If counterfeit drugs didn't exist, they should have been thought up. Too good dividends are received from their sale by players of the pharmaceutical market and officials. Now nobody can tell with confidence, the quantity of forgeries is reduced or increases. Absence of actual data and gaps in the legislation allow everyone to interpret a situation the shadow market of medicines on - to the.
At the turn of the century counters of the Russian drugstores were flooded by counterfeit "Sumamed" - an antibiotic of a wide range of the action, let out by the Croatian company Pliva. It was impossible to distinguish a counterfeit from the real medicine on appearance. The chemical analysis which has been carried out in test laboratory, showed lack of the active ingredient declared in the summary. In some parties of tablets streptocide which not only doesn't guarantee demanded medical effect was found, but also can do harm to people with hypersensibility to this substance.
Fakes extended in huge volumes, the producer had to withdraw all parties of a preparation on plant to paste special brands which soon too began to forge on packings. However original brands differed only existence of the image which could be seen in ultra-violet light, Pliva installed the special scanners revealing forgeries in drugstores. In one and a half years the producer managed to force out counterfeit "Sumamed" from the market. According to experts, fight against a counterfeit cost Pliva some million dollars and led to increase in its retail cost in Russia for 7 - 10%. Thus the Russian doctors still frighten the patients of that history and try to register this preparation as seldom as possible.
In the pharmaceutical market interests of business and the consumer are bound as anywhere more. However often for the producer questions of quality of drugs fade into the background, conceding to temptation to earn on a fake of popular preparations.In recent years government bodies try to fight actively against counterfeits, make loud statements, but measures undertake often the vague. In December, 2007 the State Duma rejected the bill of introduction of criminal liability for production and realization of inadequate production. Recently the document was brought again in the Duma. Representatives of regulators explain special attention to a subject of falsification of medicines with new priorities of demographic policy. "Efforts of the management of our country are directed now on increase of duration and quality of life of citizens therefore the problem of production and realization of the substandard and forged medicines is one of actual", - the head of Roszdravnadzor Nikolay Yurgel told.
Myths and manipulations
The producer is obliged to attach to each series of medicines the certificate or the declaration of compliance to the quality standards (farmakopeyny article). All drugs which don't meet the established law the requirements and shouldn't get to the consumer, share on three categories: forged (counterfeit), defective (lost quality during the transporting and storage, I expired an expiration date) and counterfeit (let out with violation of the rights for a trademark). The forged and counterfeit preparations are made for the purpose of extraction of illegal profit. Counterfeits can be three types: placebo, the imitation, the changed medicine. Placebo doesn't contain original active ingredient and usually for 100% consists of a filler (chalk, water and so forth). Thus in 25% of cases "the effect of placebo" is equal to effect from acceptance of the specified medicine. Imitation contains differing from declared active ingredient, usually cheaper, is frequent from the previous generations of preparations that increases risk of negative consequences from its use. The changed medicine contains the same active ingredient, as well as in an original preparation, but in smaller, and sometimes in a bigger dose. For example, the Pfizer company found the counterfeit Viagra containing three times more than active ingredient, than in the original.
Counterfeit medicine includes the necessary amount of original substance, but it is made not by that producer which name is specified on packing. The counterfeit is a fake of a trademark, instead of a preparation, but the tablet nevertheless can not correspond to the declared quality.Other name of a counterfeit - the illegal (piracy) copy, often so is called by the forged preparations, but legally these concepts differ. "We don't share concepts of the counterfeit and forged drugs as both those, and others do harm to the consumer", - Valentina Kosenko, the head of department of Roszdravnadzor emphasizes.
The volume of the drugs which aren't conforming to standard requirements arriving on the Russian market, precisely isn't known. In the country there is no total monitoring system of quality of medicines at all levels therefore to calculate a share of the market of illegal drugs it is impossible. Expert estimates differ in hundreds times, from - for what the subject of counterfeit medicines is extremely mythologized. "It becomes frequent information on level of counterfeits a subject of political speculation, some kind of "horror story" which forces alarm, provokes an agiotage. Volumes of counterfeits increase in proportion to heat of political passions", - Victor Dmitriyev, the director general of Association of the Russian farmproizvoditel (ARFP) considers.
