29 December 2014

FAS proposed to equate dietary supplements with over-the-counter medications

"As a result of unfair advertising, people for a lot of money
they get pacifiers instead of treatment"


On December 24, the Federal Antimonopoly Service of Russia held a joint meeting of the Expert Council on the Application of Advertising Legislation and the Expert Council on the Development of Competition in the Social Sphere and Healthcare.

The issues of registration of prescription and non-prescription medicines and biologically active additives under identical or confusingly similar names, as well as the problems and consequences of their circulation on the market in the context of legislative prohibitions on the advertising of prescription drugs were brought to the discussion of experts.

According to Irina Vasilenkova, Deputy Head of the Department, Head of the Department for Control of Advertising Legislation of the FAS of the Russian Federation, the Federal Antimonopoly Service receives appeals from drug market participants with complaints that prescription and non-prescription medicines, as well as dietary supplements with the same or similar names, are being used on the market.

"We faced this problem 3-4 years ago, when the first signals appeared that another prescription drug was being promoted under the guise of one over–the-counter drug, the advertising of which is prohibited for the general public, but is allowed only for pharmaceutical and medical workers," says Irina Vasilenkova. – We began to study the problem and this year we have already initiated two cases on advertising related to this issue."

The study of the market of medicines and dietary supplements circulating on the Russian market showed how large the scale of this disaster is, the representative of the FAS stated. The situation when medicines, prescription medicines and dietary supplements with the same active substance and practically in the same packages are sold on the market under the same name has become typical.

"The promotion of a brand common to these drugs on the market misleads consumers,– Irina Vasilenkova believes. – The situation is complicated by the fact that these drugs are often freely available and sold without a prescription. In addition, all these drugs, regardless of whether they are medicinal or non-medicinal, or dietary supplements, are displayed in the pharmacy on the same shelf in the same row. There is a risk that citizens will use these drugs incorrectly, and their health may be harmed."

The representative of the FAS proposed to discuss the problem associated with the registration of prescription and non-prescription drugs, as well as dietary supplements with similar names and almost identical packages.

Legislative failureElena Bokova, head of the Department for state Registration, organization of interaction with the Customs Union of Rospotrebnadzor, explained that dietary supplements are classified as specialized food products by the Technical Regulations of the Customs Union, therefore they are not medicines.

At the same time, the legislation of the Customs Union and the Eurasian Economic Commission does not prohibit the registration of medicines and dietary supplements that are not positioned as medicines under the same name.

"In this case, we have a legislative failure," stated the representative of Rospotrebnadzor.

As a result, it is not uncommon on the Russian market when, not wanting to register a drug (since this process seems difficult, lengthy and financially costly to the manufacturer), this drug, it is unknown with what therapeutic effect and side effects, is registered as a dietary supplement and is sold on the market, according to the attached instructions.

"We have been talking about this problem for many years, because the Law on Food Safety has a strange wording "biologically active additive", – said Timofey Nizhegorodtsev, head of the Department for Control of the Social Sphere and Trade of the Federal Antimonopoly Service of Russia. – In itself, this formulation is somewhat strange for people with biological, medical and chemical education. Everything in our country has biological activity. If we now cover this table in fine dust and use it, it will also show some kind of biological activity. And it is unclear whether this biological activity is useful or not, whether it is needed or not."

According to the expert, this situation has given rise to unfair practices in this country – not only in the field of advertising, but also in the field of the use of medicines and biologically active additives, when a huge number of people are deceived by imposing dietary supplements on them under the guise of medicines. As a result, people get pacifiers for a lot of money instead of treatment.

"All specialists working in the market approximately equally assess this situation as a catastrophe," Timofey Nizhegorodtsev noted. – I have not heard positive assessments from experts."

The representative of the Federal Antimonopoly Service made a proposal to make biologically active additives part of the world of medicines "Let it be over–the–counter medicines, since their activity is so low that they do not require additional regulation as prescription drugs," the expert suggested, "But within the framework of clinical studies it will be proved that this biological activity exists, that it is registered in the body, and that it somehow has a positive effect on some conditions. Then all this terrible pile of dietary supplements will fall apart by itself, because most of the dietary supplements registered by Rospotrebnadzor will not pass this procedure, because there is no useful biological activity there."

5th place in the structure of mortalityTimofey Nizhegorodtsev also drew attention to the fact that in the Russian epidemiological indicators published by the Ministry of Health of the Russian Federation, there is no cause of death from incorrect use of medicines or medical error.

And in the same United States of America – there is. Mortality from incorrect use of medicines is in 5th place there. In the USA, where supervision is more effective, where the volume of prescription drugs is 2 times higher than ours, where there are clinical protocols and a community of doctors who monitor this, 100 thousand people per year die from incorrect use of medicines. And American experts are constantly talking about this.

"And we do not even assume that people can die from the use of medicines, and the cause of mortality from the use of medicines, including over-the–counter, may occupy the 5th place in the overall mortality structure," stated Timofey Nizhegorodtsev.

According to the expert, currently in Russia, manufacturers are trying to circumvent strict legislation on regulating the circulation of medicines, each of which, even if it is over-the-counter, poses a danger to people, therefore it is in the regulatory system. Manufacturers register medicines under the guise of "dietary supplements", distribute them under the guise of "dietary supplements", endangering people, damaging their health.

"This catastrophe is growing every year," said Timofey Nizhegorodtsev. – We have many companies that build their marketing policy, harming people and putting them in danger. This becomes the way commercial structures operate in the market."

Oksana Shutrova, a representative of Roche (Moscow), said that unfair advertising of dietary supplements with medicinal properties has become a common practice on the market.

"As a manufacturer of a similar drug, we are faced with the fact that our sales have fallen sharply, and the sales of competitors who have gone this way have increased dramatically," said the representative of Roche. – We have twice appealed to the FAS with a request to find out why someone gets a competitive advantage by going this way, in our opinion, is not very right."

By the way, in Europe and America, a severe ban on this kind of advertising has been introduced for a long time, since this is a violation of advertising legislation.

"Since experts have recognized a legislative gap in this area, the law enforcement officer needs to make a decision that will form the basis for further legislative prohibition," the representative of Roche believes. – We have made such a statement to the FAS. We understand that, obviously, it will affect the entire market, but this problem cannot be solved in any other way. It has not been solved for 4 years, and if a decision is not made, it will never be solved."

Portal "Eternal youth" http://vechnayamolodost.ru29.12.2014

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