European Business Association: Clinical Trials in Ukraine: What Perspective Do We Have?

Following our practice of supporting European Business Association (EBA) member-companies in their business activities in Ukraine, let us kindly inform you on the current state of the clinical trials (research) industry in Ukraine.

Over the last year Ukraine has experienced a challenging political situation that definitely has left its mark on the general pace of life and the social sphere. During this period the Ukrainians have made crucial steps towards European integration and accomplishing governmental reform. International and Ukrainian companies operating in different business spheres in Ukraine admit that despite the previously incurred military conflict in Donetsk and Luhansk regions, the overall business climate demonstrates positive dynamics. Ukrainian society is working hard towards meeting high European standards. The Ukrainian economy has always been attractive for foreign businesses and investors. In mid-2014, we noted the positive dynamic of international investment interests in Ukraine – the Attractiveness Index of Ukraine increased to 2.74 in the first half of 2014.¹

This general trend also applies to the clinical trials market in Ukraine. As based on the feedback from the different stakeholders and from the analytical data of ongoing clinical trials from the EBA member-companies, the EBA Clinical Trials Subcommittee (that unites 33 R&D pharmaceutical companies and CRO’s ²) informs that:

• the current political and social situation related to the process of European integration has no negative impact on the conducting of clinical trials in Ukraine at the moment;
• it is safe to proceed with ongoing clinical trials (“business as usual”) and to start the new ones in Ukraine, with the exception of a few cities in Donetsk and Luhansk provinces and in Crimea (as based on recommendations from the Ministry of Health (MoH) of Ukraine).

On the Ukrainian mainland (which makes up about 90% ³ of its total), all parties involved in organizing clinical trials (pharmaceutical companies, government agencies, healthcare institutions and investigators) continue to work cohesively, and clinical trials are being conducted normally. This allows patients participating in the clinical trials to receive the necessary medicines, examinations and treatment in time.

According to the available information, the Ukrainian customs, service providers and infrastructural entities operate without interruptions (i.e. transportation, communications, ground lines, web access, banking and pharmacy outlets). All the prerequisites are in place to ensure the streamlined importation of shipments and to perform monitoring visits under the intended schedule.

Thus, Ukraine has established itself as a reliable partner for foreign sponsors and remains a promising country for conducting new trials. According to the estimates of clinical trial market experts, only 10-15% of Ukraine’s potential for conducting trials is currently used. That is why the clinical trials industry, investigators’ community and the government should work on extensively developing this sphere. Based on information from the State Expert Center of the MoH of Ukraine, the level of international clinical trials approvals hasn’t changed significantly in 2014 (for example, in 2013 there were 177 trials approvals, in 1-3 quarter of 2014 – 150). Beyond that, the timeline for Protocol approvals (with no additional amendments) has been decreased – from an average of 65 days in 2013 to an average of 50 days in 2014.

“Due to amendments to EU regulation #536/2014, from 16 May 2014, that will be implemented in 2016 in the clinical trials industry, the relevant Ukrainian legislation should also be revised. The Ministry of Health of Ukraine understands that reasonable and well-grounded deregulation is very important for developing appropriate legislation procedures” – commented Yuriy Savko, Deputy Minister on EU Integration Issues at the MoH of Ukraine, said during the Clinical Trials Forum: "Clinical Trials in Ukraine: Reality & Prospects". The Forum was held on 9 October 2014 in Kyiv and gathered more than 350 professionals and scientists from all over Ukraine, as well as international experts and mass media representatives.

The EBA would like to inform you that successful European integration should make a positive impact on the forthcoming sectorial development that will improve Ukraine’s investment attractiveness in the eyes of its clinical trials sponsors. Ukraine remains a reliable partner for securing international investment and is a country with advanced technologies and a growing number of investigative sites.

Additional Information

International Clinical Trials - Positive Approvals in Ukraine

Based on the State Expert Center information letter as of 5 August 2014 (http://www.dec.gov.ua/index.php/ua/ekspertiza-materialiv-doklinichnikh-ta-klinichnikh-viprobuvan/aktualna-informatsiya)

Clinical Trials Subcommittee of the Health Care Committee of EBA
The Clinical Trials Subcommittee unites the R&D (Research and Development) pharmaceutical companies and CRO (Contract Research Organizations). The main activities of the Subcommittee are focused on the conduct of clinical trials in Ukraine and the harmonization of local regulations through cooperation with state bodies.

Clinical trials
Clinical trials investigate the effects of medicines by testing them on humans. CT are an essential stage in the development of new drugs, and they also have a wide range of benefits for patients and the state.

• The Investment Attractiveness Index of Ukraine: The evaluation of the Investment Attractiveness Index of Ukraine is conducted by the European Business Association. The index is based on the regular monitoring of the investment climate in Ukraine by senior figures from EBA member-companies.
• Abbott, AbbVie, Alpen Pharma, Arterium Corporation, AstraZeneca, Axis Group, Bayer, Boehringer Ingelheim, Centre of Clinical Research, Clinical Trials Logistics, Delta Medical, Eli Lilly Vostok SA, Farmasoft, GlaxoSmithKline Pharmaceuticals Ukraine, ICON Clinical Research, Johnson & Johnson, KCR Ukraine, KR Consulting, Les Laboratories Servier, MB Quest, Novo Nordisk, Parexel International, Pfizer, PPD Group, PRA Ukraine, PSI-Ukraine, Roche Ukraine, SanaClis, Sanofi-Aventis, SMO-Ukraine, SPRI Clinical Trials, Synergy Group, Verum.de.
• Based on the analyses of the Clinical Trials Subcommittee assessment data