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Ukraine: Promising Prospects

Marina Gornostai of Dila and Oleksii Mikheiev of Verum examine the potential and opportunities of the clinical trial market available in Ukraine

Increasing interest has been directed at the countries in eastern Europe as a promising market for conducting international clinical trials. This interest is mainly due to the possibility of quicker patient recruitment in the region which will allow a significant reduction in expenses for clinical trial budgets. At the same time, it should be noted that high quality data are obtained while carrying out clinical trials in eastern Europe. In this article we refer to Ukraine as a clinical trials market with real potential for development, as well as the specifics of introducing clinical trials, the problems that might be encountered and the best ways of solving them.

Ukraine

Population amounts
to 46,000,000

Capital
Kiev (3,000,000)

Big cities
Kharkov (1,500,000)
Dnepropetrovsk (1,000,000)
Odessa (1,000,000)
Donetsk (1,000,000)

A BRIEF HISTORY

International clinical trials began in Ukraine about 15 years ago. In 1996, an organisation whose primary aim was to deal with the issues of clinical trials was established as part of the State Pharmacological Centre of the Ministry of Health of Ukraine. Laws and regulations for conducting clinical trials in Ukraine include the Law of Ukraine ‘On Medicines’ (1996) and the orders of the Ministry of Heath No 281,347 (2000), No 355 (2002) and No 66 (2006).

On the 17th August 2007 a new order of the Ministry of Health No 245 stated that it was possible to proceed: “on approval of the procedure of determination of specialised medical and preventive treatment facilities in which clinical trials of medicines can be carried out”. The Order of the Ministry of Health, No 43 dated 30th of January 2007, as well as the Order of the Cabinet of Ministers of Ukraine, No 1419 dated 28th of October 2004, stipulated that starting from 1st January 2009, clinical trials and application of medicines should be carried out in accordance with sector GCP standards. A recent Order of the Ministry of Health, No 690 dated 23rd September 2009, stated it is possible to proceed: “on approval of the procedure for carrying out clinical trials of medicines and expert review of the material of clinical trials and typical regulation on ethic commission”.

The first regulatory permission for carrying out multi-centre international clinical trials was granted in 1996. It was a Phase II trial involving two clinical sites and saw five times more patients than expected. Moreover, the quality of clinical trials conducted by sites in Ukraine was higher than corresponding trials conducted in western and central European countries. Nevertheless, no real growth in the number of clinical trials carried out was observed in Ukraine before 2003.

THE CHANGES WITHIN

During the first six to eight years of development the pharmaceutical companies were modest about conducting clinical trials in Ukraine. In the meantime, they examined the public healthcare system, availability of equipment, experience of doctors, and the level of quality and reliability of the data provided, as well as the correspondence of its regulatory environment to international standards. Only after having been convinced of the advantages that the region held and the high quality of their delivery did the number of clinical projects allocated in Ukraine begin to increase.

A key objective was bringing regulatory policies in the sector of clinical trials up to international and European standards by complete implementation of GCP rules and provisions of 2001/20/EC Directive. Developed infrastructure required for carrying out clinical trials was also completed by 2003: specialised transport and logistic companies (including the companies offering highly specialised services for storage and management of tested products), CROs and professional insurance companies were incorporated. Current indications show further advance of the clinical trials market in Ukraine and neighbouring countries (Belarus, Romania, Georgia and Moldova, for example).

Experts estimate that currently the potential in Ukraine and Belarus is only being used at a rate of about 10 to 15 per cent, Georgia at two per cent and Romania at 30 per cent. An advantage of Ukraine and Belarus is the preserved centralised system of public healthcare. It is represented with large local multidisciplinary clinics, research institutes (in particular, institutes of the National Academies of Sciences), private specialised clinics and medical universities. The concentration of patients in large clinics ensures quick subject recruitment. According to the State Pharmacological Centre, 1,308 clinical bases were approved in 2009 (see Figure 1).

Ukraine is very attractive for projects requiring inclusion of patients with rare illnesses or with restricted criteria of inclusion. Highly specialised large regional oncology centres, servicing administrative regions with populations of 3 to 4 million people and concentrating on patients with oncological pathology in their clinics, can ensure recruitment of patients into trials – even with limited criteria for inclusion.

For a more obvious demonstration of the potential of patients in Ukraine, a comparative analysis of the involvement of the population in clinical trials in Ukraine and in the countries of western Europe was performed (see Table 1). According to the State Pharmacological Committee of Ukraine, the highest numbers of clinical trials that are carried out in the sector were for cancers and other neoplasms, heart and blood diseases, nervous system diseases and respiratory tract diseases.

According to the analysed categories, the involvement of the Ukrainian population in clinical trials varies from 0.8 to 5.3 per cent of the maximum registered in Europe. Thus, quick and controlled subject recruitment is possible in Ukraine due to the current low involvement rate and peculiarities reflecting the way the healthcare system works.

RECOGNISING UKRAINE’S UNIQUENESS

It is important to note the persistently high level of highly motivated patients wishing to participate in clinical trials. The economic situation of the country also has an effect on the level of financing of the public healthcare system. Therefore, almost all expenses for diagnosis and treatment come from the patient. With regards to low levels of population, personal income and high cost of examination and medicines, a considerable proportion of patients can obtain cheap symptomatic care. Because of their enrolment in clinical trials the patients are provided with a possibility of treatment using up-to-date and often expensive preparations, which would not otherwise be available.

