Keep Us Strong WikiLeaks logo

Currently released so far... 97115 / 251,287

Articles

Browse latest releases

Browse by creation date

Browse by origin

A B C D F G H I J K L M N O P Q R S T U V W Y Z

Browse by tag

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
ETRD EAGR ETTC EAID ECON EFIN ECIN EINV ELAB EAIR ENRG EPET EWWT ECPS EIND EMIN ELTN EC ETMIN EUC EZ ET ELECTIONS ENVR EU EUN EG EINT ER ECONOMICS ES EMS ENIV EEB EN ECE ECOSOC EK ENVIRONMENT EFIS EI EWT ENGRD ECPSN EXIM EIAD ERIN ECPC EDEV ENGY ECTRD EPA ESTH ECCT EINVECON ENGR ERTD EUR EAP EWWC ELTD EL EXIMOPIC EXTERNAL ETRDEC ESCAP ECO EGAD ELNT ECONOMIC ENV ETRN EIAR EUMEM ENRGPARMOTRASENVKGHGPGOVECONTSPLEAID EREL ECOM ECONETRDEAGRJA ETCC ETRG ECONOMY EMED ETR ENERG EITC EFINOECD EURM EENG ERA EXPORT ENRD ECONEINVETRDEFINELABETRDKTDBPGOVOPIC EGEN EBRD EVIN ETRAD ECOWAS EFTA ECONETRDBESPAR EGOVSY EPIN EID ECONENRG EDRC ESENV ETT EB ENER ELTNSNAR ECHEVARRIA ETRC EPIT EDUC ESA EFI ENRGY ESCI EE EAIDXMXAXBXFFR EETC ECIP EIAID EIVN EBEXP ESTN EING EGOV ETRA EPETEIND ELAN ETRDGK EAIDRW ETRDEINVECINPGOVCS EPEC ENVI ELN EAG EPCS EPRT EPTED ETRB EUM EAIDS EFIC EFINECONEAIDUNGAGM EAIDAR ESF EIDN ELAM EDU EV EAIDAF ECN EDA EXBS EINTECPS ENRGTRGYETRDBEXPBTIOSZ EPREL EAC EINVEFIN ETA EAGER EINDIR ECA ECLAC ELAP EITI EUCOM ECONEFINETRDPGOVEAGRPTERKTFNKCRMEAID EARG ELDIN EINVKSCA ENNP EFINECONCS EFINTS ECCP ETC EAIRASECCASCID EINN ETRP EAIDNI EFQ ECOQKPKO EGPHUM EBUD ECONEINVEFINPGOVIZ ENERGY ELB EINDETRD EMI ECONEFIN EIB EURN ETRDEINVTINTCS EIN EFIM ETIO ELAINE EMN EATO EWTR EIPR EINVETC ETTD ETDR EIQ ECONCS EPPD ENRGIZ EISL ESPINOSA ELEC EAIG ESLCO EUREM ENTG ERD EINVECONSENVCSJA EEPET EUNCH ECINECONCS ETRO ETRDECONWTOCS ECUN EFND EPECO EAIRECONRP ERGR ETRDPGOV ECPN ENRGMO EPWR EET EAIS EAGRE EDUARDO EAGRRP EAIDPHUMPRELUG EICN ECONQH EVN EGHG ELBR EINF EAIDHO EENV ETEX ERNG ED
KMDR KPAO KPKO KJUS KCRM KGHG KFRD KWMN KDEM KTFN KHIV KGIC KIDE KSCA KNNP KHUM KIPR KSUM KISL KIRF KCOR KRCM KPAL KWBG KN KS KOMC KSEP KFLU KPWR KTIA KSEO KMPI KHLS KICC KSTH KMCA KVPR KPRM KE KU KZ KFLO KSAF KTIP KTEX KBCT KOCI KOLY KOR KAWC KACT KUNR KTDB KSTC KLIG KSKN KNN KCFE KCIP KGHA KHDP KPOW KUNC KDRL KV KPREL KCRS KPOL KRVC KRIM KGIT KWIR KT KIRC KOMO KRFD KUWAIT KG KFIN KSCI KTFIN KFTN KGOV KPRV KSAC KGIV KCRIM KPIR KSOC KBIO KW KGLB KMWN KPO KFSC KSEAO KSTCPL KSI KPRP KREC KFPC KUNH KCSA KMRS KNDP KR KICCPUR KPPAO KCSY KTBT KCIS KNEP KFRDCVISCMGTCASCKOCIASECPHUMSMIGEG KNNB KGCC KINR KPOP KMFO KENV KNAR KVIR KDRG KDMR KFCE KNAO KDEN KGCN KICA KIMMITT KMCC KLFU KMSG