Labeled packaging
A document on implementing drug labeling under development
In late October, the Federal Service for Surveillance in Healthcare and Social Development (Roszdavnadzor) informed the professional community about the development of the concept of a Federal state information system for monitoring drug flow from manufacturer to customer using labeling. Probably because this document is unfinished yet, the agency did not find it expedient to familiarize market players with its text, but promised to present it for public discussion in near future. Meantime, some experts have managed not only to review the concept developed under the auspices of the MoH but also make a conclusion on who was the real author of this draft document. It also became known to PharmVestnik that in the end of September, First Deputy Prime Minister Igor Shuvalov took care of the drug labeling issue. He issued an order to explore the issue for the Ministry of Economic Development, Ministry of Industry and Trade, and Ministry of Agriculture. PharmVestnik has failed to receive any explanation from Roszdavnadzor on whether the agency’s activities were related to Mr. Shuvalov’s initiatives.
[PharmVestnik # 36, 10/11/2015, p. 1, cont’d p. 2]
On “inoculating” localization
Natsimbio is skeptical about some foreign technology transfer projects
The National Immunobiological Company (Natsimbio) that from the very moment of emergence has been the center of talks about the state monopoly in the vaccine market continues introducing Pharma companies to the new game rules. The unitary vaccine supplier was very tough and unambiguous when stating its strategy, namely: the companies willing to continue operating in the Russian market must resolve the issue of launching a full-cycle manufacturing of their own in Russia’s territory. In late October, Natsimbio held more than 20 meetings and negotiations with pharmaceutical manufacturers on this topic. Until specific agreements are signed, the company intends to withhold from disclosing the names of the markets players who have made their way to Natsimbio’s pool. However, it is known that the focus was on API manufacturers.
[PharmVestnik # 36, 10/11/2015, p. 3]
Health technology assessment system to be formed under MoH
The development of a new system, i.e. health technology assessment (HTA), is underway in Russia. At stage 1, it will provide for assessment of drugs being included into various lists as well as those participating in the state bidding processes. Specifically to this end, the MoH is reshaping FSBI “Center for Assessment and Control of Quality of Medical Products”. The center has ambitious plans, in particular, to review the registered drugs. These plans are likely to be implemented as the idea on setting up an HTA system is being promoted by the Federation Council and FC’s Chairwoman Valentina Matvienko in person.
[PharmVestnik # 36, 10/11/2015, p. 1, cont’d p. 4]
Similar, but…
Pharma sector sizes up interchangeability regulation
Since July 2015, drug master dossiers must include assessment findings on the drug interchangeability. Despite this, the regulation on interchangeability determination procedure was signed only on October 28, 2015. However, pharmaceutical manufacturers cannot start collecting the relevant documents yet as this resolution leaves too many “but’s”.
[PharmVestnik # 36, 10/11/2015, p. 5]
Drugs to become interchangeable
The Russian government approved a procedure for determining interchangeability of human drugs. A relevant resolution was signed by Premier Dmitry Medvedev. Some market players do not recognize this document as the long-awaited resolution on drug interchangeability and consider it to be another framework paper. But the Federal Antimonopoly Service asserts that there will be no other interchangeability regulations in near future.
[PharmVestnik # 36, 10/11/2015, p. 5]
Thinking globally
BRICS countries plan to end AIDS and TB epidemics within 15 years
The representatives of the health ministries of the BRICS countries signed a declaration on joint efforts for the implementation of the sustainable development program until 2030. The 5th meeting of the health ministers of the BRICS countries was held in Moscow on October 30. The global objective set by these countries is putting an end to poverty, AIDS and TB epidemics, and reducing to minimum maternal and infantile mortality rates within the next 15 years.
[PharmVestnik # 36, 10/11/2015, p. 6]
Monopolists willy-nilly
MoH perseveres in attempts to create an ideal pharmacy chain
Russia’s MoH head Veronica Skvortsova, when speaking at the government meeting on the development of competition in healthcare, could not but mention the pharmacy market monopolization issue. At the same time, it was unclear against whom or what she urged to fight Premier Dmitry Medvedev as well as the Federal Antimonopoly Service.
[PharmVestnik # 36, 10/11/2015, p. 7]
Things nobody will speak about
Experts discussed the issues of interaction between manufacturers and pharmacy chains
A regular meeting of the Russian Association of Pharmaceutical Marketing on October 29 was devoted to collaboration of pharmaceutical retailers and manufacturers. The participants discussed the methods pharmacies use to cheat manufactures while formally performing under marketing agreements and tried to answer the question on what needs to be done in order to turn collaboration of these two parties into an effective tool for boosting sales. As all other meetings involving pharmaceutical retailers, this meeting was characterized by emotional dialogues and violent disputes.
[PharmVestnik # 36, 10/11/2015, pp. 10-11]
Playing according to new rules
GDP regulations for EEU market to be approved through the end of 2015
Common GDP (Good Distribution Practice) regulations will come in force in the EEU territory in 2017. The developers believe that the documents currently being reviewed by the Eurasian Commission will be approved through the end of this year. The primary objective of these regulations is to assure the drug quality at the acceptance, storage, and transportation stages, which means that the market needs to get rid of the distributors that cannot fulfill this requirement. Analysts say that the market concentration may increase after GDP standards are implemented.
[PharmVestnik # 36, 10/11/2015, p. 1, cont’d p. 12]
Crisis vs SIA
The largest distributor strives for resolving debt issues
In September and October 2015, seven actions for recovery of debts to a total sum of about 1 bn RUB were initiated against CJCS SIA International. Some market players believe that the distributor may shortly become a bankrupt if the situation keeps developing at the same pace. However, the company’s lawyers are not sitting around idly either: over the same period, they initiated similar actions against pharmacies to a sum total exceeding 560 mn RUB.
[PharmVestnik # 36, 10/11/2015, p. 15]
Health gadgets
Tonometer and blood glucose meter market report, MAT August 2015
Modern pharmacies boast a wide range of pharmaceuticals and parapharmaceuticals. Diagnostic devices rank third in the parapharmaceutical category in terms of sales after dietary supplements and cosmetics. This segment includes both traditional devices (such as thermometers and tonometers) and highly specific gadgets (e.g., blood glucose meters).
[PharmVestnik # 36, 10/11/2015, pp. 16-17]
Innovations beyond the law
Experts discussed standardization issues applicable to medicine and Pharma
In mid-October, Moscow hosted the conference “Prospects of Funding Science and Innovations in Current Economic Conditions”. The main idea underlying this conference was the need for a mechanism to promote scientific development to be implemented in industry. However, there is no common opinion on how such mechanism shall be implemented in the Pharma industry.
[PharmVestnik # 36, 10/11/2015, p. 18]
