// Pharma Retailing
A regional conference discusses violations of pharmacy regulations
According to SoyuzPharma Pharmacy Association, about 11,000 independent pharmacies and 2,000 small pharmacy chains (each uniting up to 9 pharmacies) operate in the Russian market, all together claiming about 30% of the pharmaceutical retail sector. Speaking at the recent regional conference “Pharmacy Today: New Standards and Regulatory Enforcement”, SoyuzPharma Executive Dmitry Tselousov mentioned a growing market consolidation along with toughening competition. However, the main topic of the conference was control of compliance with the Good Pharmacy Practice regulations that came into force this year, and triggered an enormous controversy in the professional community.
[PharmVestnik # 42, 19/12/2017, p. 1, cont’d p. 6]
// Health Strategies
MoH outlined top public health priorities
Experts assert that preventive measures account for 60% of overall success in decreasing non-infectious disease mortality rates, and that just 30% of success depends on drug treatment. Not that disease prevention lags in Russia, but it is obviously not in a good shape, either. Therefore, the Ministry of Health has set the formation of a healthy lifestyle and value-oriented healthcare as top priorities. A health strategy has already been drafted; it is likely to be finalized through the end of 2017, and to be presented next year.
[PharmVestnik # 42, 19/12/2017, p. 2]
// Regulatory & Legal
Improper filing of medical devices may end up in court
Inaccuracies in the medical device filing process or untimely changes to a Product Master File may result in finding the marketing authorization invalid, and the product itself counterfeit. Officials of the Federal Service for Surveillance in Healthcare and Social Development spoke about the arts and wiles of the marketing authorization process at a specialized conference within the framework of the Russian Healthcare Week 2017.
[PharmVestnik # 42, 19/12/2017, p. 3]
// Government Supported Programs
Auditing of medical project support programs is a necessity
Back in 2015, Ministry of Industry and Trade officials started thinking about reshaping government support of the pharmaceutical and medical industry. It was then that it was decided not to seek developers for specific projects but instead subsidize the already operating facilities. Not all innovative ideas by the ministry has been implemented, one of the reasons being incompetent contractors. However, there are other programs, in particular, those supporting pharmaceutical R&D. But they have not yielded the desired effect so far, either. Experts are sure that, to be able to move forward, one needs to review all previous steps, and avoid making the same mistakes twice.
[PharmVestnik # 42, 19/12/2017, p. 9]
// Regulatory & Legal
MoH to train pharmacists on new narcotic and psychotropic drug regulations
At a special meeting with pharmacy owners and pharmacists within the framework of Apteka 2017 Forum, Ministry of Health (MoH) officials briefed the audience about the new narcotic and psychotropic drug regulations shortly coming into force. Certain regulations have been simplified, while some of the regulatory documents are eligible for transferring into e-format. To improve the service quality, pharmacists will soon be able to receive MoH guidelines detailing narcotic drug accounting rules.
[PharmVestnik # 42, 19/12/2017, p. 10]
// Regulatory & Legal
Experts call for changing the outsourcing system
Reportedly, the Union of Professional Pharmaceutical Organizations is drafting a request to federal executive authorities to revise the applicable legislation concerning the outsourcing system in Russia. Current regulations permit pharmaceutical manufacturers to use logistic operators’ resources and entrust their products to storage or transportation. However, experts believe that the existing inconsistencies in the legislation prevent the achievement of the main purpose of the outsourcing process, i.e. cutting costs, but, on the contrary, add yet another link to the distribution chain.
[PharmVestnik # 42, 19/12/2017, p. 12]
// Market Trends
New trends determine pharma market development for years to come
One does not have to be a prophet to see that the Russian pharma market changes rapidly. As is known, changes do not only make one solve problems but also offer new opportunities for those able to come to terms with them quickly and efficiently. Akrikhin Sales Director Rustem MURATOV analyzes the present, and looks into the future of the pharma industry.
[PharmVestnik # 42, 19/12/2017, p. 13]
// Pharma Manufacturing
How international pharma manufacturers feel in Russia
Country managers of international companies operating in Russia note that the expiring year saw numerous changes of the rules of the game on the pharma market. They compare the regulatory change speed with that of Lamborghini or Ferrari. However, all of them plan to further work in Russia. They have ambitious drug submission plans, which does not rule out potential strategy changes.
