E-drug: New Polish drug law favours generics? (cont'd)
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Dear E-druggers:
The word "unfair" confuses me. The new law in Poland seems to
be a copy of that of the USA and a lot of other countries, or not?
The far as I know, when one requests a registration from the FDA
for a generic version of a drug, it is only necessary to demonstrate
equivalence (interchangeability) but not data from toxicological,
clinical or other "original" trials. These are supposed to have been
carried out by the "innovator" of the chemical entity. It is
expensive, useless and, most important, unethical, to repeat trials in
humans beings if it is only for the sake of intellectual property
rights.
In Colombia, I'm sure, the system runs like that. And we are in a
debate about protecting confidential information in the same way.
Big Pharma is requesting 5 years protection (retrospective) of
clinical information from drug registration forms. It is a fight for the
exclusivity in the market, the best business in pharmaceuticals.
Francisco Rossi
Special Projects Manager
National Hospital's Cooperative Network of Colombia
e-mail: francisco_rossi@hotmail.com
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