News Digest 20.09.2024 — 27.09.2024
Regulators
Review of industry regulations
— Resolution No. 1276 of September 18, 2024 "On the specifics of providing certain categories of citizens with social guarantees in the form of providing medicines for medical use, medical products and specialized therapeutic nutrition products for disabled children."
The government approved a resolution that regulates preferential drug provision for residents of the Belgorod, Kursk and Bryansk regions who were forced to leave their homes. Regions must apply for transfers from the federal budget twice a year.
Source: https://pharmvestnik.ru/content/news/Obzor-otraslevyh-normativno-pravovyh-aktov-303.html
The regulator will change the rules for importing medicines for medical use
The Russian Ministry of Health has developed a draft amendment to the Rules for importing medicines for medical use into the country. According to the proposed changes, manufacturers of medical devices will be allowed to import drugs for the purpose of producing certain goods, and there are a number of other innovations. If the draft government resolution is adopted, the document will be valid until September 1, 2027. Among other things, the regulator proposed to present a block of justification for the amount of imported drugs and pharmaceutical substances in a new version. Thus, the justification for the purpose of developing drugs, conducting scientific and other research is proposed to be determined based on the needs of the preclinical study and provided in the form of a study plan containing the main objectives, methodology, procedures, statistical aspects, organization and resource planning of the preclinical study (including its stages and parts), and calculations of the amount of imported drugs required to conduct pharmacological and toxicological studies during the preclinical study of the drug. Currently, this development goal is determined based on the technological scheme of production and the material balance compiled according to the industrial regulations for the production of medicinal products or its draft, and is presented in the form of extracts from the industrial regulations and regulatory documentation containing information on the quantity of the medicinal product required to conduct quality tests for the relevant indicators, references to pharmacopoeial articles of the state pharmacopoeia, the pharmacopoeia of the Eurasian Economic Union (EAEU) or foreign pharmacopeias and calculations of the expert institution carrying out the examination of medicinal products. The Ministry of Health also proposed to introduce a justification for the purposes of registration and examination of drugs intended for circulation in Russia or on the common market of the EAEU and the implementation of state registration. It is planned that the inclusion of pharmaceutical substances in the state register of medicinal products will be determined based on the needs for the drug when conducting a comparative dissolution kinetics test in vitro. The information will be presented in the form of extracts from technological instructions, regulatory documentation (normative document on quality) with information on the quantity of medicine required to conduct quality tests for the relevant indicators, references to pharmacopoeial articles, and calculations of the expert institution.
In August 2024, the Government of the Russian Federation approved an order according to which the pre-trial appeal procedure became mandatory from September 1, 2024, when challenging the actions of state and municipal bodies related to the provision of a number of licenses and permits. The order affected disputes when Roszdravnadzor issues a certificate for the right to import (export) narcotic drugs, psychotropic substances and their precursors, permits for the use of medical devices intended for the diagnosis of diseases, and other aspects.
Market news
An additional 1 trillion rubles will be allocated from the budget for healthcare in six years
An additional 1.035 trillion rubles will be allocated from the federal budget for the Russian healthcare system in the next six years. This was announced by Finance Minister Anton Siluanov, presenting the draft state budget for 2025-2027 to the government.
He clarified that these funds will be used to implement the new national project "Long and Active Life", as well as the national project "Family". In the next three years, the program of modernization of primary healthcare will continue, primary vascular departments and other units will be opened on the basis of district hospitals, a system of remote health monitoring, new facilities in the healthcare system will be created, Siluanov added.
It is noteworthy that the Ministry of Finance planned to allocate 1 trillion rubles from the budget for the national project "Healthcare" launched in 2018. Then, too, the discussion was about the modernization of medical institutions and the purchase of new equipment for state clinics, as well as the retraining of medical personnel.
Dmitry Pogrebinsky: "Import substitution in distribution is going well"
"Modern logistics and distribution involve the use of a significant amount of specialized equipment," he explained. "High-tech warehouses with large product turnovers were particularly confronted with the problem of import substitution at first - after all, against the backdrop of a shortage of high-quality personnel in the labor market, we are saved by mechanization, automation and robotization of production processes. However, representatives of those countries that left the Russian market have been perfectly replaced by Chinese companies that grew up in the European market and are now working with us." According to Dmitry Pogrebinsky, equipment for high-rise warehouses and conveyor equipment are not inferior in quality to the products of the company's previous partners.
He also noted that the presence of Russian manufacturers on the market is growing. "There are many new teams producing equipment whose characteristics satisfy the largest distributors," the speaker explained.
