15 September 2006
Import and export of gametes and embryos: future arrangements and transitional period
I am writing to inform you of the publication of the import / export HFEA policy guidance notes enclosed with this letter.
Over recent months there has been a great deal of policy change as the UK moves towards compliance with the EU Tissue and Cells Directive (EUTCD) from 7 April 2007.
The purpose of the standards in the Directive and the guidance is to ensure that patients receiving donations from outside the UK receive the same level of protection as those receiving treatment with donations from UK donors and that donors themselves are treated according to the same ethical principles. Clinics should be clear that the Directive regards unpaid donation as a factor which contributes directly to the protection of human health.
We recognise that following these changes some clinics and patients have been unsure of the arrangements required for the import of gametes. We are also very aware of the current shortage of sperm in the UK, which a number of clinics are beginning to address through improved recruitment from UK donors.
Because of these circumstances, the Authority has issued new guidance to reinforce the criteria outlined in the SEED report and required for the implementation of the EUTCD.
Arrangements for imports up until 23 February 2007
The Authority has agreed a transitional period which takes into account the need to give clinics the time needed to respond to the new guidance and the current UK shortage of sperm. Licence committees will take into account these factors when considering import applications for named patients during the transitional period.
The transitional arrangements are also designed to ensure that patients currently undergoing treatment are not prejudiced in the move to comply with the EUTCD.
There is a responsibility on Persons Responsible in each clinic during the transitional period to prepare for their obligation to meet the criteria from 7 April 2007, to be clear about how they will obtain gametes for treatment and be clear about this to their patients, and how this will impact on their ability to deliver treatment.
Centres may therefore continue to submit applications for named individuals under the transitional arrangements. The final date for applications to be received by the HFEA under the transitional arrangements is Friday 23 February 2007. Applications for imports for individual patients currently with the HFEA will be processed under the transitional arrangements as quickly as possible. Shortage of donor sperm in the UK will not of itself constitute an exceptional circumstance for departing from the guidance after 7 April 2007.
All new bulk applications must comply with the criteria from today onwards – the transitional arrangements do not apply for bulk applications.
Arrangements for applications submitted after 23 February 2007
All applications submitted after 23 February 2007 must comply with the HFEA guidance note ‘Applications to import gametes and embryos from abroad' (September 06).
Information that clinics should provide to patients
We expect clinics to give patients a clear understanding of the issues around the availability of gametes and the import criteria before commencing any new treatment. Criteria on the provision of information to patients are included in the guidance.
This guidance does not represent any change to HFEA policy. It reinforces current policy and sets out the criteria by which applications for Special Directions for import of gametes or embryos and the export of embryos will be assessed.
I also enclose, for completeness, the application forms included in my letter (CE (06)03) of 27 July 2006. The guidance and the forms are available in the ‘For Clinic Staff' section of the HFEA website: www.hfea.gov.uk
If you have any questions about this please do not hesitate to contact your inspector.
- Policy Guidance note - Application to import donated gametes and embryos from abroad (31 KB)
- Information for licensed centre staff regarding the 'transitional period' for importing sperm (32 KB)
- Policy Guidance note - Export Gametes and Embryos (48 KB)
- Application form for a Special Direction authorising the export of embryos (41 KB)
- Application form for a Special Direction authorising the import of gametes and/or embryos (52 KB)
Page last updated: 24 August 2012