FAS position on compiling the list of vital and essential drugs

The Federal Antimonopoly Service (FAS Russia) considered a petition of “Johnson & Johnson” Ltd. on the need to re-file a proposal to include medicinal drugs in the list of vital and essential drugs for 2018 in view of a positive decision of the Commission to include a drug with “Dimethyl fumarate” International Non-Proprietary Name in the list of vital and essential drugs for 2017

The Commission prepares a draft list of vital and essential drugs based on the outcome of the meetings on compiling lists of drugs and the minimum range of drugs. The final decision on approving the draft, particularly, including all medicines on the draft in the list of vital and essential drugs, is made by the Government of the Russian Federation.

The list of vital and essential drugs for 2017 was approved with No.2885-r Government Decree of 28.12.2016 and did not contain a drug with “Dimethyl fumarate” International Non-Proprietary Name.

Thus, the Government did not make a decision to include a drug with “Dimethyl fumarate” International Non-Proprietary Name in the list of vital and essential drugs for 2017.

FAS emphasizes that the Rules for compiling lists of medicinal drugs for medical use and the minimum range of drugs necessary for healthcare delivery do not provide for the procedures of preserving or transferring the resulting of Commission members’ voting to the next year.  

Head of FAS Department for Control over Social Sphere and Trade, Timophey Nizhegorodtsev commented: “We presume that “Johnson & Johnson” can file a new offer to include a drug with “Dimethyl fumarate” International Non-Proprietary Name in the list of vital and essential drugs for 2018in accord with the statutory procedure”.

Having considered the petition, FAS published its official position on re-filing proposals to include medicinal drugs in the list of vital and essential drugs for 2018.