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15 April 1996

Dear Director

STATUTORY STORAGE PERIOD FOR EMBRYOS

As you know, the Secretary of State for Health has made regulations under section 14(4) of the Human Fertilisation and Embryology Act 1990 extending the statutory storage period for embryos in certain circumstances. The regulations were laid before Parliament in February and copies of the regulations have already been sent to all licensed centres.

The regulations will come into force on 1 May 1996 and will allow the statutory storage period for embryos to be increased to ten years in most cases. In exceptional cases, embryos may be stored for more than ten years.

I attach a package of guidance for all licensed centres on changes to the statutory storage period. The package contains:

• "Guidance for Centres on the Changes to the Statutory Storage Period for Embryos";
• copies of new consent forms HFEA(96)6 and HFEA(96)7 and a new form HFEA(96)8;
• Directions revoking the current consent forms and bringing the new forms into force on 1 May 1996;
• guidance notes for the new forms;
• copies of two information leaflets on consent and storage.

The "Guidance for Centres on the Changes to the Statutory Storage Period for Embryos" will be incorporated into the Code of Practice when it is next revised. The new consent forms HFEA(96)6 and HFEA(96)7, together with the guidance notes on completing them, and the Directions bringing them into force are intended to be inserted into the Manual for Centres. Centres should ensure that the guidance notes for completing current forms HFEA(91)6 and HFEA(91)7 are removed from the Manual.

In addition to the attached guidance, you should already be aware of a number of meetings that have been arranged around the country which are intended to give centres an opportunity to raise any questions that you may have about the changes to the statutory storage period.

The new forms are in the process of being printed and will be issued to clinics before 1 May 1996.

Yours faithfully

Mrs Ruth Deech
Chairman

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HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY

GUIDANCE FOR CENTRES ON THE CHANGES TO THE STATUTORY STORAGE PERIOD FOR EMBRYOS

Summary

Parliament has passed regulations to extend the current statutory period for embryos in certain circumstances. These take effect from 1 May 1996. The normal maximum statutory storage period for embryos remains 5 years.

There are 3 principal circumstances in which the maximum storage period for embryos may be extended beyond 5 years. These are as follows:

• where the woman being treated or her partner, if he provided the sperm, has, or is likely to develop, "significantly impaired" fertility; or
• where the woman being treated or her partner, if he provided the sperm, carries a significant gene defect; or
• where the woman being treated or her partner, if he provided the sperm, is, or is likely, to become "prematurely and completely" infertile.

In addition, the following conditions must be satisfied:

• the people whose eggs and sperm have been used to produce the embryos have confirmed in writing that they have no objection to the embryos being stored for more than the normal maximum storage period of 5 years; and
• the embryos are stored for the purpose of providing treatment.

However, the five year storage period may not be extended in any case where:

• the woman to be treated using the embryos is aged 50 or over when storage begins; or
• the proposed treatment involves a surrogacy arrangement.

Contents

This guidance falls into 2 parts:

1. Information about the regulations and revised consent forms which take effect from 1 May 1996.
Implementing the regulations.
2. Please contact Beatrice Heales or Carol Perkins at the HFEA on 0171 377 5077 if you have any questions about this guidance.

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PART 1: INFORMATION ABOUT THE REGULATIONS AND REVISED CONSENT FORMS

Introduction

1. The Human Fertilisation and Embryology Act (the Act) specifies that the normal maximum statutory storage period of 5 years may be extended in certain specified circumstances. New regulations, which take effect from 1 May 1996, set out these circumstances. These are:

• where the woman being treated or her partner, if he provided the sperm, as, or is likely to develop, "significantly impaired" fertility; or
• where the woman being treated or her partner, if he provided the sperm, carries a significant gene defect; or
• where the woman being treated or her partner, if he provided the sperm, is, or is likely to become, "prematurely and completely" infertile.

In addition, the following conditions must be satisfied:

• the people whose eggs and sperm have been used to produce the embryos have confirmed in writing that they have no objection to the embryos being stored for more than the normal maximum storage period of 5 years; and
• the embryos are stored for the purpose of providing treatment.

2. However, the maximum storage period may not be extended in any case where:

• the woman to be treated using the embryos is aged 50 or over when storage begins (up to the normal maximum storage period of 5 years applies in these cases); or
• the proposed treatment involves a surrogacy arrangement.

Assessment

3. Where couples wish to have embryos stored for longer than the normal 5 years, centres must arrange for each case to be assessed to determine whether the circumstances for extended storage have been met. This assessment is a legal requirement.

