Clinical Trials Market in Ukraine
Ukraine has an adequate opportunity to become a leading country in Eastern and Central Europe with regard to the number of clinical research studies, thus promoting the development of medical science and providing its citizens with the newest medicinal products.
At the international clinical trial conferences and summits Ukraine quite often is considered a “newcomer”. On the one hand, such treatment is somewhat unfair, as the first steps in this direction have been made as far back as in 1996, when the country’s parliament has ratified the standards of GCP (Good Clinical Practice). On the other hand, until mid 2000-s this sector has been developing quite slowly as one had to overcome bureaucratic and mental vestiges of a soviet past. As the result, the clinical trial market in Ukraine is by far quite formed, but its scope is insufficient, as compared to the EU countries.
Like that, according to data presented by the State Expert Centre of the Ministry of Health of Ukraine, 250 clinical research studies (phases I-IV) have been registered in the country in 2011. In terms of population reaching 100,000 people, this rate is 3-4-fold lesser than in the neighboring Poland (and all the more so in the Western Europe and North America). If one should consider Ukraine’s achievements within CIS, they are also non-impressive. According to the PMR report «Clinical trials in CIS countries 2012 — Russia, Ukraine, Belarus and Georgia. Development forecasts for 2012–2014», almost two thirds of the clinical trial «pie» goes to Russia. With no other strong competitors Ukraine is content with the 33% share.
While analyzing the structure of the clinical studies being carried out in Ukraine, one can emphasize its similarity with the situation in the Central and Eastern Europe. There is a several-fold larger amount of international multi-centered clinical studies (which are being conducted in several countries simultaneously) in the Czech Republic, Hungary and Poland, as compared to the number of the domestic clinical trials: based on the results of the previous year, the respective ratio reached 201 to 49. Main clinical trial sponsors included such major foreign pharmaceutical companies as GlaxoSmithKline, Boehringer Ingelheim Pharmaceuticals, Nycomed, Bayer, Pfizer, and AstraZeneca, which have successfully developed the newest markets in the EU and continue to move eastward.
Growing presence on an international corporation market is also predetermined by the fact that the overwhelming majority of the clinical trials in Ukraine fall on the third and second phases. During the previous year there were, respectively, 138 and 53 cases of the phase III and II studies registered, whereas only 4 and 6 of the phase I and IV studies were being conducted in 2011. Such imbalance is primarily due to the need to involve in the II and III phase studies the greater amount of subjects that can be enrolled relatively quickly in Ukraine. I and IV phase studies are not that large-scale and, therefore, are less reasonable in this country.
The experts give high rates when assessing Ukrainian clinical trial market, as compared to the markets of the neighboring countries. As assessed by the European Business Association incorporating a profile subcommittee for several years so far, nowadays Ukraine uses only 10-15% of its potential in the clinical trial field. In the nearest years Ukraine will continue to catch up with its competitors, if there will be no dramatic worsening of the global and local economic situation. As assessed by the consulting company PMR, during the period from 2012 to 2014 there will be a 20% increase in the number of clinical trials in Ukraine, which may be considered as an unprecedented indicator.
There are sufficient grounds for such an optimistic prognosis. Firstly, as pointed out by PricewaterhouseCoopers, this includes an increasing effort of the pharmaceutical companies to optimize expenses for the development and registration of medicinal drugs. Various data confirm that an outsourcing of services for the conduct of studies to the countries of the Eastern Europe will help save 15-20% of funds. Therefore, there will be definitely a further increase in relocation of the clinical studies to the less “expensive” regions. In this context Ukraine, which is capable to provide minimal costs for logistics and remuneration of labour, is quite competitive.
An important factor of Ukraine’s appeal for the clinical trial initiators is a rapid enrollment of subjects. It has a simple explanation: the country has one of the largest populations on the continent, reaching 46 million people. As cynical as it may seem, unsatisfactory healthcare funding, poor environmental situation and low income of population have turned the country into one of the largest patient base in Europe. According to the oncology statistics, nowadays Ukraine is seventh as to the amount of cancer patients, and there is a steady increase in these numbers. Similar situation is observed for the respiratory and digestive disorders.
Contract research organizations (CRO), which are involved in more than half of the clinical studies in Ukraine, also have the professional personnel. Nowadays there are forty CROs, though 99% of them are represented by affiliates of the foreign companies, such as Quintiles, PPD, Icon, Parexel, PSI, PharmaNet, PRA International, Chiltern, Evidence, and SPRI. At the same time a few years back strictly Ukrainian companies (for instance, Axis-Group Ltd) have started to form and still successfully operate on the Ukrainian market. Independent CROs are more mobile and ready to meet the wishes of the client, which guarantees an optimal outcome of the project.
At the same time it is still early to mention about the elimination of all factors restraining the development of the clinical trial market. Along with other businesses it is impacted by inconsistencies in the economic, political and other areas of life which are characteristic of the developing countries. Thus, obtaining an authorization to conduct the clinical trial has become a subject of vivid discussions. While in the EU all papers may be obtained only in ten days, this process in Ukraine may take as long as 4,5 months. So the fact that Ukraine occupies a 137th position in the international rating “Doing Business”, yielding to Swaziland, Honduras and Cambodia, is completely justified.
Final elimination of the obstacles interfering with the development of the clinical trial market shall be beneficial for the country and its citizens. A lot of positive transformations which may be provoked by the intensification of this area are quite evident. First of all, it is another opportunity for authorities to increase the receipt of funds to the state budget, which may be quite substantial. Nowadays clinical trials bring approximately 180 million UAH to the Ukrainian state treasury annually, which is comparable to the amount Ukraine gets for using underground resources. Taking into account the country’s current potential, there may be at least a 5-fold increase in this estimate.
The current Ukrainian market of clinical trials may be considered somewhat unique. Its relatively slow development is objectively justifiable, but there is quite a significant part of subjectivity, as the foreign sponsors from force of habit primarily see the country’s disadvantages, and then focus on its benefits. Therefore, the competent government authorities of Ukraine should work in two directions simultaneously in order to make a breakthrough in the clinical trial field, which are modification of legislation and improvement of reputation.