Current issue #35, 2016

Eyes wide shut

Manufacturers ready to sign special investment contracts not being sure why

Premier Dmitry Medvedev charged the ministries of industry and trade, economic development, health, and financeas well as the Russian Federal Antimonopoly Service withelaborating an issue on terms of attributing human drugs manufactured under special investment contracts (SPICs) to products of the Russian origin. Theaboveagenciesaretoreportontheresultsto the government not later than November 24^th. Pharmaceutical manufacturers have a weird feeling about SPICs: businesse shave no doubt that this mechanism is attractive; at the same time, nobody knows how it is to be implemented. Therefore, whenfilingSPICapplications, manufacturers just believe that the situation will not change for the worse.

[PharmVestnik # 35, 01/11/2016, p. 1, cont’dp. 2]

Why Moscow does not equal Russia

The capital votes fororiginator drugs while generic sales go up at pharmacies

There sults of a joint survey made by Bayer and All-RussiaPublic Opinion Research Center “Bayer Barometer” make one turn to the issue of innovative, originator, and generic drugs once again. Persurveydata, 56% of Moscow residents preferoriginator drugs, and 52% of them do not intend to switch to generics even in case their income decreases.

[PharmVestnik # 35, 01/11/2016, p. 4]

Local generics start competing fiercely

The innovations that have been the subject of the government recentinitiative sare not close to heart of local manufacturers so far. Despitetheclinicaltrialsmarketactivityobserved over the past few years, the trend to increase in the number of innovative drugs is weak. Atthesametime, analystspointoutthattheimportsubstitutionis a reality in certain segments. However, this is notaboutinnovations;itislocalgenericsthatarestrugglingfor market shares.

[PharmVestnik # 35, 01/11/2016, p. 5]

Expertsdiscusslifeexpectancyandquality

OnOctober 26^th, PharmVestnikvisited the Open Innovations Forum at Moscow Technology Park Skolkovo that attracted 5 thousand participants. Unlikemostjournalistsandoutsideobservers, we remember much more than just the fire that has disrupted Premier D. Medvedev’s speech.

[PharmVestnik # 35, 01/11/2016, p. 6]

Thought better of it

Russia not to protect open clinical trials data

SinceJanuary1^st, 2016,the statutory provision on the exclusivity of preclinical and clinical trials data has been in force. Pursuanttoclause18 ofArticle18 oftheFederallawFZ-61 “Ondrugcirculation”, it is prohibited to use the above data without a rights holder’s consent for 6 years after the reference drug registration. Not a year has elapsed when a decision was made to abolish this provision. Thedraftlawwith appropriate amendments has been posted at regulation.gov.ru website.

[PharmVestnik # 35, 01/11/2016, p. 6]

Will new MoH’s standards affect narcotic drug avilability?

October 28^thwas the deadlinefo the public debate on the Ministry of Health draftorderincluding new standards for the calculationofnarcotic and psychotropic drug demandat health care, emergency, and palliative medical aidinstitutions.

[PharmVestnik # 35, 01/11/2016, p. 8]

Ebbs and flowsof entering new drugs into government-funded programs

Pressures mount in expectation of a new VED list. Thecommissionentrustedwithdraftingsuchlistisbeing accusedofunwillingnesstoincludenewefficacious but at the same time high-cost drugs. Thecommissionpointsouttoinadequately prepared common technical documents. Thefinaldecisionisbeingpostponed.

[PharmVestnik # 35, 01/11/2016, p. 9]

Pharmaindustry concernsover negative attitudes running high

When analyzing printed and TV materials on the Russian public health system and pharmaceutical market, experts arrive at a conclusion that the Pharma is in danger. Theflowofnegativestuffisrunninghigh; at that, it is so unfocused that the target is unclear. Pharma industry players are not surprised by the fact that mass media are dancing around the industry’s two main troubles, i.e. drug availability and high prices. Buttheyarenotwillingtokeepsilentwhenrepresentativesofspecificstateagenciesjoininthe industry demonization. Within the framework of the Russian Association of Pharmaceutical Marketing roundtable in late October, the expertsdeveloped an action plan to protect the pharma industry’s reputation.

