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Life Sciences & Healthcare

We understand the scientific and commercial as well as the legal imperatives affecting your life sciences & healthcare business. We work with and have established long-term relationships with the top 100 life sciences & healthcare companies in the areas of pharmaceuticals, medical devices, biotechnology, agriculture and food, including the top 20 global pharmaceutical companies and nine out of the top ten global medical device companies.

Our experts, many of whom have worked in-house in your sector, have developed a shared capability in the areas of pharmaceuticals, biotechnology, medical devices and diagnostics. With active memberships in major industry associations such as the ABPI, ABHI, BIVDA, PAGB, EUCOMED and EFPIA, we help shape the legal frameworks impacting the life sciences & healthcare sector. We regularly advise our clients on their day-to-day operational needs such as support with advertisement and promotion of medicine, public sector procurement, pricing and reimbursement, patent enforcement, commercial and clinical trial agreements as well as regulatory advice. Equally, when you need life sciences & healthcare specialist advice for strategic agreements, planning a corporate transaction or embarking on litigation (whether product liability or otherwise), we have a team that is well versed in the industry issues to help you.


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31/08/2022
With­draw­al and de­struc­tion of im­prop­er med­ic­al devices: new rules
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
18/07/2022
Rus­si­an Min­istry of In­dustry and Trade to have ac­cess to data of re­gis­tra­tion...
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.
13/07/2022
Pro­ced­ure in­tro­duced to trans­fer mar­ket­ing au­thor­isa­tion cer­ti­fic­ates for...
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.
15/06/2022
The former Mo­scow of­fice of CMS to con­tin­ue work­ing as an in­de­pend­ent law...
On 15 June 2022, the former Mo­scow of­fice of the in­ter­na­tion­al law firm CMS an­nounces the start of work as an in­de­pend­ent law firm un­der the new brand name SEAM­LESS Leg­al.Over 80 col­leagues of the Mo­scow of­fice con­tin­ue work­ing as one team, led by Man­aging Part­ner Jean-Fran­cois Mar­quaire and Seni­or Part­ner Le­onid Zubar­ev.We keep ad­vising our cli­ents across all 23 prac­tices and sec­tors: We lean on 30 years of ex­pert­ise and an im­pec­cable repu­ta­tion as part of an in­ter­na­tion­al law firm. We have al­ways abided by strict pro­fes­sion­al stand­ards and will con­tin­ue provid­ing ser­vices of the highest qual­ity. Jean-Fran­cois Mar­quaire, Man­aging Part­ner: “We are proud of hav­ing been able to cre­ate and pre­serve a united team with a friendly cor­por­ate cul­ture and re­spons­ible at­ti­tude to our busi­ness.”Le­onid Zubar­ev, Seni­or Part­ner: “Our new brand SEAM­LESS Leg­al most ac­cur­ately re­flects the ap­proach to work that has de­veloped over the years in our firm – in­teg­rity and co­her­ence, im­pec­cab­il­ity, con­tinu­ity and un­in­ter­rup­ted sup­port to our cli­ents at any time."
09/06/2022
New grounds in­tro­duced for the im­port and sale of un­re­gistered medi­cines...
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
15/03/2022
Latest le­gis­lat­ive ini­ti­at­ives in the Life Sci­ences sec­tor im­pact­ing for­eign...
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
14/03/2022
The Mo­scow of­fice of CMS to con­tin­ue as an in­de­pend­ent law firm
Dear FriendsWe have been through a lot dur­ing 30 years in Rus­sia. Now a dif­fi­cult de­cision has been taken by CMS to leave the Rus­si­an mar­ket. We are grate­ful to our in­ter­na­tion­al col­leagues for their...
28/01/2022
Leg­al de­vel­op­ments that may af­fect your busi­ness in 2022
CMS Rus­sia ex­perts have pre­pared their an­nu­al se­lec­tion of the most sig­ni­fic­ant leg­al de­vel­op­ments that may af­fect your busi­ness in Rus­sia in 2022.
01/11/2021
Do­ing busi­ness in Rus­sia
This is the 2021 edi­tion of the Do­ing busi­ness in Rus­sia guide. 
10/06/2021
CMS Rus­sia earns a re­cord num­ber of re­cog­ni­tions by Best Law­yers 2022
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...
19/03/2021
Di­git­al Health: data pro­tec­tion chal­lenges in Rus­sia
We in­vite you for a CMS Rus­sia we­bin­ar on data pro­tec­tion chal­lenges re­lated to di­git­al health in Rus­sia. Join our ex­perts Ir­ina Shur­mina and Vladis­lav Eltovskiy to learn about:Leg­al grounds for pro­cessing...
12/03/2021
CMS Rus­sia ex­perts re­cog­nised in the Pravo.ru-300 in­di­vidu­al rank­ing
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...