Regulatory Test Data

Test data protection for medical inventions

Test data protection is a sui generis intellectual property right that was first developed in the 1980s for pharmaceutical drugs, and has been extended recently to biologic drugs and vaccines.

Implementing the Jordan FTA rules on exclusive rights in regulatory test data

September 2, 2011
From KEI staff review of Wikileaks cables (http://keionline.org/wikileaks)

On August 30, 2011, Wikileaks published a December 19, 2005 cable written by Daniel Rubinstein. The cable illustrates the degree to which the U.S. Department of State monitors the implementation of the Jordan-US FTA agreement, as regards disputes over rules on data exclusivity.

240 Wikileaks cables on pharmaceutical data exclusivity

August 29, 2011
From KEI staff review of Wikileaks cables (http://keionline.org/wikileaks)

The following are the cables identified in an August 29, 2011 search of the wikileaks cables, from http://cablesearch.net, using the search terms data exclusivity and pharmaceutical. This search identified 240 cables. Some 40 countries are mentioned in the cables. More than half of the cables involve 5 countries: Turkey (76), Taiwan (21), El Salvador (11), Honduras (11) and Tunisia (10).

From Wikileaks, a US government cable on its involvement to shape Guatemala legislation on pharmaceutical IPR

August 28, 2011
From KEI staff review of Wikileaks cables (http://keionline.org/wikileaks)

Among the many new cables released by Wikileaks is this gem, a detailed account of the U.S. government pressure on the Guatemala legislature to shape legislation on pharmaceutical test data IPR.

http://wikileaks.org/cable/2005/03/05GUATEMALA659.html

C O N F I D E N T I A L SECTION 01 OF 05 GUATEMALA 000659

SIPDIS

E.O. 12958: DECL: 03/11/2010
TAGS: ETRD KIPR PGOV PREL GT

Ambassador Kirk's responses to Senate Finance Committee suggests enforcement of TRIPS-plus data exclusivity measures

Recently, Ambassador Ron Kirk, the United States Trade Representative (USTR) responded to follow up questions from the U.S. Senate Finance Committee regarding the 2011 Trade Agenda. In addition to asserting that the U.S. Congress is not bound by ACTA, the responses suggest USTR desire to establish requirements for the implementation of data exclusivity provisions.

Senator Sanders Letter to FDA: U.S. needs an ethical pathway for biological products

On November 2, 2010, U.S. Senator Bernard Sanders (VT-I) sent a letter to Margaret Hamburg, the FDA Commissioner, urging the agency to review the ethical implications of the 12 years of marketing exclusivity created by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Endorsements of Ethical Pathway Cost Sharing Proposal

On September 29, 2010, Senator Sanders introduced bill S. 3921 to the 111th Congress, the Ethical Pathway Act of 2010, To ensure that rules for the approval of pharmaceutical and biological products do not require violations of medical ethics in the testing of products in humans and vertebrate animals.

The following organizations and individuals have endorsed the bill.

United States

Non-government organizations:

Knowledge Ecology International
U.S. PIRG
Universities Allied for Essential Medicines (UAEM)

Senator Sanders' summary of Ethical Pathway Act of 2010 – S. 3921

The following is a summary of S. 3921, 111th Congress, the Ethical Pathway Act of 2010, provided by the Office of Senator Sanders, plus an attachment of Article 20 and 21 f the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.

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