Two sides of meldonium
Mildronate sales grew manyfold after doping scandal involving Russian athletes
[PharmVestnik # 10, 22/03/2016, p. 1, cont’d p. 4]
Syndicated antibiotics
FAS uncovered a cartel
The Russian Federal Antimonopoly Services (FAS) suspects three pharmaceutical distributors, i.e. Jodas Expoim, FC Farmakoppola, and Saticom, of price-fixing actions. In the FAS’ opinion, concerted actions by the companies helped them win 208 antibiotics supply biddings to the sum total exceeding 200 mn RUB. Currently, the antimonopoly agency is additionally inspecting about 1000 biddings in 50 Federal subjects. The officials at the FAS Anti-Cartel Department are sure that cartels present a serious threat for the Russian healthcare.
[PharmVestnik # 10, 22/03/2016, p. 2]
Minpromtorg secured minimum fine for Pharm-Sintez
On March 16, Moscow Arbitration Court continued proceedings regarding the Ministry’s of Industry and Trade (Minpromtorg) lawsuit against JSC Pharm-Sintez. According to the ministry, the company has violated the license requirements in respect of the manufacturing technology, document management, and sanitary regulations. The company partially agreed with the ministry’s claims and emphasized that the violations were discovered in the contract manufacturing site owned by Deko LLC and that part of these violations had been corrected. However, they insist at Pharm-Sintez that there have been no technological procedure violations and that the ministry officials demand the impossible. The court has satisfied the lawsuit, but the rationale is unknown so far.
[PharmVestnik # 10, 22/03/2016, p. 3]
Federal Tax Service opposes unfounded business splits
The Federal Tax Service has drawn the attention of the relevant territorial bodies to the inadmissibility of artificial splitting of business in order to receive additional tax exemptions. This follows from the letter that the tax agency distributed among its regional inspectorates. This letter describes in detail the formal split criteria.
[PharmVestnik # 10, 22/03/2016, p. 5]
Agencies explain how the “odd-man-out” regulation will be applied
The story centered on the government “odd-man-out” regulation has nearly come to its end. The Ministry of Economic Development, Minpromtorg, MoH, and FAS clarified their joint position thus having ended the chaos created when the new document designed for supporting local manufacturers proved to be biased in favor of foreign manufacturers. The officials’ approach to interpretation of this regulation is already clear for the experts as the FAS officials have earlier offered their explanations. However the letter expressing the regulators’ joint position is much more important for the Pharma industry. Notwithstanding the above, businesses are waiting for new comments as there are still some questions regarding how the new regulation is going to help the Russian Pharma.
[PharmVestnik # 10, 22/03/2016, p. 6]
API manufacturers to see no preferences in receiving GMP certificates
An understanding of the fact that the Russian GMP compliance audits are mandatory not only for foreign drug manufacturers but also for API producers has not come at once. However, when the businesses remembered that starting from 2016, mandatory GMP compliance audits were required for API vendors and that the vast majority of raw materials originated from the countries with mild control and permission systems, it was immediately supposed that a certain transition period would be introduced for such enterprises. There are fears that the Russian GMP Inspectorate will be shocked to see how things are going at specific Chinese and Indian API manufacturing facilities. Minpromtorg has made it clear that no transition periods or temporary easing of the requirements for foreign API manufacturers was provided for.
[PharmVestnik # 10, 22/03/2016, p. 7]
MoH asks for 2 bn RUB to launch a reimbursement pilot project
In the course of her task meeting with President Vladimir Putin, Russia’s Health Minister Veronica Skvortsova proposed to allocate about 2 bn RUB in the Mandatory Medical Insurance budget for the next year to be spent for reimbursing 50% of the drug costs for the stent angioplasty patients. The president had no objections on the whole, but he recommended speeding up the preparation of the documents as the 2017 budget formulation was about to start. However, it presently goes only about a local pilot project that will most likely embrace a limited number of patients. Launches of large-scale pharmaceutical insurance coverage projects that have been discussed by the MoH for a number of years are rather than not to be postponed again. According to experts, the reason is obvious: everybody knows that it is high time to change the drug coverage model, however, there is no ideal scheme of doing that technically.
[PharmVestnik # 10, 22/03/2016, p. 8]
Low-interest loans to be retargeted at smaller enterprises
In 2016, the government continues implementing large-scale measures for supporting the domestic industry. The allocations to this end are basically not being cut. This year, the Industry Development Fund is increasing its capital by 20 bn RUB. However, the loan issue conditions have changed.
[PharmVestnik # 10, 22/03/2016, p. 9]
Russian physicians to study European homeopathic experience
In Russia, homeopathy dates back to the 19th century; however, there are still a lot of unclear things related to homeopathic approach even for experienced physicians and pharmacists. Recently, Boiron was approached by a group of Russian pediatricians, ENT specialists, and clinical pharmacologists. In order to fill in the gap in knowledge and study foreign experience, they came forward with an initiative to invite the founders of the European School of Clinical Homeopathy to Russia. This way, an idea was conceived of organizing a round table to discuss rational application of homeopathy in routine medical practice.
[PharmVestnik # 10, 22/03/2016, p. 11]
Retaining the customer
Rating of pharmacy chains, 2015
When publishing the results of a traditional annual rating of the Russian pharmacy chains prepared by IMS Health, PharmVestnik decided to abandon the standard approach of describing the results and trends and provided a possibility for the rating participants themselves to comment on the situation in the sector by answering the questions prepared by the analysts.
[PharmVestnik # 10, 22/03/2016, pp. 12-14]
MIPT Biopharmaceutical building as an innovation object
In 2015, the construction of the Biopharmaceutical building, which is a new living systems research complex, was completed on the campus of Moscow Institute of Physics and Technology (MIPT) in the town of Dolgoprudny. This building is the first innovation infrastructure object put in operation within the framework of the Federal Targeted Program Pharma-2020.
[PharmVestnik # 10, 22/03/2016, p. 15]
Experts differ in their appraisal of Pharma investment environment
Today, businesses do not so much invest in the regional development as they use up the leftover assets of the Soviet period. The work on improvement of the investment environment is getting to a new level. In late February, the Agency for Strategic Initiatives hosted a meeting that involved participation of vice-governors of the Federal subjects. The results of the National Rating of the Investment Environment will be made public at St. Petersburg International Economic Forum in June 2016.
[PharmVestnik # 10, 22/03/2016, p. 18]
Ministry of Education and Science explained court judgment in respect of BIOCAD vs. Genentech case
The question of including patented treatment modalities in patient information leaflets for the drug use has for a long time excited patent specialists working in the pharmaceutical area. A controversial answer to this question was provided by the court judgment on the high-profile rituximab dispute between BIOCAD and Genentech. For explanations on the court decision, specialists turned to the Ministry of Education and Science responsible for the government intellectual property policy.
[PharmVestnik # 10, 22/03/2016, p. 24]
