Index Pharmaceutical Test Data Protection

Search CPTech
Search Listserves
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.

Data Exclusivity in the European Union                                                        Index

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 Directorate General. Letter to the European Generic Medicines Association on Tamiflu and Data Exclusivity.

European Generic Medicines Association. Chart and summary on data exclusivity.

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 Patients.

Disputes                                                                                                    Index

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.

Data Exclusivty Provisions in FTA                                                              Index

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.

Index of CPTech Pages on Multilateral, Regional, and Bilateral FTAs

Table Summarizing Data Protection Provisions in FTAs. (MS Word Format)

February 2005. Data Exclusivity & Access to Medicines in Guatemala. Doctors Without Borders/Medecins Sans Frontieres. Campaign for Access to Essential Medicines.

April 27, 2004. Joy Spencer. Comments of the Consumer Project on Technology in the CAFTA IP provisions and their effect on access to medicine at the International Trade Commission .

March 2004. Robert Weissman. Essential Action - Preliminary assessment of FTAA Intellectual Property Proposals' Effect on Access to Medicines.. Essential Action.

July 2001. Robert Weissman. Comments of the Consumer Project on Technology in the CAFTA IP provisions and their effect on access to medicine at the International Trade Commission .

January 2001. James Love and Robert Weissman. Letter to USTR's Policy Staff Committee Executive Secretary Gloria Blue, concerning the US-Chile FTA.


Relevant Articles of Multilateral and Regional FTAs:

WTO TRIPS Agreement Article 39.3

FTAA Subsection B.2.j, Aritlce 1

CAFTA Article 15.10(1)(a,b)

Relevant Articles of Bilateral FTAs

US-Jordan FTA Article 4(22)

US-Singapore FTA Article 16.8(1-3)

US-Chile FTA Article 17.10(1)

US-Australia FTA Article 17.10(1), Article 17.10(3)

US-Morocco FTA Article 15.10(1)

Special 301 Cases                                                                                        Index


March 2006. Judit Rius Sanjuan. Response to 2006 PhRMA "Special 301" Submission for Chile.Consumer Project on Technology.


January 2000. USTR Priority Foreign Countries. Argentina.


January 2003. USTR Priority Foreign Countries. Mexico.


January 2003. PhRMA Submission to USTR on India for the 2003 Special 301 Report. India.


January 2000. USTR Priority Watch Country. Australia.


January 2000. USTR Priority Watch Country. Israel.

January 2004. USTR 301 Report. Israel.

About Search Events Listserves Blogs Publications