Despite ongoing political instability in the Eastern European bloc, there has been a sea of change in the clinical trial market. In 2015, there has been increased sponsor interest in Russia, Ukraine and Belarus. In Russia, with the new personal data law coming into effect, companies can now accrue more patient data. In the Ukrainian market, there is easier access into the market with positive strides being made in import/export legislation. In Georgia and Moldova, Eastern Europe now has viable and valuable options. On customs clearance, a simplified process at local depots across the region mean significant cost savings for sponsors.
Here’s a look at the market trends in the CEE region in the past year…
Market Trends: Russia, Ukraine, Belarus
When taking a closer look into market trends in Russia, statistics show trial approvals in 2015 are generally comparable to 2014. There have been increased activities in bioequivalence trials (BE) and local clinical trials (LCT) conducted by both domestic and foreign sponsors. The requirement for local studies to be registered has lead to an increased emphasis on import substitution involving local based generics. Additionally, compliance with World Trade Organisation obligations has resulted in a decrease in customs duties for non-iodine imported drugs from 5.3 percent to 3 percent. Meanwhile, the statutorily mandated CT experience of Principal Investigators has been lowered from five years to three years. As it stands, the number of clinical trials taking place this year after quarters one and two, have decreased from 345 in 2014, to 329.
Meanwhile, in the Ukraine, Ministry of Health (MoH) approval processes significantly improved in 2015 as the result of lowered VAT on clinical trial products (from 20% to 7%). With import/export license requirements being removed earlier this year in May, MoH processes have become more streamlined.
There is also a greater emphasis on harmonising processes with the EU as the Ukraine MoH’s new ‘Conduct of Clinical trials’ aligns with the EU’s Good Clinical Practice norms. In February, New Order 966 introduced changes to clinical trial conduct, first established by Order 690, which expedites the review of materials from 47 calendar days to just 27. It also changes the concept of insurance from sponsor liability to ensuring the health and safety of the patients. Lastly, the new order has changed the approval application process making all submissions fall under the MoH’s remit instead of State Expert Centre.
Belarus has shown slow but steady growth in the clinical trial market on a yearly basis. With strict application procedures, defined by the country’s MoH, approvals are issued with statutory timelines. That means there’s a lesser saturation of competitive trials to go with a simplified import/export and logistics process.
Furthermore, the impact of the Customs Union (CU) agreement between Russia and Belarus has been twofold. For one, it makes equipment and device distribution between sites possible without the need of an import permit. What’s more, remote monitoring from Russia is now doable with no visa requirements. However, the single contract approach (with institution only) is not very popular with PIs, but it does provide transparency to sponsors.
Valuable and Viable options in Georgia and Moldova
In the Caucasus region, Georgia leads the way in clinical trials. Quick approval timelines in the country and a friendly regulatory environment mean studies go ahead with minimal fuss. Furthermore, no import permits are required for IPs, NIMPs and clinical supplies. Depots provide better control over storage and distribution, but direct ship-to-site option is available for small or urgent shipments. Study approval serves as import authorization, details of study drugs and clinical trial supplies must match imported products. VAT level is consistent with CIS region at 20 percent. As of 2015, there are 161 registered studies taking place in Georgia (35 percent in Phase II, 47 percent in Phase III) with 49 opened active studies, compared to 139 and 45 studies, respectively in 2014.
In Moldova, Eastern Europe has new player on the scene. With relatively few competitive trials taking place and a simplified MoH approval process in place, Moldova represents an attractive proposition for sponsors. Chisinau is the central CT activity hub, with site delivery provided within 24 hours after clearance. GCP guidelines are part of Moldova’s national legislation. Site-specific import permits for each shipment are prepared by depot for each site. While direct ship-to-site delivery after clearance is preferred, delivering direct to the depot is suggested for larger shipments. As it stands, in 2015 there are 89 registered studies in Moldova with 20 opened active studies. 58% and 40% of all studies are in Phase I-II and Phase III respectively.
*Statistics provided by ClinicalTrials.gov