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.

This decision did not apply to two categories of embryo testing, which continued to be licensed on a case-by-case basis. These conditions were to be 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.

From September 2009 to January 2010 the HFEA carried out a review evaluating the benefits and drawbacks of continuing to licence these conditions on a case by case basis.

 

Review aim

The aim of the review was to evaluate licensing these categories of condition on a case-by-case basis. The review assessed whether licensing on a case by case basis remained a proportionate system when compared with other examples of PGD licensing.

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

Review process

The review was carried out through:

  • Analysing case by case decisions, by gathering evidence from licence applications and minutes of decisions taken. 
  • A public event held on 1 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.

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

Conclusions

Following the proposals made by this review and recommendations made by the Ethics and Law Committee, the Authority made the following decisions:

  • The Authority decided to bring later onset, lower penetrance conditions into line with the main PGD licensing system.  This means that they will be licensed on a condition by condition basis, with PGD centres deciding whether PGD for a licensed condition is appropriate for a particular family.
  • The Authority decided to continue considering preimplantation tissue typing on a case by case basis.  The Authority noted concerns raised by contributors during the review period, and agreed to further reduce the time taken to make decisions in these sensitive cases.  The Authority also agreed to provide more comprehensive patient information regarding tissue typing on the HFEA website, including links to relevant patient groups and professional bodies.

Further Information

Page last updated: 26 May 2010

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