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27 July 2006

The Human Fertilisation and Embryology Authority (HFEA) is proposing an application fee of £975 for licensing insemination clinics under the European Union Tissues and Cells Directive (EUTD).

The remit of the HFEA has been extended by the EUTD to include the regulation of services involving fresh gametes (eggs and sperm), such as intra-uterine insemination (IUI) and gamete intra-fallopian transfer (GIFT).

All clinics providing IUI, GIFT or other uses of sperm and eggs which are not already licensed by the HFEA must do so by 7 April 2007.  It will be illegal for any clinic to carry on performing a licensable service without a licence from the HFEA after this date.

The scope of the three month consultation, which ends on the 13 October 2006, covers the application fee that clinics will be required to pay in order to obtain their initial licence.  The fee will cover: the assessment process for licence applications; provision of support and workshops to these services prior to licensing; and issuing of licenses to ensure all relevant services may continue to practice legally from 7 April 2007.  There will be a further consultation later in the year to discuss the ongoing licence and inspection costs after April 2007.

Angela McNab, Chief Executive of the HFEA said:

"It is really important that all clinics that provide IUI, GIFT or other services, which use sperm or eggs, have an HFEA licence by 7 April 2007.   We have been working with this sector for two years now and selected IUI clinics are currently piloting the inspection process in order to minimise regulatory burden on clinics.

"We also want as many clinics as possible to feed back to the consultation so that we are fair and realistic with the application fee.  It is important that we get the balance right between costs and supporting clinics with the process of licensing."

So far, 58 NHS Hospitals and 46 private clinics have contacted the HFEA but we believe that there may be more clinics that will need a licence.

Those clinics that haven't already contacted the HFEA to apply for a licence should do so immediately. Contact the HFEA Regulation department for further information on 020 7291 8200 or www.hfea.gov.uk

Ends

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Notes to editors

The European Union Tissue and Cells Directive (EUTD) covers all activities involved with procurement, donation, testing, processing, storage, preservation and distribution of tissue and cells, including gametes and embryos.

Under the EUTD, the HFEA will be required to:

• Inspect and licence services involving fresh gametes, such as IUI services at least once every two years
• Investigate serious adverse events and reactions in relation to these services
• Inspect third party premises in relation to adverse events and reactions, where necessary
• Provide appropriate guidance and advice to services seeking a licence
• Maintain a publicly available register of licensed services
• Maintain a register of incidents to be submitted annually to the European Commission

The HFEA is the independent regulator for IVF treatment and embryo research. Our role is to protect patients and the public interest, to drive improvement in the treatment and research sectors and to provide information to the public and policymakers about treatment and research.

The HFEA was set up in August 1991 as part of the Human Fertilisation and Embryology Act 1990. The HFEA's principal tasks are to license and monitor clinics that carry out in vitro fertilisation (IVF), donor insemination (DI) and human embryo research. The HFEA also regulates the storage of gametes (eggs and sperm) and embryos.

Page last updated: 11 March 2009

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