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09 January 2004

Dear Colleague,

REVISED HFEA CODE OF PRACTICE (6th EDITION)

I have pleasure in enclosing the sixth edition of the HFEA's Code of Practice, together with a copy of the Direction bringing it into force as required by section 26 of the HF&E Act 1990.  The Code of Practice has been approved by the Secretary of State for Health and laid before Parliament.  It comes into force on 1st March 2004.

The new edition of the Code includes updated policies and guidance that have changed since the last edition was published in March 2001.  This letter sets out a brief explanation of the Code's new structure as well as an outline of the key areas where policies have been revised including changes made following last year's consultation exercise. However, this is only a summary of the main changes and is not intended as a substitute for reading the full text of the new Code.

The Authority received just over 60 responses to the consultation on the 6th edition of the Code.  The majority came from Persons Responsible, professional and patient representative bodies and HFEA inspectors with some comments from patients and other individuals.  We are very grateful to everyone who took the time to give us their views.  A number of changes proposed by respondents have been taken on board in the new edition and there are some areas where the Authority has further refined its policies.

Transfer of Eggs and Embryos

Following the consultation and further analysis of the HFEA's database, the Authority has arrived at a clear policy to reduce multiple births through guidelines on the maximum number of eggs or embryos to be transferred in any one treatment cycle (see paragraphs 8.17 to 8.22 of the Code). 

The consultation draft proposed a strict limit of two eggs or embryos transferred regardless of age and the procedure used.  Although most respondents supported this proposal, others expressed concern about the likely impact of such a policy on live births rates in older women.

This is a legitimate concern and we have therefore arrived at what we believe is a reasonable balance between our overriding objective of reducing multiple births with the need to maximise a women's chance of having a healthy singleton baby.

To achieve this balance, the new Code of Practice sets out clear requirements for different categories of patient and types of treatment.  In summary:

• In cases where a patient's own eggs or embryos are used, women under 40 at the time of transfer should receive a maximum of 2 eggs or embryos in any one cycle regardless of the procedure used.   However, given their reduced fertility, women aged 40 or over may receive a maximum of 3 eggs or embryos in any one cycle. An analysis of the HFEA's database and other statistical evidence has shown that a transfer limit of 2 eggs or embryos for the under 40s should reduce multiple births significantly with only a minor reduction in the women's chances of having a healthy singleton baby.
• Where donated eggs or embryos are used a maximum of 2 eggs or embryos can be transferred regardless of the women's age at time of transfer. This takes account of the fact that the upper age limit for egg donation is 35. The same limits apply to all age groups where aneuploidy screening has been employed because of the improved chances of achieving a live birth that is associated with embryos that have the normal complement of chromosomes.

Alongside the Code, we have launched a new information leaflet to assist patients in understanding the new limits and the medical and psychological problems associated with multiple births. A copy of this leaflet is enclosed with this letter.

Reporting of Adverse Incidents

The new Code includes a new section on adverse incidents including a requirement to report adverse incidents within a fixed time limit and a new definition of adverse incidents (see paragraphs 2.23-2.26 of the Code).

This places a requirement on Centres to report all adverse incidents to the HFEA by telephone within 12 working hours of the identification of the incident and submit an incident report form within 24 working hours.

Other Changes

The remaining substantive changes are described chapter by chapter.

Part 1: Staff

• Para 1.1(iv): has been extended to emphasise the need to protect not only the welfare of potential children born as a result of treatment but also those who may be affected by the birth;
• Para 1.4 (iv):  requires the Person Responsible to ensure that suitable practices are used in the course of the activities of the centre;
• Para 1.8:  is more explicit than previously about the qualifications and experience required of nursing and midwifery staff; 
• Para 1.9:  now makes clearer that all counsellors are expected to be qualified and members of a recognised professional counselling body. Various other consequential changes are made throughout the Code (e.g. at paragraph 2.3);
• Para 1.12:  a new paragraph has been added on the qualifications and experience of scientific staff with responsibility for PGD/PGS; 
• Para 1.17:  a new paragraph has been added recognising the need for all professional staff to engage actively in continued professional training. 
• Part 3: Welfare of the Child and the Assessment of those seeking Treatment 
• Para 3.3: has been amended to ensure that Centres have clear written protocols for assessing the welfare of any child or children which may be born or which may be affected by the birth of such a child or children; 
• Para 3.4: is a new section clarifying the need for Centres to carry out an assessment of the Welfare of the Child upon first contact for licensed treatment with prospective patients. However, as patients are often placed on waiting lists for licensed treatment that may extend for one to two years Centres are expected to ensure that no changes of circumstances have occurred since the original assessment of the Welfare of Child was carried out before proceeding with treatment; 
• Para 3.5: has been added to provide additional guidance to Centres on when to repeat the Welfare of the Child assessment. 
• Para 3.18-3.19: has been amended to clarify that in the selection of donated gametes Centres are expected, as far as possible, to match the physical characteristics and ethnic background of the donor to those of the infertile partner, or in the case of embryo donation, to both partners, unless there are good reasons for departing from this procedure.

