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Current issue #12, 2018

10.04.2018

Experts discuss priorities of Pharma-2030 Strategy

The implementation of the Pharma-2020 Program is still underway, but the industry already looks into future. The Ministry of Industry and Trade is to present the first draft Pharma-2030 Strategy through the end of April, while experts continue prioritizing strategic guidelines.

[PharmVestnik # 12, 10/04/2018, p. 1, cont’d p. 2]

// Regulatory & Legal – Pharma & Medical

Pharmaceutical manufacturers may be forced to pay 5M-RUB fines for unreliable drug information

The initiative to impose administrative sanctions for providing unreliable drug information in the process of registration/reregistration of a maximum sales price of a VED-listed drug triggers debates in the pharma community. Experts agree that misstatements must be penalized; however, it is unclear how to determine whether it was data garbling on part of a marketing authorization holder or if someone is just willing to think so.

[PharmVestnik # 12, 10/04/2018, p. 4]

// Health Management

Vice-Premier Olga Golodets criticized government officials for inadequate registers of patients in need of pain management

This year, Vice-Premier of the Russian Government Olga Golodets intends to do away with the inadequate patient access to analgesics and provide for a 100% coverage of those in need of palliative care. The Government Council for Oversight of Social Services discussed the ways to achieve the above in the country with a nonexistent unified recordkeeping system to embrace all patients in need of pain management. Mrs. Golodets was tough on the officials who tried to explain why the statistics from different sources did not add up and shed all responsibility to regional authorities. The Vice-Premier allowed 3 months to solve the problem.

[PharmVestnik # 12, 10/04/2018, p. 5]

// Drug Procurement

Pharma companies practice huge price cuts

In November 2017, Biocad announced price cuts in respect of 4 drugs: two antineoplastic products, a multiple sclerosis therapy under the High-Cost Diseases Program, and a HIV medication. Thus, the manufacturer did the government a favor as the new price has become the lowest in the VED list now targeted by the government customer. The state has saved dozens of millions of rubles. However, it was other players that had to cut their prices as Biocad was bidding to supply only one pharmaceutical product.

[PharmVestnik # 12, 10/04/2018, p. 9]

// Pricing – Pharma

Manufacturer's prices must be the same for distributors and pharmacy chains

Pharma companies often become dominant because they have unique products in their portfolios. They should not worry about what the customer will do with a drug purchased, therefore, it is logical to sell this drug to everyone interested. However, things are often quite different in practice. Companies are willing to work with certain contractors and refuse to deal with others. In the opinion of the Federal Antimonopoly Service, such cases represent an abuse of dominance.

[PharmVestnik # 12, 10/04/2018, p. 11]

// Government Supported Programs

Moscow authorities to invite bidding for an offset agreement

In the capital of Russia, a new instrument to support pharmaceutical manufacturers is gaining ground. Six months passed from the signing of the first offset drug supply agreement, and now the scope of the second such agreement is being elaborated. It is expected that a bidding for an agreement to manufacture and supply vital drugs for the needs of Moscow will be invited this summer.

[PharmVestnik # 12, 10/04/2018, p. 11]

// Health Management

Going to a new cancer management level requires concerted efforts

After President Vladimir Putin once again touched upon the implementation of the National Cancer Management Program when addressing the Federal Assembly on 1 March, the efforts in this respect have broadened. March saw several meetings of high-level officials and MPs with Russian scientists and doctors, with the issue-specific announcements made. Acad. Andrey KAPRIN, Director General of the National Medical Center for Radiological Research of Russia’s MoH, speaks about the current and future developments in the field of oncology in Russia.

[PharmVestnik # 12, 10/04/2018, p. 12]

// Logistics

Main carrier of narcotic drugs suspended

For decades, transportation of narcotic and psychotropic drugs in Russia was performed by the Head Center for Special Communications. It is the only legal entity in this country that has a logistics network covering all federal subjects and owns specially equipped vehicles. However, the Center’s transportation services in respect of the above drugs have been suspended since late 2017.

