On December 2, 2015 the Russian Government published its Resolution No. 1289 on Restrictions and Conditions for Admission of Medicines on the List of Vital and Essential Medicines Originating in Foreign States for the Purposes of Procurement for State and Municipal Needs of November 30, 2015 (hereinafter "Resolution 1289"). The restrictions on state procurement of foreign-manufactured vital and essential medicines (hereinafter "Essential Medicines") are similar to the restrictions on procurement of foreign medical devices that were established in February 2015.
According to Resolution 1289, during procurement the state customer shall reject all offers to supply Essential Medicines originating in foreign states (except for member states of the Eurasian Economic Union (hereinafter "EAEU member states"), if at least two bids meeting the requirements of the notice and/or procurement documentation are submitted and, at the same time:
- contain offers to supply Essential Medicines originating from a EAEU member state;
- do not contain offers to supply Essential Medicines from the same manufacturer or manufacturers in the same group.
For these purposes, a medicine's country of origin is determined according to the procedure set forth in the Agreement on the Rules for Determining the Country of Origin of Goods in the CIS of November 20, 2009 and in accordance with the criteria for determining the country of origin established by those Rules.
When entering into and performing a contract for the supply of Essential Medicines in observance of the restrictions contemplated by Resolution 1289, it is not permitted to substitute a drug from a specific manufacturer or its country of origin indicated in the bid.
The restrictions established by Resolution 1289 do not apply:
- until December 31, 2016 in procurement of Essential Medicines originating from foreign states (except for EAEU member states) for which only primary and secondary packaging, or secondary packaging of medicines is done on the territories of EAEU member states with release quality control;
- if the customer has published a notice of Essential Medicines procurement or sent out invitations to participate in closed identification of a supplier before Resolution 1289 comes into force;
- in procurement of medicines by customers operating in a foreign state, in order to support their activities in that territory.
The current List of Essential Medicines was enshrined in Government Order No. 2782-r on Approval of the List of Vital and Essential Medicines for Medical Use for 2015 of December 30, 2014. The Russian Ministry of Health has already prepared the draft of an expanded List of Essential Medicines for 2016.
Official sources note that the Resolution was adopted to develop domestic pharmaceutical manufacturing. Minister of Industry and Trade of Russia Denis Manturov says that of the medicines affected by the Resolution, 282 have two or more Russian manufacturers.
According to the general rule, Resolution 1289 enters into force seven days after its official publication, in other words, as of December 10, 2015.