[Ip-health] KEI Comments regarding USTR Request for Comments on a Public Interest Trade Advisory Committee

Claire Cassedy claire.cassedy at keionline.org
Tue Mar 25 13:52:30 PDT 2014


*Comments of KEI, regarding USTR Request For Comments From The Public On
The Creation Of The Public Interest Trade Advisory Committee And Request
For Nominees To That Committee.*

*Submitted to Regulations.gov on March 25, 2014, under docket number

Intellectual property issues are an important element of US trade
agreements, and according to a recent study by Open Secrets, the most
intensively lobbied issue, by far.

The legal issues for intellectual property rights cover patents,
copyrights, trademarks, trade secrets, rights in test data, plant variety
rights, and other legal regimes. They are complex, and impact the public in
diverse areas.

If the Public Interest Trade Advisory Committee (PITAC) is expected to
genuinely balance the intense corporate lobbying effort, and the input from
dozens of corporate representatives serving on the various USTR advisory
boards, including but not limited to the 14 members of ITAC 15 on
Intellectual Property Rights, and the 24 members of ITAC 3 on Chemicals,
Pharmaceuticals, Health Science Products and Services, it needs to have a
sufficient number of persons on the PITAC with experience in these diverse

What type of qualifications should there be for PITAC members? It will be
critical that the PITAC members have credibility and support from the
groups now working to protect consumer interests. It will also be critical
that at least some of these members have sufficient technical expertise to
understand and evaluate the dozens of complex issues in the intellectual
property chapter, as well as related elements of the trade agreements, such
as those dealing with drug pricing, of investor state dispute settlement

The terms of reference for USTR advisory boards will likely exclude many
potential members now representing consumers in trade negotiations. By
operating under a deep regime of secrecy, where members are shown
classified documents, and face severe sanctions, including fines and prison
terms for violating the confidentiality, the PITAC is perceived by many as
a public relations effort designed to blunt demands to make texts of
negotiations public, and these criticisms will be valid if USTR does not
change its policies regarding secrecy of the text tabled in the

At present the overwhelming majority of the approximately 700 persons
serving on USTR advisory boards represent well connected businesses, some
of them foreign owned (such as several members of PhRMA, BIO, the RIAA and
the Advanced Medical Technology Association). Many of the advisory board
members from business routinely share information with their corporate
clients, privately. Groups like KEI that represent the broader public
interests, need to share information with the public, but this is both not
allowed under the current USTR non-disclosure policies, and easily
monitored if such violations occur.

The system of non-disclosure agreements (NDAs) serves the business lobbies'
interests by suppressing information from the public about the
anti-consumer policies advocated by USTR. If the PITAC members are
effectively gagged by the NDAs, then this dynamic will not change.

KEI objects to the current policy of shielding communications from industry
lobbyists from the US Freedom of Information Act (FOIA). The fact that USTR
is about to choose a new advisory board consisting of a handful of persons
of unknown expertise or values regarding consumer interests in intellectual
property rights does not fix this problem. Basically, USTR is using its
advisory board system to create a non-transparent system for lobbying on
trade policy, that lies outside of the FOIA.

USTR can do much to improve the transparency of the system. It can make
more of the advisory board documents and communications public. In some
cases, there may be a rationale for some short term embargo on such
communications, if they have actual strategic value. But USTR is gilding
the lily as regards its legitimate interests in this area. If an industry
representative, or indeed any advisory board representative, is providing
views on substantive proposals in negotiations that have been tabled and
shared with all countries in a negotiation, then the documents reporting
the views of the industry representatives should be subject to FOIA, or
even routinely and pro-actively published by USTR. Members of the advisory
board should not be treated as though they are government employees --
because they represent private interests, including companies.

It is likely that USTR will receive nominations to place several academic
experts on the advisory boards. In evaluating such nominations, it is
important to consider evidence that such persons are knowledgeable and in
agreement with the views of groups that are actually fighting for consumers
in the TPP negotiations. For example, if academic experts are nominated to
address access to medicines issues, what have they written about
intellectual property policy, and do they cite and demonstrate
understanding of the comments, statements and views of KEI, Public Citizen,
MSF, HealthGap, Oxfam, Health Action International and Third World Network?
If academic experts are nominated to address copyright issues, do they cite
and have an understanding of the views of groups like EFF, TACD, the World
Blind Union, the Library Community, Public Knowledge, the Free Software
Foundation or KEI?

USTR could, and we think should, vet the nominees for the committee, so
that the groups representing consumer interests can give feedback on the
nominees. KEI does not intend to nominate anyone to serve of the PITAC, but
we would be willing to provide feedback to USTR on the nominations they
receive. Some of the other non-nominating groups may also consider offering
this type of feedback, and if USTR is serious about improving the balance
of the advisory boards, it should consider the advantages of doing this.

