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27 March 2008

Dear Colleague,

Import and export of gametes and embryos

In July 2007, the Authority introduced Directions D2007/4 and D2007/6 which set out the obligations that all UK centres must comply with, in order to satisfy the requirements of the EU Tissue and Cells Directives (“EUTCD”). These Directions were sent to the PRs of all UK licensed centres last year.

The effect of the Directives, and subsequent amendments to UK domestic legislation, is that transfers of embryos and gametes within the European Economic Area (EEA) can only be made to centres that have been “accredited, designated, authorised or licensed” by an EEA state. This was made clear in the Directions issued in July 2007.

It is now apparent that the majority of Member States have not yet accredited their centres in compliance with the Directives.  This means that the ability to move embryos and gametes within the EEA is limited. The HFE Act 1990 (as amended to implement the Directives) does not give the HFEA power to issue Special Directions to allow transfers to and from unaccredited tissue establishments within the EEA.

In light of this situation, and following legal advice, we now have to clarify the procedures to be followed for transfers of gametes and embryos within the EEA. Directions D2007/4 have now been revised and replaced with D.2008/1 and D.2008/2. To support these Directions the notification forms have also been updated and are now available on the HFEA website.

We have also clarified the current position in relation to imports and exports of gametes and embryos involving non-EEA countries. As a consequence of this review the Authority has approved Directions D2008/3 and D2008/4.

Copies of both sets of Directions are attached. These come into force with immediate effect. 

Revised guidance on imports and exports is enclosed. The following key points should also be noted.

Imports/Exports Within the EEA

Persons Responsible at UK licensed centres, whose patients wish to transfer gametes or embryos to a tissue establishment in an EEA state, in accordance with the General Directions issued by the Authority, must satisfy themselves that such establishments have been “accredited, designated, authorised or licensed” by that EEA state in accordance with the Directives, and should obtain evidence of such accreditation before the transfer is made. Such evidence must be retained by the UK licensed centre and may be examined by the HFEA’s inspectors as part of their inspection process.

As the accompanying guidance explains, Persons Responsible who wish to export or import gametes or embryos to a tissue establishment in another EEA state but who cannot comply with conditions of the General Directions (other than the requirement on accreditation under the Tissue Directive) should apply to the Authority for Special Directions. This application will need to be accompanied by evidence that the supplying or receiving centre has been accredited etc in accordance with the Directives. Persons Responsible should note that the HFEA has no power to issue Special Directions to allow transfers to and from unaccredited tissue establishments within the EEA. 

As mentioned above, most Member States have not yet completed the accreditation of their tissue establishments. This will have an impact on clinics and patients as imports or exports from such establishments are not possible. We have provided questions and answers for patients on our website about this issue. These are attached for your reference.  A list of the countries within the EEA and information about their competent authorities, where available, is also on our website.  We hope these will help you to explain the situation to any of your patients who are considering moving their gametes or embryos within the EEA.

In the meantime, the HFEA will continue to work with the Department of Health to highlight concerns to the European Commission about the poor rate of progress made by other member states in their implementation of the Directive, and the consequences for UK patients.   We will also raise these concerns directly at a meeting with the European Commission and EEA competent authorities in April.

Imports and Exports involving centres in non-EEA countries

The EU Tissue and Cells Directive requires that:

“all imports of tissues and cells from third [ie non EEA] countries are undertaken by tissue establishments accredited ? for the purpose of those activities, and that imported tissues and cells can be traced from the donor to the recipient and vice versa in accordance with the procedures referred to in Article 8. Member States and tissue establishments that receive such imports from third countries shall ensure that they meet standards of quality and safety equivalent to the ones laid down in this Directive.”

If the gametes and/or embryos are to be transferred to or from centres outside of Gibraltar and European Economic Area (EEA) the Person Responsible is responsible for ensuring, among other things, that the supplying/receiving centre is accredited, designated, authorised or licensed under the laws or other measures of the country in which it is situated in relation to quality and safety. The PR should obtain written evidence of the centre’s accreditation and that a quality management system and a traceability system are in place.   For imports, written confirmation should also be obtained from the supplying centre that procurement and processing of the gametes/embryos has taken place in appropriate facilities and following procedures that minimise bacterial or other contamination.

Where the conditions of General Directions D2008/3 and D2008/4 cannot be complied with, Persons Responsible should apply to the Authority for Special Directions.

If you have points you wish to raise or clarify, please contact the HFEA Regulation Department (Dr Chris O’Toole at chris.otoole@hfea.gov.uk).

Yours faithfully

Walter Merricks
Interim Chair

 

Page last updated: 17 August 2012

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