// Regulatory & Legal
Pilot risk-sharing projects miss the action date
In the spring of 2017, pilot risk-sharing projects were to be launched in three Russian regions. The preparation period was lengthy, but productive: the government adopted a resolution on executing pilot projects to upgrade the health system; the Ministry of Health (MoH) drafted the agreement templates for the regions; the timeframe and reporting format were approved; pharma companies, nosologies, and drugs were selected. However, according to a Ministry of Finance spokesperson, in November, the MoH received another rejection from the Federal Antimonopoly Service (FAS). The FAS officials object to including the VED-listed products into the pilot projects.
[PharmVestnik # 40, 05/12/2017, p. 1, cont’d p. 5]
// Health Management
Experts consider healthcare officials too ambitious and underprofessional
For many years, the expert community has relished the idea that drug coverage should be part of the system of state-funded projects, which means that the patients insured under the Mandatory Health Insurance system should be entitled to receive drugs free of charge. Patient Advocacy League President Alexander Saversky undertook to prove the legitimacy of such approach. After several congresses “The Right to Drug”, heads of patient and professional associations as well as State Duma deputies have bought into the idea. They have written dozens of letters to the relevant ministries and agencies, made financial estimates, drafted a federal law, and arrived at a conclusion that the state could afford free-of-charge drug coverage of the citizens. However, they have got nowhere so far.
[PharmVestnik # 40, 05/12/2017, p. 2]
// Regulatory & Legal
Serialization and aggregation to cut the number of pharma market players
With the nearing mandatory drug marking deadline, experts become increasingly concerned about the project. The real preparedness level in the regions is in violent contrast with what the regulators and project pioneers state. Dominanta Service Sales Director Igor STOLIN speaks about how the marking project implementation will change the business structure as well as about potential risks and benefits.
[PharmVestnik # 40, 05/12/2017, p. 6]
// Health Management
R-Pharm and Valenta to pull off “price racing”
Two Russian manufacturers intend to seek state funding of their products within the framework of the High-Cost Disease Program (VZN). This year, despite the budgetary funding shortage, teriflunomide was included into the program-covered drug list. R-Pharm that is a packaging company for Sanofi’s branded Aubagio makes efforts to win in a state procurement bidding over Valenta Pharm that this year was issued a marketing authorization for teriflunomide generic, Femorix. Proceeding from the drug demand for 2018, the MoH has developed a purchaser’s price strategy. The bidding price estimated by PharmVestnik is likely to be attractive both for R-Pharm and Valenta. The MoH Drug Coverage Department faces an obligation to save the budget funds and an opportunity of purchasing the originator drug from R-Pharm. The question is what the latter is ready to do to this end.
[PharmVestnik # 40, 05/12/2017, p. 8]
// Health Management
MoH is recommended to accelerate implementation of integrated assessment of state-funded drugs
Experts state that as the healthcare costs grow the cost feasibility issue becomes increasingly pressing. Therefore, it is high time that an integrated healthcare technology assessment system be implemented. According to the MoH, such system has already passed its infancy stage, and it is more or less clearly shaped now. It is time for drastic actions.
[PharmVestnik # 40, 05/12/2017, p. 10]
// Health Management
Manufacturers do not see pediatric drug benefits
The number of compounding pharmacies and cheap pharmaceuticals has plummeted over the past years because of low profitability. It is children, especially newborn, who suffer the most, because alternative drugs could not be easily found. At a recent meeting at the Federation Council that discussed urgent pediatric drug issues, doctors and officials came face to face with heads of manufacturer and pharmacy chain associations to find out where drugs for children disappeared to, and who would undertake clinical trials of pediatric drugs. The pharma business was represented by Victor Dmitriev, head of the Association of Russian Pharmaceutical Manufacturers, and Nelly Ignatieva, head of the Russian Association of Pharmacy Chains, who tried to be as earnest as possible. “Pharma manufacturers do not always give honest answers because it is unprofitable to manufacture cheap dosage forms, while it is too expensive to close an operating production line. As a result, a manufacturer annually produces a small drug batch, and “spreads” it thinly all over the country,” confessed Mr. Dmitriev.
[PharmVestnik # 40, 05/12/2017, p. 10]
// Health Management
Mistrust for homeopathy hinges on low awareness
At a press conference in Moscow on 23 November, the All-Russia Public Opinion Research Center presented the results of the Boiron Index research studying the Russians’ attitude to homeopathic products. The study conducted together with Boiron aimed at finding out the Russian population’s awareness level on homeopathic products, their uses as well as the level of trust for such products.
