REMEDIUM

Advertising  of prescription drugs  is regulated  by general  and special  provisions  of the Federal  Law No. 38-FZ “On Advertising” dated March  13, 2006.  However,  the procedure  for application  of the relevant  rules  is disclosed  in law enforcement  practice: decisions  of the antimonopoly  authority  and courts.Law enforcement  practices  for advertising  of prescription drugs contain a separate layer of regulatory  interpretations and require special analysis and evaluation when strategically planning and strategizing to promote such drugs.In practice,  one can find answers to a number of complex and ambiguous questions. These questions include the formation of fair marketing policies of pharmacies  in relation to the circulation of prescription drugs; limitations  that may be applicable to scientific and practical  articles  reporting  information  about diseases and existing  drug options; creation  and content  of websites that may contain  information  related to the description of prescription drug properties;  procedure  for comparing  prescription drugs with each other according to the mechanism  of action and other criteria;  use of certain words and expressions in advertising  materials that are distributed  at professional  medical  events and published  in specialized  printed  publications.  In addition,  the analysis  of solutions from law enforcement practice reveals approaches to assessing the reliability of information contained in advertisements, as well as methods to identify relevant violations of the law and the procedure  for assessing  evidence by the enforcer.All these issues  are covered  in detail  in this  article  based on an analysis  of case  proceedings regarding  the unfair  advertising of prescription drugs.  The  article  provides  the  most  complete  set  of solutions  that  are  important  from  the  point  of view  of practitioners.

According to figures  provided by the  Ministry  of Health, the  autumn-winter period is characterized  by the  prevalence  of outbreaks of ARVI and influenza. In case of ARVI of no influenza  etiology,  the disease  develops  gradually, it is most often accompanied by cough, and begins  with usual fatigue and rhinitis  (runny nose), which makes nasal breathing difficult  and worsens  the  patient’s condition.  That is  why the  treatment  of rhinitis  is  an important  component  of the  comprehensive treatment  of ARVI and influenza.

The budget segment of the market plays a key role in the system of medical supply of hospital institutions and in the implementation of PD within the framework of preferential drug provision (PDP) and regional preferential provision (RPP) programmes. The key trends of this segment for 9 months of 2019 are considered in this review.

The incidences of cancer  in patients with ischaemic  heart disease and diabetes mellitus  (types 1 and 2) were analyzed  according to the electronic health records  (medical  information  system  qMS). For  several  years,  a predominance  of prostate  cancer  and colorectal  cancer  in almost 10 thousand  patients  with ischaemic  heart disease were revealed; in patients  with diabetes mellitus type 1 lung cancer  was prevailed; and in patients with diabetes mellitus type 2 colorectal  cancer  and lung cancer  were prevailed. Prostate  cancer   and  ischaemic   heart  disease  are  associated  with  a  general  imbalance  within  estrogen  receptors   ERα,  ERβ, gpER,  which  occurs  in old age with  reproductive function  fading. Hyperglycemia in diabetes  mellitus  causes  a blocking  of the parathyroid  hormone-related protein  signaling  pathway, which  creates  a favorable environment  for carcinogenesis in the lungs. Hyperinsulinemia, as a result of insulin resistance  in diabetes mellitus and in metabolic syndrome  accompanying ischaemic  heart disease, triggers  signaling  pathways,  including mTOR,  which  contribute  to the carcinogenesis in the large intestine  epithelium. Three  different  patient samples showed the different  pictures  of tumor localization, and for each of the identified  predominant cancer  localization common signaling  pathways with a concomitant metabolic disease can be distinguished.

The analysis of investment activity and financial results  of enterprises producing irradiation and electrotherapy equipment was carried out according to the data of state statistical  reports of Form No. P-2 «Information on investments in non-financial assets» and Form No. P-3 «Information on financial condition of the organization».Investments in  fixed  capital  of enterprises of various  economy  sectors  by type  of activity  with  the  OKVED2  code  26.6: «Manufacture of irradiation and electrotherapeutic equipment used in medicine» in the first half of 2019 in Russia amounted to 525.243 million rubles, which is 2.63 times higher than the previous year. At the same time the share of medical industry enterprises with the OKVED2 code 26.6 in the total volume of investments was at the level of 126.22%, which testifies to the fact that in the reporting period the trend for the redistribution  of investments by enterprises of the industry in favor of the increase in investments in other (non-core) types of activities  was observed.The financial state is the most important characteristic  of the economic activity of the industry’s enterprises, which determines its economic attractiveness. As a result of the economic activity in the first half of 2019 the enterprises of the industry of medical products with the OKVED2 code 26.6: «Manufacture of irradiation and electrotherapeutic equipment used in medicine» received revenues from the sale of products, works and services in the amount of 12.203 billion rubles, which is 1.14 times higher than the previous year. In the first half of 2019, as compared to the previous year, the industry’s enterprises increased their sales profit 1.26 times and profit before tax 1.23 times, while the sales profitability increased by 1.31 points accordingly.

The review provides an analysis of litigation  practice relating to the manufacture and circulation of medical devices to help industry specialists  avoid mistakes in solving problems of a similar nature.

Согласно данным ИАС «Клифар: Импорт-Экспорт», в августе 2019 г. в Россию было импортировано ГЛС на сумму почти 950 млн долл., что на 31% выше показателя за август 2018 г., но на 8% ниже значения за июль 2019 г. (рис.).