US embassy cable - 05ANKARA394

UNCLAS SECTION 01 OF 02 ANKARA 000394 
 
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:  GOT's New Data Exclusivity Regulation - Major 
Gaps in Protection 
 
 
SENSITIVE BUT UNCLASSIFIED.  PLEASE HANDLE ACCORDINGLY. 
 
1. (SBU) Summary:  The GOT issued a revised regulation 
on January 19 providing a six-year term of data 
exclusivity protection for confidential pharmaceuticals 
test data effective January 1, 2005.  The regulation 
contains major loopholes, including lack of 
retroactivity and other provisions which effectively 
whittle down the six-year term.  The European Commission 
is evaluating Turkey's regulation in the context of its 
Trade Barrier Review (TBR) on barriers in the 
pharmaceuticals sector.  Research-based industry is also 
meeting to consider next steps.  End Summary. 
 
2. (U) On January 19, the GOT announced its long-awaited 
policy on data exclusivity by publishing a revised 
pharmaceuticals marketing regulation in the State 
Gazette.  Based on a preliminary review of the 
regulation (see para for 5 a translation provided by 
Pfizer) and comments by one U.S. company, the policy 
seems similar to earlier, unsatisfactory drafts on data 
exclusivity.  The regulation provides a six-year term of 
data exclusivity protection beginning on January 1, 
2005, and in certain cases, beginning in 2001, but with 
exceptions that could reduce its benefits to research- 
based companies.  These include: 
 
-- Starting the six-year term on the date of licensing 
in an EU Customs Union country.  According to Pfizer, 
this provision cuts the effective term of protection 
because it can take over 200 days for a drug to go 
through the marketing approval process in Turkey; 
 
-- Limiting the term of data exclusivity to the term of 
the drug's patent in Turkey.  Note:  A Pfizer 
representative told us that this is unhelpful, but not 
inconsistent with existing EU regulations.  End Note; 
 
-- Original products licensed in a Customs Union country 
after January 1, 2001 can enjoy data exclusivity 
protection, unless generics manufacturers have applied 
for licenses in Turkey prior to 2005.  According to U.S. 
industry, there are hundreds, and possibly over 1,000 
pending applications in this category at the Ministry of 
Health.  With this vast loophole, relatively few drugs 
launched prior to 2005 will be able to benefit from data 
exclusivity protection. 
 
3. (SBU) An EU diplomat told us that the GOT had 
provided no advance notice to Brussels of this 
regulation, despite the fact that the European 
Commission had raised data exclusivity and other 
pharmaceuticals concerns with the Turks in writing 
through the TBR process.  She told Econoff that Brussels 
would evaluate the regulation in meetings later this 
week. 
 
4. (SBU) Comment and Recommendation:  It appears that 
the new GOT regulation falls far short of a satisfactory 
solution to our concerns on data exclusivity, and that 
this issue, along with patent linkage, will be leading 
subjects in the upcoming Special 301 review of Turkey. 
Although the EU declined an earlier U.S. request to do a 
joint demarche on this subject to the Turks, the time 
may be ripe for another approach to Brussels.  We 
recommend that Washington agencies consider the merits 
of a joint demarche, and, if appropriate, provide 
guidance to the Embassy and to USEU. 
 
5. (U) Begin Text Pfizer Translation - Registration 
Regulation Article 9/Temporary Article 1: 
 
Article 9- Without prejudice to the provisions of the 
Decree Law dated 24/06/1995,with no. 551, on the 
Protection of Patent Rights; 
a) In abridged applications, the applicant shall not be 
required to present the results of toxicological and 
pharmacological tests and clinical trials, provided that 
one of the following points is proved: 
1) The medicinal product shall be mostly similar to a 
medicinal product which previously registered in Turkey 
and the marketing registration holder of the original 
medicinal product shall have consented to the use of the 
toxicological, pharmacological and/or clinical 
references contained in the dossier of the original 
medicinal product for the purpose of evaluating the 
referred application, 
2) Any constituent(s) of the medicinal product shall 
have a well-established medical use, determined by means 
of detailed scientific bibliography and with a 
reasonable efficiency and acceptable level of 
reliability, 
3) The medicinal product shall be essentially similar 
with a medicinal product which has been registered in 
accordance with the current legislative provisions and 
has completed its data exclusivity period. The data 
exclusivity period called for by this subparagraph, 
shall apply on the original products for which no 
generic registration application has been submitted in 
Turkey until 01/01/2005, among the original products 
registered for the first time after 01/01/2001 in one of 
the countries within the Customs Union Area and the 
original products to be registered for the time after 
01/01/2005 in one of the countries of the Customs Union 
Area and shall be 6 (six) years to begin as of the first 
registration date in the Customs Union Area and to be 
limited with the patent period of the  relevant molecule 
in Turkey. 
However, in the event of a different therapeutical 
indication, route of administration, dosage being 
envisaged from those of the medicinal products which 
have been introduced into the market, it shall be 
necessary to submit the results of the relevant clinical 
trials and where necessary the results of toxicological, 
pharmacological studies. 
b) With regard to new medicinal products containing 
recognized constituents, but which have not yet been 
used in combination for therapeutical purposes, it shall 
be necessary to present the results of the relevant 
toxicological and pharmacological tests and clinical 
trials. However, it shall not be obligatory to present 
the references pertaining to each constituent. 
In compliance with subparagraph (2) in item (a) of the 
first paragraph of this article, in the event of the 
presentation of bibliographical references based on 
published data, the applications shall be submitted in 
accordance with Annex I. 
In exceptional cases constituting a severe threat for 
public health, the Ministry may take into consideration 
the registration applications of generic products, which 
have been presented upon taking as basis the data 
pertaining to the toxicological, pharmacological and 
clinical data published on literature, independent from 
the provisions set forth in this article. 
 
Temporary Article 1- The registration/permit 
applications submitted before the enforcement of this 
Regulation, shall be evaluated in accordance with the 
legislative provisions in force on the date such 
applications are submitted. 
With regard to the abridged applications presented in 
accordance with article 9 of this Regulation of which 
all provisions except for article 9 shall be enforced on 
30/06/2005, the applications submitted in compliance 
with the application format indicated in the Regulation 
in force shall be accepted. 
 
End Text Pfizer Translation. 
 
Edelman