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Ukraine is one step closer to the EU in terms of clinical trials regulation

22/ 11/ 2021
  On November 18, the Verkhovna Rada of Ukraine adopted draft law №5315 On Insurance as a whole. In particular, it considers amendments to the regulation of insurance issues related to clinical trials, which were proposed by the EBA Clinical Trials Subcommittee experts. Thanks to these amendments, Ukraine will move to a fully European model of liability insurance in clinical trials. The law will amend the current Law of Ukraine “On Medicinal Products”. Namely, these are amendments to Article 8 of the Law to clarify the provisions on the insurance contract that covers the liability of the clinical trial sponsor to third parties, as well as Article 2 of the Law to supplement the list of terms specified in the clinical trial insurance contract. The document helps to achieve the clear regulation of the insurance provision for clinical trials which has long been a problematic issue for the field of clinical trials in Ukraine and differed from the model operating in the EU. Previously, Ukrainian legislation on insurance in clinical trials created possibilities for double interpretations, did not fully comply with international practice, did not cover all aspects of the sponsors and researchers liability for possible harm to clinical trial subjects, and extended the periods for consideration of patients request to be included in a clinical trial that may be the only chance for him. This approach did not comply with the basic provisions of European law. As Directive 2001/20 / EC stipulates the need to provide for insurance or indemnification in order to cover the researchers or sponsors liability, it is important to move from personal insurance in clinical trials to a liability insurance scheme. Adoption of similar changes in Ukrainian legislation will improve the legal regulation of clinical trials and eliminate current problems that hinder patients prompt access to innovative treatment in clinical trials and reduce the attractiveness of Ukraine in the eyes of sponsors of clinical trials. We truly thank Mr. Zub V.O., Member of Parliament for his support of the initiative of the EBA Clinical Trials Subcommittee.   Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

On November 18, the Verkhovna Rada of Ukraine adopted draft law №5315 On Insurance” as a whole. In particular, it considers amendments to the regulation of insurance issues related to clinical trials, which were proposed by the EBA Clinical Trials Subcommittee experts. Thanks to these amendments, Ukraine will move to a fully European model of liability insurance in clinical trials.

The law will amend the current Law of Ukraine “On Medicinal Products”. Namely, these are amendments to Article 8 of the Law to clarify the provisions on the insurance contract that covers the liability of the clinical trial sponsor to third parties, as well as Article 2 of the Law to supplement the list of terms specified in the clinical trial insurance contract.

The document helps to achieve the clear regulation of the insurance provision for clinical trials which has long been a problematic issue for the field of clinical trials in Ukraine and differed from the model operating in the EU.

Previously, Ukrainian legislation on insurance in clinical trials created possibilities for double interpretations, did not fully comply with international practice, did not cover all aspects of the sponsor’s and researchers’ liability for possible harm to clinical trial subjects, and extended the periods for consideration of patient’s request to be included in a clinical trial that may be the only chance for him.

This approach did not comply with the basic provisions of European law. As Directive 2001/20 / EC stipulates the need to provide for “insurance or indemnification in order to cover the researcher’s or sponsor’s liability”, it is important to move from personal insurance in clinical trials to a liability insurance scheme.

Adoption of similar changes in Ukrainian legislation will improve the legal regulation of clinical trials and eliminate current problems that hinder patients’ prompt access to innovative treatment in clinical trials and reduce the attractiveness of Ukraine in the eyes of sponsors of clinical trials.

We truly thank Mr. Zub V.O., Member of Parliament for his support of the initiative of the EBA Clinical Trials Subcommittee.

 

Be the first to learn about the latest EBA news with our Telegram-channel EBAUkraine.

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