News Digest 17.04.2024 — 19.04.2024
Regulators
Rospotrebnadzor proposed a form for evaluating the services of disinfectants
Rospotrebnadzor intends to approve the form of an assessment sheet for applicants or confirmation of a license to provide disinfection, disinsection and deratization services in order to ensure the sanitary and epidemiological well-being of the population. The draft order was published on the portal regulation.gov.ru.
The form includes 11 items. It is planned that the document will come into force on September 1, 2024.
Rospotrebnadzor also intends to make changes to the forms of licensing documents, adding to them the words “activities for the provision of services for disinfection, disinfestation and deratization in order to ensure the sanitary and epidemiological well-being of the population.” In addition, the department has prepared a draft approving administrative regulations for licensing disinfection, disinfestation and deratization.
Earlier, the president signed a law delaying the start date for licensing disinfection services by six months: companies can submit applications from September 1, 2024, and inspections within the framework of state control can be carried out from March 1, 2025.
In March, the government approved regulations on licensing disinfection, disinfestation and deratization services. The resolution describes the requirements for license applicants, indicates the deadline for reviewing applications and lists of necessary equipment.
Source: https://medvestnik.ru/content/news/Dezinfektoram-dali-otsrochku-dlya-polucheniya-licenzii.html
The Supreme Court outlined the signs of an oral agreement on a cartel agreement at auction
The Supreme Court (SC) of the Russian Federation has identified signs that may indicate an oral agreement on a cartel agreement at a tender between the contractor and the customer. In recent years, such violations have been identified during the procurement of medical equipment, drugs and food in hospitals.
The Supreme Court, agreeing with the lower authorities, included the following as signs of an oral agreement:
- use of a single infrastructure when preparing and participating in procurement procedures (one IP address, one room for Internet access);
- submission of applications and price proposals, preparation and participation in procurement by one person;
- cases when the same person receives the right to represent the interests of companies before the Federal Antimonopoly Service;
- synchronous behavior when generating applications without an extract from the register of members of a self-regulatory organization and the use of the “battering ram” scheme (two companies alternately lower the price below cost, before closing the auction, the third company makes an offer with a minimal reduction).
According to 44-FZ “On the contract system in the field of procurement of goods, works, services to meet state and municipal needs”, the main signs of a cartel agreement are redundant documentation with unnecessary and vague information, inconsistency of information in the terms of reference and the draft contract, indication of unnecessary requirements for participants, the presence of contract terms that can only be fulfilled by a specific company, unrealistic deadlines for fulfilling obligations, and a low initial purchase price.
In the healthcare industry, regulators often find signs of cartels. For example, in April 2024, the Federal Antimonopoly Service of Russia opened a case against four companies regarding a cartel of 1.2 billion rubles in the supply of food to clinics and social institutions.
In March 2024, the Federal Antimonopoly Service of Russia in the Primorsky Territory fined five local companies 650 thousand rubles for organizing a cartel in the supply of medicines, medical equipment and consumables for the needs of Vladivostok Clinical Hospital No. 4. The anti-competitive agreement was concluded for 23 million rubles.
The Federal Antimonopoly Service for the Chelyabinsk Region in January 2024 recognized the actions of 17 companies from different regions when participating in public procurement as a violation of the Law “On Protection of Competition”. The OFAS found that organizations, including Medservice-Region CJSC, entered into an anti-competitive agreement for 500 million rubles for the supply of medical equipment.
Matvienko called for finalizing and adopting bills to regulate the circulation of methanol and introduce excise taxes on medical alcohol by the end of 2024
By the end of 2024, it is necessary to finalize and adopt bills aimed at state regulation of the alcohol market, including the turnover of methanol and excise taxes on medical alcohol. Speaker of the Federation Council Valentina Matvienko said this at the 565th plenary meeting of the chamber.
According to her, over the past 5-6 years, senators have done a lot of important work to combat counterfeit alcohol and regulate legislation in this area. This significantly influenced the increase in budget revenues at all levels and, most importantly, had a beneficial effect on people’s health.
Today, according to her, it is necessary to continue to promote the passage of bills to regulate the circulation of methanol, the introduction of excise taxes on medical alcohol and a number of other innovations.
Market news
Chinese MinFound tomographs will be registered in Russia
The Chinese manufacturer of tomographs MinFound registers its products in Russia. R-Pharm may distribute it, Kommersant reported.
