Falsification of medicines: who benefits?
A MEANS TO STRENGTHEN PANICRoman Rozhkov, Kommersant
In the Russian media, information about falsification often appears, but Russia is not at all a leader in counterfeit medicines: both the United States and Europe overtake us in the number of fake medicines. Nevertheless, thanks to this speculative topic, a variety of forces extract their dividends from us.
Medicinal decayFor the first time, the falsification of medicines in Russia was talked about in the early 1990s, and in 1997 the first domestic fake was discovered - the blood substitute reopoliglyukin produced by the Krasnoyarsk Pharmaceutical Plant.
Since then, the number of fakes has increased many times. According to the definition of the World Health Organization (WHO), "a falsified medicinal product (FLS) is a product intentionally and unlawfully provided with a label that incorrectly indicates the authenticity of the drug and/or manufacturer." In the Russian legislation, the concept of "falsified medicinal product" appeared only in 2004, after an amendment to the law "On Medicines".
According to the American analytical center CMPI, by 2010 the turnover of counterfeit medicines will amount to $75 billion. Over the past 40 years, counterfeit medicines have killed 200 thousand people, while 65 thousand people have died due to the fault of terrorists during the same time. It turns out that counterfeit pharmaceutical products are three times more dangerous than international terrorism.
In September 2008, the head of the Department of Public Order Protection of the Ministry of Internal Affairs of Russia Gennady Zarapkin said that the sales volume of FLS for the year is $ 200-300 million, or 10-15% of the legal turnover of medicines. CEO of the Association of Russian Pharmaceutical Manufacturers (ARFP) Viktor Dmitriev claims that the volume of falsification in the Russian pharmaceutical market is about twice as low. Whatever it was, law enforcement agencies annually withdraw only 4-5 million rubles from the circulation of falsified and substandard medicines.
However, according to the head of the Healthy Planet holding, Roman Burmistrov, any figures concerning the share of counterfeit in our market will be approximate: no one will be able to accurately track all drug fakes. Director of the Institute of Public Health Problems Yuri Krestinsky has his own opinion: "The problem of counterfeiting is not deep and cannot be solved for the pharmaceutical industry, since, according to my estimates, the share of counterfeit in Russia is within 1%, which is less than in the EU and the USA. But the situation still remains acute, because 1% are specific cases that can adversely affect people's health."
Classification of counterfeitExperts warn against confusing the concepts of "counterfeit" and "counterfeit": according to David Melik-Huseynov, Director of Marketing Research at Pharmexpert, counterfeit drugs include drugs imported into the country bypassing official customs procedures.
And a fake is exactly a fake. There is also a third category of medicines that do not meet the requirements established by law: rejected drugs that have lost quality during transportation and storage or with expired shelf life. According to Pharmexpert, there are 8-9% of them in our market.
According to Nastasia Ivanova, CEO of the National Distribution Company, there are four types of counterfeit drugs. The first is a dummy drug (placebo), in which there is no medicinal substance. Often it is a simple chalk in the form of a tablet. In the case of complex diseases or heart attacks, the use of a placebo can lead to trouble. The second type is an imitation drug, in which the active substance is replaced by a cheaper and, as a rule, less effective. This is the most dangerous fake, which may well lead to the death of the patient. The third type is a modified drug, it contains the same substance as in the original, but in larger or smaller quantities. When using such a dangerous drug, neither the therapeutic result nor the absence of side effects from overdose are guaranteed. The fourth, most common type of forgery is a copy, it contains the same substances as in the original, and in the same quantities. However, the quality of the medicinal substance of such a drug purchased in India, China, the UAE, and Eastern European countries can only be confirmed by the manufacturer of the counterfeit.
According to various estimates, today 50-65% of counterfeit medicines are produced in Russia. And a significant part of such counterfeit (according to the Association of International Pharmaceutical Manufacturers, about 40%) is produced by the same Russian pharmaceutical enterprises that produce the original product.
According to Valentina Kosenko, the head of the department of the organization of state control of the circulation of medical products and rehabilitation of disabled people of Roszdravnadzor, drugs that are in high demand and are in the middle price category are most often falsified. "It is unprofitable to forge a penny drug," David Melik-Huseynov reflects.– For example, a package of activated carbon costs about 10 rubles. The benefit from malicious intent can be obtained with very large sales volumes of such a product, especially since the production process itself (stamping tablets, packaging) costs about 50-60% of the final cost of this drug." It is also risky to fake expensive products: it is not difficult to verify the authenticity and quickly identify the supplier, Melik–Huseynov continues.
