E-drug: Generic substitution (cont'd)
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Dear all,
Sana raised one of the fears that informs the decision not to
substitute a brand with a generic product. This is the inequivalence /
bioavailability factor. As Sana has mentioned, there appears to be no
study to support this position. However, in the case of Colombia, as
with other countries, one might present another reason for unwilling to
directly substitute a known, well-supported brand with a generic
product. Where the national regulatory authority does not have the
appropriate infrastructure (tools, well-trained staff, financing, etc) to
conduct appropriate tests to prove equivalence between the generic
and the brand (especially where there are issues of inequivalence),
one can understand such an authority taking the cautious position of
sticking to the trusted branded product, in spite of its cost. After all, it
is the national authority, or in fact the government that would carry the
liability for releasing a 'suspect' product on the market, specially in
cases where a generic manufacturer my not have the track record to
supply quality products.
Others have called for regional drug regulatory offices that would
address these matters, where some individual governments in such a
region may lack infrastructure to do this work; I would support that
position.
Regards,
Bonnie
Bonnie Fundafunda
Contracts Officer
UNICEF - Supply Division (Immunisation)
Copenhagen, Denmark
e-mail: bfundafunda@unicef.org
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