TURKEY: PHRMA IPR ISSUES IN EU PROGRESS REPORT

UNCLAS ANKARA 006611

SIPDIS

DEPT PLEASE PASS USTR FOR LERRION/BPEUK
DEPT PLEASE PASS USPTO FOR JO ELLEN URBAN
USDOC FOR ITA/MAC/CRUSNAK
USEU FOR JULIE NUTTER AND USTR

SENSITIVE
SIPDIS

E.O. 12958: N/A
TAGS: ETRD KIPR USTR EUN TU
SUBJECT: TURKEY: PHRMA IPR ISSUES IN EU PROGRESS REPORT


SENSITIVE BUT UNCLASSIFIED. NOT FOR INTERNET DISTRIBUTION.

Ref: (A) Ankara 5335 and previous


1. (SBU) Summary: The November EU Commission Progress Report on
Turkey's accession process included language about the slow movement
of pharmaceutical IPR reforms. While U.S. pharmaceutical companies
in Turkey have not received any new information from the Ministry of
Health regarding the MOH's August 3 letter outlining which products
would benefit from data exclusivity (ref A),PhRMA company
representatives express guarded optimism based on the issue's
inclusion in the Progress Report and another "strongly worded"
letter sent by the Commission on November 6 to Turkey's EU
Delegation. However, depending how the accession process proceeds
after the December 15 EU Summit, PhRMA companies may call on the USG
to intensify its efforts if EU influence begins to wane. End
summary.


2. (SBU) Innovative pharmaceutical companies in Turkey, through
their European trade association (EFPIA) in Brussels, have been
pushing the EU Commission on three items for EU action to pressure
Turkey to fully implement its data exclusivity (DE) obligations
under the Customs Union. The first was that the Commission demand
from Turkey's MOH a moratorium on generics approvals for the
products in question until the ongoing DE issues are completely
resolved. The second was that the EU send the GOT a firm letter
rejecting generics claims to products filed before 1 January 2005,
which covered new medicines registered in Europe between 2001 and

2005. Finally, PhRMA companies requested clear language in the 2006
Turkey Progress Report expressing EU concerns about DE
implementation.


3. (SBU) In response to this pressure from EFPIA, the EU
Directorate-General for Trade wrote in a November 6 letter to the
GOT that, in light of the most recent list of products for which DE
has been granted or rejected (ref A),the Commission is "in fact
even more concerned than before on the criteria that have been
applied" for processing generics applications. The letter once
again urges the Turkish MOH to apply all regulatory conditions and
requirements related to regulatory data exclusivity, as derived from
both its international obligations, including the acquis
communautaire, binding upon Turkey and from Turkish legislation. It
ends by calling on Turkey to refrain from "receiving, evaluating and
approving" generics applications that violate the GOT's obligations
under the Customs Union rules.


4. (SBU) In its November Progress Report on Turkey's EU accession,
the Commission included language that refers to "limited progress"
in the area of pharmaceuticals and uncertainty linked to the
authorization regime applied to a number of generics, which
"continues to constitute a source of concern and disagreement."
PhRMA company representatives viewed this as a major victory and
hope that along with the November 6 letter, it will dissuade
Turkey's MOH from taking further action to approve additional
generics applications from the disputed molecules.


5. (SBU) Comment: The questions about Turkey's EU accession have
made the EU's ongoing influence on this issue more uncertain. PhRMA
company representatives understand this reality and have cautioned
that if EU pressure becomes less than successful, they will be
looking to the USG to intensify its efforts. End comment.

WILSON