A permitted egg is one--
      1. a which has been produced by or extracted from the ovaries of a woman, and
      2. b whose nuclear or mitochondrial DNA has not been altered.
    3. 3 Permitted sperm are sperm--
      1. a which have been produced by or extracted from the testes of a man, and
      2. b whose nuclear or mitochondrial DNA has not been altered.
    4. 4 An embryo is a permitted embryo if--
      1. a it has been created by the fertilisation of a permitted egg by permitted sperm,
      2. b no nuclear or mitochondrial DNA of any cell of the embryo has been altered, and
      3. c no cell has been added to it other than by division of the embryo's own cells.
    5. 5 Regulations may provide that--
      1. a an egg can be a permitted egg, or
      2. b an embryo can be a permitted embryo,
      3. 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. 6 In this section--
      1. a "woman" and "man" include respectively a girl and a boy (from birth), and
      2. b "prescribed" means prescribed by regulations.]

31 Register information

  1. 31ZA Request for information as to genetic parentage or mitochondrial donors etc,
    1. 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) or (2A).
    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--
      1. 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
      2. 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--
        1. i the number of those other persons,
        2. ii the sex of each of them, and
        3. iii the year of birth of each of them.
    3. 2A 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 is the applicant’s mitochondrial donor, and if it does show that, giving the applicant the following information contained in the register —
      1. a the screening tests carried out on the mitochondrial donor and information on that donor’s personal and family medical history,
      2. b matters contained in any description of the mitochondrial donor as a person which that donor has provided, and
      3. c any additional matter which the mitochondrial donor has provided with the intention that it be made available to a person who requests information under this section, but not giving any information which may identify the mitochondrial donor or any person who was or may have been born in consequence of treatment services using genetic material from the applicant’s mitochondrial donor, by itself or in combination with any other information which is in, or is likely to come into, the possession of the applicant.
    4. 3 The Authority shall comply with a request under subsection (2) if--
      1. a the information contained in the register shows that the applicant is a relevant individual, and
      2. b the applicant has been given a suitable opportunity to receive proper counselling about the implica-tions of compliance with the request.
    5. 3A The Authority must comply with a request under subsection (2A) if—
      1. a the information contained in the register shows that the applicant is a mitochondrial donor-conceived person, and
      2. b the applicant has been given a suitable opportunity to receive proper counselling about the implications of compliance with the request.
    6. 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.
    7. 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 in-formation of the kind in question.
    8. 6 The Authority need not comply with a request made under subsection (2)(b) by any applicant if it consid-ers that special circumstances exist which increase the likelihood that compliance with the request would enable the applicant--
      1. 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
      2. b to identify any person about whom information is given under subsection (2)(b).
    9. 7 In this section--
      1. "relevant individual" has the same meaning as in section 31;
      2. "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.]
  2. 31ZD Provision to donor of information about resulting children
    1. 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 -
      1. 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
      2. b the use of the donor’s gametes for the purposes of non-medical fertility services provided under a licence.
    2. 2 In subsection (1)--
      1. a "treatment services" do not include treatment services provided to the donor, or to the donor and another person together, and
      2. b "non-medical fertility services" do not include any services involving partner-donated sperm.
    3. 3 The donor may by notice request the appropriate person to give the donor notice stating--
      1. 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,
      2. b the sex of each of those persons, and
      3. c the year of birth of each of those persons.
    4. 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. 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. 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 sub-section (1)(a) continues to hold a licence under paragraph 1 of Schedule 2, unless the donor has previ-ously made a request under subsection (3) to the person responsible and the person responsible--
      1. a has notified the donor that the information concerned is not held, or
      2. b has failed to comply with the request within a reasonable period.
    7. 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 sub-section (1)(b) continues to hold a licence under paragraph 1A of Schedule 2, unless the donor has previ-ously made a request under subsection (3) to the person responsible and the person responsible--
      1. a has notified the donor that the information concerned is not held, or
      2. b has failed to comply with the request within a reasonable period.
    8. 8 In this section "the appropriate person" means--
      1. a in the case of a donor who consented as described in paragraph (a) of subsection (1)--
        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
        2. ii the Authority, and
      2. b in the case of a donor who consented as described in paragraph (b) of subsection (1)--
        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
        2. ii the Authority.
    9. 9 In this section "the relevant statutory provisions" has the same meaning as in section 31ZA.]

