VZCZCXRO3889
PP RUEHDA
DE RUEHAK #5335/01 2580453
ZNR UUUUU ZZH
P 150453Z SEP 06
FM AMEMBASSY ANKARA
TO RUEHC/SECSTATE WASHDC PRIORITY 8672
INFO RUCPDOC/USDOC WASHDC PRIORITY
RUEHIT/AMCONSUL ISTANBUL 1267
RUEHDA/AMCONSUL ADANA 1097
RUEHBS/USEU BRUSSELS

UNCLAS SECTION 01 OF 02 ANKARA 005335 
 
SIPDIS 
 
DEPT PLEASE PASS USTR FOR LERRION/BPECK 
DEPT PLEASE PASS USPTO FOR JO ELLEN URBAN 
USDOC FOR ITA/MAC/CRUSNAK 
USEU FOR CHRIS WILSON 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: ETRD KIPR USTR EUN TU
SUBJECT: TURKEY: PHRMA INDUSTRY DATA EXCLUSIVITY UPDATE 
 
 
SENSITIVE BUT UNCLASSIFIED. NOT FOR INTERNET DISTRIBUTION. 
 
Ref: (A) Ankara 1898 and previous 
 
¶1. (SBU) Summary:  According to PhRMA company representatives in 
Turkey, an August 3 Turkish MOH letter to the EU has specifically 
acknowledged data protection for 22 of the 67 molecules for which 
data exclusivity (DE) had been ambiguous under Turkey's new DE 
regulations (ref A).  The remaining 45, however, are not covered by 
DE for various reasons.  State Minister for Foreign Trade Kursad 
Tuzmen will meet with PhRMA in D.C. on September 15 to discuss this 
issue.  Pharmaceutical companies are urging the EU to delay opening 
of accession negotiations on the "Free Movement of Goods" and 
"Intellectual Property Rights" chapters of the acquis communitaire 
until Turkey has met its IPR obligations.  End summary. 
 
THE GOOD NEWS 
------------- 
 
¶2. (SBU) According to representatives of research-based 
pharmaceutical companies in Turkey, Turkey's MOH provided 
confirmation to the EU in an August 3 letter that the confidential 
test data for 22 of the 67 molecules for which data exclusivity (DE) 
had not been assured by the GOT (now increased from the previous 45 
to a total of 67) would be protected.  This correspondence resulted 
from a special June 30 EU meeting with Turkey's health officials in 
Brussels that followed GOT approval of a generic copy of one of 
Danish firm Lundbeck's products (ref A) that the companies believed 
should have benefited from DE.  EU officials in Brussels reportedly 
referred to this approval as a "clear violation" of Turkey's 
Customs' Union obligations.  This information represents the first 
written communication from the MOH specifically addressing DE since 
research-based pharmaceutical companies submitted their list of 
molecules whose status was not clear under the new regulations in 
¶2005. 
 
THE BAD NEWS 
------------ 
 
¶3. (SBU) Also in this MOH letter was a list of the 45 remaining 
molecules that would not receive data exclusivity and the reasons 
why the MOH was not granting this protection: 
 
  -- 22 because generic applications were filed before the January 
1, 2005 start of Turkey's stronger data protection legislation; 
 
  -- 6 because the original innovative product has not yet been 
approved in Turkey; 
 
  -- 7 (which had previously been granted DE) because the original 
innovative product has not yet been registered in Turkey; 
 
  -- 1 because it was a vaccine; 
 
  -- 3 because it was a "combination product"; 
 
  -- 1 because a generic was already on the market in Turkey; 
 
  -- 5 because they either were not eligible for DE in the EU or 
because they were licensed in the EU prior to 2001 (in which case 
the six years DE will expire at the latest by the end of this 
year). 
 
¶4. (SBU) PhRMA company officials in Turkey plan to meet with MOH 
officials for clarification on this decision.  For those molecules 
that were denied DE because the original product has not yet been 
approved in Turkey, it appears that this violates current Turkish 
domestic legislation because DE protection was linked to the 
original product's approval in any EU country. 
 
NEXT STEPS 
---------- 
 
¶5. (SBU) PhRMA companies in Turkey learned about the August 3 letter 
in early September, only a few days after they submitted a letter to 
USTR in support of the retention of Turkey's GSP benefits.  While 
company officials tell us that they still support this position, 
they are concerned that it could send the wrong message to the GOT. 
State Minister for Foreign Trade Kursad Tuzmen, who is conducting a 
trade mission to the U.S. during the week of September 11 to promote 
his "Year of America" strategy, will meet with PhRMA in D.C. on the 
morning of September 15. 
 
¶6. (SBU) EU representatives in Ankara told PhRMA officials that the 
 
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EU plans to send another "strongly worded" response to the GOT in 
light of this new information.  Included in this letter will be a 
call for a moratorium on the approval of generic applications for 
the molecules still in question.  This information will also be 
included in the EU's November progress report on Turkey's accession 
process.  Finally, pharmaceutical company representatives and 
interest groups are urging the EU to delay the beginning of 
accession talks regarding the "Free Movement of Goods" and 
"Intellectual Property Rights" chapters until the GOT meets its IPR 
obligations. 
 
COMMENT: MOH STILL THE PROBLEM 
------------------------------ 
 
¶7. (SBU) Foreign Ministry and Foreign Trade officials understand 
Turkey's IPR obligations and appear committed to working to fix the 
problem.  As with many trade issues in Turkey, however, the 
ministries who hold responsibility for complying with international 
agreements have limited ability to effect a change in domestic 
policy.  It is clear that domestic generics manufacturers are 
continuing to exert political pressure on the government.  In our 
recent meetings with MOH officials, they have not communicated 
either an understanding of the need for greater data protection than 
what is currently allowed or the will to fix the problem.  In 
addition to continued engagement with FTU, MFA and MOH officials, we 
have suggested that company representatives consider discussing the 
issue with Turkey's EU Secretariat office (which coordinates EU 
accession negotiations) and with the PM's advisors.  We will 
continue to raise this issue at all levels.  End comment. 
 
WILSON