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Cablegate: Health Ministry Views 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 006371

SIPDIS

DEPT FOR E, EB/TPP/MTA/IPC, EUR/ERA, EUR/SE
USTR FOR LERRION/BPECK
USEU FOR CHRIS WILSON
USPTO FOR ELAINE WU
USDOC FOR ITA/MAC/DDEFALCO

SENSITIVE

E.O. 12958: N/A
TAGS: ETRD KIPR TU
SUBJECT: Health Ministry Views on Data Exclusivity;
Danish Embassy Interested in Joint Action


SENSITIVE BUT UNCLASSIFIED. PLEASE HANDLE ACCORDINGLY.

Ref: Ankara 6279 and previous

Summary
-------

1. (SBU) Health Ministry officials hinted that they
could support immediate implementation of data
exclusivity protection for confidential pharmaceutical
test data if research-based industry were to make
concessions in other areas. They said they had
established a good dialog with industry on health care
reform, and were considering industry views on the
"positive list" of drugs to be eligible for
reimbursement. On Zyprexa, officials stated that no
patent-infringing copies had been approved, and that the
Ministry would act in accordance with Turkish law and
regulation. The Danish Embassy expressed frustration
with the European Commission's efforts to convince
Turkey to implement data exclusivity and expressed
interest in a joint approach with the USG to the GOT on
this subject. End Summary.

Health Ministry on Data Exclusivity, Reform, Zyprexa
--------------------------------------------- -------

2. (U) Econ Counselor, Econoff and Econ Specialist
called on Health Ministry Undersecretary Unuvar and
Director General for Pharmaceuticals Gumrukoglu November
10 to press for positive steps on data exclusivity, ask
for a status report on drug reimbursement policy, and
caution against approval of a generic drug which would
infringe Eli Lilly's Turkish patent on Zyprexa.

3. (SBU) Data Exclusivity: Unuvar noted that GOT
agencies have been meeting frequently with industry
representatives in response to the EC's Trade Barrier
Report (TBR). He acknowledged data exclusivity to be an
international obligation, and said the Health Ministry
had suggested to the Foreign Trade Undersecretariat that
it could be implemented immediately if research-based
industry were to "ease public access" to
pharmaceuticals. Note: Unuvar did not define what
concessions he had in mind; possibly, he is referring to
price discounts or restricted access to certain original
drugs under the health care reform. End Note.

4. (U) Health Care Reform/Positive List: Unuvar said
that the GOT has established a good dialog with
companies and has received their feedback on the draft
"positive list" of drugs which could be reimbursed under
a reformed health care system. He told us that
"reasonable" suggestions by industry would be
implemented.

5. (U) Zyprexa: Gumrukoglu acknowledged letters from
Senator Lugar and the Ambassador to the Health Minister
on Zyprexa. Gumrukoglu emphasized that no generic
copies of Zyprexa have been licensed as yet, and said
the Health Ministry would deal with generic applications
for this molecule and others impartially, and in
accordance with Turkish law and regulation. To act
otherwise would risk legal action against the GOT. Econ
Couns responded that, even if Eli Lilly were to go to
court to stop sale of a licensed generic copy of a
patented molecule, the brand name manufacturer would
suffer large and possibly irrecoverable losses.

Danes Interested in Joint Action
--------------------------------

6. (SBU) Danish Embassy DCM called on Econoff November
10 to exchange views on data exclusivity, the TBR report
and the possibility of joint representations to the GOT.
Danish DCM expressed some frustration with the
Commission's hesitation to take a tough line on data
exclusivity with the Turks in the runup to December 17,
arguing that the EC has more leverage now than it will
after the EU Summit. He said that EU member state
ambassadors in Ankara had recently discussed the TBR.
Many of them shared Danish concerns, and several,
include the Danish Ambassador, are interested in
exploring a joint demarche with the USG on this issue
(see also reftel).
Edelman

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