US embassy cable - 04ZAGREB2113

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, Intellectual Property 
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 
 
 
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