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Cablegate: Russia Rises As Major Center for Clinical Drug Trials

VZCZCXRO1356
RR RUEHAST RUEHHM RUEHLN RUEHMA RUEHPB RUEHPOD RUEHTM
DE RUEHMO #2240/01 2141351
ZNR UUUUU ZZH
R 011351Z AUG 08
FM AMEMBASSY MOSCOW
TO RUEHC/SECSTATE WASHDC 9282
INFO RUEHVK/AMCONSUL VLADIVOSTOK 2904
RUEHYG/AMCONSUL YEKATERINBURG 3263
RUEHZN/EST COLLECTIVE
RUCPDOC/DEPT OF COMMERCE WASHINGTON DC
RUEHPH/CDC ATLANTA GA
RUEAUSA/DEPT OF HHS WASHINGTON DC

UNCLAS SECTION 01 OF 02 MOSCOW 002240

SENSITIVE
SIPDIS

DEPARTMENT FOR OES/IHA
HHS FOR OGHA

E.O. 12958: N/A
TAGS: TBIO ETRD EINV EIND RS
SUBJECT: RUSSIA RISES AS MAJOR CENTER FOR CLINICAL DRUG TRIALS

REFS: 07 MOSCOW 2533

MOSCOW 00002240 001.2 OF 002


SENSITIVE BUT UNCLASSIFIED. PLEASE PROTECT ACCORDINGLY.

1. (SBU) SUMMARY: With the volume of clinical drug trials in Russia
enjoying rapid growth over the past few years, Russia has become the
market leader for clinical drug trials among the BRIC countries
(Brazil, Russia, India and China). Russia enjoys numerous
advantages in conducting trials, including a centralized health care
system, availability of skilled doctors, and large cohorts of
treatment-naive patients. END SUMMARY.

----------------------------------------
Russian Clinical Trials Market Takes Off
----------------------------------------

2. (SBU) The number of clinical trials approved in Russia grew by 11
percent in 2007 compared to 2006, and by 16 percent in 2006 compared
to 2005, according to data compiled by the Federal Service for
Health and Social Development (Roszdravnadzor). Russia has emerged
as the clear leader among the BRIC countries with a total of 713 FDA
clinical drug trials currently on-going (Brazil is in second place
with 390 FDA clinical drug trials), according to CenterWatch, a
clinical drug trial listing and information service. Some 50
percent of drug trials in Russia are in late-stage, Phase III
testing. Foreign firms sponsored over 65 percent of all drug trials
approved in Russia in 2007. Leading multinational pharmaceutical
companies such as Sanofi-Aventis, Merck, GlaxoSmithKline, Boehringer
Ingelheim and Novartis have become leaders in Russia's clinical drug
trials market. The most popular areas of clinical drug trial
research are treatments for cardiovascular disease, cancer,
psychiatry (including medicines for depression and schizophrenia),
and neurology (medicines for multiple sclerosis and Parkinson's
disease).

3. (SBU) While most drug companies still conduct trials in Russia
through their own research departments, a growing number of
companies are outsourcing trials to contract research organizations
(CROs), independent multinational firms that specialize in
conducting ethical and unbiased drug trials. CROs are now
conducting 42% of all Russian drug trials, up from 30% three years
ago. Over ten major and fifty smaller CROs now operate within
Russia.

---------------------------------------------
Russia's Advantages in Clinical Drug Research
---------------------------------------------

4. (SBU) The centralized medical system in Russia is perfect for
clinical drug trials, because large numbers of patients with similar
illnesses are found at the same treatment centers, according to our
CRO and pharmaceuticals contacts. The relatively high quality of
Russian doctors also means that the quality of the trials is often
as good as trials conducted in Western Europe. Although many
Russian doctors do not speak English, there are six times more
doctors in Russia per capita than in India. The high amount of
treatment-naive patients in Russia (i.e., patients who have never
before received medicine or treatment for a particular ailment)
offers a large pool of potential test subjects that is not available
in many other countries.

5. (SBU) One CRO representative told us that the main disadvantage
of clinical drug trials in Russia is the high customs duties for
imports of drugs used in trials. Other experts cite the
1.5-month-long paralysis of the economy during the summer 'dacha'
season and strict regulations for drug trials from Roszdravnadzor as
additional concerns. Even so, the waiting period for trial
approvals from Roszdravnadzor is only three months in Russia, as
opposed to eight to twelve months in China. Many industry players
consider that the high customs duty is offset by the comparatively
low costs of conducting drug trials in Russia. The cost savings in
Russia stem primarily from the relative ease in recruiting and
enrolling large volumes of patients.

6. (SBU) While noting that the market was growing at a rate of at
least 15% per year, one pharmaceutical industry contact complained
that the market was beginning to become saturated. The boom in drug
trials began three years ago, and all of the main clinical and
hospital centers in Moscow and St. Petersburg are now running
multiple trials and do not have the capacity or staffing to handle
more. This has forced some major companies to move drug trials to
other cities such as Novosibirsk and Nizhny Novgorod, which have
more drug-naive patients and hospitals with more capacity and

MOSCOW 00002240 002.2 OF 002


staffing to begin new trials.

7. (SBU) According to one CRO industry representative, the June 2007
temporary ban on exports of all human biological samples (Reftel)
had a significant impact on the clinical drug trial market,
interrupting trials for several weeks and ruining many samples in
need of export to Europe and the United States for further analysis.
However, another drug company representative felt that the brevity
of the ban, lasting only a few weeks, inflicted no major long-term
damage to the clinical drug trials market aside from creating worry
in the industry that the ban might be repeated at some point in the
future. While there are no signs that the export ban would reoccur,
a growing number of CROs and pharmaceutical companies are
considering establishing their own proprietary testing labs in
Russia, or partnering with an existing Russian lab, to handle all
testing for trials within Russia. To help meet the demand for
testing of biological samples from drug trials and to ensure the
availability of independent testing expertise within Russia,
Roszdravnadzor is also establishing a government-owned central
testing lab that will be accredited by the European laboratory
accreditation body, and has plans to set up seven other regional
testing labs.

8. (SBU) One pharmaceutical representative told us that Russia
could, in theory, also become a major center for the testing of
pediatric medicines, but that the lack of legislation regulating
pediatric drug trials was a significant impediment to developing
that segment of the market. There is a growing worldwide demand for
research and development of pediatric drugs, and within Russia
itself, demand for childhood medicines is high, but few drugs are
registered for children. In 2005, a poorly conducted trial on a
childhood vaccine was halted and spawned lawsuits by the parents of
some children allegedly harmed by the trial. Those lawsuits are
still making their way through the Russian court system. A leading
Russian patients' rights advocate has also claimed that Russian
doctors and PhD candidates sometimes engage in unethical and illegal
clinical trials in order to gather research data. The Federation
Council (Russia's upper parliamentary house) is currently drafting
legislation to regulate pediatric drug trials in consultation with
industry and government representatives.

9. (SBU) COMMENT: We believe the clinical drug trials market will
continue to expand over the next few years in light of Russia's
numerous advantages in hosting drug trials, including the relatively
low cost of trials, centralized health care system, large cohorts of
treatment-naive patients, and the availability of skilled doctors.
This trend is likely to continue despite some minor impediments such
as the temporary export ban, high customs duties for drug imports
used in trials, and the relative saturation of drug trial sites in
Moscow and St. Petersburg. As the market continues to develop, CROs
and pharmaceutical companies will increasingly look outside of
Russia's two largest cities for sites to host trials.

RUBIN

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