Healthy Skepticism Library item: 18954

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

ICH: an exclusive club of drug regulatory agencies and drug companies imposing its rules on the rest of the world.
Prescrire Int. 2010; 19:(108):183-6

Abstract:

Under the pretext of harmonising
regulatory requirements for
marketing authorisation of new
drugs, the drug regulatory agencies
of the world’s wealthiest countries
and three pharmaceutical industry
trade associations, joined together
since 1990 in the ICH, are promoting
their own interests by imposing
their criteria for evaluating drugs
on the whole world. The toxicity
standards advocated by ICH sometimes
promote faster, cheaper drug
development over patient protection.
The drug quality standards advocated
by ICH sometimes increase
manufacturing costs without
providing any public health benefit.
It would be preferable if the World
Health Organization were in charge
of setting standards for drug
development, focusing on patients’
interests.