FAS to consider submission on 36.6 & A5 deal
In mid-December, the Russian Federal Antimonopoly Service (FAS) approved a submission by Concern Rossium Ltd, parent company of CJSC Moscow Credit Bank. The FAS website does not specify the assets the concern is planning to acquire, but reportedly it goes about an acquisition of legal entities that are part of A5 Group. According to market experts, A.v.e Group is to manage Rossium’s new asset. Stockholders of 36.6 and A5 pharmacy chains keep sticking to “no comment” policy. If the deal is closed, A.v.e Group will lead a pharmacy giant able to dictate terms both to distributors and manufacturers. No wonder that 36.6 has already declared about cancellation of a contract with CV Protek distributor, allegedly due to an increase of the manufacturers direct supply share. Protek itself called the cancellation of contractual obligations with the pharmacy chain a formality. The distributor stated that shipments for 36.6 had been basically nil because of increased nonpayment risks.
[PharmVestnik # 42, 22/12/2015, p. 1, cont'd p. 3]
Everybody to be inspected
In early December, the Cabinet of Ministers approved the Regulations for the organization and execution of drug manufacturer inspection for GMP compliance as well as the rules of issuing the appropriate expert findings. Experts differ substantially in their attitude to this document. Some are quite loyal and are willing to become familiar with the law enforcement practice, while others make statements on the necessity to reconceptualize the GMP inspection philosophy. The inspection regulations will become effective on January 1, 2016; however, reportedly, the State Duma considers a possibility for foreign manufacturers to be submitting certificates issued by a non-Russian inspectorate for a year following the drug registration in Russia.
[PharmVestnik # 42, 22/12/2015, p. 2]
Russian breakthrough
Local pharmaceutical manufacturers to introduce a breakthrough drug concept
The Russian public associations are willing to upgrade the national legislation governing drug circulation and purchases. The Russian Union of Industrialists and Entrepreneurs and All-Russia Business Association "Delovaya Rossiya" (Business Russia) prepared a package of amendments to the respective laws. One of the amendments concerns innovative drugs being developed in Russia.
[PharmVestnik # 42, 22/12/2015, p. 4]
It is not necessarily the case that counterfeits may be overcome
The Russian economy is drowning in the counterfeit and fake product flow. It is presently admitted by all, including the state leaders who declared counterfeits and fakes to be a most serious threat for the national security. The problem embraces a variety of industries, including Pharma. One cannot but wonder that, according to official data, the situation in the Pharma market is more than optimistic.
[PharmVestnik # 42, 22/12/2015, p. 5]
Three paths
The National Center for Informatization and the Internet Initiative Development Foundation are to start selection and preparation of most promising IT startups for a specialized medical accelerator. Company representatives made statements regarding this project at the Smart Health conference held in mid-December. Preference will be given to the development of mobile patient monitoring gadgets, software for the recognition and analysis of medical images as well as medical services facilitating document management.
[PharmVestnik # 42, 22/12/2015, p. 5]
There are a lot of things we can and are obliged to change
At the end of October, Naira ADAMYAN was appointed Sanofi Group CEO for Eurasia. Prior to that appointment, Ms. Adamyan held the position of Managing Director – Russia and CIS with Janssen (Johnson & Johnson). Within the “Editorial Fireplace” rubric, Naira Adamyan offered her opinion regarding the changes underway in the Pharma market and related whether or not the corporate strategy was going to change after the new leader took the office.
[PharmVestnik # 42, 22/12/2015, p. 6]
The right to withhold part of the truth
The Russian Federal Antimonopoly Service raised the issue of the necessity to provide the information on all contraindications known in respect of the API in the drug label. This move was triggered off by the situation when the Acellbia (biosimilar by BIOCAD) package insert included not all of the contraindications specified in the Mabthera (originator drug by F. Hoffmann — La Roche) label. The Russian company explained that the reason for such difference was the originator’s patent for one of the routes of administration for rituximab. Such patents have earlier become an antimonopoly service’s target.
[PharmVestnik # 42, 22/12/2015, p. 8]
Consolidation without conglomeration
Consolidation of pharmacy chains continues, but there are very few powerful conglomerates
While the economic crisis has virtually put a brake on M&A deals in the manufacturing and distribution sectors of the Russian Pharma market, consolidation has grown in the retail sector. It is easier to survive together in conditions of a consumer demand decrease. However, consolidation in itself does not always provide for advantages. ASNA pharmacy chain uniting 1,500 pharmacies tried to find answers to challenging questions.
[PharmVestnik # 42, 22/12/2015, p. 12]
Sticking point
In a dispute over Nescler, a Russian generic of Gilenya by Novartis, the scales of justice have had a swing to the local manufacturer’s side again. On December 15, Biointegrator’s stand was supported by the intellectual property rights court. Having basically no doubt that the opponent intends to continue struggling at the court of last resort, Biointegrator plans to launch Nescler to the EEU market at the beginning of 2016.
