[Random-bits] Congressman to Secretary Leavitt on WHA R&D resolution

[James Love]

http://www.cptech.org/ip/health/who/59wha/congress05192006.pdf

May 19, 2006

The Honorable Michael Leavitt
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Secretary Leavitt:

During the week of May 22, the World Health Assembly (WHA) will meet
in Geneva to debate the World Health Organization's (WHO) Executive
Board Draft resolution EB117.R13, with a bracketed title of "[Global
framework on] essential health research and development."

At present, consumers in the United States are the major source of
financing for global R&D on new medicines, both because they pay the
highest prices in the world for patented medicines, and because
through taxes they pay more for public sector medical R&D than all
other countries combined.  It is in our national interest to share
more equitably the costs of new drug development.

Around the world, policymakers and health officials share a common
interest in encouraging greater investments in research and
development (R&D) on innovative medicines, especially those to treat
or cure pandemic diseases or neglected diseases that afflict
developing countries.  There is also a common interest in promoting a
fairer distribution of the burden for paying for new drug R&D.

There have been a number of different approaches recommended for
advancing the dual goals of increasing global research on new drugs
and of fairly sharing the R&D burden.  Some have called for
liberalization of parallel trade in medicines (also called
reimportation) between the U.S., Canada, Europe and other nations as
a market-based approach to minimizing pricing differentials among
high-income countries.  While this approach could help equalize the
R&D burden, it is unclear whether it would increase global R&D outlays.

Another approach has been to call for the elimination of so-called
price controls and reference pricing in high income countries, on the
grounds that forcing consumers in other countries to pay more for
medicines would create revenues that could be channeled into R&D
spending.  Another approach is the U.S. government's practice of
including extensive intellectual property provisions in bilateral
trade agreements, on the argument that such measures will lead to
more R&D investment.  In both these cases, it is not clear that
additional revenues raised though these policies would necessarily be
invested into R&D, and further, that such R&D would be directed at
priority research of special concern in other, especially developing,
countries.

The WHO Executive Board's resolution suggests a different model for a
more equitable sharing of medical R&D costs, which seeks not only an
overall increase in R&D outlays, but a method of focusing research on
priority public health concerns.

At the moment there is ongoing debate about what a global R&D
framework might look like.   Some governments and public health
experts have called for a broad WHO treaty on medical R&D, which
would obligate countries to support essential R&D at a certain
proportion of national income, and create a mechanism to identify and
support special priority R&D, such as for avian flu, malaria or
AIDS.  Others have suggested creating "best practice" norms, and
greater coordination on support for priority R&D projects,
particularly in the area of neglected diseases.  All parties to these
discussions correctly recognize the importance of both public and
private sector investments, and the legitimacy of a number of
different tools to stimulate investments in R&D, including
intellectual property rights.

The growing global interest in a new international agreement on
medical R&D has received endorsements by several leading medical
researchers, non-government public health, development and consumer
rights organizations and other experts.

These discussions on a global R&D framework are important, and should
be given serious consideration and debate.  The initiative before the
WHA does not bind the United States or any other party to an
outcome.  It merely provides the opportunity for a dialogue on how to
best reconcile the needs of supporting innovation in a world where
governments will also protect their consumers from high drug prices.
If the U.S. government wants its concerns about the global R&D burden
to be taken seriously by our trading partners, it should allow a full
and fair debate on the global R&D framework at the World Health
Organization.

The WHA proposal to discuss new ways to addressing the global sharing
of R&D costs is timely and important, and should be supported by the
United States government.

Thank you in advance for your consideration of our request.

Sincerely,

	Tom Allen						Dan Burton
	Member of Congress				Member of Congress

	Lloyd Doggett					Bernard Sanders
	Member of Congress				Member of Congress

	Dennis Kucinich
	Member of Congress

cc: The Honorable Susan Schwab, United States Trade Representative-
designate


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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

"If everyone thinks the same: No one thinks."  Bill Walton