// Regulatory & Legal
Russian MoH and Biocad rethink FAS’ role in determining drug interchangeability
In the end of August, an arbitration process will start in respect the Ministry of Health suit challenging FAS’ (Federal Antimonopoly Service) letters regarding interchangeability of drugs with different INNs. Since 2010, the FAS issued about 20 letters stating the agency’s opinion on specific drug interchangeability. As a rule, the interchangeability issue is raised by the market players. This case is of interest because Biocad first applied for recognizing its product’s equivalence, and then switched sides. The situation was short of reaching absurd lengths when the MoH intervened having decided to go into litigation with the FAS.
[PharmVestnik # 25, 15/08/2017, p. 1, cont’d p. 4]
// Regulatory & Legal
Interaction with regulators gets to a new level
The authorities and businesses are learning to read each other, which is largely related to a barrage of legislative initiatives. Drug marking, transformation of the “odd-man-out” regulation, another revision of the pricing procedure, EAEU common market, legalization of online drug selling, etc. are just a short list of topics discussed simultaneously. The legislation changes so swiftly that the core ministries and businesses have to work together to find a common language, notes Union of Professional Pharmaceutical Organization COO Liliya TITOVA.
[PharmVestnik # 25, 15/08/2017, p. 2]
// Regulatory & Legal
Russian Supreme Court believes that FAS is not entitled to determine drug interchangeability
Interchangeability decision-making has become part of the Russian Federal Antimonopoly Service’s (FAS) daily routine. Up to date, pharmaceutical manufacturers challenged various FAS’ actions in the court of arbitration with mixed results. Just one manufacturer has made its way to the Supreme Court that ruled that the FAS had gone beyond powers when determining interchangeability of two drugs.
[PharmVestnik # 25, 15/08/2017, p. 5]
// Sanctions
Pharma businesses do not believe in bans on drug imports from the USA
Russia’s tit-for-tat sanctions in respect of the USA is a topic that is not new, but discouraging. When certain mass media informed that drug imports from the USA might be banned, pharma companies operating in Russia declined to comment this information. The explanation is simple: businesses do not believe that the government may make a decision equivalent to shooting one’s own leg. They call speculations on putting drugs on the stop list a dirty information attack to destabilize the situation. However, spokespersons of certain companies note that the market has braced itself for the worst case scenario.
[PharmVestnik # 25, 15/08/2017, p. 6]
// In Detail
Patient associations funded by pharma companies not disclosing this fact
Increasingly often, pharma companies engage in social projects such as charitable actions and programs; naturally, they are eager to make the public aware of their efforts. But there is another side of pharma business social activities, i.e. support of patient associations. Thus, manufacturers try to market their drugs via this channel. Mutual benefits are evident: patients are interested in having access to the drugs they need, and pharma companies are interested in boosting sales of their products. However, talking to both parties revealed that mutual hopes did not come true.
[PharmVestnik # 25, 15/08/2017, p. 7]
// In Detail
Point-of-sale terminals to improve pharmacy performance
Despite the growing number of pharmacies, the demand for queue management systems remains low. Less than 10% of points-of-sales use electronic terminals for servicing their customers. IT solution developers think that the pharma industry may improve analytics and boost sales through extending point-of-sale terminal functions.
[PharmVestnik # 25, 15/08/2017, p. 8]
// Monitoring – EAEU
EAEU APM for extending transition periods of common drug market for at least two years
The EAEU Association of Pharmaceutical Manufacturers (APM) approached EAEC Minister for Technical Regulation Valery Koreshkov with a letter asking for support in decision-making on extending transition periods in respect of drug circulation within the EAEU. Based on PharmVestnik’s information, the Eurasian Union Economic Commission may evaluate the possibility of discussing this application within the framework of the workgroup meeting in mid-August.
[PharmVestnik # 25, 15/08/2017, p. 9]
// High-Tech MediCare
Russian MoH considers an opportunity of curing blind patients for free
In Russia, a retinal implant surgery was performed for the first time to improve the eyesight in a deaf-blind patient. The experiment was conducted under surveillance of the MoH already planning to include this method into the high-tech medical care scope.
[PharmVestnik # 25, 15/08/2017, p. 10]
// In Detail
Forthcoming hepatitis therapy supply bidding discussed in Moscow
Moscow Health Department plans purchasing 3,300 simeprevir packages to treat viral hepatitis in 1,100 patients entitled for beneficiary drug coverage. On August 2, the forthcoming bidding underwent a public discussion at the Bidding Exchange project’s site.
