Federal Tax Service: implementation of drug marking system not to horrify
[PharmVestnik # 15, 02/05/2017, p. 1, cont’d p.2]
Experts pinpointed major regulatory risk factors in pharma
Speaking about regulating the pharma industry is like trying to seize the unseizable. Yet, major industry events cannot do without discussing the regulatory aspects of the market drivers. The 6th International Forum “Pharma and Biotech 2017: Pharma business regulation and development in a down economy” was not an exception either.
[PharmVestnik # 15, 02/05/2017, p. 4]
Computerization: major issue of common market launch
Experts of the Eurasian Economic Commission (EAEC) admit that ratification by Kyrgyz Republic of the Protocol of Armenia accession to the EAEU took more time than expected. Nonetheless, the EAEC considers the protocol ratification a fait accompli, although the start of the drug registration to the uniform rules has not been announced yet. There is another difficulty, namely the information support tools for the drug registration processes are not completely in place so far.
[PharmVestnik # 15, 02/05/2017, p. 12]
Local manufacture of orphan drugs is optimum given export prospects
More than ten court proceedings associated with orphan drug coverage were held over the past two weeks in various Russian regions. The problem is common, i.e. the nearly spent regional budgets cannot afford purchasing high-cost drugs. Local manufacturers are ready to produce orphan drugs, which, in their opinion, will be significantly cheaper. However, both patients and physicians have questions in respect of local drugs.
[PharmVestnik # 15, 02/05/2017, p. 16]
Report on Russia’s Seven (High-Cost) Diseases segment, 2016
Centralized federal procurement of drugs for treatment of the Federal Register-listed patients with hemophilia; mucoviscidosis; hypophyseal nanism; Gaucher's disease; malignant lymphoid, hematopoietic, and similar neoplasms; multiple sclerosis; and patients after organ and/or tissue transplantation is rightfully considered a high-cost activity. If a patient is left alone struggling with the above diseases, he/she will be unlikely to afford purchasing advanced drugs without the government support. This report based on AlphaRM data analyzes the federal budget expenditures as well as the companies supplying high-cost drugs.
[PharmVestnik # 15, 02/05/2017, pp. 22-24]
Benchmarking of wholesale and retail prices in Russian pharmacy sector, 2016
More often than not, pharmacy sector reports focus on manufacturer, pharmacy, and drug sales as well as market share dynamics. Sometimes drug prices are reviewed as well, which is important for customers. Most frequently, retail drug prices are reviewed incorporating both the manufacturer and distributor as well as pharmacy chain prices. Recently, the pharmacy sector players have been complaining about falling profit margins. At the same time, for some reason, the number of pharmacies has not been going down. On the contrary, new pharmacies are being set up every quarter totaling more than 60.4 thsd, according to AlphaRM. And if one takes into account Magnit’s (FMCG retailer) recent statement of intent to launch pharmacies and enter the pharmaceutical retail sector, it would be difficult to believe that the pharmacy sector has been operating at a loss.
[PharmVestnik # 15, 02/05/2017, pp. 25-27]
Ural Biomedical Cluster participants invest in startups
Medsintez called for cooperation of the companies promoting innovative biomedical and pharmaceutical projects. It goes about drugs either at various clinical trial stages or ready for production.
[PharmVestnik # 15, 02/05/2017, p. 28]
Investor of new manufacturing facilities interested in banning second-generation syringes
Medintech starts construction of a manufacturing facility for 3rd generation self-destroying syringes. This facility exceeding 760 m RUB in costs, with capacity of up to 200 m items a year, is scheduled to be launched through the end of this year. Experts believe that to promote sales of costly new generation products, a statutory bar on the use of traditional syringes will be required. Is the government likely to fall with this idea given the health budget cuts?
[PharmVestnik # 15, 02/05/2017, p. 28]
Russian molecular diagnostics is among the best in the world so far
Annually, dozens of millions of molecular diagnostic tests are performed in Russia. The vast majority of the test sets are manufactured locally. Their wide use may be explained by their price that is an order of magnitude lower than that of imported diagnostic sets. Besides, Russian diagnostic tests are known and being used in many countries. However, the situation may change dramatically if an adequate regulation in this field is not implemented pretty soon.
