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Regulatory Conditions for the Rapid Start of Clinical Trials in Ukraine – A Opportunity to Improve Ukraine’s Attractiveness for International Sponsors in the Current Environment

19/ 08/ 2024
  Last week, the Minister of Health of Ukraine Viktor Lyashko, Chairman of the VRU Committee on National Health, Medical Aid and Medical Insurance Mykhailo Radutsky met with representatives of European Business Association, American Chamber of Commers, representatives of the pharmaceutical industry.   Among the topics important for the health care system, the Clinical Trials Subcommittee of the European Business Association raised the issue of the situation with clinical trials (CTs) in the country and possible ways of improvement for the restoration of CTs in Ukraine. It is well known that participation in CTs is one of the opportunities for patients to access innovative treatments. With the beginning of the full-scale invasion, the number of CTs in Ukraine has decreased. According to the EBA experts, during this period, more than 800 CTs did not come to Ukraine, 128 CTs were prematurely terminated in the first years of the full-scale war, and 33 approved CTs were never started. This could mean approximately 40,000 patients lost the opportunity to participate in these CTs. The loss of clinical trials by the country is not only the loss of patients access to innovative treatment, but also the loss of multimillion-dollar investments, including funds that could have been received by health care institutions, regulator, and the state budget of Ukraine as a whole. It also significantly reduces the number of highly qualified personnel in clinical sites, clinical departments of pharmaceutical companies and contract research organizations (CROs) in Ukraine. The usual criteria for choosing Ukraine by international CT sponsors, such as developed CT infrastructure, qualified staff, availability of patients, quality of CTs, cost-effectiveness, healthcare system development, rapid harmonization of CT legislation with the EU, etc., ceased to be a priority during the full-scale war due to many risks associated with the war. However, even in such conditions, we as a country can still improve certain aspects to attract clinical trials in line with the challenges faced by sponsors. Such an aspect is, first, the speed and predictability of the start of CTs, that is, the speed of approval of CTs and the start of patient recruitment. Accelerating the start of CTs may allow clinical trial sites in Ukraine to join clinical trials that are already held in the EU and other highly regulated countries where patient recruitment is delayed. Of course, sponsors also take into account the possibility of reducing the cost of clinical trials, in particular due to a significant increase in the cost of logistics services and other factors.   To realize this possibility, we have several mechanisms to improve the situation with the involvement of CTs in Ukraine: Reduction of the total term for approval of clinical trials from submission of the application to the publication of the MOH order (based on the terms declared in the new edition of the Law of Ukraine On Medicinal Products) and ensuring fulfillment of such terms. Prioritizing the procedures for approving CTs and Compassion Programs, in particular PTTA. Introduction of online submission of the CT application and CT materials in electronic form through the MOH Single Window. Simplification/reduction of the internal procedure for organizing the payment for the expertise in the State Expert Center (SEC) (referral to the SEC, issuing the invoice, confirmation of payment), including the option of prepayment. Simplification/reduction of the expertise for CTs that are approved/conducted in countries with strict regulatory authorities. Bringing the Labeling section of the Order of the Ministry of Health #690 in line with Regulation 536/2014, which will enable sponsors to optimize the use of investigational medicinal products. At the beginning of the full-scale war, we proposed to the Ministry of Health to consider possibility of introducing a moratorium on raising prices for examination in hryvnia during martial law, which would allow sponsors to plan long-term budgets for clinical trials. We believe that this proposal remains relevant now. According to experts, it is important for the Ministry of Health to control the implementation of the general deadlines for the approval of clinical trials, analysis of the main causes of delays and further adjustment of processes in the MOH and SEC to accelerate the start of clinical trials and quickly resolve regulatory and operational issues. It is also important to further regulate the requirements and meet the deadlines for approval of programs for patients access to the investigational medicinal product after the end of their participation in the clinical trial by amending the MOH order dated 24.08.2022 #1525 with a clear wording on the need to approve such programs before the end of the clinical trial as a whole, in order to enable patients who have completed their participation in the clinical trial to continue treatment outside the clinical trial. As a result of the discussion, it was agreed that Clinical Trials Subcommittee would submit proposals to the Minister with specific wording in the letter to address these issues and support the CTs in Ukraine, to make urgent changes to the Procedure for the expertise and conduct of the CTs. These changes may contribute to the sponsors decision to include Ukraine in international clinical trials and maintain a stable positive trend in the restoration of clinical trials in our country. We sincerely thank Viktor Liashko and Mykhailo Radutsky for the opportunity to meet with business and discuss topical issues of the industry and hope to continue the dialogue and consider business proposals in further developments!

