[Ip-health] Avoding unethical experiments, and drug registration, what are the issues

[James Love]

Shortly the IGWG committee as a whole will debate

5.1 (h) [establish measures to avoid unethical experiments involving
human beings as a requirement for registration of medicines and
technologies.]

What is this about?  When there are exclusive rights to rely upon human
use clinical trial data, and the only way that a generic drug company
can register a product is to replicate the clinical trials, there is a
conflict with medical ethics.  You are not supposed to put human
subjects into experiments simply to repeat something that is known, such
as the fact that a drug is safe and effective.

5.1(h) calls for measures to avoid these problems, and it calls into
question the entire global call for data exclusivity.

This issue was also addressed in the CIPIH report, as follows:

=E2=80=9CThe only alternative for a generic company would be to repeat clin=
ical
trials, which would be costly and wasteful, and would raise ethical
issues since it would involve replicating tests in humans to demonstrate
what is already known to be effective=E2=80=9D

We will report what each country who speaks says on this provision.

Jamie

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_____________________________
James Love, Knowledge Ecology International (KEI)
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