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20 July 2006

Dear Colleague,                                                                                   

HFEA consultation on application fees for licensing under the European Tissue and Cells Directive

The European Tissue and Cells Directive (EUTD) introduces new regulatory requirements for all services involved in donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. The implementation date for the Directive in the UK is 7 April 2007.

The Directive extends the remit of the HFEA to include regulation of services involving fresh gametes, such as IUI and GIFT. The HFEA has already made contact with all establishments known to be affected, and regular information has been provided through the HFEA's EUTD Newsletter.

All previously unlicensed services will have to apply for a licence from the HFEA. Application forms and detailed instructions around the licensing process will be issued later in the year. There will be an application fee charged to cover the licensing process up to April 2007. 

The enclosed consultation document sets out a proposal for the application fee, which has been set to cover:

• assessment process for licence applications from previously unlicensed services under the EUTD
• provision of support to these services prior to licensing, including three regional workshops
• issuing of licences under the EUTD to ensure all relevant services may continue to practice legally from 7 April 2007

The proposal is based upon detailed evaluation of the HFEA's duty as competent authority under the EUTD, and follows a comprehensive pilot study to assess the necessary cost of licensing. We have also been engaged in thorough ongoing formal and informal dialogue with stakeholders over the last two years, in preparation for implementing the EUTD.

The HFEA is committed to furthering best practice and this commitment includes regular consultation with all relevant stakeholders. This consultation is a contribution to that ongoing dialogue.

There will be a further consultation later in the year to cover the ongoing licence and inspection costs post April 2007. This issue is to be consulted on separately following further work to explore the practical ways in which the ongoing costs to clinics can be minimised. We expect however to propose a flat rate fee payable annually by each clinic brought into licensing for the first time by the EUTD.

Any additional queries concerning the Directive, or the regulatory framework should be referred to Charles Lister, Head of Policy (0207 291 8230) or Hannah Darby, Policy Officer (0207 291 8237).

Yours sincerely

Angela McNab
Chief Executive

 

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• Consultation on application fees for licensing under the EU Tissues and Cells Directive (36 Kb)

• EU Tissues and Cells Directive page

Page last updated: 24 August 2012

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