[PharmVestnik # 40, 05/12/2017, p. 11]
// Pharma Manufacturing
Pharma companies adjust their development strategies to new environment
Pharma companies have virtually not been affected by the economic crisis that broke out in 2014. In the past 2 to 3 years, many leaders of both local and foreign companies interviewed by PharmVestnik spoke about a continuing growth, although no longer two-digit as before. This is largely thanks to traditionally higher drug prices in Russia. Now manufacturers face a new “quest’, i.e. change of the regulatory environment. Experts are sure that pharma businesses will survive without substantial losses.
[PharmVestnik # 40, 05/12/2017, p. 12]
// Regulatory & Legal
State Duma deputies to consider permitting online sales of Rx drugs
Amendments to Federal Law # 61 “On Drug Circulation” concerning permit of online drug sales are scheduled to be reviewed in the first reading by the State Duma on 13 December. In accordance with the law-making tradition in Russia, the text of the document with not change after its first review by the deputies vs. the variant submitted by the government. It means that the deputies will approve online delivery of OTC drugs only. However, Rx drugs may make their way to the bill by the second reading.
[PharmVestnik # 40, 05/12/2017, p. 12]
// Regulatory & Legal
Drug registration errors create site inspection problems
Quite often and not without reason, drug manufacturers complain about inspectors from relevant regulatory agencies frequenting their production sites. In turn, the regulators say that the number of site visits may be reduced but not earlier than Russian manufacturers are ready for that. This is primarily about the necessity to focus closer on drug master files as most violations found by inspectors relate to document errors.
[PharmVestnik # 40, 05/12/2017, p. 13]
// Regulatory & Legal
Shifting orphan drug procurement to federal level lacks appropriate funding
The idea of bringing orphan drug procurement to the federal level that has been recently much talked about and hoped for, raises questions if studied closely. Experts are painstaking to find an alternative solution.
[PharmVestnik # 40, 05/12/2017, p. 14]
// Health Management
Flu vaccination campaign brought down morbidity rate
Annually, 3% of the Earth’s population, i.e. 15 million people, die of influenza. From year to year, the medical and pharma communities do their best to get prepared for the invasion of the next virus strain: they manufacture huge amounts of relevant vaccine shots, and develop new, more efficacious, and universal vaccines using genetic engineering technologies. Doctors and representatives of pharma business discussed vaccination advances and challenges at the 2nd Scientific Council meeting at Doctor TV studio.
[PharmVestnik # 40, 05/12/2017, p. 15]
// Pharma Retailing
Manufacturers want reports on spending every ruble invested in pharmacy chains
Against the background of pharmacy chains’ massive “advent” to various associations, the issue of effective sales of product categories remains unsolved. Numerous pharmacy associations are not always capable of offering analytical tools for effective product promotion. In return for providing marketing budgets, manufacturers require increasingly detailed sales reports from pharmacy chains. Experts believe that only those pharmacy chains and associations that will implement effective analytical software solutions are likely to survive on the market.
[PharmVestnik # 40, 05/12/2017, p. 16]
// Pharma Market – Regional Specifics
Regional specifics of Russian pharma market
Russia’s huge territory drives differences between regional drug coverage programs. At the same time, it is not only that regional authorities differ in how they spend drug budgets. The regional populations may differ in their drug preferences as well as approaches to specific disease treatment, and drug payment patterns.
[PharmVestnik # 40, 05/12/2017, p. 18]
// Insight
Cumulative rating of Russian largest pharmaceutical distributors, Q1-317
According to IQVIA, in the first 9 months of 2017, the TOP10 distributors account for 68.1% of the direct sales market, up 0.5% year-on-year. The TOP3 distributors (Protek, Katren, and Puls) take up 48.5% of the market. Protek that leads the ranks is 1.1% ahead of its immediate rival, Katren.
[PharmVestnik # 40, 05/12/2017, pp. 20-21]
// Insight
Pharmacy dietary supplement sales, Q1-317
Dietary supplements are sold at pharmacies as well as at specialized stores or supermarket departments, e.g. Auchan, Metro, Azbuka Vkusa etc. Food retail chains invest heavily in departments selling health products including supplements. However, despite the above trends, pharmacies remain the major sales channel for this product category. According to DSM Group, dietary supplements generate about 21% of pharmacy sales of parapharmaceutical products in value terms, and they are represented by a large number of commodity items.
