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.
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.
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.
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.
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.
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.
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.