E-DRUG: Affordable prescription drugs Act (USA) (cont)
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I believe that for most drugs in the North American market the average
time of market exclusivity is actually about 10-11 years. Patent life
is currently 20 years from date of filing but filing doesn't necessarily
occur right at the time of discovery so that some of the preclinical
work may be going on before a company applies for a patent. Also in the
United States there is patent life restoration which means that
companies get 6 months extra patent life for every year the drug spends
in the regulatory approval process. (The maximum amount of market
exclusivity a drug can have under this scheme is, I believe, 14 years.)
In Canada, we had compulsory licensing until 1991 and the time it took
to get a license issued was relatively short; certainly not in the order
of years. There were generic equivalents coming on to the market in
Canada for some of the better selling brand name drugs within 5-7 years
of appearance of the brand name product. Also despite protestations
about compulsory licensing by the brand name industry there is no good
evidence that profitability suffered. According to a major government
inquiry in the early 1980s on a worldwide basis the only place the
pharmaceuticeutical industry was more profitable than in Canada was the
United States. While compulsory licensing was in place in Canada the
pharmaceutical industry was between the 1st to 5th most profitable
manufacturing industry out of 84.
Joel Lexchin
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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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