Current issue #6, 2018

Rating of the most influential subjects of the Russian pharma market, 2017 (Part 2)

This rating is based on research by Battersea Marketing and KPMG that unloved 525 experts in 33 cities of all Russia’s federal districts. This piece covers the most influential Russian and foreign manufacturers, distributors, pharmacy chains, entrepreneurs/CEOs, professional associations, politicians/government officials, specialized periodicals, websites as well as the most popular Rx and OTC drugs. To take into account the diverging opinions, PharmVestnik separately presents the responses by pharmacists (including pharmacy managers) and all other experts.

[PharmVestnik # 06, 20/02/2018, p. 1, cont’d pp. 10-12]

// Regulatory & Legal – Pharma Retailing

Experts refer to the bill that approves drug sales at stores as «detrimental»

On 12 February, the Russian Chamber of Commerce and Industry hosted the debates on the bill “On amendments to the Federal Law ‘On drug circulation’” and Article 2 of the Federal Law “On fundamental healthcare principles in the Russian Federation” concerning drug sales via FMCG distribution channels. The debaters involved representatives of pharmacy businesses, professional associations, Ministry of Health, Federal Service for Surveillance in Healthcare and Social Development, and Federal Antimonopoly Service. The Ministry of Industry and Trade officials who have developed the scandal bill have ignored the debates.

[PharmVestnik # 06, 20/02/2018, p. 2]

// Regulatory & Legal – Patents

In Russia, Pfizer’s losses exceeded half a billion rubles due to generic launches before patent expiry

In Russia’s regions, the winner of about 30 biddings for supplying Pfizer’s sunitinib was the generic drug by Russian Nativa. Even though Pfizer’s originator drug is patent-protected until 2022, the Russian generic has made its way to civil commerce, and bids for this drug are invited. The originator manufacturer has taken court actions to stand against the generic’s further distribution, but to no avail as injunctive relief is missing from Russia’s court practice so far.

[PharmVestnik # 06, 20/02/2018, p. 3]

// Health Management

Russia still lags in oncotherapy solutions for children

On 15 February, the International Childhood Cancer Day was marked in more than 40 countries. Over the past decade, Russia has made significant advances in cancer management in children; however, certain major issues are still outstanding. One of such issues is that oncotherapy solutions for children permanently lag behind those for adults.

[PharmVestnik # 06, 20/02/2018, p. 4]

// Regulatory & Legal – Pharma & Medical

Pharma industry discussed drug marking risks

Despite the long-awaited adoption of the drug marking law, the pharma industry is still in the state of uncertainty. The major risks and challenges facing the market players were the focus of the business brunch meeting on the legal aspects of drug marking hosted by Kommersant Publishers.

[PharmVestnik # 06, 20/02/2018, p. 6]

// Regulatory & Legal – Pharma & Medical

Drug marking changes terminology, timeframe remaining uncertain

A year has passed since the drug marking pilot has been launched. The pharma market players, being overall satisfied with the project implementation deadline extension, went to the second lap of the marking race full of danger and hardships. The roundtable “Drug marking in the Russian Federation: Still manned” hosted by KPMG summed up the initial results and discussed further tasks of the experiment.

[PharmVestnik # 06, 20/02/2018, p. 7]

// Regulatory & Legal – Pharma & Medical

Vaccine release quality control to change in Russia

In March 2018, the State Duma will review amendments to Federal Law No. 61-FZ “On drug circulation” concerning putting drugs into civil circulation. Whereas these amendments are minor for conventional drug manufacturers, they are going to be revolutionary for immunobiological manufacturers. Formerly, manufacturing facilities were issued batch production certificates valid for a year, and lab tests were performed for individual batches only; now, testing of every batch is required. The bill developers assert that Russia follows the best international practices. PharmVestnik investigates if this is the case.

[PharmVestnik # 06, 20/02/2018, p. 8]

// Market Research

A new player may emerge on the analytical services market

A federal information monitoring system tracking the manufacturer-end customer drug flow that will use means of identification will provide for maximum transparency of the market players’ operations. The problems associated with the goods flowing into secondary distribution must become a thing of the past, while for businesses, an aggregate drug flow picture will become available. It is rumored in the pharma community that another analytical company may emerge that will aggregate data and sell it to businesses. The question is what the already operating analytical companies have to do about it.

