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| Data Exclusivity and the USA |
April 12, 2006. Judit Rius Sanjuan.
U.S and E.U Protection of Pharmaceutical Test Data. CPTech Discussion Paper No. 1.
21 USC 355(c)(3)(E)(ii,iii), which set out the period of
data exclusivity under US law. (U.S. law provides five years of data exclusivity for new
chemical entities, and three years for other pharmaceutical products. To see the broader
statutory framework, see
21 USC 355 on the Cornell Law School web page. This was last updated August 18, 2005.
FDA's Frequently Asked Questions for New Drug Product Exclusivity.
June 10, 2003.
Statement of Representative Henry Waxman.
[The Hatch/Waxman period of data exclusivity] works in this country because most people
in the U.S. have health insurance that pays for essential drugs and
because we have a health care safety net to assure that the poorest in
our society are not left without medical care and treatment. But to
impose such a system on a country without a safety net, depriving
millions of people of life-saving drugs, is irresponsible and even
unethical. In developing countries, we must do everything in our power
to make affordable drugs for life-threatening diseases available now...
Whether in Central America, Latin America, Morocco, or Southern
Africa, there is a long slate of USTR negotiations where the
Hatch-Waxman could have devastating results.
1997 Specter hearings
CPT Testimony on
Health Registration Data Exclusivity, Biomedical Research, and
Restrictions on the Introduction of Generic Drugs. Hearings in the
U.S. Senate, Committee on Appropriations, Subcommittee on Labor, Health
and Human Services and Education and Related Agencies. The hearings focus
on a proposal to extend US health registration protection from 5 to 10
years, in exchange for R&D royalty of 3 percent paid to NIH and 3 percent
R&D reinvestment requirement. The proposal, which is pushed by
Bristol-Myers Squibb to protect Taxol, is rejected.
Taxol Disputes
CPTech's page on disputes involving Taxol..
Pharma Documents
July 1, 1999. Australia.
Intellectual Property Protection.
July 1, 1999. Korea.
Intellectual Property Protection.
July 1, 1999. Japan.
Intellectual Property Protection.
South African Dispute
July 29, 1997, Ralph Nader, James Love
and Robert Weissman
letter to Vice President Gore Regarding U.S. policy
toward South Africa pharmaceutical policies, particularly the
section regarding health registration data and Taxol.
Argentine Sanctions
June 9, 1997, James Love and Ralph Nader,
Letter to USTR Charlene Barshefsky,
particularly section regarding health registration data.
February 4, 1997, Ralph Nader, James Love and Robert Weissman, letter to
President Clinton regarding trade sanctions against Argentina for policies
on health registration data.
January 15, 1997, USTR Press Release
USTR-Designate Barshefsky Announces GSP Sanctions Against Argentina for
Continuing IPR Problems.
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