Schedule 3 - Consent to use or storage of gametes, embryos or human admixed embryos etc

4 Variation and withdrawal of consent

  1. 1 The terms of any consent under this Schedule may from time to time be varied, and the consent may be withdrawn, by notice given by the person who gave the consent to the person keeping the gametes[, hu-man cells, embryo or human admixed embryo] to which the consent is relevant.
  2. 1A Sub-paragraph (1B) applies to a case where an egg is used in the process set out in regulation 4 of the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 (and “egg A” and “egg B” have the same meanings in this paragraph as in that regulation).
  3. 1B The terms of the consent to that use of egg A or egg B cannot be varied, and such consent cannot be withdrawn, once all the nuclear DNA of egg B which is not polar body nuclear DNA is inserted into egg A.
  4. 2 [Subject to sub-paragraph (3), the] terms of any consent to the use of any embryo cannot be varied, and such consent cannot be withdrawn, once the embryo has been used--
    1. a in providing treatment services,
    2. aa in training persons in embryo biopsy, embryo storage or other embryological techniques, or]
    3. b for the purposes of any project of research.
  5. 3 Where the terms of any consent to the use of an embryo ("embryo A") include consent to the use of an embryo or human admixed embryo whose creation may be brought about in vitro using embryo A, that consent to the use of that subsequent embryo or human admixed embryo cannot be varied or withdrawn once embryo A has been used for one or more of the purposes mentioned in sub-paragraph (2)(a) or (b).
  6. 3A Sub-paragraph (3B) applies to a case where an embryo is used in the process set out in regulation 7 of the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 (and “embryo A” and “embryo B” have the same meanings in sub-paragraph (3B) as in that regulation).
  7. 3B The terms of the consent to that use of embryo A or embryo B cannot be varied, and such consent cannot be withdrawn, once all the nuclear DNA of embryo B which is not polar body nuclear DNA is inserted into embryo A…
  8. 4 Subject to sub-paragraph (5), the terms of any consent to the use of any human admixed embryo cannot be varied, and such consent cannot be withdrawn, once the human admixed embryo has been used for the purposes of any project of research.
  9. 5 Where the terms of any consent to the use of a human admixed embryo ("human admixed embryo A") in-clude consent to the use of a human admixed embryo or embryo whose creation may be brought about in vitro using human admixed embryo A, that consent to the use of that subsequent human admixed em-bryo or embryo cannot be varied or withdrawn once human admixed embryo A has been used for the purposes of any project of research.]