KSEC KUM KCUL KMNP KSMT KCOM KOMCSG KSPR KPMI KRAD KIND KCRP KAUST KWAWC KTER KCHG KRDP KPAS KITA KTSC KPAOPREL KWGB KIRP KJUST KMIG KLAB KTFR KSEI KSTT KAPO KSTS KLSO KWNN KPOA KHSA KNPP KPAONZ KBTS KWWW KY KJRE KPAOKMDRKE KCRCM KSCS KWMNCI KESO KWUN KPLS KIIP KEDEM KPAOY KRIF KGICKS KREF KTRD KFRDSOCIRO KTAO KJU KWMNPHUMPRELKPAOZW KEN KO KNEI KEMR KKIV KEAI KWAC KRCIM KWCI KFIU KWIC KCORR KOMS KNNO KPAI KBWG KTTB KTBD KTIALG KILS KFEM KTDM KESS KNUC KPA KOMCCO KCEM KRCS KWBGSY KNPPIS KNNPMNUC KWN KERG KLTN KALM KCCP KSUMPHUM KREL KGH KLIP KTLA KAWK KWMM KVRP KVRC KAID KSLG KDEMK KX KIF KNPR KCFC KFTFN KTFM KPDD KCERS KMOC KDEMAF KMEPI KEMS KDRM KEPREL KBTR KEDU KNP KIRL KNNR KMPT KISLPINR KTPN KA KJUSTH KPIN KDEV KTDD KAKA KFRP KWNM KTSD KINL KJUSKUNR KWWMN KECF KWBC KPRO KVBL KOM KFRDKIRFCVISCMGTKOCIASECPHUMSMIGEG KEDM KFLD KLPM KRGY KNNF KICR KIFR KM KWMNCS KAWS KLAP KPAK KDDG KCGC KID KNSD KMPF KPFO KDP KCMR KRMS KNPT KNNNP KTIAPARM KDTB KNUP KPGOV KNAP KNNC KUK KSRE KREISLER KIVP KQ KTIAEUN KPALAOIS KRM KISLAO KWM KFLOA
PHUM PINR PTER PGOV PREL PREF PL PM PHSA PE PARM PINS PK PUNE PO PALESTINIAN PU PBTS PROP PTBS POL POLI PA PGOVZI POLMIL POLITICAL PARTIES POLM PD POLITICS POLICY PAS PMIL PINT PNAT PV PKO PPOL PERSONS PING PBIO PH PETR PARMS PRES PCON PETERS PRELBR PT PLAB PP PAK PDEM PKPA PSOCI PF PLO PTERM PJUS PSOE PELOSI PROPERTY PGOVPREL PARP PRL PNIR PHUMKPAL PG PREZ PGIC PBOV PAO PKK PROV PHSAK PHUMPREL PROTECTION PGOVBL PSI PRELPK PGOVENRG PUM PRELKPKO PATTY PSOC PRIVATIZATION PRELSP PGOVEAIDUKNOSWGMHUCANLLHFRSPITNZ PMIG PREC PAIGH PROG PSHA PARK PETER POG PHUS PPREL PS PTERPREL PRELPGOV POV PKPO PGOVECON POUS PGOVPRELPHUMPREFSMIGELABEAIDKCRMKWMN PWBG PMAR PREM PAR PNR PRELPGOVEAIDECONEINVBEXPSCULOIIPBTIO PARMIR PGOVGM PHUH PARTM PN PRE PTE PY POLUN PPEL PDOV PGOVSOCI PIRF PGOVPM PBST PRELEVU PGOR PBTSRU PRM PRELKPAOIZ PGVO PERL PGOC PAGR PMIN PHUMR PVIP PPD PGV PRAM PINL PKPAL PTERE PGOF PINO PHAS PODC PRHUM PHUMA PREO PPA PEPFAR PGO PRGOV PAC PRESL PORG PKFK PEPR PRELP PREFA PNG PGOVPHUMKPAO PRELECON PINOCHET PFOR PGOVLO PHUMBA PRELC PREK PHUME PHJM POLINT PGOVPZ PGOVKCRM PGOVE PHALANAGE PARTY PECON PEACE PROCESS PLN PRELSW PAHO PEDRO PRELA PASS PPAO PGPV PNUM PCUL PGGV PSA PGOVSMIGKCRMKWMNPHUMCVISKFRDCA PGIV PRFE POGOV PEL PBT PAMQ PINF PSEPC POSTS PHUMPGOV PVOV PHSAPREL PROLIFERATION PENA PRELTBIOBA PIN PRELL PGOVPTER PHAM PHYTRP PTEL PTERPGOV PHARM PROTESTS PRELAF PKBL PRELKPAO PKNP PARMP PHUML PFOV PERM PUOS PRELGOV PHUMPTER PARAGRAPH PERURENA PBTSEWWT PCI PETROL PINSO PINSCE PQL PEREZ PBS

