Counterfeit medicines: the problem can be solved

Reflecting on the problem…V.T.MAZEIN, P.P.ELISOV, Candidate of Law, Senior Researchers of the Institute of the Ministry of Internal Affairs of Russia

The presence of falsified medicines (FLS) in the pharmaceutical market of Russia today is recognized by everyone: politicians from high tribunes and pensioners in queues for free medicine talk about it. What is the amount of counterfeit circulating in the domestic pharmaceutical market, and is there a real possibility of its reduction?

The problem is not only RussianAccording to the WHO definition, "a falsified medicinal product is a product intentionally and unlawfully provided with a label that incorrectly indicates the authenticity of the drug and/or manufacturer", i.e. falsified medicines may contain ingredients that correspond to the label, and may not contain; may contain, but not the right amount, or contain the wrong ingredients, which are indicated on the label, and finally, the packaging itself may be fake.

There are many options…

From 1982 to 1997, according to WHO, 751 cases of falsification of pharmaceutical products were registered. At the same time, 443 (59%) preparations did not contain active ingredients, 170 had deviations in the content of active substances, 16 contained other active substances.

Forgers fake everything that is in demand. Approximately half of all falsified medicines are antibiotics. Then there are psychotropic substances, hormonal drugs, blood substitutes, cancer remedies. The list of fakes includes both penny nystatin and super-expensive AIDS medications.

WHO, which includes 192 States, has been dealing with the problem of counterfeit medicines since 1982. At the same time, the idea of creating a special data bank was born in order to immediately inform WHO member countries about cases of detection of forgeries. But so far, the work on creating a data bank has not been completed: both countries and pharmaceutical companies are not very willing to supply this information, fearing that consumers, unable to distinguish fake medicines from real ones, will stop buying them altogether.

Digital MessIn modern Russia, the first mention of a fake drug dates back to 1997, when the falsified blood substitute Polyglucin produced by the Krasnoyarsk Pharmaceutical Plant "Krasfarma" was identified.

This was the only case that year, and it can be said that they did not pay attention to it. Even the Law of the Russian Federation "On Medicines" adopted in June 1998 did not contain such a thing as a "falsified medicinal product", it appeared much later, in 2004.

In various Russian printed sources, figures are given reflecting the number of falsified drugs being used in the domestic pharmaceutical market, and the difference in the data on the FLS is enormous − from 0.4 to 60% of the total mass of drugs. At the same time, it should be noted that we are talking not only about those counterfeit medicines that are sold through pharmacies at commercial prices and free of charge under the DLO program, but also those that are treated free of charge in medical and preventive institutions.

Nevertheless, we will try to determine the more or less real number of falsified drugs in the domestic pharmaceutical market by referring to official sources. According to WHO, the number of counterfeit medicines in Russia is at the level of 12% of the total number of drugs. In the final documents of the parliamentary hearings in the State Duma (February 2006) "On legislative measures and technical methods to counteract the turnover of counterfeit, falsified and low-quality products in the Russian Federation", it was noted that the share of falsified medicines in Russia is 20%. Roszdravnadzor claims that in Russia the share of counterfeit drugs in the total volume of drugs in circulation is about 10-12%, and, according to experts of this federal service, there is a decrease in the volume of counterfeit drugs in Russia.

However, we note that a number of experts question the indicators of Roszdravnadzor. They believe that Russia, together with China, have already come out on top in the production and shadow turnover of counterfeit medicines, overtaking India, Brazil and Turkey, traditionally considered the main producers and consumers of counterfeit medicines at the same time.

Nevertheless, the authors of this article, based on the analysis of the Russian pharmaceutical market and the activities of the internal affairs bodies to identify and solve crimes related to the trafficking of counterfeit drugs, tend to support the assessment of Roszdravnadzor and agree that the share of FLS in the total mass of drugs in the pharmaceutical market of Russia is only 10-12%.

