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Cablegate: Croatia Finally Provides Data Exclusivity;

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

UNCLAS ZAGREB 002113

SIPDIS


SENSITIVE

STATE FOR USTR/LERRION
USDOC FOR 4232/ITA/MAC/EUR/MROGERS

E.O. 12958: N/A
TAGS: KIPR ETRD PREL HR
SUBJECT: CROATIA FINALLY PROVIDES DATA EXCLUSIVITY;
PIPELINE PROTECTION IN DOUBT

REF: A. ZAGREB 1836 AND PREVIOUS
B. TELCOM ERRION/DETWILER 11/17/04

1. (U) On December 3, the Croatian parliament passed an
amendment to the Drug Law which provides data exclusivity
(protection against other companies using clinical trial data
provided to the government as a condition of marketing
authorization). The protection lasts for six years after the
drug is first registered in either Croatia or in any EU
member country. While the language is not as strong as that
originally sought in the 1998 bilateral MOU on Intellectual
Property (there is usually a lag of several years between
when a drug is first registered somewhere in the EU and in
Croatia), local U.S. pharmaceutical representatives have
voiced their satisfaction with the provision. The opposition
in parliament unsuccessfully attacked the legislation,
charging the government with ignoring the interests of the
Croatian health system and Croatian pharmaceutical companies.
The government defended the measure, citing obligations
under the MOU and to the EU.

2. (SBU) We understand from Ref B that the interagency group
considering the initiatation of exchange of dipnotes
necessary to bring the MOU into effect has determined that
the USG cannot currently meet all the requirements of the
MOU, and therefore will not bring the MOU into effect. In
the absence of a determination that the USG is willing to
bring the MOU into force, the embassy is uncertain about the
prospects for pursuing pipeline protection legislation, which
would have provided our companies a "second chance" to patent
drugs not currently protected. As we understand it, such a
provision is not called for under TRIPS; our argument for it
was based on the obligations of the MOU. If the USG is now
doubtful about bringing the MOU into force, we will have
difficulty pressing the GOC on that basis.
FRANK


NNNN

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