Part 4: Assessing and Screening Potential Donors

• Para 4.1 (i):  now makes clear that potential donors should understand not just which tests must be carried out but why they are necessary;
• Para 4.1 (iv): now clarifies that donors should be informed of their right to withdraw from the process of donation at any time until the gametes or embryos have been used in treatment; 
• Para 4.1 (v): has been added to confirm to Centres that donors are expected not to experience pressure or undue influence to donate sperm, eggs or embryos by centre staff, friends or relatives; 
• Para 4.1 (vii) is a new section recognising that donors and their partners should be given the opportunity to see an independent counsellor to explore the implications of the donation. This is further emphasised at paragraph 4.8;
• Para 4.4:  has a new final sentence stating that Centres are expected to record instances where a donor cannot give a full and accurate family history; 
• Para 4.8 (v):  adds a further two categories for Centres to consider when assessing the suitability of potential donors – for donors with children, the implications for themselves and their existing families and for childless donors, the implications for themselves and any future family; 
• Para 4.9:  now states that the possibility of people undergoing treatment donating gametes should be raised by the counsellor.

Part 5:  Information

• Para 5.5 (i):  adds ‘the centre's policy on selecting patients' to the list of information to be given to individuals seeking treatment;
• Para 5.5 (vi):  has been amended to include information to be given to prospective patients on the risks to the woman and fetus associated with multiple pregnancy including the impact of multiple births on individual children as well as the family unit;
• Para 5.9 (vi): additional wording has been added to specify that Centres are expected to provide information to patients, that if they donate embryos to research which includes the derivation of stem cell then any stem cell line created may continue indefinitely and may be used in different research projects; 
• Para 5.10:  a new paragraph stating that specific consent should be obtained where any genetic research is to be carried out on identifiable samples.

Part 6:  Consent

• Para 6.1: expands the list of relevant guidance on consent;
• Para 6.2:  states the exceptional circumstances under which centres may examine or treat people without first obtaining their consent;
• Para 6.3:  clarifies to Centres the concept of valid consent and makes it clear that patients should be given sufficient time to consider the information before giving consent;
• Para 6.5-6.6: these paragraphs have been introduced to provide guidance to Centres, so that they can ensure that patients who return for treatment e.g. in cases such as Donor Insemination or treatment using frozen /thawed embryos, where a long period of time has lapsed and in cases where the personal circumstances of patients could have changed without the centre being aware, return with the same partner;
• Para 6.10-6.12:  a new section has been added on ‘consent by children and young people'. This section clarifies to Centres that parents cannot consent on behalf of their children to any licensed procedure and that centres are expected to have written information that is accessible to children and young people given by a member of staff with competence in communicating with children;
• Para 6.25:  has been amended to take account of the Human Fertilisation and Embryology (Deceased Fathers) Act 2003;
• Para 6.34: adds an additional requirement that Centres are expected to obtain written consent from the husband in cases where married women are receiving treatment using donated sperm;
• Para 6.36:  has been amended to clarify that Centres should record whether the male partner was present at each appointment and obtain written consent from the male partner that he and his partner are being treated together and, if applicable, donated sperm is to be used. 
• Para 6.52: has been amended to clarify that Centres are expected to ensure that, in egg sharing arrangements where embryos are to be stored, the women's consent to the storage of embryos using her eggs is consistent with the consent of the man whose sperm fertilised those eggs, both for the egg provider and the egg recipient.

Part 7:  Counselling

This chapter has been reorganised in what we hope is a more logical sequence.

• Para 7.4 (i):  a sentence has been added to make clear that implications counselling provided by a qualified counsellor (see paragraph 7.12) should be distinguished from implications advice or guidance provided by other members of the multidisciplinary team; 
• Para 7.5: has been amended to reinforce the importance that all patients are offered counselling and they are made aware that this offer is a routine part of the treatment service;
• Para 7.6:  now makes clear that, in providing counselling, Centres are expected to be aware of the individual needs of patients including disability and language; 
• Para 7.10:  places an expectation on Centres to invite those seeking treatment to consider their attitude to their own or partner's infertility and the possibility that treatment will fail; 
• Para 7.19:  adds people experiencing difficulty coping with a treatment cycle to the list of those who should be offered support counselling; 
• Para 7.20:  makes more explicit that all staff who are in contact with the patient should receive training in providing emotional support.

Part 8: Use of Gametes and Embryos

• Para 8.11: has been revised to provide guidance to Centres in situations where one of the gamete providers withdraws their consent to the continued storage of embryos.
• Part 9: Storage and handling of Gametes and Embryos
• Para 9.2: has been added to give guidance to Centres on the screening of patients placing gametes, embryos, ovarian or testicular tissue in storage;
• Para 9.3: has been added to ensure that Centres storing tissue that does not require a HFEA licence should only store this tissue if the Centre fulfils the requirements of the Department of Health's Code of Practice for Tissue Banks;
• Para 9.4: clarifies the necessity to store screened and unscreened samples separately.

