News Digest 16.09.2024 — 18.09.2024
Regulators
For administrative violations, medical equipment will be confiscated from clinics in favor of the regions
The Russian government has added medical equipment and drugs to the list of confiscated property that was the instrument of committing or the subject of an administrative offense subject to conversion into the ownership of the subjects of the Russian Federation. The new rule will affect the work of clinics, pharmacies and other specialized organizations. The mechanism will be applied in all cases, except for violations under Art. 14.10 of the Code of Administrative Offenses of the Russian Federation - illegal use of someone else's trademark, service mark, name of the place of origin of goods, as well as Art. 16 - violations in the field of customs.
The list of such property also includes perfumery and cosmetic products, telephones, computer and household appliances with components, furniture and other products.
The property will be transferred to the ownership of the regions at the place of its location. The procedure for disposing of such products in the subjects will be determined by a government act. At the moment, the disposal of property converted to state ownership is regulated by law. In this case, a decision may be made to process, destroy or sell.
In July 2024, Deputy Chairmen of the State Duma Pyotr Tolstoy and Anna Kuznetsova, First Deputy Chairman of the Committee on Economic Policy Denis Kravchenko and other deputies prepared a bill providing for the confiscation of property for organizing illegal migration. If adopted, the norms will also affect clinics that issue medical certificates that recipients use for illegal migration. In 2021-2024, law enforcement officers opened several similar criminal cases.
The Code of Administrative Offenses regulates the procedure for imposing fines for non-compliance with the legislation on the circulation of medicines (Article 14.4.2). For example, violation of the established rules for dispensing drugs subject to quantitative accounting, if these actions do not contain signs of a criminal offense, entails a fine of 10 to 20 thousand rubles for officials or disqualification for a period of six months to one year, from 50 to 100 thousand rubles in fines for individual entrepreneurs, from 150 to 200 thousand in sanctions for legal entities. According to the National Scientific Competence Center in the Sphere of Combating Illegal Circulation of Industrial Products (NSCC), in the first nine months of 2023, 70 cases of administrative offenses were initiated under Part 1, 4 of Art. 14.4.2 of the Code of Administrative Offenses of the Russian Federation (dispensing drugs in violation of the requirements regarding the establishment of maximum wholesale markups to actual selling prices). Most often, violations were observed in the Volgograd Region, the Kabardino-Balkarian Republic and Moscow. In total, according to the calculations of the National Scientific Center of Drug Control, the number of drugs confiscated or withdrawn from illegal circulation for the first nine months of 2023 amounted to 8,921 packages, which is 5.3 times less than for the first nine months of 2022 (47,095 packages). The leading regions in terms of confiscation were Moscow (3,290 packages) and the Republic of Mordovia (659 packages). According to Roszdravnadzor data for 2023, the most frequently withdrawn drugs from circulation were substandard drugs (number of batches - 258), counterfeit drugs (5 batches), drugs that were in civil circulation in violation of the law (17) and three batches of unregistered drugs. In August 2024, the Ministry of Industry and Trade developed a draft resolution of the Government of the Russian Federation on the procedure for the further use or destruction of confiscated or seized narcotic drugs, psychotropic substances and precursors, as well as tools and equipment under special control and used for their production. The amendment is intended to replace a similar document (Resolution No. 647 of June 18, 1999), excluding from it the possibility of using such products for medical purposes, including after their processing. According to the Federal Customs Service of Russia, together with law enforcement agencies, the agency in the first quarter of 2024 seized 30 times more controlled substances from illegal circulation than in the same period last year. A total of 6 tons were seized, of which 2.4 tons were narcotic drugs, 3.8 tons were precursors, and another 111 kg were potent and psychotropic substances.
Market news
The Ministry of Industry and Trade of the Russian Federation failed to sue Kurgan Sintez for 86 million rubles
The Moscow Arbitration Court rejected the Ministry of Industry and Trade of the Russian Federation's claim against PAO Joint-Stock Kurgan Society of Medical Preparations and Products Sintez to collect a fine of 85.6 million rubles. In February 2016, the parties entered into an agreement on the provision of subsidies for the implementation of the project "Modernization and expansion of high-tech production of disposable medical products and consumables for medical products." The Ministry of Industry and Trade stated that PAO Sintez failed to fulfill its obligations to achieve the required p revenue providers. The plaintiff indicated that, according to the agreement, the project implementation was to be divided into three stages, spread over three years. All indicators were achieved for the first stage, which was confirmed by the report of PAO Sintez for 2016. The Ministry of Industry and Trade did not have any complaints about the document, but in the reports for 2017 and 2018, the agency found that the targets for the indicator "revenue from the sale of medical products manufactured within the framework of the project" were not achieved. With the required revenue of 471.3 million rubles in 2017, Sintez earned 224.32 million rubles; in 2018, with the required 558.8 rubles, the manufacturer reported revenue of 255.78 million.
Referring to the clause of the agreement on the provision of a subsidy, in February 2024, the Ministry of Industry and Trade sent PJSC Sintez a demand for a fine for failure to achieve the quantitative values of the indicators of the effectiveness of the project implementation. The claim became the basis for going to court.
The Moscow Arbitration Court, having reviewed the case materials, pointed to the provisions of Article 196 of the Civil Code of the Russian Federation on the general limitation period, which in this case is 3 years. In the statement of claim, the department wrote that the failure to achieve the indicators became known based on the results of the review of the final reporting documentation of PJSC Sintez, which was received by the Ministry of Industry and Trade in October 2020. Moreover, the manufacturer's appeal "did not contain any new information that had not been previously submitted to the Ministry of Industry and Trade." Therefore, the court points out, October 2020 cannot be the start date of the limitation period, since the Ministry of Industry and Trade learned or should have learned about the grounds for filing a claim for payment of the fine earlier, on the date of receiving the last report back in April 2019. But the arbitration court decided that the claim for recovery of the fine was filed almost 3.5 years after the last communication regarding the reporting on the project, accepted without comments from the Ministry of Industry and Trade. Therefore, the Moscow Arbitration Court decided that, under the given circumstances, the department's claims are not subject to satisfaction. The decision can be appealed within a month from the date of its adoption in the Ninth Arbitration Court of Appeal. In January 2023, the Investigative Committee of the Russian Federation for the Kurgan Region completed the investigation of the criminal case against the head of the workshop of the Sintez production site in Kurgan. In April 2022, a dust-air mixture explosion occurred at the enterprise, which partially collapsed the structures of workshop No. 4. One of the workers was injured. According to the investigation, the emergency occurred due to the violation of industrial safety requirements by the head of the workshop.
Other
Apple received permission to use headphones as a hearing aid
The US Food and Drug Administration (FDA) has granted Apple permission to use the sleep apnea detection option in the Apple Watch Series 10 and a software update for AirPods Pro 2 headphones, which allows the gadget to be used as an over-the-counter hearing aid.
The Sleep Apnea Monitoring feature in Apple Watch Series 10 measures the user's breathing rate over multiple sleep sessions to detect the risk of apnea. The collected data will be sent to the customer as a report in the Health app. If necessary, this report can be consulted with the attending physician.
The hearing aid mode in AirPods Pro 2 will be available to people with mild to moderate hearing loss. In addition to the ability to amplify external sounds, the device will allow you to apply individual settings to the system sounds of the smartphone. To determine the level of hearing, users will be able to take a five-minute test, which will also be synced with the Health app. During the test, customers will be asked to listen to a series of beeps of varying volume and frequency. F
DA approved the use of over-the-counter hearing aids in 2022.
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