The Russians with a number of rare diseases are unable to obtain the necessary drugs because of the epidemic of the coronavirus, state “b” in several patient organizations — this group of patients competing for antiviral medications with patients with coronavirus infection. With the shortage of commercial retail, and in the framework of preferential drug provision already faced by patients with rheumatoid arthritis, systemic lupus erythematosus and systemic scleroderma, the number of which in Russia reaches 1 million people. The Ministry of health has indirectly acknowledged the problem by proposing to give the health Ministry additional powers to monitor the presence of drugs. But the Agency is unlikely to do so effectively prior to the introduction of labelling of medicines — and, as fear of patients, the complexity with the introduction of the marker can reduce the presence of a number of drugs on the market, although solve the problem of counterfeit goods and avoid disruptions in the supply of bulk drugs.Patients with orphan diseases can face a shortage of drugs because of the epidemic of the coronavirus. A number of products have grown in demand due mention in the recommendations of the Ministry of health for the treatment of coronavirus infection, and in terms of quarantine, pharmaceutical companies became more difficult to implement mandatory labeling of drugs.As reported by “Kommersant” in the Russian rheumatologic Association “Nadezhda”, the majority of patients with rheumatoid arthritis and systemic lupus erythematosus (SLE) in March of this year it became more difficult to obtain or purchase necessary medications. “A number of drugs have disappeared from pharmacies, and it is impossible to state benefits nor buy for the money. The problems began when the Ministry of health has included them in the list of drugs recommended for the treatment of complications of novel coronavirus infection,” says the member of Presidium of Association of Polina Pchelnikova. Also yesterday, the Ministry of health updated recommendations, adding some more vital rheumatologic drugs are among the recommended for treating coronavirus infection. “A similar situation may occur around them — one of the drugs intended for the treatment of severe rheumatoid arthritis in children and adults, as well as severe forms of systemic vasculitis, still’s disease, and other severe rheumatic diseases,” she says. Judging on the basis of public procurement, one drug from the list already started to buy national medical surgical center named after N. I. Pirogov, previously converted for the treatment of patients with coronavirus.All, according to the Association, in Russia there are 1.3 million people with rheumatic diseases using immunosuppressive therapy, of which rheumatoid arthritis affects about 800 thousand people. “The drugs that they use, have long and effectively used to treat rheumat��odnogo arthritis and many other rheumatic diseases included in the clinical guidelines of the Ministry of health. On the contrary, their use in the treatment of coronavirus requires high-quality clinical trials evaluating the efficacy and safety for people with complications of a new coronavirus infection. These drugs, like many others, have very severe side effects,” says Polina Pchelnikova.Had a similar problem, as told “Kommersant” the Chairman of the Board of the national society of orphan diseases Irina Myasnikova, faced and patients with systemic scleroderma. “They can’t purchase the drug “Plaquenil”, as it was included in the list recommended by the Ministry of health and disappeared from pharmacies due to centralized purchasing. Because of this, can suffer at least a few thousand people,” she says. According to the head of the Russian public organization of disabled patients with multiple sclerosis, Yana Vlasova, in the next version of the recommendations of the Ministry of health can appear preparations for the treatment of patients with multiple sclerosis — a shortage of drugs can face them.As suggested by the co-chair of the all-Russian Union of patients (VSP) Yuri Zhulev, “because a number of countries accept restrictions on the transportation of goods and movement of people at the pharmaceutical companies have significantly shifted the timing of commissioning of equipment for applying code markings”. In his opinion, the majority of the drugs (for the treatment of hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, neoplasms of blood and related tissue, multiple sclerosis, drugs used in transplantation) may not enter the Russian market. However, at the Centre of development of advanced technologies, implementing the projects of marking, wonder, in these populations drug labeling is already October, and, according to DSM Group, these drugs were imported further from October 2019 in large volumes, thus avoiding their shortage in the market despite disruptions in the supply of substances. However, VSP appealed to the government temporarily, until the beginning of 2021, to allow circulation of certain drugs without the labelling. Previously, the Association of Russian pharmaceutical manufacturers and represents the interests of international pharmaceutical companies Association “Infarma” and AIPM also asked to postpone the