Protection of Pharmaceutical Test Data
May 18, 2006. Judit Rius Sanjuan, James Love & Robert Weissman. A cost sharing model to protect investments in pharmaceutical test data.
CPTech Policy Brief No. 1.
April 12, 2006. Judit Rius Sanjuan.
U.S and E.U Protection of Pharmaceutical Test Data.CPTech Discussion Paper No. 1.
February 20, 2006. Martin Terberger, European Commission Enterprice and Industry
Letter to the European Generic Medicines Association on Tamiflu and Data Exclusivity.
Data Exclusivity Provisions in FTAs
TRIPS-Plus rules concerning the protection of test data for pharmaceutical
and agrichemical products has been a major negotiating objective of the USTR in
the Free Trade Agreements it has negotiated with various regions and countries.
- 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.
- February 10, 2005. Wilbert Bannenberg on E-Drug.
Note on the difference between data protection and data exclusivity.
- February, 2005. Medecins Sans Frontieres.
Data Exclusivity & Access to Medicines in Guatemala.
- July 5, 2004. Affordable Medicines and Treatment Campaign (AMTC).
Submission before the Committee for the Protection of Undisclosed Information
under Article 39.3 of the TRIPS Agreement.
- May 4, 2004. Brook Baker for Health GAP.
USTR's 2004 Special 301 Report Highlights the U.S.'s Global Ambition to Use
Heightened Protection of Innovators' Drug Registration Data to Block and
Delay Registration of Competing Generic Drugs.
- March 23, 2004. CUMVIVIUM press release.
CUMVIVIUM Denounces New EU Regulations which will Hurt Access to Affordable Medicines -
It Warns Other Countries From Adopting Similar Actions.
- March 9, 2004. Affordable Medicines and Traetment Campaign.
Letter to Mr. Pradush Sinha, Secretary, Department of Chemicals and Petrochemicals.
- February 16, 2004. Brook Baker for Health GAP.
The Drug Registration Battlefield: U.S. Trade Policy Erects New, Nearly
Impenetrable Barriers to Lower-Cost Generic Medicines of Assured Quality.
- December 13, 2003. Medecins Sans Frontieres press release.
US Pressure Threatening Access to Medicines in Central America.
- CPT web page on
disputes involving Taxol.
- January 9, 2001. IMS News.
Data exclusivity - the generics market's third hurdle.
- 2000, November. European Federation of Pharmaceutical Industries and Associations.
TRIPS Article 39.3 (Protection of Undisclosed Data) A Critical Issue
for the Continued Development of Safe and Innovative Medicines for
- 1997 Specter hearings
- South African Dispute on health registration data
- Argentine Sanctions
June 9, 1997, James Love and Ralph Nader,
Letter to US Trade Representative 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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