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2016 ; 11
(4
): 70-81
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Quelques chiffres derrière la décision du Canada d'adopter une politique sur les
médicaments orphelins: approbations pour les médicaments orphelins des
États-Unis, 1997-2012
#MMPMID27232238
Herder M
; Krahn TM
Healthc Policy
2016[May]; 11
(4
): 70-81
PMID27232238
show ga
We examined whether access to US-approved orphan drugs in Canada has changed
between 1997 (when Canada chose not to adopt an orphan drug policy) and 2012
(when Canada reversed its policy decision). Specifically, we looked at two
dimensions of access to US-approved orphan drugs in Canada: (1) regulatory
access; and (2) temporal access. Whereas only 63% of US-approved orphan drugs
were granted regulatory approval in 1997, we found that regulatory access to
US-approved orphan drugs in Canada increased to 74% between 1997 and 2012.
However, temporal access to orphan drugs is slower in Canada: in a head-on
comparison of 40 matched drugs, only two were submitted and four were approved
first in Canada; moreover, the mean review time in Canada (423 days) was longer
than that in the US (mean = 341 days), a statistically significant difference
(t[39] = 2.04, p = 0.048). These results raise questions about what motivated
Canada's apparent shift in orphan drug policy.
|*Orphan Drug Production/legislation & jurisprudence/methods/statistics &
numerical data
[MESH]
|Canada
[MESH]
|Drug Approval/methods/organization & administration/statistics & numerical data
[MESH]