CE(96)06

To: All Persons Responsible at licensed centres

Date: 5th July 1996

Dear Colleague

STATUTORY STORAGE PERIOD FOR EMBRYOS

On 15 April the Chairman wrote to all licensed clinics with guidance on the changes to the statutory storage period for embryos. During April and May the Executive followed up the written guidance with a series of regional meetings which were intended to resolve any queries that might arise. At the meetings a number of questions were raised that required more information and legal advice before a clear answer could be given. I attach some additional guidance to address these points. The guidance has been set out in a question and answer format and I hope that you will find it helpful.

Please contact Beatrice Heales or Carol Perkins at the HFEA on 0171 377 5077 if you have any queries or concerns about this guidance.

Yours sincerely

Mrs Flora Goldhill
Chief Executive

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STATUTORY STORAGE PERIOD FOR EMBRYOS

Issues for clarification

1. The regulations exclude from those cases in which the storage period may be extended any case in which it is intended that the embryos will be replaced in a woman who would be a surrogate mother. Why?

The provision was introduced by the Department of Health into the Regulations on the basis that before the statutory storage period can be extended a named-woman must be identified in whom it is intended the embryos may be placed, i.e. "the woman being treated".

The view was taken that surrogacy is always a complicated and difficult route to take and steps which might encourage its use would seem undesirable.  With this in mind it was decided that it should not be possible in association with the regulations to extend the statutory storage period of embryos.

2. What lengths do clinics have to go to track down the providers of gametes (whether patients or donors) used in embryos now in storage? What is the patient's responsibility?

Where individuals are not presently in contact with the clinic and cannot be found there is nothing which clinics are legally required to do.

However, as a matter of good practice, the HFEA has issued guidance that clinics should make "all reasonable efforts" to contact couples with embryos in storage. Further details are given in paragraph 21 of the guidance issued on 15 April 1996. As to donors whose gametes were used to create embryos currently in storage, advice is given in paragraphs 25-27 of the guidance.

The status of the guidance to clinics is equivalent to the Code of Practice. This means that clinics should comply with it unless there are particular and exceptional reasons why they should not do so in a particular case. A licence committee can have regard to the clinic's compliance with such guidance when considering the clinic's licence.

The approaches known to have been adopted by clinics have included use of registered letters, and contacting the couple's or donor's GP if known, having regard to issues of confidentiality.

The Authority itself has issued several press releases urging people to get in touch with their clinics, and it continues to look for opportunities to publicise the issue between now and 31 July.
 

3. Should not clinics have the consent of the couple concerned before they destroy their embryos?

This is not needed in law.  The relevant consent is not consent to destroy the embryos, but the consent to storage. Consent to storage is an indication from the relevant individuals that they allow the clinic to freeze and store embryos produced from their gametes. Clinics may store the embryos for as long as they hold these consents, and the consents are compatible. If a consent is -withdrawn, or it expires, the clinic may no longer continue lawfully to keep the embryos in storage. All consents given on or before 1 August 1991 -will expire on 31 July 1996. Clinics do not have any authority to continue to store such embryos unless they have obtained new consents on forms HFEA(96)6 and HFEA(96)7 and a doctor has completed form HFEA(96)8.

4. Where sperm used in stored embryos was provided by a sperm bank, is it the IVF clinic or the donor bank that should attempt (where appropriate) to contact the donor for extended consent?

While the Authority, and receiving clinics, recognise the difficulties that some donor banks might face in contacting a number of donors who had donated over five years ago, it may be unrealistic to suggest that anyone other than the donor bank could contact donors to seek their renewed consents. Only the donor bank will know the donor's circumstances at the time of the donation and will be able to make a proper judgement about whether to attempt to contact the donor again.

5. Could clinics be sued for destroying embryos where the 5-year storage period has expired and where the couple could not be contacted? Is legal action more likely if the clinic had made insufficient efforts to make contact?

Clinics may not lawfully keep embryos beyond the storage period if the individuals cannot be contacted and no renewed consent is obtained. This position arises because the Human Fertilisation and Embryology Act 1990 only permits the storage of embryos provided there is ongoing "effective consent".  This basic position has not been altered by the 1996 regulations.  While nobody can guarantee that a case will not be brought, it is difficult to see how it can succeed as clinics have no option but to comply with the law set out in the 1990 Act.

6. Will the HFEA prosecute clinics for refusing to dispose of embryos where the 5-year storage period has expired?

Clinics -would be acting illegally if they refused to dispose of embryos which had reached the expiry of their storage period, and it is the duty of the person responsible to ensure that the clinic complies with the law as well as with the conditions of licence, directions and the Code of Practice.
 
If a clinic refused to dispose of such embryos the Authority would have no choice but to refer the matter to the Director of Public Prosecutions. The DPP - not the HFEA -would decide in each case -whether a prosecution should be brought. In any event, the DPP can bring a prosecution without it having been referred by the HFEA.

7. If a couple decides before the end of the 5-year period that they do not need the embryos for their own further treatment, and they wish to donate them for the treatment of others or for research, can the storage period for those embryos be extended?

No.  The criteria for extending the storage period beyond five years refer in all cases to "the woman being treated".  The regulations define the "-woman being treated" as " the -woman in whom, at the relevant date, it is intended that such an embryo may be placed, whether or not she is one of the relevant persons ". The "relevant persons" are the per sons whose eggs and sperm were actually used; and the "relevant date " is the date on -which the embryos were first placed in storage (or 1 August 1991 if they were stored before that date).  Where the woman being treated remains the same the criteria for extended storage may apply.  Where, however, a couple decide during the storage of their embryos to donate them to another woman the criteria for extended storage cannot apply.  This is because another woman cannot come within the definition "woman being treated" as she was not the woman being treated when the embryos were first placed in storage.