Significantly impaired fertility

4. The maximum statutory storage period allowed is 10 years if a woman being treated or her partner, if he provided the sperm, has, or is likely to develop, significantly impaired fertility. This clinical judgement should be provided in writing by a registered medical practitioner who is familiar with the woman and her treatment or her partner, their condition and their medical history.

Significant gene defect

5. The maximum statutory period allowed is 10 years if a woman being treated or her partner, if he provided the sperm, carries a gene defect such that a child born with that gene might suffer severe disability. This clinical judgement should be provided in writing by a registered medical practitioner who is familiar with the woman and her treatment or her partner, their condition and their medical history.

Premature and complete infertility

6. The maximum statutory storage period can be more than 10 years if a woman being treated or her partner, if he provided the sperm, is, or is likely to become, prematurely and completely infertile. This clinical judgement should be provided in writing by two registered medical practitioners who are familiar with the woman and her treatment or her partner, their condition and their medical history. Unless there are exceptional circumstances, one of the registered medical practitioners should practise independently of the centre.

7. Storage beyond 10 years should be considered only exceptionally. For example, the period might be extended beyond 10 years for a young woman undergoing cancer treatment which might make her completely infertile. The actual storage period in these cases is determined by the date the woman being treated becomes 55.

Example 1: A woman who is 24 at the start of the storage period would be allowed to store the embryos until she was 55, a maximum storage period of 31 years.

Example 2: A woman who is 36 at the start of the storage period would be allowed to store the embryos until she was 55, a maximum storage period of 19 years.

Form HFEA(96)8

8. As a result of the introduction of the new regulations, the HFEA has produced a new form, form HFEA(96)8, which must be completed by the registered general practitioner(s) providing the opinion(s) about significantly impaired fertility, significant gene defect and premature and complete infertility. Form HFEA(96)8 must be completed in every case in which embryos are to remain in storage for longer than the normal maximum storage period of 5 years.

9. A copy of form HFEA(96)8 is attached, together with guidance on how to complete it. The forms will be issued to centres in the same way as consent forms. The HFEA will be sending centres the first batch of forms towards the end of April. Further copies may be obtained from the HFEA in the usual way.

10. Centres should inform patients that the new regulations relate to storage only. The guidance in Part 3 of the Code of Practice on assessing patients for treatment is not affected. Therefore, when couples wish to use embryos that they have in storage for their own treatment, centres must take account of the welfare of the potential child and any existing children, in addition to the clinical review that will need to take place before treatment is offered. This applies to treatment offered at any point, whether the storage period is 5 years, 10 years or longer.

Consent

11. The regulations require that people providing gametes, including donors, must have given written confirmation that they have no objection to embryos produced from their gametes being stored for longer than the normal maximum storage period of 5 years. This must be obtained in addition to the normal consent required under Schedule 3 to the Act. The HFEA consent forms have therefore been revised to give people providing gametes the opportunity to say how long they would be willing for embryos produced from the gametes to be stored.

12. People who currently have embryos in storage and who wish to extend the storage period beyond 5 years must also complete the revised consent forms before the storage period can be extended.

NOTE: Embryos must never be stored beyond the normal maximum statutory storage period of 5 years unless the persons who provided the gametes, including donors, have given consent to a longer storage period. Embryos must never be stored beyond the maximum storage period specified by these persons.

13. Copies of the revised consent forms HFEA(96)6 and HFEA(96)7 are attached and the current versions, HFEA(91)6 and 7, should be destroyed after 30 April 1996.

Information

14. Information on the following points should be given to people seeking to store embryos for more than the normal maximum storage period of 5 years:

a) the normal maximum storage period for embryos is 5 years;
b) the option to extend the storage period beyond 5 years is available only if certain specific conditions are met;
c) the circumstances in which storage may be extended up to 10 years;
d) storage beyond 10 years is exceptional. It is allowed in certain special categories of patient, such as a young woman undergoing cancer treatment which might make her completely infertile;
e) couples who have embryos in storage must be re-assessed before treatment with the stored embryos can be offered;
f) the possible side effects and risks of treatment using embryos stored for an extended period;
g) embryo storage cannot continue indefinitely;
h) what will happen to the embryos at the end of the storage period if they have not been used by the couple for their own treatment. Embryos in storage at the end of the storage period will have to be allowed to perish if they have not been used;
i) consent to storage and use can be varied or withdrawn at any time before the embryos are used or before the end of the storage period;
j) where donor gametes are to be used to produce the embryos in storage, the donor has to have given consent which allows for storage beyond the normal maximum storage period of 5 years. Donors can also change their consent at any time before the embryos are used, including withdrawing the consent to the use of the embryos, in which case the couple could not have treatment using the embryos;
k) for embryos created from donor gametes and placed in storage before 1 May 1996, storage beyond the normal statutory maximum of 5 years is not allowed unless the donor's written confirmation that they have no objection to extended storage has been obtained.

