News Digest 01.07.2024 — 03.07.2024
Regulators
The Government has outlined the goals for the national project "New Health-Saving Technologies"
The Russian government has outlined the main goals for the new national project "New Health-Saving Technologies". One of the main areas will be import substitution in the field of medicine. According to Prime Minister Mikhail Mishustin, this year import substitution has demonstrated high dynamics: over five months, the growth in the production of medicines and medical devices has approached 8%, "and the national project is designed to support this trend."
The national project is expected to increase the share of domestic production in the field of vital and essential drugs to 90%, and in medical devices - to 40%. Mishustin noted that it is planned to ensure the development of 25 gene therapy drugs and personalized cell products, as well as 11 products based on artificial intelligence.
Deputy Prime Minister Tatyana Golikova reported a reduction in the import of medical devices to Russia in 2023 by 4.5%. According to her data, the average annual growth in the volume of industrial production of drugs and medical products exceeds other sectors of the economy and ranks third among industries.
According to her, the "road maps" for organizing the production of drugs and medical products previously imported to Russia now include 186 drugs and 368 medical products.
In 2024, it will be ten years since the start of the import substitution program in Russia. At that time, it was calculated that foreign medical equipment accounted for 80% of the market, and, according to the most optimistic forecasts, the share of domestic medical products by 2024 should have been only about 30%. Despite the rhetoric about the success of import substitution, doctors complain about shortages, and clinics complain that because of this they have to raise prices for medical services.
The President instructed the government to work on the development of self-regulation in pharmaceutical activities
The President instructed the government to consider issues and submit proposals on the development of the self-regulation institute in the field of medical and pharmaceutical activities by August 15. Prime Minister Mikhail Mishustin has been appointed responsible, according to a publication on the Kremlin website.
Discussions about the possibility of self-regulatory organizations becoming assistants to Roszdravnadzor in monitoring pharmaceutical activities have been going on for several years.
“Recognition of the results of SRO activities is a new stage in the development of a socially responsible pharmacy business that takes seriously the requirements established by law,” noted Victoria Presnyakova, director of the SRO Association of Independent Pharmacies and head of the Alliance of Pharmaceutical Associations.
In February 2023, AAU (SRO) SoyuzPharma, in particular, asked to officially recognize the results of its audits conducted in pharmacies. In this case, pharmaceutical organizations that have passed inspections by self-regulatory organizations could count on a reduction in the risk category, if it was still high. However, the initiative was criticized by the Ministry of Health.
"We sent our proposals to the Ministry of Health on the development of the self-regulation institute in the field of pharmaceutical activity and in December 2023 we received a lengthy response, the essence of which was that this area does not need additional participation of SROs, that government agencies are already keeping everything under control," Maria Litvinova, executive director of AAU (SRO) SoyuzPharma, commented to FV. The mechanism of self-regulation in the spheres of healthcare, circulation of medicines and medical devices has never been implemented in Russia, therefore the development of this issue should be accompanied by an analysis of Russian and foreign law enforcement practice, the results of statistical, sociological and political research, an assessment of socio-economic, political, legal and other consequences, according to a five-page letter signed by Deputy Minister Sergei Glagolev.
Market news
Khabarovsk equipment supplier fined for bribe to former official of Kamchatka Ministry of Health
The heads of a commercial organization from Khabarovsk Krai were brought to administrative responsibility under the article on illegal remuneration from a legal entity in a large amount (Part 2 of Article 19.28 of the Code of Administrative Offenses of the Russian Federation). Details about the case were reported by the press service of the Kamchatka Territory Prosecutor's Office.
It was established that the company's management transferred 8 million rubles to a former official of the Kamchatka Territory Ministry of Health. The organization did this in order to supply equipment to the region's healthcare institutions without obstacles and competition.
The organization was fined 10 million rubles, and the bribe was confiscated. The court seized the organization's property to ensure payment of the fine. The criminal case against the defendants is under investigation. and.
Other
Another sliding endoprosthesis produced by Samara State Medical University has been successfully installed in a patient
Another sliding endoprosthesis, developed and manufactured at the Samara State Medical University of the Ministry of Health of the Russian Federation, has been successfully installed in a patient with oncology. This is the second sliding implant manufactured in Russia entirely from domestic materials. The operation was performed at the Samara Regional Clinical Oncology Dispensary (SRCD) on a 71-year-old woman. She needed to replace the upper third of her femur and gradually restore the length of her leg. In the future, the length of the endoprosthesis can be increased without a second operation.
In September 2023, the patient was admitted to one of the city hospitals with a fracture. During the examination, the woman was diagnosed with a tumor in the upper third of the femur, which caused a pathological fracture. After this, the patient was examined at the oncology center, where she was diagnosed with aggressive desmoplastic fibroma. Such tumors grow very quickly and lead to serious consequences - they cause softening of the bone, as a result of which the bone "dissolves".
