[Ip-health] unethical experiments involving human beings as a requirement for registration of medicines and technologies

[James Love]

This morning, the IGWG will begin with 5.1(h), which reads:

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

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This was discussed in the CIPIH report as follows

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>From page 125 of the CIPIH report

"If the patent period has expired, or there is no patent on the product,
this sui generis data exclusivity may act independently of patent status
to delay the entry of any generic companies wishing to enter the market.
This is because the regulators cannot use the data in the period of
protection to approve a product, even if the product is demonstrated to
be bio-equivalent, where required. The only alternative for a generic
company would be to repeat clinical 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. These sui generis regimes, which provide for data exclusivity
need to be clearly differentiated from the TRIPS agreement's requirement
for data protection."


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James Love, Knowledge Ecology International (KEI)
http://www.keionline.org, mailto:james.love@keionline.org
voice +1.202.332.2670, fax +1.202.332.2673, US mobile +1.202.361.3040, Geneva mobile +41.76.413.6584

When everyone thinks the same, no one thinks.  Bill Walton remix of Walter Lippmann