Comparing and comparingNo less a problem, according to the authors, is the determination of the number of names (assortment) and series of identified counterfeits circulating in the pharmaceutical market of Russia.

The figure presented to your attention draws attention to the sharp increase in the detected counterfeit drugs and series in 2006 and its significant decrease in 2007. This is due to the results of the fight against their production and sale by both Roszdravnadzor and the Department of Internal Affairs. In 2006, during the usual annual quality control of drugs in circulation, 52 names of 101 series of drugs were identified (the figure shows data excluding drugs whose turnover was suspended due to doubts about their authenticity). In addition, in 2006, in addition to the specified number, another 105 names of 300 series of FLS were identified, which were discovered at the pharmaceutical enterprise CJSC "Bryntsalov A" during the investigation of a criminal case. It should be noted that the participants of the pharmaceutical market do not know about this number of FLS, because incomplete information was brought to them, only about 65 names of 119 series identified at the beginning of the inspection (letters of Roszdravnadzor: dated 17.04.2006 No. 01I-316/6 and dated 02.05.2006 No. 01I-366/6). Nevertheless, the positive results of the fight against counterfeiting achieved in 2006 made it possible to significantly reduce its presence in the pharmaceutical market in 2007. (only 44 titles of 79 FLS series were revealed).

It is important to emphasize that the sources of counterfeit drugs entering the Russian pharmaceutical market are not only domestic, but also foreign manufacturers. At the same time, about 65% of the counterfeit is produced by domestic manufacturers, about 27% comes from non-CIS countries (Bulgaria, Poland, India, China, etc.), 8% from the CIS and Baltic countries. Moreover, a significant number of counterfeit medicines enter Russia almost unhindered: customs authorities are not able to make a qualified examination of imported pharmaceutical products, and all the necessary accompanying documents, including certificates of conformity, the manufacturers of fakes have learned to forge better than the drugs themselves.

The accounting of the detected falsified medicines is carried out by Roszdravnadzor, whose data was also used by the authors. However, this service does not analyze the data, and therefore the indicators of Roszdravnadzor on the number of names and series of FLS for 2006 and 2007 differ from those shown in the diagram. According to Roszdravnadzor, in 2006-2007, 66/58 titles of 147/146 FLS series were identified, respectively.

Here are the results of another analysis, which is not carried out in Roszdravnadzor, because the number of detected packages of counterfeit medicines is not taken into account. The essence of this analysis boils down to the fact that FLS packages were identified both in the process of their production and in the process of implementation. This allows you to determine the approximate number of packages that could not be withdrawn from circulation.

For the first time, the largest number of FLS packages was revealed in 2006 at the pharmaceutical enterprise CJSC "Bryntsalov A". As established by the investigation, over 2 years of criminal activity, more than 1.8 million packages of counterfeit drugs were manufactured and sold, the right to manufacture which belongs to foreign manufacturers.

During the pre-investigation inspection and preliminary investigation, more than 1 million packages of counterfeit medicines of the same names and series were found and seized on the territory of Bryntsalov A CJSC, as well as warehouses used by it. Thus, the implementation of this falsification was prevented.

It should be noted that in the period from 2004 to 2006, only a few tens of thousands of packages of FLS were withdrawn from circulation. So, for example, during 10 days of the operation "Pharmacologist", conducted by the staff of the Department of Internal Affairs together with Roszdravnadzor throughout Russia, 1,600 packages of FLS were found and withdrawn from circulation in 600 pharmacies. Among them were medicines with names and series similar to those produced at Bryntsalov A CJSC. It is impossible to give a more accurate figure of the seized packages of FLS, because the systematic collection, accounting and analysis of this information is not centrally conducted, and, therefore, it is not possible to even approximately determine the number of packages of counterfeit medicines that reach patients.

