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• National Donation Strategy Group
• Multiple births after IVF
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  • Fees and regulation
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    • 7th Code of Practice
    • Standards for Assisted Conception Centres
    • Modernisation of regulation and the new fee strategy
    • Annual fees for licensed centres (EUTCD)
    • Research fees
    • Public attitudes to regulation
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Background

The European Union Tissue and Cells Directive (EUTCD) introduced regulatory requirements for all services involving donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells.

The aim of the EUTCD is to maintain a high level of health protection within the European community. Under the EUTCD, the HFEA’s regulatory remit was extended to cover services involving fresh gametes such as Intra Uterine Insemination (IUI) and Gamete Intra-Fallopian Transfer (GIFT) . As a result of these changes to the remit all centres which provided these services are required to apply for a licence from the HFEA.

Under the EUTCD the HFEA is 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
• Where necessary, inspect third party premises in relation to adverse events and reactions
• 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 EUTCD was implemented on 7 April 2007.

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Consultation process

In August 2006 the HFEA carried out a consultation on the annual and licence renewal fees for the centres which would be coming into the regulatory framework from April 2007.

The HFEA further consulted on the long term costs from ongoing licence and inspections.

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Consultation outcomes

The consultation concluded that there would be charged a licence application fee of £975 for those centres coming into the regulatory framework from April 2007.

The fee would be used to cover the costs of the application process, assessment of applications, and the issuing of licences prior to 7 April 2007.

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Further information

The HFEA, in collaboration with the professional bodies of the assisted conception sector, produced a set of Standards for Assisted Conception Centres, which included the requirements of the EU Tissues and Cells Directive.

The Standards for Assisted Conception Centreswas published alongside the 7th edition of the Code of Practice, which came into force on 5th July 2007.

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Supporting Documents

The HFEA produced the following guidance to ensure that clinics complied with the legal requirements set out in the EUTCD:

Links to be added shortly.

• A set of Standards for Assisted Conception Centres 
• Explanatory papers for IUI and GIFT establishments
• Guidance Note on Third Parties
• Guidance Note on Air Quality
• EU Tissues and Cells Directive (EUTCD)
• First Technical Directive (EUTCD)
• Second Technical Directive (EUTCD)
• Third Party Guidance Note 
• Air Quality Guidance Note 
• Consultation on application fees for licensing under the EU Tissues and Cells Directive
• Letter to centres for the Department of Heath
• EU Tissues and Cells Directive - Implementation dates
• Information for IUI and GIFT establishments
• Explanatory Paper for IUI and GIFT Establishments

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Page last updated: 11 January 2012

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