[PharmVestnik # 25, 15/08/2017, p. 11]
// Insight
Homeopathic drug market continues going down
Nearly six months have passed since approving the memorandum on pseudoscientific character of homeopathy. Its authors and adherers, when responding to accusations of being biased, keep pointing out that they have never aimed at banning homeopathy; they just wanted to “divorce” it with science. Anyway, such documents inevitably produce an effect on the market environment. According to QuintilesIMS, the homeopathic drug segment has demonstrated negative dynamics since the beginning of 2017.
[PharmVestnik # 25, 15/08/2017, p. 12]
// Regulatory & Legal
Orphan disease bill is deficient
In mid-July 2017, a federal bill “On amendments to the Federal Law ‘On fundamental healthcare principles in the Russian Federation’ with regard to treatment of rare (orphan) diseases” was submitted to the Russian Government. A basic novelty of this document is shifting drug procurement for six diseases on the List-24 to the federal level. Denis BELYAKOV, COO of Interregional Charitable Public Organization of the Disabled “Union of Rare Disease Patients and Patient Associations”, speaks on problems of working on the bill, and prospects of this work.
[PharmVestnik # 25, 15/08/2017, p. 14]
// Regulatory & Legal
FAS has its own methods to detect government procurement fix-ups
In late July, it transpired that the Russian Federal Antimonopoly Service (FAS) was inspecting Biocad and Pharmstandard to detect fix-up features in drug procurement bidding. Pharmstandard has already been fighting with the FAS before on this issue. Biocad, as far as public sources provide for conclusion, has been caught with fix-up allegations for the first time.
[PharmVestnik # 25, 15/08/2017, p. 15]
// Insight
Review of Russian pharma retail sector, H117
When a current year passes its equator, market players usually give a sigh of relief as they are past the “lean” quarters, and face an autumn and winter sales growth topped by lucrative December sales. There is more reason for optimism if the sales growth rate in the 1st half-year is higher than the year before. QuintilesIMS data will let us see if this is the case in 2017 as well as adjust the short-term outlook for the pharma retail sector.
[PharmVestnik # 25, 15/08/2017, pp. 18-19]
// Insight
Rating of Russian pharmacy chains, H117
According to RNC Pharma, consolidation among pharma chain retailers continues against the background of low growth rates in the out-of-pocket segment. Some deals result in emerging new industry leaders heading for top ranks; others provide for strengthening positions of certain players on local markets. Paradoxically, the fight for leaderships basically does not affect the market players that can be nicknamed the “back row”, and that have been one of major pharmaceutical retail drivers in Russia so far.
[PharmVestnik # 25, 15/08/2017, pp. 22-24]
// Insight
Veterinary medication and feed supplement imports to Russia
RNC Pharma analysts note that both from historic and financial perspectives, the veterinary medication market has been closely related to human pharma market. Suffice it to say that about 50% of large foreign vet med manufacturers lead human drug markets as well. Naturally, in 2015—2016 crisis period, both sectors experienced similar problems: the growing imported drug prices affected both the demand and import substitution processes. It is true that the vet med market was substantially affected by the tit-for-tat sanctions implemented by Russia against foreign agricultural manufacturers. They stimulated the development of local agriculture, and consequently the demand for veterinary products.
[PharmVestnik # 25, 15/08/2017, pp. 26-27]
// Manufacturing
Infusion solution manufacture to resume in Nalchik, Kabardino-Balkar Republic
Pharma International Co. Russia-CIS LLC facility in Nalchik is ready to resume operations after standing idle for nearly a year. The facility purchased new production equipment, received a GMP certificate, and agreed with the North Caucasus Development Corporation to implement a joint investment project on extending the existing infusion solution manufacture and setting up new drug manufacturing capacities. The production launch is scheduled for November 2017.
[PharmVestnik # 25, 15/08/2017, p. 29]
// Diagnostics
Russia allergy diagnostics market burgeoning
None of doctors, even the most advanced professionals, will risk making a diagnosis without lab diagnostics. Adequate treatment depends not only on doctors’ training level but also on quality of diagnostic devices and methods, especially if allergy with its multiple causative agents is the case.
[PharmVestnik # 25, 15/08/2017, p. 29]