Regulations

Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

  1. Part 1 Introductory Provisions
    1. 2 Interpretation
      1. 1 In these Regulations “the Act” means the Human Fertilisation and Embryology Act 1990.
      2. 2 In these Regulations “polar body nuclear DNA” means any nuclear DNA located in a polar body.
      3. 3 In these Regulations a reference to the removal of any nuclear DNA (including polar body nuclear DNA) includes a reference to the removal of any material which is necessarily removed along with that DNA, and such material may include any associated organelles.
      4. 4 For the purposes of these Regulations, the following are to be treated as removed from an egg—
        1. a any polar body nuclear DNA which is destroyed while still located in the egg; and
        2. b any material which is necessarily destroyed along with that DNA, and such material may include any associated organelles.
      5. 5 In these Regulations a reference to the insertion of nuclear DNA includes a reference to the insertion of any material which is necessarily inserted along with that DNA, and such material may include any associated organelles.
  2. Part 2 Permitted eggs and permitted embryos
    1. Permitted egg
      1. 3 An egg (“egg P”) is a permitted egg for the purposes of section 3(2)(b)(a) of the Act if—
        1. a egg P results from the application of the process specified in regulation 4 to two eggs, each of which—
          1. i is a permitted egg as defined in section 3ZA(2)(b) of the Act (not an egg which is a permitted egg by virtue of these regulations), and
          2. ii was extracted from the ovaries of a different woman;
        2. b that process has been applied to those eggs in the circumstances specified in regulation 5; and
        3. c there have been no alterations in the nuclear or mitochondrial DNA of egg P since egg P was created by means of the application of that process.
    2. Permitted egg: process
      1. 4 -
        1. 1 The process referred to in regulation 3(a) consists of the following two steps.
        2. 2 In step 1—
          1. a either—
            1. i all the nuclear DNA of an egg (“egg A”) is removed, or
            2. ii all the nuclear DNA of egg A other than polar body nuclear DNA is removed; and
          2. b either—
            1. i all the nuclear DNA of another egg (“egg B”) is removed, or
            2. ii all the nuclear DNA of egg B other than polar body nuclear DNA is removed.
        3. 3 In step 2 all the nuclear DNA of egg B which is not polar body nuclear DNA is inserted into egg A.
    3. Permitted egg: circumstances
      1. 5 The circumstances referred to in regulation 3(b) are that—
        1. a the Authority has issued a determination that—
          1. i there is a particular risk that any egg extracted from the ovaries of a woman named in the determination may have mitochondrial abnormalities caused by mitochondrial DNA; and
          2. ii there is a significant risk that a person with those abnormalities will have or develop serious mitochondrial disease; and
        2. b egg B was extracted from the ovaries of the woman so named.
    4. Permitted embryo
      1. 6 An embryo (“embryo P”) is a permitted embryo for the purposes of section 3(2)(a) of the Act if—
        1. a embryo P results from the application of the process specified in regulation 7 to two embryos, each of which—
          1. i is a permitted embryo as defined in section 3ZA(4) of the Act (not an embryo which is a permitted embryo by virtue of these regulations), and
          2. ii was created by the fertilisation of a permitted egg as defined in section 3ZA(2) of the Act (not an egg which was a permitted egg by virtue of these regulations) extracted from the ovaries of a different woman;
        2. b that process has been applied to those embryos in the circumstances specified in regulation 8; and
        3. c since embryo P was created by means of the application of that process—
          1. i there have been no alterations in the nuclear or mitochondrial DNA of any cell of embryo P, and
          2. ii no cell has been added to embryo P other than by the division of embryo P’s own cells.
    5. Permitted embryo: process
      1. 7 -
        1. 1 The process referred to in regulation 6(a) consists of the following two steps.
        2. 2 In step 1—
          1. a either—
            1. i all the nuclear DNA of an embryo (“embryo A”) is removed, or
            2. ii all the nuclear DNA of embryo A other than polar body nuclear DNA is removed; and
          2. b either—
            1. i all the nuclear DNA of another embryo (“embryo B”) is removed, or
            2. ii all the nuclear DNA of embryo B other than polar body nuclear DNA is removed.
        3. 3 In step 2 all the nuclear DNA of embryo B which is not polar body nuclear DNA is inserted into embryo A.
    6. Permitted embryo: circumstances
      1. 8 The circumstances referred to in regulation 6(b) are that—
        1. a the Authority has issued a determination that—
          1. i there is a particular risk that any embryo which is created by the fertilisation of an egg extracted from the ovaries of a woman named in the determination may have mitochondrial abnormalities caused by mitochondrial DNA; and
          2. ii there is a significant risk that a person with those abnormalities will have or develop serious mitochondrial disease; and
        2. b embryo B was created by the fertilisation of an egg extracted from the ovaries of the woman so named.
    7. Supplemental provision – licences
      1. 9 (1) Any reference to a permitted egg in a licence whenever issued does not include an egg which is a permitted egg for the purposes of section 3(2) of the Act by virtue of regulation 3 unless express provision is made in the licence to that effect.
      2. (2) Any reference to a permitted embryo in a licence whenever issued does not include an embryo which is a permitted embryo for the purposes of section 3(2) of the Act by virtue of regulation 6 unless express provision is made in the licence to that effect.
  3. Part 3 Related modifications and amendments
    1. Modification of paragraph 22 of Schedule 3 to the Act
      1. 17 In a case where this regulation has effect, paragraph 22 of Schedule 3 to the Act applies as if before sub-paragraph (1) there were inserted—
        1. “(A1) For the purposes of this Schedule, neither of the following is to be treated as a person whose gametes were used to create an embryo (“embryo E”)—
          1. a where embryo E is a permitted embryo by virtue of regulations under section 3ZA(5), the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of embryo E;
          2. b where embryo E has been created by the fertilisation of an egg which was a permitted egg by virtue of regulations under section 3ZA(5), the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of thatpermitted egg.
        2. (3B) For the purposes of this Schedule, in a case where an egg is permitted egg by virtue of regulations under section 3ZA(5) the egg is not to be treated as the egg of the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of that permitted egg.”.

