US embassy cable - 03ANKARA5808

UNCLAS ANKARA 005808 
 
SIPDIS 
 
 
DEPT FOR EB/TPP/MTA/IPC 
DEPT PASS USTR FOR MARK WU/LISA ERRION 
DEPT PASS LIBRARY OF CONGRESS 
USDOC FOR ITA/MAC/DDEFALCO 
 
 
SENSITIVE 
 
 
E.O. 12958: N/A 
TAGS: ETRD, KIPR, TU 
SUBJECT:  Pharmaceuticals IPR Update 
 
 
1. (SBU) Summary:  Following heavy lobbying by the local 
generics industry, the GOT is contemplating introduction 
of data exclusivity protection for pharmaceutical test 
data only in 2007 and even watering down patent 
protection, but, to our knowledge, no final decisions 
have been taken on these matters.  In contacts with the 
Health and Foreign Ministries and the Turkish Patent 
Institute, we have stressed the importance of these 
issues in the bilateral economic relationship and have 
urged that the GOT comply with its WTO commitments.  End 
Summary. 
 
 
2. (SBU) Citing a leaked report prepared for the GOT's 
Board for the Evaluation of Economic Problems in the 
Pharmaceuticals Sector, U.S. pharmaceutical companies 
operating in Turkey contacted the Embassy in late August 
and early September to register strong concern about 
reports that the GOT intends to delay implementation of 
data exclusivity protection until 2007 and to water down 
patent protection for pharmaceuticals.  The report 
followed discussions in late August between the GOT and 
local generics producers.  At the same time, Eli Lilly 
representatives noted some progress in diminishing price 
discrimination against imported drugs, including the 
beginning of a dialogue with the Health Ministry on 
margins and ad hoc suspension of reference pricing for 
some drugs. 
 
 
3. (SBU) Econoff and Econ Specialist raised these issues 
with Hayriye Mihcak, Director General for 
Pharmaceuticals at the Turkish Ministry of Health on 
September 9.  Mihcak confirmed that an interministerial 
board was developing reports on data exclusivity, patent 
protection and pricing.  These reports are to form the 
basis for a response to the European Union on these 
issues. 
 
 
4. (SBU) Mihcak hesitated in discussing the contents of 
the reports until Econoff shared an English translation 
of the one concerning data exclusivity and patent 
protection.  We emphasized that data exclusivity and 
patent protection were not only an EU-Turkey issue, but 
also WTO requirements for Turkey and of great interest 
to the United States.  Econoff underlined that delays in 
implementing data exclusivity and any movement to 
degrade patent protection would be received very 
negatively by the USG and U.S. industry.  He also noted 
that at least one key stakeholder - the research-based 
industry - had not been consulted in preparing the 
report.  Mihcak responded that the report was not yet 
finalized, and that she would take our points into 
consideration in future interagency discussions on this 
issue. 
 
 
5. (SBU) Mihcak said she regarded the current pricing 
system in pharmaceuticals to be inequitable and said the 
GOT was considering changes to it, but she declined to 
go into the specifics of this issue. 
 
 
6. (SBU) Econoff raised these issues with Selim Sengun, 
President of the Turkish Patent Institute (TPI), on 
September 10.  Sengun stated that the report on data 
exclusivity and patent protection represented the 
maximum demands of the generic industry, and that there 
was a fair chance that the GOT would not decide to fully 
implement these provisions.  In interagency discussions, 
TPI's representative urged against weakening patent 
protection.  He also pointed out that weakening Turkish 
patent protection would have limited effect since, in 
the near future, most pharmaceuticals patents would be 
take effect on the basis of approvals made by European 
Patent Office.  Sengun cautioned that local generics 
manufacturers constituted a strong lobby against IPR 
protections in its sector, one that apparently had the 
ear of the Health Ministry as well as other GOT 
agencies. 
 
 
7. (SBU) Econ and Commercial Counselors also raised 
pharmaceuticals issues with MFA Deputy Director General 
for Bilateral Economic Affairs Mehmet Gucuk on September 
12.  Gucuk asked us to provide further details on these 
issues in writing, which Embassy will do in the near 
future.  Edelman