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07KYIV2865, UKRAINE: IPR ENFORCEMENT COOPERATION GROUP

November 23, 2007

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Reference ID Created Released Classification Origin
07KYIV2865 2007-11-23 13:00 2011-08-30 01:44 UNCLASSIFIED Embassy Kyiv

VZCZCXRO4027
PP RUEHDBU RUEHLN RUEHVK RUEHYG
DE RUEHKV #2865/01 3271300
ZNR UUUUU ZZH
P 231300Z NOV 07
FM AMEMBASSY KYIV
TO RUEHC/SECSTATE WASHDC PRIORITY 4392
INFO RUEAWJA/DEPT OF JUSTICE WASHDC
RUCPDOC/USDOC WASHDC
RUCNCIS/CIS COLLECTIVE

UNCLAS SECTION 01 OF 02 KYIV 002865 
 
SIPDIS 
 
SIPDIS 
 
STATE FOR EUR/UMB AND EB/TPP/IPE 
STATE PLEASE PASS TO USTR FOR BURKHEAD/GROVES 
USDOC FOR 4201/DOC/ITA/MAC/BISNIS 
USDOC FOR 4231/ITA/OEENIS/NISD/CLUCYCK 
 
E.O. 12958: DECL: N/A 
TAGS: ETRD KIPR ECON UP
SUBJECT: UKRAINE: IPR ENFORCEMENT COOPERATION GROUP 
DISCUSSES PHARMACEUTICAL INDUSTRY ISSUES 
 
REFS: A) KYIV 1450 and previous 
 
      B) 2006 KYIV 4304 
 
1. Summary: GOU, Embassy and industry representatives 
discussed IPR issues of importance to pharmaceutical 
producers at a November 21 Enforcement Cooperation Group 
(ECG) meeting.  The Ambassador emphasized the importance of 
IPR enforcement generally, and for the pharmaceutical 
industry specifically.  GOU officials argued that recent 
legislative and regulatory changes made as part of WTO 
accession marked major progress.  Industry expressed 
dissatisfaction that the GOU had not fully taken its 
comments on previous draft regulations into account.  The 
GOU pledged to work to improve the transparency of the drug 
approval process, and offered to expand its consultations 
with industry reps.  Econoff urged the GOU to properly 
notify pharmaceutical companies of new market approval 
applications; the GOU said it was working on the problem 
and had only the day before resumed posting applications on 
the internet.  The meeting's tone was constructive, and it 
helped lay the groundwork for improved cooperation between 
the GOU and the pharmaceutical industry.  End Summary. 
 
2. On November 21 Ukraine's State Department of 
Intellectual Property (SDIP) hosted the sixth meeting of 
the IPR Enforcement Cooperation Group (ECG), with 
participation of numerous industry representatives. (Note: 
See Ref A for previous ECG meetings.  End Note.)  The 
meeting focused exclusively on IPR issues of importance to 
the pharmaceutical industry.  The Ambassador represented 
the Embassy and emphasized the importance of IPR 
enforcement for Ukraine in meeting international and 
European standards.  The Ambassador noted the particular 
importance of protecting IP rights for the pharmaceutical 
industry, and encouraged the GOU to cooperate closely with 
industry. 
 
3. The following is a list of key participants: 
 
GOU 
--- 
Mykola Paladiy   - Chairman, SDIP 
Volodymyr Zharov - 1st Deputy Chairman, SDIP 
Olga Baula       - 1st Deputy Chairwoman, State 
                   Pharmacological Center 
Ludmila Plyuto   - Ukrainian Institute of Industrial 
                   Property (UkrPatent) 
Oleg Gaschytskiy - State Customs Service 
Vadim Vnukov     - Security Service of Ukraine 
 
Industry 
-------- 
Igor Mozolevich      - Delta Medical 
Tatiana Avdeenko     - Eli Lilly 
Irina Kukovskaya-Rud - GlaxoSmithKline 
Mikhail Aristov      - Boehringer Ingelheim 
Irina Kirichenko     - Law Firm "Ilyashev and Partners" 
Ludmila Lushpenko    - Servier 
Yuliya Kobuk         - American Chamber of Commerce 
 
(Note: Yuriy Savko, Director of the Association of 
Pharmaceutical Research and Development (APRaD), industry's 
lead lobbying group in Ukraine, was unable to attend. 
Mozolevich represented APRaD on his behalf.  End Note.) 
 
