VZCZCXYZ0024
PP RUEHWEB

DE RUEHSL #0199/01 0691556
ZNR UUUUU ZZH
P 101556Z MAR 06
FM AMEMBASSY BRATISLAVA
TO RUEHC/SECSTATE WASHDC PRIORITY 9618
INFO RUCPDOC/USDOC WASHDC

UNCLAS BRATISLAVA 000199 
 
SIPDIS 
 
SIPDIS 
 
DEPARTMENT FOR EUR/NCE AND EB/IPE:CLACROSSE 
DEPT PLEASE PASS TO USTR JCHOE-GROVES AND LERRION 
USDOC FOR JBOGER AND MROGERS 
USDOC PLEASE PASS TO USPTO JURBAN AND LOC STEPP 
 
E.O. 12958: N/A 
TAGS: KIPR ETRD ECON LO
SUBJECT: SPECIAL 301: SLOVAKIA PROCURES NEW STORAGE FACILITY 
 
REF: A) BRATISLAVA 143 B) December 15, 2005 DVC between USG 
 
and GOS representatives. 
 
¶1. Summary - The Ministry of Health (MOH) has found a secure 
building for the storage of proprietary drug application 
data on a military base.  Econ officers visited the facility 
on March 8 and were fully satisfied that once it is 
renovated according to MOH's plans the building will serve 
as a secure and functional structure for the storage of 
sensitive pharmaceutical data.  Together with the recent 
successful efforts to enhance linkage regulations to better 
protect patent holders, this development gives us confidence 
that Slovakia is committed to fully resolving our 
outstanding 301 concerns.  We strongly recommend removing 
Slovakia from the 2006 Watch List, believing that failure to 
do so would be counterproductive and could harm future 
efforts to work with the Ministries of Health and Economy in 
areas of mutual concern.  End summary. 
 
NEW STORAGE FACILITY 
-------------------- 
 
¶2. As outlined in reftel A, the MOH received three bids for 
a public tender for a secure storage facility and had 
planned to select a winning bid by the end of February. 
Before this process was complete, however, Minister of 
Health Rudolf Zajac notified the Embassy that his ministry 
had identified a vacant government building that fit the 
criteria and could be procured more quickly and at a 
fraction of the cost of a private facility.  The building 
belongs to the Ministry of Defense and is located on a 
military base in Malacky, about 45 minutes north of 
Bratislava.  It is a former mess hall and officers club that 
has not been used for several years.  The Ministry of 
Defense has agreed to transfer this building to the MOH. 
 
¶3. Econoffs visited the facility on March 8 with officials 
from the Drug Control Authority (SUKL), who together with 
the MOH will be responsible for the renovation and transfer 
of documents to the Malacky facility.  The 20 year-old two- 
story building is in good condition and will provide 
sufficient space (approximately 13,750 square feet) to house 
the sensitive drug company files.  The SUKL officials 
brought detailed architectural designs and used the visit to 
provide an overview of their renovation plans.  SUKL plans 
to tear down the interior walls to make one large warehouse- 
like room on each level, redo the floors, and install an 
elevator.  They will also install security and fire alarm 
systems, and reduce the number of exterior entrances to the 
building.  Security will also be enhanced by the fact that 
the building is located on an active military base and will 
have round-the-clock military security.  SUKL estimates that 
the total cost of reconstruction will be approximately USD 
500,000.  As outlined in Ref. A, the MOH has already 
allocated funds to SUKL for this project. 
 
¶4. SUKL requested the Embassy's informal approval of the 
facilities before finalizing arrangements for the transfer 
of title from the Ministry of Defense and moving ahead with 
reconstruction. (Note: Ambassador sent a letter to Minister 
of Health Zajac on March 9 noting our satisfaction with the 
facilities and encouraging the minister to move as quickly 
as possible to finalize arrangements and begin 
construction.)  By their own estimates, SUKL will need two 
to four weeks to transfer the title and get the necessary 
building permits.  After selecting a contractor, 
construction is expected to take two months.  SUKL plans to 
finish the renovations and move the proprietary data to the 
Malacky facility by July or August, 2006. 
 
LINKAGE LEGISLATION SENT TO PARLIAMENT 
-------------------------------------- 
 
¶5.  The draft amendment to the Medicines Act was approved by 
the cabinet without changes on February 15 and is the second 
item that will be taken up by the Parliament when the new 
session opens on March 15.  The legislation obligates SUKL 
to notify the patent holder when it receives a request for 
marketing approval from a generic company, and to coordinate 
with the Patent Office if there is any question as to the 
status of the patent.  As outlined in Ref A, as an interim 
measure the MOH issued a decree in January requiring SUKL to 
abide by the provisions of the draft amendment until it 
becomes law.  A translated version of the draft amendment 
and the MOH decree will be sent by email to Washington 
officials. 
 
¶6. Comment - After our visit to Malacky and briefing by SUKL 
officials, we are fully satisfied that once the building is 
renovated it will meet all of the criteria for a secure 
storage facility for proprietary drug application data. 
Although the new facilities will not be ready by March 31, 
as promised by SUKL officials at the Ref B. digital video 
conference (DVC), the Health Minister and other GOS 
officials have taken major steps towards this goal and have 
given every indication that they are committed to completing 
the process as soon as possible.  Even the Director of SUKL, 
Milan Rybar, who has been a reluctant participant from the 
beginning of our discussions with the GOS, now seems 
enthusiastic about the project and even requested our help 
in encouraging the MOH to act quickly to obtain the 
necessary permits so that they can begin work on the 
building. 
 
¶7. Comment continued - GOS officials have acted in good 
faith to meet the commitments that they made at the December 
15, 2005 DVC to address the outstanding IPR concerns that 
have kept them on the Watch List for the last five years. 
Although some work implementing these strong commitments 
remains to be done, we strongly recommend acknowledging 
their efforts by removing Slovakia from the 2006 Watch List. 
Leaving Slovakia on the list would be counterproductive, 
souring the strong working relationship that we have built 
with the ministries of health and economy and making further 
cooperation to improve the business environment more 
difficult. End Comment. 
 
VALLEE