Identifier
Created
Classification
Origin
05ANKARA394
2005-01-25 15:35:00
UNCLASSIFIED//FOR OFFICIAL USE ONLY
Embassy Ankara
Cable title:  

GOT's New Data Exclusivity Regulation - Major

Tags:  ETRD KIPR TU 
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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.

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