TIMOPHEI NIZHEGORODTSEV: WE PROPOSE SOLUTIONS TO DETERMINE SUBSTITUTABILITY OF MEDICINES

Under FAS proposals, the work on substitutability of most medicines can be completed in 2019

Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev made a report on the difficulties of ascertaining substitutability. Speaking at the “Regulation in Healthcare: the Main Goals of the Pharmaceutical Industry” Forum, he reminded that the medicine registration principles are formalized in Russian law since 1998. Under these principles, reference medicine is equivalent to a generic and vice versa.

“Thus, if a medicine is registered as a generic, it has already proved its equivalence to the reference drug, it means that they are substitutes”, emphasized Timophei Nizhegorodtsev.

Medicine registered as generics can have only the same indications and counter-indications as the reference medicine. Additional indications must be confirmed by additional clinical trials.

He pointed out that in spite of the established procedure, there are other varieties of generics on the market. For each of those categories FAS proposes several steps to resolve disputes.

“Since medicine is registered in accordance with particular indications, circulates on the market during a long period, is proscribed and used, and the system of pharmaceutical control does not identify adverse effect of using it, we must take it into account.  Effectively, use of medical medicine is some sort of a specific clinical trial”, explained Head of FAS Department for Control over Social Sphere and Trade.

Regarding generics registered in the absence of a reference medicine, that include, for example, absorbent carbon, water for injections, etc., FAS proposes to recognize their substitutability under the same international non-proprietary name with equivalent indications in view of comparability of dosage form and strength, and, if data in registration folders are insufficient request the necessary data form manufacturers and use them for sustainability.

Thus, for most medicine substitutability can be established following the main above-listed principles based on the findings of comparative research conducted when registering medicine.

“It is our understanding that the number of medicine, for which additional studies are necessary, will not be big and the work on determining substitutability for most medicine in line with the above principles can be completed during 2019“, said Head of FAS Department for Control over Social Sphere and Trade.

The event was organized by FAS and its Centre for Education and Methodics. It took place in Kazan on 3 October.