[PharmVestnik # 12, 10/04/2018, p. 14]

// Insight – Drug Procurement

State contracts to procure antibiotics, 2017: a review

In the 2nd half of the 20th century, the implementation of antibiotics into clinical practice made it possible to extend life expectancy worldwide by 20 years, on average. Analyzing state contracts for purchasing antibiotics signed in 2017 makes one wonder why the Ministry of Health is optimistic about further extension of life expectancy of the Russians if this segment shows virtually a flat growth year over year, with reduction for certain items. Does it mean that the MoH officials know how to manage bacteria without antibacterials? The review is based on Data Analytics Platform ‘Zakupki’.

[PharmVestnik # 12, 10/04/2018, pp. 16-17]

// Insight – Preferential Drug Coverage

Preferential Drug Coverage in Russia’s regions, 2017: a review

According to AlphaRM, the hospital drug purchases have been stagnating with a trend to a reduction in the number of health providers due to restructuring programs conducted over the past few years. The High-Cost Diseases (VZN) sector is strictly regulated, therefore, the drug purchase dynamics is usually within 10%. The federal preferential drug coverage sector has been relatively stable, whereas the similar regional sector has demonstrated the highest drug shipment rates among all Russian pharma market sectors over a few years running.

[PharmVestnik # 12, 10/04/2018, pp. 18-19]

// Insight – Preferential Drug Coverage

Preferential Drug Coverage, 2017: a review

According to DSM Group, in 2017, drug purchases for the beneficiary population groups reached 115.4B RUB, up 6.6% year over year (y-o-y). Purchases in real terms have retained a downtrend, with 80.0M drug units purchased in 2017, which indicates a 1.0% reduction y-o-y.

[PharmVestnik # 12, 10/04/2018, p. 20-21]

// Import Substitution

Sverdlovsk pharmaceutical and medical manufacturers appraised new market opportunities

Residents of the Ural Biomedical Cluster have agreed on their joint efforts for the next two years. They consider it possible to put pressure on foreign pharmaceutical and medical manufacturers in the region.

[PharmVestnik # 12, 10/04/2018, p. 24]

// Regulatory & Legal – Pharma & Medical

Innovative products require new regulatory approaches

The workshop for medical manufacturers hosted by Skolkovo Technopark on 30 March has been totally sold out. The main topic was the specifics of launching to the EAEU market of innovative medical devices and healthcare software & applications.

[PharmVestnik # 12, 10/04/2018, p. 27]

// R&D – Medical

Scientists explained why it takes long to implement medical R&D products

Local high-tech R&D products will provide for making endoprosthesis replacement more affordable, better accessible, and cost-saving. In Russia, the demand for replacement arthroplasty is still outstanding. A low durability of implants and a high replacement demand is also an issue. Moscow Institute of Steel and Alloys (MISA) has traditionally been a core materials research center. MISA scientists speak about their solutions associated with the development of implantable medical devices currently going through different clinical trial phases.

[PharmVestnik # 12, 10/04/2018, p. 28]

// Regulatory & Legal – Pharma & Medical

In 2017, Roszdravnadzor restricted sales of more than 1 million medical devices

Annually, more than 1,000 new medical devices are authorized for marketing in Russia; in parallel, the information on the formerly approved medical devices is being updated. However, the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) states that the rate of non-compliant medical devices in terms of quality and safety is still high and is commensurable with 2016 findings.

[PharmVestnik # 12, 10/04/2018, p. 29]

// Digital Health

Medical and health IT startups bound for a difficult path to telehealth

The development of mobile medical devices and applications is to enhance the role of telehealth and IT companies. At the same time, it must be borne in mind that there are no quick success stories in store for such businesses. App manufacturers will be dependent on the timeframe of mobile medical devices implementation not only on the Russian but also on the EAEU market. Experts are sure that playing around with health diagnostic wearables is nothing more than marketing.

[PharmVestnik # 12, 10/04/2018, p. 29]

// Insight – Medical Devices & Equipment

State purchasing of defibrillators, 2016—2017: a review

According to Medconsult, over the 2 years, Russian health providers purchased more than 5,000 automatic external defibrillators worth 1.3B RUB in total. It is worth noting that in 2017, purchases went down by 9.5% in value terms year over year, whereas there was a growth in real terms.

[PharmVestnik # 12, 10/04/2018, p. 30]

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