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International Clinical Trials

Cracking Kiev

As Ukraine takes a more prominent role within the world market of clinical research, the legal framework operating within the country is taking slow but sure steps towards modernisation.

PricewaterhouseCoopers research has recently revealed that the global clinical trials market is worth an estimated $50-80 billion (1). In the report, it is stated that the clinical trials market share will keep changing for the better, although authors do not give specific predictions concerning the change in R&D cost in the near future. Yet it is not known which countries will show the most dynamic growth. This largely depends on which countries will be able to attract a greater number of clinical studies and benefit from the growth.

According to data, created by the National Institute of Health in collaboration with the FDA pursuant to FDA Modernization Act, the number of clinical trials held globally in 2011 was over 18,000 (2). The largest number of conducted clinical trials was in the region of North America, while Europe retained second place, and Asia came in third. The key markets of the latter were China (677 projects) and South Korea (774 projects). Among the EU countries, the greatest investment into clinical studies up to 2011 came from the UK. Yet the data provided by the Clinical interactive service states that last year the largest number of clinical studies was registered in Germany.

Eastern Europe and Ukraine

The largest market of clinical research among the countries of central and eastern Europe and the Commonwealth of Independent States (CIS) is Poland. It accounts for about 20 per cent of all clinical trials projects in eastern Europe. The countries of central and eastern Europe with smaller populations, such as the Czech Republic and Hungary, conduct the most clinical research per capita. Poland still has the largest number of patients per clinical trial. It is important to mention that, for over half of the pharmaceutical companies in the Polish market, 80 per cent of clinical trials for new drugs were held in Poland.

According to the PMR research report entitled Clinical Trials in CIS countries 2012 – Russia, UA, BY and Georgia, development forecasts for 2012 -2014, the general market of clinical trials of the CIS in 2011 was an estimated €429 million, which shows a 19 per cent market growth compared to the previous year (3). Russia holds a huge 63 per cent share of the clinical trials market of CIS countries, and the share of Ukraine is estimated at 33 per cent. The PMR forecast for 2012-2014 predicts a financial growth figure for the CIS clinical trials market of 14 per cent on average, reaching €712 million in 2014.

Ukraine and Russia are the key markets for clinical research in the CIS: as PricewaterhouseCoopers estimated, this was due to a relatively low cost of conducting clinical trials in these countries. Ukraine has the second largest share in the CIS, and according to the European Business Association data, Ukraine has been using only 10-15 per cent of its clinical research capacity. The relatively small size of the market of clinical trials in Ukraine and its huge potential are the main reasons for the predicted growth, estimated to be at least 10-20 per cent over the next three years.

In this respect it is necessary to give a more detailed explanation of the key aspects of the legal framework of Ukraine, as its positive changes have had a significant impact on the growth of clinical research in the country.

Legal Framework in Ukraine

For several years, Ukraine has been actively trying to implement the economic equivalent of the Ugly Duckling by Hans Christian Andersen. Just as the chick grew into a swan in the fairy tale, the country is growing out of its post-communist regime into a modern constitutional state with an open market economy. This transformation has been very successful – with slow, but sure steps. WTO experts forecast that by 2020, the Ukrainian market will be among the top 10 fastest growing markets in the world. Indeed, all of the necessary prerequisites are in place. At the moment, the legal system of the country is being actively modernised and undergoing economic growth oriented around western Europe.

It is important to mention that, in 2012, Ukraine switched to International Financial Reporting Standards (IFRS). According to the amended Ukrainian law, ‘On Accounting’, public stock companies, banks, insurance companies and certain enterprises engaged in economic activity will fill in their financial statements from 2012 in accordance with accepted international standards.

In 2012 customs legislation has also been significantly simplified. The new Customs Code, unified with EU norms, has been adopted. As a result, the number of customs procedures has been minimised and a list of medicines that are fully exempt from tax has been introduced. Customs authorities shifted their focus of attention from immediate clearance to the post-auditing of enterprises. Among other important innovations, the following should be mentioned:

  • Time restrictions for customs clearance (up to four hours from the moment of declaration)
  • The possibility of applying customs clearance documents electronically
  • A complete list of documents needed for customs clearance
  • Personal liability of customs officials for illegal clearance delay
  • The possibility of mediating settlement of customs rules violations

In the area of non-tariff regulation, regarding the import of unregistered drugs, only two authorising documents need to be obtained from the Ministry of Health, with a minimum list of documents available to confirm the quality of the produce.

It is also important to recognise the influence of the European Business Association (EBA), which has been actively promoting the interests of the clinical trials market, thus helping to minimise bureaucracy. Companies can now hold constructive negotiations with senior governmental authorities in the country.

Alternative Ways to Save Costs

Clinical trials make it possible to reduce public expenses for healthcare by using sponsors’ funds for their projects. A sponsor will often pay in full for the treatment of a patient, including routine elements and supporting procedures. This, in turn, saves the state from having to pay for the healthcare of the person if they participate in clinical research. Moreover, clinical trials can provide a higher level of quality and more modern standards of healthcare.

The scale of savings that these alternative means of treatment can bring to Ukrainian taxpayers will vary depending on the specifics of clinical trials, the hospital premises where the clinical trial is held, and other factors. Taking these points into account, the most money-saving clinical trials for Ukrainian patients will take place in the fields of oncology and cardiology. If the value of a molecule, used in clinical trials, is of a more virtual nature, the impact of clinical research on the costs in healthcare is truly significant. According to PricewaterhouseCoopers, routine treatment only can lead to an increase in the pharmaceutical market of approximately 50-60 per cent.

The development of the clinical trials market has many advantages for patients, healthcare in general and for the whole economy of the country. Ukraine has great potential in this area; the market is rapidly developing and moving forward. After all, business is like riding a bicycle – either you keep moving or you fall over.

  1. PriceWaterhouseCoopers, Clinical Trials in Poland – Key Challenges, November 2010. Visit: en_GX/gx/pharma-life-sciences/assets/clinical-trialsin- poland-2010.pd
  2. Visit: ClinicalTrials.Gov
  3. PMR report, ‘Clinical Trials in CIS countries 2012 – Russia, UA, BY and Georgia. Development forecasts for 2012-2014’

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Oksana Maksimova has over 10 years’ experience in the pharmaceutical and CRO industry. Since completing a PhD in Pharmacy at Moscow Medical Academy, Oksana has held various positions within the industry, including those which have focused on clinical supplies management, clinical logistics and quality management. Oksana joined CTL as an Investigational Product Manager/QA in 2008. During this period she has been involved in preparation and conducting of internal and external company audits, writing SOPs and preparing and implementing international GXP standards into the company’s working practice.

Tetyana Demidenko has over ten years’ experience in the pharmaceutical and CRO industries. She graduated from State Medical University in Zaporozhie and received the diploma of a doctor-gynecologist. Tetyana has held various positions within the industry, including those which have focused on Project Management, Clinical Trials Supplies Management, Clinical Logistics. Tetyana Demidenko joined CTL as a General Manager in 2009. During the last three years, the company Clinical Trials Logistics has been one of the leading companies in Ukraine which provides full logistic service for clinical trials. Tetyana has experience in SOPs writing, preparation and conducting of internal and external company audits, conducting of trainings, work with different regulatory authorities.
Oksana Maksimova
Tetyana Demidenko
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