[PharmVestnik # 35, 01/11/2016, pp. 10-11]

Russian inspectors recommend to be well-prepared to GMP compliance audits

Withintheframeworkofthe 8^thInternationalConference “Whatisgoingoninthepharmaceuticalmarket”, Vladislav SHESTAKOV, Director of the State Institute of Drugs and Good Practices (Russian GMP Inspectorate), elaborated on the current GMP inspection situation, reaudit costs, inspectors’ salaries etc.

[PharmVestnik # 35, 01/11/2016, p. 12]

Import substitution is an evil

Russian physicians look forward tolocaloriginat or drugs

In late October,thePharmaceuticalandMedicalIndustryCommissionofthe Russian Union of Industrialists and Entrepreneurs jointly with Acad. AlexanderChuchalin, DirectorofMoscowResearchInstituteofPulmonology, hosted a roundtable “Competencies of local industries in respiratory disease prevention and treatment”. The event’s objective was to provide an opportunity for physicians to tell the Russian pharma industry players directly what drugs were necessary. Itturnedoutthatphysicianswerelookingforward to new drugs, but pharmaceutical manufacturers were not always able to help their newly developed medicinal products work the whole way through to prescribers.

[PharmVestnik # 35, 01/11/2016, p. 13]

Seasalt drugmarket report

Nobody knows why seawater became one of the item on th eimport ban listpursuant to the Russian Government Resolution # 897 of 10.09.2016. Butnowitisquiteclearhowthisbanmayaffectrunny nose patients. StartingfromNovember1^st, theymaybedeprivedoftheopportunityofusing their traditional remedies based on sea salt, sea water, or sodium chloride (either separately or in a combination).

[PharmVestnik # 35, 01/11/2016, p. 20]

Sofosbuvir halfway in Russia

Part 1. A phantom of mandatory licensing

Oneofthehot topics of the Russian pharmaceutical industry is mandatory licensing of high-cost vital drugs. Theissueiswordedingeneralterms, thoughquiteemotionally: the state is obligated to provide the Russian citizens with drugs, and in case a foreign patent holder creates hindrances to achieving that target based on its monopoly, the patent shall be expropriated.

[PharmVestnik # 35, 01/11/2016, p. 21]

Substituteandexport

Permterritoria lpharmaceutical industry goes federal

Theclusterdevelopmentpolicyimplementation is well underway in Perm territory. The region has been successfully developing two innovative clusters under the Ministry of Economic Development programs, i.e. the aviation and rocket engine engineering cluster “Technopolis ‘New Zvyozdnyj’” and fiber-optic technology cluster “Photonics”. Inmid-September 2016, thePermTerritoryGovernment and the Association “Industrial Pharmaceutical Cluster of PermTerritory” signed an agreement on creating a territorial pharma cluster with more than 10 participants.

[PharmVestnik # 35, 01/11/2016, p. 22]

Pharmacy pricing to be audited in Ural Federal District

State Duma Deputy Alexander Petrov declared that he was initiating an audit by supervisory agencies of pharmaceutical manufacturers, distributors, and pharmacies of Sverdlovsk region. Thematterindisputewastheunreasonably high drug price growth. However, market players believe that the government has the right to control public procurement only.

[PharmVestnik # 35, 01/11/2016, p. 23]

Scientists discovered a compound possessing a strong analgesic effect

In 2016, theRussianMoHregisteredtwolocalanalgesicsto be manufactured at a Russia plant. And there is more to come as Ru-1205 agent developed by South Russian scientists has successfully passed preclinical trials. Currently, the developer is looking for clinicaltrialinvestors.

[PharmVestnik # 35, 01/11/2016, p. 23]