[Ip-health] USTR's new hearings on 301 list

[Malini Aisola]

http://keionline.org/node/745

USTR's new hearings on 301 list
By James Love

12 Jan 2010

USTR has issued an announcement for new procedures including public
hearings on the 2010 Special 301 list. This is an effort to make the 301
process somewhat more open, and to provide more formal opportunities to
both supporters and critics of USTR's bilateral trade pressures to make
their case. USTR's actions are welcomed by several NGOs that have been
critical of the unilateral trade pressures initiative, as it seems to
provide the beginning of a more mature discussion about the objectives
of trade policy, and the evidence to support different positions.
Whether this optimism is warranted remains to be seen, as the nature of
IP policy remains quite political and analytically shallow, within
Washington, DC political circles.

KEI will be providing comments in this proceeding, and we encourage
other to as well. Given that this is the first time the hearings will be
held, and it will be the first time the Obama Administration has truly
been managing the process, it should provide an important opportunity to
present arguments in support of changes in trade policy that would
include a less hostile attitude to consumer interests. Whether or not
such arguments will resonate with USTR or other agencies in the federal
government is an open question, given the mixed messages that have
emerged over the past year on intellectual property issues.

Historically, the USTR Special 301 list has been primarily based upon
submissions from two organizations -- PhRMA, which focuses on IPR and
pricing issues relating to medicines, and the International Intellectual
Property Alliance (IIPA) [1], which represents publishers and copyright
owners. Both PhRMA and IIPA provide detailed "asks" to USTR, which are
generally edited down into somewhat more modest demands the US
government places on other countries. The 301 list is a roadmap to U.S.
foreign policy in this area. As important as the position on the list
(which includes different pejorative categories) are the specific acts
described in the report. For example, when a country is "listed" for
considering a compulsory license on a medicine patent or curbing
excessive prices of textbooks, this normally means the trade and foreign
policy bureaucracy engages with countries to change policies. This
engagement can be at a low level, but in many well known cases is
escalated to ambassadors, members of the President's cabinet, and even
the Vice President and the President of the United States. The Special
301 report is actually part of an extensive and intensively managed
process within the government, that is largely unknown to U.S. citizens,
but has a high profile in some foreign countries.

In 2009, public health groups lobbied the Obama administration
intensively to keep Thailand off the 301 list for having issued
compulsory licenses on medicines -- a practice that is endorsed in the
2001 WTO Doha Declaration on TRIPS and Public Health (and similar WHO
trade and health global norms), all of which were approved by the US
government. During his 2008 campaign, Obama had promised to protect
developing countries from pressures on AIDS drug patents, and Hillary
Clinton had gone further and said she would not punish Thailand for
issuing compulsory licenses on patents for other diseases. To the
disappointment of public health groups, USTR placed Thailand on the
priority watch list, for having issued compulsory licenses on medicine
patents. USTR later defended its actions by saying there were no formal
submissions from public health groups on this issue. The response was
that there was no procedure for such submissions from health groups.
That discussion probably contributed to the changes in policy this
year.

Below is the USTR notice:

[Billing Code 3190-W0]
January 12, 2010

Office of the United States Trade Representative

2010 Special 301 Review: Identification of Countries Under Section 182
of the Trade Act of 1974: Request for Public Comment and Announcement of
Public Hearing

Agency: Office of the United States Trade Representative

Action: Request for written submissions from the public and announcement
of public hearing.

Summary:
Section 182 of the Trade Act of 1974 (Trade Act) (19 U.S.C. ' 2242)
requires the United States Trade Representative (USTR) to identify
countries that deny adequate and effective protection of intellectual
property rights (IPR) or deny fair and equitable market access to U.S.
persons who rely on intellectual property protection. (The provisions of
Section 182 are commonly referred to as the =E2=80=9CSpecial 301=E2=80=9D p=
rovisions of
the Trade Act.). The USTR is required to determine which, if any, of
these countries should be identified as Priority Foreign Countries.
Acts, policies, or practices that are the basis of a country=E2=80=99s
identification as a Priority Foreign Country can be subject to the
procedures set out in sections 301-305 of the Trade Act.

In addition, USTR has created a =E2=80=9CPriority Watch List=E2=80=9D and =
=E2=80=9CWatch List=E2=80=9D
to assist the Administration in pursuing the goals of the Special 301
provisions. Placement of a trading partner on the Priority Watch List or
Watch List indicates that particular problems exist in that country with
respect to IPR protection, enforcement, or market access for persons
relying on intellectual property. Trading partners placed on the
Priority Watch List are the focus of increased bilateral attention
concerning the problem areas.

