E-drug: Drug approval criteria (cont'd)
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To add on the discussion about approval and cost/benefit considerations.
Different layers of accessibility for drugs may be useful to a certain
extent (e.g. for the health insurance system to save money and put it into
more useful means to improve health). But at the same time this has
limitations.
Take Germany as a bad example: We have not managed even to get rid of our
"Grandfather drugs" i.e. drugs which had been licensed before 1978 when
there was no procedure to check drugs for safety and efficacy (in 1998 more
than 20,000 or half of the drugs on the market). At the same time the
standards for approving new drugs were not very high. The workaround was
and is to exclude drugs from the health insurance system by "negative
lists".
But this means that
1) patients tend to pay for these "good old drugs" themselves,
2) industry tries to stop negative lists in the court (which happened again
two weeks ago in Germany) on purely commercial reasons i.e. unfair
competition as the health insurance system has a large purchasing power.
I find this extensive double strategy difficult to accept on public health
grounds. There is certainly a justification for some drugs to be on the
market without beeing refunded by the public health insurance system, but
at least in Germany it rather looks like a substitute for a more strict
review and approval process.
Jorg Schaaber
BUKO Pharma-Kampagne, August-Bebel-Str. 62, D-33602 Bielefeld, Germany
Phone +49-521-60550 Fax +49-521-63789 email: bukopharma@compuserve.com
homepage: www.epo.de/bukopharma/
[Note from moderator: Jorg, this is to some extent also a reply to Niyada's
question the re-evaluation process. Obviously Germany is having problems
with this. Do you have more information for Niyada or useful contacts for
him? Kirsten Myhr]
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