On 4 September 2018, the parliament of Ukraine adopted Law of Ukraine No. 2519-VIII "On Amending Article 9 of the Law of Ukraine "On Pharmaceuticals" Regarding Access to the Results of Preclinical Studies and Clinical Trials of Pharmaceuticals" ("Law"). The Law became effective on 4 October 2018.
The Law sets forth that reports on pre-clinical studies and clinical trials of pharmaceuticals should be published on the website of the Ministry of Health of Ukraine ("MOH"). The templates of these reports must be adopted by the MOH by 4 April 2019.
The Law remains silent on the timelines for publishing reports and the possibility of redacting commercial confidential information by companies. Furthermore, the wording of the Law does not provide a straightforward response to the question of whether such reports should be submitted with respect to all studied pharmaceuticals, including those which are not submitted for state registration due to, e.g., poor results of a pre-clinical study or a clinical trial, or only to those pharmaceuticals which are submitted for state registration. These issues may be addressed in the bylaw(s) to be adopted by the MOH in the course of implementing the Law.
The Law should contribute to the transparency of clinical data. At the same time, if the bylaw(s) to be developed by the MOH do not provide for the possibility of companies to redact commercial confidential information and/or if the template report contains excessive information, this may create additional regulatory hurdles for companies conducting clinical trials in Ukraine. We will monitor the MOH's preparation of these bylaws and will update you on these developments in our newsletter.