Since Feb­ru­ary 2022 busi­ness in Rus­sia has been af­fected by dra­mat­ic polit­ic­al and eco­nom­ic events. Mil­it­ary ac­tion and sanc­tions have giv­en rise to lo­gist­ic­al, man­u­fac­tur­ing and repu­ta­tion­al chal­lenges...

On 1 Septem­ber 2022, rules for the with­draw­al from cir­cu­la­tion and de­struc­tion of fals­i­fied, de­fect­ive and coun­ter­feit med­ic­al devices will come in­to force, as per Rus­si­an Gov­ern­ment De­cree No. 145 dated 10 Feb­ru­ary 2022*.Pre­vi­ously, the with­draw­al of such med­ic­al devices was out of the reg­u­lat­ory land­scape, and the de­struc­tion pro­ced­ure was only de­scribed in gen­er­al terms.The with­draw­al of fals­i­fied, de­fect­ive and coun­ter­feit med­ic­al devices from cir­cu­la­tion im­plies that their own­er en­sures that the devices are stored in such a way that they can­not be used, op­er­ated, sold, in­stalled, com­mis­sioned, main­tained or re­paired.Fals­i­fied and de­fect­ive med­ic­al devices can be with­drawn from cir­cu­la­tion and des­troyed by de­cision of:In the case of coun­ter­feit med­ic­al devices, this de­cision can only be taken by a court.The de­cision of Roszdravn­ad­zor to with­draw and des­troy med­ic­al devices can be chal­lenged either by fil­ing a claim with a court or as an ad­min­is­trat­ive re­course (i.e. by fil­ing a com­plaint to Roszdravn­ad­zor it­self). The lat­ter means of chal­len­ging the de­cision is avail­able to the own­er of med­ic­al devices and their man­u­fac­turer. If the own­er with­draws and de­structs the fals­i­fied or de­fect­ive med­ic­al devices at its own ini­ti­at­ive, the own­er must do the fol­low­ing:Form­ally, the de­cision of the med­ic­al devices’ own­er to with­draw and des­troy the med­ic­al devices can be ex­ecuted only after 60 busi­ness days from the date of no­ti­fic­a­tion of the man­u­fac­turer and Roszdravn­ad­zor (even if there are no ob­jec­tions from the man­u­fac­turer). However, in case of ob­vi­ous falsi­fic­a­tion or de­fect­ive­ness of the med­ic­al devices, Roszdravn­ad­zor may de­cide on with­draw­al and de­struc­tion with­in a short­er peri­od of time.Once the med­ic­al devices have been des­troyed, Roszdravn­ad­zor must be no­ti­fied with­in five busi­ness days.We re­com­mend that com­pan­ies in the med­ic­al device in­dustry bring their in­tern­al doc­u­ments (stand­ard op­er­at­ing pro­ced­ures, policies, etc.) gov­ern­ing the pro­cesses for re­spond­ing to the de­tec­tion and dis­pos­al of im­prop­er products in line with the new reg­u­la­tions.* In Rus­si­an

The Rus­si­an Pres­id­ent signed Fed­er­al Law No. 311* al­low­ing the Min­istry of Health to provide the Min­istry of In­dustry and Trade with sens­it­ive in­form­a­tion from re­gis­tra­tion dossiers of medi­cines even if the in­form­a­tion is pro­tec­ted as a trade secret. The rel­ev­ant amend­ments to the Fed­er­al Laws “On Com­mer­cial Secrets”* and “On Cir­cu­la­tion of Medi­cines”* will be of­fi­cially pub­lished this week.Pre­vi­ously, in­form­a­tion con­sti­tut­ing a trade secret held by the Min­istry of Health could only be trans­ferred at the re­quest of the courts or the bod­ies re­spons­ible for in­quir­ies and pre­lim­in­ary in­vest­ig­a­tions.This in­form­a­tion will now be trans­ferred to the Min­istry of In­dustry and Trade with­in the frame­work of in­ter­de­part­ment­al in­ter­ac­tion, and the com­pany will be no­ti­fied of the trans­fer. The Min­istry of Health and the Min­istry of In­dustry and Trade will jointly de­term­ine the de­tailed pro­ced­ure for such in­ter­ac­tion.Ac­cord­ing to the amend­ments, the in­form­a­tion can be trans­ferred to the Min­istry of In­dustry and Trade only for li­cens­ing pur­poses or to in­spect medi­cine pro­duc­tion fa­cil­it­ies. However, the new law neither es­tab­lishes con­trol mech­an­isms for such re­stric­tions nor provides any dir­ect sanc­tions for non-com­pli­ance.The above changes do not form­ally af­fect the pro­tec­tion of trade secrets and in­tel­lec­tu­al prop­erty in Rus­sia. However, in prac­tice, the in­crease in the num­ber of re­cip­i­ents of con­fid­en­tial in­form­a­tion about medi­cines and pro­duc­tion pro­cesses nat­ur­ally in­creases the risk of leak­age.* In Rus­si­anCo-au­thored by Ivan Za­raiskiy, As­so­ci­ate, and Maria Volkodaeva, Paralegal in Life Sci­ences & Health­care.

