07MOSCOW2533, RUSSIA BANS EXPORTS OF HUMAN BIOLOGICAL SPECIMENS

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Reference ID Created Released Classification Origin
07MOSCOW2533 2007-05-30 15:46 2011-08-30 01:44 CONFIDENTIAL Embassy Moscow

VZCZCXRO0219
OO RUEHHM RUEHPB
DE RUEHMO #2533/01 1501546
ZNY CCCCC ZZH
O 301546Z MAY 07
FM AMEMBASSY MOSCOW
TO RUEHC/SECSTATE WASHDC IMMEDIATE 0719
INFO RUEHZN/EST COLLECTIVE PRIORITY
RUCPDOC/DEPT OF COMMERCE WASHDC PRIORITY
RUEHPH/CDC ATLANTA GA PRIORITY
RHEHNSC/NSC WASHDC PRIORITY
RUEAEPA/HQ EPA WASHDC PRIORITY
RUEAUSA/DEPT OF HHS WASHDC PRIORITY
RUEKJCS/SECDEF WASHDC PRIORITY
RUEHC/DEPT OF AGRICULTURE WASHDC PRIORITY

C O N F I D E N T I A L SECTION 01 OF 03 MOSCOW 002533 
 
SIPDIS 
 
SIPDIS 
 
 
DEPARTMENT FOR EUR/RUS, S/GAC, OES/OA AND OES/IHA 
STATE PASS USTR FOR MOLNAR AND KLEIN 
COMMERCE FOR ITA/PERELLI AND EDWARDS 
USAID FOR GH, E&E 
HHS FOR OGHA 
BERLIN ALSO FOR LABOR COUNSELOR HAGEN 
DOD/CTR FOR AWEBER 
EPA FOR BILL FREEMAN 
USDA FOR OSEC/DAN CAINE; FAS FOR OSTA/MACKE, WRIGHT, LEIER, 
ROSENBAUM; OCRA/THOMAS, FLEMINGS; OA/PATRICK CLERKIN 
 
E.O. 12958: DECL: 05/29/2017 
TAGS: TBIO SOCI ETRD RS
SUBJECT: RUSSIA BANS EXPORTS OF HUMAN BIOLOGICAL SPECIMENS 
 
REF: A. MOSCOW 976 
     B. 06 MOSCOW 13072 
     C. 05 MOSCOW 13418 
 
Classified By: EST Counselor Daniel J. O'Grady. Reason: 1.4(b,d) 
 
1. (C) SUMMARY:  The Federal Customs Service has temporarily 
banned all exports of human biological specimens from Russia, 
including hair, tissue, urine, and blood samples.  According 
to press reports, the ban was imposed after an intelligence 
report to the Kremlin alleged that Western researchers who 
receive Russian samples are engaged in a program to develop 
"genetic biological weapons."  The government's decision to 
impose an export ban appears to have been taken in haste, and 
without fully thinking through the impact on international 
scientific collaboration, on the tens of thousands of 
Russians in clinical trials for new medicines, or those 
needing life-saving organ or tissue transplants from abroad. 
END SUMMARY. 
 
Customs Service Bans Exports of Human Bio-Materials 
--------------------------------------------- ------ 
 
2. (SBU) Russia's Federal Customs Service has banned the 
export of human biological specimens from Russia.  According 
to press reports, the move came after a government 
intelligence report alleged that Western organizations who 
receive such samples are allegedly engaged in a program to 
develop "genetic biological weapons" that could harm the 
Russian population.  One press report specifically mentioned 
certain U.S. and European organizations that were involved in 
such research, including the Harvard School of Public Health, 
the U.S. Environmental Protection Agency, the American 
International Health Alliance (AIHA, a health NGO in Russia 
that receives Global Fund and USG funding), the Karolinian 
Institute in Sweden, the Swedish Agency for International 
Development, and the Indian Genome Institute. 
 
3. (SBU) AIHA quickly denied that it is involved in any such 
research or in taking specimens out of Russia.  The ban was 
also swiftly condemned by Academy of Medical Sciences 
President Davydov, who noted the devastating impact the ban 
would have on Russia's on-going scientific collaboration with 
many Western researchers, including in the United States. 
Chief Medical Officer Onishchenko was more muted and simply 
observed that "any civilized country" needs to regulate the 
import and export of biological specimens for security 
reasons.  Onishchenko's comment, however, failed to explain 
how an outright ban, rather than regulation, was justified. 
 
