SLOVENIA: 2009 SPECIAL 301 REVIEW - RECOMMEND

UNCLAS LJUBLJANA 000056

SENSITIVE
SIPDIS

EEB/TPP/IPE - TMCGOWAN
DEPT PASS TO USTR (JCHOE-GROVES)

E.O. 12958: N/A
TAGS: ECON ETRD KIPR SI
SUBJECT: SLOVENIA: 2009 SPECIAL 301 REVIEW - RECOMMEND
AGAINST WATCHLIST INCLUSION

REF: A. SECSTATE 8401

B. 08 LJUBLJANA 81

C. 07 LJUBLJANA 103

D. 06 LJUBLJANA 119

E. 05 LJUBLJANA 127

Summary
--------------

1. (SBU) Post recommends that Slovenia continue to not be
included on the Special 301 watch list. Slovenian
legislation on intellectual property rights (IPR) and data
protection is fully aligned with EU legislation, TRIPS, WIPO,
and other ratified international treaties. The Government of
Slovenia, however, has yet to implement the EU Transparency
Directive. In practice, U.S. pharmaceutical companies have
access to the Slovene market. 2008 efforts by the former
Government of Slovenia (GoS) to balance the health-care
budget, curb inflation, and reduce government spending, posed
some problems for "innovative" drug producers. But the GoS
has been responsive to commercial concerns. The Ministry of
Health's MoH incorporation of the Pharmaceutical Research and
Manufacturers of America (PhRMA) and Post's pricing concerns
in the pricing regulation implemented in 2007 and the
omission of the therapeutic reference pricing from the
Medicine Act submitted by the MoH in February 2008 are both
positive signs. As well as working with PhRMA to address its
concerns, over the last few years, Post has been cooperating
with the GoS to provide training for judges, prosecutors, and
staff at the Slovenian Intellectual Property Office to help
address the challenges of the overburdened courts and
strengthen U.S.-EU cooperation of IPR protection. In
September, Slovenia held elections and a new Government was
sworn in in November 2008. PhRMA has informed us that it is
lobbying the new government and is waiting to see the new
government's position. Post believes GoS cooperation will
continue to increase, and recommends that Slovenia not be
included on the Special 301 Watch List. END SUMMARY.

PhRMA's Special 301 Submission
--------------

2. (SBU) PhRMA's Special 301 Submission highlights the
Slovenian MoH pricing policies and reimbursement programs.
The most serious complaint is that: "Slovenia was required to
implement the provisions of the European Union's Transparency
Directive governing pricing and reimbursement of
pharmaceuticals regulation by the end of June 2008, but has
failed to do so." Although Post has not received a response
from the GoS on this point, the government has since changed,
and Post believes it would be unfair and unwise to penalize
the new government for failings of the last regime. PhRMA
had asked Post to advocate on their behalf on pricing issues
with the prior government. However, PhRMA representatives
told EmbOffs in January 2009, that they were in the process
of negotiating with the new MoH and did not want Embassy
advocacy at that point. Post interprets this as a positive
sign that PhRMA has a more cooperative relationship with the
current GoS.


3. (SBU) PhRMA points out that "Slovenian government pricing
regulations have changed, on average, every 18 months."
PhRMA has been working with the GoS to ensure the next
pricing regulation changes are in-line with other EU
countries pricing regulations. PhRMA lodged similar
complaints about Slovenia in 2005, 2006, 2007 and 2008
(reftels B - E),but as in prior years, Post does not believe
the complaints justify placing Slovenia on the watchlist. In
2008, Slovenia effectively dealt with one persistent PhRMA
complaint from prior years - inefficient and slow judicial
process due to court backlog. In 2008 they reduced the
backlog of cases by 52%. Slovenia's continual improvements
in the judicial field indicate a willingness to address
identified issues and bring Slovenia into line with EU
directives.

Conclusion
--------------

4. (SBU) In all other areas of IPR and data protection,
Slovenia complies with international standards. Post's 2008
comments on related IPR issues (Reftel B) remain valid for

2009. Post recommends that Slovenia stay off the Special 301
Watch List in 2009.
FREDEN