CPTech Documents

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 Directorate General. 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.

• Index of CPTech Pages on Multilateral, Regional, and Bilateral FTAs
• Table Summarizing Data Protection Provisions in FTAs. (MS Word Format)
• Relevent 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)

US Government Documents

• 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.

NGO Documents

• 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.

Academic Documents

• 2002. Book by Carlos Correa Published by the South Centre. Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement.
• June 21, 2006. Robin J. Strongin. George Washington University National Health Policy Forum. Hatch-Waxman, Generics, and Patents: Balancing Prescription Drug Innovation, Competition, and Affordability.

News Stories

• April, 2005. Danna Farhang for Business Today Egypt. A Pill by Any Other Name.
• April 25, 2004. Hadas Manor for O Globes. Gov't postpones data exclusivity law vote because of US pressure - Negotiations with the US over data exclusivity for drug registration files will continue.
• March 9, 2004. Harish Damodaran for the Hindu Business Line. Pesticide Multinational Corporations Seek 5-10 Year Data Exclusivity.
• May 27, 2003. Ajay Jain for India's Financial Express. Pharma Cos In Grip Of Feverish Debate On Data Exclusivity: No obligation under TRIPS, says PMO official.

Older Documents

• 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 Patients.
• 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.
• South African Dispute on health registration data
  • 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 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.