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Viewing cable 06ZAGREB223, CROATIA SPECIAL 301 REVIEW

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Reference ID Created Released Classification Origin
06ZAGREB223 2006-02-17 15:34 2011-08-25 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Zagreb
VZCZCXRO1334
RR RUEHAG RUEHDA RUEHDF RUEHFL RUEHIK RUEHKW RUEHLA RUEHLN RUEHLZ
RUEHROV RUEHSR RUEHVK RUEHYG
DE RUEHVB #0223/01 0481534
ZNR UUUUU ZZH
R 171534Z FEB 06
FM AMEMBASSY ZAGREB
TO RUEHC/SECSTATE WASHDC 5725
INFO RUEHZL/EUROPEAN POLITICAL COLLECTIVE
RUCPDOC/DEPT OF COMMERCE WASHDC
UNCLAS SECTION 01 OF 02 ZAGREB 000223 
 
SIPDIS 
 
SIPDIS 
 
SENSITIVE 
 
COMMERCE PASS USPTO 
STATE PASS USTR 
 
E.O. 12958: N/A 
TAGS: KIPR ETRD ECON HR
SUBJECT: CROATIA SPECIAL 301 REVIEW 
 
REF: A) STATE 14937 
 
     B) 05 ZAGREB 1721 
 
1.  Summary and Recommendation: Croatia's 
intellectual property (IP) protection regime is 
generally adequate and in accordance with accepted 
standards.  However, problems in the area of 
patent protection for pharmaceuticals continue. 
Unfortunately, the GOC has done nothing in the 
last year to resolve this issue, despite our 
continued pressure.  Although pharmaceutical 
patent infringement is an anomaly within Croatia's 
IP regime, post recommends that Croatia remain on 
the Special 301 Watch List.  We do not believe, 
however, that this problem is of sufficient 
gravity to warrant moving Croatia to the Priority 
Watch List, as industry has recommended.  End 
Summary and Recommendation. 
 
Pharmaceutical Protection Weak 
------------------------------ 
2.  Croatia's main weaknesses in IP protection are 
in patent linkage (see ref B) and inconsistent 
enforcement of the bilateral memorandum of 
understanding (MOU) on data exclusivity.  Post has 
worked consistently over the past year to urge the 
GOC to implement some form of patent linkage to 
prevent marketing authorization from being given 
for generic copies of drugs that are still 
protected by a valid patent in Croatia. 
Unfortunately, the GOC has not yet acted to 
address this problem, although we are hopeful that 
pressure brought to bear in Croatia's EU accession 
negotiations could prove instrumental in finally 
bringing about a resolution in the near term. 
 
3.  Croatia's implementation of data exclusivity 
legislation in late 2004 was a significant, if 
imperfect, step forward in tightening IP 
protection for pharmaceuticals.  Enforcement of 
the MOU, however, appears to be inconsistent. 
Post was made aware of one instance where the 
state drug agency was on the verge of issuing 
marketing authorization for a compound still 
protected by 6-year data exclusivity in Croatia. 
Authorization was ultimately withheld following 
post's intervention with the health ministry. 
 
301 Recommendation 
------------------ 
4.  Although we do not believe that either of 
these problems is endemic or indicative of overall 
weakness in Croatia's IP protection regime, we 
nevertheless recommend that Croatia remain on the 
Special 301 Watch List.  Despite the relatively 
narrow scope of the problem, removing Croatia from 
the Watch List would send the wrong signal about 
the seriousness of the 301 process.  However, we 
do not believe that Croatia should be moved to the 
Priority Watch List, as PhRma has recommended. 
 
5.  Post is aware of the other concerns raised by 
PhRMA concerning market access and reimbursements 
for pharmaceutical products.  Although we are 
sympathetic to these problems and urge the GOC at 
every opportunity not to jeopardize public access 
to innovative drugs, we do not believe that this 
is an IP issue that should be factored into the 
301 decision on Croatia. 
 
Other Developments 
------------------- 
6.  Croatia is currently undergoing "screening" on 
IP protection as part of its EU accession 
negotiations.  In November, the GOC released a new 
National Strategy for IP protection in an effort 
to bring Croatia's laws into conformity with the 
EU acquis. 
 
7.  In general, Croatia's enforcement of IP laws 
is good.  Nevertheless, piracy remains a constant 
problem, with police and customs officials making 
regular seizures of pirated audio and video 
material.  Software piracy remains common among 
private users, although business and industry 
generally use legal copies. 
 
 
ZAGREB 00000223  002 OF 002 
 
 
FRANK