Generic drugs should be less costly than reference drugs

On 13 September 2016, Moscow Arbitration Court pronounced legitimacy of the refusal by the Federal Antimonopoly Service (FAS Russia) to agree upon the maximum ex-works price for the “Sulpiride” medicinal drug (presentation -   “oral solution”), announced by “SVICH” Ltd.

The reason of the FAS refusal was the failure by the claimant to apply a decreasing coefficient of the price for reference (original) drug. The FAS decision gave the grounds for the Ministry of Health Care to refuse sate registration of the maximum ex-works price of “Sulpiride”.

On 1 October 2015, a norm came into force obligating all manufacturers of generic drugs to announce the price estimated in view of the decreasing coefficient from the reference medicinal drugs.

According to the expert conclusion given by an institution of the Ministry of Health Care, “Sulpiride” (the International Non-Proprietary Name - “Sulpiride”), presentation - “oral solution”, is a generic for the “Eglonyl” reference medicinal drug, presentation – “tablets”. Conducting economic analysis and making the decision, FAS was guided by the current rules and the data presented by an expert institution of the Ministry of Health Care.

The claimant disagreed with the arguments put forward by the regulator and filed a lawsuit. Moscow Arbitration Court pronounced legitimacy of the decisions made by FAS and the Ministry of Health Care and refused the claim in full.