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Criminal liability for violation of pre-clinical trials is unique to Ukraine, say experts

Kyiv. September 6, 2012

The introduction of criminal liability for the violation of pre-clinical trials and the state registration of drugs in Ukraine has no analogues in the European and international legislation and hinders the development of innovative pharmaceutical business in Ukraine.
Executive Director of the European Business Association (EBA) Hanna Derevianko told this to Interfax-Ukraine when commenting on bill No.11129 of MP Valeriy Kharlim (the Regions Party faction) abolishing criminal liability for the violation of pre-clinical trials and the state registration of drugs.
She noted that the EBA repeatedly stated in its appeals to the government the inadvisability of the introduction of such an excessive and disproportionate responsibility for health care workers involved in clinical trials, as well as pharmaceutical company employees involved in the registration of medicines.
"Unfortunately, the article of the Criminal Code [321-2] was adopted, and we believe that it hinders the development of medicines in Ukraine both at international pharmaceutical companies and domestic producers. It is dangerous primarily for patients, especially those with cancer and neurological diseases, for whom participation in clinical trials is the only way to get high-quality treatment at the European level and free treatment using innovative medicines," said Derevianko.
Lawyer of the Volkov and Partners law firm Oleh Shekhovtsov, in turn, said the procedural violation of the procedure of clinical trials and the state registration of medicines (with no impact on the health of citizens), in terms of its danger to society, does not meet the concept of criminal offense and certainly should not be punished by imprisonment only.
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