Directions

  1. 0001 Gamete and Embryo Donation Download
  2. 0005 Collecting and recording information for the HFEA Download
  3. 0006 Import and export of gametes and embryos Download
  4. 0007 Consent Download
  5. 0008 Information to be submitted to the HFEA as part of the licensing process Download

Licence conditions

  1. T124 -
    1. a No clinic may carry out either the process of pronuclear transfer* (PNT) or maternal spindle transfer* (MST) or part of either process, unless express provision has been made on the clinic’s licence permitting it to undertake either or both processes.
    2. b Neither PNT nor MST may be carried out under third party, satellite or transport agreements.
    3. c No clinic may provide treatment using gametes or embryos which have been created using PNT or MST unless express provision has been made on the clinic’s licence permitting the clinic to undertake either or both processes.
  2. T125 PNT and MST must only be carried out on premises of clinics licensed to undertake mitochondrial donation (‘MD’). These processes must not be carried out on the premises of a clinic that is operating under a third party, satellite or transport agreement with a clinic that holds a licence to undertake MD.
  3. T127 -
    1. a No alterations may be made to the nuclear or mitochondrial DNA of an egg created by means of the application of MST.
    2. b No alterations may be made to the nuclear or mitochondrial DNA of an embryo created by means of the application of PNT, and no cell may be added to an embryo created by means of the application of PNT other than by the division of the embryo’s own cells.
  4. T128 In the case of treatment involving mitochondrial donation, the clinic must ensure that it only carries out the process of PNT or MST for a particular, named patient once the Authority has issued a determination that:
    1. there is a particular risk that any egg extracted from the ovaries of the named woman, or any embryo created by the fertilisation of an egg extracted from the ovaries of the named woman, may have mitochondrial abnormalities cause by mitochondrial DNA, and
    2. there is a significant risk that a person with those abnormalities will have or develop a serious mitochondrial disease.
  5. T129 Only those embryologists assessed as competent by the Authority to undertake PNT, MST or both, and named on the front of this licence, are permitted to undertake those processes or any part thereof.

Staff to be involved in mitochondrial donation

  1. 33.1 A senior clinical geneticist/mitochondrial disease specialist should be involved in deciding whether a particular patient should receive mitochondrial donation treatment.

  2. 33.2 The centre should ensure that a multidisciplinary team is involved in providing the treatment. The team should include mitochondrial disease specialists, reproductive specialists, embryologists, clinical geneticists, genetic counsellors and molecular geneticists. It should maintain close contact with the primary care physician, the referring clinician, or the mitochondrial disease centre.

  3. 33.3 Only embryologists who have been assessed as competent by the HFEA and named on the clinic’s licence can perform maternal spindle transfer (MST) or pronuclear transfer (PNT) techniques as defined in Regulation 4 and 7 of the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015. An application for an assessment of the competence of an embryologist must be submitted to the HFEA and will be considered by a Licence Committee. When submitting an application to the HFEA for a competency assessment, the person responsible (PR) and the relevant embryologist should provide:

    1. a evidence of the embryologist’s experience of carrying out MST or PNT in treatment, training or research on human eggs or embryos (eg, embryo survival rates, blastocyst development, and rate of carryover of mitochondria, in line with key performance indicators (KPIs) determined by the HFEA)

    2. b references to support the embryologist’s experience and knowledge, and

    3. c any other information that may demonstrate competence (such as the embryologist’s experience of performing micro-manipulation on human or animal (eg, mice) eggs or embryos).

  4. 33.4 The PR should submit an application to the HFEA for an assessment of the competence of each embryologist who intends to perform MST or PNT or any part thereof. A PR wishing to make any changes to the authorised embryologists must submit an application to the HFEA for a variation of the clinic’s licence, accompanied by the relevant evidence of competency for each proposed embryologist.

Mitochondrial donation for the avoidance of serious mitochondrial disease

  1. 33A Interpretation of mandatory requirements

    1. Maternal spindle transfer (MST) can only be carried out where the Authority has issued a determination that—

      1. there is a particular risk that any eggs collected from the patient named in the application form may have mitochondrial abnormalities caused by mitochondrial DNA; and

      2. there is a significant risk that a person with those abnormalities will have, or develop, serious mitochondrial disease.

