[Random-bits] Thailand and medicine patents: an early test for Obama trade policy

[James Love]

http://www.huffingtonpost.com/james-love/thailand-and-medicine-pat_b_173839.html

Thailand and medicine patents: an early test for Obama trade policy

Around the 30th of April, the United States Trade Representative will
issue something called the "Special 301 Report." The USTR 301 report,
while practically unknown within the United States, will make front page
news in many developing countries. USTR describes the report as follows:

---The "Special 301" Report is an annual review of the global state of
intellectual property rights (IPR) protection and enforcement, conducted
by the Office of the United States Trade Representative (USTR) pursuant
to Special 301 provisions of the Trade Act of 1974 (Trade Act).----

This is a list of the countries that the USTR says are not meeting U.S.
standards of intellectual property protection. Countries that make the
list are put into different categories, such as "Priority Watch list,"
the "Watch List," and "Section 306." The 51 page 2008 301 Report starts
with a 15 page discussion of U.S trade policy on intellectual property
rights, followed by extensive reviews of individual countries. It is a
highly transparent and detailed expression of U.S. trade policy,
covering a diverse set of issues, such as the use of compulsory licenses
on life saving medicines, consumer protection policies for digital music
players, or exceptions in copyright law for education purposes.

In the past (through Reagan, GHW Bush, Clinton, and GW Bush
presidencies), the list has been deeply biased. It is basically an
edited version of one-sided submissions from a handful of corporate
lobby groups representing the pharmaceutical, entertainment and
publishing industries, reviewed by an advisory board made up entirely of
lobbyists for these same industries.

An early test of the Obama Administration will be the 2009 301 Report,
which is due in a few weeks. PhRMA and a significant bi-partisan group
of U.S. members of Congress are pushing to punish Thailand, for having
in the past exercised the rights guaranteed in WTO agreements and
countless World Health Organization (WHO) resolutions to protect its own
population from high drug prices, by issuing a handful of compulsory
licenses on drug patents.

The U.S. pressure on Thailand has been the subject of widespread censure
within the global public health community. Our government has ignored
and violated countless global agreements that allow or even demand that
Thailand take steps to promote access to medicine for all.

The U.S. position violates the human rights of people who living in
Thailand, and demonstrates our callous disregard for commitments we have
made in the WTO (the 2001 Doha Declaration on TRIPS and Public Health).

Many members of Congress, from both parties, are prone to making
demagogic statements about IPR enforcement in developing countries. They
often understand practically nothing of the legal, moral or practical
issues at play. Pushed by lobbyists who shovel out money to anyone in
power, some members of the U.S. Congress find it much easier to give a
speech about how U.S. industries are being ripped off by developing
countries who steal our intellectual property, than to find ways that
would truly make the U.S. more innovative and competitive in the modern
economy.

In a few weeks, Obama will set his first stamp on U.S. trade policy. It
will be challenging to change policy in the short run, given the deeply
embedded values and prejudices that exist in the current system, and the
lack of IPR knowledge and sophistication by the incoming USTR head, Ron
Kirk. At a very minimum, Thailand should be spared a 301 listing for its
commendable efforts to promote access to medicines for all, and the
White House should have its own talented innovation and public health
teams take a close look at the wrong headed policies that USTR is
pushing globally.

White House officials like Michael Froman should give some face time to
NGOs that work on public health and trade issues, consumer groups,
librarians, and innovative businesses that understand the benefits of
more balanced IPR policies generally.

Notes: Bangkok Post on recent U.S. trade pressures.
http://www.bangkokpost.com/news/local/12667/cheap-drug-cap-raises-outcry

KEI Web page on disputes involving Thailand and medicine patents.
http://www.keionline.org/content/view/90/1/

==============================================

    All of these issues are technically complex, and difficult to
evaluate based only upon the USTR 301 Report, which is highly selective
or biased in how it presents disputes. Here are a few examples of the
provisions of the 51 page 2008 301 Report:

    Thailand
    While the United States recognizes the importance of Thailand's
public health challenges, Thailand's recent policies and actions
regarding the compulsory licensing of patented medicines have
contributed to continuing concerns regarding the adequate and effective
protection of IPR in Thailand. The United States is awaiting further
information on the new Thai government's approach in this area and hopes
to work constructively on this and other IPR issues in order to
strengthen Thailand's IPR regime.

    Chile
    Chile will remain on the Priority Watch List in 2008. Chile's IPR
performance continues to fall well below expectations for a U.S. free
trade agreement partner. The United States remains concerned about
inadequate protection against unfair commercial use of undisclosed test
and other data generated to obtain marketing approval for pharmaceutical
products and insufficient coordination between Chile's health and patent
authorities to prevent the issuance of marketing approvals for
unauthorized copies of patented pharmaceutical products.

    Supporting Pharmaceutical Innovation
    Historically, the Special 301 process has focused on the strength of
intellectual property protection and enforcement by our trading
partners. However, even where a country's IPR regime is adequate, price
controls and regulatory and other market access barriers can discourage
the development of new drugs.

    China
    The United States continues to urge China to price drugs in a manner
that appropriately values innovations and to add new drugs to its
national formulary, which controls access to medicines 16 for China. The
United States also urges China to adopt regulatory and reimbursement
policies for medical devices that support innovation and increase the
transparency and predictability in that market.

    IPR and Interoperability
    In France, for example, copyright legislation enacted in August 2006
contains provisions enabling a government entity to mandate the
disclosure of IP-protected digital rights management information in the
interest of promoting interoperability. The United States has expressed
concern that this legislation may, depending on its implementation,
impinge upon IPR of both the creators of the digital rights management
technologies and of creative works protected by those technologies.
Similar approaches reportedly are being considered in other European
countries, including Belgium, Germany, Norway, and Sweden. In addition,
these issues are receiving attention within the European Commission. In
some cases, consumer protection laws and regulatory authorities have
been engaged to pursue interoperability at the potential expense of IP
right holders. This complex intersection of issues will continue to
receive U.S. policy attention in the coming year.


-- 
James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
Wk: +1.202.332.2671 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.6584