Half-words and confusion influence specifics of perception of medicines. The law No. 86 Federal Law "About Medicines" calls drugs "the substances applied to prevention, diagnostics, treatment of an illness, prevention the pregnancies received from blood, blood plasma, and also bodies, tissues of the person or an animal, plants, minerals, methods of synthesis or with application of biological technologies". And the domestic consumer considers as medicine the certain means which acceptance has to lead to healing immediately. From there is a distorted treatment of concept of counterfeit medicines: "If didn't help - means, it is forged". Actually medicine can not help for other reasons: it lost the properties from - for the wrong storage or transportation, at it expired an expiration date, the doctor appointed incorrect treatment, the person for various reasons can have (or to appear) an immunity to this preparation.
It isn't decided, but it is exaggerated
According to Roszdravnadzor, in 2007 the number of the revealed and withdrawn from circulation forged and defective drugs decreased in comparison with 2006. The number of defective series of medicines was reduced with 1343 to 537, and the forged series - with 147 to 76 (0,07% of number of the series which were in circulation).The state regulator has no other data, thus Nikolay Yurgel doubts their accuracy, considering that the share of such preparations can be more. "By average estimates of experts, the volume of such production makes not less than 13 - 18 billion rubles. Law-enforcement bodies from circulation annually withdraw the forged and substandard drugs for the sum of 4 - 5 million rubles", - he speaks.
The World Health Organization (WHO) considers that counterfeits and a counterfeit borrow from 4 to 12% of the Russian market of medicines. However reliability of these figures raises doubts as the organization uses expert data. The association of the Russian pharmaceutical producers estimates their share at 7 - 10% of the market. According to the director general of DSM Group Alexander Kuzin, the counterfeit share in the Russian market makes from 1 to 3%. "The problem exists, but round it there is a lot of populism therefore estimates differ in hundreds times, - Nikolay Demidov, the director general of TsMI "Pharmexpert" explains. - We define a share of fakes no more than in 1 - 1,5%. Here preparations which are a trademark fake (piracy) and that don't possess the declared therapeutic properties" enter also.
Practicing doctors who call figure in 60 - 70% aggravate confusion, refusing to write out these or those brands of drugs. "Doctors, unfortunately, incorrectly treat this situation, often covering own incompetence, - Maria Denisova, the director general of marketing agency RMBC notes. - Art of the doctor consists in ability to pick up the necessary preparation to the specific patient, instead of in writing out all and from all diseases one antibiotic, and then to complain that it is forged".
The majority of experts recognize that the present situation with counterfeit and counterfeit drugs radically differs from that that it developed 5 - 10 years ago. "At the turn of the century the problem of fakes really became rather dramatic, then producers lost shares of sales. Exposing publications in mass media were at that time very actual", - the director general of consulting agency PharmaSmart Alexey Prozorov assures. Emergence of such problem at that time was quite natural. "With arrival to Russia the western players who are actively advancing the brands, there were also falsifiers", - Maria Denisova explains.
As Alexander Kuzin notes, then 10 - 20% of import drugs were counterfeit or imported without payment of the customs duty that gave them owners 10%-Nov advantage in the market. According to other experts, the counterfeit in general filled up all drugstores. "Today information on illegally imported drugs hasn't enough", - Alexander Kuzin speaks. "The share of the elicited facts of the address of the forged, substandard and counterfeit drugs in the total amount of a turn of drugs not only didn't increase, and decreased rather as the Russian legal pharmaceutical market grew quicker shadow", - Sergey Maksimov, the vice-chairman of Public council on health care and social protection recognizes at Association of employees of law enforcement agencies of the Russian Federation (ARPO).
The only thing in what all experts, so it in confidence are solidary that fakes and a counterfeit in the market exist. Even some percent from the market are hundreds millions dollars. According to TsMI "Pharmexpert", in 2007 the volume of the Russian retail pharmaceutical market grew by 16,5% and reached $8 billion (only medicine, without accompanying goods). The total amount of the market, including hospital and preferential, made about $12 billion. "The size of the market of fakes of medicines can make $100-300 million", - Alexander Kuzin, the director general of DSM Group confirms.
