Five keys to successful cold-chain logistics
in Russia, Ukraine and Belarus
Operating in the geographical region of Russia,
Ukraine and Belarus is not an easy task; but,
according to Leon Dzivinsky, VP and General Counsel
of ClinStar/IMP Logistics, it is
manageable through the first-hand knowledge of
local specifics or the use of a capable partner.
So, the decision has been made and your clinical
trial is going to Russia, Ukraine or Belarus.
Your
contract research organisation has a good
reputation, the central lab is set up and the
best dates for
the investigator meeting have been selected. Everything
seems to be coming together nicely and then you
break a
cold sweat: How will the study drug be imported
into the
country? Where will it be stored? How will it
get to the
remote locations of the trial sites? How can you
ensure
that there will be no temperature deviations on
the way?
What happens to the unused drug supply? The questions
are piling up and you need answers.
Regulatory processes and customs clearance
The first key to success is to have a clear understanding
of the regulatory processes in these countries
to avoid
unnecessary delays with your drug shipments and
customs clearance. While the governing legislation
is still being refined, these countries already
have
procedures in place for obtaining clinical trial
approvals,
issuance of import/export licences and customs
clearance
of investigational drugs and study materials;
however,
it is not easy to navigate the specific regulatory
requirements, let alone keep track of ongoing
changes
and developments in legislation.
|
|
 |
| |
Conducting a clinical
trial in Russia, Ukraine (above) and Belarus
requires in-depth knowledge of local customs
and regulations.
|
Russia passed a law effective from 1 September
2010 that, among other changes in the circulation
of medicines, revamped the regulatory aspect of
clinical trials with the intention of simplifying
the process. The law has since been amended four
times to correct the deficiencies of the original
version; for example, the Russian Ministry of
Health and Social Development (MoH) stopped issuing
import licences for commercial comparators because
the new law did not directly give the MoH the
authority to issue such licences. Although the
overarching Customs Union legislation provided
for such authority, the MoH took a cautious approach
and put a hold on issuing import licences until
the problem was cleared many months after the
new law came into effect.
While Ukraine provides more stability in terms
of the
regulatory processes, it appears to be more challenging
on
the customs clearance side. Customs posts have
the
authority to assess tariffs on commercial drugs
imported
for clinical trial purposes based on the market
price as
listed in the customs authority databases. If
the drug is not
registered in Ukraine, customs will do a web search
for a
similar product and assess the tariffs based on
the market
price of a similar drug. This creates unpredictability
in
calculating customs clearance costs, because each
customs post uses its own sources/databases as
a basis
for tariff assessment.
Belarus, while having straightforward regulatory
and
customs clearance processes, requires individual
import
licences for each shipment of drug and/or clinical
trial
supplies, thus creating a need to constantly submit
applications for such licences to its health authorities.
Warehousing facilities
The second key to success is the assurance that
the
warehouse you selected has all the processes and
procedures in place for the proper storage and
distribution
of the investigative drug and clinical trial supplies.
Your
QA department can help by auditing the provider’s
facilities, checking standard operating procedures
and
assessing the quality of the provider’s operations.
The best solution is to choose a provider that
has
sufficient storage capacities with the potential
for
expansion, operates out of a modern warehousing
facility
and has dedicated departments for each area of
operations,
be that quality assurance, regulatory or logistics.
Courier selection
Selection of a proper transportation company is
the third
key. The courier must be experienced in deliveries
to
remote locations within Russia, Ukraine or Belarus,
and
must ensure that the drug is delivered to participating
sites in time for patients’ visits. The easiest
way, of course,
is to select a global courier company; however,
can this
particular courier ensure deliveries without temperature
deviations from the warehouse located in, say,
Moscow to
the northern city of Novosibirsk during cold winters
or
from a Kiev warehouse to the southern city of
Odessa,
Ukraine, during a hot summer? Will the package
be
delivered directly to the investigator conducting
the trial or
will it be left at the hospital’s front desk,
waiting for hours
to be picked up by the proper recipient?
To ensure the smooth delivery of shipments and
to
address all of these concerns, input from the
local
warehousing and logistics partner about its experience
with
courier companies in this region will prove invaluable.
Pharmaceutical licence/comparator purchasing
A back-up plan for the import of your comparators
is important. After the new regulatory changes
came into effect in Russia and the MoH temporarily
stopped issuing import licences, study sponsors
were forced to rethink their drug supply strategies
and seek alternative methods to supply comparators
in the country.
In Russia, Ukraine and Belarus, it is possible
to buy
comparators locally only with a pharmaceutical
licence
that allows wholesale drug purchasing and distribution.
Make sure your warehousing and logistics provider
holds pharmaceutical licences in the countries
where
the clinical trial will be conducted so that commercially
available comparators can be bought from authorised
local distributors, should it become necessary.
Key performance indicators
The most important key to success is ensuring
that the local warehousing and logistics provider
has a system of tracking key performance indicators
to consistently deliver positive results on all
projects. Request KPIs with a two-year history
to view the provider’s record of timely handling
of incoming and outgoing shipments, its picking
and packing accuracy, and its ability to avoid
shipment losses and temperature deviations and
arrange the destruction of returned products.
The selection of a proper warehousing and logistics
provider within Russia, Ukraine and Belarus can
save
undue stress and ensure a successful cold chain
logistics
process for your clinical trial.
|