WTO-Related Amendments Mark Major Progress... 
--------------------------------------------- 
 
4. Paladiy and Zharov said that the November 2006 
amendments to the Law "On Medical Drugs" providing 
pharmaceutical producers with a five-year period of data 
exclusivity (ref B) marked a major step forward for IPR 
protection in Ukraine.  Baula, whose State Pharmacological 
Center handles market approvals for medical drugs, seconded 
that the corresponding implementing regulations -- Cabinet 
of Ministers Resolution No. 503 (dated 03/21/07) and 
Ministry of Health Order No. 426 (dated 10/05/07) -- had 
clarified regulatory procedures.  Baula said that 
regulations now required all market approval applications 
to include copies of patent licenses, and that any 
applications without the necessary documentation were 
rejected.  She said that the State Pharmacological Center's 
Qualification Council met every Friday to review market 
approval decisions, and that over 20 percent of 
applications were in fact rejected. 
 
KYIV 00002865  002 OF 002 
 
 
 
... But Industry Concerns not Fully Taken into Account 
--------------------------------------------- --------- 
 
5. Econoff congratulated the GOU on the significant 
progress, but cautioned that current procedures likely 
needed additional improvement.  Mozolevich asked why 
industry's proposals on the draft regulatory amendments, 
sent twice to the GOU by APRaD and the American Chamber of 
Commerce, were not reflected in the final version of the 
amendments.  (Note: Econoff had participated in meetings of 
the American Chamber of Commerce's Health Care Committee, 
during which industry worked out detailed proposals on the 
draft regulations.  End Note.)  Baula questioned whether 
the Ministry had ever actually received their proposals, 
incensing the industry reps. 
 
6. Paladiy stepped in and encouraged industry to send a 
copy of all such correspondence to SDIP, so that he could 
ensure
it received the attention of the proper GOU agency. 
Baula subsequently pledged to work with industry to improve 
the "transparency and openness" of the drug approval 
process.  She noted that the Ministry of Health was willing 
to introduce additional amendments to regulatory acts, as 
needed.  Econoff noted that, despite a past failure to 
communicate, the potential for cooperation now seemed ripe 
-- the GOU was expressing an interest in improving its 
regulatory procedures, and industry was ready with specific 
suggestions.  Paladiy proposed that Baula and industry reps 
schedule a follow-on meeting to discuss industry's 
proposals in detail. 
 
7. Paladiy also encouraged industry to comment on a draft 
Law "On Confidential Information" currently being developed 
by SDIP.  Baula added that the Ministry of Health was 
drafting a law meant to eliminate any conflicts of interest 
in the market approval process (i.e. domestic, generic 
producers playing a role in application decisions), and 
welcomed industry comment on the draft. 
 
GOU Fixing Notification Problem 
------------------------------- 
 
8. Econoff emphasized the importance of informing major 
pharmaceutical producers when another company tried to 
register a drug similar to one already on the market. 
(Note: In June, the State Pharmacological Center abruptly 
stopped posting notifications of registration applications 
on its website.  End Note.)  Zharov confirmed that the GOU 
had promised to address this problem during bilateral 
consultations held on the margins of October's WTO Working 
Party Meeting. 
 
9. Baula informed participants that the State 
Pharmacological Center had resumed posting new market 
approval applications on its website as of November 10 
(i.e. the day before the ECG), blaming the temporary change 
in practice on "technical issues."  Mozolevich and 
Lushpenko asked if industry would be able to access records 
from the five-month period when the website posting was 
halted.  Baula said yes, but then asked that APRaD send a 
formal request in order to aid the process. 
 
Comment: First Step towards Better Cooperation? 
--------------------------------------------- -- 
 
10. Except for frustration over past communication 
difficulties, the tone of the meeting was overwhelmingly 
constructive.  Baula stayed after the meeting and spoke 
privately with individual industry reps for over 30 
minutes, at one point telling them, "We're all on the same 
side."  Following the meeting, Mozolevich confirmed that 
APRaD and the American Chamber of Commerce will provide 
fresh comments on Ministry of Health Order No. 426 to the 
Ministry, and to Baula personally.  Post believes there is 
goodwill from the GOU and is optimistic that this meeting 
will mark the beginning of improved cooperation between the 
GOU and the pharmaceutical industry. 
 
TAYLOR

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