In closing, note that all persons who have headed the IP policy making at
the USTR have taken lobbying positions with right-holder groups after
leaving USTR, and that the lead negotiator for ACTA now works for Abbvie, a
pharmaceutical company, the first Pharma Czar for USTR works for AdvaMed,
the trade association, Victoria Espinel is now the head of BSA, a former
BSA head has been nominated to a high level job at USTR where he reportedly
wants to supervise IPR policy, and Stan McCoy is reportedly on his way to a
right-holder lobbying job in Brussels, an occupation he held before joining
USTR. USTR has a big revolving door problem, and putting a handful of
persons on an advisory board saddled with non-disclosure agreements is a
weak response to large issues -- USTR's continued war on poor people and
more generally, USTR's ongoing war on consumers. The new advisory board
should not be the end of reforms as regards the lack of transparency and
asymmetric secrecy of negotiating texts, or the need to address the capture
of USTR policy by a handful of right-holder industry lobbies.

*ANNEX, members of ITAC 15 and ITAC 3.*

*Intellectual Property Rights, ITAC 15 (Total Members = 14)*

Gregg H. Alton, Esq.
Executive Vice President, Corporate and Medical Affairs, Secretary and
Chief Compliance Officer
Gilead Sciences, Inc.

Mark Chandler, Esq.
Senior Vice President, General Counsel, and Secretary
Cisco Systems, Inc.

Laura H. Covington, Esq.
Vice President, Intellectual Property Policy
Yahoo! Inc.

Sarah B. Deutsch, Esq
Vice President and Deputy General Counsel
Verizon Communications

Tanuja Garde, Esq.
Executive Counsel for Intellectual Property, General Counsel for Engineering
GE Aviation

Mr. Erin-Michael Gill
Executive Vice President, Technology Division
Representing MDB Capital Group LLC

J. Anthony Imler, Ph.D.
Representing Johnson & Johnson

Mr. Erik H. Iverson
President, Business and Operations
Infectious Disease Research Institute

Mr. Roy S. Kaufman
Managing Director, New Ventures
Copyright Clearance Center

Mr. Richard H. Kjeldgaard
Representing Pharmaceutical Research and Manufacturers of America

Jeffrey P. Kushan, Esq.
Sidley Austin
Representing Biotechnology Industry Organization

Brian S. Roman, Esq.
Senior Vice President
and Chief Compliance Officer
Mylan Inc.

Mr. Timothy P. Trainer
Galaxy Systems, Inc.

Neil I. Turkewitz, Esq.
Executive Vice President, International
Recording Industry Association of America

*Chemicals, Pharmaceuticals, Health Science Products and Services, ITAC 3 *
(Total Members = 24)

Mr. Luis H. Arguello, Jr.
Vice President
DemeTech Corporation

Mr. V. M. (Jim) DeLisi
Fanwood Chemical, Inc.

Mr. Donald E. Ellison
President, Government Relations, LLC
Representing Damping Technologies, Inc.

Ms. Justine Freisleben
Manager, Government Relations
Society of Chemical Manufacturers & Affiliates

D. Geoffrey Gamble, Esq.
Representing The National Foreign Trade Council, Inc.

Mr. David R. Gaugh
Senior Vice President, Sciences and Regulatory Affairs
Generic Pharmaceutical Association

Mr. Edward L. Gibbs
Chief Executive Officer
North Coast Medical Equipment, Inc.

Mr. Vijay Goradia
Vinmar International, Ltd.

Trevor J. Gunn, Ph.D.
Managing Director, International Relations
Medtronic, Inc.

Jonathan Herzog, Esq.
Counsel, Trade-International
St. Jude Medical, Inc.

Mr. Ralph F. Ives
Executive Vice President, Global
Strategy and Analysis
AdvaMed: Advanced Medical Technology Association

Ms. Tonya L. Kemp
Director, International Trade Policy
Global Strategies
Personal Care Products Council

Mr. Maurice J. Kerins
Airmed Biotech, Inc.

Mr. Craig S. Kramer
Vice President, International
Government Affairs
Johnson & Johnson

Mr. Adrian Krygsman
Director, Product Registration
Troy Corporation

Mr. A. E. (Ted) May, III
Vice President and General Manager
Andersen Products, Inc.

Matthew T. McGrath, Esq.
Barnes, Richardson and Colburn
Representing FMC Corporation

Douglas T. Nelson, Esq.
Senior Advisor for Trade, Intellectual Property
and Strategic Affairs
CropLife America

Ms. Michelle L. Orfei
Director, Global Affairs
American Chemistry Council

Ms. Lisa A. Phillip
President and Chief Executive Officer
Hybas International, LLC

George L. Rolofson, Ph.D.
Consultant in Agricultural Science
and Environmental, Regulatory, and Trade Policy
Rolofson Consulting
Representing Gowan Company

Mr. Richard I. Sedlak
Executive Vice President, Technical
and International Affairs
The American Cleaning Institute

Harry L. Vroomen, Ph.D.
Vice President, Economic Services
The Fertilizer Institute

Mr. Thomas G. Zieser
President and Chief Executive Officer
JACE Systems

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