02 December 2013
Dear Colleague
Storage and use of ovarian and testicular tissue
The Authority has been working with the Human Tissue Authority (HTA) to reduce the regulatory overlap regarding the storage of ovarian and testicular tissue, and ensure appropriate regulation according to the intended use of the tissue.
Following this work we have reinterpreted the requirements of the Act. As a result ovarian or testicular tissue which is intended for transplantation, can be now be stored solely under the auspices of an HTA licence. An HFEA licence is no longer needed.
HFEA-licensed clinics currently storing ovarian or testicular tissue can continue to do so without an HTA licence until the tissue is to be used. At time of use, if a patient’s own tissue is to be transplanted (autologous transplant) it must then be transferred to an HTA-licensed facility for processing and/or distribution to the transplant facility. Details of HTA-licensed facilities can be found on the HTA website.
An HTA licence is not needed to store ovarian or testicular tissue intended for fertility treatment (eg, in vitro maturation of gametes). HFEA centres licensed to store gametes can store, process and use ovarian or testicular tissue to extract gametes for patients’ own use in licensed fertility treatment, subject to the same conditions that apply to the use of sperm and eggs.
Further information on these and other scenarios is outlined in the attached joint HFEA/HTA policy statement and flow diagram. If you have any questions, please contact your HFEA Inspector or enquiries@hta.gov.uk for HTA-related enquiries.
Yours sincerely
Professor Lisa Jardine CBE
Chair, Human Fertilisation and Embryology Authority
Page last updated: 04 December 2013