Cablegate: Pharmaceuticals Ipr Update

This record is a partial extract of the original cable. The full text of the original cable is not available.





E.O. 12958: N/A
SUBJECT: Pharmaceuticals IPR Update

1. (SBU) Summary: Following heavy lobbying by the local
generics industry, the GOT is contemplating introduction
of data exclusivity protection for pharmaceutical test
data only in 2007 and even watering down patent
protection, but, to our knowledge, no final decisions
have been taken on these matters. In contacts with the
Health and Foreign Ministries and the Turkish Patent
Institute, we have stressed the importance of these
issues in the bilateral economic relationship and have
urged that the GOT comply with its WTO commitments. End

2. (SBU) Citing a leaked report prepared for the GOT's
Board for the Evaluation of Economic Problems in the
Pharmaceuticals Sector, U.S. pharmaceutical companies
operating in Turkey contacted the Embassy in late August
and early September to register strong concern about
reports that the GOT intends to delay implementation of
data exclusivity protection until 2007 and to water down
patent protection for pharmaceuticals. The report
followed discussions in late August between the GOT and
local generics producers. At the same time, Eli Lilly
representatives noted some progress in diminishing price
discrimination against imported drugs, including the
beginning of a dialogue with the Health Ministry on
margins and ad hoc suspension of reference pricing for
some drugs.

3. (SBU) Econoff and Econ Specialist raised these issues
with Hayriye Mihcak, Director General for
Pharmaceuticals at the Turkish Ministry of Health on
September 9. Mihcak confirmed that an interministerial
board was developing reports on data exclusivity, patent
protection and pricing. These reports are to form the
basis for a response to the European Union on these

4. (SBU) Mihcak hesitated in discussing the contents of
the reports until Econoff shared an English translation
of the one concerning data exclusivity and patent
protection. We emphasized that data exclusivity and
patent protection were not only an EU-Turkey issue, but
also WTO requirements for Turkey and of great interest
to the United States. Econoff underlined that delays in
implementing data exclusivity and any movement to
degrade patent protection would be received very
negatively by the USG and U.S. industry. He also noted
that at least one key stakeholder - the research-based
industry - had not been consulted in preparing the
report. Mihcak responded that the report was not yet
finalized, and that she would take our points into
consideration in future interagency discussions on this

5. (SBU) Mihcak said she regarded the current pricing
system in pharmaceuticals to be inequitable and said the
GOT was considering changes to it, but she declined to
go into the specifics of this issue.

6. (SBU) Econoff raised these issues with Selim Sengun,
President of the Turkish Patent Institute (TPI), on
September 10. Sengun stated that the report on data
exclusivity and patent protection represented the
maximum demands of the generic industry, and that there
was a fair chance that the GOT would not decide to fully
implement these provisions. In interagency discussions,
TPI's representative urged against weakening patent
protection. He also pointed out that weakening Turkish
patent protection would have limited effect since, in
the near future, most pharmaceuticals patents would be
take effect on the basis of approvals made by European
Patent Office. Sengun cautioned that local generics
manufacturers constituted a strong lobby against IPR
protections in its sector, one that apparently had the
ear of the Health Ministry as well as other GOT

7. (SBU) Econ and Commercial Counselors also raised
pharmaceuticals issues with MFA Deputy Director General
for Bilateral Economic Affairs Mehmet Gucuk on September
12. Gucuk asked us to provide further details on these
issues in writing, which Embassy will do in the near
future. Edelman

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