Counterfeiting of vitamins and dietary supplements is common. "It should also be noted antibiotics, painkillers (paracetamol), atorvastatin, growth hormones, paclitaxel and filgrastim, sildenafil, tadalafil," Gennady Shirshov, executive director of the Union of Professional Pharmaceutical Organizations, expands the list of fakes.
For the sake of self - interestFalsification of medicines is beneficial not only to those who are directly involved in their production and sale.
Often, information about the level of falsification among medicines becomes the subject of political speculation, a kind of horror story for the population when the topic is deliberately exploited, thinks Viktor Dmitriev. "In such cases, the number of FLS automatically increases as political passions heat up," he says. "For example, in Ukraine, at the height of election campaigns, the level of falsifications in the country was estimated by some politicians at 60%."Indeed, to "nightmare" the population with fake medicines is beneficial primarily to those who work with voters, confirms Alexander Kuzin, CEO of the DSM Group marketing agency: "After all, the topic is known and understandable to everyone, it can always be raised, for example, in the Public Chamber, to start a discussion and thus earn yourself extra points."
Among those who earn money on the topic of FLS, there are companies that build their business on the identification of the authenticity of goods (see "Money" from February 26, 2007). The information that must be sent via SMS to the four-digit number of the service provider company to identify the authenticity of the product is a set of numbers and letters. They are applied to the product or its packaging. At the same time, the buyer not only makes sure that the product is not counterfeit (or counterfeit), but also learns, for example, about the expiration date of the product or the recommended price. Thus, according to Dmitry Kochnev, director of the Agency for Creative Solutions, the client receives reliable protection, and the manufacturer (or state control and audit bodies) - an effective and fast communication channel signaling problems with counterfeit.
However, an informed source of "Money", who asked not to be named, recalled that there were already examples in Russia when companies supported by law enforcement agencies offered means and methods of control, which became a real gold mine for a few, but did not solve the problem of control. According to him, one of these companies initiated the creation of the infamous EGAIS, due to the introduction of which in 2006, alcohol producers suffered billions in losses. "A separate barcode, a separate database, a separate authorized organization (the government appointed the Federal Tax Service as the authorized body for the introduction of USAIS.– "Money"). It was a very profitable project for her. Moreover, all this was supervised at the State Duma level with the participation of law enforcement agencies," the source says.
According to him, the same thing is happening in the pharmaceutical market. He calls the hype about the falsification "an accompanying PR campaign when lobbying for the next services": they can again introduce an additional barcode for a separate brand of medicines, appoint an authorized organization that will charge money for each brand, etc. "This is the creation of a huge business, because medicines are billions of packages, and if you take from each packages, for example, for 3 rubles, it turns out a very decent amount," the source continues.– In fact, this is corruption. Bursts of such information occurred before the introduction of bills to the State Duma on additional protection of medicines from counterfeiting with the use of stamps and an electronic control system." Hearings in the State Duma on this topic have already been held, but decisions have not yet been made: the negative experience of introducing a system for the protection of alcohol has been taken into account, the source summarizes.
Soil for fakesAnalysts and players of the pharmaceutical market name two main reasons for the spread of counterfeit.
The first is the high profitability of this business, Nastasia Ivanova believes. "In the conditions of unlicensed production, the lack of means of product quality control, the cost of production of pharmaceutical products is extremely low – and profitability increases sharply," explains Gennady Shirshov.Different price levels for the same or similar medicines also have an impact on this shadow market.
A huge number of intermediaries who are engaged in the purchase and distribution of medicines also benefit the counterfeiters: it is much easier for them to sell their goods. According to Nastasia Ivanova, there are more than 2.5 thousand distributors of medicines in Russia, while there are no more than a dozen such companies in Germany, and only four in France.
But the main problem players and experts consider a legal gap: the articles in the Criminal Code and the Administrative Code, providing for punishment for this activity, are too vague and fix only general rules of responsibility for crimes related to the circulation of counterfeit medicines, such as for the illegal use of other people's intangible assets or fraud. The absurdity of the current legislation also lies in the fact that the falsification discovered during inspections cannot be immediately recognized as evidence in an administrative and then criminal case, but is subject to destruction in accordance with the procedure established by law. This practice leads to the collapse of the criminal case even before the trial. It turns out that the illegal trafficking of medicines is not prescribed in a separate line in the legislation, and it is difficult to summarize these facts under other articles, for example, under "theft of intellectual property".
