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22 September 2011

Sperm sourced via the internet

22 September 2011

Dear Colleague

Sperm sourced via the internet

The Authority has become increasingly concerned about the rapid expansion of web-based operations offering services aimed at matching potential sperm donors with individuals who are seeking donor insemination.

The Authority has a number of serious concerns about these online activities, which include:

• potential health risks arising out of inadequate screening;
• quality assurance issues in relation to storage and distribution;
• traceability;
• provision of inadequate information to donors about matters such as legal parenthood;
• depriving donor conceived persons of their right to access information about their genetic origins;
• compliance with limits on the number of families that may be treated using gametes from a particular donor; and
• payments to donors in excess of the limits permitted by the Authority.

In addition, the Authority has a broader concern that people finding donors in this way may not fully understand the significant legal ramifications of assisted conception outside the regulatory framework.

In seeking to address these concerns, the Authority has obtained legal advice on the meaning and extent of the provisions of the Human Fertilisation and Embryology Act 1990 (as amended), with particular reference to the meaning of ‘procurement’ and whether the Authority has the power to license and regulate such online activities.

The meaning of procurement

Section 4(1A) of the Act provides that ‘no person shall procure, test, process or distribute any gametes intended for human application except in pursuance of a licence or a third party agreement.’ The term ‘procurement’ is defined in section 2(1) of the Act. In relation to gametes intended for human application, it is defined as ‘any process by which they are made available.’

By section 41(1) of the Act, procuring or distributing gametes intended for human application without a licence or third party agreement is a criminal offence.
In the light of the legal advice it has received, the Authority takes the view that there must be a causal link between the ‘process’ and the ‘making available’ of the gametes. The Authority considers that sperm is only ‘procured’ for the purposes of the Act if the direct outcome of the process is that it is made physically available to the recipient.

Where, for example, the services offered include making arrangements for sperm to be delivered, the Authority considers this would constitute ‘procurement’. Equally, the actual delivery of sperm would amount to ‘distribution’ in the UK.

Action taken by the Authority

The Authority is writing to the web-based operations of which it is aware, to inform them of the requirements of the legislation and the Authority’s interpretation of the meaning of procurement. This interpretation will be included in the April 2012 update to the Code of Practice.

The Authority is advising any web-based operation which undertakes, or intends to undertake, any activity which may amount to procurement for the purposes of the Act, to apply to be licensed by the Authority.

The question of whether the services offered by various websites may amount to ‘procurement’ for the purposes of the Act, is a question of fact which the Authority will assess on a case-by-case basis.

Where the Authority considers that a potential criminal offence is being committed, it may refer the matter to the police for investigation.

The Authority has raised its concerns about these websites with the Department of Health and has written to the Minister to bring the matter to her attention.

The Authority has also modified the information on its website which relates to sperm obtained via the internet.

Action to be taken by centres

The Authority advises any licensed clinic that decides to enter into an agreement with a web-based operation undertaking procurement, to ensure that the terms of that agreement explicitly incorporate the relevant provisions of the Code of Practice issued by the Authority.

I would also like to take this opportunity to remind you of the requirements of paragraphs 7 and 8 of Direction 0001, which are reproduced below:

‘7. No licensed centre shall accept an individual as a donor who is known by that centre to have received or to be about to receive, or is reasonably suspected of receiving or being about to receive:

a. Money or money’s worth in excess of reasonable expenses incurred in connection with the donation or for loss of earnings; or

b. Other benefits of a kind not permitted to be given by these Directions, received through the means of, and/or with the assistance of, any agency or intermediary.

8. Where the person responsible is aware that a person wishes to be treated using gametes obtained from a donor sourced via an internet website, the person responsible should take reasonable steps to satisfy himself that the requirements of paragraph 7 have not been breached and shall keep a record of the steps taken for this purpose.’

I would also like to remind all centres that where patients proactively choose a donor through sperm banks based overseas, all transfers of gametes must be made directly from the sperm bank to the treating centre in accordance with Direction 0006. Where the conditions specified in Direction 0006 cannot be complied with the treating centre may wish to consider making an application to the Authority’s Compliance Committee for special directions to import particular gametes.

Under no circumstances, however, should sperm be transferred directly to patients.

In the meantime, the Authority will continue to encourage patients seeking treatment with donor sperm to use only the services of licensed centres, so that they can be assured that the safeguards provided by the regulatory framework have been met.

Yours sincerely

 

Lisa Jardine CBE
Chair

Page last updated: 17 August 2012

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