[Ip-health] Essential LTE in The Hill: WTO allows broad grounds to copy patented medicines --
[ Picked text/plain from multipart/alternative ]


LETTERS

WTO allows broad grounds to copy patented medicines
By Peter Maybarduk and Robert Weissman of Essential Action
June 05, 2007
Ian Swansonâs article, âPhRMA takes aim at Thailand for production of
generics, hints that it will push for sanctionsâ (May 23), states,
âWorld Trade Organization (WTO) rules do grant poor countries the
right to issue compulsory licenses authorizing the production of
generic drugs to deal with public health crises.â While this is true,
it is important to note WTO rules do not limit compulsory licensing
to public health crises or to poor countries.

Under the WTOâs Agreement on Trade-Related Aspects of Intellectual
Property Rights, countries are free to issue compulsory licenses on
whatever grounds they choose (TRIPS Article 31). To remedy confusion
about this point, the member countries of the WTO adopted the Doha
Declaration on the TRIPS Agreement and Public Health. It specifically
states, âEach member has the right to grant compulsory licences and
the freedom to determine the grounds upon which such licences are
granted (Paragraph 5(b)).â Government use or emergency circumstances
such as public health crises simply allow members to bypass otherwise
required procedures, such as negotiating with rights holders before
issuing a license (TRIPS Article 31(b)).

On its Frequently Asked Questions page, the WTO calls the idea of an
emergency requirement âa common misunderstanding.â

Also, the provisions of TRIPS Article 31 and Doha extend to all WTO
âMembers.â Indeed, rich countries routinely use compulsory licensing
in a variety of contexts. The United States is likely the most
frequent user of compulsory licensing.

~Peter Maybarduk and Robert Weissman of Essential Action, Washington

-------------



BUSINESS & LOBBYING

PhRMA takes aim at Thailand for production of generics, hints that it
will push for sanctions
By Ian Swanson
May 23, 2007
Drug companies are making a concerted effort to increase pressure on
Thailand and other developing countries to honor U.S. drug patents.

The Pharmaceutical Research and Manufacturers Association (PhRMA) is
alarmed by Thailandâs decision to authorize the production of generic
versions of two AIDS drugs that are still under U.S. company patents,
as well as one cardiovascular drug.

In particular, U.S. drug-makers worry that other countries could
emulate Thailandâs decision. Brazil earlier this month announced it
will authorize a license for the production of an AIDS drugs, PhRMA
notes.

PhRMA President and Chief Executive Officer Bill Tauzin said that in
the long term, this move could cost U.S. jobs and cause the entire
system of protecting intellectual property âto crumble.â

If other countries also issue compulsory licenses for the production
of generic drugs, particularly emerging markets like Thailand, Tauzin
said U.S. consumers would be forced to carry a greater burden of
covering the industryâs research and development costs.

World Trade Organization (WTO) rules do grant poor countries the
right to issue compulsory licenses authorizing the production of
generic drugs to deal with public health crises. But critics feel
Thailand is pushing the envelope by announcing a license for Plavix,
a cardiovascular disease medication.

Tauzin met with Thailand Health Minister Mongkol na Songkhla on
Tuesday to discuss the issuance of the three compulsory licenses. In
a follow-up call to reporters, Tauzin emphasized that his talks with
the Thai minister were frank and helpful, and that Mongkol emphasized
that his country sees the issuance of compulsory licenses as a rare
event.

Thailand officials have also suggested they may issue a compulsory
license for a cancer drug, but Tauzin said Mongkol
offered nothing new during the meeting on that subject.

Tauzin said Mongkolâs message to PhRMA was that many of Thailandâs
citizens are mired in poverty and that the country has a need for
access to cheap medicines. Tauzin said PhRMAâs hope is that Thailand
will fully consult with U.S.
companies to lower drug costs without resorting to authorizing the
production of generic drugs.

At the same time, Tauzin said that if Thailand continues to issue
compulsory licenses for the production of drugs protected by patents,
PhRMA could press the administration for tougher action. He
specifically mentioned the possibility that the U.S. could eliminate
trade preferences allowing some Thai imports to enter the country
duty-free.

Indeed, the Office of the U.S. Trade Representative late last month
issued an annual U.S. report on the status of intellectual property
protections that faulted Thailand for deteriorating patent
protections. The Special 301 report elevated Thailand to a list of
âpriority watchâ countries, which could lead to a decision to
withdraw trade preferences.

But it is unclear whether Washington will want to punish poor
countries that issue compulsory licenses to increase their supplies
of affordable drugs, particularly with Democrats in charge of
Congress and PhRMAâs influence on the wane.

Thailandâs actions have received support from some key advocates,
including former President Bill Clinton, whose Clinton Foundation has
worked with drug companies to lower prices for medicines in
developing countries. The Reuters news service this week quoted
Clinton as stating that âno company will live or die because of high
price premiums for AIDS drugs in middle-income countries, but
patients may.â

Rep. Henry Waxman (D-Calif.), in a statement released after his
meeting with the health minister said the U.S. should respect
Thailandâs decision.

But some in the pharmaceutical industry believe members of Congress
will draw a distinction between drugs for the treatment of AIDS,
malaria and tuberculosis, and those for other diseases such as cancer
or heart disease. âHow can a chronic, slow-acting, non-contagious
condition be considered a public-health crisis?â asked one lobbyist.
He suggested there could be bipartisan support for actions against
Thailand or other countries that issue compulsory licenses for non-
AIDS drugs.

In March, five Democratic senators and 12 Democratic House members
raised the issue in letters to U.S. Trade Representative Susan
Schwab. They said the use of WTO rules to produce generic AIDS drugs
is one thing, but the rules were not intended to be used on just any
medicine.

While Thailand has argued the issuance of compulsory licenses was
necessary to pay for drugs through its national health-care system,
Tauzin said the countryâs government, run by the military after a
coup last year, has increased military spending while arguing it
cannot afford to pay for patented drugs.

Tauzin said the debate will always be controversial because finding
the balance between access to medicines and paying for research and
development costs is always difficult. At the same time, he expressed
some confidence that PhRMAâs arguments would have support.


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