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