"The problem of counterfeit drugs is characteristic not only for developing countries to which often carry Russia, but also for the developed European and American markets", - Nikolay Demidov from TsMI "Pharmexpert" notes. So, in 2006 the customs service of the European Union intercepted 2,5 million packings of the forged and counterfeit drugs on the borders, it is five times more, than in 2005. India where 30% of counterfeit medicines were made was the main source of such preparations, according to the European federation of associations of pharmaceutical industry (EFPIA), in 2006. Further the United Arab Emirates and China to which share together with India 80% of production of forgeries and the counterfeit getting to EU fell followed. Following the results of 2007, first place on production of a counterfeit was won by Switzerland to which share 40% of forgeries fell. This country pushed aside India and the United Arab Emirates on the second and third places (respectively 35% and 15%). Experts aren't inclined to regard these data as the evidence of transfer of the center of the underground pharmaceutical industry in the heart of Europe."It isn't a real tendency of reduction or increase in production of counterfeit drugs. I think that efficiency of tracking of this type of production customs and other authorities, including by means of pharmaceutical companies which are very anxious with financial losses from similar abuses" increased, - Nikolay Demidov speaks.
The missed benefit
"In the domestic market to 80% of fakes it is the share of import preparations of average price group. It is considered that expensive drugs it is unprofitable to forge as them slowly buy up", - Sergey Maksimov speaks. According to its data, among the forged drugs of 35 - 47% make antibiotics, 18 - 20% - hormonal preparations, 7% - antifungal means. "Most often forge drugs the effect from which is sometimes comparable with placebo. It is difficult to forge highly effective preparations - for example, hormonal or it is contrast - diagnostic. The mechanism of their action absolutely other, and any counterfeit will be exposed at once", - the medical adviser of Bayer Schering Pharma AG Nicolay Szymanowski agrees.
According to the experts, from 50 to 67% of counterfeits it is made directly in Russia (the others - in Hugo's countries - East Asia, the CIS, India, Bulgaria, Poland and even the USA). And quality of counterfeits grows. It is considered that part of fakes make in the small shops equipped with the modern equipment, without license for a farmproizvodstvo, and part on licensed the farmpredpriyatiyakh informally is issued. According to Roszdravnadzor and test laboratories, most often forge such preparations, as "Suprastin", "Trikhopol", "Mezim", "Viagra", "Lineks", "But - шпа", "Omez", "Milgamma", "Nystatin". As experts emphasize, falsification has dot character - in large volumes only some known brands are forged. Victor Dmitriyev gives an example: recently large multinational company found out that 40% of one of its the most known in Russia and the CIS of brands - a counterfeit, on quality practically for 100% equivalent to the original. "If as a whole a picture more or less quiet, on the separate companies and preparations a situation very brisk", - Gennady Shirshov, the executive director of the Union of the Professional Pharmaceutical Organizations (UPPO) adds.
As Victor Dmitriyev, the producer, unlike other players of a pharmaceutical market considers, sustains essential losses from falsification of its production.Distributors and druggists suffer much less as mistrust arises to the concrete name of a preparation and the company. The damage is connected and with blow to reputation, and with an economic loss. "For example, two preparations from eight, let out by one successful Russian company, are constantly forged. The annual damage of the producer makes $2 million. Plus the mass of purely bureaucratic work on a response of the forged series from the market and to their destruction", - is told by Gennady Shirshov. Thus image loss on a pharmaceutical market costs still dearer.
"If the forged preparation is put on the market, it already causes damage to the producer because the trademark is used, the rights for possession of a brand are violated, - Valentin Kiselevich, the manager on examination of counterfeit production and communications with Sanofi Aventis government agencies argues. - For an assessment of economic damage as a result of sale of the forged preparation it is necessary to know the cost of the trademark and volumes of forged production, to estimate which difficult. But it is possible to assume that small parties are unprofitable to the manufacturer of a counterfeit".
It is even more difficult to estimate the extent of the missed benefit. According to Nikolay Demidov, the direct loss for the producer isn't too great. "There can be a big resonance if patients suffer from counterfeit drugs, here not to avoid financial losses", - he explains. In domestic JSC Verofarm didn't face counterfeits, but its director general Marina Penkova notes that in Russia efforts on fight against fakes lay down on producers. For example, they change packing, supplement it with special stickers and holograms that increases the cost of production and, as a result, creates additional earnings to falsifiers.
I will tell anything to nobody
"The companies, possessing information on existence of fakes of the drugs, don't seek to advertize it: after all it will at once undermine trust to a trademark in the opinion of participants of the market and consumers and, as a result, will lead to decrease in sales, - Victor Dmitriyev complains. - Producers don't see benefit in informing of state agencies on fakes. Until now on the criminal cases connected with falsification of drugs, it isn't awarded any real term, and for violation of intellectual property rights in pharmaceutics it isn't collected any serious material compensation".