Browse by classification

Community resources

courage is contagious

Viewing cable 04ANKARA2071, Pharmaceuticals Update: GOT's Unsatisfactory

If you are new to these pages, please read an introduction on the structure of a cable as well as how to discuss them with others. See also the FAQs

Understanding cables
Every cable message consists of three parts:
  • The top box shows each cables unique reference number, when and by whom it originally was sent, and what its initial classification was.
  • The middle box contains the header information that is associated with the cable. It includes information about the receiver(s) as well as a general subject.
  • The bottom box presents the body of the cable. The opening can contain a more specific subject, references to other cables (browse by origin to find them) or additional comment. This is followed by the main contents of the cable: a summary, a collection of specific topics and a comment section.
To understand the justification used for the classification of each cable, please use this WikiSource article as reference.

Discussing cables
If you find meaningful or important information in a cable, please link directly to its unique reference number. Linking to a specific paragraph in the body of a cable is also possible by copying the appropriate link (to be found at theparagraph symbol). Please mark messages for social networking services like Twitter with the hash tags #cablegate and a hash containing the reference ID e.g. #04ANKARA2071.
Reference ID Created Released Classification Origin
04ANKARA2071 2004-04-09 13:38 2011-08-24 01:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Ankara
This record is a partial extract of the original cable. The full text of the original cable is not available.
UNCLAS SECTION 01 OF 03 ANKARA 002071 
 
SIPDIS 
 
 
DEPT FOR EB/TPP/MTA/IPC - SWILSON/JURBAN AND EUR/SE 
DEPT PASS USTR FOR LERRION/BPECK 
DEPT PASS LIBRARY OF CONGRESS 
DEPT PASS USPTO FOR ELAINE WU 
USDOC FOR ITA/MAC/DDEFALCO 
 
 
SENSITIVE 
 
 
E.O. 12958: N/A 
TAGS: ETRD KIPR TU
SUBJECT: Pharmaceuticals Update:  GOT's Unsatisfactory 
Data Exclusivity Proposal, Revised Pricing Decree 
 
 
Ref:  Ankara 1157 and previous 
 
 
Summary 
------- 
 
 
1. (SBU) The Health Ministry has proposed a data 
exclusivity strategy predicated on implementation at the 
end of 2007, and with an effective term of less than 
three years.  The research-based pharmaceutical industry 
is reacting very negatively, and the Embassy has again 
weighed in on this issue.  The Ministry is revising its 
decree on drug pricing in ways that are, on balance, 
likely to make its implementation less painful for U.S. 
companies.  Embassy recommends increased Washington 
pressure on the GOT on data exclusivity.  End Summary. 
 
 
Limited Data Exclusivity in 2007 
-------------------------------- 
 
 
2. (U) On March 31, the Health Ministry proposed a 
strategy (translation at end of cable) on data 
exclusivity which calls for implementation on December 
31, 2007.  Although the term of exclusivity (and patent 
protection) is to be six years, it would in fact be less 
than half of that, as no drug could be registered in 
Turkey until three years had elapsed from registration 
in a foreign country, with the term of exclusivity 
beginning from that earlier date.  The term of 
protection would be further shortened by the period 
required for registration procedures in Turkey.  The 
Ministry asked that the Association of Research-Based 
Pharmaceutical Companies (AIFD) comment on this by April 
9. 
 
 
3. (SBU) Not surprisingly, AIFD members have sharply 
criticized the GOT proposal as inadequate.  Chris 
Kartalis, the General Manager of Bristol-Myers Squibb 
Turkey, told Econoff that AIFD would send a strong 
response to the Ministry before the deadline. 
Additionally, former Secretary Albright, who is visiting 
Ankara in connection with an invitation from research- 
based industry, is likely to raise the issue in a 
meeting with the Health Minister on April 9. 
 
 
4. (SBU) Acting DCM raised the Ministry strategy in an 
April 7 meeting with Undersecretary Unuvar.  A/DCM 
maintained that swift implementation of data exclusivity 
protection was essential to building a strong investment 
climate in Turkey.  Unuvar refused to comment in any 
detail on the strategy, maintaining that the 
implementation date and other provisions were subject to 
the approval of other GOT agencies.  He raised the 
generic industry's exaggerated estimates of the 
budgetary cost of data exclusivity as a factor in the 
GOT's deliberations on this issue. 
 
