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Cablegate: Got's Unclear Message On Data Exclusivity

This record is a partial extract of the original cable. The full text of the original cable is not available.

UNCLAS SECTION 01 OF 02 ANKARA 007761

SIPDIS


DEPT FOR EB/TPP/MTA/IPC, EUR/SE AND E/CBA
DEPT PASS USTR FOR MARK WU/LISA ERRION
DEPT PASS USPTO FOR ELAINE WU
USDOC FOR ITA/MAC/DDEFALCO


SENSITIVE


E.O. 12958: N/A
TAGS: ETRD KIPR TU
SUBJECT: GOT's Unclear Message on Data Exclusivity


Ref: (A) State 322108 (B) Ankara 6847


Summary
-------


1. (SBU) At the December Economic Partnership Commission
meeting, the Turkish Health Ministry and Foreign Trade
Undersecretariat took seemingly contradictory positions on
data exclusivity protection for pharmaceuticals. A followup
meeting with the Health Undersecretary reinforced our
impression that there is no GOT interagency consensus on
this issue, and that any GOT move toward data exclusivity in
early 2004 is like to be unsatisfactory. The Ambassador is
raising this issue at the political level (septel), but we
also request Washington's assistance in following up in the
near future, including by sending an expert-level delegation
and, possibly, a Minister-level letter on this issue. End
Summary.


2. (SBU) At the December Economic Partnership Commission
(EPC) meeting, Health Ministry Pharmaceuticals Director
General Hayriye Mihcak presented a paper stating that new
legislation on data exclusivity protection for
pharmaceuticals would be enacted in the first half of 2004,
but did not specify whether and how long a transition period
for implementation would be included in the law. At the
EPC's private sector session the following day, Tevfik
Mengu, Foreign Trade's Director General for Agreements,
appeared to contradict the Health Ministry in saying that
Turkey believed it was already satisfying its TRIPS
obligations in this area.


3. (SBU) Following up on the EPC discussions, Econ Counselor
requested clarification in a meeting with Health Ministry
Undersecretary Necdet Unuvar and Pharmaceuticals Director
General Hayriye Mihcak on December 12. Mihcak stated that
the Ministry intended to implement a regulation (not new
legislation) on data exclusivity in the second quarter of
2004, but added that the GOT was evaluating "international
best practices" in this area in formulating its regulation.
She also noted that the Ministry was not the only state body
which would have to approve the regulation, and implied that
there may not be an interagency consensus on data
exclusivity as yet. Mihcak disputed Foreign Trade's
contention that Turkey was already in full compliance with
TRIPS Article 39.3. Unuvar and Mihcak raised concerns about
the potential costs of implementation which range from
several million dollars (according to the research-based
companies) and several billion (according to their generic
competition).


4. (SBU) Econ Counselor responded that the generic producers
had a strong incentive to frighten the GOT with inflated
cost estimates and contended that their figures were far
from accurate. He emphasized that data exclusivity
protection was long overdue under the TRIPS Agreement (not
to mention Turkey's EU Customs Union Agreement), that the
current Turkish pharmaceutical regime allowed local
companies to "steal" from U.S. companies, and that the USG
was losing patience on this issue. Turkey would likely be
elevated in our Special 301 Watch Lists in the absence of
swift corrective action, which had to include moving to
TRIPS-compliant data exclusivity quickly. Econ Counselor
noted that the EPC delegations committed to a followup
meeting at the expert level on intellectual property and
other issues. Unuvar and Mihcak responded that they looked
forward to these expert-level discussions.


EU Balks at Joint Demarche
--------------------------


5. (SBU) EU MISSION ECONOMIC COUNSELOR OSKAR BENEDIKT
CONTACTED ECONOFF ON DECEMBER 16 TO REPORT THAT BRUSSELS HAD
DECIDED NOT TO PURSUE A JOINT DEMARCHE WITH THE USG ON DATA
EXCLUSIVITY (REF A) UNTIL IT HAS COMPLETED ITS TRADE
BARRIERS REVIEW (TBR) OF TURKEY. HOWEVER, HE LEFT OPEN THE
POSSIBILITY THAT SOME JOINT ACTION COULD BE CONSIDERED AFTER
THE TBR IS COMPLETED.


RECOMMENDED ACTIONS
-------------------


6. (SBU) TO GET THE MOST MILEAGE OUT OF THE SPECIAL 301
PROCESS, WE SHOULD USE ALL NEAR-TERM OPPORTUNITIES TO ENGAGE
THE GOT ON IPR ISSUES. FOR EXAMPLE, THE AMBASSADOR RAISED
THE ISSUE FORCEFULLY WITH MINISTERS BABACAN AND UNAKITAN ON
DECEMBER 17 (SEPTEL). AT THE EPC, WE AGREED TO PRESENT THE
TURKS WITH AN ANALYSIS OF AREAS IN WHICH WE BELIEVE TRIPS IS
NOT BEING IMPLEMENTED. BOTH SIDES AGREED TO MEET AT THE
EXPERT LEVEL EARLY IN 2004 ON IPR AND OTHER TRADE/INVESTMENT
ISSUES. EMBASSY URGES WASHINGTON AGENCIES TO PROPOSE A
DELEGATION AND DATES AS EARLY AS POSSIBLE. WE ALSO
REITERATE OUR SUGGESTION THAT WASHINGTON OUTLINE OUR
CONCERNS IN WRITING, SUCH AS THROUGH A JOINT LETTER FROM
USTR ZOELLICK AND COMMERCE SECRETARY EVANS TO STATE MINISTER
TUZMEN (REF B). WASHINGTON AGENCIES MIGHT ALSO THINK ABOUT
ASKING EU AUTHORITIES TO RECONSIDER THEIR POSITION ON A
JOINT DEMARCHE. EDELMAN

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