Human Fertilisation and Embryology (HFE) Act 1990 (as amended)

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

Use of gametes for treatment of others

• 5

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

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

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

• 31ZD

  Provision to donor of information about resulting children

  (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) and (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.

Conditions of licences for treatment

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

  (a) a serious physical or mental disability,

  (b) a serious illness, or

  (c) any other serious medical condition,

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

Licence conditions

• 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

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

  • HIV 1 and 2: Anti-HIV – 1, 2
  • Hepatitis B: HBsAg/Anti-HBc
  • Hepatitis C: Anti-HCV-Ab
  • Syphilis: see (d) below
  
  c. the centre must devise a system of storage which clearly separates:
  
  • quarantined/unscreened gametes and embryos,
  • gametes and embryos which have tested negative, and
  • gametes and embryos which have tested positive.
  
  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
  
  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)
  
  f. This requirement has been removed.
  
  g. HTLV-1 antibody testing must be performed for donors living in or originating from high incidence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas, and
  
  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).

• T53

  The centre must ensure that the laboratory tests required by licence condition T52 meet the following
  requirements, namely:

  a. the test must be carried out by a qualified laboratory, which has suitable accreditation (for example by CPA (UK) Ltd or another body accrediting to an equivalent standard), using CE marked testing kits where appropriate. The type of test used must be validated for the purpose in accordance with current scientific knowledge,
  
  b. blood samples must be obtained within a timeframe specified by the Authority, and
  
  c. donor sperm must be quarantined for a minimum of 180 days, after which repeat testing is required. If the blood donation sample is additionally tested by the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, quarantining of the gametes and re-testing of a repeat blood sample is not required. Quarantine and re-testing is also not required if the processing
  includes an inactivation step that has been validated for the viruses concerned.

• T55

  Potential donors that are known to have a gene, chromosome or mitochondrion abnormality involving a significant risk that a person with the abnormality will have or develop:

  a. a serious physical or mental disability

  b. a serious illness, or

  c. any other serious medical condition,

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

Directions

• • 0001 – Gametes and embryo donation 
  • 0005 – Collecting and recording information for the HFEA

Regulations

Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004

 

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Advertising

• 11.1
  Advertising and publicity materials should be designed and written with regard to the sensitive issues involved in recruiting donors.

Age of prospective donors

• 11.2
  Centres should refer to the relevant professional guidelines on age limits before accepting gametes for the treatment of others.
  
  Note: Current professional guidelines state that eggs should not be taken from donors aged 36 or over, and sperm should not be taken from donors aged 41 or over.
• 11.3
  For donated eggs, the relevant age limit should be observed unless there are exceptional reasons not to do so. The centre should record any such reasons in the patient’s medical records.
• 11.4
  For donated sperm, the relevant age limit should normally be observed. However, due to less substantial evidence on age limits for sperm donors, centres should assess the possible effect of the donor’s age on a case-by-case basis. The centre should record in the patient’s medical records the reasons for using a donor above the recommended age limit.
• 11.5
  For donated embryos, the guidance above applies to both gamete providers.
• 11.6
  Gametes for the treatment of others should not be taken from anyone under the age of 18.

General enquiries to be made

• 11.7
  The recruiting centre should take reasonable steps to verify the identity of the prospective donor by asking for appropriate identification (eg, passport or photocard driving licence). Failure to obtain satisfactory evidence of identity should be taken into account in deciding whether to accept their gametes or embryos for treatment.
• 11.8

  When obtaining gametes or embryos for the treatment of others (whether directly from a donor, from another licensed centre or from a foreign supplier), the centre should take appropriate steps to discover whether gametes from that donor have been obtained for use in licensed treatment before and, if so:

  a) establish which centre is the primary centre for that donor

  b) notify that centre that it proposes to use that donor’s gametes

  c) seek authorisation to do so, if appropriate, and

  d) ensure that the limit of 10 families per donor will not be exceeded.

Family and other relevant history

• 11.9
  Before a prospective donor provides gametes, the recruiting centre should take their medical and family histories, and details of previous donations. The centre should encourage prospective donors to provide as much other non-identifying biographical information as possible, so that it may be available to prospective recipients, parents and resulting children. If a prospective donor cannot give a full and accurate family history, the centre should record this fact and take it into account in deciding whether or not to accept their gametes or embryos for treatment.
• 11.10

  The centre should seek the prospective donor’s consent to approach their GP for further factual information if it suspects the donor might be unsuitable. The centre should always seek further information if:

  a) information provided by the patient suggests there are risk factors that may affect anyone treated using their gametes or any child born as a result

  b) the prospective donor has failed to provide any information requested

  c) the information provided by the prospective donor is inconsistent, or

  d) there is evidence of deception.