Counselling

15. People consenting to the storage of embryos beyond the normal maximum storage period of 5 years must be given be given "a suitable opportunity to receive proper counselling about the implications of taking the proposed steps". In addition to the guidance on counselling given in part 6 of the Code of Practice, counsellors should invite people to consider the following issues:

a) the possibility that treatment may not be offered even if extended storage has been allowed;
b) unless embryos in storage are used before the end of the agreed storage period or donated for research, they will have to be allowed to perish at the end of the storage period;
c) where donated gametes are used to create the embryos in storage, the possibility that a donor may vary or withdraw their consent to the use or storage of those embryos;
d) how and when they will reach decisions about what is to happen to their embryos if they are not to be used in their own treatment.

Storage Review

16. Centres should draw up protocols for carrying out a review of the storage position with couples who have embryos in storage for more than the normal storage period of 5 years. The review should take place in the 7th and 9th year of storage. Amongst the issues to be covered, centres should invite couples to consider:

a) whether the reasons for continuing to store the embryos have changed;
b) whether they wish to vary their consents;
c) whether they wish to have counselling to help them reach decisions about what should happen to the embryos.

17. Centres may carry out storage reviews by post or by inviting the couples to visit the centre. If storage reviews are carried out by post, centres should ensure that appropriate steps are taken to ensure that new HFEA consent forms are completed by the couple if they wish to vary their consents, and that counselling is offered as appropriate.

Embryos in Storage

18. Centres will be required to provide figures for the number of embryos in storage for more than 10 years with each licence renewal application.

Centres should develop clear written procedures for dealing with the new storage regulations coming into force on 1 May 1996.

PART 2: IMPLEMENTING THE NEW REGULATIONS

19. In implementing the regulations from 1 May 1996, centres will need to take account of when couples placed embryos in storage. There are 3 categories:

I. couples who placed embryos in storage before 1 August 1991;
II. couples who placed embryos in storage between 1 August 1991 and 30 April 1996;
III. couples who place embryos in storage from 1 May 1996.

I. Couples Who Placed Embryos in Storage Before 1 August 1991

20. For couples in this category, centres will need to establish in each case whether they wish to extend the storage period beyond 5 years. Centres should ensure that the requirements for extended storage have been met in all relevant cases by 31 July 1996. Centres will also need to establish whether any donor gametes were used to create embryos that couples in this category have in storage. If donor gametes were used, centres will require the consent of the donor to storage of more than five years.

21. Centres should make all reasonable efforts to contact couples. This should include writing to the last known address, telephoning and contacting the couple's general practitioner or any other third party who may be able to help. In doing so, centres will need to ensure that they do not disclose that treatment had taken place so as not to break the law regarding confidentiality. Centres should keep a full record of the attempts made to contact each couple. If centres are unable to contact any couple whose embryos they have in storage then those embryos will have to allowed to perish after 31 July 1996.

Assessment

22. Once it has been established that a couple wish to extend the storage period for their embryos, centres will need to determine whether the couple satisfy the relevant conditions. If the conditions for storage of more than five years are satisfied, centres should arrange for form HFEA(96)8 to be completed by 31 July 1996 if embryos are to remain in storage beyond that date.

Consent

23. Where extended storage is appropriate, the people who provided the gametes which produced the embryos in storage will need to complete the new consent forms HFEA(96)6 and HFEA(96)7 stating that they wish to have the embryos stored for more than the normal maximum storage period of 5 years.

24. If couples have embryos in storage created from donor sperm or eggs or both, the donor(s) must have given renewed consent for the embryos to remain in storage after 31 July 1996. If the donor(s) cannot be contacted or will not give consent to storage of more than 5 years, the embryos created from their gametes must be allowed to perish after 31 July 1996.

25. Where donor gametes have been used, centres should provide couples with a realistic appraisal of the chances of contact being made with the donor again.

