[e-drug] Data exclusivity and trials data disclosure - collision?(6)

["pierre chirac" <pierchir@club-internet.fr>]

Dear e-druggers,

I think there is no collision at all.
Drug manufacturers have to provide trials data to drug agencies to get
approval for a new drug. For a generic drug, the abbreviated dossier can
refer to trials data already provided in the originator's dossier, if
the patent has expired, and if data protection has expired.
So, even if the trials data are perfectly accessible for everybody, drug
agencies are not allowed to deliver an approval to a generic drug on the
basis of an abbreviated dossier if the data are still protected.

PS : data protection's main effect and aim is providing exclusivity for
second uses of drugs (new therapeutic indications) in countries where
theses second uses are not patentable (e.g. Europe, in theory).

Pierre Chirac
MSF
Access campaign
pierchir@club-internet.fr