US embassy cable - 04ANKARA6371

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