• 11.11
  If the prospective donor refuses to give such consent, the centre should take this into consideration when deciding whether to accept that donor. Such refusal should not in itself be grounds for not accepting the donor. The centre should discuss with the prospective donor their reason for refusing.

Suitability as a donor

• 11.12
  The use of gametes from a donor known to have an abnormality as described above, should be subject to consideration of the welfare of any resulting child and should normally have approval from a clinical ethics committee.
• 11.13
  If a centre determines that it is appropriate to provide treatment services for a woman using a donor known to have an abnormality as described above, it should document the reason for the use of that donor.

• 11.14

  Before accepting gametes for the treatment of others, the recruiting centre should consider the suitability of the prospective donor. In particular, the centre should consider:

  a) personal or family history of heritable disorders

  b) personal history of transmissible infection

  c) the level of potential fertility indicated by semen analysis (where appropriate)

  d) the implications of the donation for the prospective donor and their family, especially for any children they may have at the time of donation or in the future, and

  e) the implications for any children born as a result of the donation, in the short and long term.

• 11.15

  A centre should not perform treatment that involves mixing gametes (eg, through insemination, IVF or ICSI) of close relatives who are genetically related, including between:

  a) grandfather and granddaughter

  b) grandmother and grandson

  c) father and daughter

  d) mother and son

  e) brother and sister

  f) half-brother and half-sister

  g) uncle and niece

  h) aunt and nephew

  i) uncle and half-niece

  j) aunt and half-nephew

• 11.16
  The restriction described in 11.15 does not include treatment that involves replacing the gametes of close relatives who are genetically related (eg, sister-to-sister egg donation).

• 11.17
  The centre should ensure that its procedures for recruiting donors are fair and non-discriminatory.

Conditions placed on a donation

• 11.18
  The centre should inform anyone providing gametes that they can, if they wish, specify extra conditions for storing or using their gametes (or embryos created using them).
• 11.19

  However, some conditions imposed by donors may be incompatible with the Equality Act 2010. The Equality Act prohibits service providers (such as clinics) from discriminating by treating people less favourably because of various protected characteristics. The protected characteristics are:

  a) age

  b) disability

  c) gender reassignment

  d) marriage and civil partnership

  e) pregnancy and maternity

  f) race

  g) religion or belief

  h) sex

  i) sexual orientation.

• 11.20
  When deciding whether or not to recruit donors who place conditions on the use of their gametes or embryos, the centre should judge whether this will result in less favourable treatment because of a protected characteristic (eg, if it will reduce the choice of donors for a particular person by virtue of a protected characteristic).

Medical and laboratory tests

• 11.21
  In addition to meeting the requirements set out in licence conditions, donors of gametes and embryos should be screened in accordance with current professional guidance produced by the relevant professional bodies.
• 11.22
  Centres should screen potential donors both before accepting them as donors, and before using the donated gametes and embryos in treatment.
• 11.23
  In addition to meeting the mandatory requirements outlined in this guidance note, the centre should quarantine donated gametes and embryos in line with guidance from the relevant professional bodies.

People considered unsuitable as donors

• 11.24

  A prospective donor should not be accepted if the centre:

  a) concludes that a recipient or any child born as a result of treatment using the donor’s gametes is likely to experience serious physical, psychological or medical harm, or

  b) cannot get enough further information to conclude there is no significant risk.

• 11.25
  When the centre decides that a prospective donor is unsuitable to donate, it should record the reasons and explain them to the prospective donor. The centre should present the reasons for the decision sensitively and answer any questions in a straightforward and comprehensive way.
• 11.26
  The centre should offer counselling to all prospective donors who are considered unsuitable for any reason. When the centre refuses to accept a prospective gamete donor because of physical or psychological problems that require separate treatment or specialist counselling, the centre should provide reasonable assistance to the individual to obtain relevant treatment or counselling.
• 11.27
  If information affecting the suitability of a prospective donor becomes known after the selection process, the centre should review the prospective donor’s suitability and take appropriate action.

