December 15, 2006
The Anti-Trial Directive
This week on CNE I wrote about the clinical trials directive, an EU directive with proven disastrous effects. I have previously written about it, but it deserves to be flogged again.
It manages to double costs of research trials, produce an endless number of false alarms and reduces the number of trials held. Especially international trials are now harder since previously the rules were incompatible, requiring much legal footwork, but now the interpretation of the directive are different and uncertain - and much harder to find out, since no regulatory agency will ever admit that it is not following all EU regulations perfectly and as intended. The result is risk aversion and over-interpretation of the rules since nobody dares being wrong about them.
It is a typical case of the all too common administrative assumption that extra rules have no costs and simplify things.
Posted by Anders3 at December 15, 2006 08:47 PM