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24 August 2011

Summary of Request

The Authority was asked for several pieces of information regarding donation. Each question is set out below, alongside the HFEA's response.

HFEA response

1. How many sperm donors have reached the upper limit of 10 families as per your recommendations?
5.(a) How many incidents of donors exceeding the recommended limit have come to light? (b) If so, how were they dealt with?

For the purpose of responding to your request I have interpreted the time period for which you request information to be since 1 April 2006 when the HFEA SEED Review recommendations were implemented.

Extracting the information required to answer your questions about the number of donors that have reached the 10 family limit and the number of incidents where the limit has been breached and how they were dealt with would require analysis of the HFEA Register and manual checking of donor records. The Authority estimates that the cost of complying with this part of your request would exceed the ‘appropriate limit’ set out in the Freedom of Information and Data Protection (Appropriate Limit and Fees) Regulations 2004 ('the Regulations').  This limit is £450 and for the purposes of estimating cost, staff time is calculated at a notional rate of £25 per hour. Section 12 of the FOIA allows public authorities to decline to provide information requested under the FOIA where the cost of doing so would exceed this appropriate limit. 

The following advice was also given:

In accordance with our duty to advise and assist, I would like to draw your attention to the following. As you know, in July 2010 the Authority decided to continue the HFEA’s policy of a 10 family donor limit that was introduced after the SEED Review. Following this decision, the HFEA Chief Executive asked that the work required to submit a paper on consequent actions for the Authority should be begun. This is due to be considered at its meeting on the 14th September. The Authority paper will examine what we know about compliance with the 10 family limit and will be available on our website in advance of the meeting in accordance with our usual procedure.

2. What provision is in place to ensure that registered sperm donors are not also engaging in multiple private donations?
3. What provision if any is in place to monitor private donation?

For the purpose of responding to your request I have interpreted private donation to mean donation that takes place outside an HFEA licensed clinic using donor gametes procured from a private individual or from an unlicensed organisation such as an internet website.

With effect from July 2007, the Human Fertilisation and Embryology Act 1990 (as amended) (‘the Act’) was amended to make it a criminal offence to "procure; test; process; or distribute" any gametes intended for human application without a licence from the HFEA, or a third party agreement with a clinic that does have an HFEA licence.  Under the Act responsibility for prosecuting anyone suspected of committing an offence rests with the Crown Prosecution Service.  Where the HFEA suspects that an individual is committing an offence it may refer the matter to the police for investigation. 

You may be aware of an organisation called Fertility First (also known as First 4 Fertility) which was involved in online procurement of donor sperm without a licence from the HFEA.  In September 2010, following a referral by the HFEA, a police investigation resulted in the prosecution of the individuals involved.

The HFEA has in past written to organisations to advise them of the law pertaining to procurement and where appropriate has invited them to make application for a licence.  In light of the prosecution, the HFEA has sought authoritative advice on its powers. We will be writing to those organisations that are currently not licensed by the HFEA but may be involved in procurement or other activities set out in section 4(1A) of the Act to advise them of the law.  It is, of course, possible that we will not be aware of all such organisations.

The HFEA makes it clear on its website that patients seeking fertility treatment with donated gametes should ensure that they only use the services of clinics that are licensed by the HFEA.  The HFEA provides information to patients and donors about the risks associated with using internet sperm websites at: http://www.hfea.gov.uk/76.html and http://www.hfea.gov.uk/patient-questions-fertility-treatment.html .

4. What is required as a proof of identification for a sperm donor?
Section 11.6 of the HFEA Code of Practice sets out guidance for clinics on the steps they should take to verify the identity of a potential donor. 

“11.6 The recruiting centre should take reasonable steps to verify the identity of the prospective donor by asking for appropriate identification (eg, passport or photocard driving licence). Failure to obtain satisfactory evidence of identity should be taken into account in deciding whether to accept their gametes or embryos for treatment.”

A copy of the HFEA Code of Practice can be found on our website at: http://www.hfea.gov.uk/498.html#guidanceSection4296 .

Page last updated: 16 August 2012

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