FAQs about new EU standards (EUTCD)

The HFE Act 1990 was ammended with effect from 5th July 2007 to bring the EU Tissues and Cells Directive (EUTCD) into UK law. The EUTCD sets standards of quality and safety for patients. It covers processes for:

  • the donation
  • procurement
  • testing
  • coding
  • processing
  • preservation
  • storage and
  • distribution of tissues and cells.

The Directive aims to ensure a high level of health protection within the European community. The UK has implemented the EUTCD and this has extended the regulatory remit of the HFEA to include services involving fresh sperm and eggs.

 

 

If I use my partner's sperm for treatment, does it need to be screened?
No. Only non-partner sperm need to be screened for diseases like HIV and Hepatitis B and must be quarantined for 6 months. However, if your partner's sperm is frozen to be used in treatment, it will need to screened.

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Can I use fresh sperm from internet websites? Is it safe?
Following the implementation of the EUTCD the procurement, testing, processing or distribution of any embryo or sperm and eggs intended for human use must be licensed by the HFEA or be subject to an agreement with a licensed service.

Internet sperm providers must therefore be licensed by the HFEA or have a third party agreement with a licensed centre to ensure standards of quality and safety of the sperm. If they are not licensed, or do not have a valid third party agreement, then they would be committing a criminal offence and the safety of the sperm may not be guaranteed.

As part of their licence, all donated sperm or eggs, would need to be screened for diseases and quarantined for 6 months. For this to happen, these sperm and eggs would need to be frozen.

 

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I've donated fresh sperm to an internet sperm provider in the past, can I remain still remain anonymous if I donate again?
No. All internet sperm providers need to be licensed by the HFEA under the EUTCD legislation and therefore have to abide by the UK standards, which include all donors being identifiable.

 

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Why is there a 6 month quarantine period?
All non-partner donated sperm has to be screened for diseases like HIV and Hepatitis B and this requires a 6 month quarantine period. Partner donated sperm that is being frozen and stored for future use, will be screened but does not require a quarantined for 6 months.

 

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What has changed since the implementation of EUTCD?
Basic partner treatment services involving fresh sperm and eggs, such as as IUI and GIFT are now regulated by the HFEA.

Non-medical fertility services such as internet sperm providers, are now also under HFEA regulation.

 

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What are the treatments that require a licence under the EUTCD?
The implementation of EUTCD means that there are some treatments/services that now come under HFEA regulation and would need to have had a licence by the 5th July 2007 in order to continue with treatment services:

  • Gamete intra-fallopian transfer (GIFT) (with donor and partner sperm and eggs)
  • Artificial insemination using patient or donor sperm and eggs, such as, intrauterine insemination (IUI), intracervical insemination (ICI) and any other insemination methods where processing of sperm or eggs occurs
  • Surgical procedures to collect eggs and/or sperm
  • Preparation and testing of sperm for human application, including sperm washing, sperm sorting and sperm viability tests (such as the hypo-osmotic swelling (HOS) Test).
  • Donor sperm supply services such as non-medical fertility services

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How can I be sure that if I obtain sperm from the internet, that it is identifiable?
The internet sperm providers would have to be licensed by the HFEA in order to operate and will therefore have to provide only identifiable donors.

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I need to obtain sperm, eggs or embryos from abroad. What should my clinic tell me about the process?

Obtaining sperm, eggs or embryos from within the EU
If you are considering obtaining sperm, eggs or embryos from within the EU, the clinic will organise for a transfer to be made from that country.

The donations will need to meet the following criteria:

  • The EU/EEA country from which the transfer is being made has implemented EU wide quality and standards known as the EU Tissues and Cells Directive (EUTCD).
  • The clinic from which the transfer is being made is licensed or accredited under the laws of that EU country.
  • The sperm, eggs or embryos transferred meet UK requirements on screening, as set out in HFEA licence conditions and the HFEA Code of Practice.
  • The donor of the sperm, eggs or embryos:
     o is identifiable,
     o has consented to the transfer of their sperm, eggs or embryos to the UK and
     o has been made aware of the legal position in the UK on identifying donors (including the implications for the donor).
  • The donor of the sperm, eggs or embryos must have only received reasonable expenses or reimbursement for loss of earnings. No inconvenience payments should have been made to the donor.

The UK clinic receiving the donation must make sure that the EU/EEA clinic providing the donation has met these criteria in order for the transfer to take place. If they cannot assure themselves that the criteria has been met then the clinic will need to apply to the HFEA for a Special Direction.

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Last updated: 28 March 2008