It is very difficult to establish whether the medicine is fake or not, says Yuri Krestinsky. The specifics of the products are such that only specialists in an equipped laboratory can install it. And today, according to Valentina Kosenko, only 5% of operating laboratories can carry out all types of drug research. Therefore, Roszdravnadzor is implementing a project to create laboratory complexes worth 3 billion rubles. for random testing of medicines in each federal district in order to unload the capital's laboratories.
According to Valentina Kosenko, there is no differentiation of responsibility depending on the severity of the crime today. Responsibility for repeated violations in this area and for the use of FLS in medical institutions is not stipulated. Moreover, the mechanism of bringing to responsibility for the turnover of the FLS is not regulated.
Roszdravnadzor itself has no serious leverage in such cases. He can only bring violators to administrative responsibility. The fine for violation can reach 50 thousand rubles, and the decision on punishment is made not by the federal service, but by the court. With the turnover that exists in the FLS market, the punishment is completely inadequate.
A recent story with JSC "Pharmasynthesis" (Irkutsk region), which for two years produced an unregistered tuberculosis drug "Protub-4" from unknown substances, can serve as an eloquent illustration. According to the head of Roszdravnadzor Nikolay Yurgel, the total cost of the drug amounted to over 532 million rubles, and the arbitration court of the Irkutsk region imposed a penalty of 40 thousand rubles on the violator. "for violating licensing requirements." The matter did not end there: the fine did not prevent the manufacturer of "Protuba-4" from immediately contacting Roszdravnadzor with applications for reissuing licenses for pharmaceutical activity and production of medicines. The agency refused to renew the license. Pharmasynthesis appealed to the court, which on December 16 recognized the actions of Roszdravnadzor as unjustified and ordered the federal service to issue a new license within ten days.
Course correctionThe manufacturer suffers the most significant losses from counterfeiting – this is due to both reputation and a specific economic loss, says Viktor Dmitriev.
However, at the same time, the companies themselves, who have information about the counterfeits of their medicines, do not seek to make this information public, because, in their opinion, it can undermine the credibility of the brand, lead to a decrease in sales. If you catch a thief, you suffer yourself."The reason for this behavior of the manufacturer is simple: the lack of proper motivation, because the damage from the disclosure of information about fakes is obvious, and the benefits are extremely doubtful," explains ARFP CEO Viktor Dmitriev.
"So it turns out that up to now there is not a single real term in criminal cases related to falsified medicines, and no serious material compensation has been collected for violation of intellectual property rights in pharmaceuticals."
The players of the pharmaceutical market, experts and law enforcement agencies are saying with one voice about the need to tighten legislation against those who falsify medicines. According to Gennady Zarapkin, the release and sale of such drugs should be considered as a direct encroachment on the life and health of people. Here, for example, scammers complete car first-aid kits with fakes. "Instead of hemostatic wipes, ordinary ones are put into them, and in case of an accident it is impossible to provide first aid with them," Gennady Scratchkin is indignant.
In the West, such crimes are punished very severely. In the USA, for example, the trade in counterfeit medicines is punishable by a fine of up to $200 million or life imprisonment. In Turkey, they will be imprisoned for a term of 30 to 50 years for this, in India they will provide a life sentence. In France, the production and import of FLS is punishable by law by imprisonment for four years or a fine of € 400 thousand, and the organization of an illegal distribution network – for a period of five years or a fine of € 500 thousand. In Germany, a sentence of up to eight years in prison can be imposed for counterfeiting drugs.
Roszdravnadzor proposed to introduce criminal liability for counterfeiting of medicines in November 2008. The Agency, together with the Institute of State and Law of the Russian Academy of Sciences and the Association of Law Enforcement Officers, has developed a corresponding bill. A year and a half before that, the deputies had already voted for amendments to the Criminal Code, tightening liability against manufacturers and sellers of counterfeit drugs. The new bill provided for a fine of 500 thousand rubles for the production, sale, storage and importation of counterfeit medicines into Russia, as well as imprisonment for a term of 6 to 15 years if two or more people died as a result of the use of "left" pharmaceutical products. This document was approved in the first reading, but it has not gone further yet.
According to Nikolay Yurgel, the fighters against falsification are actively supported by the profile committee of the State Duma and its chairman Olga Borzova, so sooner or later the Roszdravnadzor project will be adopted. It would be nice – it's not too late.
Portal "Eternal youth" www.vechnayamolodost.ru
20.03.2009