28 September 2000
Dear Colleague,
Guidance for Egg Sharing Arrangements
Enclosed with this letter is a copy of the HFEA's Guidance for Egg Sharing Arrangements. This guidance was prepared by the HFEA after extensive consultation with representatives from the British Fertility Society and The Royal College of Obstetricians and Gynaecologists. Following a feasibility study, involving a number of centres, the guidance has been finalised and will be included in the next edition of the HFEA's Code of Practice.
The guidance is based on two general principles. The first requires the preparation of two separate agreements, one between the egg provider and the centre and the other between the egg recipient and the centre. The guidance describes what the HFEA would expect to see covered by such agreements. This is not intended to be exhaustive, and centres are advised to obtain their own legal advice on the content and legal consequences of their agreements.
The second principle reflects the importance the HFEA attaches to the treatment services given to the egg provider when only a few eggs are available. The guidance provides that, where there are fewer eggs collected than the minimum needed for sharing, the egg provider should be given the option of using all of her eggs at no additional cost to herself and with no further commitment. This should be reflected in the agreements.
Centres should give special attention to the requirement that two HFEA (00)7 consent forms should be completed by egg providers in egg sharing arrangements. One HFEA(00)7 should be completed for the use of the eggs and the storage of the embryos created for her own use, .the other for the use of the donated eggs and the embryos created for use by the recipient couple. This is explained more fully in the guidance and example forms have been completed and annexed for your information.
The HFEA will expect centres to apply the requirements of this guidance to their egg sharing arrangements without delay. Centres will also be required to submit their egg sharing documentation to the HFEA with their next interim/renewal application. In addition, a specific inspection protocol will be developed for centres offering egg sharing as a treatment service. This new protocol will be based on the contents of the guidance for egg sharing.
Any queries relating to this new guidance for egg sharing should be directed to Ginny Shires at the HFEA (tel: 020 7539 3311).
Yours sincerely,
Ruth Deech
Chairman
GUIDANCE FOR EGG SHARING ARRANGEMENTS
Introduction
The HFEA has drawn up guidance for licensed centres offering or intending to offer licensed treatments involving an egg sharing arrangement. The guidance for egg sharing arrangements operates around two general principles, supplemented by more detailed guidance that will be included in the next edition of the Code of Practice.
Throughout this guidance the term egg provider is used to describe the woman sharing her eggs. The term egg recipient is used for the woman receiving some of these eggs.
Any egg sharing arrangement where the egg provider is herself undergoing licensed treatment should be subject to this guidance. Centres are reminded that this is a unique situation in which the egg provider is both an IVF patient and an egg donor. The HFEA recognises there may be a potential conflict of interest in egg sharing arrangements but this should not interfere with the clinical care that is provided.
A checklist of information that should be submitted to the HFEA with interim or renewal documentation is attached at Annex A.
General Principles
1) In addition to the statutory consent required, two additional separate agreements should be drawn up. One should be between the egg provider and the centre and the other between the egg recipient(s) and the centre (Detailed guidance for the writing of egg sharing agreements is attached at Annex B).
2) Where there are few eggs available the arrangement for egg sharing should not compromise the egg provider's treatment (see also the additional guidance given on the drafting of agreements attached at Annex B).
The Code of Practice
In addition to the general principles already outlined, any centre wishing to carry out egg sharing will need to fulfil the requirements of the HFEA's Code of Practice. Certain requirements such as consent, patient information, screening of donors, welfare of the child assessments and so forth will require special attention for egg sharing arrangements. Additional guidance is provided in the following sections.
Information
In addition to standard information, separate written information for providers and recipients should be available. This information should include the following:
- The criteria used for selection of egg providers and recipients for egg sharing arrangements;
- The centre's procedures for determining how the eggs will be shared between the provider and the recipient(s);
- The screening egg providers will be required to undergo;
- The terms of the agreement to be signed;
- The law relating to consent and the rights of the egg provider to vary or withdraw her consent. Any implications that may result from the withdrawal of consent should be made clear to all parties prior to treatment commencing;
- The alternative treatment options available.
Consent
Statutory HFEA consent forms should be completed and signed as follows:
a) The egg provider should complete a HFEA(00)7 for the use of the eggs and the storage of the embryos created for her own use. This HFEA(00)7 should be completed as though the egg provider was an IVF patient in accordance with HFEA guidance for the completion of HFEA (00)7.
b) The egg provider should also complete a SEPARATE HFEA(00)7 for the use of the donated eggs and the embryos created for use by the recipient couple. This second HFEA (00)7 should be completed as though the egg provider was an egg donor in accordance with HFEA guidance for the completion of HFEA(00)7.
This arrangement allows different conditions to be placed on the storage of any spare embryos that may be created and cryopreserved. Using only one HFEA(00)7 does not allowed consent to be varied in this way. It should be emphasised that, in accordance with the HFE Act 1990, the provider may withdraw or vary her consent up to the time an embryo containing her gametes is used in treatment services or research, including cryopreserved embryos.