    2. Pronuclear transfer (PNT) can only be carried out where the Authority has issued a determination that—

      1. there is a particular risk that any embryos created with eggs collected from the patient named in the application form may have mitochondrial abnormalities caused by mitochondrial DNA; and

      2. there is a significant risk that a person with those abnormalities will have, or develop, serious mitochondrial disease.

    3. Treatment involving mitochondrial donation can only be carried out by a clinic that is licensed to do so, as evidenced by express provision on the clinic’s licence permitting it to undertake either MST, PNT or both.

    4. The process of MST or PNT (as defined in Regulation 4 and 7 of the Human Fertilisation and Embryology Authority (Mitochondrial Donation) Regulations 2015) may only be carried out by embryologists who have been assessed by the HFEA as competent to undertake these processes and who are named on the clinic’s licence.

    5. MST or PNT may only be carried out on the premises of a clinic licensed to undertake mitochondrial donation and may not be done on third party premises or the premises of any satellite centre.

    6. Clinics that are not licensed to undertake MST or PNT for treatment purposes may not use eggs or embryos created using these techniques in treatment services.

  2. 33.5 The centre should discuss with the patient the likely outcomes of the proposed treatment, the nature and potential risks of the treatment, and any other treatment options that may be suitable, such as preimplantation genetic diagnosis (PGD) or egg donation.

  3. 33.6 When deciding if it is appropriate to offer MST or PNT in particular cases, the seriousness of the disease in that case should be discussed between the patient seeking treatment and the clinical team. The level of risk for those seeking treatment and any child that may be born will also be an important factor for the centre to consider, and should be discussed with the patient.

    1. The centre should only offer MST or PNT to patients for whom PGD is inappropriate or likely to be unsuccessful and who exhibit (or are predicted to exhibit) high levels of germ line heteroplasmy or homoplasmy. In making this assessment, the centre should take into account:

      1. the particular mutation involved,

      2. the inheritance pattern in the family, and

      3. the likely clinical manifestations of disease and the efficacy of any previous treatments such as PGD.

    2. For an overview of how the Statutory Approvals Committee will assess a case by case application, download ‘Mitochondrial donation: explanatory note for Statutory Approvals Committee’.

  4. 33.7 The centre should consider the following factors before deciding whether it is appropriate to offer MST or PNT in particular cases. Having considered these factors, if a decision is taken to offer MST or PNT, the clinic would need to submit an application for authorisation to the HFEA.

    1. The Authority’s assessment of the seriousness of a mitochondrial disease will be made, where possible, based on the most severe symptoms that could be expected for a particular patient’s case. When submitting an application to the HFEA, the PR must, wherever possible, provide supporting evidence detailing:

      1. a the patient’s medical history

      2. b the patient’s family medical history of mitochondrial disease (to include previous cases of PGD treatment or details of affected family members)

      3. c the patient’s mutant mitochondrial DNA (mtDNA) load and threshold associated with symptoms of disease (to include details about the level of heteroplasmy or whether the patient is homoplasmic for a mitochondrial mutation)

      4. d scientific literature relevant to the mtDNA mutation or disease, and

      5. e any additional information which the clinician may consider is relevant to the application, such as a statement from a genetic counsellor.

Embryo transfer using embryos following mitochondrial donation

  1. 33.8 Embryos that have undergone either MST or PNT (or any other technique) should not be transferred with any other embryos that have not undergone the same technique in the same treatment cycle.

  2. 33.9 A centre should not perform embryo biopsy (such as for the purpose of PGD or preimplantation genetic screening (PGS)) on embryos that have undergone MST or PNT.

  3. 33.10 A centre should use the same sperm provider for both steps of PNT unless there is a good reason for not doing so (ie, if the mitochondria donor is a close genetic relative of the intended father).

Genetic consultation and counselling

  1. 33.11 The centre should ensure that people seeking treatment have access to mitochondrial specialists, clinical geneticists, genetic counsellors and, where appropriate, infertility counsellors. Patients who have been referred by one clinic to another for the purposes of mitochondrial donation must be offered specific counselling about mitochondrial donation by the clinic licensed to do mitochondrial donation, regardless of whether the patient has previously been offered counselling by the referring centre.

