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.?

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