In Russia there is no the direct provision of the law, allowing to bring someone to trial for production and sale of drugs of inadequate quality. Unfair players can incriminate only a trademark fake. Therefore many companies lay hopes on trial against heads of JSC Bryntsalov-A which began at the end of last year in Simonovsky court of Moscow. Top - managers accuse of illegal business (h. 2 Art. 171 of the criminal code of Russian Federation) and illegal use of the trademark (h. 3 Art. 180 of the criminal code of Russian Federation). As considers a consequence, at the enterprise forged 97 names of drugs which then came true through false firms. As material evidence the packings of a set of preparations of foreign production printed with typographical way serve. According to the investigation, for some months 2005 of JSC Bryntsalov-A sold counterfeits approximately on 68,5 million rubles. According to participants of the market, results of process will slightly open a true position of the state in a question of a fake of drugs.
"This first high-profile criminal case which is started in Russia against producers of counterfeits, its results can influence further development of a situation. For transfer of business to court it is necessary to collect good evidential base. For example, the producer of fakes of production of our company was revealed, but lawsuit yet didn't begin", - Valentin Kiselevich speaks. It is a question of recent identification forged "Essentsiale forte N, capsules of 300 mg No. 30" series of 68061 productions Sanofi Aventis. "The found fake was declared by the company Sanofi Aventis. Usually the producer, being afraid of decrease in volumes of sale of quick-selling goods, tries as it is possible not to make more long information public, being limited to own investigation and acceptance of the technological measures directed on the prevention of fakes from now on", - Sergey Maksimov claims.
To all sisters
Distributors too sustain losses from - for fakes. Forge the most sold preparations that reduces trust to an original medicine, and its sales fall. Purchase prices of illegal drugs are lower, than on original that, in turn, attracts some players of the market. Thus the wholesale companies nevertheless are less vulnerable from the economic point of view and from a law position, than producers and drugstores.In case of fake or marriage identification wholesalers often appear in a shadow due to repeated resales of wholesale parties of drugs. Names of the companies - distributors are usually unknown to end users that allows some of them to specialize on sales of illegal drugs.
For fake drugstores - the two-edged razor. If the counterfeit is revealed by the drugstore, it will lose the means spent for purchases. If supervisory authority - receives collecting and if the consumer - spoils image. "It is a question not of loss of money, but, first of all, about health, and at times and lives of buyers, - the director general of a network of drugstores "Doctor Stoletov" Tatyana Shostik speaks. - In a drugstore the consumer receives a guarantee of safety which is formed including due to strict quality control of drugs from a network, cooperation only with the large checked distributors and the qualified consultations of our pharmacists and druggists". Therefore the fake acquired in a drugstore, can become a shock for the consumer. Besides, for trade in inadequate goods licenses can deprive a drugstore, and networks have the federal license, that is one on all the points.
Large distributors and pharmacy networks persistently try "to lay the blame" on small wholesalers of the third - the fourth level and small individual drugstores. Such structures are, as a rule, involved in shadow schemes of distribution of drugs. By recognition of workers of drugstores, to them people with the offer to buy drugs cheaper, allegedly from representatives of the known companies regularly come. "Representatives" carry a sale subject with themselves in shopping bags. On a rod of false delegates of pharmaceutical companies, according to the logic of experts, not network drugstores both especially pharmaceutical points and booths of non-state form of ownership to which the disposable prize in $200-300 from party of preparations of not clear origin is attractive have to come across. "At the same time low cost of counterfeits is illusory. Them let out to earn as much as possible money, and sell at the price close to cost of original preparations", - Maria Denisova speaks. Thus in Moscow there are pharmacy networks - the discounters attracting buyers with the minimum margins, but their management assures that it only the testimony of high professionalism.
In fight for quality
Territorial administrations of Roszdravnadzor, created in all subjects of Federation have to reveal and withdraw parties of unusable drugs.As Nikolay Yurgel explained, information on counterfeit preparations usually arrives in Roszdravnadzor from producers of medicines, test laboratories, subjects of a pharmaceutical market. "Territorial bodies of Roszdravnadzor can suspend the address of substandard drugs and the preparations which authenticity raised doubts, - he explains. - The decision on withdrawal of the preparation which isn't conforming to established requirements, a certain series is accepted by Roszdravnadzor after receiving from the expert organization or the producer of results of the comparative analysis of samples of the forged preparation and archival samples of the producer. Information on need of retirement and further destruction of these medicines is published on the official website of Roszdravnadzor and is brought to the attention of all subjects of the address of medicines". According to experts, the system is so sluggish that while on a site there will be number of the defective series, all goods happen long ago are sold already out.
