U.S.-Belgium Confidentiality Agreement Signed

UNCLAS BRUSSELS 001371

SIPDIS

SIPDIS

STATE FOR OES/IHA AND EUR/UBI
USDOC FOR 4212/OECA/JLEVINE

E.O. 12958: N/A
TAGS: TBIO ETRD BE
SUBJECT: U.S.-Belgium Confidentiality Agreement Signed



1. (SBU) On April 23, U.S. Food and Drug Administration
(FDA) Deputy Commissioner Murray Lumpkin signed a Bilateral
Confidentiality Agreement with Piet Vanthemsche, head of

SIPDIS
the recently created Belgian Federal Agency for Medications
and Health Products (AFMPS). Deputy Econ Counselor
represented the Embassy at the signing. The agreement,
which has been under discussion for the past three years,
will assure confidential handling of information -
including nonpublic, regulatory, and/or business
proprietary information - about pharmaceutical production
that is shared by the two countries as they verify
production standards and quality of medications, as well as
cooperate on public information regarding health products.


2. (SBU) The new Agreement can facilitate the production
and sharing of drugs and vaccinations, which would be
particularly important in the event of an avian flu
pandemic. The Agreement also will aid coordination in the
fight against counterfeit pharmaceuticals. Trade in
counterfeit versions of legitimate pharmaceuticals is
expanding rapidly, reportedly overtaking the illegal drug
trade in terms of profitability. Unauthorized, ineffective
and sometimes lethal versions of prescription medications
from aspirin to Viagra are flooding markets, particularly
in the developing world. The FDA is pursuing bilateral
agreements with European Union member states because this
facilitates U.S. information exchange with the European
Commission. Priority in negotiating these, however, is
given to countries with significant pharmaceutical
production capacity.

FOX