Dur­ing the events of Spring 2022, there were some sig­ni­fic­ant le­gis­lat­ive changes which have not been widely re­por­ted, but are of in­terest to busi­nesses act­ive in the EAEU.One of these changes is the in­tro­duc­tion of a pro­ced­ure for trans­fer­ring a mar­ket­ing au­thor­isa­tion cer­ti­fic­ate for a medi­cine (the “Mar­ket­ing Au­thor­isa­tion”) from one com­pany to an­oth­er. Rel­ev­ant changes were in­tro­duced by EEC Coun­cil De­cision No. 36* to the Rules for Re­gis­tra­tion and Ex­am­in­a­tion of Medi­cines for Med­ic­al Use ap­proved by EEC Coun­cil De­cision No. 78*.The lack of a reg­u­lated pro­ced­ure for trans­fer­ring Mar­ket­ing Au­thor­isa­tions had been a re­cur­ring is­sue of Euras­i­an and Rus­si­an reg­u­la­tion. This com­plic­ated a vari­ety of busi­ness pro­cesses: from in­tra­group re­or­gan­isa­tion to the sale of a product line.This gap in the law has now been filled. To trans­fer a Mar­ket­ing Au­thor­isa­tion, doc­u­ments have to be provided to the rel­ev­ant au­thor­ised bod­ies to jus­ti­fy the trans­fer of the Mar­ket­ing Au­thor­isa­tion and the new hold­er’s abil­ity to ful­fil the ac­quired reg­u­lat­ory re­spons­ib­il­it­ies. In ad­di­tion, some tech­nic­al in­form­a­tion must be provided, in­clud­ing a re­vised phar­ma­covi­gil­ance sys­tem spe­cific­a­tion, up­dated in­form­a­tion for some sec­tions of the dossier and a reg­u­lat­ory doc­u­ment per­tain­ing to qual­ity.At the same time, changes in con­nec­tion with the trans­fer of a Mar­ket­ing Au­thor­isa­tion can be made sim­ul­tan­eously with the pro­ced­ure of bring­ing the re­gis­tra­tion dossier in line with the re­quire­ments of the EAEU.The new Mar­ket­ing Au­thor­isa­tion trans­fer pro­ced­ure makes the Euras­i­an Eco­nom­ic Uni­on’s reg­u­lat­ory space more open for trans­ac­tions with phar­ma­ceut­ic­al as­sets. It also eases the re­or­gan­isa­tion of Euras­i­an busi­nesses, something which has re­cently be­come of in­terest to many for­eign com­pan­ies.* In Rus­si­anCo-au­thored by Ivan Za­raiskiy, As­so­ci­ate, and Maria Volkodaeva, Paralegal in Life Sci­ences & Health­care.

In the spring of 2022, the Rus­si­an gov­ern­ment ad­op­ted De­cree No. 593* aimed at en­sur­ing the sus­tain­ab­il­ity of drug sup­ply in the con­text of for­eign sanc­tions. One of the main meas­ures in­tro­duced is the pos­sib­il­ity to tem­por­ar­ily cir­cu­late batches or series of un­re­gistered medi­cines in Rus­sia on the basis of a spe­cial per­mit from the Min­istry of Health (“Per­mit”).The nov­elty primar­ily con­cerns medi­cines that are not re­gistered in Rus­sia, are au­thor­ised for use abroad and have ana­logues re­gistered in Rus­sia with the same in­ter­na­tion­al non-pro­pri­et­ary name.However, this meas­ure could not be ap­plied for a peri­od of time due to the fact a spe­cial inter-min­is­teri­al com­mis­sion (the “Com­mis­sion”), whose de­cision on the fol­low­ing is­sues must form the basis for is­su­ing the Per­mit, had not yet been set up:de­term­in­ing wheth­er there is a short­age of a medi­cine or the risk it may oc­cur;de­term­in­ing wheth­er a batch or series of un­re­gistered medi­cine can be cir­cu­lated tem­por­ar­ily.The Reg­u­la­tion on the func­tion­ing of the Com­mis­sion was ap­proved by Or­der No. 339n of the Rus­si­an Min­istry of Health* and came in­to force on 7 June 2022. The Com­mis­sion in­cludes rep­res­ent­at­ives of the Min­istry of Health, the Fed­er­al Ser­vice for Sur­veil­lance in Health­care, the Min­istry of In­dustry and Trade, the Min­istry of Fin­ance, the Fed­er­al Anti-Mono­poly Ser­vice and the Fed­er­al Cus­toms Ser­vice. At the ini­ti­at­ive of the Com­mis­sion, mar­ket­ing au­thor­isa­tion hold­ers and Per­mit ap­plic­ants may par­ti­cip­ate in its meet­ings without the right to vote.Ex­ec­ut­ive au­thor­it­ies and en­tit­ies in­volved in the cir­cu­la­tion of medi­cines (e.g. phar­ma­cies, dis­trib­ut­ors, man­u­fac­tur­ers) can be sources of in­form­a­tion on un­avail­ab­il­ity or risk of un­avail­ab­il­ity of a medi­cine.In mak­ing its de­cisions, the Com­mis­sion takes in­to ac­count factors such as the with­draw­al of mar­ket­ing au­thor­isa­tions, the risk that man­u­fac­tur­ers or sup­pli­ers of fin­ished medi­cines or raw ma­ter­i­als may dis­con­tin­ue busi­ness.The de­cision on the pos­sib­il­ity of tem­por­ary cir­cu­la­tion of a drug must be un­an­im­ous.Con­clu­sionThe Com­mis­sion is ex­pec­ted to start its activ­it­ies shortly. This will give for­eign com­pan­ies con­tinu­ing to op­er­ate on the Rus­si­an mar­ket ad­di­tion­al op­por­tun­it­ies to sup­ply medi­cines that are not re­gistered in Rus­sia to meet pa­tients’ needs.* In Rus­si­an

