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.
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