Positive Changes for Clinical Trials in Ukraine

Although clinicaltrials.gov provides data on over 400 active studies conducted in Ukraine, the latter’s potential as a clinical trial site has not yet been utilized to the full extent. According to the European Business Association in Ukraine (EBA), the country has utilized only 15% of its current potential for hosting clinical trials.

Ukraine offers advantages for conducting clinical trials, including:

· High quality of data confirmed by numerous FDA/EMA audits¹

· A large pool of highly motivated, experienced, and GCP-trained clinicians, which includes 782 specialists, of which there are 58 doctors of medical and pharmaceutical sciences, 39 professors, and 33 candidates of science²

· A large pool of potential study subjects

· Public healthcare system comprising over 2,500 public healthcare facilities

· International standards for medical care³

Additionally, experts have reported major improvements in legislative and regulatory environment over the past years. Based on the results of the European Business Association investment research,⁴ the Ukraine’s investment potential has finally been overturned and is currently demonstrating an increasing growth.

The Ukrainian Government represented by the Ministry of Health of Ukraine (MOH) and its expert division, the State Expert Center (SEC), has implemented several important measures to make the country more attractive for clinical trials.

In 2012, the MOH issued a new version of the Procedure for Conducting Clinical Trials of Medicinal Products, which was developed by leading medical experts, including the MOH, the SEC and relevant organizations in collaboration with legal experts. As a result, the new Procedure has been recognized as closely resembling the EU regulations with numerous references to the GCP and favorable for the clinical trials industry. It has been amended several times since then in order to correspond to the world’s best practices and the current European legislation. The current Ukrainian legislation governing clinical trials is considered to be quite developed and favorable for their conduct. Even though ICH E6 (R2) GCP Addendum has been implemented by the EMA only recently, Ukraine is preparing for implementation of a new amendment to the relevant legislation. Having signed the EU-Ukraine Association Agreement, Ukraine is undergoing a process of harmonization with the EU requirements, which may lead to even greater convergence with the European legislation adopted in the field of clinical trials. “Over the recent years, the Ukrainian regulatory authority (Ministry of Health of Ukraine and State Expert Center) responsible for expertise, approvals, and supervision of clinical trials have focused closely on the protection of patients’ rights, compliance with ICH-GCP requirements and the quality of delivered data. Furthermore, the strategic aim of the regulatory authority is to create a high-availability environment that will be favorable for launching and conducting trials in Ukraine with allowance for the highest standards of patient safety,” comments Oleksii Mikheiev, the Head of the Clinical Trials Unit in Ukraine.⁵

Ongoing medical reform is another major step that is currently being implemented in Ukraine. The new model proposed by the MOH is based on the UK healthcare system and envisages implementation of state funded medical insurance for all Ukrainians and establishment of a safe, stable, and guaranteed system, which will raise the Ukrainian healthcare level to international standards.

Moreover, the new healthcare system will grant the state and municipally-owned healthcare institutions greater autonomy and independence, which will simplify cooperation between potential sponsors and the relevant institutions. These changes, which have already begun, will lead to the formation of even vaster pool of potential clinical study sites will also contribute to the process of establishing clinical research centers as independent units as well as constituent parts of healthcare institutions.

Meanwhile, manufacturers of medicinal products (acting as sponsors of clinical trials), and contract research organizations continue to work on optimizing processes related to clinical trials. Such attempts comprise changes in the standard contract models adopted in the field of clinical trials and introduce new contract models with the engagement of full-cycle site management organizations, additional contract research organizations with limited functions, and new participants of the processes related to clinical research, e.g. data management assistants. These changes are aimed at optimizing budgets and improving the quality and representativeness of the data obtained within the framework of clinical trials. It is important to remember that the relevant issues, e.g. access to personal data, medical confidentiality, allocation of functions and budget, must be properly addressed within the framework of implementation of new contract models.

The primary goal at present is the establishment of an electronic document flow at the MOH, with the online submission option rendering the procedure more transparent and accelerating the approval of clinical studies even further. This process has already begun and the first steps were made last month when the SEC launched the test mode of its Register of the Clinical Trials of the Medicinal Products (hereinafter – the Register) aimed at creation of the unified database of clinical trials, which are conducted within the territory of Ukraine.⁶ The Register contains the information on the trial sites, investigational products as well as the trial's profile.

The confidence in positive transformations is attributed to the results that have already been achieved. For instance, the procedure for obtaining permits authorizing import of clinical study materials was significantly simplified and the tax rates applicable to the import of medicines and medical devices intended for clinical studies into Ukraine were significantly reduced in 2015. These improvements are attributed to the continuous dialogue between the relevant state authorities and various stakeholders, including sponsors, legal experts, and healthcare professionals involved in the process.

Such joint efforts of the relevant regulatory authority, healthcare professionals, and experts in the field of creation of attractive investment climate in Ukraine may lead to a significant increase in the number of clinical studies conducted in Ukraine in the nearest future. Meanwhile, Ukraine is prepared for new studies more than ever. It is the largest European country with a population of approximately 42.5 million, which makes it the 8th most populous European state. With a large number of public health care facilities and with one of the highest physician per inhabitant rates in the world (4.9 physicians per 1,000 inhabitants in 2011), Ukraine is able to offer an expecting combination of optimized costs and high quality of obtained data.

1 State Expert Center available (SEC) at: http://www.apteka.ua/article/411376

2 SEC available at: http://www.dec.gov.ua/site/files/klinika/dec.pdf

3 Registry of medical and technological documents on medical care standardization - http://mtd.dec.gov.ua/index.php/en/

4 European Business Association, Investment Attractiveness Index. http://www.eba.com.ua/static/indices/iai/EBA_IAI_1H_2017_ENG.pdf

5 The Clinical Trials Unit (Subcommittee) of the European Business Association – the largest community in Ukraine that is involved in clinical trials; brings together 33 CROs and R&D pharmaceutical companies. https://eba.com.ua/en/committee/ohorony-zdorovya/

6 According to the information of the SEC available at: http://www.dec.gov.ua/index.php/en/2-uncategorised/2099-shanovni-kolegi-ta-vidviduvachi-sajtu

Lana Sinichkina, Partner, Arzinger Law Firm

Volodymyr Svintsitskyi, Associate, Arzinger Law Firm

Antonina Smolina, Clinical Trials Subcommittee Manager, European Business Association