Unsuspected heritable conditions in donors

• 11.28
  At registration, donors should indicate whether or not they wish to be notified if the centre learns (eg, through the birth of an affected child) that they have a previously unsuspected genetic disease or they are a carrier of a harmful inherited condition. They should also be asked whether or not they would like their primary care physician to be informed. Their wishes should be recorded in the donors’ medical records.
• 11.29

  If a centre learns that a donor has a previously unsuspected genetic disease or is a carrier of a harmful inherited condition, the centre should:

  a) notify the primary centre (where there is one) and the HFEA immediately (the primary centre should immediately notify other centres who have received gametes obtained from that donor)

  b) inform patients who have had a live birth as a result of treatment with gametes from that donor, and offer these patients appropriate counselling

  c) carefully consider when and how a woman who is pregnant, as a result of treatment with gametes from that donor, is given this information, and

  d) refer to the donor's medical records to establish whether, and in what way, they would like to be given the information. If the donor has indicated that they would like to be given such information, the centre should notify their primary care physician, so that the donor can be referred for the appropriate medical care and counselling. If the donor has indicated that they would not like their primary care physician to be informed, the centre should contact the donor directly.

• 11.30

  The centre should tell gamete donors that they should inform the centre if, after the donation:

  a) they discover they are affected by an unsuspected genetic disease, or

  b) they find they are a carrier of a harmful recessively inherited condition (eg, through the birth of an affected child).

  The centre should then proceed as indicated above.

Information for prospective donors

• 11.31

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

  a) the screening that will be done, and why it is necessary

  b) the possibility that the screening may reveal unsuspected conditions (eg, low sperm count, genetic anomalies or HIV infection) and the practical implications

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

  d) the importance of informing the recruiting centre of any medical information that may come to light after donation that may have health implications for any woman who receives treatment with those gametes or for any child born as a result of such treatment

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

  f) the legal parenthood of any child born as a result of their donation

  g) the restriction on using gametes and embryos from an individual donor when the number of families that have already had children as a result of treatment using such gametes or embryos has reached 10 (or any lower figure specified by the donor)

  h) what information about the donor must be collected by the centre and held on the HFEA Register

  i) the fact that the centre or the HFEA (or both) may disclose non-identifying information about the donor, for example to prospective recipients or to the parents of donor-conceived children

  j) the HFEA’s obligation to disclose non-identifying information (and identifying information if donation took place after 31 March 2005), to someone who applies for such information if:

  i) the applicant is aged over 16 (to access non-identifying information) or 18 (to access identifying information), and

  ii) the applicant appears to have been conceived using the donor’s gametes, or embryos created using the donor’s gametes

  k) the importance of supplying up-to-date contact information so that they can be informed if and when disclosure of identifiable information will be made

  l) the importance of the information provided at 11.29 and 11.30 to people born as a result of their donation

  m) the possibility that a donor-conceived person 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

  n) the procedure for donors to withdraw consent for the use of their gametes, or embryos created with their gametes, and

  o) the fact that if the donor is an egg donor who is not a patient, she is free to withdraw from the donation process after preparation for egg recovery has begun without incurring a financial or other penalty.

• 11.32

  Men who wish to donate embryos originally created for the treatment of their partner and themselves, and those people considering treatment with such embryos, should be:

  a) informed of the uncertain legal status of men donating embryos created originally for the treatment of their partner and themselves, when the embryos are used in the treatment of a single woman

  b) referred to information on the HFEA’s website on this issue, and

  c) advised to seek independent legal advice before consenting to donate their embryos or being treated with the embryos.

Giving donors information about children born as a result of their donation

• 11.33
  The centre should inform donors and potential donors that they may ask at any time how many children have been born as a result of their donation.
• 11.34
  The centre should inform donors seeking information about children born as a result of their donation that they may find counselling, or similar support services, helpful in considering the implications of receiving such information.
• 11.35
  The centre should inform anonymous donors seeking information about children resulting from their donation that they have the right to re-register as identifiable, if they wish.

Informing donors about information available to donor-conceived people

• 11.36

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

  a) physical description (height, weight, and eye, hair and skin colours)

  b) year and country of birth

  c) ethnic group

  d) whether the donor had any genetic children when they registered, and the number and sex of those children

  e) other details the donor may have chosen to supply (eg, occupation, religion and interests)

  f) the ethnic group(s) of the donor’s parents

  g) whether the donor was adopted or donor conceived (if they are aware of this)

  h) marital status (at the time of donation)

  i) details of any screening tests and medical history

  j) skills

  k) reason for donating

  l) a goodwill message, and

  m) a description of themselves as a person (pen portrait).

• 11.37

  The centre should also inform donors who register or re-register after 31 March 2005 that anyone born as a result of their donation will have access to the following identifying information, from the age of 18:

  a) full names (and any previous names)

  b) date of birth, and town or district where born, and

  c) last known postal address (or address at time of registration).

