Businesses and government attempt at reaching an agreement on health investment terms
[PharmVestnik # 02, 24/01/2017, p. 1, cont’d p. 4]
Drug storage and transportation regulations approved
A relevant order will become effective in early spring. Market players believe that this is another step to increasing the pharma logistics quality. The only problem is the implementation of this brilliant idea. Experts are not sure that the regulators will have the cadre and capacities sufficient for auditing all storage sites and vehicles.
[PharmVestnik # 02, 24/01/2017, p. 2]
Tobacco addiction drugs may be VED listed
The new antismoking concept developed by the Russian Ministry of Health provides for medical aid to tobacco addicts. Experts have reasons to believe that the ministry is serious about including tobacco addiction drugs into the VED list, and the relevant medical aid – in the mandatory health insurance scope.
[PharmVestnik # 02, 24/01/2017, p. 3]
Russia to implement novel drug coverage ideas
Up to this point, the drug coverage market development has not been too fast in Russia. Just a few projects were proposed over the past years, e.g. Essential Drug Coverage (ONLS) and Seven Diseases subprograms. Meantime, the setting has changed dramatically. On the one hand, funding is limited due to the economic crisis; on the other hand, many new expensive drugs and medical technologies have emerged. Russia does not intend to keep out of what the progressive countries are doing, and is willing to take one of the most advanced drug coverage techniques on board.
[PharmVestnik # 02, 24/01/2017, p. 5]
From July 1st, pharmacies must use new point-of-sale terminals
The period of voluntary transfer to using new POS terminals reporting all payment data directly to tax agencies will be over on July 1st, 2017. From that moment on, this procedure will be mandatory for all cash register owners. According to Russia’s Federal Tax Service preliminary data as at December 29th, 2016, about 7,500 cash registers were updated for operating under the new procedure. Large food chains were mainly among the volunteers. Pharma businesses that are to go online shortly, too, are not in a hurry to substitute their cash registers so far but assert that they will be able to do that on time. Businesses do not understand how the drug marking system to be pilot tested starting from March will be implemented in the new POS terminal software.
[PharmVestnik # 02, 24/01/2017, p. 6]
Distinctive marks to be used at pharmacies’ own disposal
The Good Pharmacy Practice regulations will become effective on March 1st pursuant to the MoH order. Over the development period, the pharmacy community proposed their initiatives, however not all of them found their way to the final document. E.g. using a green cross to distinguish a pharmacy is not mandatory.
[PharmVestnik # 02, 24/01/2017, p. 7]
State Duma to fight fiercely over telehealth draft law
Telehealth has all chances to evolve as a top priority topic this year. Experts criticized the first version of the draft law on telehealth for vagueness. The finalized version that has provided for much wider opportunities both for physicians and patients has received positive opinion of the Ministry of Economic Development and has been supported by the Presidential Expert Council. Now it is time to convince the State Duma deputies to approve this law as is.
[PharmVestnik # 02, 24/01/2017, p. 8]
A tissue breakthrough
Law on biomedical tissue products has come in force
Cell therapy has been legalized in Russia since January 1st. Some experts believe that it has a huge potential, and that its importance is comparable to that of antibiotics discovery. However, sceptics warn that legislative and regulatory drawbacks may slow down the development of local regeneration technologies, and that foreign Big Pharma companies already involved in R&D in this field may occupy this promising niche.
[PharmVestnik # 02, 24/01/2017, p. 10]
Pharmacy chain owners not scared by new penalties
Penalties for dispensing Rx drugs without prescription have increased manifold since the beginning of the year after the relevant amendments to the Administrative Offense Code came in force in January. Now a pharmacist may be penalized for violating the retail drug sales regulations in the amount of 5—10 thsd RUB (previously 1.5—3 thsd RUB), executive — 20—30 thsd RUB (previously 5—10 thsd RUB), and legal entity — 100—150 thsd RUB (previously 20—30 thsd RUB); or the pharmacy operations may be suspended for up to 90 days.
[PharmVestnik # 02, 24/01/2017, p. 11]
Federal Antimonopoly Service proposes price cuts for 95 drugs
On January 17th, the Russian Federal Antimonopoly Service (FAS) published a report on the results of the second stage of the international drug price benchmarking. HIV, hepatitis B&C, antibacterial, and TB drug prices were benchmarked. Based on the benchmarking findings, the FAS proposed a seven-item list of actions including new pricing constraints. Some pharma market players are alarmed by those, others note that not every alarm signal becomes a guideline.
[PharmVestnik # 02, 24/01/2017, p. 12]
Legislators to return an arbitration clause to government contracts
Three components, i.e. financial, managerial, and legal, provide for company’s performance. Finance department is responsible for cash flow. The management provides for continuous staff operation to execute deals. Lawyers must provide for contract legality and correctness to have all debts repaid or losses compensated in case of obligations violation.
[PharmVestnik # 02, 24/01/2017, p. 14]
Are generics really cheap?
Price dynamics against generic share growth in various ATC groups (out-of-pocket segment), Q316
The out-of-pocket drug sales in Russia in Q316 totaled nearly 200 bn RUB (5,200 thsd trade names, 2,421 INNs). These figures represent a sales growth in value terms against the background of insignificant decrease in the number of trade marks sold year-on-year. As the share of generics increased from 76.7% to 77,1%, and the share of local drugs in the total number of pharmaceutical trade names selling on the market grew from 38.8% to 40.1%, we may conclude that originator drugs are gradually being substituted by generics, and imported drugs – by local products.
[PharmVestnik # 02, 24/01/2017, p. 15]
Autumn flu
Flu and ARVI drug sales dynamics in Russian out-of-pocket segment, autumn 2016 vs autumn 2015
Analysis of flu and ARVI drugs availability at pharmacies over the three autumn months gives a clue whether patients need to worry about the appropriate pharmacy stocks.
[PharmVestnik # 02, 24/01/2017, pp. 16-17]
Import substitution without cost-saving
Many physicians not satisfied with local generics quality
Sverdlovsk regional MoH is concerned about drug supply failures and low quality of the import substitution products. This was reported by a MoH official responsible for the drug coverage of the region. His opponents assert that there is nothing to worry about.
[PharmVestnik # 02, 24/01/2017, p. 19]
Prix Galien Russia awarded to two American and three Russian scientists
The Prix Galien was created in France in 1970 by a pharmacist named Roland Mehl. Its aim was to promote significant advances in pharmaceutical research. The international judges include well-known researchers, toxicologists, and pharmacologists. Since that time, this prize has been awarded as a recognition of scientific advances, breakthrough drugs, and treatment methods. This award is like the Nobel Prize in biopharmaceutical research. The Prix Galien Russia was awarded for the first time in Moscow in 2013.
[PharmVestnik # 02, 24/01/2017, p. 19]