The Federal Antimonopoly Service (FAS) found errors in the purchase of medical products in Bashkiria for 188 million rubles
The Federal Antimonopoly Service (FAS) Office in Bashkiria found errors in 14 purchases of medical products in the documentation of the republican Pension and Social Insurance Fund. As reported by the press service of the regional FAS, the service reviewed several complaints about auctions from KST LLC.
The Fund held 14 auctions for the supply of special rehabilitation equipment for disorders of excretory functions. During the review of the complaints, it was revealed that the customer set excessive parameters for the necessary medical products in all auctions.
"Such actions could have led to a limitation on the number of auction participants," the FAS shared.
In addition, in seven of the auctions under consideration, the customer did not set a restriction on the admission of foreign goods. The total value of the contracts is more than 188 million rubles.
FAS admitted that the Social Fund of Bashkiria violated the law on the contract system. The Service also issued an order to amend the documentation for all auctions. An administrative case will be initiated.
The prosecutor's office of the Krasnoyarsk Territory referred to court a case of fraud in the supply of prostheses
The prosecutor's office issued an indictment in a criminal case against the director of an unnamed commercial organization engaged in the manufacture of prostheses, as well as her daughter, an individual entrepreneur. Depending on the role and degree of participation, they are charged under Parts 3, 4 of Art. 159.2 of the Criminal Code of the Russian Federation (fraud in receiving payments). According to law enforcement agencies, the damage to the budget is 4.7 million rubles.
According to the investigation, from 2021 to 2022, the Krasnoyarsk regional branch of the Social Insurance Fund of Russia held an electronic tender for the performance of work to provide two disabled people with microprocessor-controlled hip and forearm prostheses. According to investigators, when submitting bids for the tender, the women reduced the price of the contracts from the initial cost of 2.4 million and 1.9 million rubles to 500 thousand and 800 thousand rubles, which ensured victory in the tenders.
The defendants allegedly planned to obtain personal data about the disabled people in order to contact them and convince them to refuse prostheses at a reduced cost due to their low quality. Two disabled people refused to receive prostheses under the contracts and applied to the Social Insurance Fund with applications for compensation for the costs of independently purchased prostheses at an inflated cost. The Fund made payments to the applicants, who then transferred the money received to the accused.
Property belonging to the defendants, worth more than 11 million rubles, has been seized. The case has been sent to the Leninsky District Court of Krasnoyarsk for consideration on the merits.
Source: https://t.me/vademecum_live/15708
Other
A helmet for hair loss due to chemotherapy has been invented in America
The device from the American startup Luminate is intended for cancer patients undergoing chemotherapy, and is currently undergoing testing to launch sales. According to Techcrunch, there is no magic in the technology used in the helmet: by distributing pressure on the scalp, the helmet blocks the capillaries and prevents the toxic chemo cocktail from reaching the patient's hair follicles. The technology, according to the developers, helped prevent hair loss in 75% of patients testing the helmet.
Currently, the startup has raised $15 million for large-scale testing of the device and obtaining approval from the American regulator - the US Food and Drug Administration (FDA).
Source: https://t.me/medicalksu/5256
A scientist from the University of California has developed a mask for diagnosing COPD, asthma and coronavirus for $1
The covid pandemic is over, but paper supplies are x masks left at home. A scientist from the University of California, Wei Gao, figured out how to make a device for diagnosing diseases from a simple paper mask, writes EurekAlert!
Unlike other smart masks that track health indicators such as temperature or breathing rate, an innovative mask called EBCare can analyze chemicals in the breath in real time.
For example, the mask can monitor the level of nitrite in asthma patients, a chemical that indicates inflammation of the airways. The mask has built-in biosensors based on bio-inspired microfluidics technology to detect disease biomarkers from breath condensate. The analysis data is sent to an app on a smartphone or tablet.
To test the masks, the team conducted a series of studies in people, primarily focused on patients with asthma or COPD. They specifically monitored the patients' breath for nitrite, a biomarker of inflammation in both conditions. The results showed that the masks accurately detected the biomarker, indicating inflammation in the patients' airways. In another study, the group demonstrated that the masks accurately detect blood alcohol levels in people, suggesting that the masks could be used to test drivers' alcohol levels.
The mask's developer says the cost of the mask will not exceed $1, although this is highly doubtful — Wei Goa probably meant the cost of the mask without taking into account the biosensors.
Source: https://t.me/medicalksu/5247
Newly registered medical devices
We publish a list of new medical devices registered from 09.20.2024 to 09.27.2024
Link to the list: [see table in the attachment]
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