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Ukraine

General Country Info

Ukraine is the largest country in Eastern Europe. Its area exceeds that of the combined territories of Romania, Latvia, Czech Republic, Slovakia and Hungary.

 

In 2014, Russia occupied 7% of Ukrainian territory (the Crimea, districts of Donetsk and Luhansk regions). Apart from the occupied territory, the rest of the country is kept in order and peace. All major investigational sites and facilities remain on the free territory and and go on with their regular study activities.

 

Ukraine has about 45mln residents. The dominating majority of population is of Caucasian race. The official country language is Ukrainian, but the country is actually bilingual with Russian often utilized in some local documents (e.g. source documents of patients).

 

2500 public health care facilities provide medical care in Ukraine with a number of private clinics rising but remaining very low. In 2011 the country had approximately 225 000 physicians (4.9 per 1000 inhabitants, one of the highest rates in the world).

 

There are more than 12 thousand locally registered Medical Products (Oct 2014) in the country.

 

Public healthcare facilities are organized by a territorial principle with vertical patients’ referrals which quite favorable for fast subject recruitment.

 

Local Clinical Research Market

According to www.clinicaltrials.gov, Ukraine has had 1324 clinical trials registered (Nov 2015).

 

By 2013 the country had more than 1500 investigational sites with experience in clinical trials. So Ukraine is a major participant of clinical trial projects in Eastern Europe.

 

In the last years, the number of approvals for international clinical trials in Ukraine was: year 2010 – 177, year 2011 – 201, year 2012 – 213, year 2013 – 177, year 2014 – 188.

 

Nevertheless, as experts of European Business Association Ukraine say, the country has only utilized 15% of its current potential for clinical trials conduct. This data proves to be true after comparison with neighboring Poland that has smaller population (38mln against 45mln) but was engaged in 2,512 studies while Ukraine had only 320 ongoing trials in 2011.

 

Many investigational sites in Ukraine have been participating in clinical trials for over a decade now. Over the years, investigating teams have been acquiring specific skills and knowledge, starting from working with study equipment and electronic systems to timely reporting and effective communication in English.

 

Ukraine as a location for clinical trials has several advantages that are attractive to sponsors:

-        Ukraine still has a centralized public health care system that facilitates high enrollment rates and engagement of patients with rare diseases

-        Moderate costs of clinical trials

-        Good quality data confirmed by a number of FDA/EMA audits

 

The key players of Ukrainian clinical trials market and their estimated market shares are listed in the table below:

Company 2012 2013 2014
“Quintiles, Ukraine” 15% 12% 15%
“KDO InnoFarm-Ukraine”, Ltd. (PPD affiliate) 8% 11% 10%
“Parexel, Ukraine” 7% 3% 10%
“INC research, Ukraine”, Ltd. 6,5% 3% 10%
“Clinical research Icon”, Ltd. 6,5% 3% 5%
“GlaxoSmithCline Pharmaceuticals, Ukraine”, Ltd. 4% 4% 6%
“AstraZeneca, Ukraine”, Ltd. 3,5% No data 5%

 

Overall, more than 60 clinical research organizations operate in the Ukrainian market.

 

Top medical areas with international multicenter clinical trials approved for conduct in Ukraine in 2012-2014 were:

Medical area year 2012 year 2013 year 2014
Oncology 45 27 30
Psychiatry and Neurology 36 38 25
Pulmonology 30 16 30
Rheumatology 21 22 21
Cardiology 12 18 14
Endocrinology 12 10 15
Hematology 10 16 8

 

With oncology treatments development in the world on the rise and high prevalence of tumors in population (see the table below), Ukrainian oncologists are most widely involved in international oncology trials.

Tumor, clinical form Prevalence among 100 000 people
Cancer (common) 430
Lung cancer 60
Gastric cancer 30
Cervical cancer 18,7
Breast cancer 65,7
Skin cancer (incl. melanoma) 47
Prostate cancer 25
Colorectal cancer 35
Pancreatic cancer 10,2

 

At the same time, the opportunities that Ukraine provides are still unfairly undervalued by Sponsors for some therapeutic areas like Eye Diseases or Dermatology. These studies are occasionally conducted in Ukraine in spite of presence of motivated and qualified investigators.

 

Most often, Phase III clinical trials are most frequently conducted in Ukraine:

Phase of clinical trial year 2012 year 2013 year 2014
Phase I 7 2 2
Phase I/II 0 0 4
Phase II 75 33 34
Phase III 122 134 136
Phase IV 8 7 5

 

PharmaSich sees attracting of Early Phase studies in Ukraine as one of its most important tasks.

 

Ukrainian investigational sites have been regularly involved in international clinical trials in children. Children’s participation in clinical trials is quite detailed. With important differences in pharmacokinetics and pharmacological effects, a number of diseases that are prevalent in children’s population only, Ukrainian authorities recognize the need for clinical trials in this population.

 

Year 2012 2013 2014
Number of approved clinical pediatric trials 36 20 19

 

Regulatory Framework

The national clinical trials regulator is State Expert Center of Ministry of Health (MOH) of Ukraine ()– Ukraine has been adopting current European regulations and practices in the area of clinical trials.

 

The closer Ukraine is getting on its way to join European Community, the more efforts are being made for harmonization of local regulations with EU legislation.

 

For reference purposes, the table below summarizes the Orders of Ministry of Health (MOH) of Ukraine currently regulating the conduct of clinical trials.

