[e-drug] Data exclusivity and trials data disclosure - collision? (3)

e-drug
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E-DRUG: Data exclusivity and trials data disclosure - collision? (3)
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Dear Friends:

I share the concern of Andy with all of you about data exclusivity.
This type of TRIPS plus provisions will have an adverse impact on the
generic sector especially from countries like India, Brazil and
Argentina. India so far has not provided for this unreasonable demand
of provdiding for data exclusivity. Countries like France also have
supplementary protection certificate to provide for the time lost in
processing the patent application.

Dr. N. LALITHA
Associate Professor
Gujarat Institute of Development Research
Gota 380 060, Ahmedabad, India.
Phone: +91-2717-242366, 242367, 242368
Fax: +91-2717-242365
Res. Phone: +91-79-2685 0227
lalitha_narayanan@hotmail.com

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E-DRUG: Data exclusivity and trials data disclosure - collision?(4)
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I do not see why clinical trials information that is gathered by a
public regulatory body, to serve a public interest, is not public rather
than proprietary information. Companies pay for the relevant trials
(aside from other trials they do) only because they are required for
public purposes, to protect the public. By analogy, what is the legal
and practical status of information on crash tests for automobiles, or
safety information on airlines? And who pays for them?

Donald Light
Professor of comparative health care policy
tel: 1-609-915-1588
fax: 1-609-924-1830
dlight@Princeton.EDU