Case by case decision making in embryo testing

Background

On October 1 2009, the HFEA moved to licensing Preimplantation genetic diagnosis (PGD) on a condition by condition basis. This means that once a condition has been licensed by the HFEA, any clinic in the UK licensed for PGD can test for that condition.

What is Preimplantation genetic diagnosis?

This decision did not apply to two categories of embryo testing, which have continued to be licensed on a case-by-case basis. These conditions are licensed for use in a specific family, one family at a time.

These conditions are:

Conditions defined as ‘later onset’ and ‘lower penetrance.’ These are often tests for genes associated with an increased susceptibility to particular forms of cancer. An example is BRCA1, which is linked to an increased risk of breast cancer.
Embryo testing which involves HLA (human leukocyte antigen) tissue typing for the purposes of conceiving a tissue-matched sibling to provide cord blood (or other tissue) for a sick sibling.

Over the next few months the HFEA will be evaluating the benefits and drawbacks of continuing to licence these conditions on a case by case basis.

Review aims and objectives

The aim of this project is to evaluate licensing these categories of condition on a case-by-case basis. This project will assess whether licensing on a case by case basis remains a proportionate system when compared with other examples of PGD licensing.

On the basis of this evaluation a recommendation will be made to the Authority for the future licensing of later onset, lower penetrance conditions and tissue typing conditions.

To achieve this aim, this project's objectives are:

to produce a recommendation for future licensing of later onset, lower penetrance conditions and tissue-typing
to ensure that in both cases the licensing process remains robust and fair, removing any unnecessary delays for people seeking treatment
to ensure information about these conditions and associated explanations about the licensing process are clear and up to date
to communicate with the sector regarding the development and the outcome of this review, and any changes made to the licence application process.

Review process

The review will be carried out through:

an analysis of case by case decisions, with evidence gathered from both licence applications and minutes of decisions taken
a public event scheduled for the 1st of December, at which clinicians, patient groups and other interested parties will be invited to give their views on the current system, and on proposals for future licensing
gathering the opinions of experts in cancer genetics and consultants involved in the care of children where an HLA tissue-matched sibling is the only available treatment.

Next steps

The outcomes of the evaluation will be considered first by the Ethics and Law Committee (ELAC) of the Authority in December 2009. The Authority will then be asked to consider the outcomes of the project and the recommendation of the Ethics and Law Committee at the January 2010 meeting.

Further Information

Information about the decision to licence PGD conditions on a condition by condition basis
Information about the in principle decision to license later onset and lower penetrance conditions
Information about the in principle decision to license tissue typing

If you have further questions about case by case licensing of embryo testing or would like to make a suggestion about this area of work, contact:

Danny Edwards
Policy Manager

Phone: 020 7291 8239
Email: danny.edwards@hfea.gov.uk

Page last updated: 29 October 2009

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