[PharmVestnik # 06, 20/02/2018, p. 9]

// Pharma Retailing

Pharmaceutical manufacturers shift sales from pharmacy to online chains

While the regulatory authorities tiptoe around the online drug sales bill, manufacturers plunge deeper into online selling. Given the development of marketing tools, and the growing number of web pharmacies, in a couple of years pharma will be ready not only to take orders online but also deliver drugs. With the falling demand, online sales channels provide for cutting distribution and promotion costs.

[PharmVestnik # 06, 20/02/2018, p. 17]

// Insight – Dietary Supplements

Sales of immunity boosting and cold & flu prevention supplements, 2017: a report

According to AlphaRM, the entire group of immunity boosting and cold & flu prevention supplements accounts for about the same percentage of total sales in the out-out-pocket segment as just one cough or cold pharmaceutical brand ranking last among the TOP10 relevant trademarks.

[PharmVestnik # 06, 20/02/2018, pp. 20-21]

// Counterfeit Drugs

Supervision authorities got hold of the «mystery» wholesaler

Sverdlovsk prosecutor’s office published the details of counterfeit drug supplies to an oncology center in Ekaterinburg. The license of the supplier that has won the bidding will be cancelled. It has become possible due to the Federal Service for Surveillance in Healthcare and Social Development that spent a year collecting evidence.

[PharmVestnik # 06, 20/02/2018, p. 22]

// R&D – Medical

Scientists master stem cell-based technologies

A regenerative medicine laboratory is being created on the premises of Stavropol Medical University. The university scientists have developed several cell-based products for boosting regeneration processes in dentistry. There are also new stem cell-based products and bone matrices in the pipeline. Over the long term, this technology is likely to be used in other medical areas.

[PharmVestnik # 06, 20/02/2018, p. 23]

// Cartels

Sales scheming may come at a cost to drug suppliers

Kemerovo Department of the Federal Antimonopoly Service has proved in court a large-scale cartel agreement in drug supply biddings. The bidding players were imposed turnover-based fines. The companies are ready to litigate these fines. However, the large number of sales scheming cases under investigation in the Kemerovo Region indicates that the bidding schemes involving affiliated companies not only fail but also become dangerous.

[PharmVestnik # 06, 20/02/2018, p. 23]

// Investment – Medical

Doctors and officials speak on nuclear medicine development prospects in Russia

On February 1, an opening ceremony was held for Gamma Clinic, a private precision radiology center set up on the premises of A.F. Tsyb State Medical Research Center for Radiology in Obninsk (Kaluga Region). Technologically, it is based on Gamma Knife radiosurgery that is a gold standard in treatment of specific brain pathologies. Gamma Clinic is one of the first successful public-private partnership projects in healthcare based on private investment only.

[PharmVestnik # 06, 20/02/2018, p. 25]

// Pharma Market – Regional Specifics

Experts debate over feasibility of lab services centralization

The lab services centralization processes demonstrate specific features in virtually each Russia’s region as a common concept is missing. In late 2017, the Federation Council became concerned about the situation and sent proposals on reforming lab services to the Ministry of Health, Federal Mandatory Health Insurance Fund, and heads of sub-federal entities. The Federation Council proposes to set forth the criteria for assigning the centralized service status. However, in the absence of approved guidelines, regions act as they will. Frequently, lab centralization goes along with purchasing imported equipment, which makes local medical manufacturers angry.

[PharmVestnik # 06, 20/02/2018, p. 26]

// Patient Advocacy

Patient Advocacy League offers help to medical manufacturers in controlling supplies

Patient Advocacy League President Alexander Saversky sees many opportunities still unused by medical manufacturers to expand their sales markets. In his opinion, expansion is possible if the market players learn how to stand up for their right to participate in regional state-funded programs.

[PharmVestnik # 06, 20/02/2018, p. 27]

// R&D – Medical

Russian mobile health solutions to make the disabled persons life easier

Kaliningrad engineers have developed a Balalayka, a neural (brain-computer) interface that controls an exoskeleton. Presumably, this interface may become applicable to drive wheelchairs, too.

[PharmVestnik # 06, 20/02/2018, p. 27]

// Insight – Medical Devices & Equipment

State procurement of portable blood-sugar monitors and test strips, MAT Q316-Q317: a report

According to MedConsult, the 3^rd quarter 2017 saw the largest procurement of multifunctional glucometers in Russia’s state purchasing history. Test strip purchases grew year over year, too.

[PharmVestnik # 06, 20/02/2018, p. 28]