Re: E-DRUG:ICH

[Catherine Hodgkin <chodgkin@xs4all.nl>]

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Re: E-DRUG:ICH

Joel says very little has been written on this subject, he refers to an
article of mine which was published in HAI-LIghts. In fact this is a
somewhat shortened version of material in  two other papers I wrote at
about the same time. One was published in the International Journal of Risk
and Safety in Medicine IJMDEM 9 (3) 1996 entitled "International
Harmonisation - the need for transparency". The other was presented at the
International Conference on National Medicinal Drug Policies in Sydney in
1995 and is published in the procedings of this conference as a paper
entitled "Who makes the rules for the markets of the future?"

Both of these papers are quite dated by now but might be of interest as
background material and for some of the basic points they make. As Joel
says one of my central themes was the lack of openess and democratic
procedures around the whole process, but I also tried to explain how a
consumer/health driven agenda for harmonisation might differ from the
industry driven agenda.

I talked to many highly critical regulators at this time - in general they
felt quite unable to voice their criticisms other than privately. The most
common complaint was that ICH is ultimately about time-lines and about
speeding up processes and that this objective dominated nearly all the
discussions. Another (related) complaint was the lack of scientific debate
and discussion. 

I attended a meeting organised by the FDA in 1996 in which I argued that
without agreed mechanisms for monitoring, evaluation and review the ICH
process would be uncontrollable. Several of the people at this meeting
supported this view and agreed that the mechanisms for "maintenance" of ICH
were insufficient. As far as I know this has not changed. 

I welcome renewed interest in this topic and hope that it will be possible
to create opportunities to influence this process.
Catherine Hodgkin
Catherine Hodgkin MPH
Linnaeusparkweg 35
1098CP Amsterdam
The Netherlands
Phone/Fax 6949365


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