Vital and Essential Drug List
State Duma of the Russian Federation has approved a draft of law in the second and in the third reading On making amendments to clause 61 of the Federal Law “On Drug Circulation”. The new document helps avoid the legal uncertainty in the field of state regulation of prices for Vital and Essential Drugs.
The explanatory note says that according to Article 4, Law 61 No 61-FZ in the previous edition it is not allowed to market and sell medicinal drugs to wholesale and retail organizations at prices, which including the maximum wholesale markup and the maximum retail markup exceeds the actual retail price. At the same time, part 4, clause 61 of the Federal Law No 611-FZ does not specify the level of actual retail price, established by the drug manufacturer. It led to ambiguity in interpretation of the term “actual retail price”, which gave a possibility to perform state control in regions differently.
In the new edition of clause 61 of the law a statement that wholesale and retail selling companies must not market and cell drugs from the vital and essential drugs list at prices, which after inclusion of the maximum retail markup, exceed the actual retail price.
Besides, the new law shows that interchangeability of drugs for medicinal use authorized before July 1, 2015, is performed by comparison with reference drug according to the government established procedure and according to provisions of the Law on Drug Circulation.