Mr. Eugene Lennon:

I will comment briefly before Dr. Devlin responds. One can probably say from the Health Products Regulatory Authority, HPRA, report and the Minister's acceptance of that report, there is a clear political direction - the Government has decided this is the way it is going and has set out the three conditions under which the access programme will be available. If one is a consultant working in those areas, one will know the Government has made a policy decision in that direction.

The issue of liability has not been raised directly with us. Consultants who work in the public system are in the clinical indemnity scheme and sometimes they prescribe products that are not authorised, but their employers are aware of the treatment that is proposed and have approved it. Consultants cannot decide to prescribe, but if the authorities are aware that one is trying a product, for which one has a licence from the Minister, that is a different scenario.

Those issues can be explored further. I am not sure that is the absolute barrier in the case of a consultant working in a public hospital. My belief is that in some cases, the fact that they are not dealing with an authorised medicine, the evidence may not be sufficient for some consultants at this stage to use such a medicine. Possibly the Health Products Regulatory Authority, HPRA, report and the work of the group that Dr. Devlin has referred to may provide further confidence in these medicines.

Dr. Devlin may elaborate further.