  2. 33.12 The centre should work closely with the local genetics/mitochondrial disease centre of those seeking treatment.

Information for those seeking mitochondrial donation

  1. 33.13 The centre should ensure that people seeking MST or PNT are given appropriate information about the treatment. Where a patient has been referred by one clinic to another for the purposes of mitochondrial donation, the clinic licensed to provide mitochondrial donation must ensure that it provides the patient with appropriate information including:

    1. a information about the process, procedures and possible risks involved in mitochondrial donation, including the risks for any child that may be born following the mitochondrial donation, and the risks of IVF treatment,

    2. b information about prenatal testing following treatment (in these circumstances, the patient should be counselled about the specific additional risks associated with prenatal testing), and

    3. c information about the experience of the centre and embryologist(s) carrying out the techniques.

  2. 33.14 The centre should also provide information to those seeking treatment to help them make decisions about their treatment, including:

    1. a genetic and clinical information about the mitochondrial disease

    2. b the possible impact (if known) of the mitochondrial disease on those affected and their families

    3. c the importance of telling any resulting children of the mitochondrial donation treatment

    4. d information about treatment and social support available, and

    5. e information from a relevant patient support group or the testimony of people living with the condition, if those seeking treatment have no direct experience of it themselves.

  3. 33.15 If the person seeking treatment has already been given information about the particular mitochondrial disease, for example from a regional mitochondrial disease centre with appropriate expertise, the centre does not need to provide this information again. However, the centre should ensure that the information which has been provided is accurate, sufficiently detailed and that the patient fully understands the information.

  4. 33.16 Before providing mitochondrial donation treatment, the centre should ensure that those seeking treatment have had sufficient opportunity to fully consider the possible outcomes and risks of these techniques and their implications.

  5. 33.17 The centre should provide information to people seeking mitochondrial donation treatment about the collection and provision of information, specifically:

    1. a information that centres must collect and register with the HFEA about the donors

    2. b what information may be disclosed to people born as a result of the mitochondrial donation and in what circumstances, and

    3. c that person’s right to access anonymous information about the mitochondrial donor from the age of 16.

  6. 33.18 The centre should give people seeking mitochondrial donation treatment information about the screening of people providing mitochondria. This information should include details about:

    1. a the sensitivity and suitability of the tests, and

    2. b the possibility that a screened provider of mitochondria may be a carrier of a mitochondrial disease or infection.

  7. 33.19 The centre should provide information that explains the limitations of procedures and the risks of treatment to anyone seeking mitochondrial donation treatment. The centre should make available appropriate counselling. See also >

  8. NOTE Guidance note 20 applies to mitochondrial donation except sections 20.1, 20.2 (d)ii)-v) and 20.12.

Importance of informing children of their origins

  1. 33.20 The centre should tell people who seek mitochondrial donation treatment that it is best for any resulting child to be told about their origin early in childhood. Centres should refer to guidance set out in guidance note 20 on the importance of informing children of their donor origins.

  2. 33.21 Centres should inform patients of the potential risk of mitochondrial disease in future generations and the potential ways to avoid this (eg, that any female born following MST or PNT, should she wish to have children of her own, could have her eggs or early embryos analysed by PGD in order to select for embryos free of abnormal mitochondria). See also >

Eligibility requirements for mitochondrial donors

  1. Mandatory requirements

    1. T52 Prior to the use and/or storage of donor gametes and/or embryos created with donor gametes the centre must comply with the selection criteria for donors and the requirements for laboratory tests and storage set out below, namely:

      1. a donors must be selected on the basis of their age, health and medical history, provided on a questionnaire and through a personal interview performed by a qualified and trained healthcare professional. This assessment must include relevant factors that may assist in identifying and screening out persons whose donations could present a health risk to others, such as the possibility of transmitting diseases, (such as sexually transmitted infections) or health risks to themselves (eg, superovulation, sedation or the risks associated with the egg collection procedure or the psychological consequences of being a donor)

      2. b the donors must be negative for HIV1 and 2, HCV, HBV and syphilis on a serum or plasma sample tested as follows, namely:

