In late August 2014, two national newspapers - the Daily Mail (1) and The Telegraph (2) - reported Human
Fertilisation and Embryology Authority (HFEA) data showing that donations from nine
sperm donors had produced 21 or more children each, while another six donors
had produced 20 children (see BioNews 768).
These reports prompted
two linked, but independent, Freedom of Information requests (3,4) by us to the
HFEA. Subsequent email communication (5) also enquired about breaches of the 'ten
family' limit introduced
by the HFEA on 1 April 2006, and to what extent affected donors, recipients,
and (where they were eligible) donor-conceived individuals had been advised of
response to our inquiries indicates a worrying policy
confusion in which the potential interests of donors, recipients, and eligible
donor-conceived individuals in learning information about donations that affect
them may go unacknowledged.
While none of the 15 sperm donors mentioned in the
media reports breached the ten family limit, the HFEA said it was aware of six
breaches of this limit by other donors. It indicated that no affected parent or
donor-conceived individual entitled to information by virtue of their age had
been informed of the breach (4).
As regards informing donors, the HFEA provided conflicting
information. We were first advised that, even though the HFEA had determined
such breaches of the donor's consent to be a 'critical' area of non-compliance, it had not informed
any affected donor. Ultimately, the HFEA considered
the confidentiality risks too high to justify proactive contact and presumed
that donors who do not enquire about the outcome of their donation may not wish
to know (4). However, this runs
counter to both HFEA policy and other information with which the HFEA provided
First, at its meeting on 7 December 2011, the
'Should it come to light that a donor's
gametes had been used to create more than ten families it would be incumbent upon the centre to inform the donor and families
concerned' (our emphasis) (6).
also informed us:
'A breach of the ten-family limit is treated as an "incident"
by the Clinical Governance Team. In the process of investigating each such
incident the team will be in regular correspondence with the centre or centres
in question in order to satisfy themselves that any necessary procedural
improvements have been put in place to minimise the risk of such occurrences
happening again. During this correspondence the Clinical Governance team will
request assurances that the donors in question are contacted' (5).
HFEA failed to adequately explain how clinics were to notify donors or parents
in the event that multiple clinics
open letter from the chief executive says that, in the event of a family-limit
breach, 'centres should contact the Register Information Team at
the HFEA to check if a potential donor has registered recently at another
clinic' (7). Email communication to us adds that 'at this time the centre can
enquire as to the policy of informing affected donors in the event of a breach
and if multiple centres are involved, they can inform them of the situation' (5).
To our mind the HFEA responses to our
enquiries reveal a singular lack of coherence as regards breaches of its family-limit
it appears that, rather than being proactive itself, the onus is on centres to
enquire about the HFEA policy in relation to breaches. There is
no reference at all in the HFEA Code of Practice to procedures to be followed
in the event of a breach.
Second, inconsistency is evident regarding
informing affected donors following a breach of the limit. The HFEA advised us
that affected donors should be informed, but also that no affected donor had
been informed; yet it also indicated satisfaction with compliance with its
Third, it is evident that by virtue of
its specific reference to donors only, the HFEA has no policy of informing
affected recipients or donor-conceived individuals, despite its recorded intention
that 'families' should be informed.
Fourth, despite our best endeavours we
have so far unable to ascertain exactly how the HFEA and clinics have responded
to the actual breaches of the ten-family limit.
We recognise that breaches of the family limit and associated breaches of
donor consent are rare events. Nevertheless, it is incumbent on the HFEA to
clarify its policy as regards breaches. Given the contradictory information we
have identified and, in order to remove any possibility of confusion, we
suggest that at the point of donation and taking consent clinics should enquire
under what circumstances both donors and recipients of donated gametes would
wish to be contacted and given information.
Such circumstances could include breach of the family limit or adverse
health outcomes affecting any offspring or donor that might have a genetic
cause. As regards those who have already contacted the HFEA for information (for
example, donor-conceived individuals over the age of 16, recipients of donor
gametes and donors) it seems reasonable to assume that if they have already sought
information, they would be interested in relevant updated information such as
we have highlighted above.
However, in order to remove any possibility of ambiguity, we further
suggest that when such information is first requested, the applicants could be
given the option of registering their interest in being updated. These measures
will ensure that no one is provided with unsolicited information that they do
not actually want.
Further, we would endorse an even more proactive stance for individuals
whose details are already on the HFEA Register. Since no donor would expect their gametes to be used in breach of HFEA
rules or the conditions of their consent, we believe that proactive contact
with donors is always justified and remain unconvinced that such contact could
not be undertaken without breaching confidentiality. (As researchers we
ourselves have made contact with former sperm donors whilst adhering to the
stringent conditions for confidentiality required by an ethics committee (8, 9)).
believe that parents and donor-conceived adults, even if they have not sought
further information from the HFEA, would not expect the family limit to be
breached and should be told when this occurs.