transition period for the labelling of medicines from 1 July this year, at least for a few months.The Ministry of health, as follows from the draft government resolution on the extension of the powers of Roszdravnadzor in the monitoring not only of range but also the volume drugs from the essential drugs list (document posted on regulation.gov.ru), sees risks of shortage of medicines in the Russian market. However, how quickly and accurately the service will be able to do it, who — knowsnow, as explained “Kommersant” a source in one of the pharmaceutical companies, businesses are encouraged to send information about the production and supply of their products by e-mail. Much more effective this process will make marking, explained “Kommersant” in CBT: it “will allow the government real-time monitoring of their availability, adequacy and origin in each outlet and in the supply chain”. “With the spread of the coronavirus has also exacerbated the problem of illegal drugs — their share increased worldwide, in particular the share of counterfeit antiviral increased by 18%,”— said the press service of development center. Thus they believe that problems with the introduction of marks in the prescribed period not: according to them, now in the “Honest sign” was 86% of all drugs available in the Russian turnover, 94% of Russian and 80% of foreign pharmaceutical manufacturers on the Russian market.Anastasia Manuylova the beginning of 2020, according to information from the database gostorg, reduced the number of unfounded complaints to the Federal Antimonopoly service for the purchase of drugs on FL-44 for the Russian health care system. If in the first quarter of 2019, it was announced more than 98 thousand trades, which were filed with 777 complaints and 238 — proven this year — about 100 thousand, which complained 595 times and for 199 of them, the FAS issued a negative decision. We will remind, according to the antitrust legislation of the Russian Federation the complaint to the FAS for the organization of public procurement may submit any natural or legal person, after which the purchase is suspended for 10 days before removal of the decision on the presence of violations.At the same time, as noted by the head of Antimonopoly regulation of state orders and IT-technologies legal company a.t.Legal Love Bozhenko, up to half of these complaints in purchasing drugs are those who could be sent to the professional complainers. “For example, from a database on public procurement, we see that the company “Rustproof” sent in the last month 88 complaints in Moscow and regional offices of the FAS. In the case of 60% of these, the Agency found no violations, in particular because they purchased the drug, represented on the Russian market by only one manufacturer. However, the company prodoljaet to send the same complaints, while it itself, as follows from the Unified state register of legal entities working in the construction industry and is not related to the pharmaceutical market”,— said the expert. As explained to Kommersant, the Federal Antimonopoly service “Rustproof” is also not registered in the unified information system in procurement and cannot, in principle, to participate in procurement procedures. “These circumstances suggests that this company is not a potential party contested its procurement �� about the motive of such number of complaints of customers of the health sector at a time in a controlling body is necessary to guess only”,— commented the Deputy head of the Moscow Department of the FAS Alexander Knyazyan-were. However, according to “Kommersant”, after complaints the company was not asked to withdraw either to customers or to prospective suppliers will not find in its activities and ulterior motive. On request “b” the company said. At the same time, celebrates the Love of God, even if the Complainants can’t stop buying or to blackmail its members, they still harm them, because it increase the life of the contract. “At a time when health care providers need to quickly purchase medicines in terms of the epidemic of the coronavirus, even a small delay could harm their patients,” she says.The existence of such a problem — unwarranted complaints for bids in the absence of violations of the FAS was recognized early, particularly in public contracts for construction services which are the most expensive (see “Kommersant” on March 21, 2019). In General, every year in the FAS receives tens of thousands of complaints, half of which are unfounded. To deal with “professional complainers”, the Federal Antimonopoly service proposed to introduce duties on the recognition of the complaint unfounded. This, however, according to pharmaceutical lawyer Vladimir Anikeev, can do more harm than good. “It is impossible to regulate access to justice on the basis of the presence of the Complainant of a few extra tens of thousands of rubles. So we will get justice only for the rich, which is contrary to the essence of the right,” he says. In addition, according to him, if the complaint is established with the objective to intercept a major contract — and their value in the procurement of medicines often exceeds tens of millions of rubles, the amount of the fee is unlikely to stop the Complainants.Anastasia Manuylova