Any implications that may result from the withdrawal of consent should be made clear to all parties prior to treatment commencing. This should be fully detailed in the information given to the egg provider and the egg recipient. It should also be included in the written agreements.
The male partner of the egg provider and of the egg recipient should complete HFEA (00)6 in accordance with HFEA guidance as necessary.
Counselling
The HFEA strongly recommends that all couples contemplating participation in an egg sharing arrangement receive implications counselling.
Independent counsellors should be aware of the medical processes involved as well as the particular legal and social issues relevant to egg sharing arrangements.
Counselling equivalent to that provided for gamete donors should be given to an egg provider and her partner.
Implications counselling must be offered to both egg providers and recipients and should cover the following issues:
- the implications of not knowing whether the other couple has succeeded or not;
- the implications for the provider remaining childless;
- the implications for the recipient of using a sub-fertile egg provider;
- the implications of there possibly being half-siblings of a similar age resulting from the treatment.
Suitability of treatment
Centres should ensure that the medical suitability of egg providers participating in egg sharing arrangements is fully assessed and care is taken in the selection of these patients. The treatment offered should be the most suitable to meet the medical needs of both the egg provider and the egg recipient.
Both the egg provider and the egg recipient should have access to an individual, such as a nurse, who would be available to provide impartial support throughout the egg sharing treatment cycle. The person providing support for the egg provider should be different from the person providing support for the egg recipient(s).
This should be in addition to the counselling provision.
Confidentiality
In anonymous egg sharing arrangements every care should be taken to ensure that this confidentiality is not compromised. To achieve this, centres should give special consideration to the physical and/or temporal separation of provider and recipient notes, facilities, procedures, and protocols.
Prospective Donors and People Seeking Storage of Gametes
Some aspects of the treatment of egg providers will be the same as other gamete donors. For example, they will need to undergo testing and screening in accordance with guidance for egg donors currently in the Code of Practice.
Egg providers and recipients should be made aware of the screening that will be undertaken before treatment is commenced.
Use of gametes and embryos
The limit of 10 live children resulting from the donation of gametes should be applied in the same way for egg providers as for other gamete donors.
Additional Points
Centres should note the HFEA Direction on Information Requirements. This Direction refers to the completion of the Donor information form (99) D.1.0 (previously (91)4) and applies equally to egg providers in egg sharing arrangements as to other donors.
There is space for the egg provider to supply a description of herself as a person.
The egg provider should be given the opportunity to complete this form and it should be brought to her attention. Space is provided for the inclusion of additional, non-identifying information that the egg provider thinks would be helpful to an adult later enquiring about his or her genetic origins, e.g. further information about the donor's interests, family background, childhood, region of origin etc. If additional space is required, a second sheet of paper should be used, duplicated for the centre's records and stapled to each copy of the form.
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ANNEX A
CHECKLIST OF DOCUMENTATION TO BE SUBMITTED TO THE HFEA WITH RENEWAL OR INTERIM APPLICATIONS BY CENTRES WISHING TO CARRY OUT EGG SHARING
ATTACH TO THE FRONT COVER OF SUBMITTED EGG SHARING DOCUMENTATION
CENTRE NUMBER ...................................................
PERSON RESPONSIBLE .................................................................
Tick if enclosed
- All patient information for the egg provider
- All patient information for the egg recipient
- A copy of a blank egg sharing agreement between the centre and the egg provider
- A copy of a blank egg sharing agreement between the centre and the egg recipient
- A copy of the egg sharing protocols the centre intends to use
These should explain how the centre will share the eggs and the possible procedures that may be followed if, for example, fewer eggs are collected than predicted or if consent is varied or withdrawn by either party.
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ANNEX B
Guidance for the Drafting of Agreements for Egg Sharing Arrangements
Within the general principles set out by the HFEA for egg sharing arrangements centres are required to draw up agreements between themselves and the egg providers and themselves and the egg recipients. The following is a guide to the kind of information that could be included in these agreements. Centres should ensure that the information contained in the agreement for the egg provider is consistent with that in the agreements of the egg recipient(s). Much of this guidance reflects the requirements of the current Code of Practice (Fourth Edition).
The information is not intended to be exhaustive, and centres should obtain their own legal advice on the content and legal consequences of their agreements.
Agreement between a licensed centre and the egg provider
The agreement between the centre and the egg provider should set out the terms of the arrangement in full. It should be signed by both and should include a series of statements including those outlined below.
The document should clearly identify the egg provider and the centre.
i) Treatment
A statement from the patient confirming that they have:
- had an opportunity to discuss the treatment procedures involved in providing her eggs as part of an egg sharing arrangement with a member of the centre's staff;
- received verbal and written information about the treatment provided;
- received all the required information listed in the relevant sections of the Human Fertilisation and Embryology Authority's (HFEA) Code of Practice. This information could be attached to the agreement; and
- been offered counselling about the implications of the treatment.
