CH(05)03

10 August 2005

Dear Colleague

Regulation of Preimplantation Testing

I am writing to advise you of changes to the process of regulating preimplantation genetic diagnosis (PGD) and preimplantation genetic screening for aneuploidy (PGS). This new process will streamline the system of dealing with applications for embryo screening, cut down bureaucracy and speed up the approval process, in the interests of the patients who benefit from this treatment and the clinicians treating them.  

Licensing of Preimplantation Genetic Diagnosis
From now, Centres already licensed to carry out PGD which subsequently wish to use PGD for another single gene disorder or for another X-linked condition, will have to submit information on the new disorder as outlined in the new application forms to the HFEA. This information will then be considered by the HFEA Executive.  The HFEA will approve the application without having to go through a full Licence Committee process provided the following criteria are met:

  • The Centre has proven expertise in performing embryo biopsies
  • The laboratory where the genetic testing will take place has previously been recognised by the HFEA
  • The genetic disorder has already been licensed by the HFEA.

Furthermore, Centres authorised to carry out PGD for a chromosomal rearrangement, like reciprocal or Robertsonian translocation, will not have to seek further approval in order to carry out PGD for additional chromosomal rearrangements.

However, a number of cases will still require consideration by a HFEA Licence Committee. These include:

  • Initial applications from Centres wishing to carry out PGD / PGS for the first time
  • All cases where the genetic condition has not previously been licensed by the Authority
  • Preimplantation testing for HLA tissue typing with or without PGD for specific genetic condition(s).

A flowchart illustrating this process is enclosed with this letter (attached at Annex A).

Licensing of Preimplantation Genetic Screening

Centres already licensed to carry out PGS which subsequently wish to use the same technique to screen for additional chromosomes, or combination of chromosomes, will not have to seek further approval in order to do so.

New Application Forms

To support this new process and to ensure effective regulation of preimplantation testing the HFEA is issuing Directions requiring Centres to provide information to the HFEA using standard application forms. Directions instructing Centres to this effect are enclosed with this letter (attached at Annex B).

If you have any queries, please do not hesitate to contact your HFEA Inspector.

Yours sincerely

Suzi Leather
Chair

Page last updated: 23 August 2012