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03 August 1999

To: all IVF Centres

Dear Colleague

Preimplantation Genetic Diagnosis

Please find attached the interim licensing guidance for PGD and guidelines for the licensing of embryo biopsy practitioners. As you will know, the HFEA is in the process of preparing a consultation document on PGD with the Advisory Committee on Genetic Testing (ACGT). The consultation will include questions about how PGD should be regulated, but until the consultation process is complete, the attached interim system will be used. It is recognised that the requirements of the system represent a high level of regulation. The consultation process will provide you with an opportunity to comment on this and the HFEA will review the guidance again in the light of the comments received.

Guidance notes on the interim licensing of PGD — Annex I
These outline the system that has been in operation for a while and are designed to inform centres about exactly what information is needed when applying to carry out PGD.

Guidelines on the licensing of embryo biopsy practitioners - Annex II
In order to ensure a consistent level of competence by practitioners of embryo biopsy (as already established for ICSI practitioners), the HFEA set up a Working Group to develop specific guidelines for the licensing of embryo biopsy practitioners for PGD. The full guidelines are enclosed in Annex II to this letter. I would like to draw your attention to the following points.

•  An embryo biopsy practitioner is defined as the person who removes cells from the embryo for the purposes of PGD. The information that we require about practitioners will vary according to whether or not they have already been recognised by the HFEA as competent to perform clinical embryo biopsies.

Practitioners Already Recognised

•  The Person Responsible (PR) should submit a list of all individuals already carrying out clinical embryo biopsy at their centre. In addition, a record of practise for the clinical embryo biopsies performed by each of these persons over the past 12 months should be submitted (as per the proforma 'Twelve Month Record of Clinical Embryo Biopsy').

New Practitioners

•  An HFEA inspector will assess new practitioners once they can demonstrate competency and technical expertise in a minimum of 50 consecutive human embryos with a survival rate of at least 80% or more and upon receipt of an application by the PR to recognise a new practitioner. A practitioner who is ICSI licensed and is training on the same equipment will need to demonstrate the same survival rate in respect of a minimum of 25 consecutive human embryos. Please note that as training must be obtained using human embryos donated for a licensed project of research, the PR must apply for and be granted an appropriate research licence before training can commence.

If you have any questions about the attached interim guidance, please contact your inspector co-ordinator.

Yours sincerely

Suzanne McCarthy
Chief Executive

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Annex I

GUIDANCE NOTES FOR CENTRES ON THE INTERIM LICENSING OF PRE-IMPLANTATION GENETIC DIAGNOSIS (PGD)

The PGD Annex

1. Centres carrying out PGD will have a standard additional licence condition "that PGD may only be carried out for those disorders specifically listed in the PGD Annex to the licence". Depending on what tests a centre wishes to carry out, there are potentially three sections to the PGD Annex:

• Specific Diagnoses - including tests for Chromosomal Aberrations, e.g. translocations, deletions, duplications and inversions
• Sexing for X-Linked Disorders
• Special Category -These will be cases where the disorder affecting a family does not have a well recognised pattern of inheritance.

2. Details of the information requirements for each of these sections will be
explained in more detail below.

Basic Information Requirements

3. There is much repetition in the information requirements for specific diagnoses, tests for chromosome abnormalities and sexing. If a centre is applying to carry out a range of tests then the general information, applicable to each of the different types of test, need only be provided to the HFEA once. This information will usually consist of the following:

• Staff involved
• Procedures for obtaining consent and consent forms
• Clinical and laboratory protocols
• Arrangements for genetic counselling
• Decision-making process used to determine whether PGD should be offered(Centres have been encouraged to use the RCOG Guidelines on Termination for Fetal Abnormality) Patient information
  The patient information for PGD should include reference to the process, procedures and risks involved in undertaking IVF and embryo biopsy procedures in the context of the provision of a sophisticated genetic test. Reference should be made to the experience of the clinic in carrying out the procedure. Where information about the particular genetic disorder has already been provided, for example by a regional genetics centre, it will not be necessary to provide this information again. It is for the centre to satisfy themselves that this information has already been provided to a satisfactory standard.

4. If a centre is already licensed to carry out one type of test and subsequently applies to carry out a different type of test, only information that is new and which is not already held on file should be provided. What information is unchanged and what is new should be clarified as part of the application process.

Information about the efficiency and reliability of probes (FISH and PCR)

5. The centre should provide information to the HFEA about:

the centre's knowledge of the use of the probe in the context of PND;
the centre's experience of the use of any tissues and controls they have used in order to develop the probes;
the centre's experience of the human embryo and controls they have used in order to develop the probes;
whether the person carrying out the procedure carries out a test on other cells of the embryo to confirm a positive test and details of false positive results;
whether there are any checks in pregnancy and how the centre informs and advises patients of these the centres views on communicating misdiagnosis rates to subsequent patients

Use of the On Line Mendelian Inheritance in Man System (OMIM)

6. The PGD Annex will list all the disorders for which a centre is licensed to carry out PGD. To help centres provide information on disorders, the HFEA would like to make use of the On Line Mendelian Inheritance in Man System (OMIM). When centres wish to test for a new disorder, for the first time, whether it is a specific diagnosis or is sex-linked, they should provide the OMIM number. If such a number is provided the HFEA will have a clear idea of what the disorder is without having to request detailed information from the centre.

