An HFEA Consultative Meeting was held on 1st Dec 2009 to review the licensing conditions for PGD for later onset, lower penetrance conditions and for HLA tissue typing. See Agenda and Discussion document – case by case approach to PGD

The meeting was attended by around 50 people with speakers for and against change. Attendees with an interest in FA included Dr Josu de la Fuente from St Mary’s Hospital, London, Colleen Lynch from Genesis Genetics and Bob Dalgleish from Fanconi Hope. This post is written by Bob Dalgleish.

An introduction from Juliet Tizzard, HFEA Head of Policy was followed by presentations from:-

- Dr Sue Price, HFEA Authority Member
- Dr Sioban Sengupta, UCL Centre for PGD
- Dr David King, Human Genetics Alert

Presentation material from the first two speakers is available on request. (Dr David King spoke without supporting material).

2 Consultation workshops were then run in parallel:-

Workshop A. Case-by-case licensing of lower penetrance, later onset conditions. (No Fanconi Hope representation)
A workshop in which participants were asked for their experience of the
case by case licensing process lower penetrance, later onset conditions
and consulted on alternative models for the future.
 
Workshop B. Case-by-case licensing of tissue typing applications. (Attended by Bob Dalgleish from Fanconi Hope)
A workshop in which participants were asked for their experience of the
case by case licensing process for preimplantation tissue typing and
consulted on alternative models for the future.

In Workshop B three options were presented for discussion, namely;

Option 1. Status quo: Continue to license applications on a case by case basis. The Licence Committee
would continue to be responsible for licensing novel conditions, and the ELP responsible for
licensing applications from subsequent families, on the basis of evidence provided from the
clinician responsible for the sibling’s care. This delegation of subsequent decisions to the ELP
may help to resolve concerns about the time the process takes.

Option 2. Centres to notify the HFEA of the intention to tissue type. The Licence Committee would
continue to licence novel conditions. Clinicians would assess the appropriateness of treatment in
particular family cases, using HFEA Code of Practice guidance. Centres would simply notify the
HFEA that they intended to tissue type, by supplying to the HFEA a letter indicating the support
of the sibling’s treating clinician.

Option 3. Cease consideration on a case by case basis. The Licence Committee would continue to license
novel conditions. The clinician would have responsibility for deciding the appropriateness of
treatment in particular cases, using HFEA Code of Practice guidance. The HFEA would require
clinics to obtain the support of the sibling’s treating clinician, as currently set out in the case by
case application form. Evidence of this support and adherence to Code of Practice Guidance
could be checked on inspection.
It was clear that few could see the logic or benefit of case-by-case applications as the application forms per family were ‘largely cut and paste’ according to the London PGD/HLA/IVF provider so the decision was not actually being made on a per family basis in any case. The HFEA were also unable to say whether for any two families with the same condition different decisions had been made.  It was seen that the patient’s clinician was in the best position to judge the appropriateness of PGD/HLA/IVF and those clinicians were already working within a framework of HFEA guidelines so the checks and balances were still there. This view came from across the spectrum of clinicians, both PGD/HLA/IVF providers and support groups.

Of the 3 options, out of around 18 participants I believe 17 voted for Option 3, with only Dr David King dissenting.
The forum was advised by the HFEA that taking position 3 required acceptance of the fact that the HFEA could review the position in the light of new evidence such as embryo damage during cell selection.

Plenary Session Summary
Danny Edwards summarised the Tissue Typing Applications Workshop View in the Plenary Session as follows.
There was a very strong view that HLA tissue typing should be brought into line with PGD, and in fact there is an even stronger justification for this than for cancer predisposition. This would mean a move away from case-by-case approval removing one of the main uncertainties for families, who already have to deal with the uncertainties of funding, in particular as some funding bodies will not consider funding until the HFEA have licensed the case of a particular family.
This will require a Framework of Guidance which will define for which conditions HLA will always be the best treatment.
There was a call for more research on cure rates as there is a lack of information for families on the efficacy of the treatment.

The summary on Licensing of Lower Penetrance, Later Onset Conditions was that this had to be considered on a condition by condition basis as to whether it should be agreed on a case-by-case basis

Next Steps
The recommendations will be taken to the Ethics and Law committee on 15th Dec with subsequent recommendations to the HFEA in January 2010.

This entry was posted on Saturday, December 5th, 2009 at 2:56 pm