Part 10: Research

• Para 10.11: has been added and the guidance given is taken directly from the General Medical Council's guidance on research in relation to funding and payment.

Part 12:  Confidentiality

• Para 12.9: this has been extended to include gamete and embryo donation as well as egg sharing.

Part 13:  Complaints

• Para 13.4:  now makes clear that information on Centres' complaints procedures should be given to patients as well as displayed.

Part 14:  Preimplantation Testing

This new chapter provides revised guidance to clinics on Preimplantation Testing and covers Polar Body/blastomere biopsy; Licensing of preimplantation testing; Accreditation of Genetics laboratories; staff involved in PGD; Patient information; Clinical decision making; Preimplantation genetic screening for aneuploidy; recording and reporting information.

Part 15: Witnessing Clinical and Laboratory Procedures

This is a new chapter and provides guidance to all licensed Centres that they are expected to have procedures in place to double-check the identification of:

(i)  The individuals undergoing treatment

(ii)  The sperm and eggs at the time of insemination

(iii)  The embryos and the patient at the time of embryo transfer

(iv)  The gametes and embryos at the time of cryopreservation and thawing.

Part 16: Intracytoplasmic Sperm Injection (ICSI)

This new chapter provides guidance on ICSI and contains information on recognising ICSI practitioners, Licensing obligations and circumstances for using ICSI.

Appendix A: Guidance for Egg Sharing Arrangements

This appendix has been amended to include a statement that in anonymous egg sharing arrangements, the Centre may only release non identifyingoutcome information where certain criteria have been satisfied.  It must be that both the egg recipient and their partner have consented in writing to this information being released and the donor has consented in writing to this information being released to her and the appropriate counselling has been given to both parties.

Appendix B:  Consent to Disclosure of Identifying Information

Para 3 of Consent Form:  a further box has been added for patients to give informed consent for National Care Standard Commission inspectors to see their treatment records.

Appendix D: Parental Orders in Surrogacy Cases

This appendix has been updated to inform Centres that they must not offer surrogacy in the situations described unless they have taken account of the legal requirements of the Adoption Act 1972.  This would include the need to involve a registered adoption agency prior to the birth of the baby and the full adoption procedure would need to be gone through. Where a child is born to a surrogate mother, the placement of that child with the commissioning couple for them to adopt may involve a breach of the Adoption Act 1972.  Centres are in danger of breaching the Adoption Act 1972 if they set up or offer to set up a surrogacy arrangement that could not result in an application for a parental order being applied for.

 Appendix F: Guidelines from professional Organisations

This appendix has been updated to include additional organisations that Centres are expected to take account of.

Appendix H: Standard Licence Conditions

This additional appendix has been included to list the standard conditions that are applicable to all licenses. These conditions are by no means exhaustive as additional licence conditions can be added to a treatment or a research licence at the discretion of a Licence Committee.

Appendix I: The HFEA Register

This appendix includes information about those who may apply to the HFEA to discover whether the register shows that they were born as result of assisted reproductive technologies or, if they are contemplating marriage, whether they and their intended spouse might be related.

New Directions

In addition to issuing Directions to bring into force the 6th edition of the Code of Practice, the Authority is also issuing two further Directions with the Code.

The first Direction will require Centres to record and keep detailed records each time three eggs or embryos are transferred in any one treatment cycle. For all cycles in which three eggs or embryos are transferred Centres will be required to record and keep a summary log explaining the reasons for the transfer of three eggs or embryos, the number of fetal sacs detected in the early scans and the outcome of the pregnancy.

The second Direction will require all Centres to report all adverse incidents to the HFEA by telephone within 12 working hours of the identification of the incident and submit an incident report form within 24 working hours. The Directions include the new incident report form to be completed by centres.

The Directions will come into force on the same date as the Code of Practice (1st March 2004).

Format of the Code

We have put some effort into making the Code more accessible.  As in the consultation version, each section is preceded by the relevant legal text of the Act.  This is highlighted in blue to distinguish the guidance from the legal requirement.  For added clarity, a section on interpretation of the Code has been included at the beginning of the document. The font, the design and the layout have also been improved to make the document easier to read.

Despite these improvements, we recognise that a new approach is needed to the way the Code is presented and packaged to make it a more useful tool for Centres. The future shape of the Code is also likely to be influenced by the new national accreditation standards for assisted conception clinics, currently being developed with the professional bodies, and the requirements of the EU Directive on Tissues and Cells. We envisage that HFEA will conduct a consultation exercise on a new-look Code early in 2005-06, with a view to issuing the 7th edition towards the end of that financial year.

Further Information

 Further information on the changes to the Code can be obtained from either Charles Lister, Head of Policy (on 020 7539 3334 or at charles.lister@hfea.gov.uk) or Dr Chris O'Toole, Policy Manager (on 020 7539 3324 or at chris.otoole@hfea.gov.uk).

Yours sincerely

Suzi Leather
Chair

Page last updated: 14 April 2009

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