TURKEY: PHRMA INDUSTRY DATA EXCLUSIVITY UPDATE

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SUBJECT: TURKEY: PHRMA INDUSTRY DATA EXCLUSIVITY UPDATE


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Ref: (A) Ankara 1898 and previous


1. (SBU) Summary: According to PhRMA company representatives in
Turkey, an August 3 Turkish MOH letter to the EU has specifically
acknowledged data protection for 22 of the 67 molecules for which
data exclusivity (DE) had been ambiguous under Turkey's new DE
regulations (ref A). The remaining 45, however, are not covered by
DE for various reasons. State Minister for Foreign Trade Kursad
Tuzmen will meet with PhRMA in D.C. on September 15 to discuss this
issue. Pharmaceutical companies are urging the EU to delay opening
of accession negotiations on the "Free Movement of Goods" and
"Intellectual Property Rights" chapters of the acquis communitaire
until Turkey has met its IPR obligations. End summary.

THE GOOD NEWS
--------------


2. (SBU) According to representatives of research-based
pharmaceutical companies in Turkey, Turkey's MOH provided
confirmation to the EU in an August 3 letter that the confidential
test data for 22 of the 67 molecules for which data exclusivity (DE)
had not been assured by the GOT (now increased from the previous 45
to a total of 67) would be protected. This correspondence resulted
from a special June 30 EU meeting with Turkey's health officials in
Brussels that followed GOT approval of a generic copy of one of
Danish firm Lundbeck's products (ref A) that the companies believed
should have benefited from DE. EU officials in Brussels reportedly
referred to this approval as a "clear violation" of Turkey's
Customs' Union obligations. This information represents the first
written communication from the MOH specifically addressing DE since
research-based pharmaceutical companies submitted their list of
molecules whose status was not clear under the new regulations in

2005.

THE BAD NEWS
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3. (SBU) Also in this MOH letter was a list of the 45 remaining
molecules that would not receive data exclusivity and the reasons
why the MOH was not granting this protection:

-- 22 because generic applications were filed before the January
1, 2005 start of Turkey's stronger data protection legislation;

-- 6 because the original innovative product has not yet been
approved in Turkey;

-- 7 (which had previously been granted DE) because the original
innovative product has not yet been registered in Turkey;

-- 1 because it was a vaccine;

-- 3 because it was a "combination product";

-- 1 because a generic was already on the market in Turkey;

-- 5 because they either were not eligible for DE in the EU or
because they were licensed in the EU prior to 2001 (in which case
the six years DE will expire at the latest by the end of this
year).


4. (SBU) PhRMA company officials in Turkey plan to meet with MOH
officials for clarification on this decision. For those molecules
that were denied DE because the original product has not yet been
approved in Turkey, it appears that this violates current Turkish
domestic legislation because DE protection was linked to the
original product's approval in any EU country.

NEXT STEPS
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5. (SBU) PhRMA companies in Turkey learned about the August 3 letter
in early September, only a few days after they submitted a letter to
USTR in support of the retention of Turkey's GSP benefits. While
company officials tell us that they still support this position,
they are concerned that it could send the wrong message to the GOT.
State Minister for Foreign Trade Kursad Tuzmen, who is conducting a
trade mission to the U.S. during the week of September 11 to promote
his "Year of America" strategy, will meet with PhRMA in D.C. on the
morning of September 15.


6. (SBU) EU representatives in Ankara told PhRMA officials that the

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EU plans to send another "strongly worded" response to the GOT in
light of this new information. Included in this letter will be a
call for a moratorium on the approval of generic applications for
the molecules still in question. This information will also be
included in the EU's November progress report on Turkey's accession
process. Finally, pharmaceutical company representatives and
interest groups are urging the EU to delay the beginning of
accession talks regarding the "Free Movement of Goods" and
"Intellectual Property Rights" chapters until the GOT meets its IPR
obligations.

COMMENT: MOH STILL THE PROBLEM
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7. (SBU) Foreign Ministry and Foreign Trade officials understand
Turkey's IPR obligations and appear committed to working to fix the
problem. As with many trade issues in Turkey, however, the
ministries who hold responsibility for complying with international
agreements have limited ability to effect a change in domestic
policy. It is clear that domestic generics manufacturers are
continuing to exert political pressure on the government. In our
recent meetings with MOH officials, they have not communicated
either an understanding of the need for greater data protection than
what is currently allowed or the will to fix the problem. In
addition to continued engagement with FTU, MFA and MOH officials, we
have suggested that company representatives consider discussing the
issue with Turkey's EU Secretariat office (which coordinates EU
accession negotiations) and with the PM's advisors. We will
continue to raise this issue at all levels. End comment.

WILSON