The nature of the treatment should be set out in full. This should include:
- the number of cycles of treatment involved;
- the date upon which treatment will commence; and
- full details of the egg sharing arrangement (more guidance on this is given later).
The nature and duration of the treatment covered by the agreement should be clear.
The patient and centre are encouraged to confirm that the treatment and payment for it will be carried out in accordance with the agreement and that both parties are bound by this agreement.
ii) Consent
A statement confirming:
- that consent of the patient for the treatment has been obtained;
- that two HFEA statutory consent forms 00(7) have been completed (see additional note on consent);
- that this agreement does not override the terms of paragraph 4 of schedule 3 of the HFE Act 1990. This means that the egg provider may withdraw or vary her consent in respect of any embryo created using her egg at any time until that embryo is used for treatment or research; and
- the consequences of any withdrawal of consent and the liability of the parties involved and any additional costs that may be incurred.
iii) Cost
A statement describing:
- what costs (if any) should be paid by the egg provider to the centre; and
- the circumstances that would result in the egg provider being liable for the total cost and the total sums they would have to pay (also see part iv)Egg sharing arrangements below).
iv) Egg sharing arrangements
The egg sharing agreement should make it clear that where there are fewer eggs collected than the minimum needed for sharing, the egg provider should be given the option of using all the eggs at no additional cost to her and with no further commitment.
The agreement should also cover full details of the egg sharing arrangements, including:
- the minimum number of eggs required for sharing;
- how these will be allocated;
- whether or not the egg provider will be liable to pay for any of the costs of the treatment. If the treatment is free, an appropriate caveat could be included if the egg provider becomes liable for payment if she varies her consent at any time before the embryos are used for treatment/or research.
v) General
A statement confirming that:
- any patient consenting to donate eggs under the HFE Act 1990 will not be the legal parent of any child(ren) resulting from the donation;
- in an anonymous egg sharing arrangement, neither the egg provider nor the egg recipient(s) will be made aware of the outcome of the other's treatment. No information will be available to either party that might identify the other or any resulting child(ren).
The agreement should be signed and dated by the egg provider and a representative of the centre.
Agreement between a licensed centre and the egg recipient
The agreement between the centre and the egg recipient should set out the terms of the arrangement in full. It should be signed by both and contain a series of statements including those outlined below.
The document should clearly identify the egg recipient and the centre.
i) Treatment
A statement from the patient confirming that they have:
- had an opportunity to discuss with a member of the centre's staff the treatment procedures involved in receiving eggs as part of an egg sharing arrangement;
- received verbal and written information about the treatment provided;
- received all the required information listed in the relevant sections of the Human Fertilisation and Embryology Authority's (HFEA) Code of Practice. This information could be attached to the agreement; and
- been offered counselling about the implications of the treatment.
The nature of the treatment of the egg recipient should be set out in full. This should include:
- the number of cycles of treatment involved;
- the date upon which treatment will commence;
- details of the egg sharing arrangement; and
- as part of the treatment of the egg recipient she will be provided with eggs from an egg provider donor.
The egg provider will also have undergone treatment procedures to obtain the eggs to be donated to the egg recipient. The nature and duration of the recipient's treatment and the egg-provider's treatment covered by the agreement should be clearly specified.
The patient and centre should confirm that the treatment and payment for it will be carried out in accordance with the agreement and that both parties are bound by this agreement.
ii) Consent
A statement that this agreement does not override the terms of paragraph 4 of schedule 3 of the HFE Act 1990. This means that the egg provider may withdraw or vary her consent in respect of any embryo created using her egg at any time until that embryo is used for treatment or research.
iii) Cost
A statement describing:
- what costs the egg recipient is liable for; and
- what treatment services these costs will cover. This may include all or part of the egg provider's treatment. This should be stated clearly in the agreement.
iv) Egg sharing arrangements
The full details of the egg sharing arrangements including:
- the minimum number of eggs required for sharing;
- how these will be allocated;
- whether or not the egg recipient will be liable to pay for any of the costs of the egg provider's treatment, including an appropriate caveat dealing with altered consent.
- the procedures, options and cost implications if one of the parties varies or withdraws their consent.
v) General
A statement confirming that:
- any patient that has given effective consent to donate eggs under the HFE Act 1990 will not be the legal parent of any child(ren) resulting from the donation.
- in an anonymous egg sharing arrangement, neither the egg provider nor the egg recipient(s) will be made aware of the outcome of the other's treatment. No information will be available to either party that might identify the other or any resulting child(ren).
The agreement should be signed and dated by the egg recipient and a representative of the centre.
Page last updated: 14 April 2009