[Ip-health] in HuffPo: What Bush did not Explain About Bird Flu

[James Love]

http://www.huffingtonpost.com/james-love/what-bush-did-not-
explain_b_9968.html

www.HuffingtonPost.com
November 1, 2005

James Love

What Bush did not Explain About Bird Flu

George Bush=92s presidential address on avian flu was welcome, even if
it was clearly designed to achieve some public relations purposes.
But it left out any coherent explanation as to how the US will deal
with the woeful state of stockpiles of antiviral drugs. And, he did
not explain why the US is actually embracing trade policies that make
things worse -- for the United States.

As Bush pointed out, if a pandemic hits, it will likely take several
months before an effective vaccine can be made available. In the
meantime, the first line of defense against avian flu will be
antiviral drugs. Despite its known shortcomings, oseltamivir, sold by
Roche under the brand name of Tamiflu, is the best drug we have, for
now. The Infectious Diseases Society of America recommends a
stockpile large enough to treat half the population. The US
stockpiles today are tiny -- enough to treat only 1 to 2 percent of
the population. This is far lower than many other high-income
countries, many of which have stockpiles large enough for 10 to 25
percent of their populations.

And these figures are based upon the assumption that each person will
only need 10 doses of Tamiflu. But the actual course of treatment may
require more doses, and use to prevent rather than treat avian flu
could require ten times as much.

The situation is far worse in developing countries, most of which
have no stockpiles of antiviral drugs at all.

Roche cannot meet the exploding demand for Tamiflu, and it is still
trying to fight off or limit efforts by generic producers in
Argentina, Canada, India, Korea, Taiwan and Thailand to produce cheap
copies of the drug.

However, even if these countries succeed in issuing compulsory
licenses to the Roche/Gillead patents on Tamiflu, to enable generic
competition for the drug, the US will still have problems importing
the medicine. This is because of a little known provision in a 2003
WTO agreement on patents and medicine. The United States elected to
"opt-out" of the WTO provisions that would have allowed foreign
countries to export generic medicines to the US, when there is a
compulsory liciense on a patent.

The US "opt-out" was extreme. It covers every conceivable case,
including cases of national emergency, such as flu pandemic, an
anthrax attack, SARS, or anything else. Now the Bush Administration
seeks to make this policy permanent, in negotiations taking place
right now, so that it can be announced a the December WTO meeting in
Hong Kong. This policy, which is coordinated with the European
Commission, is designed to undermine compulsory licensing, and
pressure poor countries not to use this tool. But now it will prevent
the US from effectively harnassing the power of the market to produce
needed stockples of generic Tamiflu.

As a consequence, we will wait years before we have the stockpiles,
putting our citizens at risk.
This is the letter we sent to USTR about the WTO issue, and here is
an earlier story I posted in the HuffPo, which describes the key role
of White House official Karl Rove in the clause that prevents the US
from importing generic medicines in a time of emergency.
Of course if we really wanted to get this right, we would adapt a
much different policy toward stockpiling of medicines for
emergencies. This is a proposal I recently wrote for the Financial
Times.

For those who care about the rest of the world, you should know that
the US government is also putting pressure on countries to stop
compulsory licensing of Tamiflu, making prices higher and shortages
worse. US trade officials are also asking poor countries to errect
very significant barriers for the registration of generic drugs,
using aggressive new demands for intellectual property rights in the
scientific evidence from clinical trials that drugs are safe and
effective. All of this is deeply resented and fuels anti-american
sentiments. The US is also opposing a global treaty on medical R&D,
that would promote global cooperation in funding new treatments for
infectious diseases and other global public health problems, because
it wants to focus on higher intellectual property rights as the only
mechanism to address innovation in new medicines.


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James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040