Roszdravnadzor confirmed that it had received registration documents from the company founded by Alexey Repik for five ScintCare computed tomography systems produced by MinFound - PET/CT 720E, Blue 755, CT 16, CT 128, QuantumEye 789.
MinFound International Product Director Nathan Xu said that the company plans to register other products together with R-Pharm, and is also considering the possibility of localizing production in Russia.
According to Eqiva company estimates, the volume of the Russian market for magnetic resonance imaging devices was at least 13.2 billion rubles, and computed tomography - about 24 billion rubles. The share of locally produced tomographs in government procurement is 10%, so MinFound will have to compete with Siemens Healthineers, GE Healthcare, and Philips in this segment. The company also competes with them in China, where international hospitals prefer to purchase imported medical equipment.
R-Pharm has long been supplying medical equipment to Russia, including tomographs, from the Japanese Canon Medical Systems. And in 2020, the partners created the joint venture “ArPi Canon Medical Systems” for these purposes with the prospect of localizing production.
According to MDPro, government purchases of computed tomographs in 2023 decreased by half in Russia year-on-year in physical terms (to 204 units) and in money (to 9.8 billion rubles). Purchases of Canon Medical Systems products also decreased - almost three times, to 1.6 billion rubles.
Source: https://medvestnik.ru/content/news/V-Rossii-zaregistriruut-kitaiskie-tomografy-MinFound.html
The Chiesi project to develop inhalers with a minimal carbon footprint has entered a new stage
To date, two clinical studies have been completed to evaluate the short-term safety of the new propellant1 and clinical studies to study the pharmacological characteristics of a new fixed-dose combination with a minimal carbon footprint, consisting of an inhaled glucocorticosteroid and a long-acting beta2-agonist. These studies provided encouraging evidence of comparable efficacy and tolerability of the new formulation compared to the existing drug when used to treat patients with asthma and chronic obstructive pulmonary disease (COPD).
This milestone follows the successful completion of similar studies examining the fixed triple combination in July 2022.
In 2019, COPD became the third leading cause of death in the world, killing 3.23 million people2. In the same year, there were an estimated 262 million people with asthma and 455,000 deaths from the disease. Many patients with COPD and asthma depend on treatment with metered-dose aerosol inhalers (MDIs). However, there is debate about the extent to which MDIs contribute to global warming. Efforts are currently being made to reduce their negative impact on the environment4.
The development of the low carbon inhaler platform aims to enable the Chiesi Group to reduce emissions associated with the use of its products by up to 90%, with significant reductions expected in both direct (manufacturing processes) and indirect (use of MDIs) emissions. This is expected to be a key milestone in achieving the Net Zero carbon neutral status that Chiesi wants to achieve by 2035, while continuing to meet the needs of patients with asthma and COPD.
“At the Chiesi Group we firmly believe that patients should not be held responsible for the environmental impact of their treatment choices,” said Chiesi Group CEO Giuseppe Accogli. “The completion of these additional studies and the start of the Phase III clinical trial marks an important milestone for us in developing a platform of new inhalers with a minimal carbon footprint. We are confident that we can provide propellant products with a minimal carbon footprint to patients without compromising safety, ease of use or effectiveness.”
International guidelines for the treatment of asthma and COPD support the concept of selecting the appropriate drug for the patient to reduce the risk of severe exacerbations5.
“We are committed to developing inhalers that meet the needs of patients while minimizing the negative impact on the environment,” concluded Accogli. “By addressing climate change, one of the leading causes of respiratory disease, we can benefit both patients and the planet at the same time.” No compromises are possible here.”
St. Petersburg is trying to deprive the medical device distributor Smith Healthcare of its SEZ resident status
The Committee on Industrial Policy, Innovation and Trade (KIPIT) of St. Petersburg filed a lawsuit with the Arbitration Court of St. Petersburg and the Leningrad Region in order to terminate the agreement with Smith Healthcare (JSC Smithelskea) on the implementation of technology development activities in a special economic zone ( SEZ) "St. Petersburg". The reason for going to court was the project to build a plant for the production of medical devices for dialysis in the SEZ, in which Smith Healthcare planned to invest 2.21 billion rubles, but which, according to city authorities, was never implemented.