Can carry out the chemical analysis of preparations now 75 test laboratories. A few years ago them was more than 80. Practically in each subject of Federation there was a Center of certification and quality control of drugs (TsSKKL) of regional submission with the test laboratory. However in 2005 the state represented by Roszdravnadzor initiated development of system of branches of the Federal state institution of Nauchny center ekspertizy sredstv meditsinskogo primeneniya (NTs ESMP Federal State Institution) therefore a number of TsSKKL was closed as function of quality control of drugs was transferred on federal level.
The place closed TsSKKL was taken by "NTs ESMP" branches of federal state institution. To local authorities was economic to remove from balance of the TsSKKL area especially as their equipment leased to the same experts who have replaced submission from regional with the federal. In other territories the regional management left quality check of drugs in own maintaining, and in 1,5 years the converting initiative of Roszdravnadzor came to naught. Examination cost in self-supporting branches of federal state institution of "NTs ESMP" is much more expensive, than in regional TsSKKL which are supported by local budgets. The elementary procedure - comparison imported on the territory of area of series of preparations with base of the rejected and forged series of Roszdravnadzor - costs about 1000 rub in the Ryazan region.in a month (base to wholesalers and drugstores TsSKKL updates), and monitoring (just the same check on base of Roszdravnadzor) in Ivanovskoye "NTs ESMP" branch of federal state institution - from 2000 to 10 000 rub a month (depends on number of the series handed over on check). Thus imported on the territory of area of drugs all laboratories conduct quality check on the basis of contracts which wholesalers sign with them on a voluntary basis, paying procedure from the pocket. In this regard directors of branches of federal state institution are compelled to conduct continuous fight for clients, convincing them of need of quality check of preparations. According to a number of experts, actually the system voluntary - compulsory collection of surtaxes (the hidden taxation) from producers and sellers of medicines works.
To whom it is favorable
The turn of the forged drugs is favorable not only to underground manufacturers and dishonest sellers. Journalists, officials, deputies and public organizations quite often operate this subject, achieving the personal or corporate objectives. For example, playing on this subject, it is possible to receive additional public financing. Nikolay Yurgel constantly draws attention to a problem of a deplorable condition of material resources of test laboratories. Recently he reported about the new project of creation in each federal district of a modern laboratory complex. On it it is required to 3 billion rubles.
"Fakes of a trademark for which this or that consumer - whether it be the state or the individual - is ready to pay rather big money, very attractive business, - Nikolay Demidov explains. - Especially as in Russia there are no serious punishments in the form of imprisonment or other severe measures, unlike other civilized world where against fakes fight rather rigidly". For example, in Denmark, Norway and San - Marino producers of fakes pursue in a criminal order. "In Russia still the revealed producers of forgeries were pursued only administratively that created very attractive conditions for development of similar business in Russia", - Sergey Maksimov speaks.
Recently the Association of employees of law enforcement agencies took the initiative of introduction of criminal liability for production and realization of the forged, counterfeit and defective drugs if their turn exceeded 1 million rubles."The criminal code of the Russian Federation should be added with the new article 238 "The Address of the Substandard and Forged Medicines and Biologically Active Supplements", and the Code of the Russian Federation about administrative offenses - the article 6.15 "The Address of Substandard Medicines and Biologically Active Supplements in an Insignificant Size", - Sergey Maksimov, one of authors of the project, the doctor of jurisprudence explained. In his opinion, all participants of the market have to bear criminal liability: producers, distributors and drugstores.
Opinions of experts in this occasion were shared. Nicolay Szymanowski, Victor Dmitriyev, Nikolay Yurgel support such position. Some participants of the market doubt need and efficiency of similar norm. "First of all it is necessary to give competent interpretation to the concept "the forged drugs" and to create an evidential basis as under definition existing now "low-quality" the producer" can get, - Marina Penkova warns. "The punishment measure, and its inevitability is important not. And now there are articles, allowing to involve violators to the answer. Why they aren't carried out? " - Alexander Kuzin asks a rhetorical question. Maria Denisova too considers criminal article as an excess. "Under "distribution" drugstores in which will reveal fakes will get, and it is necessary to punish the producer, - it specifies. - Specifics of a farmproduktion such is that can define a fake only the expert in the equipped laboratory".