E-DRUG: Bolar Roche provision (cont'd)

[Joel Lexchin <joel.lexchin@utoronto.ca>]

E-drug: Bolar Roche provision (cont'd)
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As I understand Roche/Bolar, this is the name of a tradeoff that was
introduced into the U.S. law back in the 1980s.  The multinational
companies got patent life restoration, i.e. extra patent life for drugs to
make up for time spent in the regulatory approval process and the generic
companies got easier access to the market for their products.  Prior to
this time, in the U.S., generic companies had to repeat all the safety and
efficacy tests before they could get approval to market their drugs.
Roche/Bolar let them use safety and efficacy data from the originator
company provided that the generic was bioequivalent to the originator
product.  Roche/Bolar also allowed the generic companies to file for
approval before the patent on the originator product expired.

If I'm wrong maybe one of the Americans who subscribe to e-drug
can correct me.

Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone:  (416)-964-7186
Fax:  (416)-923-9515
e mail:  joel.lexchin@utoronto.ca
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