SPECIAL 301: PARLIAMENT APPROVES PATENT LINKAGE

UNCLAS BRATISLAVA 000323

SIPDIS

SIPDIS

DEPARTMENT FOR EUR/NCE AND EB/IPE: CLACROSSE AND EFELSING
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E.O. 12958: N/A
TAGS: KIPR ETRD ECON LO
SUBJECT: SPECIAL 301: PARLIAMENT APPROVES PATENT LINKAGE
LEGISLATION

REF: A) URBAN/POTTS EMAILS ON 4/13; B) BRATISLAVA 199; C)

BRATISLAVA 143


1. In a very positive step, parliament approved the
Amendment to the Medicines Act on April 19 in its third
reading without any changes to the original version of the
section on patent linkage. This is the version that was
reviewed by USG officials and is designed to close the
loophole that had allowed generic producers to manufacture
and market drugs that were still under patent protection.
The legislation will now be sent to the President for
signature and, once signed, will become law on June 14,

2006. The patent linkage amendment is consistent with the
interim decree, which was signed by the Health Minister in
January. The interim decree will remain in force until the
law goes into effect. (Note: the section of the amendment
transposing the EU Directive on data exclusivity also passed
without any changes.)


2. As outlined in Ref A, the Minister of Health Rudolf Zajac
presented an alternative "watered-down" version of the
patent linkage provision during the parliamentary healthcare
committee meeting last week. As we made clear in a follow-
on letter to the Health Minister, this revised amendment
fundamentally changed the intent of the provision and would
not protect the rights of the patent holder. We met with
Minister Zajac on Tuesday (4/18) before the final healthcare
committee meeting and got his commitment to return the
patent linkage legislation to its original form, which had
been approved by Parliament in the amendment's "first
reading" last month. Zajac defended the original patent
linkage provisions during the April 19 debate in Parliament,
and was successful in fending off two attempts by opposition
parliamentarians to remove the patent linkage section from
the legislation. The head of the parliamentary healthcare
committee also supported the effort and was pleased with
passage of the reform. The Local Area Working Group (LAWG)
is fully satisfied with the final legislation, and has
already communicated this back to PhRMA officials in
Washington.


3. Comment: We had heard that the generic manufacturers were
applying significant pressure on government and
parliamentary officials to change or eliminate the provision
in the amendment on patent linkage. We are pleased that
ultimately they were not successful, and that this amendment
will close the loophole that had allowed patent-infringing
generic pharmaceuticals to enter the Slovak market.
Together with the strengthening of data exclusivity
protection, which was also a part of the amendment, and the
efforts underway to renovate a new storage facility for
proprietary pharmaceutical data, Slovakia has significantly
improved its protection of intellectual property rights. We
strongly recommend acknowledging these positive developments
by removing Slovakia from the 2006 Watch List. End Comment.


SILVERMAN