7. There will be a number of disorders that are rare and others where the mode of inheritance has not been well established or is unusual. Such disorders will not have an OMIM number. However, there may still be clear clinical justification for using PGD. In these circumstances the centre will be asked to provide information about the following:

• The known risk
• Severity of the particular case
• The way it affects the family
• The mode of inheritance

8. These conditions will be listed under a special category in the PGD Annex of the centre's licence. Where, although, it is acknowledged that the genetic condition is not well recognised and may not be catalogued because the mode of inheritance is unclear, clinical justification has been sought from the centre.

9. The above four pieces of information will also be requested for chromosome aberrations, which do not have OMIM numbers.

SPECIFIC DIAGNOSES

Applications from a centre to carry out a specific diagnosis, including tests for chromosome aberrations (e.g. translocations)

10. When a centre plans to test for a new genetic disorder for the first tune, the following information will be required:

• the information listed in paragraph 3 above, if not already supplied;
• specific information about the test's safety and reliability (paragraph 5), including relevant data and suitable published papers, should also be provided;
• the OMIM number for the condition, or the information at paragraph 7, where appropriate.

Generally, where it is intended to use a new probe, other than those already licensed, a separate application will need to be made to the HFEA.

Applications from a centre to carry out a new specific diagnosis for a different mutation of a disorder for which that centre already has a licence

11. Where a centre wishes to test for a different mutation they will need to apply to the HFEA in advance to do so. The information that should be provided is the OMIM number of the particular mutation (or the information at paragraph 7) and any new or different information from that already provided. In the vast majority of cases this will essentially amount to information about the safety and reliability of the new test to be used (see paragraph 5) although there may also be some changes to existing
protocols.

Applications from centres to carry out tests for new chromosome aberrations

12. Those centres that have been licensed to carry out a test for one aberration will need to apply to carry out any new tests. The centre should apply to the HFEA in advance. The information required will be any new or different information from that already provided when the centre initially applied to carry out a test for a chromosome aberration. In the vast majority of cases this will essentially amount to information about the safety and reliability of the new probe to be used (paragraph 5), the information at paragraph 7, and any changes to existing protocols.

X-LINKED DISORDERS

Applications from centres to carry out sexing for X-linked disorders for the first time

13. When a centre plans to test for an X-linked disorders for the first time, the following information will be required:

• the information listed in paragraph 3 above, if not already supplied;
• specific information about the test's safety and reliability (paragraph 5), including relevant data and published papers, should also be provided;
• the OMIM number for each condition or the information at paragraph 7, where appropriate.

Applications to carry out sexing for new disorders

14. Those centres licensed to carry out sexing of embryos are required to apply to the HFEA in advance before carrying out sexing for each new disorder for the first time. As the probe being used will be the same, no further information will be required about this. However, the disorder's OMIM number or the information at paragraph 7 will be needed.

Panel of peer reviewers

15. The HFEA is in the process of putting together a panel of peer reviewers and specialist inspectors who will help in considering applications.

HFEA Executive August 1999

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Annex II
LICENSING OF EMBRYO BIOPSY PRACTITIONERS FOR PREIMPLANTATION GENETIC DIAGNOSIS
The following standard licensing conditions will apply equally to centres which have or are applying for a license to carry out PGD (embryo biopsy and the diagnostic test), and those that are licensed for just the embryo biopsy part of the PGD procedure.

Standard Licence Conditions

Condition 1

That embryos which have been BIOPSIED are not replaced with any other embryos in the same treatment cycle

The Authority takes the view that it should be possible to monitor the outcome of PGD in licensed centres. It is essential that the Authority collects information which distinguishes PGD procedures. The replacement of embryos which have been biopsied with those that have not, and therefore have not been tested, is a highly unlikely event which would undermine the purpose of PGD.

Condition 2

That when applying for a PGD or embryo biopsy licence the Person Responsible provides the Authority with the information set out in Annex A. (An embryo biopsy practitioner is defined as the person who removes cells from the embryo for the purposes of PGD.)

The Authority will require details regarding patient selection criteria for PGD, the information about embryo biopsy/PGD provided for patients, consent forms, protocols, procedures and results as set out in Annex A of this letter, hi recognition of the important role played by the embryo biopsy practitioner, the Authority will also require detailed information regarding the performance of each embryo biopsy practitioner at the centre.

Condition 3

That embryo biopsy is carried out only by trained competent staff recognised as such by the Authority.

Condition 4

That the Person Responsible at a centre notifies the Authority before clinical embryo biopsy procedures are first carried out by a particular practitioner at that centre.

Condition 5

That 12 months after an embryo biopsy practitioner has been recognised as competent, the Person Responsible provides the Authority with the information set out in the proforma attached to Annex B.

Conditions 4 and 5 reinforce that clinical embryo biopsy is to be carried out by suitably trained competent staff only.

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Annex A & B

Page last updated: 24 August 2012

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