[PharmVestnik # 15, 02/05/2017, p. 31]
Economic crisis drives private clinic advent to mandatory health insurance segment
Some experts consider the advent of private clinics to the mandatory health insurance system a factor negatively affecting the public medicine. However, there are segments where the public-private partnership is quite effective. The government is ready to outsource such segments overall. First, it goes about high-tech medical care. Whether private clinics will be able to substitute primary care institutions is a big question.
[PharmVestnik # 15, 02/05/2017, p. 32]
Cancer insurance not available for all levels of population yet
The first cancer insurance programs emerged a few years ago, but have not become widespread. They are still either too expensive or provide for a small sun insured. Besides, many companies offering cancer insurance policies include some types of cancer insurance exemptions.
[PharmVestnik # 15, 02/05/2017, p. 32]
Private medicine still attractive despite recession
In line with the Ministry of Economic Development forecast, in 2017, the Russian GDP growth rate will reach 0.6%. This is indicative of stabilization, but does not provide for speaking about a massive macroeconomic improvement. KPMG experts believe that this situation will determine several trends on the private medical services market. In particular, this it about saturation of the voluntary health insurance market, inflow of new clients to the legal private medicine segment, etc.
[PharmVestnik # 15, 02/05/2017, p. 33]
Roszdravnadzor to assess quality of private clinic services soon
In Russia, no assessment of the quality of medical services provided beyond the mandatory health insurance framework has been performed. This regulatory norm was stipulated in the Federal Law No. 323 of 2011 “On fundamental healthcare principles in the Russian Federation”. At the same time, the law has it that the assessment procedure is to be determined by a relevant federal agency, i.e. the Ministry of Health. However, no appropriate order has been issued yet. At the closing Board meeting of the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) on April 14th, the agency’s head Mikhail Murashko said that the order was being reviewed by the Ministry of Justice.
[PharmVestnik # 15, 02/05/2017, p. 34]
Medical manufacturers and FAS differ in approaches to competition
The main reason why local medical manufacturers currently account just for 20% of the medical device market is problems associated with the government procurement system. The Russian companies and the Federal Antimonopoly Service (FAS) have opposing ideas of competition; therefore, businesses fail to assert themselves even in court. FAS officials believe that the government procurement market abounds in unfair competition schemes, and that the major competition problem is inadequate medical device circulation legislation.
[PharmVestnik # 15, 02/05/2017, p. 35]
Nine percent of medical device vendors control 80% of government procurement
Some experts believe that this is good news. If one looks at the overall government procurement market analysis, the figures will be even more impressive, i.e. 80% of government orders go to 6% of vendors. But these are approximate figures. Analysts differ substantially in respect of the overall government procurement market size. Therefore, experts insist that to understand whether the right impulse was given to the medical device market development, first one has to answer the question: “Do we know what we regulate?”
[PharmVestnik # 15, 02/05/2017, p. 36]
Businesses ask for clarifications regarding medical device registration regulations
Medical manufacturers look forward to the time when they will be able to use in practice the Regulations for medical device registration and safety, quality, and efficacy assessment within the EAEU framework. An obvious advantage is the opportunity to assess the document package before submitting it for registration. But the devil is in the detail: businesses do not completely understand the role of expert organizations that will provide consulting services, and whether the latter’s arguments will be weighty.
[PharmVestnik # 15, 02/05/2017, p. 36]
Russia’s national blood bank not ready to shift to local equipment
For several years running, the issue of federalization of the Russian blood bank has been worked over. According to the Federal Medical and Biological Agency (FMBA), this work is to be completed in 2018. The major objective of the transformation underway is not only to turn the regional blood donor centers over to FMBA’s command but also facilitate the distribution of the blood and components stockpiled among medical and preventive treatment facilities all over the country. In the federalization process, the issue of merging small blood donor centers and implementing unified requirements to the blood banking equipment overall is most likely to arise.
[PharmVestnik # 15, 02/05/2017, p. 37]