• 11.38
  The centre should inform identifiable donors that it will make a reasonable attempt to contact and forewarn them before disclosing identifiable details to anyone born as a result of their donation. The centre should encourage donors to provide up-to-date contact details to facilitate this.

Provision of counselling to those considering donation

• 11.39
  If the possibility of donating gametes or embryos for the treatment of others, or for research or training, arises during the course of treatment, the centre should allow potential donors enough time to consider the implications and to receive counselling before giving consent.

Consent

• 11.40
  Where someone intends to donate gametes or embryos for the treatment of others, the centre should ensure it obtains written consent to do so from that person. Such consent should include the number of families that may have children using the donated gametes or embryos.
• 11.41
  Centres should aim to make best use of donated sperm within the maximum number of families the donor has consented to (up to the 10-family limit).
• 11.42
  If the donor has consented to using the sperm for more than one family, the recruiting centre should not allow patients to reserve more sperm than is reasonable for one family allocation.
• 11.43
  Where the centre uses sperm from donors who have been recruited at another centre, the centre should take reasonable steps to assure itself that patients have not reserved more sperm than is reasonable for one family allocation.
• 11.44
  The centre is not required to obtain the consent of the donor’s partner or spouse. However, if the donor is married, in a civil partnership or in a long-term relationship, the centre should encourage them to seek their partner’s support for the donation of their gametes.

Monitoring and complying with the 10 family limit

• 11.45
  The centre should establish documented procedures to ensure that if the number of families created using gametes (or embryos created using donated gametes) from a particular donor has reached 10 (or any lower figure specified by the donor), that those gametes or embryos are not used or distributed for use in further treatment.
• 11.46

  Before authorising a secondary centre to use gametes (or embryos created using gametes) from a particular donor, the primary centre should ensure that no more than 10 families (or any lower figure specified by the donor) at any time:

  a) have had live births as a result of treatment using that donor’s gametes
  
  b) have embryos created using that donor’s gametes and placed in storage so they are available for subsequent transfer, or
  
  c) are being treated using that donor’s gametes (or embryos created using gametes).

• 11.47

  If a centre uses gametes (or embryos created using gametes) from a particular donor who was recruited by another centre, it should notify that primary centre each time a new patient has:

  a) a live birth as a result of treatment using that donor’s gametes, or
  
  b) embryos created using that donor’s gametes and placed in storage so they are available for subsequent transfer.

• 11.48

  The primary centre for a particular donor should notify any secondary centres having or using gametes (or embryos created using gametes) from that donor, within two working days, when it becomes aware that six families (The six-family alert applies where the donor has not specified a family limit lower than 10) have had:

  a) a live birth as a result of treatment using that donor’s gametes, or
  
  b) embryos created using that donor’s gametes and placed in storage so they are available for subsequent transfer.

  After this, gametes (or embryos created using gametes) from that donor should not be used without authorisation from the primary centre, unless they are used to treat a family who already has a child using that donor. However, if recipients have already begun or had medical, surgical or obstetric treatment (such as ovarian stimulation or egg collection) when the notification is given, this should be allowed to continue.

• 11.49
  When using gametes (or embryos created using gametes) from a particular donor authorised in this way by a primary centre, a secondary centre should notify the primary centre each time a woman starts or ends relevant treatment.
• 11.50

  Relevant treatment situations are where the woman has:

  a) begun, but not completed, a treatment cycle (eg, ovarian stimulation)

  b) received treatment (insemination or embryo transfer) and is awaiting confirmation of pregnancy

  c) a confirmed ongoing pregnancy

  d) embryos created that have not yet been transferred (eg, placed in storage), or

  e) received treatment but has not reported the outcome.

• 11.51
  Primary centres should notify secondary centres, and vice versa, when embryos created using a donor’s gametes are removed from storage and allowed to perish, donated to research or used for training.

Benefits in kind

• 11.52
  Centres may offer benefits in kind, in the form of reduced-price or free licensed services (for example, fertility treatment or storage) or quicker access to those services, in return for providing eggs or sperm for the treatment of others.
• 11.53
  The centre should, as appropriate, treat gamete providers donating for benefits in kind in the same way as other potential gamete donors.

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Association of Biomedical Andrologists/Association of Clinical Embryologists/British Andrology Society/
British Fertility Society/Royal College of Obstetricians and Gynaecologists – UK guidelines for the medical
and laboratory screening of sperm, egg and embryo donors (2008)

British Infertility Counselling Association - Guidelines for Good Practice in Infertility Counselling, 3rd edition (2012)

 

 

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