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29 September 2006

The Human Fertilisation and Embryology Authority (HFEA) is proposing an annual licence fee of £2950 that previously unlicensed insemination clinics will be required to pay under the European Union Tissues and Cells Directive (EUTD).

The remit of the HFEA has been extended by the EUTD to include that 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, eggs which are not already licensed by the HFEA must do so by 7 April 2007, these include:

• Hospital obstetrics departments IUI services;
• GPs offering insemination services;
• Private clinics offering services such as sperm sorting

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 7 week consultation, which ends on 17 November 2006, sets out a proposal for the ongoing regulation and inspection of clinics providing IUI, GIFT, internet procurement companies and centres providing sperm sorting service.  The consultation also covers the renewal application fees and third party agreement fees that involve licensable activities, such as sperm preparation processes or transport IVF arrangements.

The services and benefits that will be offered to clinics include:

• access to guidance and advice from a named contact of HFEA staff
• inspection of centres, including a site visit, at least once every two years
• investigation of adverse events and reactions including inclusion in the HFEA incident alert system
• a register of incidents to be submitted annually to the European Commission
• provision of HFEA communications including regular updates.

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 know that regulation provides IVF patients with confidence in the quality of service they are receiving. We will help ensure confidence to a much fuller range of fertility patients by bringing the safeguards of regulation to this area.

"We also want as many clinics as possible to feed back to the consultation so that we are fair and realistic with the regulation fees.  It is important that we get the balance right between costs for clinics and safeguarding public, patient and professional interests."

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

For more information on EUTD and how it regulation of fertility treatment  see the policy section on the website.

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.

For further information please contact the HFEA press office.

Page last updated: 11 March 2009

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