Source: https://samsmu.ru/news/2024/1006/
Scientists have created "human" conditions for transporting a donor heart
Specialists from the Moscow Institute of Physics and Technology (MIPT) have created a unique device for transporting donor hearts intended for transplantation. This is the first Russian system where the organ can be transported without cooling, at body temperature. When transported in ice, the donor heart remains suitable for transplantation for mainly four hours, the new device extends this period by one and a half times.
Now the developers have prepared a prototype in the form of a container, which is placed in an ambulance. In addition to the camera itself, the device includes a system to support the life of the heart, a fluid pumping system, and a humidity support system to prevent the organ from drying out
Russian flexible sternum prosthesis will allow you to breathe deeply
Up to 3.1% of patients with bone tumors of various localizations have damage to the sternum, so after cancer treatment they require the installation of an implant for chest reconstruction. "And here the quality and properties of the installed product are of great importance. Our work was aimed at finding the optimal technological solution that will increase the efficiency of the sternum implant survival and improve the quality of life of patients," said Danil Anisimov, design engineer at CML AT Medical.
The design methodology and configuration of the flexible rib element of the sternum implant using additive technologies improve the efficiency of using such products in the treatment of not only patients with oncological diseases of the chest bones, but also with congenital anomalies of its development or after severe injuries.
Cyclic and mechanical tests of the new prototype of the flexible 3D-printed rib showed that the design is capable of providing 80 million breathing iterations without destruction and deformation.
As the developers explained, traditionally used designs cannot fully restore natural biomechanics and chest breathing, but perform only protective and cosmetic functions. Due to the mobility of the ribs, it is impossible to permanently fix rigid sternum implants to the ribs. The new design compensates for these shortcomings.
Previously, CML AT Medica developed unique implants to replace damaged areas of the skull and dura mater, and also manufactured an endoprosthesis on a 3D printer according to the patient's parameters. In November 2023, the Priorov Central Institute of Traumatology and Orthopedics reported the successful installation of sternum prostheses developed here using 3D modeling and additive technologies.
In January 2024, the Moscow Technical School, together with Sechenov University, opened courses on training in additive manufacturing of medical devices.
Source: https://pharmmedprom.ru/news/rossiiskii-gibkii-protez-grudini-pozvolit-dishat-polnotsenno/
Moscow scientists have developed a fetal phantom for diagnosing pregnant women
Phantoms are models that imitate organs, tissues, and parts of the human body. They are used to practice various medical procedures. The new development will allow research to be carried out faster and will make this diagnostic method more accessible to pregnant women.
"Today in Moscow, such an informative research method as MRI for diagnosing fetal abnormalities is not used as often as it could. Its use is limited, among other things, by the complexity of setting up scanning protocols. According to statistics, there is a need for this method, since in some cases it is MRI that can provide the most important information not only for pregnancy management, but also for possible planning of various intrauterine surgical interventions. Moscow scientists have developed a fetal phantom that allows you to customize and test scanning technology during diagnostics. This will improve the quality of the images obtained and make this type of research even more accurate and, as a result, more widespread,” noted Anastasia Rakova.
Magnetic resonance imaging (MRI) is a highly accurate diagnostic method used to examine the fetus, abdominal cavity and pelvis of a pregnant woman.
This method allows you to obtain detailed images without the use of ionizing radiation. High contrast and spatial resolution make MRI an important additional tool for assessing various pathological conditions in both women and fetuses.
Sechenov University students have created a new system for analyzing the quality of embryos
A new system for automatic analysis of the morphokinetic state of a human embryo has been developed by students of the First Moscow State Medical University named after I.M. Sechenov. It will improve the accuracy of assessing embryo implantation, the university's press service told TASS.
"The developed system will significantly speed up and simplify the process of analyzing the quality of human embryos in IVF laboratories, which previously had to be done manually. This development can become a key module in the system for supporting medical decision-making in the field of embryology, increasing the accuracy and reliability of assessing the implantation capacity of embryos," said the project manager, lecturer at the Department of Information and Internet Technologies in Healthcare of the Center for Digital Medicine at Sechenov University Gleb Nemkovsky, whose words are quoted by the university's press service.
They specified that the system for automatic analysis of the morphokinetic state of the human embryo was developed in accordance with the goals of the national project "Science and Universities". The technology is based on research conducted jointly with the Russian company Westtrade LTD. The company is a developer and manufacturer of special incubators with time-lapse technology, which allows recording and analyzing the development of embryos through the process of their cultivation. The possibility of using video recording based on the ability to slow down filming (time-lapse) allows detecting pathologies that cannot be determined using traditional control methods.
Source: https://nauka.tass.ru/nauka/21128651
Newly registered medical devices
We publish a list of new medical devices registered from 06/28/2024 to 07/05/2024
Link to the list: [see table in the attachment]
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