F-2012-00082 – Cases of misdiagnosis in PGD during 2012 - 2010

Summary of request

The Authority was asked for the number of incidents or complaints received by the HFEA, or that the HFEA has been made aware of, during the last 24 months in relation to misdiagnosis in preimplantation genetic diagnosis (PGD) at HFEA licensed clinics. Also, that this information be broken down by the genetic condition tested for and the HFEA licensed clinic carrying out the PGD, in particular whether the clinic was CARE Nottingham, another CARE clinic or St Georges’ Hospital London.

HFEA response

One incident has been reported by a licensed clinic and one patient complaint has been received by the HFEA in the last 24 months in relation to misdiagnosis in PGD. There have been no other incidents or complaints reported to the HFEA in the past 24 months.

The relevant incident is currently being investigated by the HFEA Compliance Directorate and may be reported to the HFEA Licence Committee, in line with the HFEA’s Compliance and Enforcement Policy. The remaining information requested (clinic and condition name) is therefore withheld from disclosure under section 31(1)(g) FOIA.

Section 31(1)(g) FOIA permits the withholding of information that would, or would be likely to, prejudice the  exercise by any public authority of its functions for purposes such as ascertaining whether circumstances which would justify regulatory action in pursuance of any enactment exist or may arise.

It is considered that the public interest in withholding this information outweighs the public interest in disclosure. The public interest in disclosing the information in question has been weighed against the public interest in ensuring that quasi judicial proceedings are conducted fairly and the public interest in ensuring that the rights of the individual subject to those proceedings to have a fair hearing are properly protected. 

In reaching this decision, the HFEA is not making a blanket refusal to provide the information and would, if requested, reconsider the decision after the regulatory proceedings are complete.

Page last updated: 17 August 2012