USTR chairs an interagency team that reviews information from many
sources, and that consults with and makes recommendations to the USTR on
issues arising under Special 301. Written submissions from interested
persons are a key source of information for the Special 301 review
process. In 2010, USTR through the Special 301 Committee will conduct a
public hearing as part of the review process.

USTR is hereby requesting written submissions from the public concerning
foreign countries=E2=80=99 acts, policies, or practices that are relevant t=
o the
decision on whether a particular trading partner should be identified as
a priority foreign country under Section 182 of the Trade Act or placed
on the Priority Watch List or Watch List. Interested parties, including
foreign governments, who want to testify at the public hearing must
submit a request to testify at the hearing and a short hearing
statement. The deadlines for these procedures are set out below.

DATES:
The schedule for the 2010 Special 301 review is set forth below.

Tuesday, February 16, 2010 (by 5:00 p.m.) =E2=80=93 For interested parties,
except for foreign governments:  Submit written comments, requests to
testify at the Special 301 Public Hearing, and hearing statements.

Tuesday, February 23, 2010 (by 5:00 p.m.) =E2=80=93 For foreign governments=
:
Submit written comments, requests to testify at the Special 301 Public
Hearing, and hearing statements.

Wednesday, March 3, 2010, and additional days from March 4-8, 2010 as
necessary =E2=80=93 Special 301 Committee Public Hearing for interested par=
ties,
including representatives of foreign governments, will be held at the
United States International Trade Commission, 500 E St. S.W.,
Washington, D.C. 20436.

On or about April 30, 2010 -- In accordance with statutory requirements,
USTR will publish the 2010 Special 301 Report on or about April 30,
2010.

Address: All written comments, requests to testify, and hearing
statements should be sent electronically via http://www.regulations.gov
[2], docket number USTR-2010-0003. Submissions should contain the term
=E2=80=9C2010 Special 301 Review=E2=80=9D in the =E2=80=9CType comment & Up=
load file=E2=80=9D field on
www.regulations.gov [2].

For further information contact: Jennifer Choe Groves, Senior Director
for Intellectual Property and Innovation and Chair of the Special 301
Committee, Office of the United States Trade Representative, at (202)
395-4510. Further information about Special 301 can be located at
www.ustr.gov [3].

Supplementary Information:

1. Background

USTR requests that interested persons identify those countries that deny
adequate and effective protection for intellectual property rights or
deny fair and equitable market access to U.S. persons who rely on
intellectual property protection. USTR requests that, where relevant,
submissions mention particular regions, provinces, states, or other
subdivisions of a country in which an act, policy, or practice is
believed to warrant special attention. Submissions may report positive
or negative developments with respect to these sub-national entities.

Section 182 contains a special rule regarding actions of Canada
affecting United States cultural industries. The USTR must identify any
act, policy or practice of Canada that affects cultural industries, is
adopted or expanded after December 17, 1992, and is actionable under
Article 2106 of the North American Free Trade Agreement (NAFTA). USTR
must make the above-referenced identifications within 30 days after
publication of the National Trade Estimate (NTE) report, i.e.,
approximately April 30, 2010.

2. Public Comments

a. Written Comments
The Special 301 Committee invites written submissions from the public
concerning foreign countries=E2=80=99 acts, policies, or practices that are
relevant to the decision whether a particular trading partner should be
identified under Section 182 of the Trade Act. As noted above,
interested parties, except for foreign governments, must submit written
comments by February 16, 2010 at 5:00 p.m. Interested foreign
governments must submit written comments by February 23, 2010 at 5:00
p.m.

b. Requirements for Comments
Written comments should include a description of the problems
experienced by the submitter and the effect of the acts, policies, and
practices on U.S. industry. Comments should be as detailed as possible
and should provide all necessary information for assessing the effect of
the acts, policies, and practices. Any comments that include
quantitative loss claims should be accompanied by the methodology used
in calculating such estimated losses. Comments must be in English. All
comments should be sent electronically via http://www.regulations.gov
[2], docket number USTR-2010-0003.

To submit comments to http://www.regulations.gov [2], find the docket by
entering the number USTR-2010-0003 in the ``Enter Keyword or ID'' window
at the http://www.regulations.gov [2] home page and click ``Search.''
The site will provide a search-results page listing all documents
associated with this docket. Find a reference to this notice by
selecting =E2=80=9CNotice=E2=80=9D under =E2=80=9CDocument Type=E2=80=9D on=
 the left side of the
search-results page, and click on the link entitled =E2=80=9CSubmit a
comment.=E2=80=9D (For further information on using the
http://www.regulations.gov [2] website, please consult the resources
provided on the website by clicking on =E2=80=9CHow to Use This Site=E2=80=
=9D on the
left side of the home page).

