GOT to Announce Data Exclusivity Policy Soon: Need

UNCLAS SECTION 01 OF 02 ANKARA 000137

SIPDIS


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


SENSITIVE


E.O. 12958: N/A
TAGS: ETRD KIPR TU
SUBJECT: GOT to Announce Data Exclusivity Policy Soon: Need
to Weigh in Now


Ref: (A) Ankara 21 (B) 2003 Ankara 7785
(C) Ankara 7761



1. (U) This is an action cable. Please see para 7.


Summary
--------------



2. (SBU) Prompted by the need to respond to the European
Commission's decision last month to examine pharmaceuticals
trade policies, the GOT is likely to announce its plans to
implement data exclusivity protection for pharmaceuticals
and to address price discrimination and other issues raised
by the industry. According to press reports and industry
sources, this announcement might come as early as January

15. However, pressure from Turkish generics manufacturers
is likely to result in a proposal to implement data
exclusivity with an unacceptably long transition period
and/or linkage to Turkey's EU accession. Embassy urges
Washington agencies to weigh in on this issue promptly,
posing dates for an expert-level delegation, sending a
Minister-level letter and - if necessary - raising it during
the Prime Minister's Washington visit in late January. End
Summary.


GOT Under Pressure to Address Data Exclusivity
-------------- -



3. (U) In December, the European Commission accepted the
European Federation of Pharmaceuticals Industries and
Associations' (EFPIA's) request for an investigation of
Turkish trade policies under the EU's Trade Barrier
Regulation. Data exclusivity, lack of regulatory
transparency and discriminatory pricing practices are among
EFPIA's complaints. According to press reports, the GOT is
planning to respond to the EU within 30 days (January 15).



4. (SBU) GOT officials, including Ministers Babacan and
Coskun, have told the Ambassador that the GOT is working on
the data exclusivity problem (ref A and B),and Health
Ministry officials promised that a regulation would be
implemented during the first half of 2004 (ref C). They did
not provide details, but hinted at a lengthy transition
process, which we said would be unacceptable. MFA Deputy
U/S for Economic Affairs Kilic also told the Charge on
January 7 that the GOT was working on this problem, but did
not provide any details. Pfizer's Health Policy Manager
Fahreddin Tatar told us on January 6 that the Prime Minister
had indicated his desire to resolve the issue at a meeting
with the foreign investors association (Turkish acronym
YASED) members in December.



5. (U) In the last month, however, the generics industry has
gone on a public relations offensive to convince the GOT and
the public that the costs of implementing data exclusivity
are unacceptably high. In December, Bulent Eczacibasi,
Chairman of the generics-dominated Pharmaceuticals
Manufacturers' Association, told the press that data
exclusivity would cost Turkish manufacturers USD 660 million
and that overall drug spending would increase by twice that
much over the first six years of implementation. He
contended that immediate implementation would threaten the
existence of a local pharmaceuticals industry and
significantly boost government spending. Eczacibasi
maintained that the GOT should insist on a transition period
for implementation, perhaps lasting until 2007.



6. (SBU) Pfizer believes that the GOT is under intense
pressure from the generics industry and that it may announce
implementation by January 15 with a transition period that
could run as long as the end of 2007. We understand that
Eczacibasi and his colleagues visited Ankara this week to
lobby government officials on this. Tatar said that the
research-based industry association (Turkish acronym AIFD)
was attempting to lobby the Prime Minister directly on this
issue, and that it had asked the EU Mission in Ankara to
press its case as well. He suggested that further USG
support on this issue would be helpful. AIFD plans its own
press conference on data exclusivity and related issues in
Istanbul on January 9.


COMMENT AND ACTION REQUEST
--------------



7. (SBU) EMBASSY BELIEVES THE GOT MAY BE CLOSE TO ANNOUNCING
THAT IT WILL IMPLEMENT DATA EXCLUSIVITY WITH A TRANSITION
PERIOD OF SEVERAL YEARS. EMBASSY WILL CONTINUE TO ARGUE
VIGOROUSLY AGAINST SUCH A LENGTHY TRANSITION PERIOD, BUT
ALSO RECOMMENDS THAT WASHINGTON AGENCIES ENGAGE THE GOT ON
THIS ISSUE AS SOON AS POSSIBLE. WASHINGTON COULD PROPOSE
DATES FOR THE EXPERT-LEVEL DISCUSSIONS ON IPR PROMISED AT
THE 2003 ECONOMIC PARTNERSHIP COMMISSION MEETING. WE ALSO
REITERATE OUR RECOMMENDATION 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 C). IF NECESSARY, WE SHOULD ALSO RAISE THE
ISSUE DURING PM ERDOGAN'S VISIT TO WASHINGTON IN LATE
JANUARY. DEUTSCH