26. Centres should attempt to contact donors where it is reasonable to do so. Centres should consider carefully the interests of both the couple and the donor before attempting to contact a donor. Centres should approach each case on an individual basis and take appropriate advice if they consider it necessary. Centres should keep a full record of the reasons for the decision and any action taken in each case.

27. Centres should bear in mind that it is a criminal offence to disclose a donor's identity to a third party without the donor's consent. Centres should ensure that they do not disclose inadvertently that a person has been a donor and it may be appropriate in certain circumstances to try to contact a donor through an intermediary, such as a solicitor, without disclosing the name of the centre or the nature of the enquiry.

28. The new consent forms must be completed by the people who provided the gametes, whether they be patients or donors, by 31 July 1996. If, for any reason, new consents cannot be obtained from one or both of the persons who provided the gametes which produced the embryos, the embryos cannot remain in storage and must be allowed to perish. This is a matter of law and centres must comply with the law. Any storage of embryos without effective consent is a breach of the Act.

29. Centres should keep a record of the number of couples who cannot be contacted and whose embryos are left to perish after 31 July 1996. Centres should also keep a record of the number of embryos which are allowed to perish. Centres should be able to provide this information to the HFEA on request.

Counselling

30. Counselling should be offered to all couples whose embryos are approaching the end of the storage period.

Storage review

31. Centres should inform all couples whose embryos will be stored for more than five years of the storage reviews that should be carried out in the 7th and 9th years of storage. Centres should ensure that all couples are aware of the importance of remaining in contact with the centre and of informing the centre of any changes of address.

II. Couples Who Placed Embryos in Storage Between 1 August 1991 and 30 April 1996

32. For couples in this category who wish to extend the storage period beyond 5 years, centres should ensure that all the requirements for extended storage have been met no later than 5 years after the start of the storage period. In all other respects, centres should also follow the guidance given in paragraphs 20 to 31 above.

33. Centres should identify couples who might wish to extend the storage period for their embryos beyond the normal maximum of 5 years well in advance so that they have sufficient time to consider the issues involved and come to the decision that is right for them. Centres should bear in mind that the risk of losing contact with a couple increases over time and that the process of contacting couples, irrespective of when storage started, should not be delayed.

III. Couples Who Wish to Place Embryos in Storage from 1 May 1996

34. People, including donors, who provide gametes to produce embryos which may be placed in storage from 1 May 1996 must complete the new consent forms HFEA(96)6 and HFEA(96)7, showing the period for which the embryos may be stored. Centres should first explain the different storage periods that can apply and allow the people providing the gametes time to consider the options available before they complete a consent form.

35. If donor gametes are to be used in treatment, centres should check that the storage period to which the donor has consented corresponds with the needs of the couple who may place embryos in storage. This is particularly important in the exceptional cases in which storage may be required for more than 10 years.

36. People, including donors, can opt for a different period of storage at any time before the embryos produced from their gametes are used. If they wish to change the storage period, they should complete a new consent form HFEA(96)6 or HFEA(96)7 showing the new storage period.

37. Centres must arrange for form HFEA(96)8 to be completed for each couple for whom they are considering storing embryos for longer than the normal 5 year maximum storage period. This must be done before the couple are asked to complete consent forms HFEA(96)6 and HFEA(96)7. Centres should not accept a consent form for storage for longer than 5 years from couples unless form HFEA(96)8 has previously been completed, by 1 or 2 registered medical practitioner(s), according to how long the storage period is to be extended.

Note: It is illegal to store embryos beyond the normal maximum storage period of 5 years unless form HFEA(96)8 and consent forms HFEA(96)6 and HFEA(96)7 have been completed.

Disposal of Embryos

38. Embryos should be allowed to perish at the end of the normal statutory storage period of 5 years if:

• either or both the people who provided the gametes, including the donor if donor gametes were used, have not completed a consent form HFEA(96)6 and/or HFEA(96)7 extending the storage before period; or
• completion of form HFEA(96)8 cannot be obtained; or
• the woman who would be treated with those is already aged 55; or
• the woman who would be treated with those embryos would be a surrogate mother.

39. Centres should be prepared to deal with requests from couples for information about the circumstances in which any embryos were allowed to perish and how this took place. The procedure should be sensitively devised and recorded. Couples should have an opportunity to discuss this with centres and counselling should be offered to any couple whose embryos were allowed to perish. Centres should be ready to take account of the particular needs of any couple whom they could not contact but who subsequently returned to the centre and whose embryos were allowed to perish in accordance with the legislation.

Page last updated: 17 August 2012

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