[PharmVestnik # 42, 22/12/2015, p. 13]
When somebody wouldn’t listen, we try to speak louder
December traditionally sees a burst of regulatory activity. Signing and approving the documents destined to significantly change the Russian Pharma landscape is in full swing. Without doubt, the professional community has always taken a most active part in the development of basic regulatory documents. It is possible to judge about how strong the professionals’ voice is by the amendments made to the documents. COO of the Association of International Pharmaceutical Manufacturers Vladimir SHIPKOV told PharmVestnik about the role that business had to play in lawmaking and the issues the professional community would be off fighting for next year.
[PharmVestnik # 42, 22/12/2015, p. 14]
Only 30% of drugs to be procured under special investment contracts
In his Address to the Federal Assembly, President Vladimir Putin specified preferences under special investment contracts. A pharmaceutical company that has organized drug manufacturing under such contracts will be able to sell to the state up to 30% of its packaged products. The industry representatives believe that this is enough, but there are pitfalls.
[PharmVestnik # 42, 22/12/2015, p. 16]
To insure the President
Budgetary expenditures for medical services for state officials to be included in Healthcare development program
Year-on-year, healthcare funding from the federal budget is decreasing. As envisioned by the authorities, all money for the state-funded medicine shall be accumulated in the same “purse”, i.e. under the Federal Compulsory Medical Insurance Fund’s budget. However, this looks like a long way to go. So far, the officials have failed to accumulate the health expenditures as a single whole even under the federal budget. It goes about providing medical services to individual federal agencies.
[PharmVestnik # 42, 22/12/2015, p. 16]
Arbidol’s case
What are the drug new clinical trials indicative of?
Arbidol’s fame has brought to its manufacturer (first Pharmstandard, then OTCPharm) not only billions of rubles but also a lot of criticism. The key charge boiled down to the absence of the evidence base supporting the drug clinical efficacy as well as noncompliance of the previous studies with the up-to-date international requirements and standards. After the results of the ARBITR postmarketing study were published, some attackers have changed the tone of what they were saying. However, this has not altered the situation so far. And this is already not a history of an individual drug, but an evidence of misbalance built up in the industry.
[PharmVestnik # 42, 22/12/2015, p. 17]
Officials would better listen to industry associations
In October, Igor BODYAGIN took the office as Deputy COO of the Union of Professional Pharmaceutical Organizations. Mr. Bodyagin is quite well-known among the regulators and businesses. He has a vast experience of working in the pricing field as a state official. Now he draws from this experience while representing manufacturer and distributor interests. Igor Bodyagin is sure that switching to new pricing models will only make sense if implemented concurrently with a drug reimbursement program reform. Together with that, the expert calls on the regulators to pay more attention to proposals generated within professional associations.
[PharmVestnik # 42, 22/12/2015, p. 20]
Glimpse of market
[PharmVestnik # 42, 22/12/2015, p. 25]
Under federals’ pressure
Rating of Russian pharmacy chains, Q1-315
Conventional “diarchy” that has formed in the rating based on the results of the first three quarters of 2015, is most likely to become nonexistent after the reported period. The rating of pharmacy chains is to end the year 2015 with a single leader. Judging by the rumors on a potential deal in the top ranks, this leader with take a firm stand ranking first.
[PharmVestnik # 42, 22/12/2015, pp. 28-29]
Health funding in 2016: what’s in store?
Laws approving the federal budget and Federal Compulsory Medical Insurance Fund’s budget for 2016 have been signed. Laws on regional budgets for the Russian federal subjects are being approved one after the other. A draft state guarantee program is at the final approval stage. What changes are in store for the Russian healthcare in terms of funding next year?
[PharmVestnik # 42, 22/12/2015, pp. 30-31]
Fighting over clients
Report on Pharma companies promo activity, consumer and doctor behavior
The current economic situation is accompanied by cuts in the population’s earnings and retail turnover reduction. However, according to GfK Omnibus regular opinion poll, drugs and medical services are among those commodities and services the Russians are not ready to refuse from (together with food and other FMCG, mobile communications etc.). Nonetheless, the crisis may force people to change their consumer strategies and consequently promotion strategies. How does consumer behavior change? What changes occur in Pharma company strategies of working with doctors and pharmacists as well as in professionals’ recommendations to patients and consumers?
[PharmVestnik # 42, 22/12/2015, pp. 32-33]
Ranking third in mortality
Antithrombotic drugs to be manufactured in Siberia from 2018
St. Petersburg Research Institute of Vaccines and Sera under the Russian Federal Medical and Biological Agency plans to set up a full-cycle manufacturing facility in Tomsk region. In three years, in it to start manufacturing heparin API and antithrombotic drugs. Annually in Russia, more people die of venous thromboembolism than of AIDS, breast cancer, prostate cancer, and car accidents combined.
[PharmVestnik # 42, 22/12/2015, p. 39]