With hope for info-resources and... conscientiousnessThe materials of criminal cases initiated on the facts of the production and sale of drugs indicate that the falsifiers carried out their illegal activities for a long time (from 2 to 4 years), and this, according to the authors, indicates inadequate control over the production and sale of drugs.

For example, the pharmaceutical enterprise CJSC "Bryntsalov A", as established by the investigation, produced falsified medicines of more than 100 names of 300 series, however, during their 2-year implementation in 2004 and 2005, only 16 names of 31 series were identified. At the same time, as can be seen from the materials of the criminal case, the falsified medicines and their packaging were not made so perfectly that it was impossible to distinguish them from the original drugs. Thus, in the conclusions of the Federal State University of the National Medical Center, which conducted a comparative study of these drugs, it was indicated that the studied drugs differ from the original samples in such parameters as "Packaging", "Labeling", "Description". In this regard, the experts concluded that the samples presented were falsified drugs. Representative offices in Russia of 25 foreign pharmaceutical companies in their responses to the investigation reported that there are signs on the presented samples of drugs and on their packages that allow you to visually distinguish these drugs from the original drugs.

The question arises, what prevented the timely identification of these counterfeit medicines in the retail network according to the distinctive features available on them?

As a clear example of long-term and uncontrolled illegal activities for the implementation of the FLS, we can cite the data of the criminal case initiated against the CEO of Phytomarket LLC. During the investigation, it was established that this organization had been carrying out wholesale and retail sales of counterfeit medicines without a license for more than 2 years (a photocopy of the fake license was presented to buyers and inspectors). At the same time, the main buyers of medicines were, as a rule, budgetary healthcare institutions of various subjects of the Russian Federation. Most often and for large amounts (from 100,000 rubles) medicines were purchased by the territorial funds of compulsory medical insurance for healthcare institutions operating in the compulsory health insurance system.

In this criminal case, the following fact is noteworthy: when the counterfeit drug Linex (capsules No. 16) series 0606802G was detected in retail trade, Roszdravnadzor, by its letter dated 02.03.2006 No. 01 and 165/06, invited all participants of the pharmaceutical market to withdraw this counterfeit from circulation and destroy it. However, only the wholesale commercial company SAI International LLC appealed to Phytomarket LLC with a demand to take the falsified Linex and return it the money in the amount of 900,000 rubles. No budget organization has filed such claims, therefore, only the company SAI International LLC was recognized as the injured party in this criminal case.

We are confident that the conscientious attitude of pharmacy employees to their duties will allow us to organize the work so that it is possible to timely identify not only falsified drugs, but also fraudsters who sell them. After all, in order to check the seller for the availability of the appropriate license, it is enough on the Internet on the website www.roszdravnadzor.ru in the section "Licensing of pharmaceutical activities" in the subsections "Suspended and renewed licenses" and "Cancelled licenses for pharmaceutical activities", get acquainted with the available information of Roszdravnadzor about licensees. In the event that there is no information about the company of interest in these databases, you should send a request to Roszdravnadzor to confirm the license of the individual or legal entity of interest.

In addition, it is advisable in every pharmacy institution:

• have a list of Roszdravnadzor containing the names of rejected and falsified drugs. This list has been maintained since 1999. As of 12/30/2007, it contained 15,500 names and series of rejected and falsified drugs. This list is posted on the Internet on the website www.farmcontrol.ru (tel. (495) 737-75-25) and constantly, as such drugs are identified, replenished;
• to receive timely information from Roszdravnadzor about rejected and falsified medicines. This information in the form of letters from Roszdravnadzor, as such drugs are identified, is posted on the Internet on the website http://www.regmed.ru /.

Employees of pharmacy institutions, using these databases of substandard and falsified drugs, already today have the opportunity to identify such drugs in a timely manner and withdraw them from circulation. Falsifying drugs that will stop buying will simply not be economically profitable. The conclusion is that the conscientiousness of pharmacy retail is the easiest way to get rid of counterfeit drugs in circulation.