Production is Transferred. Will the Price be the Same?
This issue is actively discussed in mass media with a reference to Association International Pharmaceutical Manufacturers (AIPM). It concerns difficulties that pharma manufacturers face because of a change of production site.
According to statement of government on regulations of maintaining a register of prices for Vital and Essential Drug List, the Ministry of Health makes amendments without renegotiation of the price for the drug. If amendments on the drug were not included into the register, the manufacturer has no right to sell them.
According to FAS it is sufficient to make amendments to the register entry. From the point of view of the Ministry of Health full package of documents and a new price revaluation is required. There is no single opinion about that.
According to FAS of Russia the approach of the Ministry of Health on methods of forming prices for a number of registered drugs from the Vital and Essential Drug List without antimonopoly agency may lead to sharp increase of price for drugs. Federal Antimonopoly Service also reports risks of sharp increase of prices for original drugs because of increased dollar and euro exchange rates versus ruble and absence of new rules of comparison to similar drugs and earlier registered prices. However, prices for generics may either increase or unjustifiably decrease.
In conclusion, the institutions should in shortest term take a consolidated decision on registration of prices for drugs.