        1. HIV 1 and 2: Anti-HIV – 1, 2

        2. Hepatitis B: HBsAg and Anti-HBc

        3. Hepatitis C: Anti-HCV-Ab

        4. Syphilis: see (d) below

      3. c the centre must devise a system of storage which clearly separates:

        1. quarantined/unscreened gametes and embryos

        2. gametes and embryos which have tested negative, and

        3. gametes and embryos which have tested positive

      4. d a validated testing algorithm must be applied to exclude the presence of active infection with Treponema pallidum. The non-reactive test, specific or non-specific, can allow gametes to be released. When a non-specific test is performed, a reactive result will not prevent procurement or release if a specific Treponema confirmatory test is non-reactive. The donor whose specimen test reacted on a Treponema-specific test will require a thorough risk assessment to determine eligibility for clinical use

      5. e in addition to the requirements in (b) and (d) above, sperm donors must be negative for chlamydia on a urine sample tested by the nucleic acid amplification technique (NAT)

      6. f This requirement has been removed.

      7. g HTLV-1 antibody testing must be performed for donors living in or originating from highprevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas

      8. h in certain circumstances, additional testing may be required depending on the donor’s history and the characteristics of the gametes donated (eg, RhD, Malaria, T.cruzi), and

      9. i genetic screening for autosomal recessive genes known to be prevalent, according to international scientific evidence, in the donor’s ethnic background and an assessment of the risk of transmission of inherited conditions known to be present in the family must be carried out, after consent is obtained. Complete information on the associated risk and on the measures undertaken for its mitigation must be communicated and clearly explained to the recipient.

    2. T126

      1. Donors of gametes for use in MST and or PNT must be screened for pathogenic mitochondrial DNA mutations, and an assessment of the risk of transmission of any mitochondrial disease in the donor’s family must be carried out, after consent is obtained. Complete information on the associated risk and on the measures undertaken for its mitigation must be clearly communicated and explained to the recipient.

  2. 33B Interpretation of mandatory requirements

    1. Sections (a) to (h) of Licence condition T52 on medical and laboratory tests should apply to mitochondrial donors and to men providing sperm used to fertilise eggs of the mitochondrial donor in the process of PNT.

  3. 33.22 As well as taking their medical history (in line with T52 and T126), the recruiting centre should take details of previous donations. If a prospective donor cannot give a full and accurate maternal family history, the centre should record this fact and take it into account in deciding whether or not to accept their eggs for treatment.

  4. 33.23 Centres should ensure that they keep up to date with relevant literature and professional guidance, such as on refinements to the techniques, to improve their efficacy in treatment. Centres should also keep up to date with emerging research relevant to mitochondria haplotype matching and consider matching the haplotypes of donors with recipients where possible.

  5. 33.24 Before accepting a mitochondrial donor, centres should follow the same requirements and guidance as set out in guidance note 11, except guidance 11.2, 11.3, 11.32 g) and j), 11.32 i)-l), 11.36, 11.37, 11.38, 11.39, 11.42, 11.46-11.52.

  6. 33.25 Guidance on the upper age limits for egg and embryo donors does not apply for mitochondrial donors. There is some evidence to suggest that mitochondria in a woman’s eggs accumulate damage over time meaning the eggs of older donors may have reduced mitochondrial function. Age should therefore be taken into consideration when determining the suitability of a woman donating her eggs, in conjunction with an assessment of her reproductive health, such as an assessment of ovarian reserve.

  7. 33.26 The ten family limit guidance for those providing donor gametes (or embryos created using donated gametes) outlined at 11.46, does not apply to: See also >

    1. a egg donors who have donated their mitochondria only, or

    2. b sperm donors who have donated for pronuclear transfer where they will not be genetically related to the child.