Last week, the Minister of Health of Ukraine Viktor Lyashko, Chairman of the VRU Committee on National Health, Medical Aid and Medical Insurance Mykhailo Radutsky met with representatives of European Business Association, American Chamber of Commers, representatives of the pharmaceutical industry.  

Among the topics important for the health care system, the Clinical Trials Subcommittee of the European Business Association raised the issue of the situation with clinical trials (CTs) in the country and possible ways of improvement for the restoration of CTs in Ukraine.

It is well known that participation in CTs is one of the opportunities for patients to access innovative treatments. With the beginning of the full-scale invasion, the number of CTs in Ukraine has decreased. According to the EBA experts, during this period, more than 800 CTs did not come to Ukraine, 128 CTs were prematurely terminated in the first years of the full-scale war, and 33 approved CTs were never started. This could mean approximately 40,000 patients lost the opportunity to participate in these CTs.

The loss of clinical trials by the country is not only the loss of patients’ access to innovative treatment, but also the loss of multimillion-dollar investments, including funds that could have been received by health care institutions, regulator, and the state budget of Ukraine as a whole. It also significantly reduces the number of highly qualified personnel in clinical sites, clinical departments of pharmaceutical companies and contract research organizations (CROs) in Ukraine.

The usual criteria for choosing Ukraine by international CT sponsors, such as developed CT infrastructure, qualified staff, availability of patients, quality of CTs, cost-effectiveness, healthcare system development, rapid harmonization of CT legislation with the EU, etc., ceased to be a priority during the full-scale war due to many risks associated with the war. However, even in such conditions, we as a country can still improve certain aspects to attract clinical trials in line with the challenges faced by sponsors.

Such an aspect is, first, the speed and predictability of the start of CTs, that is, the speed of approval of CTs and the start of patient recruitment. Accelerating the start of CTs may allow clinical trial sites in Ukraine to join clinical trials that are already held in the EU and other highly regulated countries where patient recruitment is delayed. Of course, sponsors also take into account the possibility of reducing the cost of clinical trials, in particular due to a significant increase in the cost of logistics services and other factors.  

To realize this possibility, we have several mechanisms to improve the situation with the involvement of CTs in Ukraine:

  • Reduction of the total term for approval of clinical trials from submission of the application to the publication of the MOH order (based on the terms declared in the new edition of the Law of Ukraine “On Medicinal Products”) and ensuring fulfillment of such terms.
  • Prioritizing the procedures for approving CTs and Compassion Programs, in particular PTTA.
  • Introduction of online submission of the CT application and CT materials in electronic form through the MOH Single Window.
  • Simplification/reduction of the internal procedure for organizing the payment for the expertise in the State Expert Center (SEC) (referral to the SEC, issuing the invoice, confirmation of payment), including the option of prepayment.
  • Simplification/reduction of the expertise for CTs that are approved/conducted in countries with strict regulatory authorities.
  • Bringing the “Labeling” section of the Order of the Ministry of Health #690 in line with Regulation 536/2014, which will enable sponsors to optimize the use of investigational medicinal products.

At the beginning of the full-scale war, we proposed to the Ministry of Health to consider possibility of introducing a moratorium on raising prices for examination in hryvnia during martial law, which would allow sponsors to plan long-term budgets for clinical trials. We believe that this proposal remains relevant now.

According to experts, it is important for the Ministry of Health to control the implementation of the general deadlines for the approval of clinical trials, analysis of the main causes of delays and further adjustment of processes in the MOH and SEC to accelerate the start of clinical trials and quickly resolve regulatory and operational issues.

It is also important to further regulate the requirements and meet the deadlines for approval of programs for patients’ access to the investigational medicinal product after the end of their participation in the clinical trial by amending the MOH order dated 24.08.2022 #1525 with a clear wording on the need to approve such programs before the end of the clinical trial as a whole, in order to enable patients who have completed their participation in the clinical trial to continue treatment outside the clinical trial.

As a result of the discussion, it was agreed that Clinical Trials Subcommittee would submit proposals to the Minister with specific wording in the letter to address these issues and support the CTs in Ukraine, to make urgent changes to the Procedure for the expertise and conduct of the CTs. These changes may contribute to the sponsors’ decision to include Ukraine in international clinical trials and maintain a stable positive trend in the restoration of clinical trials in our country.

We sincerely thank Viktor Liashko and Mykhailo Radutsky for the opportunity to meet with business and discuss topical issues of the industry and hope to continue the dialogue and consider business proposals in further developments!

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