Date Title Comments
Order of Ministry of Health of Ukraine #95 as of 16 Feb 2009 Guidance “Medicinal Products. Good Clinical Practice.Guidelines 42-7.0: 2008″ This guidance has been developed on the basis of guidelines on Good Clinical Practice (Guideline СРСР/ICH/135/95 (Е6) «Note for Guidance on Good Clinical Practice», 1997)
Order of Ministry of Health of Ukraine #690 as of 23 Sep 2009 Procedure for conducting clinical trials of medicinal products and expert evaluation of materials pertinent to clinical trialsand Model of regulations of the ethics committees Registered in the Ministry of Justice of Ukraine on 29 Nov 2009 with #1010/17026 and #1011/17027.Amended later (see below)
Order of Ministry of Health of Ukraine #523 as of 12 Jul 2012 On Amendments to the Order of the Ministry of Health of Ukraine as of 23.09.2009 #690 Registered in the Ministry of Justice of Ukraine on   20 Jul 2012 with #1235/21547 and #1236/21548
Order of Ministry of Health of Ukraine #304 as of 06 May 2012 On Amendments to the Order of the Ministry of Health of Ukraine as of 23.09.2009 #690 Registered in the Ministry of Justice of Ukraine on   07 Jul 2014 with #739 / 25516
Order of the Ministry of Health of Ukraine of 26 Apr 2011 №237 On Approval of the Procedure for the Import of Unregistered Medicinal Products, Certified Reference Materials, and Reagents into the territory of Ukraine Today, according to the Tax Code of Ukraine medicines imported for the purpose of clinical trials are subjected to 20% taxation.

 

The regulations set out basic requirements for clinical trials conduct:

  • Start of a clinical trial is possible after positive conclusions by the State Expert Center and an Institutional Ethics Committee
  • Submitted study documents can be reviewed by the State Expert Center and an Institutional Ethics Committee in parallel
  • No EC fees
  • The response time for initial applications for clinical trials conduct is up to 60 days and for protocol amendments – 35 days from the submission date

 

Study start-up in Ukraine will take 4-5 months on average. Major keystones of a start-up and their estimated durations are listed below:

-        Collection of site specific regulatory documents for submission: 3 weeks;

-        Study review by Regulatory Authorities (RA): 60 days.

-        Site Contracts: may be signed in parallel with RA/LECs submissions. Separate contracts should be signed with Investigator and Institution. Contract templates should better be reviewed by a local lawyer;

-        Delivery of IMP/Clinical Supplies to the local depot and distribution to the sites: 3-4 weeks. Local IMP depot should be utilized for import/export, local storage and distribution;

-        Several modern laboratories have customized their services and can be utilized as central labs or for support of individual sites when out-of-standard care tests are needed.

 

Country Health Authorities actively audit clinical trials. A preliminary schedule of audits can be located on the Center’s official internet site and contains a list of facilities which are going to be audited and preliminary dates. The schedule is updated on a quarterly basis.

Clinical audits are conducted no earlier than 14 days after notification and confirmation with a primary investigator and/or the sponsor of the start date of the audit, its expected duration, its aims, a list of documents and facilities which are going to be checked. Results of the clinical audit are reflected in the Final inspection report (Act), where findings/remarks (if any) are described and timeframes for appropriate actions are set. The act is sent to both the sponsor and the responsible investigator of the clinical study center.

 

Why Ukraine

The combination of the following factors may influence your choice of Ukraine as a preferred location for patients’ recruitment:

1)     Geographical location and demography

-        Predominantly Caucasian population;

-        Located in Eastern Europe;

-        Five cities have a population of over a million.

 

2)     Mature clinical research infrastructure

-        Majority of world’s top CROs and Sponsors conduct their studies here.

-        Global delivery companies (e.g. TNT, DHL, FedEx) have their operations in Ukraine ensuring fast delivery of clinical study materials from all over the world and throughout the country.

-        A number of local IMP depots exclusively serve clinical trial logistics providing efficient logistical support.

-        Several commercial laboratories have customized their services to meet most of the industry needs and may be used as study central labs.

 

3)     Developed public healthcare system

-        The national healthcare provider has an established network of public sector healthcare facilities. This structure is based on the territorial principle with vertical patient referrals and enables concentration of patients with certain pathologies in major clinics (large specialized regional centers).

-        The medical education system includes 15 medical universities, and a number of specialized scientific and postgraduate educational institutions.

 

4)     Regulations

-        National legislation is undergoing a process of harmonization with the EU requirements, pursuing the strategic country’s objective to join the European Union.

-        Regulatory policy is generally favorable towards the clinical trials industry. Participation in clinical trials is yet another tool for bringing the investments in the country, keeping up with current medical treatment technologies and preventing ‘brain drain’.

-        Review of initial applications by authorities takes around two months (comparable to the EU countries). The majority of clinical trials are approved including pediatric and placebo-controlled studies.

 

5)     Study performance

-        There are many patients who are willing to have free access to innovative treatments, which influences high recruitment rates;

-        There are many both treatment-naive and previously treated patients;

-        Investigators are motivated and qualified. For most investigators, participation in clinical trials is a major source of income. Moreover, involvement in clinical trials is a primary opportunity for them to get in touch with innovative medicine and get integrated into the global medical science community.

-        Faster recruitment, reasonable startup period, cheaper infrastructure (compared to other European countries and Russia) favorably influence an overall cost-efficiency of projects performed here;

-        Most local CRAs are certified physicians, which considerably improves quality of clinical oversight and obtained data.

 

 

PharmaSich has been successfully operating in Ukrainian market since 2012. If you have decided to locate your clinical development project in Ukraine, contact us for detailed information. If you still doubt, why don’t ask a question? Make your next step towards fast and good quality clinical data with us!

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