Spy bridge
Professional associations to play foreign agents
[PharmVestnik # 13, 12/04/2016, p. 1, cont’d p. 3]
Hostages of interchangeability
Professional community believes that sticking point of interchangeability shall not act as a brake on EEU common market launch
The Federal Antimonopoly Service (FAS) activity in promoting the term “interchangeability” into the regulatory environment of the Russia Federation has borne first fruit. It is this term that has become the stumbling block in the process of reviewing the documents on the EEU common market. None of the EEU member states agree with Russia’s arguments. The professional community has split into two parties in forecasting whose side was going to win. In the end of March, at a relevant conference, it was for the first time proposed to remove this term from the national legislation as the FAS do not have any authority to establish interchangeability. In its turn, the antimonopoly agency is ready to press its point and keep ground.
[PharmVestnik # 13, 12/04/2016, p. 2]
Doing a disservice
Russian pharmaceutical manufacturers treat FAS’ initiatives with reserve
The beginning of 2016 has given rise to a lot of regulatory initiatives in the pharmaceutical industry – from the EEU common market currently pending resolution to the draft law permitting drug sales at supermarkets. Therefore, the roundtable discussion on healthcare innovations within the framework of the InfoSpace innovative technology forum focused mainly on regulatory novelties. It turned out that not all of the regulatory initiatives were indisputable.
[PharmVestnik # 13, 12/04/2016, p. 4]
Minpromtorg overdid looking for Pharm-Sintez’ violations
On April 4, pursuant to court judgment, JSC Pharm-Sintez voluntarily paid a 100,000 RUB worth penalty for violating the license legislation. It was the Ministry of Industry and Trade (Minpromtorg) that brought a case against the company to Moscow Arbitration court. In fact, it was for the first time that the ministry filed a lawsuit against a large pharmaceutical company since it started licensing drug manufacture. However, the court proceedings revealed that the inspecting party has somewhat overdone when they found the alleged violations where there were none.
[PharmVestnik # 13, 12/04/2016, p. 5]
He who pays makes decisions, too
Experts lack clear vision of drug insurance mechanism
On March 31, the participants of a regular meeting of the Russian Association of Pharmaceutical Marketing tried to answer the question whether a drug insurance system was mandatory. The dispute between analysts, developers of the pilot drug reimbursement program as well as spokespersons for the Ministry of Health (MoH), insurers, and pharma industry was quite violent. The answer to the main question of the meeting was clear-cut: the reimbursement program will be implemented as this initiative is being monitored by the top government, and the MoH is waiting for reasoned proposals from experts.
[PharmVestnik # 13, 12/04/2016, pp. 6-7]
Do not make partners be like yourself
Tom Finn on JVs and Russian pharma market
In mid-March, President of Global Health Care at Procter & Gamble Tom FINN was one of the participants of the Speakers’ Night at Skolkovo Innovation Center. This format provides for regular meetings with standout and the most successful persons engaged in business, arts, politics, and sports. Proceeding from the example of the P&G and Teva JV deal, Mr. Finn shared his experience of setting up efficient joint ventures and confessed that he liked the Russian market and thought JVs to be the most promising form of partnership despite the volatile regulatory environment in Russia.
[PharmVestnik # 13, 12/04/2016, p. 8]
BIOCAD litigates drug set registration practices
In early April, court proceedings were held in respect of BIOCAD’s suit against the MoH. The company tried to challenge the issuance of a marketing authorization for Beyodime consisting of two different INNs, i.e. pertuzumab and trastuzumab. According to BIOCAD spokespersons, the practice of drug set registration may result in restriction of competition.
[PharmVestnik # 13, 12/04/2016, p. 9]
Pharma industry proved to be more fit for operating on EEU common market than regulators
Three months have already passed since the official launch of the EEU common pharmaceutical market. However, this launch has been executed just on paper. There are still heated debates over the package of documents without which the market launch may not be considered a fact. Some experts are sure that the draft documents prepared on time and approved by the Eurasian Economic Commission mostly generate doubts in agencies that have no responsibility over drug circulation in Russia.
[PharmVestnik # 13, 12/04/2016, p. 10]
We’ve lost Ebola
ACTO failed to find an original state registry entry on clinical trials of Ebola vaccines
The Association of Clinical Trials Organizations (ACTO) summed up the 2015 results by publishing a traditional information and analytical bulletin. The last section of this document is devoted to analysis of clinical trials of Ebola vaccines developed in Russia. Proceeding from the state registry that publishes clinical trial permits, the experts have failed to find any evidence that the vaccines have passed all trials required. The registry entry regarding these trials miraculously appeared, disappeared, and reappeared again.
[PharmVestnik # 13, 12/04/2016, p. 11]
Full-fledged exclusivity of drug master file data still nonexistent in Russia
The new version of the law “On drug circulation” is applicable since January 1, 2016. Among other things, the amendments touched upon the data exclusivity. Before that, the Russian legislation lacked an efficient data exclusivity protection mechanism, or, to be more precise, the right of the developer of the originator drug (now – reference drug) to the nonclinical and clinical trial results. Are such mechanisms in place following the law amendments?
[PharmVestnik # 13, 12/04/2016, p. 14]
Zero-risk investment
Report on advertising activities of pharmaceutical companies, 2015
For pharma companies, advertising remains an efficient tool for promoting their products. Pharmaceutical advertising investments in all media channels increased by 8.5% year-on-year. However, while the pharmaceutical advertising growth trend still prevailed, a growth rate reduction over the past year was observed.
[PharmVestnik # 13, 12/04/2016, pp. 16-17]
Peeping into the state pocket
Report on state bidding sector (according to CURSOR agency)
Over the past few years, budgetary expenditures account for about one third of the drug market value as a whole. In the Rx segment, the state bidding budgets account for more than 50% overall. The state bidding sector is a fancy mix of both commercial and political interests of companies manufacturing and selling pharmaceuticals. That is why it is especially interesting to analyze the economically turbulent year 2015 through the prism of the state bidding.
[PharmVestnik # 13, 12/04/2016, pp. 18-19]
Draft law on e-pharmacies fails to embrace all aspects of distance selling
In 2015, the amendments to the Federal law # 61 (FZ-61) “On drug circulation” came in force that empowered federal authorities with pre-court closedown of websites selling pharmaceuticals without proper permits. Currently, an inter-agency review is underway of the draft law “On amendments to specific statutes of the Russian Federation regarding distance retail sales of pharmaceuticals”.
[PharmVestnik # 13, 12/04/2016, p. 20]