There are plans to:pro­hib­it man­u­fac­tur­ers and dis­trib­ut­ors of med­ic­al devices from leav­ing the Rus­si­an mar­ket without at least six months pri­or no­tice; an­dper­mit the sale of for­eign medi­cines in their ori­gin­al pack­ages.Exit no­tice for man­u­fac­tur­ers and dis­trib­ut­ors of med­ic­al devicesThe Rus­si­an gov­ern­ment has de­veloped and in­tro­duced to the State Duma a bill* to amend the laws “On the ba­sics of pub­lic health pro­tec­tion in the Rus­si­an Fed­er­a­tion”, “On the cir­cu­la­tion of medi­cines” and “On the con­tract sys­tem in the pro­cure­ment of goods, works, ser­vices for state and mu­ni­cip­al needs”. To re­duce the risk of un­avail­ab­il­ity of med­ic­al devices and the threat to the life and health of cit­izens (in­clud­ing due to un­timely pro­vi­sion of med­ic­al care), there are plans to pro­hib­it man­u­fac­tur­ers and dis­trib­ut­ors of med­ic­al devices from sus­pend­ing or ter­min­at­ing the pro­duc­tion of med­ic­al devices or their im­port in­to Rus­sia without giv­ing the Rus­si­an Min­istry of Health no less than six months’ no­tice.Sale of for­eign medi­cines in their ori­gin­al pack­agesIt is pro­posed to ac­cel­er­ate the pro­cess of put­ting newly-re­gistered medi­cines on the Rus­si­an mar­ket. In case of their short­age (or the risk of short­age) while sanc­tions are in place, it will be pos­sible to im­port medi­cines, put them on the mar­ket and use them in Rus­sia in the ori­gin­al (i.e. for­eign) pack­aging without a Rus­si­an trans­la­tion.The rel­ev­ant bill* has already passed first read­ing and, if ad­op­ted, will come in­to force on the date of its of­fi­cial pub­lic­a­tion. Giv­en the prompt­ness of the ad­op­tion of counter-sanc­tions in Rus­sia, the ad­op­tion of this law can be ex­pec­ted in the com­ing days.* In Rus­si­an

Strong re­cog­ni­tion by the rank­ing 32 CMS Rus­sia ex­perts have been se­lec­ted for in­clu­sion in­to the 2022 edi­tion of the Best Law­yers rank­ing. In total, we have earned 74 re­cog­ni­tions by the rank­ing :Ant­on...

CMS Rus­sia has been ranked in the fol­low­ing cat­egor­ies: Bank­ing & Fin­ance­Com­pet­i­tion/An­ti­trust Cor­por­ate/M&A: High-End Cap­ab­il­it­ies Em­ploy­ment Life Sci­ences TMT In­di­vidu­al ac­know­ledg­ment re­ceivedElena...

The lead­ing na­tion­al leg­al dir­ect­ory Pravo.ru-300 has re­vealed the re­com­men­ded law­yers across 29 areas of law.This year sev­en CMS Rus­sia ex­perts have been ac­know­ledged by the rank­ing this year. Pravo.ru-300...

CMS has suc­cess­fully de­fen­ded in­terests of GE Health­care in the court of ap­peal and fur­ther in the court of cas­sa­tion against the Rus­si­an health­care reg­u­lat­ory au­thor­ity (Roszdravn­ad­zor), in the case...