04 June 2001
Dear Colleague,
STORAGE OF GAMETES
Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991
Licensed, clinics need to have in place systems to ensure that they meet the requirements of the Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991 in relation to gametes in storage since 1st August 1991 or before. By the 31st July 2001 each centre must identify gametes as they reach their respective end of storage dates and ensure disposal of the gametes by that date. In effect this will only apply to samples of cryopreserved sperm as the storage of eggs has only been licensed by the HFEA since 2000.
The HFEA has discussed the end of this first 10 year statutory storage period for gametes with many centres and has consulted with professional organisations. It has obtained legal advice to establish how different categories of men will be affected and to help centre staff identify how sperm samples stored in their centres may be affected.
STATUTORY STORAGE PERIOD FOR SPERM (GENERAL)
- All sperm put in storage can be stored for the statutory storage period (10 years) unless the man providing the sperm has specified a shorter storage period on his consent form. The age of the man and the reason for storage i.e. own use or for donation does not alter the 10 year permitted storage period in the first instance.
SPERM THAT CANNOT BE STORED BEYOND 10 YEARS
- All DONATED sperm will need to be disposed of once it has been in storage for 10 years. There are no exceptions to this position.
- All sperm that is in storage for OWN USE by men who do not fulfil the criteria for extension must be disposed of once it has been in storage for 10 years.
SPERM ELIGIBLE FOR EXTENDED STORAGE
Samples stored on or after 1 August 1991
- Men who meet the criteria in the Regulations (see enclosed copy of the Regulations) can have their sperm stored for more than the 10 year period.
- This extension can apply without the need to obtain further written consent as long as the gamete provider consented to the maximum storage period in the first instance. The consent should be documented on a statutory HFEA consent form ((91) 61(96) 6/(00) 6) and the requirements of the Regulations met. Sperm can remain in storage for more than the 10 years, up to the amount of time specified in the Regulations.
Samples stored before 1 August 1991
- Sperm put into storage before 1 August 1991, for which there was no written consent, was permitted to remain in storage for an additional 10 years commencing 1 August 1991 (in accordance with the Transitional Provisions Orders 1991). But this sperm cannot be used in treatment services without written consent from the gamete provider.
- The storage period may be extended in line with the 1991 Regulations provided the requisite criteria are met. If an appropriate medical opinion can be obtained and the man who stored the sperm has not reached his 55th birthday, sperm put in storage for own use prior to 1991 can also have the benefit of extended storage. The extended period would be set to end on the man's 55th birthday.
- If the man who provided the sperm is not in contact with the centre (if he were, written consent to storage would have been obtained for the sample) the written medical opinion would need to be based on clinical case notes relating to the gamete provider. If these notes stated that the gamete provider was storing sperm in advance of chemotherapy treatment, for example, it would be reasonable for a medical practitioner to assume that the gamete provider's fertility has or is likely to have been impaired since providing the gametes. If this were the case sperm that had been put in
storage by someone who was under 45 in 1991 for his own use could remain in storage until his 55th birthday.
EXTENDED STORAGE OF POSTHUMOUS SAMPLES
- Where the man who provided the sperm was already eligible for extended storage of sperm beyond 10 years before he died, the sperm can continue to be stored after his death for the amount of time specified by Regulations. This is, of course, provided the man had consented to the storage and use of his sperm in the event of death or mental incapacity. Any posthumous use of this sperm would need to comply with the provisions given in the Regulations. It may be that a medical opinion would need to be obtained after death, but this would have to be based on medical evidence that would suggest the gamete provider might have suffered impaired fertility e.g. from chemotherapy treatment prior to death.
- If, however, the man who provided the sperm was not eligible for extended storage before his death the storage period for the sperm cannot be extended. The sperm can, however, stay in storage for the initial 10-year statutory storage period provided the man has consented to the storage and use of his sperm in the event of death or mental incapacity.
To try and assist centres' interpretation of the implications an Appendix has been attached illustrating some potential scenarios and addressing some frequently asked questions on this subject. If you have any further queries relating to the contents of this letter please contact your centre's inspector co-ordinator or a member of the policy team at the HFEA. You may also wish to obtain your own legal advice.
Yours sincerely,
Ruth Deech
Chairman
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APPENDIX
Potential Case Examples
1) If a man aged 35 stores sperm he can give consent for a number of years' storage up to the statutory storage limit of 10 years. If he becomes eligible for extended storage within that 10 years he may wish to extend the storage period beyond 10 years in accordance with the Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991.
2) If a man aged 60 stores sperm he too can give consent for a number of years' storage up to the statutory storage limit of 10 years. As this man was aged over 45 when he put the sperm in storage he would not be eligible for extended storage.
3) All DONATED sperm can be kept in storage for 10 years, provided the donor has not specified a shorter period of time on his consent form. However, all stocks of sperm must be used or removed from storage once the sperm has been in storage for 10 years. This includes all sibling stocks held in storage.
If fall siblings from a particular donor's sperm were desired but the sperm had come to the end of its statutory storage period it may be possible to create embryos with the remaining stocks of donor sperm. These could then be stored for 5 years and in some cases longer. The terms of the donor's consent would need to be examined to ensure that he had given permission for embryo creation using his sperm and storage of those embryos. If consent for embryo creation and storage has not been given by the donor, embryos cannot be created and stored under any circumstances.
4) A 35 year old man puts sperm in storage prior to chemotherapy treatment for cancer. He consents to 10 years' storage on form HFEA (00) 6. Provided a written medical opinion is obtained that confirms that the chemotherapy has or is likely to significantly impair the fertility of the man in question the sperm can remain in storage for 20 years i.e. until his 55th birthday. With regard to consent, 20 years can be substituted for the 10 on HFEA (00) 6 in accordance with the Regulations.
5) A man aged 28 who put sperm in storage in 1988 would not have been required to provide written consent to its storage. When the HFE Act was passed in 1990 this sperm was allowed to remain in storage in accordance with the Transitional Provisions Orders 1991. This allowed sperm to be stored without written consent in accordance with the HFE Act. The centre holding this man's sperm has unable to contact him to obtain his written consent in the intervening 10 years.
In this example, the man was under 45 in 1991 and could therefore be eligible for extended storage of his sperm if the centre holding the sperm could satisfy itself from the man's medical notes that his fertility is likely to be significantly impaired since putting the sperm in storage. In addition, a medical practitioner would need to be willing to give a written opinion to that effect. If these requirements could be met the man's sperm could remain in storage for a farther 14 years, until the man's 55th birthday, although it could not be used for any purpose without the man's written consent.
This means that sperm stored pre-Act by young men in anticipation of treatments that could be damaging to their fertility, such as chemotherapy or radiotherapy, could remain in storage despite there being no written consent in place.
Sperm samples put in storage pre-Act by men who will have already reached their 55th birthday by 31st July 2001 will have to be disposed of on that date.
6) So if in the above example 5) the man had been 45 in 1988 when he stored his sperm he would not be eligible to extend the storage period beyond the statutory 10 years as he would have been over 45 in 1991.
Page last updated: 14 April 2009