Information for prospective mitochondrial donors

  1. 33.27 Before any consents or samples are obtained from a prospective mitochondrial donor, the recruiting centre should provide information about:

    1. a the screening that will be done and why it is necessary

    2. b the possibility that the screening may reveal unsuspected conditions (eg, mitochondrial related anomalies or HIV infection) and the practical implications of this

    3. c the scope and limitations of the genetic testing that will be done and the implications for the mitochondria donor and their family

    4. d the importance of informing the recruiting centre of any medical information that may come to light after donation and that may have health implications for any woman who received treatment with their mitochondria, or for any child born as a result of such treatment

    5. e the procedure used to collect gametes, including any discomfort, pain and risk to the mitochondria donor (eg, from the use of superovulatory drugs)

    6. f the legal parenthood of any child born as a result of their mitochondrial donation

    7. g what information about the mitochondrial donor must be collected by the centre and held on the HFEA Register

    8. h that only non-identifying information will be disclosed when the applicant is aged over 16. No identifying information about the donor will be disclosed

    9. i the possibility that a child born as a result of their mitochondrial donation who is disabled as a result of an inherited condition that the donor knew about, or ought reasonably to have known about, but failed to disclose, may be able to sue the donor for damages, and

    10. j the ability of the mitochondrial donor to withdraw consent, the procedure for withdrawal of consent for the use of their mitochondria, and the point up until which the donor can withdraw consent

Informing mitochondrial donors about information available to children born from the treatment

  1. 33.28 The centre should inform mitochondrial donors that anyone born as a result of their mitochondrial donation will have access to the following non-identifying information provided by them, from the age of 16:

    1. a the screening tests carried out on the mitochondrial donor and information on that donor’s personal and family medical history

    2. b matters contained in any description of the mitochondrial donor as a person which that donor has provided, and

    3. c any additional matter which the mitochondrial donor has provided with the intention that it be made available to a person born from their donation.

Consent

  1. 33.29 The centre should obtain written informed consent from patients and their spouse or partner (if relevant), for mitochondrial donation treatment. Where a patient and their partner have been referred by one centre to another for the purposes of mitochondrial donation, the clinic that will be undertaking the mitochondrial donation must obtain consent specific to the treatment involving mitochondrial donation, regardless of what consent the patient and their partner may have provided to the referring centre. This is because the centre doing the mitochondrial treatment will have the necessary experience and expertise in mitochondrial donation and is best placed to provide the relevant information and obtain fully informed consent.

  2. 33.30 For mitochondrial donors, the centre should obtain the donor’s written informed consent to the donation of her eggs or embryos for MST or PNT.

  3. 33.31 Any prospective women donating their eggs for mitochondrial donation, or men donating sperm for PNT where they will not be genetically related to the child, should be aware that they cannot withdraw or vary their consent once the donated egg or embryo has undergone the process of MST or PNT (ie, all the nuclear material has been moved from one egg or embryo to another).

  4. 33.32 Centres should follow all other requirements and guidance on consent as outlined in guidance note 11 on donor recruitment, assessment and screening and in guidance note 5 on consent to treatment, storage, donation and disclosure of information.

Import of eggs or embryos which have undergone mitochondrial donation

    1. It is not lawful in the UK to provide treatment using gametes or embryos created abroad following the use of pronuclear transfer or maternal spindle transfer. Schedule 1(f) and 3 (i) of General Direction 0006 provides that the purpose of importing gametes or embryos must be to provide treatment services. However, as treatment using gametes or embryos created abroad following the use of pronuclear transfer or maternal spindle transfer is not lawful, it follows that the import of such gametes or embryos should not take place.

Follow-up arrangements

  1. 33.33 Centres offering mitochondrial donation should have a documented process setting out how children born from mitochondrial donation will be followed up, where patients have consented to follow-up. These should include long-term medical follow-up of children born as a result. Centres should establish links with mitochondrial disease centres to facilitate follow-up. If the patient is not a UK resident but nevertheless wishes to participate in follow-up, the centre and patient should discuss whether the patient wishes to be followed up at a mitochondrial disease centre based in the UK or a relevant centre overseas, in a location more convenient for the patient.

  2. 33.34 Centres should explain to patients the benefits of participating in follow-up, both immediate follow-up and long term follow-up.

  3. 33.35 If a centre becomes aware that a child born following mitochondrial donation has been born with a mitochondrial disease, birth defect, or genetic abnormality, or if there has been some other adverse outcome (including but not limited to failed or no embryo development, miscarriage or premature birth) following treatment involving mitochondrial donation, the centre must regard this as an adverse incident and report this to the HFEA in line with the requirements on adverse incidents set out in guidance note 27. This is to capture information about any abnormalities that may occur as a result of carrying out the MST or PNT treatment, to inform any regulatory or licensing action that the HFEA may wish to take and to inform the scientific sector. See also >