VZCZCXRO9152
PP RUEHDA
DE RUEHAK #6611 3411457
ZNR UUUUU ZZH
P 071457Z DEC 06
FM AMEMBASSY ANKARA
TO RUEHC/SECSTATE WASHDC PRIORITY 0228
INFO RUCPDOC/USDOC WASHDC PRIORITY
RUEHIT/AMCONSUL ISTANBUL 1759
RUEHDA/AMCONSUL ADANA 1407
RUEHBS/USEU BRUSSELS

UNCLAS ANKARA 006611 
 
SIPDIS 
 
DEPT PLEASE PASS USTR FOR LERRION/BPEUK 
DEPT PLEASE PASS USPTO FOR JO ELLEN URBAN 
USDOC FOR ITA/MAC/CRUSNAK 
USEU FOR JULIE NUTTER AND USTR 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: ETRD KIPR USTR EUN TU
SUBJECT: TURKEY: PHRMA IPR ISSUES IN EU PROGRESS REPORT 
 
 
SENSITIVE BUT UNCLASSIFIED.  NOT FOR INTERNET DISTRIBUTION. 
 
Ref: (A) Ankara 5335 and previous 
 
¶1. (SBU) Summary:  The November EU Commission Progress Report on 
Turkey's accession process included language about the slow movement 
of pharmaceutical IPR reforms.  While U.S. pharmaceutical companies 
in Turkey have not received any new information from the Ministry of 
Health regarding the MOH's August 3 letter outlining which products 
would benefit from data exclusivity (ref A), PhRMA company 
representatives express guarded optimism based on the issue's 
inclusion in the Progress Report and another "strongly worded" 
letter sent by the Commission on November 6 to Turkey's EU 
Delegation.  However, depending how the accession process proceeds 
after the December 15 EU Summit, PhRMA companies may call on the USG 
to intensify its efforts if EU influence begins to wane.  End 
summary. 
 
¶2. (SBU) Innovative pharmaceutical companies in Turkey, through 
their European trade association (EFPIA) in Brussels, have been 
pushing the EU Commission on three items for EU action to pressure 
Turkey to fully implement its data exclusivity (DE) obligations 
under the Customs Union.  The first was that the Commission demand 
from Turkey's MOH a moratorium on generics approvals for the 
products in question until the ongoing DE issues are completely 
resolved.  The second was that the EU send the GOT a firm letter 
rejecting generics claims to products filed before 1 January 2005, 
which covered new medicines registered in Europe between 2001 and 
¶2005.  Finally, PhRMA companies requested clear language in the 2006 
Turkey Progress Report expressing EU concerns about DE 
implementation. 
 
¶3. (SBU) In response to this pressure from EFPIA, the EU 
Directorate-General for Trade wrote in a November 6 letter to the 
GOT that, in light of the most recent list of products for which DE 
has been granted or rejected (ref A), the Commission is "in fact 
even more concerned than before on the criteria that have been 
applied" for processing generics applications.  The letter once 
again urges the Turkish MOH to apply all regulatory conditions and 
requirements related to regulatory data exclusivity, as derived from 
both its international obligations, including the acquis 
communautaire, binding upon Turkey and from Turkish legislation.  It 
ends by calling on Turkey to refrain from "receiving, evaluating and 
approving" generics applications that violate the GOT's obligations 
under the Customs Union rules. 
 
¶4.  (SBU) In its November Progress Report on Turkey's EU accession, 
the Commission included language that refers to "limited progress" 
in the area of pharmaceuticals and uncertainty linked to the 
authorization regime applied to a number of generics, which 
"continues to constitute a source of concern and disagreement." 
PhRMA company representatives viewed this as a major victory and 
hope that along with the November 6 letter, it will dissuade 
Turkey's MOH from taking further action to approve additional 
generics applications from the disputed molecules. 
 
¶5. (SBU) Comment: The questions about Turkey's EU accession have 
made the EU's ongoing influence on this issue more uncertain.  PhRMA 
company representatives understand this reality and have cautioned 
that if EU pressure becomes less than successful, they will be 
looking to the USG to intensify its efforts.  End comment. 
 
WILSON