VZCZCXRO4932
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DE RUEHMO #0335/01 0471924
ZNR UUUUU ZZH
P 161924Z FEB 10
FM AMEMBASSY MOSCOW
TO RUEHC/SECSTATE WASHDC PRIORITY 6250
INFO RUEHXD/MOSCOW POLITICAL COLLECTIVE PRIORITY
RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE PRIORITY
RUEHZL/EUROPEAN POLITICAL COLLECTIVE PRIORITY
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UNCLAS SECTION 01 OF 02 MOSCOW 000335
SENSITIVE
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STATE FOR EUR/RUS, EUR/PGI, OES/PCI, OES/IHB
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TAGS: PGOV TBIO PREL SOCI ETRD KIPR RS
SUBJECT: RUSSIA HEALTH REGULATOR DISMISSED AFTER PUBLIC COMMENTS ON
DRAFT PHARMA LAW
REF: MOSCOW 189
MOSCOW 00000335 001.2 OF 002
SENSITIVE BUT UNCLASSIFIED -- NOT FOR INTERNET DISTRIBUTION.
1. (SBU) SUMMARY: On February 6, Prime Minister Putin dismissed
Nikolai Yurgel, head of Russian pharmaceutical watchdog
Roszdravnadzor, two days after Yurgel publicly criticized the
government's draft "Law on the Circulation of Medicines," echoing
numerous objections of the pharmaceutical industry and other
stakeholders. The USG has expressed concerns about the draft
relating to intellectual property rights and drug testing
requirements. Yurgel also had a parochial reason to object to the
bill: if passed, it would move drug and testing from Roszdravnadzor
into a new agency. Despite Yurgel's firing, the intellectual
property rights issue may still be addressed through an amendment
which has been drafted, but not submitted to the Duma. But Yurgel
has had difficult relations with Health and Social Development
Minister Golikova for some time, and his criticism of the law may
have been simply a convenient excuse for his dismissal. END
SUMMARY.
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HEALTH REGULATOR SPEAKS OUT, LOSES JOB
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2. (U) On February 6, Prime Minister Putin dismissed Nikolai Yurgel,
head of the Russian Federal Service for Surveillance in the Sphere
of Health and Social Development (Roszdravnadzor), the agency
responsible for supervision and regulation of the pharmaceutical
industry. Yurgel has headed the agency since March 2007. His
dismissal came two days after he publicly criticized the
government's draft "Law on the Circulation of Medicines," now in the
Duma. He commented on the draft law in an interview printed in the
newspaper "Vzglyad," saying that the draft needed serious work. He
also agreed with the concerns raised by the private sector and other
groups and warned that the law would open the doors to corruption.
3. (U) The official justification for his sacking was "violation of
the law on state service." Article 17 of that law prohibits
government officials from publicly commenting on the activities and
decisions of state bodies and leaders. Yurgel is the first federal
official fired for violating this law. In announcing the dismissal,
the government press service explained that Yurgel "publicly
expressed his disagreement with the position of the Ministry of
Health and Social Development (MOHSD), allowing statements similar
to positions of a number of experts who either didn't read the
details of the text and didn't understand its novelty, or are openly
lobbying somebody's interests."
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OBJECTIONS TO THE DRAFT LAW ON MEDICINES
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4. (SBU) The draft law was developed by the Ministry of Health and
Social Development (MOHSD) with no involvement by Roszdravnadzor or
outside trade and health experts. It was submitted to the State
Duma for consideration at the end of 2009. The draft was approved
by the State Duma in its first reading on January 29. (NOTE: Before
the bill can become law, it must pass two more readings in the Duma,
and then be approved by a vote of the upper chamber of parliament
and signed by the President. END NOTE.)
5. (SBU) The text has come under fire from the pharmaceutical
industry, health experts, patients' rights groups, and the Federal
Antimonopoly Service. In December, Ambassador Beyrle explained U.S.
concerns with the law to MOHSD Deputy Minister Veronika Skvortsova
(reftel). Specifically, the draft law does not provide six years of
data exclusivity protection as agreed to in the 2006 IPR side
letter, part of the U.S.-Russia bilateral agreement for Russia's
accession to the World Trade Organization. The bill also requires,
if only by implication, that any new drugs undergo clinical testing
in Russia in order to be registered in the country. (NOTE: The
draft requires that trial results presented at registration come
from facilities and medical institutions accredited by the Russian
MOSCOW 00000335 002.2 OF 002
government; the government cannot accredit medical institutions
outside of Russia. END NOTE.)
6. (U) Diverse stakeholders met with the ruling United Russia
faction in the Duma on February 4 to discuss concerns about the
draft law. Their wide-ranging complaints included the fear that the
law would give excessive powers to MOHSD, and that a massive
proposed hike in drug registration fees would raise drug prices for
consumers and government health services and threaten producers of
low-cost drugs and some innovative drugs. According to health
experts quoted in the media, the requirement for all drugs to be
tested in Russian facilities would risk depriving Russian patients
of critical medications that have already been successfully tested
in other countries. In a press quote, Timofey Nizhegorodtsev, a
department director in the Federal Antimonopoly Service, called the
law "weak" and expressed astonishment at the idea of requiring
clinical trials in Russia for drugs already approved abroad.
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ROSZDRAVNADZOR VS. THE HEALTH MINISTRY
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7. (U) Yurgel also had his own parochial reasons to object to the
law, which reflect a rivalry between Roszdravnadzor and MOHSD, its
parent ministry. Although Roszdravnadzor is the lead agency on drug
registration and quality control, it is almost not mentioned in the
text of the draft law. The law would create a new agency
responsible for testing of new drugs, a function that now belongs to
Roszdravnadzor.
8. (U) Roszdravnadzor was established in 2004 as part of a
government restructuring that separated public health policymaking,
supervision, and implementing functions into three separate
entities. Roszdravnadzor, a supervision agency, received control
over registration and quality control of drugs and medical devices,
licensing of health care facilities, authorization of clinical
trials, and other functions. Aleksey Makarkin, Vice-President of a
Russian think-tank, the Center for Political Technologies, was
quoted in the newspaper "Nezavisimaya Gazeta" saying that Minister
of Health and Social Development Tatyana Golikova has worked to
gradually bring some supervision and implementing functions back
under the Ministry's direct control. Two implementing agencies
created in the 2004 restructuring have already been eliminated,
returning most of their functions to MOHSD.
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COMMENT: CONSEQUENCES OF YURGEL'S FIRING
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9. (SBU) Despite Yurgel's dismissal, we understand from discussions
with the Ministry of Economic Development that that ministry is
working on amendments, either to the current Law on Medicines, or to
MOHSD's new draft, to address the intellectual property provisions
for compliance with the Trade Related Aspects of Intellectual
Property (TRIPs) Agreement. But these amendments have not yet been
submitted to the Duma. In terms of our work with Roszdravnadzor,
our senior contacts at the agency have indicated to us that Yurgel's
departure will not affect those activities -- specifically, a
proposed project with the U.S. Food and Drug Administration aimed at
implementing Good Clinical Practice in Russia. And judging from
press comments on the difficult relationship between Yurgel and the
Health Ministry, Yurgel's comments on the draft law may have been
only a convenient excuse for his dismissal.
BEYRLE