As to research, there is no provision allowing storage to be extended in anticipation of embryos being used in licensed research.

8. If a couple extend their consent from five to ten years, and then after a further two years they decide that they no longer need the embryos for their own treatment, can the embryos continue to be stored for up to ten years for use in research or donation (with the necessary consents) or would the embryos have to be immediately allowed to perish once the couple no longer wished to keep them for their own use?

The embryos could remain in storage if, after the statutory storage period has been extended, the couple wished then to donate them to another couple or to research. This is because the woman being treated when the embryos were placed in storage was the person in whom it was intended to place the embryos at the time when the statutory storage period was extended. Once the storage period and the consents have been extended, the couple are subsequently able to vary their consents as they might during the first 5 years of storage and if they wish, donate the embryos for the treatment of others or for research.
 
However, centres should ensure that at the time the statutory storage period is extended, the intention is for the embryos to be used in the treatment of the original couple as explained at Question 7.

9. What kind of cases fall within the "defective gene" category?

Cases -where preimplantation genetic diagnosis might be used would clearly fall within this category. These are cases where IVF treatment and embryo storage are used to avoid passing on a serious inherited genetic disorder, but where the couple are otherwise fertile.  This category might also apply where donor oocytes are used to avoid passing on such a disorder. In such cases IVF and embryo freezing would be appropriate, yet there would be no impairment of fertility in the couple.

Where donor sperm is used to avoid passing on such a disorder this would ordinarily be done using donor insemination. If IVF is used it would normally be because the woman is suffering impaired fertility, and she would probably qualify for extended storage under the "significantly impaired fertility" criterion.

10. Can a clinic choose not to store for the full period for which consent has been given?

Yes. The consent, whether for five years, ten years or more, represents merely the permission given by the relevant individuals to the clinic allowing them to store the embryos. The exact terms of storage and the period which is agreed between the clinic and its patients is a different issue, separate from and one which is not affected by the consents, other than that the period agreed should not exceed the storage period given in the consents.

11. Can clinic staff exercise a conscientious objection to destroying embryos when their storage reaches the end of its five-year limit?

Yes. Section 38 of the Act states that "no person who has a conscientious objection to participating in any activity governed by this Act shall be under any duty, however arising, to do so." However, the person responsible retains the duty to ensure that the Act is complied with, even though one or more individuals in the clinic may exercise their right to state their conscientious objection to destroying embryos in these circumstances. Clinics should contact the Authority as soon as possible if they anticipate difficulty in complying with the Act because of conscientious objection being exercised by their staff.
 
12. If a couple made a legal challenge against a clinic where the clinic proposed to destroy "their" embryos because the donor of the sperm used could not be contacted, could the clinic continue to store the embryos pending the outcome of the case?

If, for example, a couple were storing embryos which were created using donor sperm, and the donor could not be contacted, the clinic would have to destroy the embryos at the end of the five year storage period. If the couple obtained an order from a court which ordered the clinic not to destroy the embryos pending the outcome of the court's review of the case, the clinic should comply with that court order in respect of those particular embryos.  The order could not, unless clearly specified, apply to any other embryos, so each case would have to be taken individually.

13. Where embryos were created and stored before August 1991 the transitional provisions allow for the assumption that the consent of the donor was given to the storage of sperm and embryos. This consent is limited by the Act to five years. Can we now assume that the donor had effectively consented for a longer period, or that he has consented to the use of the embryos in research?

No.  The transitional arrangements which applied at 1 August 1991 allowed for the storage of gametes and embryos provided before 1 August 1991 to continue as if relevant consents for the current storage were in place.  The provisions of the Act otherwise have effect in the same way as for gametes provided after 1 August 1991. This means that storage beyond Jive years can only be allowed with the specific informed consent of each individual, and that consent for any other use would also need to be specific, informed and written.

14. Where sperm for IVF treatment is supplied by a donor bank, the IVF clinic may not always know what consents have been given in terms of the use in IVF and the storage of embryos. Indeed it has been suggested that some donor banks do not always obtain the consent of donors to the use of sperm in IVF or to the storage of embryos, yet this sperm might be supplied to another clinic and subsequently used for IVF / embryo freezing.

For embryos currently in storage this will need to be considered on a case by case basis as and when the need to review the storage period, and to consider approaching the donor for consent to extended storage, arises. For the future, supplying banks should send with the samples details of what consents have been given by the donor. Sperm banks should always ensure that all relevant parts of the statutory consent form (HFEA(96)6) are completed, including consent to IVF, and to the use and storage of embryos. Clearly, sperm banks must not supply sperm for use in IVF unless the donor's specific consent has been obtained.

IVF clinics receiving donor sperm from another bank or clinic should ensure that they have been notified of the details of the donor's consents so that they can be sure that consent to the intended procedures is in place, and that the storage period consented to by the donor is not in conflict with the consent of the patient or other provider of gametes.

15. After 31 July 1996 clinics will regularly have embryos reaching the expiry of their storage period. Must clinics check every day for embryos where the period has expired, or could they at the end of each month thaw and allow to perish those embryos which have reached the expiry of their storage period during that month?

Clinics should have a clear -written procedure for regularly reviewing the status of embryos currently in storage.  This should include a procedure for identifying embryos reaching the end of their storage period. It would be reasonable for such a procedure to be carried out weekly though clinics should ensure:

a) that reasonable efforts have been made to inform couples in cases where contact has been lost;
b) that the relevant individuals have, where appropriate, been given the opportunity to consider extending the storage period; and
c) that embryos are not thawed and disposed of before the expiry of their storage period, even by a few days.