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International Clinical Trials
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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 ClinicalTrials.gov 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 Trials.gov 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.
References
- PriceWaterhouseCoopers, Clinical Trials in Poland – Key
Challenges, November 2010. Visit: www.pwc.com/
en_GX/gx/pharma-life-sciences/assets/clinical-trialsin- poland-2010.pd
- Visit: ClinicalTrials.Gov
- 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.
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