[Ip-health] The USTR Special 301 Report, some initial reactions

Meri Koivusalo merikoivusalo at yahoo.co.uk
Mon May 2 22:50:23 PDT 2011

I am not sure if the emphasis on not addressing pharmaceutical policy matters is 
valid in the context of 

suggested measures, for example, with respect to Finland. I do not think there 
is a failure in protection of
IPR, but rather a failure of not paying more for pharmaceuticals, when on the 
basis of international law you
do not need to. 

Finland and I believe also Norway remain because of pharmaceutical policies in 
essence as there should be no
reason why these countries should have had product patent protection before 
becoming Members 

of WTO. I do not know how matters prior to TRIPS negotiations have become part 
of trade concerns. In Finland the background is in a successful reference 
pricing programme, which managed to cut pharmaceutical costs.

Meri Koivusalo
Senior Researcher
National Institute for Health and Welfare

From: Jamie Love <james.love at keionline.org>
To: Ip-health <ip-health at lists.keionline.org>; a2k at lists.keionline.org
Sent: Tue, 3 May, 2011 1:19:50
Subject: [Ip-health] The USTR Special 301 Report, some initial reactions

Source URL: http://keionline.org/node/1124

The USTR Special 301 Report, some initial reactions
2 May 2011

The USTR Special 301 Report was issued today. The full report is here
[1], the USTR web page on the report is here [2], and a link to the
USTR press release about the report is here [3]. Earlier copies of the
301 Reports are available at: http://keionline.org/ustr/special301 [4]

Making the list were 12 countries on the "Priority Watch List," 28
countries on the "Watch List" and one country for Section 306

The 41 countries include 5 of the 27 members of the European Union, 2
of 2 non_US members of NAFTA, 3 of 4 members of Mercosur, 2 of 53
members of the African Union, 5 of the 9 countries in the TransPacific
Partnership negotiations, 11 countries in Latin America, and 19 of 52
countries in Asia. (Some countries fit in more than one category).

It will take a while to digest the latest round of the 301 report. On
the copyright side, much of it is fairly familiar. On the medicines
side, note that USTR cited 20 countries for inadequate intellectual
property protection for data used to register pharmaceutical drugs,
including 4 of the 9 members of the TPP negotiation, one of which is
classified as a least developed country (Viet Nam).

Several countries, including Poland, Japan and New Zealand, which were
not on any of the lists, were nonetheless mentioned in the context on
drug and medical device pricing issues.

Overall, the Special 301 Report should be looked at as only part of a
much larger campaign by the Obama Administration to press trading
partners to change intellectual property norms. The USTR discussion of
IPR policy concerns seems muted in the report, compared to the
pressure that the US government actually applies both behind the
scenes and in different trade fora. In practice, the 301 Report
represents only a fraction of the issues being raised and the
pressures being applied by the White House and various federal

That said, it was a disappointment to read that USTR is pressing so
hard on the pharmaceutical test data issue, including even for a Least
Developed Country (LDC), and that the USTR cites the Philippines for
tying patentability of certain chemical forms unless the applicant
demonstrates increased efficacy, and complains that India does not
patent "temperature-stable forms of a drug or new means of drug
delivery." During the hearings, public health groups made it quite
clear that it was important for developing countries to continue to
have the flexibility to limit the evergreening of pharmaceutical
products via these types of patents.

Beyond the 301 Report, public health groups need to monitor the less
transparent aspects of the Obama trade policy, and the remarkable
revolving door with industry lobbyists.

>From the 301 Report discussion of pharmaceuticval and medical device pricing:

Supporting Pharmaceutical and Medical Device Innovation through
Improved Market Access
USTR has sought to reduce market access barriers that U.S.
pharmaceutical and medical device companies face in many countries,
and to facilitate both affordable health care today and the innovation
that assures improved health care tomorrow. For example, this year’s
Special 301 Report highlights concerns regarding market access
barriers affecting pharmaceutical products in Algeria and Indonesia.

Even where a trading partner’s IPR regime demonstrates a commitment to
strong IPR protection, other types of measures have the potential to
affect market access in the pharmaceutical and medical device sector.
For example, government practices including unreasonable regulatory
approval delays and potentially unfair reimbursement policies can
discourage the development of new drugs and other medical products.
The criteria, rationale, and operation of such measures are often
nontransparent or not fully disclosed to patients or to pharmaceutical
and medical device companies seeking to market their products. USTR
encourages trading partners to provide appropriate mechanisms for
transparency, procedural and due process protections, and
opportunities for public engagement in the context of their relevant
health care systems.

U.S. industry has expressed concerns regarding the policies of several
industrialized trading partners, including Finland, Germany, Greece,
Japan, Korea, New Zealand, Poland, and Taiwan, on issues related to
innovation in the pharmaceutical sector and other aspects of health
care goods and services. Examples include:

* With respect to Japan, pharmaceutical and medical device issues are
an integral part of regular bilateral discussions. While Japan has
made progress on these issues, the United States continues to work
with Japan to seek continued improvements in transparency in addition
to further reform of reimbursement and regulatory systems that would
facilitate the timely introduction of innovative pharmaceuticals and
medical devices into Japan’s market.

* With respect to Poland, U.S. industry is concerned about healthcare
reform legislation introduced in 2010 that would alter Poland’s
pricing, reimbursement, and clinical trials policies. Industry
continues to express concern about the pharmaceutical industry’s
general lack of ability to meet with the Ministry of Health to provide
their perspectives on policy initiatives.

* With respect to New Zealand, U.S. industry has expressed serious
concerns about the policies and operation of New Zealand’s
Pharmaceutical Management Agency (PhARMAC). Industry continues to
express concerns regarding, among other things, the transparency,
fairness, and predictability of the PHARMAC pricing and reimbursement
regime, as well as the overall climate for innovative medicines in New

The United States is seeking to establish or continue dialogues with
relevant trading partners to address these and other sectoral
concerns, and encourage a common understanding on questions related to
innovation in the pharmaceutical and medical device sectors. For
example, the United States-Korea Free Trade Agreement, once in force,
would improve access to innovative medical products and ensure the
transparent, predictable, and non-discriminatory pricing and
reimbursement of innovative and generic pharmaceutical products, and
medical devices. The United States is also continuing its engagement
with China to promote fair and transparent policies in this sector.
The United States shares policy goals and concerns related to health
care with other countries, including challenges surrounding aging
populations and rising health care costs. The United States also
shares the objective of continued improvement in the health and
quality of life of its citizens, and the objective of delivering care
in the most efficient and responsive way possible. The United States
looks forward to engaging with these trading partners to address
specific concerns related to reimbursements, regulatory policies, and

Source URL: http://keionline.org/node/1124
[1] http://keionline.org/sites/default/files/2011Special301Report.pdf


[4] http://keionline.org/ustr/special301

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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