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
Monitoring.
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 agencies.
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.
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>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 years Special 301 Report highlights
concerns regarding market access barriers affecting pharmaceutical products in
Algeria and Indonesia.
Even where a trading partners 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 Japans market.
* With respect to Poland, U.S. industry is concerned about healthcare reform
legislation introduced in 2010 that would alter Polands pricing, reimbursement,
and clinical trials policies. Industry continues
to express concern about the pharmaceutical industrys 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 Zealands 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 Zealand.
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 transparency
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