Clinics and universities also show strong interest in delivering clinical trials. An important factor for increasing clinical trials is support from public authorities, and the Ministry of Healthcare, the State Pharmaceutical Centre and local healthcare authorities in particular. For the last two years, it has been clear that they are increasing their understanding of the importance of efforts to promote the Ukrainian clinical trial market as an additional source of investments into healthcare. For instance, in some local healthcare authorities there are even specialists who are appointed to coordinate efforts to attract projects into regional clinics.

An important peculiarity of the clinical trials market in Ukraine is the fact that a considerable number (about 75 per cent) of clinical trials are regulated and monitored through contracting organisations – in distinction from countries such as Russia, where pharmaceutical companies have their own R&D organisation units which support their own research projects. About 35 contracting organisations, both global and local, work in Ukraine.

A considerable obstacle deterring the development of clinical trials in Ukraine has been the lack of adequate specialised laboratory services. The equipment and standard of the laboratories in the public healthcare sector have failed to meet the standard employed in clinical laboratories in western countries. The data provided by the laboratories of public healthcare, with the small exception of laboratories of medical, scientific and research institutes, left much to be desired and were always the subject for auditors and inspectors of clinical trials.

The problem was resolved when centralised clinical laboratories entered the market; either fully focused on servicing clinical trials or having strong specialised organisation units in their structure, providing laboratory support to research and development projects. The cost of laboratory analyses at regional laboratories was lower than in European laboratories, although testing was performed with the same instruments and using the same reagents as at the leading central laboratories. This was the result of lower remuneration for laboratory personnel. The cost of shipping frozen shipments to Ukraine using world delivery services is five times cheaper when compared to shipping to EU countries, and the forwarding of ambient samples is six times cheaper in Ukraine than forwarding to the EU. Moreover, when using regional laboratories the cost of delivery services is about 25 per cent of the laboratory budget. The use of central laboratories results in an increase of transportation costs and thus the cost of transportation logistics, which can cost the sponsor nearly half of the total laboratory budget. Regional laboratories can cover one country but in terms of functionality, they render additional support to projects which are similar to the functions of central laboratories, such as data management, project management, logistics, laboratory services and QA.

The development of modern laboratory bases in Ukraine allows investors to save considerable money in pre-analytical, analytical and post-analytical phases; regional laboratories are exempt from possible problems with delivery of materials due to force-majeure events. European airlines recently suffered from the eruption of ashes of the Eyjafjallajökull volcano in Iceland and the cancellation of flights from Ukraine to Europe endangered the quality of clinical trials carrying out the evaluation of the biological materials at the central laboratories. As a result the central European laboratories, within one day and without any preliminary plans to do so, managed to redirect the flows to the regional laboratory which had 10 years of experience in clinical trials. This allowed investigators to verify their results at Ukrainian laboratories and encouraged sponsors to protect themselves from similar troubles.

Aleksey Mikheyev, Director of Ukrainian Representative Office of Verum Staticon CRO, described the perspectives of cooperation with regional laboratories and attractiveness of Ukraine for international clinical trials: “We would like to note our positive experience in cooperation with regional laboratories in Ukraine, rendering services to the sponsors of clinical trials for provision of laboratory support and being our partner for more than five years”. The correct marketing policy, consistent investments and high quality of the services provided allowed regional laboratories firm settlement in their positions in the Ukrainian market and attract clients which include both the large pharmaceutical companies (having R&D organisation units in Ukraine), as well as leading international and regional contract research organisations. The flexible marketing and pricing policy of the laboratories ensured them a stable position in the market and repeat business with leading customers of laboratory service.

CONCLUSION

Ukraine is currently a promising market for carrying out international clinical trials. The improvement of legal framework, peculiarities of Ukrainian healthcare, availability of highly qualified medical personnel, development of the regional laboratories sector and the low level of involvement of patients in clinical trials has led to favourable conditions for quick subject recruitment for research, all the acquisitions of high quality results and a reduction of expenditures for carrying out clinical trials.


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Marina Gornostai graduated from the National Medical University of Ukraine in 1998, and obtained a postgraduate qualification in economics in 2009. She worked as a paediatrician from 1998 to 2004. From 2004 to 2006, she worked at the sales department of Nycomed, Ukraine, and from 2006 to 2007 at JSC Pharmak, where she was responsible for the organisation of clinical trials. Marina has been working at Dila Medical Laboratory since 2007 as a marketologist.

Oleksii Mikheiev has been the Regional Managing Director of Verum CRO since 1999 and is an expert in clinical trials organisation in Ukraine. Oleksii started his work in clinical trials in 1996 as coinvestigator and he is Head of a regional office. He has also participated in the formulation of national regulations for clinical trials and the implementation of 2001/20/EC requirements in Ukraine. Oleksii has authored several publications on the subject of clinical trial organisation in eastern European countries and is a candidate of medical sciences.

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Marina Gornostai
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Oleksii Mikheiev
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