// GxP
Results of GMP audits by Russian and foreign inspectorates often differ
The Russian Federation has practiced on-site audits since January 1st, 2016. As of September 2017, foreign manufacturing sites in 59 countries were audited. Already after the first audits, inspectors from the State Institute of Medicinal Products and Good Practices reported about violations at the sites certified by the US FDA and EU regulators as at the time of inspection. PharmVestnik found out that reverse situations occur as well.
[PharmVestnik # 32, 10/10/2017, p. 1, cont’d p. 3]
// Pharma Retailing
Classical pharmacy chains skeptical about home drug delivery legalization
The pharmacy market has been growing slowly, which makes business owners often change the tone of their reasoning about future. They intensely look at the government that is obligated to improve access to medical services, which, in turn, will provide a stable pharmacy growth. Another promising channel is manufacturers making marketing agreements with pharmacies. In this context, online drug sales that have not been legalized yet are considered a misunderstanding.
[PharmVestnik # 32, 10/10/2017, p. 4]
// Budgets & Funding
Next year, drug expenditures from all budget types may remain at 2017 level
In the draft 2018 budget, health expenditures are set to grow by 15% to exceed 3 trln RUB. Alas, looking closely at e.g. the draft federal budget, one will see that centralized drug procurement expenses will not grow next year. Regional budgets are unlikely to be set for drug coverage breakthroughs. Expenses of the Federal Mandatory Medical Insurance Fund for medicinal products, materials, nutrition, and communal services will increase by 4%, which reflects consumer inflation. Health Minister Veronica Skvortsova asserts that the situation will at least not change for the worse. Regional officials add that it could not be worse.
[PharmVestnik # 32, 10/10/2017, p. 6]
// Monitoring – EAEU
EAEU common drug market: achievements and drawbacks
The regulatory documents governing the Eurasian common drug market came into force in May 2017. The development of more than 60 third-level documents is underway. In late September, manufacture validation regulations were approved, the approval of the rest of the package pending next year. Certain EAEU pharmacopoeial monographs are being brought for public discussion. According to EAEC experts, all works associated with the launch of a common drug market are on schedule. Experts offered clarifications during the 9th International Conference “What is Going on in the Pharma Market?” held in Moscow on 3 October.
[PharmVestnik # 32, 10/10/2017, p. 7]
// Market Trends
Russian pharma market traditionally demonstrates anomalous trends
Experts characterize the current pharma market as a market with an abnormally low originator drug share, abnormally large OTC drug segment, abnormally high promotion costs, and growing investment in trade marketing. Abnormal features occur intermittently with revolutionary processes initiated by the government. According to certain analysts, since H117, country managers of pharma companies have been increasingly often thinking about feasibility of further operations on the Russian market.
[PharmVestnik # 32, 10/10/2017, pp. 8-9]
// Regulatory & Legal
Experts hope for interagency revision of draft methods for determining maximum drug selling prices
Pharma industry leaders use specific figures to prove to the government the inefficiency of the calculation techniques related to registered VED prices. The draft methods essence is as follows: the more expensive the drug the bigger the discount for major procurer, i.e. the government. Manufacturers keep saying that such approach will hinder the local pharma development, and will make companies scale down their R&D efforts.
[PharmVestnik # 32, 10/10/2017, p. 10]
// Regulatory & Legal
Reference drug list may impede generic circulation
The Russian Ministry of Health has drafted a reference drug list. The Federal Antimonopoly Service has called on the market players to actively discuss the document required to implement new pricing methods. However, pharmaceutical manufacturers doubt that they should make haste.
[PharmVestnik # 32, 10/10/2017, p. 11]
// Monitoring – EAEU
EAEC suggests prolongation for filing local GMP certificates when applying for MA’s to EAEU regulations
The story with shifting the transition period dates stipulated by the common drug and medical device market documents within the EAEU has been logically extended. The initiative on postponing the common market launch put forward by businesses was reviewed by the EAEC workgroup. The EAEC’s decision was reflected in the draft document posted for public discussion ending on 3 November.
[PharmVestnik # 32, 10/10/2017, p. 13]
// Regulatory & Legal
Experts sum up pilot drug marking results
Both officials and certain pharma business players wonder what companies are waiting for not getting ready for implementation of the drug marking system, with just a few months left until the deadline. If they join the marking project last-minute when the marking becomes mandatory for everyone, this may entail higher expenses as well as shortage of the appropriate equipment. The first pilot drug marking results were summed up during the 9th International Conference “What is Going on in the Pharma Market?” held in Moscow on 3 October.
[PharmVestnik # 32, 10/10/2017, p. 14]
// Regulatory & Legal
Pharmacies concerned about certain wording of narcotic-containing drug dispensing regulations
The Russian Ministry of Health Order # 403n has caused massive comments and misreadings among the pharmacy community, which made the ministry issue special clarifications on the alcohol and narcotic-containing drug dispensing procedure. But this does not seem to have helped as tension among pharma retailers persists. PharmVestnik interviewed Pharmacy Guild and National Pharmaceutical Chamber COO Elena NEVOLINA on certain subtleties of interpreting provisions of the document that came into effect on 22 September.
[PharmVestnik # 32, 10/10/2017, p. 15]
// Pharma Retailing
IT-based stock reserve analysis for cost saving
When speaking about stock reserve optimization, some pharmacy chain representatives view this process as routine and minor. However, implementation of analytical IT solutions for warehouse stock management often provides for saving dozens and even hundreds million rubles in costs. Manual stock management does not provide for boosting turnover and balancing inventory shortage. Pharmacy chain heads admit that the assets frozen in stock reserves are commensurable with investment into launching new pharmacies on an annual basis.
[PharmVestnik # 32, 10/10/2017, p. 16]
// Insight
Drug procurement procedure review, 2016—2017
In this country, the drug procurement system is continuously reformed and improved. Regulators driven by good intentions to cut prices of the drugs being purchased due to a growing competition devised a transparent e-bidding system. Based on Cursor Marketing data, PharmVestnik analysts assess to what extent legislative mechanisms have worked in this area as well as who purchases and sells drugs, and how purchasing and selling is arranged.
[PharmVestnik # 32, 10/10/2017, pp. 18-20]
// Pharma Retailing
Erkapharm boosted position in Volgograd in less than a year
Last year, Erkapharm Group made a strategic agreement with Volgograd supermarket chain MAN aimed at opening its pharmacies at each of 68 operating stores and all those to be launched. As of the end of this summer, 47 MAN stores were left, with plans for opening new stores nonexistent. PharmVestnik finds out how this will affect Erkapharm development strategy in Volgograd region.
[PharmVestnik # 32, 10/10/2017, p. 22]
// Pharma Retailing
Private entrepreneur acquired a pharmacy chain
Tyumen administration sold Panacea municipal pharmacy chain to a non-pharmaceutical private entrepreneur as none of core investors was interested in the deal.
[PharmVestnik # 32, 10/10/2017, p. 23]
// Monitoring – EAEU
Medrep activities and corrupt practice prevention in Belarus
Belarus uses medreps as a drug marketing channel. Sore issues of this scheme are corruption risks involved in relationships with health providers that are officials, and violation of special regulations applicable to medreps.
[PharmVestnik # 32, 10/10/2017, p. 23]
