Cablegate: Poland: Pharmacuetical Data Exclusivity Update

VZCZCXRO2852
RR RUEHKW
DE RUEHWR #0595 0711629
ZNR UUUUU ZZH
R 121629Z MAR 07
FM AMEMBASSY WARSAW
TO RUEHC/SECSTATE WASHDC 3536
INFO RUEHKW/AMCONSUL KRAKOW 1633
RUEHBS/USEU BRUSSELS
RUCPDOC/DEPT OF COMMERCE WASHINGTON DC

UNCLAS WARSAW 000595

SIPDIS

SENSITIVE, SIPDIS

STATE FOR EUR/NCE/BPUTNEY
STATE PASS USTR FOR WILSON/MOORE
COMMERCE FOR 4232/ITA/MAC/EUR/OECA/MROGERS

E.O. 12958: N/A
TAGS: ETRD KIPR PL
SUBJECT: POLAND: PHARMACUETICAL DATA EXCLUSIVITY UPDATE

1. (SBU) According to representatives of the Employer's Union of
Innovative Pharmaceutical Companies (INFARMA), Poland has adopted
the "8+2+1" data exclusivity system for drugs centrally registered
in the European Union (EU) through the European Medicines Agency
(EMEA). This means that innovative pharmaceutical companies in
Poland now receive 8 years of data exclusivity, followed by an
additional 2-3 years of market exclusivity, for new innovative
molecules registered at the EU level. While Poland recognizes the
8+2+1 system for EMEA-registered drugs, those drugs registered
nationally in Poland (mostly prior to May 1, 2004) using the
'decentralized' method still only receive six years of data
exclusivity.

2. (SBU) Poland has thus far resisted implementation of EU Directive
2004/27/EC to provide 8+2+1 data exclusivity for nationally
registered original drugs (in practice, mostly those drugs
registered prior to May 1, 2004). The EU requires all member states
to comply with the directive by November 2005, but Poland (along
with Lithuania, Malta and Hungary) applied for a 15-year derogation
in early 2006. In October 2006, the EU Commissioner reportedly
decided against granting the 15-year delay, but has not officially
informed Poland of its decision. Currently, INFARMA and the
European Federation of Pharmaceutical Industries and Associations
(EFPIA) are in negotiations with the EU Commission to get the EC to
send the letter of official notice. According to INFARMA, as well
as industry representatives, the EC is delaying official
notification for "unspecified" political reasons.

3. (SBU) It is therefore unlikely that new Polish health care
legislation currently under consideration in Poland's Senate (and
scheduled to go into effect on April, 15, 2007) will incorporate new
data exclusivity laws for 'decentrally' registered drugs. In
INFARMA's opinion, raising the data exclusivity period for these
drugs to the EU standard will probably require a new draft
amendment. INFARMA believes the GOP will only start work on this
legislation once it receives official notice from the EC that its
derogation request has been denied.

4. (SBU) At stake is a group of innovative drugs registered in
Poland before its adoption of the centralized EU procedure in 2004.
While INFARMA representatives were not at liberty to discuss the
precise number or value of these drugs, they indicated that they
would face generic competition 4-5 years earlier under Poland's
current 6-year data exclusivity laws than with the EU-mandated 8+2+1
formula. According to INFARMA, this is by GOP design, since the
government wants to decrease drug prices as quickly as possible by
introducing generic competition.

5. (SBU) Comment: Prior to joining the EU on May 1, 2004, Poland
granted only three years of data exclusivity. Based on its EU
accession commitments, the GOP extended its national data
exclusivity to six years, and allowed an exception for drugs
centrally registered with the EU (initially 10-years and later
changed to the 8+2+1 formula). In the eyes of the GOP, Poland never
agreed to apply the 8+2+1 system to its own national registration
system. The respective directive, 2004/27/EC, was implemented on
March 31, 2004, approximately one month before Poland's EU accession
and without Polish consultation. Thus, the GOP feels it has a
legitimate reason to resist the changes, an impasse exacerbated by
the lack of official EC notice demanding that Poland comply. Once
the EC sends its official notification of denial to Poland, Poland
will have no choice but to amend its pharmaceutical act to reflect
the standard 8+2+1 EU data exclusivity protection, or risk EC legal
proceedings. The main issue will be how fast these changes will
take to become law. Industry representatives in Warsaw guess the
period could be from several months to several years.

HILLAS

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