RussianLegal Advises a Foreign Company on the Russian Clinical Study Procedures during the CoVID-19 Epidemic
When conducting clinical studies of its new product, an international pharmaceutical company imported it into Russia for further delivery to medical institutions.
The measures taken by the government to fight CoVID-19 resulted in the operation of the research division of a medical centre being suspended and those patients taking an outpatient treatment and drugs at home being deprived of the possibility to get it in person. That breached the study protocol and made it impossible for the company to collect relevant data to be able to present the unique drug to the market in due time.
Our review of the applicable pharmaceutical laws and good clinical practices showed the lack of any legal provision governing how patients should get access to drugs.
In order to avoid the suspension of the research, we reviewed the applicable good clinical practices and developed a contactless delivery scheme eliminating the need for a patient to visit a medical institution in person while ensuring a required degree of control over the issue process.