The http://www.regulations.gov [2] site provides the option of providing
comments by filling in a =E2=80=9CType comment & Upload file=E2=80=9D field=
, or by
attaching a document. It is USTR=E2=80=99s preference that comments be prov=
ided
in an attached document. If a document is attached, please type =E2=80=9C20=
10
Special 301 Review=E2=80=9D in the =E2=80=9CType comment & Upload file=E2=
=80=9D field. USTR
prefers submissions in Microsoft Word (.doc) or Adobe Acrobat (.pdf). If
the submission is in an application other than those two, please
indicate the name of the application in the ``Comments'' field.

3. Public Hearing

a. Notice of Public Hearing
The Special 301 Committee will hold a public hearing at the United
States International Trade Commission, 500 E St. S.W., Washington, D.C.
20436 for interested parties, including representatives of foreign
governments, beginning on March 3 and continuing through March 4-8 (as
necessary). The hearing will be open to the public, and a transcript of
the hearing will be made available on www.ustr.gov [3].

b. Submission of Requests to Testify at the Public Hearing and Hearing
Statements

All interested parties, except foreign governments, wishing to testify
at the hearing must submit, by 5:00 p.m. on February 16, 2010, a =E2=80=9CN=
otice
of Intent to Testify=E2=80=9D and =E2=80=9CHearing Statement=E2=80=9D to
http://www.regulations.gov [2] (following the procedures set forth in
=E2=80=9CRequirements for Comments=E2=80=9D above), the name of the witness=
, name of the
organization (if applicable), address, telephone number, fax number, and
e-mail address. Oral testimony before the Special 301 Committee will be
limited to one five-minute presentation in English. A five-minute period
will be allowed for questions from the Special 301 Committee. If those
testifying wish to submit a longer =E2=80=9CHearing Statement=E2=80=9D for =
the record,
it must accompany the =E2=80=9CNotice of Intent to Testify=E2=80=9D to be s=
ubmitted on
February 16, 2010.

All interested foreign governments who wish to testify at the hearing
must submit, by 5:00 p.m. on February 23, 2010, a =E2=80=9CNotice of Intent=
 to
Testify=E2=80=9D to http://www.regulations.gov [2] (following the procedure=
s set
forth in =E2=80=9CRequirements for Comments=E2=80=9D above), the name of th=
e witness,
name of the organization (if applicable), address, telephone number, fax
number, and e-mail address. Oral testimony before the Special 301
Committee will be limited to one five-minute presentation in English. A
five-minute period will be allowed for questions from the Special 301
Committee. If foreign governments testifying wish to submit a =E2=80=9CHear=
ing
Statement=E2=80=9D for the record, it must be submitted by February 23, 201=
0.

4. Business Confidential Information
A person requesting that information contained in a comment submitted by
that person be treated as confidential business information must certify
that such information is business confidential and would not customarily
be released to the public by the submitter. Confidential business
information must be clearly designated as such, the submission must be
marked =E2=80=9CBUSINESS CONFIDENTIAL=E2=80=9D at the top and bottom of the=
 cover page
and each succeeding page, and the submission should indicate, via
brackets, the specific information that is confidential. Additionally,
=E2=80=9CBusiness Confidential=E2=80=9D should be included in the =E2=80=9C=
Type comment & Upload
file=E2=80=9D field. Anyone submitting a comment containing business
confidential information must also submit as a separate submission a
non-confidential version of the confidential submission, indicating
where confidential information has been redacted. The non-confidential
summary will be placed in the docket and open to public inspection.

5. Inspection of Comments, Notices, and Hearing Statements
USTR will maintain a docket on the 2010 Special 301 Review, accessible
to the public. The public file will include non-confidential comments,
notices of intent to testify, and hearing statements received by USTR
from the public, including foreign governments, with respect to the 2010
Special 301 Review. Comments will be placed in the docket and open to
public inspection pursuant to 15 CFR 2006.13, except confidential
business information exempt from public inspection in accordance with 15
CFR 2006.15. Comments may be viewed on the http://www.regulations.gov
[2] website by entering docket number USTR-2010-0003 in the search field
on the home page.

Stanford K. McCoy
Assistant U.S. Trade Representative for Intellectual Property and
Innovation


Links:
[1] http://www.iipa.com/
[2] http://www.regulations.gov
[3] http://www.ustr.gov



--
Malini Aisola
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington DC 20009
malini.aisola@keionline.org|Tel: +1.202.332.2670|Fax: +1.202.332.2673