4. (SBU) Most immediately, the ban will affect basic clinical 
trials of new drugs run by multinational pharmaceutical 
companies.  There are over 28,000 Russians currently 
receiving new medicines through clinical trials, and experts 
value the Russian market for clinical trials at $100-150 
million.  During these trials, blood, urine or other 
biological samples from patients are routinely sent abroad 
for testing at a single specialized international laboratory, 
in order to maintain the consistency of data.  Glaxo Smith 
Kline's Moscow office issued a statement saying the ban was a 
serious blow to domestic health care and would hinder 
clinical trials in Russia. 
 
5. (SBU) Beyond the effect on clinical trials, Russians 
suffering from leukemia or other blood cancers frequently 
need bone marrow or other transplants, and blood samples are 
regularly sent abroad to type the specimen and find a donor 
match.  The ban would also affect more unique programs, like 
the CDC's Tuberculosis Program and the Arctic Investigations 
Program, which collaborate with Russian researchers on 
tracking the drug-resistance of tuberculosis in Russia and 
the health of Russia's indigenous communities in the Far 
North. 
 
 
MOSCOW 00002533  002 OF 003 
 
 
6. (SBU) The ban also seems inconsistent with Russia's 
long-term goals to establish itself as an international 
health player.  The focus on infectious diseases during 
Russia's 2006 G8 Presidency included establishing the Vector 
State Research Center of Virology and Biotechnology as a 
regional center for influenza and ultimately as a WHO 
collaborating center for avian influenza.  A complex of 
Russian institutes are also supposed to be established as a 
regional center for HIV vaccine development.  Neither of 
these international research efforts will be feasible if 
Russia is not willing to share specimens with the rest of the 
world.

 
Pharmaceutical Companies Left Wondering What to Do 
--------------------------------------------- ----- 
 
7. (C) A contact at Merck's Moscow office confirmed the 
export ban has been in place since May 28, and has left the 
company perplexed about how to continue its 21 separate 
clinical trials of new drugs involving 1,500 patients in 
Russia.  The International Association of Pharmaceutical 
Manufacturers (AIPM) sent a letter to the Russian Federal 
Surveillance Service for Health and Social Development 
(Roszdravnadzor) on May 29 asking for clarification on the 
export ban.  Roszdravnadzor is responsible for approving 
clinical trials in Russia and also is involved in issuing 
export and import permits for biological specimens, but the 
health agency has reportedly not yet even seen the text of 
the export ban issued by the Federal Customs Service. 
 
8. (C) The Merck official told us that the conditions for 
clinical trials have been extremely favorable over the last 
two years.  While Ramil Khabriyev was the head of 
Roszdravnadzor, the agency was quick to approve such trials, 
and apparently recognized they benefited not only Russian 
patients, but also helped stimulate domestic pharmaceutical 
and medical research.  With Khabriyev's firing earlier this 
year over the financing and supply problems with the 
government's drug benefits program (Ref A), the 
representative did not rule out the possibility that domestic 
drug makers might be trying to make business more difficult 
for their international competitors. 
 
9. (C) The Health and Social Development Ministry's chief 
infectious disease specialist told us that the ban would 
clearly damage international medical collaboration and 
scientific exchanges.  While he felt greater regulation of 
cross-border transfers of human biological specimens could be 
justified, he said he believes an outright ban made no sense. 
 
Comment: Not Seeing the Forest for the Trees 
-------------------------------------------- 
 
10. (C) The apparently knee-jerk decision to impose an export 
ban on human biological specimens suggests lingering paranoia 
among Russian leaders regarding Western organizations' 
motives in engaging in international research in Russia. 
Paranoia that the West is somehow engaged in biological 
meddling in Russia has also occasionally surfaced during 
avian influenza outbreaks, when some political figures have 
made irresponsible statements to the media about the causes 
of outbreaks (Ref C).  An outright export ban is too broad 
and ultimately unworkable, because it would harm too many 
infirm Russians, who receive new medicines in clinical trials 
funded by foreign pharmaceutical companies, or who are 
seeking life-saving tissue and organ transplants from abroad. 
 
 
11. (C) We suspect the government will have to scale back the 
ban and instead adopt some form of stricter regulation of the 
export and import of such specimens.  There is recent 
precedent that cooler heads will prevail and quickly reverse 
this hasty decision.  For instance, a botched drug tender 
issued by the Health and Social Development Ministry for 
 
MOSCOW 00002533  003 OF 003 
 
 
expensive AIDS drugs in December 2006 was reversed a month 
later at a meeting of Russia's National HIV/AIDS Committee 
following complaints by AIDS activists and the international 
community (Ref B). 
BURNS

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