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The regulation of clinical trials in Ukraine is approaching the European one

On November 18, the Parliament adopted, in general, the draft law “On Insurance”, registered on March 29, 2021, at № 5315, which takes into account changes to the regulation of insurance in clinical trials.

Thanks to these changes, Ukraine will move to a fully European model of liability insurance in clinical trials.

The law amends the current Law of Ukraine “On Medicinal Products”. In particular, we are talking about changes to Art. 8 to clarify the provisions of the contract of liability insurance of the sponsor of the clinical trial to third parties, as well as to Art. 2 to supplement the list of terms specified in the insurance contract in the clinical trial.

The main achievement was the clear regulation of the provision on insurance in clinical trials, which was a problematic issue for the field of clinical trials in Ukraine and differed from the model operating in the European Union.

Previously, Ukrainian legislation on insurance in clinical trials created opportunities 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 patient’s overall inclusion in a clinical trial. to become the only chance for him.

This approach was not in line with the main provisions of European law due to the fact that in the Directive 2001/20 / EC of the European Parliament and of the Council on the approximation of laws, regulations and administrative provisions of the Member States relating to good clinical practice in clinical trials of April 4, 2001, the need to provide for “insurance or indemnity insurance to cover the researcher’s or sponsor’s liability” is important, and the transition from personal insurance in clinical trials to a liability insurance system is important.

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

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