[PharmVestnik # 42, 19/12/2017, p. 16]
// Marketing
Conventional private label promotion depends on fast data analysis
Pharmaceutical retailers believe that the end margin justifies all means. Manufacturers share this viewpoint. As a result, it has given birth to a joint project that is gaining ground. Conventional private labels have emerged over the past 3-5 years. This “child” co-parented by manufacturers and pharmacies needs a close attention as each “parent” has its own approach. Manufacturers think about broadening their portfolios and boosting sales, while retailers think about marginality and keeping the customer traffic. The need for a fast data analysis keeps growing, which means that the players will not be able to do without implementing analytical software.
[PharmVestnik # 42, 19/12/2017, p. 17]
// Regulatory & Legal
Pharma market gets ready for new drug procurement regulations
One after another, regulatory documents are being drafted for launching a new government procurement system that will help prevent restrictions on the number of companies allowed for bidding. The drug description rules for bidding as well as the procedure for determining the maximum initial contract price have been finalized. Both documents have been substantially revised as compared with their previous versions.
[PharmVestnik # 42, 19/12/2017, p. 18]
// Pharma Retailing
Pharmacy associations and small retailers feel each other out
While pharmacy associations and federal pharmacy chains ramp up their potential, local pharmaceutical retailers keep losing momentum. One of the survival options for the latter is joining someone bigger and stronger. However, this option has a hidden agenda that was discussed during the recent roundtable on choice of pharmaceutical retailing development models in Russia hosted by the Russian Association of Pharmaceutical Marketing.
[PharmVestnik # 42, 19/12/2017, p. 20-21]
// Health Management
Tariff calculation as a means of reducing cancer drug costs
Over the past 5 years, targeted cancer therapies and immunobiologicals have made their way to the market, their efficacy being 50—70% vs. 20—30% efficacy of standard chemotherapy. The price to pay for such efficacy is a high cost of such treatments alongside the growing number of patients with cancer. In 2016, about 600,000 new malignancy cases were diagnosed in Russia. More than 3.5M patients with malignant neoplasms are registered with healthcare institutions. Cost reduction of cancer drugs would have made them more affordable for patients. Evidently, to solve this problem, a set of measures needs to be adopted, ranging from drug pricing to legislation.
[PharmVestnik # 42, 19/12/2017, p. 26]
// Health Strategies
Experts assess healthy lifestyle prospects
Ministry of Health officials believe that if the Russians choose a healthy lifestyle, this will provide for saving up to 60% of the healthcare budget due to lower morbidity rates associated with smoking, alcohol addiction, overeating, and lack of physical activity. Primarily, this refers to cardiovascular diseases ranking first among mortality causes. PharmVestnik quizzed experts on the drug cost percentage of the provisional healthcare budget saving, and whether pharma companies were set for losses because of the “vogue” of a healthy lifestyle.
[PharmVestnik # 42, 19/12/2017, p. 30]
// Insight
State drug procurement, Q1-317
This report is based on the Information and Analytical System “Zakupki” (Procurement) data. The drug procurement segment is a focus of attention of both pharmaceutical manufacturers and distributors, on the one hand, and healthcare authorities, on the other hand. For the former, this is an attractive market where winning a few biddings provides for boosting sales; for the latter, this is a source of continuous aches and pains because of controversies of saving budgets and covering the population with innovative drugs. At the same time, any move shall serve for avoiding social tension, especially given the presidential election ahead.
[PharmVestnik # 42, 19/12/2017, pp. 34-35]
// Insight
Drug procurement in the “targeted” segment of the Russian pharma market, Q1-317
AlphaRM identified the trends prevalent in the state drug procurement segment both in 2017 and the year before. The hospital drug purchasing segment, which is the largest in value terms, has been shrinking fastest vs. the other state-funded segments. The segment of purchases based on the regional subsidized drug lists that ranks seconds in value terms has been growing at a highest rate, mainly due to drug coverage of patients with orphan diseases on List 24. The “targeted” segment including drug supplies under regional and federal target programs as well as some other types of drug coverage ranks third in value terms, at the same time driving drug procurement along with purchases based on the regional subsidized drug lists.
[PharmVestnik # 42, 19/12/2017, pp. 36-37]
// Insight
Cumulative rating of pharmacy chains and associations, Q1-317
According to IQVIA, in the first 9 months of 2017, the TOP10 pharmacy chains and associations account for 36.17% of the retail market, up 11.63% year-on-year. ASNA still leads the ranks with a 13.45% market share.
[PharmVestnik # 42, 19/12/2017, pp. 38-40]
// GxP
Ural pharmaceutical retailers assessed GPP
Sverdlovsk Service for Surveillance in Healthcare and Social Development summed up the pharmacy audit results for 11 months of 2017. Major findings relate to violations of Good Pharmacy Practice regulations that many market players take with a grain of salt.
[PharmVestnik # 42, 19/12/2017, p. 45]
