Drug manufacturers do not want to take the trash out of the house
Falsification reduction rates
FAS asks drug manufacturers to help it detect fakesIrina Vlasova, Gazeta
The Federal Antimonopoly Service (FAS) insists on a significant expansion of the powers of Roszdravnadzor. In particular, the agency should get more opportunities in the field of control in the market of medicines in the event that manufacturing companies continue to refuse to cooperate with the regulatory authority in the turnover of counterfeit drugs. This was announced yesterday at the FAS expert council by Timofey Nizhegorodtsev, head of the Department for Control of the Social Sphere and Trade of the FAS.
Today, it is very difficult to track the chain of movement of a particular drug on the market from the manufacturer to a pharmacy or hospital. Only the manufacturer of the original drug can easily identify a fake, however, as a rule, he is in no hurry to declare the appearance of a fake medicine, fearing damage to his image.
Even attending the expert council, Madina Torchinova, a representative of the Association of International Pharmaceutical Manufacturers, asked Roszdravnadzor to remove explanations from the department's public website on how to distinguish fake drug packaging from the original, so as not to "instruct falsifiers." The head of the Roszdravnadzor Department, Valentina Kosenko, refused this request. According to her, instructions are posted to inform the population and pharmacy workers.
According to the data contained in the report of Valentina Kosenko, the peak of the turnover of counterfeits in the Russian drug market occurred in 2006. Then 66 names of counterfeit drugs of 147 series were revealed. In 2007, 58 names of 146 series were seized, in 2008 - 33 names of 66 series of drugs.
This year, the problem of falsification of the imported active basis for the manufacture of drugs – substances that in 80% of cases are imported into the Russian Federation not under direct contracts - has become particularly relevant. So, in 2008, 162 series of substances of unknown origin and 1094 series of drugs from them were seized. Last year, drugs such as albumin, preductal, essentiale, cycloferon were more often forged, that is, in more than half of the cases imported medicines of the average price category. In 67% of the fakes, packaging and labeling were forged, in 38% – the content of the active substance. German companies suffered the most from counterfeiters, followed by companies from Belgium, Italy and France in terms of the frequency of forgeries.
To date, Roszdravnadzor's proposals on criminal liability for the manufacture of counterfeit medicines remain without promotion in the State Duma, and the agency itself can impose a fine of no more than 50 thousand rubles, which does not stop manufacturers of counterfeit drugs. When transferring cases to the courts, the proceedings are often delayed, while the turnover of suspicious drugs continues. As for sanctions, the FAS can significantly help the control agency here. According to Nikolay Kartashov, head of the Department for Control of Advertising and Unfair Competition of the Federal Antimonopoly Service, in case of joint actions, a turnover fine may be imposed on the manufacturer of counterfeit goods – from 1 to 15% of revenue. But in order to initiate a case with the FAS, the manufacturer of the original medicine must submit an application on the fact of unfair competition, provide samples of the original and forged drug, as well as evidence that the fake was sold (for example, a receipt from a pharmacy).
According to representatives of Roszdravnadzor, as soon as control laboratories start working in all federal districts, the number of detected counterfeits in the Russian drug market will increase.
Portal "Eternal youth" www.vechnayamolodost.ru25.11.2008