[PharmVestnik # 40, 05/12/2017, pp. 22-23]
// Insight
Rating of Russian pharmaceutical distributors, Q1-317
This rating is based on RNC Pharma data. The company’s analysts see the formal start of a drug marking system implementation in Russia as one of the key events of the expiring year. Putting the system into operation has both obvious benefits and not so obvious risks in store for all market players. The benefits are mainly associated with broadening the range of manufacturers’ opportunities of controlling the product distribution system. The risks are predominantly connected with the regulators’ desire to implement the drug marking system in the shortest possible time, which may generate many problems, including for wholesalers operating on the Russian pharma market.
[PharmVestnik # 40, 05/12/2017, pp. 24-26]
// Health Management
Novosibirsk governor’s “manual control” helped solve problems of diabetes patients
In November, a scandal erupted in Novosibirsk because of insulin drugs shortage for diabetes patients. First, they asked the MoH, and then the region’s governor to provide them with insulin drugs or at least with prescriptions to purchase these drugs out-of-pocket. After the governor intervened, the patients not only received access to insulin drugs but also personal invitations to pharmacies to collect their drugs. The regional authorities promise to solve the problems of every patient until the drug coverage system runs smoothly. At the same time, people queueing at pharmacies clearly signal about the population’s concerns and mistrust.
[PharmVestnik # 40, 05/12/2017, p. 28]
// Health IT
Novel technologies tested in Russia’s regions
The Bank for Foreign Economic Activity (Vnesheconombank) and Novgorod region administration are launching a joint pilot project for drug coverage monitoring based on blockchain technology. The working prototype software testing is to complete by the end of the year.
[PharmVestnik # 40, 05/12/2017, p. 29]
// Pharma Manufacturing
Scientists to earn via drug synthesis and collaboration with other universities
The Ural Federal University has won the contest run by the Russian Ministry of Education and Science, and is entitled to receive a 33M RUB funding from the state budget for the development of a diabetes mellitus drug. Part of this sum will be spent for purchasing equipment for the university-affiliated Chemical and Pharmaceutical Center that has a promising future.
[PharmVestnik # 40, 05/12/2017, p. 30]
// Monitoring – EAEU
State drug procurement in Belarus
Drug supplies for state-funded institutions is the key focus for certain pharmaceutical companies. To work with Belarus state sector, it is important to understand the drug purchasing specifics of the country.
[PharmVestnik # 40, 05/12/2017, p. 31]
// Health Investment
Investors do not expect an international operator coming to Russian private medical services market
The Russian private medicine is quite interesting from the investor’s perspective. Market players say that now it is much easier to raise money from capitalists. Local banks and investment companies are already much better aware about medical project specifics. Foreign investors see the Russian market potential, too, but they are not numerous because of the sanctions imposed against Russia. The market operators do not expect a large international medical company coming to Russia in the short term.
[PharmVestnik # 40, 05/12/2017, p. 35]
// Health Management
Experts foresee transfer to a different system for assessing medical services quality
A system of criteria used for the assessment of medical services quality is always halfway between experts and evidence-based medicine. In Russia, the process of forming these criteria was very difficult. It turned out that it was impossible to extrapolate international experience and expertise to Russia’s environment because of different approaches to funding and treatment as well as legislation. Nonetheless, the assessment system developed by local experts is based to a certain extent on the world practice elements. However, it is not to medical practitioners’ liking.
[PharmVestnik # 40, 05/12/2017, p. 37]
// Health Management
Nearly 90% of Russians are ready to pay for telehealth services
According to a survey conducted by IPT Group, about 75% of Russia’s population are positive about using long-distance communication with their doctor as part of medical services at a private clinic, while 68% of the population consider using telehealth services either for themselves or their family members in 2018—2020. The survey conducted in this November embraced 150 respondents.
[PharmVestnik # 40, 05/12/2017, p. 37]
// Health Management
Private clinics seek to boost operational effectiveness
In Russia, private medicine develops largely because of underdeveloped public medical services. If a patient cannot receive high-quality services within the framework of the Mandatory Health Insurance system, such an individual has to pay. The big question is what clinic the patient will prefer – private or public. Presently, public clinics often make extra money on the private services market. Such play is far from being fair because public clinics do not have to invest in equipment; therefore, they can afford lower prices vs. private healthcare providers. What is left for private clinics to do? Upgrade quality and reduce costs.
[PharmVestnik # 40, 05/12/2017, p. 38]
