Case of medical equipment

False documents were discovered at Roszdravnadzor

Health officials appear to be becoming law enforcement's regular clientele. Recently, another criminal case was opened in the capital - this time investigators are studying schemes through which foreign-mademedical equipment and medical products were imported into Russia. All such products must be tested in our country and registered accordingly. However, during an inspection recently conducted by the Department of Economic Security of the Ministry of Internal Affairs on behalf of Deputy Prosecutor General Viktor Grin, it turned out that in the piles of certificates issued annually for medical equipment there are also fakes. In particular, forged seals and signatures were found on documents received by the Federal Service for Surveillance in Healthcare and Social Development - it is this agency that is responsible for registering medical products. This fact served as the reason for initiating a criminal case under Article No. 327 of the Criminal Code (“Forgery, production or sale of counterfeit documents, state awards, stamps, seals, forms”).

The main defendants in the criminal case are key officials of Roszdravnadzor, including the head of this department, Nikolai Yurgel. The other day, the first three witnesses in the case were questioned at the Internal Affairs Directorate of the Central Administrative District of Moscow. This is the deputy head of the department for registration of foreign medical equipment and medical products of Roszdravnadzor Valery Kovalev, the head of the legal department of this department Isamutdin Gusenbekov and one of his deputies. Actually, it was Mr. Gusenbekov who undertook to “open the corruption boil” in the department. It was he who openly wrote a complaint about the actions of his own leadership to the Prosecutor General’s Office and personally handed over nine folders with falsified documents to the inspectors.

Isamutdin Gusenbekov’s ill-wishers claim that he was forced to “wash out his dirty linen” from the federal service by the fact that he was subject to personnel cuts; the lawyer was informed of his impending dismissal at the end of the summer. But Mr. Gusenbekov himself believes that it was his exposing activities, aimed solely at identifying corrupt officials, that served as the immediate reason for his dismissal. “Back in April, I wrote a memo addressed to the head of the federal service, in which I spoke about the existing violations, but there was no reaction,” Mr. Gusenbekov told Vremya Novostey. According to him, after some time they made it clear to him in the most impartial terms that the legal department did not need to understand the peculiarities of registration documents. And after the restless lawyer began to write to external authorities, he was simply fired. Apparently, the last straw was the letter that Isamutdin Gusenbekov sent to the Minister of Health and Social Development Tatyana Golikova on August 4. It says: “Roszdravnadzor has been grossly violating the requirements of the legislation of the Russian Federation for a long time. Registration of foreign-made medical devices is carried out through intermediary companies controlled by the head of Roszdravnadzor N.V. Yurgel and his close associates (Center for Certification and Declaration LLC, Regmedservice LLC, Medresurs LLC, etc.), and on the basis of forged documents (test results, notary stamps and signatures, seals of organizations are falsified). Almost all test results for foreign-made medical devices registered for the first time are fake.”

There is still no response to this letter. But, as Vremya Novostei learned, even before going on vacation, the minister instructed several departments to look into the situation and even put her resolution on the document. Its content, of course, can still be adjusted taking into account the fact that a criminal case has emerged during Ms. Golikova’s vacation. But for now, the Ministry of Health and Social Development officially informed Vremya Novostei that they are studying the available materials. And in the near future the actions of all parties to the conflict will be assessed.

In turn, Roszdravnadzor claims that an internal investigation, following a signal from a lawyer, was carried out back in the summer. “The companies listed in Mr. Gusenbekov’s appeal have never had any relationship with the federal service. We checked - they did not work with us. As for the criminal case, there is nothing unusual in this. We work closely with the Ministry of Internal Affairs and, having suspected forgeries at the stage of document preparation for a completely different company - Santaproduct LLC, we turned to them ourselves. This decision was made at the level of the leadership of Roszdravnadzor,” Valery Kovalev, deputy head of the department for registration of foreign medical equipment and medical products, told Vremya Novostei.

