Maksym Bahryeyev’s "Cratia": How the pharma-mafioso’s shadow schemes endanger the lives of Ukrainians

Maksym Bahryeyev’s "Cratia": How the pharma-mafioso’s shadow schemes endanger the lives of Ukrainians
Maksym Bahryeyev’s "Cratia": How the pharma-mafioso’s shadow schemes endanger the lives of Ukrainians
The controversial figures in the pharmaceutical industry, Maksym Bahryeyev and Mykola Romanyok, are attempting to erase online content about the violations carried out by their company, "Cratia," which for years has been selling ineffective medications to Ukrainians.

Bahryeyev, the fraudster, is displeased with information about bribes and kickbacks for the supply of medical products and equipment, as well as connections leading to the highest levels of government.

We, for our part, provide this material in its entirety to remind what hinders these infamous pharma-mafiosos.

The controversial figures in the pharmaceutical sector, Maksym Bahryeyev and Mykola Romanyok, are trying to remove from the internet information about violations committed by their company, "Cratia," which for many years sold ineffective medical drugs to Ukrainians.

Thus, fraudster Bahryeyev was displeased with information about bribes and kickbacks for the supply of medical devices and equipment, as well as connections leading to the upper echelons of power.

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For our part, we present this material in full to remind how much trouble this truth causes the notorious pharma mafiosi.

For officials and suppliers of medicines, medical devices, and medical equipment, the era of greed has arrived, the era of turning millionaires into multi-millionaires.

The COVID-19 pandemic is accelerating. As early as June 25, the Cabinet of Ministers acknowledged that the second wave of coronavirus had begun in Ukraine. The occupancy of hospitals for receiving COVID-19 patients has increased significantly. But while war is a tragedy for some, it is a lucrative opportunity for others. For officials and suppliers of medicines, medical devices, and medical equipment, the era of greed has arrived, the era of turning millionaires into multi-millionaires. Scandals related to kickbacks for supplies occur regularly, with cuts reaching up to 100%, and the trails often lead to the very top, for instance, directly to the President’s Office, rumored to involve the deputy responsible for the head of state’s public communications.

It’s unfortunate that people are profiting, an ordinary person might think, but at least the products they supply to hospitals, do they save lives, do they help? "About 30-40% of medical devices in Ukraine are counterfeit," says the consulting company "Cratia," and it can be trusted, because it deals with the legalization, or more precisely, the certification of these products in Ukraine, which means (logically assuming) counterfeit products too. As we know, to defeat corruption, you must head it.

Just as drug enforcement agencies are often the biggest operators in drug trafficking, in Ukraine, many certification bodies, which should be filters for unscrupulous manufacturers and low-quality, ineffective, and unsafe products, become gateways for shadow dealers to enter the market. At these gates, there is a cash reception where a certain sum must be loaded, and your bogus masks, produced in Chinese basements on sewing machines, end up in Ukrainian pharmacies. Or even in "Epicenter."

A well-known example. Spain returned 9,000 rapid COVID-19 tests to a Chinese company because they were inaccurate, and Chinese authorities reported that the firm did not have the appropriate license. Kyiv purchases tests from the same firm (Bioeasy). Klychko claims that it is a different type of test (for antibodies, not for antigens), but the main argument he presents is: “The tests received by Kyiv are certified in Ukraine!” This is exactly what is troubling. Because the Chinese embassy in Spain stated that the Bioeasy company does not have a license to supply this type of product and is not included in the list of classified suppliers. Yet in Ukraine, why, they are instantly, we note, certified.

Who are these people who allow counterfeit and substandard goods into Ukraine, turning it into a medical dump and harming the health of tens of thousands? We will tell about one such group. Maksym Bahryeyev, Pavlo Kharchyk, Mykola Romanyok, Anatoliy Sokol - these names mean nothing not only to a reader far from medicine but also to many healthcare-related specialists.