In March, an Italian collagen filler entered the Russian market - a medical product used to correct the shape of the face, the shape of the lips, and eliminate wrinkles
As the Right to Health found out, we are talking about the injectable collagen stimulator Karizma. Its exclusive distributor in Russia is the Voronezh-based Jess Medical Company. According to information from the manufacturer, this is a “new generation filler based on recombinant human collagen Rh Collagen, which is synthesized by silkworms.” It, according to statements, “restores the skin by qualitatively and quantitatively increasing collagen fibers” - triggers cellular stimulation, restores volume, corrects wrinkles, improves skin tone and firmness and provides lifting. The composition states Rh Collagen (2 mg/ml), hyaluronic acid (20 mg/ml, 1500 kDa) and carboxymethylcellulose (40 mg/ml).
The company writes on social networks that a presentation in honor of the “launch” of the drug on the Russian market took place on March 14 in Moscow. On its website, the supplier posted a registration certificate dated March 12, 2024 No. RZN 2024/12124 - the document states the registration of the medical product “Implant for intradermal use based on sodium hyaluronate Karisma Face” from the Italian manufacturer “Taumedica S.R.L.” (Taumedika S.R.L.). The RU, according to the document, was issued to the Jes Medical Company, based in Voronezh. The company has branches in Kursk, Belgorod and Lipetsk.
“The market was really looking forward to the appearance of this filler. But when we checked the availability of the product in the register of medical devices of Roszdravnadzor, we realized that it was not there, and decided not to take the product for sale until we were sure that it was indeed officially registered in Russia,” says head of one of the distribution companies operating in the aesthetic medicine market.
It was also not possible to find the specified registration certificate in the Roszdravnadzor “Right to Health” register. The presence of the RU was checked by a source in the department - he confirmed the absence of the document; there is no information about this medical device in the registry.
The drug has already begun to be shipped to the regions. As Ekaterina Shibakova, chairman of the committee for the development of the beauty industry of the Rostov region branch of Opora Rossii, told Right to Health, they began to use it in clinics in Rostov. She filed a complaint with Roszdravnadzor, where she was told (the document is available to the channel) that the specified registration certificate was not issued by the supervisory authority and that “information about the unreliable (fake) registration certificate was sent to law enforcement agencies.”
The supplier company did not respond to the “Rights to Health” request. When contacted, managers claim that the injectable drug is registered and is being sold to doctors and clinics.
The company, according to SPARK-Interfax, was founded in 2018 and is engaged in the wholesale trade of products used for medical purposes.
Source: https://t.me/MedPharmaPulse/737
Other
Russian scientists have created a new device for stress management
In the neurotechnology laboratory of Novgorod University, a unique hardware and software complex was developed that determines the level of stress and helps a person relax using biofeedback, the university website reports. The innovative complex consists of a wrist bracelet and a mobile application. The unique feature of this device is that it determines a person's stress level by measuring galvanic skin response, instead of measuring pulse, as similar devices do. “But this method (pulse measurement) has disadvantages. Your pulse depends on many indicators: what your health is like at the moment, whether you are sick now, whether you play sports, and so on. In addition, it can be quite difficult to accurately measure your pulse using a bracelet. And in many scientific articles, recording stress in this way is questioned,” explained Egor Zemnukhov, head of the neurotechnology laboratory at NovSU.
On the new device, galvanic skin response is measured using two contacts on the wristband that send a minimum safe dose of current through the skin. The skin's response to this current (that is, its conductivity) changes depending on the person's stress level, which is displayed in real time in the mobile application. In this way, the user receives feedback on how effectively he or she is relaxing. This complex also divides the resistance signal into tonic and physical components to give a more detailed understanding of the level of a person's condition at different points in time. In addition, the application allows you to track changes in stress levels throughout the day, as well as assess your overall condition over the past five days.
It must be said that the developers printed the components of their product - the bracelet body - on a university 3D printer. For stationary use, they also made an LED lamp with a scale that shows the stress level instead of an application.
The developers' future plans include creating software for iOS, improving the design of the bracelet, adding new functions to the application and launching the product on the market. The authors of the device consider companies with hazardous production processes, as well as enterprises interested in maintaining the psychological comfort of their employees, as potential users of their product.
The development of this complex was made possible thanks to grants from the “Umnik” and “Student Startup” programs, supported by the Foundation for Assistance to the Development of Small Enterprises in the Scientific and Technical Sphere.
In March 2024, scientists from the St. Petersburg State Electrotechnical University LETI spoke about the creation of a complex for testing new pharmaceuticals to relieve stress.
Source: https://pharmmedprom.ru/news/rossiiskie-uchenie-sozdali-novoe-ustroistvo-dlya-upravleniya-stressom/
New registered medical devices
We publish a list of new medical devices registered from 04/12/2024 to 04/19/2024
Link to the list: [see. table in attachment]
News
