VZCZCXYZ0007
PP RUEHWEB

DE RUEHSL #0173/01 0811443
ZNR UUUUU ZZH
P 221443Z MAR 07
FM AMEMBASSY BRATISLAVA
TO RUEHC/SECSTATE WASHDC PRIORITY 0790
INFO RUEHPG/AMEMBASSY PRAGUE PRIORITY 4124
RUEHBS/USEU BRUSSELS PRIORITY
RUCPDOC/DEPT OF COMMERCE WASHDC PRIORITY

UNCLAS BRATISLAVA 000173 
 
SIPDIS 
 
SIPDIS 
 
DEPT FOR EB/IPE: CLACROSSE AND JURBAN 
DEPT PASS TO USTC JCHOE-GROVES AND WMOORE 
USDOC FOR JBOGER AND MROGERS 
 
E.O. 12958: N/A 
TAGS: KIPR ETRD ECON LO
SUBJECT: PATENT PROTECTION THREATENED BY PROPOSAL IN 
PARLIAMENT 
 
 
¶1. Summary and Action Recommendation - An amendment designed 
to overturn pharmaceutical patent legislation approved last 
Spring passed the first reading in the Slovak Parliament on 
March 20.  The measure, introduced by an MP with significant 
generic pharmaceutical business interests, will be reviewed 
by the Slovak government and the relevant Parliamentary 
committees before being considered again by the Parliament in 
May.  Post will continue to work closely with local pharma 
companies to ensure that the recent improvements in 
pharmaceutical patent protection, which led to Slovakia being 
removed from the 2006 Special 301 Watch list, are not undone 
through this amendment.  State and Commerce can assist this 
effort by raising the issue with Slovak Economy Minister 
Lubomir Jahnatek during his April 3 and 4 visit to 
Washington.  End Summary. 
 
¶2. On March 20 the Slovak Parliament approved in the first 
reading an amendment to the Medicines Act proposed by MP Ivan 
Varga from the leading coalition party, Smer (Direction). 
The amendment proposes to overturn legislation passed in May, 
2006, that established a formal link between the Drug Control 
Authority (SUKL) and the Industrial Property Office (Patent 
Office) to ensure that patent-infringing drugs would not be 
given market access.  We fought hard to obtain the May 2006 
changes.  The lack of patent linkage was a key reason 
Slovakia had remained on the Special 301 Watch List for 
several years.  Due to progress made towards implementing the 
patent linkage provision last Spring, as well as other GOS 
measures to enhance the protection of IPR, Slovakia was not 
included on the 2006 Watch List.  In addition, no industry 
associations or individual companies recommended Slovakia for 
inclusion in the 2007 Special 301 Review. 
 
¶3. The Varga amendment claims that the provision in Article 
21a (8) g) from the Medicines Act, as amended in May, 2006, 
does not comply with Article 26 of the EU Directive 
2004/27/EC relating to reasons for refusing a marketing 
authorization.  This new amendment proposes to eliminate a 
sentence from the Medicines Act that requires SUKL to 
'refuse' a generic registration if a valid patent still 
exists.  The implementing regulations issued by the Health 
Minister in July 2006 had already clarified this point by 
noting that SUKL will not deny registration due to the 
existence of a valid patent, but will tie the final market 
authorization to the date of patent expiration.  This was 
designed to appease concerns by the generic companies that 
they would not be able to take the necessary steps to 
register a drug (equivalency studies, etc.) in advance of 
patent expiration. 
 
¶4. Ivan Varga had a lead role in trying to stop the 2006 
legislation from passing.  At the time he used many of the 
same arguments that are outlined in this current amendment. 
In addition to his current legislative efforts, Varga has 
also lodged a complaint with the European Commission, asking 
them to comment on the 2006 amendment.  The EC provided a 
series of questions to the Ministry of Health based on these 
complaints, to which MOH replied in early March.  Varga has 
ownership interests in at least three generic manufacturers 
in Slovakia including Biotika Slovenska Lupca and 
Slovakofarma Hlohovec, which he helped to privatize in the 
1990's, as well as Zentiva.  His companies have benefited in 
the past from the previous lack of adequate patent linkage in 
Slovakia by introducing generic equivalents of patent 
protected drugs to the marketplace. 
 
¶5. Post was aware that the Slovak generic industry remained 
interested in overturning the patent linkage legislation. 
Ambassador has raised this concern each time he has met with 
Health Minister Ivan Valentovic, most recently during a 
February 2007 meeting.  Although the legislation was proposed 
independently from the Health Ministry, a point that was 
stressed to EconOff by MOH officials on 3/21, Valentovic will 
have a lead role in both providing GOS comments on this 
legislation and leading the debate over the amendment in the 
Parliamentary Health Care Committee.  The Ambassador sent 
Valentovic a letter March 22 outlining our concerns and 
encouraging the Minister to take action to ensure that patent 
protection is noted undermined.  With the amendment having 
passed first reading, the government and separately each of 
the assigned Parliamentary committees (this includes the 
Health Care, Constitutional and Legal and Agricultural 
committees) have 30 days to provide comments.  The Health 
Care committee will submit a combined report by May 4 to the 
Parliament. 
 
¶6. Comment - As we did last Spring in support of the 
amendment that established patent linkage, Post will continue 
to work closely with AmCham's Local Area Working Group (LAWG) 
to ensure that this new amendment is not successful.  The 
first step is to get the Smer-led government on board with 
our efforts.  Slovak Economy Minister Lubomir Jahnatek's 
meetings with Commerce U/S Lavin on April 4 and State EEB A/S 
Sullivan on April 3 (to be confirmed) offer excellent 
opportunities to follow up on the Ambassador's letter to the 
Health Minister by stressing to Jahnatek the importance of 
IPR protection.  Defeating this measure will also require 
significant outreach to ruling and opposition political 
parties.  End Comment. 
VALLEE