Позитивні зміни для клінічних випробувань в Україні

15/ 12/ 2017

By Lana SinichkinaVolodymyr SvintsitskyiAntonina Smolina

Applied Clinical Trials

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 experts of the European Business Association in Ukraine (EBA), the country has utilized only 15% of its current potential for hosting clinical trials.

As a site, Ukraine offers preeminent advantages for conducting clinical trials, including:

  • Supreme quality of data confirmed by numerous FDA/EMA audits [1]
  • A large pool of highly motivated, experienced, and GCP-trained clinicians (782 specialists, including 58 Doctors of Medical and Pharmaceutical Sciences, 39 Professors, 33 Candidates of Science [2])
  • A large pool of potential study subjects
  • Public healthcare system comprising over 2500 public healthcare facilities
  • International standards for medical care [3].

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. A total of 40 % of the CEOs believe that the Ukraine’s market could be profitable for new investors in Q2/2017,” – comments Antonina Smolina, Manager of the Clinical Trials Unit [5] at EBA.

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

Important steps were made back in 2012 when the MOH issued a new version of the Procedure for Conducting Clinical Trials of Medicinal Products (the Procedure), which had been 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 (MOH and SEC) 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 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.

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 that have already begun and that will lead to 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, business operators, including manufacturers of medicinal products (acting as sponsors of clinical trials), contract research organizations are continuously working on optimization of the processes related to clinical trials. Such attempts comprise in changes in the standard contract models adopted in the field of clinical trials and introduction of 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. The changes above 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 have been already made: in November 2017 the SEC has launched in the test mode the 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. As Lana Sinichkina, a legal expert in clinical trials, [7] mentioned: “All positive results in the field of clinical trials in Ukraine have been attributed to a highly proactive position of the Ukrainian business and effective dialogue between the latter and the representatives of the relevant state authorities, especially SEC experts, who continuously collaborate with the view to simplify and modernize the regulatory environment in the relevant area.”

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 located entirely within Europe 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 1000 inhabitants in 2011), Ukraine is able to offer an expecting combination of optimized costs and high quality of obtained data.

Lana Sinichkina, Partner, Arzinger Law Firm

Volodymyr Svintsitskyi, Associate, Arzinger Law Firm

Antonina Smolina, Clinical Trials Subcommittee Manager, European Business Association

[1] According to the information of the State Expert Centre available (SEC) at: http://www.apteka.ua/article/411376

[2] According to the information of the 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]   The Investment Attractiveness Index – the European Business Association research project that reflects the status of the Ukrainian business climate on the basis of expert evaluations provided by top-managers from its member-companies. 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 (studies); brings together 33 CROs and R&D pharmaceutical companies. Its primary emphasis is placed on the process of development of international clinical studies in Ukraine as well as harmonization and improvement of legislative requirements imposed with respect to the relevant issues by means of collaboration with the relevant state bodies.

[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

[7] Lana Sinichkina is a partner at Arzinger law firm and the Head of the Life Sciences & Healthcare practice.

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