Evgenia Zinovieva: "Our task ‒ to promote the safe handling of high-quality medical products in aesthetic medicine"
The fact that experts estimate the turnover of unregistered or counterfeit drugs and medical products for aesthetic medicine at 100 billion rubles, which, in fact, accounts for 40% of the entire market, GxP News has already written earlier. A number of experts also expressed their opinion on how to change the current situation in the podcast.
Today, Evgenia Zinovieva, PhD, Director of Development at the Association of Importers of Cosmetology, Cosmetics and Medical Products (AICCMP), and I are discussing new ways to solve existing problems.
The grey market is being discussed on many platforms. But despite the attention to the problem from both business and the medical community and regulatory authorities, there remains a huge layer of unresolved issues. And the market itself is growing and is difficult to whitewash. Was the Association of Importers of Cosmetology, Cosmetics and Medical Products created specifically to solve a wider range of problems?
Unfortunately, not only the gray segment of the market is growing, but also the number of counterfeit and substandard products. And now we are talking only about registered products, but do not forget about the growing number of unregistered products that are freely sold through marketplaces and used uncontrollably, often independently at home. This sector is not controlled, as Roszdravnadzor carries out inspections only of those organizations that have a medical license. We are aware that it will not be possible to solve all the problems overnight, so we have defined a range of initial tasks, and the main one is to promote the safe handling of high‒quality medical products in aesthetic medicine.
A major problem remains the lack of awareness of patients, as well as those "nedokosmetologov" about the dangers of improper use of beauty products.
Neither doctors, nor even patients, think about checking the product for state registration, and even those who think about it often do not know how and where to get this information.
In addition, there is a problem of poor quality of specialist training, as well as a huge number of those who, without medical education, earn money from "beauty injections" in premises that do not have a license for medical activity.
These are priority tasks, but there are other pressing requests from distributors who are members of the association: issues of state registration, inspection, taxation, customs regulation, and many others.
Distributors often complain about the high cost, duration and other problems associated with obtaining a registration certificate, claiming that this provokes their departure into a gray area.
I have been working in the field of medical device circulation for more than 15 years and I can say that there have always been voiced problems. Now the process of state registration has become more understandable and regulated, and thus the guarantee of entry into the market of high-quality products is increased. At the moment, the association is dealing with the problems of its members that have arisen as a result of some imperfections in legislation.
The Association of Importers of Cosmetology, Cosmetics and Medical Products also has a successful experience in combating counterfeit products. Tell us more about it.
One of the members of the association, the exclusive distributor of a Korean manufacturer, asked for support when it became clear that the products were being marketed as counterfeit products and without his knowledge. The examination conducted after the control purchase confirmed the unoriginality of the products. The counterfeit products were seized, and then a criminal case was opened under Article 238.1 of the Criminal Code of the Russian Federation. And we have quite a few successful cases, as serious work is underway to identify counterfeit and falsified products in cooperation with the Ministry of Internal Affairs of the Russian Federation, the Investigative Committee of the Russian Federation, the Federal State Budgetary Institution "VNIIMT" Roszdravnadzor and other organizations.
So it turns out that only the court and law enforcement agencies can help the manufacturer? Is it really impossible to protect manufacturers from fakes without bringing them to court?
We offer the manufacturer to protect himself by applying a unique marking on the products, which was developed by the association's specialists, and it is printed by our order at Goznak JSC. If we talk about well-known labeling approaches, this is a fundamentally new approach that was previously used only on banknotes. Labeling will allow the manufacturer or his representative to keep a record of the original products and ensure quality control of the goods.
But we already have the state label "Honest sign". In your opinion, is it not enough?
We are not competitors. Our labeling is voluntary, it is used at the request of manufacturers, authorized representatives or distributors. It can be applied both in Russia and abroad, if it is convenient for manufacturers who are abroad but supply goods to our country.
And, unfortunately, we all know that an "Honest Sign" is forged because materials such as paper and ink are used in the manufacture. Our marking is a hologram with special dyes, it contains several degrees of protection: light and sound. In the coming decades, it will be impossible to fake it. Therefore, this is an excellent test for the authenticity of goods and compliance with the rules of their importation into the territory of Russia, i.e. detection of counterfeit in the broadest sense of the word.
If we talk not about producers, but about ordinary consumers: is the association ready to protect their rights?
We are currently developing a number of cases that have come from different sources. For example, the case that occurred in Chelyabinsk. The patient received a number of catastrophic complications after an injectable cosmetic procedure. Obviously, there is a question of the quality of medical services, and such "work" will have to be criminally responsible.
GxP News has already written that the association has developed a special chatbot. Tell us in more detail: What can he do?
The Association has developed a project that also has no analogues in Russia. The chatbot "MedInspektor" in Telegram is free and accessible to all market participants. It was created as part of a cooperation agreement between the AICCMP and the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor, as this expert organization monitors the safety of medical devices. The bot is unique in its capabilities and solves several problems. You can check the availability of the registration certificate by the name of the product or manufacturer. The bot provides information according to the latest updates of the State Register of Medical Devices and organizations engaged in the manufacture and manufacture of medical devices by Roszdravnadzor.
In addition, it is possible to send a message if a substandard medical device is detected or a low-quality cosmetic service is provided.
Can a person come to the marketplace pick-up point and check the filler or biorevitalization drug they are buying using a chatbot?
Yes, of course. The number of the registration certificate must be indicated on the label, and this is quite enough to enter into the search box. You can also enter the name of the product or manufacturer. But it is better to do all this in advance, before buying. I would like to draw your attention to the fact that when buying medical products on marketplaces, even with a registration certificate, you cannot be sure that the rules of storage and transportation are followed.
Both doctors and patients can check the product. I would like marketplaces to use a bot before placing a product on the marketplace. We are also working on this, but, alas, this is not a quick story.
If we talk about the prospects, what else is in the plans of the AICCMP?
We are currently working on a huge block of educational activities among patients with the prospect of further involvement of administrative resources in the regions. This is necessary in order to reduce the number of visits to specialists who do not have a diploma in cosmetology. Unfortunately, only a few consumers think about the possible consequences of "beauty injections", which are carried out in unsanitary conditions and counterfeit medical products and drugs.
It turns out that the activities of the association are aimed at comprehensive support of the beauty industry?
We believe that the mission of the association is to protect the interests of all participants in the aesthetic medicine market, as well as the citizens of our country from substandard products.
Source: GxP News