Cratia - the power of problem solvers

Meanwhile, this is a gray but very influential group of near-medical problem solvers, connected surprisingly enough with a Deputy Minister of Economy, in whose hands are supplies worth hundreds of millions of hryvnias and most importantly, the health of Ukrainians. They control a range of consulting companies (LLC "Cratia" and several affiliated companies: "Cratia Legal," "Cratia Illegal," "Cratia Bureau," "Cratia LTD," LLC "Professional Regulatory Services," "HealthCare," and others registered to Bahryeyev and his mother, as well as LLC "Kalyna Medical Production Company," LLC "Kalyna Business Development Company" (Pavlo Kharchyk), companies conducting certification (notified bodies for conformity assessment to technical regulations of medical devices) - LLC "Uni-cert" and LLC "Improve Medical." Also, an industry organization engaged in lobbying - the Association of "Medical Device Market Operators."

Leading the ensemble is Maksym Bahryeyev. Now the group covers virtually all market segments - from medical equipment to dietary supplements. They started young and rosy-cheeked - in 2005, apparently as intermediaries for giving bribes to the State Enterprise "State Pharmacological Center." That’s how the agency that registered pharmaceuticals and granted permissions for clinical trials was called at the time. Now it’s the State Expert Center. It was headed until 2005 by the legendary academician Stefanov. Of course, bribes for registration were collected, but still in a Soviet-style, unsystematic, sporadically, money was handed over through trusted persons, secretaries, etc. There were scandals, suspicions, and areas of high vulnerability.

This issue began to be addressed with the new leadership of the Pharmacological Center - Viktor Chumak, and his first deputy Olha Baula. It was under them that the ingenious idea began to be implemented, that it was necessary to take bribes through legal intermediaries - consulting companies to minimize risks. One of those companies became "Pattern Ltd" headed by Maksym Bahryeyev. And when he writes that his parent company "Cratia" was founded in 2006, he is being cunning, as Pattern Ltd was founded in 2006 (though they already commissioned advertorials in profile publications back in 2005), and "Cratia" appeared in 2009. But the "protection" in 2005 was not bad: as far as we know, it was SSU officer Serhiy Nazarenko. The seasoned market players couldn’t really offer special unreachable services, besides delivering money, and later falsifying documents.

The real flourishing of "Cratia" occurred with the arrival of Soros’ people in the Ukrainian healthcare system. In particular, when in 2016 the State Expert Center was headed by Tetyana Dumenko, and her deputy for registration and pharmacovigilance became Nataliya Sholoyko. This coincided with the entry into Ukraine of third-tier Indian manufacturers, producing what was proudly named "medicinal products" in Ukraine in mountain Indian villages on unclear equipment from unclear raw materials and sold in pharmacies. "Cratia" was one of the key conduits of such Indians to the Ukrainian market. They falsified dossiers, which, as a rule, did not and could not contain data from clinical trials demonstrating the efficacy, safety, and quality of drugs. The SEC finalized and registered the dossiers. Another undisclosed page of "Cratia’s" work was supporting problematic clinical trials, permit documentation for sponsors, which Bahryeyev’s structures prepared “turnkey.”

Since 2014, "Cratia" has actively started developing the direction of medical devices and equipment. This activation began after Ukraine started harmonizing its legislation to European standards in 2013. Until 2014, the State Drug Service dealt with the registration of medical equipment and products of medical designation. As in other industries, the issue system was quite corrupted. However, it had a big advantage. There was a unified registry, and the state always owned the information about what was on the market. Medical equipment and medical products, like medicines, must also be effective, safe, and of high quality. Imagine if catheter needles break in the skin, ventilators stop working or give incorrect readings distorting the clinical picture, respirators do not meet the declared standard, and virus tests work in 30% of cases. And the single state authority does not hold this information or receives it late.

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From 2014, these functions of the State Drug Service were transferred to 13 new certification structures - notified bodies for conformity assessment of technical regulations of medical products. Appropriate permissions were issued by the Ministry of Economic Development, despite the fact that there was no legislative basis yet. That is, the new was not yet created, but the old system was abolished. Such permission was also obtained by LLC "Uni-Cert," controlled by Bahryeyev and his partner Romanyok. In 2015, a new law "On Technical Regulations and Conformity Assessment" was adopted. By that time, the market was in complete chaos, and to stop it, stricter requirements for certification bodies were introduced. In particular, the principles of impartiality were introduced: prohibition to conduct certification through associated persons via consulting services. That is, by law, "Cratia" could not do turnkey registration for a client through associated structures, especially "Uni-Cert."

