Penalties to be Imposed
It is proposed to establish penalties for violation of principles of conducting preclinical and clinical trials of drugs, for exceeding prices for drugs, and for violation the principles of medical aid, rules of medical examinations and expertise.
The corresponding draft of law “On making amendments to the Code of the Russian Federation about administrative offence with regard to update of administrative liability in the field of healthcare” has been prepared by the Ministry of Healthcare to fill in the gaps in the current legislation on administrative offence and establishment of administrative liability for infringement of rights of citizens in the field of healthcare. The proposal was introduced to the State Duma in spring 2016, and now it has been approved in the first reading. In particular, this document refers to infringement of good laboratory and clinical practice guidelines while conducting clinical and preclinical trials of medicinal drugs, the order of providing medical care and medical expert assessments, examinations and check-ups.
Amendments to the draft of law should be prepared within thirty days.