Pharmaceuticals & Healthcare Russia Legal Alert December 2015 www.bakermckenzie.com For further information please contact Paul Melling +7 495 787 27 00 firstname.lastname@example.org Alexey Trusov +7 495 787 27 00 email@example.com Sergei Lomakin +7 495 787 27 00 firstname.lastname@example.org Maxim Kalinin +7 812 303 90 00 email@example.com Baker & McKenzie — CIS, Limited White Gardens, 10th floor 9 Lesnaya Street Moscow, 125047, Russia Tel: +7 495 787 27 00 Fax: +7 495 787 27 01 BolloevCenter, 2nd Floor 4a Grivtsova Lane St. Petersburg 190000, Russia Tel.: +7 812 303 90 00 Fax: +7 812 325 60 13 Procurement of Certain Foreign Medicines is Restricted by Russian Government On 30 November 2015 the Russian Government adopted Decree No. 1289 “On Restrictions and Conditions on the Access of Medicinal Preparations Originating from Foreign Countries and Included into the List of Vital and Essential Medicines for the Purposes of Procurement for State and Municipal Needs” (the “Decree”). The Decree is a part of the anti-crisis plan, developed by the Government earlier, that has development of the local manufacturing of medicines as one of its aims. It will come into force on 10 December 2015. This Decree applies only to medicinal preparations included in the List of Vital and Essential Medicines (the “List”) also know as Russian Essential Drugs List. In a tender for conclusion of a single contract (single lot) for the purchase of a medicinal preparation included in the List, a state or municipal purchaser must reject any bid offering a medicinal preparation of foreign origin (or several medicinal preparations, one of which is of foreign origin), if there are two or more other bids which: offer one or more medicinal preparations, the country of origin of which is in the Eurasian Economic Union or EAEU (Russia, Belarus, Kazakhstan, the Kyrgyz Republic or Armenia); and do not offer one and the same type of medicinal preparation from one manufacturer or manufacturers from the same group of companies (as defined in accordance with the antimonopoly legislation). According to the Decree, the country of origin of a medicinal preparation is evidenced by a certificate of origin of goods issued in accordance with the form and criteria for determining the country of origin provided for in the Agreement on the Rules of Determination of the Country of Origin in the Commonwealth of Independent States, dated 20 November 2009 (the so-called “customs rules”). The restrictions imposed by the Decree do not apply in the following cases: to procurement of medicinal preparations originating from foreign countries but for which primary and/or secondary packaging with release quality control is performed in the EAEU - until 31 December 2016; if procurement orders were placed before the entry into force of the Decree; to procurement of medicinal preparations by special categories of contractors (e.g., diplomatic missions and consular posts) for their operations on the territory of foreign states. Our recommendation for clients wishing to ascertain the possible impact of the Decree on their Russian business is to consider whether any of their products are on the List and, if so, whether they have local analogues. This LEGAL ALERT is issued to inform Baker & McKenzie clients and other interested parties of legal developments that may affect or otherwise be of interest to them The comments above do not constitute legal or other advice and should not be regarded as a substitute for specific advice in individual cases.