E-drug: Globalization of the drug market /ICH (cont)
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Dear Thomas Poe,
Sorry but sincerely I don't think that the ICH process (namely "the
international conference on harmonisation of technical requirements
for the registration of pharmaceuticals for human use") is the best
way and example to introduce what is globalisation of the drug market.
Anyway, if we take it as an example, be sure we understand what it
concretely means.
1. ICH is only a regional initiative, started in the 1990s (European
Union region, USA and Japan), - but apparently with global and
dominating ambitions what could be a real matter of concern and be
questionable in the future, particularly on its legitimacy and to
whom this process is accountable.
2. ICH is related to the harmonisation of regulatory requirements of
pharmaceuticals in the ICH region and so far applicable only to new
chemical entities, - but more and more considered and perceived as a
"gold standard" (the 40 ICH guidelines) issued jointly by the drug
regulatory authorities of 17 industrialised countries (EU, USA and
Japan) and by the pharmaceutical industry (IFPMA, PhRMA, EPPIA and
JPMA) with the ambition to extend "de facto" its application field to
176 other countries (the non-ICH countries).
Whether a kind of globalisation through the harmonisation of regulatory
requirements is a necessity, cannot be contested. It's a way of
avoiding redundant studies for the registration and then a way of
accelerating the process and reducing costs. It is a way of making
easier circulation of pharmaceuticals and as well improving safety
issues thanks to the exchange of data and information.
- But on the other hand it could constitute a sort of barrier to trade by
setting up specific norms not globally applicable, considering that the
secretariat of the ICH steering committee is under the responsibility
of the IFPMA.
Laying the foundations of a possible global system on such narrow and
biased bases is like when in politics a minority imposes its views on
a majority. Is not it the definition of "dictatorship" ?
Patrice Trouiller, Pharm D, MB
WHO/EURO Copenhagen
T: +45 39 17 15 02
E-mail: ptr@who.dk
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