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Dear Colleague,                                                                                   

HFEA consultation on annual fees for centres licensed 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.

The enclosed consultation document sets out a proposal for the ongoing licence and inspection costs which centres will be required to pay under the EUTD from April 2007. These include:

  • The annual fee and renewal application fee that will be applied to previously unlicensed IUI, GIFT, internet procurement companies and centres providing sperm sorting services from April 2007.
  • Fees for third party agreements that involve licensable activities, such as the sperm preparation processes outsourced to an off-site laboratory, or transport IVF arrangements.

The proposal is based upon detailed evaluation of the HFEA's duty as competent authority under the EUTD, and follows a 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.

Comments on the proposal should be submitted to eutdfees2@hfea.gov.uk by 17 November 2006.

A separate consultation is already underway regarding the application fee that previously unlicensed centres must pay to cover the cost of processing the initial licence that will enable them to continue offering services legally from 7 April 2007. This consultation can be viewed at www.hfea.gov.uk under the "for clinic staff" section, Chief Executive letter CE(06)02. The consultation closes on 13 October 2006.

Any queries concerning the Directive, or the regulatory framework should be referred to Charles Lister, Head of Policy (0207 291 8230) or Helen Coath, Policy Manager (0207 291 8238).

Yours sincerely

Angela McNab
Chief Executive

Page last updated: 24 August 2012