[Ip-health] Waxman, Rangel and Levin letter to Zoellick on CAFTA

[Mike Palmedo]

http://www.cptech.org/ip/health/trade/cafta/waxman-levin-rangel12102003.pdf

The Honorable Robert B. Zoellick
United States Trade Representative
Winder Building, 600 17th Street, NW
Washington, DC 20508

Dear Mr. Ambassador:

We are writing to express our strong opposition to the inclusion of
marketing approval restrictions for pharmaceutical products in the
Central American Free trade Agreement (CAFTA).  Specifically, we
understand that USTR is proposing to include a provision that would
preclude generic alternatives from obtaining regulatory marketing
approval based on approval granted for a brand name drug in that market,
or another market, for a 5-8 year period.  (For ease of reference, we
refer to the provisions as "marketing exclusivity" requirements.)  We
believe that imposing such a requirement on developing countries will
stifle the pharmaceutical marketplace, impede access to and availability
of drugs, and drive drug prices to unaffordable levels for many in
Central America.

The United States has successfully used a limited period of marketing
exclusivity to enhance the availability of lower-cost drugs.  It has
been done, however, in conjunction with measures to accelerate the
approval of generic alternatives.  As you know, marketing exclusivity
was granted to pharmaceutical companies in return for a new program
under which low-cost generic drugs became available to Americans for the
first time.

The situation in Central America is very different.  First, the Central
American countries already have access to a robust generic market and
will receive nothing in exchange for delaying that access.  Second,
unlike the United States, the CAFTA countries have large rural and
uninsured populations who pay out-of-pocket for drugs.  Many Central
American consumers could become entirely shut out of the healthcare
system if fewer generics were available.  For any patient, particularly
those with high-risk diseases, five years without access to affordable
drugs can be the difference between life and death.  The prospect is
especially dangerous considering that four of the six countries with the
highest HIV/AIDS prevalence in Latin America are in Central America,
rising rates of untreated diabetes and heart disease are already
crippling, and the highly indebted CAFTA countries cannot afford to
divert their limited healthcare budgets to pay for higher drug costs.

Delaying the introduction of generic competition for 8 years or more -
even where patent barriers no longer exist - is inappropriate for
developing countries facing these challenges.  We urge you to strike the
articles of the CAFTA agreement requiring 5- and 3-year marketing
restrictions for pharmaceutical products and ensure that the people of
Central America retain their right to affordable, life-saving medicine,
in a timely and efficient way.

Sincerely,

HENRY A. WAXMAN
Renking Member
House Committee on Government Reform

CHARLES B. RANGEL
Ranking Member
House Committee on Ways and Means

SANDER M. LEVIN
Ranking Member
Housee Committee on Ways and Means
Subcommittee on Trade