VZCZCXRO4349
OO RUEHAG RUEHDF RUEHIK RUEHLZ RUEHROV RUEHSR
DE RUEHFR #0336 0681648
ZNR UUUUU ZZH
O 091648Z MAR 09
FM AMEMBASSY PARIS
TO RUEHC/SECSTATE WASHDC IMMEDIATE 5707
INFO RUCPDOC/DEPARTMENT OF COMMERCE WASHDC
RUCNMEM/EU MEMBER STATES COLLECTIVE

UNCLAS PARIS 000336 
 
SENSITIVE 
SIPDIS 
 
STATE FOR EB/TPP/IPE TIMOTHY MCGOWAN 
STATE PASS USTR 
COMMERCE FOR ITA 
 
E.O. 12958: N/A 
TAGS: ECON ETRD EINV EUN FR
SUBJECT: FRANCE Q SPECIAL 301 2009 ANNUAL REVIEW 
 
REF: A) STATE 8410 B) 08 PARIS 409  C) 08 PARIS 2285 
 
¶1. (SBU) Post has reviewed PhRMA's Special 301 
submission on France and recommends against inclusion 
of France on the 2009 Special 301 Watch List.  As we 
reported in 2008 (refs B and C) GOF efforts to rein 
in state health insurance spending on pharmaceuticals 
has made for a challenging environment, particularly 
for less innovative prescription drugs.  But Post 
sees no deficiencies in IPR protection provided 
to pharmaceutical products, nor in the provision 
of fair and equitable market access to pharmaceutical 
companies. 
 
¶2. (U) Pricing and distribution margins on non- 
reimbursable pharmaceuticals are unregulated in 
France.  Pharmaceutical companies that do not seek to 
include their products on the list of drugs to be 
reimbursed by the state health insurance program can 
market products immediately upon receipt of market 
authorization (either via the centralized European 
procedure or via national procedure). 
 
¶3. (U) The GOF is employing different strategies to 
limit the cost of its reimbursable drug program, 
including aggressive use of generics and campaigns 
to reduce consumption.  A September 2008 working paper 
by the Institut de Recherche et Documentation en 
Economie de la Sante (IRDES) indicates the nature of 
the challenge.  With 90% of medical consultations 
resulting in a prescription, and annual per-capita 
consumption of pharmaceuticals of 500 euros (tops in 
Europe), France is a high-volume pharmaceutical 
market. 
 
¶4. (U) Companies wishing to get a drug included on the 
reimbursable list first approach France's "Transparency 
Committee."   Made up of epidemiologists, pharmacologists, 
medical doctors and other experts, the Committee assigns 
an "innovation" rating from ASMR I to ASMR V (I 
representing a "major therapeutic advance," V "no 
treatment benefit") based on clinical criteria.  Minutes 
from Commission meetings are posted at http://www.has- 
sante.fr/portail/jcms/c_692477/commission-de- la- 
transparence.  Once the ASMR rating has been assigned, 
price negotiations with the Economic Committee for 
Health Products (CEPS) ensue.  Innovative outpatient 
drugs are considered in an accelerated process, which 
now are extended to the all drugs up to ASMR III and 
some low-cost ASMR IV drugs.  Maximum delay for 
setting a price during the registration of a new drug 
is 180 days.  According to IRDES the average was 164 
days in 2007. 
 
¶5. (U) In its September 2008 report IRDES noted that 
the structure of pharmaceutical sales in France has 
changed in recent years to favor more expensive 
products.  IRDES concluded that the French, both 
patients and doctors, "seem to prefer innovative and 
expensive drugs, even when less expensive ones are as 
effective, " and that the possibility of higher prices 
for innovative specialties "makes France an attractive 
location for the early commercialization of innovative 
therapies." 
 
¶6. (SBU) Comment: France's national health insurance 
cost containment efforts do not/not deny adequate and 
effective IP protection to the U.S. pharmaceutical 
industry, nor do they prevent fair and equitable 
market access.  Post will continue to support U.S. 
pharmaceutical industry efforts to expand markets in 
France, but recommends against France's inclusion on 
the 2009 Special 301 Watch List. 
 
PEKALA