 
Limited Progress on Pricing Decree 
---------------------------------- 
 
 
5. (SBU) Following intense AIFD lobbying and Commerce 
U/S Aldonas' letter on the GOT's new reference pricing 
system, the Health Ministry is revising it in ways that 
should make it less painful for research-based industry. 
U/S Unuvar confirmed that, instead of limiting 
pharmaceuticals prices to a maximum of 90 percent of the 
average of the lowest two prices prevailing in a group 
of five European countries, 100 percent of the lowest 
price in these five countries will be used as a 
reference.  While industry sources tell us this is an 
improvement, several companies say this revised system 
will still be painful and unfair because Turkey will not 
permit upward price adjustment if the minimum price in 
Europe is higher than the previous Turkish maximum. 
AIFD advises that it may pursue a legal challenge to the 
new price decree when it is issued (protect). 
 
 
Comment 
------- 
 
 
6. (SBU) Although the data exclusivity scheme proposed 
on March 31 may be amended, Embassy believes that the 
GOT is not likely to implement a satisfactory data 
exclusivity policy without significantly increased 
external pressure and engagement.  We have proposed, by 
diplomatic note, an expert-level bilateral discussion of 
intellectual property issues via digital video 
conference to the MFA.  USTR is due to issue its Special 
301 report at the end of April.  As recommended reftels, 
further Washington engagement would buttress these 
steps.  In particular, Washington agencies should rebut 
Turkey's argument that the TRIPS Agreement does not 
require data exclusivity and provide an analysis of any 
other areas in which we believe that the GOT is not 
fulfilling its TRIPS obligations, as promised after the 
December 2003 Economic Partnership Commission meeting. 
We continue to believe that sending an interagency IPR 
delegation to Ankara would have more impact on GOT 
decisionmaking than a discussion by DVC. 
 
 
7. (U) Begin Text AIFD Translation of Health Ministry 
Letter: 
 
 
THE MINISTRY OF HEALTH 
OF THE TURKISH REPUBLIC 
The Pharmaceutical General Directorate 
NO   : B100IEG0100007/014283 
ISSUE     : 
ANKARA 
March 31,2004 
 
 
THE ASSOCIATION OF RESEARCH-BASED 
PHARMACEUTICAL COMPANIES 
Barbaros Bulvary No:85/A D:4 
Besiktas/ISTANBUL 
 
 
 
 
As you may know, the "National Programme of Turkey for 
the Adoption of the European Union Acquis 
Communautaire", had been published on the Reiterated 
Official Gazette dated July 24, 2003, no. 25178. 
 
 
As a result of the works conducted within the framework 
of the "Directive 2001/83/EC of the European Parliament 
and of the Council, of November 6, 2001, relating to 
medicinal products for human use", anticipated to be 
harmonised according to the National Programme, it has 
been deemed necessary to revoke the Regulation on the 
Registration of Medicinal Pharmaceutical Products, 
published on the Official Gazette no. 22218, dated March 
02, 1995 and draw up a new Regulation in line with the 
section about market introduction of above mentioned 
directive. 
 
 
The following issues are planned to be reflected in the 
Regulation Regarding the Registration of Medicinal 
Products for Human Use which is being drawn up: 
Any medicinal product for human use, including blood 
products, vaccines and radiopharmaceuticals: 
1. will be registered earliest three years after its 
first registration in the EU, the United States or any 
other country, 
2. the implementation of data exclusivity in our country 
will be initiated as of December 31, 2007, 
3. the implementation of data exclusivity and patent 
period will be limited for 6 years in our country, as of 
the first registration date of the product in the EU, 
the United States or any other country, 
4. an additional period of 1 year will be implemented in 
the event of the addition of a new indication, by 
condition that such period is limited by the patent 
period in our country, 
5. the targeted completion of the registration procedure 
within 210 working days will be implemented upon the 
institutionalization of our General Directorate; in 
other words, it will be implemented after the 
establishment of the National Pharmaceutical Institution 
and a transition period will be foreseen to allow an 
improvement of the physical structure until such an 
institutional structuring takes place, 
6. in the event of the change of the registration holder 
and the positive evaluation of the application submitted 
with the document required by the related legislation, 
with the exemption of the scientific and technological 
inspections and laboratory analyses, a registration will 
be drawn up in the name of the new applicant but the 
company of origin will be prevented from transferring 
the import registration unilaterally to another company, 
before the completion of 5 years, 
Furthermore, 
7. the implementation of the procedure for granting 
registration/permission to Homeopathic Products in our 
country will be initiated as of the EU candidacy date of 
Turkey. 
 
 
We would highly appreciate if you could submit your 
comments about the following issues to the General 
Directorate by April 9, 2004. 
 
 
Pharm. Hayriye MIHCAK 
General Director 
End Text AIFD Translation of Health Ministry Letter. 
Edelman