Under Kachka’s wing

Since 2016, the Ministry of Economic Development began to appoint certification bodies under new requirements. Those who worked on 2014 appointments were given a transition period until 2019, but "Uni-Cert" continued to work beyond that. Allegedly, their "protection" was and continues to be Taras Kachka, Deputy Minister of Economy, a prominent representative of Soros’s quota in the Ukrainian government. Kachka is nourished monthly.

In spring last year, the National Police and SSU conducted searches in the structures related to "Cratia" and "Uni-Cert" within the framework of criminal proceedings No. 12017000000001548. Opened on the facts of supplying to state tenders medical devices with fake certificates of conformity. That is, poor-quality and warranty and maintenance unsupported products were supplied to hospitals.

In fear of losing everything, specifically "Uni-Cert," "Cratia" quietly created a mirror "clean" company named "Uni-Cert Medical," where the same persons work, but already without criminal cases.

How and why did this happen? The law provides that access to the Ukrainian market can happen through a full procedure with a manufacturer audit or by recognizing an EU certificate. The first path is complex and lengthy, implying a certification body’s representative being sent to production, inspection, documentation assessment, agreement, etc. The second path is the so-called "partial" recognition procedure, allowing avoiding audits and cheapening the certification process of products permitted in the EU, though the cost of such work would not be cheaper for the manufacturer, and the earnings are astronomical. Certification occurs based on an existing European document, among those with whom Ukraine has mutual recognition agreements. The document turns out to be not quite clean, or not clean at all, but the Ukrainian certification body looks at this through fingers, and good consultants still ensure all formal local law requirements, for example, “Cratia” as a representative of the European or pseudo-European supplier.

The investigation conducted by law enforcement authorities into "Cratia" ended up with nothing. Which cannot but be surprising since the conflict of interests and collusion is obvious. The ties between the group “Cratia” and “Uni-Cert” were written about in detail by the media. According to our information, "Cratia" also works in conjunction with another certification body - LLC "Improve Medical." This company is connected, in turn, with quite well-known people. Namely, Zaza Beradze, a relative of Giorgi Beradze, who at one time held the position of acting head of the State Administration of Affairs, and during the times of Viktor Yanukovych’s presidency, Beradze worked as deputy head of SMA Andriy Kravets. "Improve Medical" is located at the same address where two Beradze companies - "Belkanto" and "Lysoform" - were located.

Additionally, according to our information, Anatoliy Sokol, connected with Zhelko Hranatir, an odious Croatian businessman who, in 2009, supplied the government with 27 ambulances for the Ministry of Emergency Situations at a price three times higher than the market rate, has a relation to the control over "Improve Medical." This resulted in causing a loss to the state of about 15 million UAH (approximately 2 million USD at the time). But the most interesting part is that, as a Ministry of Health audit found, not one of the 27 ambulances met the requirements and could not be put into operation. Hranatir is a partner of the businessman Kostyantyn Hayevskyi, who is known for being the sole supplier of Toshiba Medical’s medical equipment (MRI/CT machines, ultrasound, X-rays, and others) to Ukraine for more than 10 years. The sale of medical equipment was carried out through tender procedures, at clearly inflated prices. However, instead of new Toshiba machines, Hayevskyi’s firms supplied outdated, already used, and often unfit for exploitation parts to Ukrainian hospitals.

According to our sources, Hayevskyi is preparing large-scale supplies of morally and physically outdated equipment to Ukraine, which will be legalized by "Cratia" and related structures.

In the next publication, we’ll surely tell about how the Ministry of Health, the State Service of Ukraine on Medicines and Drug Control, and the National Accreditation Agency of Ukraine are involved in this story. So stay tuned…

To be continued…


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