It is noteworthy that the Certification and Declaration Center LLC itself is confident that it works with Roszdravnadzor, and moreover, it regularly submits applications to this agency for certification. “The name of our company appeared in connection with this unpleasant story, most likely due to the fact that Mr. Gusenbekov looked into the federal service database and saw that most of the requests there were from us. We are truly leaders in the market for consulting services in this area,” Dmitry Zubarev, general director of the Center for Certification and Declaration LLC, who previously also worked at Roszdravnadzor, told Vremya Novostey. Two years ago, Mr. Zubarev created his own company, which is a Gosstandart certification body. “Our company helps foreign manufacturers understand the rules of work in the Russian market and has the right to issue certificates of conformity for products,” noted Mr. Zubarev.

It is noteworthy that the emergence of a criminal case did not cause any particular surprise or concern among participants in the medical equipment market. The system for registering medical products in our country is designed in such a way that it will not work at all except in violation of regulatory documents and in the presence of a corruption component. The chairman of the European Association of Medical Products Manufacturers, Vitaly Omilyanovsky, is almost sure of this. In a legal vacuum, when there is no law “On Medical Products” and this entire market is regulated exclusively by administrative regulations and decisions of officials, any predictability is valued above all else by foreign manufacturers. They don’t mind paying an intermediary company to organize the registration of their products from 500 (in vitro reagents) to 30 thousand dollars (computed tomograph) and sleep peacefully, knowing that everything will be smooth and done on time. “These registration costs are included in the budget of any company,” Mr. Omilyanovsky told Vremya Novostey. How the intermediary company organizes everything is of little concern to the manufacturer. “The system works, and today it is predictable. Medical products are registered and put on the market,” the head of the professional association is confident.

In practice, virtually all suppliers of medical products use the services of intermediaries, whom the chief lawyer of Roszdravnadzor accuses of falsifying documents and collusion with the leadership of the federal service. The fact is that according to Russian legislation, the circulation of such products on the territory of the country without registration is prohibited. To obtain the necessary certificates, a product must undergo a number of procedures, the main one of which is checking its qualities at one or another testing base (this can be either a medical institution or a special laboratory). But in order to bring a prototype product for testing, you need to receive a special letter from Roszdravnadzor and wait for the federal service to agree on an import permit with the customs authorities. This is a long procedure, and in reality no one uses it.

“I have never seen such requests from manufacturers, although after the administrative reform they would have to go through my department,” says Isamutdin Gusenbekov. According to him, all intermediaries have a set of seals from various hospitals and calmly issue certificates themselves confirming the successful completion of tests by one or another device. True, from time to time it turns out that the signatures of the same head physician on such papers are completely different, but previously, according to the lawyer, they always turned a blind eye to this. And the registration certificate was issued by Roszdravnadzor without any problems.

To be fair, it should be said that this situation has never caused any particular damage to the health of citizens, because imported equipment always undergoes very serious testing in the countries where it is produced. Moreover, in the vast majority of cases, it is simply impossible to truly assess its working qualities in Russia. “There is no system of modern, equipped expert organizations with professional experts on staff,” explains Vitaly Omilyanovsky. Now an ordinary city hospital is testing a very complex CT scanner and giving some conclusions about it.

According to market representatives, if you give a “green corridor” to well-known foreign companies, freeing them from administrative fees, this will significantly reduce unaccounted financial flows in the system and at the same time make it possible to conduct real checks of truly suspicious equipment, say, from China or India. Indeed, with the current flow of newly registered medical products, it is impossible to seriously understand the consumer properties of even a tenth of them. According to the Department of Registration of Foreign Medical Equipment and Medical Products of Roszdravnadzor, in 2007, 1,033 names of imported products that were not previously supplied to our country received registration certificates, and in the first half of this year - 950. At the same time, 32% of issued certificates were for in vitro reagents, 24% for dental prostheses, 9% for medical kits, 8% for instruments and apparatus, 3% for surgical instruments, 2% for spectacle optics. All others fall under the so-called “other goods”, which are not subject to separate classification.

Galina PAPERNAYA