The problem of illegal products intended for use in the field of aesthetic medicine is extremely relevant. This year, according to a survey of major market participants conducted by estet-portal.com, there has been an unprecedented increase in counterfeit products. This problem worries manufacturers, official distributors, doctors, and, of course, patients.
Accordingly, every consumer should be aware of the consequences of using illegal drugs and know how to protect themselves from fakes. Oleksandr Golubnichy, Medical Director of IPSEN Pharma in Ukraine – a company that manufactures Dysport® used in the field of aesthetic medicine.
Rev. How does IPSEN combat counterfeit and illegal products on the market?
A.G. It should be noted that any product in packaging other than intended for the Ukrainian market is illegal and may be falsified. The terms "illegal" and "falsified" used in relation to a product must be differentiated. The contraband drug is in any case not legal for the Ukrainian market.
The counterfeit product is also illegal and is produced by persons who have nothing to do with IPSEN Pharma. As a rule, starting from the packaging and ending with the contents, such products are literally counterfeit. To falsify a product, it is enough to print the same packaging, find a similar bottle, stick the appropriate label on it and attach the instructions.
Of course, IPSEN Pharma, like other manufacturers, has certain features of printing and other packaging elements that help specialists to unambiguously identify counterfeit products.
Ed. What is the danger of illegal and falsified products, in particular botulinum toxin preparations?
A.G. As you know, the preparation of botulinum toxin requires special storage and transportation conditions. IPSEN Pharma supplies such products in thermoboxes specially designed for this purpose. Each box, located in a large thermal box, is equipped with temperature control devices, which must be maintained at all stages of transportation – from the beginning of the loading to the placement of the drug in the refrigerator at the customs warehouse and further along the route of the drug to the end customer.
Illegal products enter the Ukrainian market without officially crossing the border, respectively, its main danger lies in non-compliance with the conditions for proper transportation, since the provision of a cold regime in case of illegal import of a thermolabile drug is not guaranteed.
Botulinum toxin type A is contained in the medicinal product in a strictly defined dose. Non-compliance with the cold chain during transportation entails a decrease in the activity of the active substance, as a result of which the activity of the administered drug may not correspond to the number of units that the doctor expects. Accordingly, after the introduction of the product, there may be a weakening of the effect or its complete absence.
With regard to counterfeit products, it is important to understand that the manufacturing process of Dysport® consists of certain stages: the isolation of botulinum toxin type A from the bacteria Clostridium botulinum, its accumulation and titration, after which the amount of the substance in conventional units is derived for each individual batch of the drug. Using a counterfeit, the doctor cannot be sure that it is botulinum toxin type A in the vial and that the actual dose of the active substance corresponds to the declared one.
As a result, the effect of using such "products" unpredictable and dangerous.
Besides this, the purification of botulinum toxin at the factories of the manufacturing company – a guarantee of getting rid of impurities that can cause side reactions and undesirable effects. In the case of a counterfeit, of course, there is no such guarantee.
Responsibility for the use of illegal or counterfeit products lies with a specialist who endangers not only his reputation, but also the health of the patient.
Ed. What documents confirm the legality of the drug being sold?
A.G. Medicinal – this is a special product, since its legal sale requires registration of the drug as a medicinal product in the relevant territory. This fact is confirmed by the registration certificate issued by the Ministry of Health of Ukraine.
Any person can check the drug for the presence or absence of such registration in the publicly available official database "State Register of Medicines of Ukraine": http://www.drlz.com.ua/.
The second obligatory document, which testifies to the legal origin of the drug and its circulation, – permission to sell each batch of the drug – issued by the State Service for Medicines and Drugs Control. Such a certificate can be requested from the pharmacy when buying the drug. The pharmacy is obliged to provide a certificate of the product series with its seal. This is the second documented barrier that states, also for Dysport®, the number of active units, which is critical for the correct and safe dosing of botulinum toxin preparations.
These two – a certificate issued for a specific series of the drug, and a registration certificate – confirm the legality of the sold series of a particular product.
And the last – only licensed companies are allowed to sell the medicinal product. A license issued to a distributor certifies that the distributor complies with Good Distribution Practices and local laws, as well as the ability to properly transport and store the product.
Similarly, having a license from a pharmacy gives these medical institutions the right to trade in medicines, complying with all legal requirements and relevant license conditions.
Ed. How does IPSEN respond to cases of counterfeit or counterfeit products being sold?
A.G. When purchasing IPSEN Pharma products, a specialist receives all the information about where a legal product can be purchased and what documents it must be accompanied by. All cases of smuggling goods into Ukraine and the sale of counterfeit products are recorded by the competent authorities, which react to the facts of illegal activities.
There are some signs that should alert the doctor: first of all, it is the appearance of offers to sell suspicious products in inappropriate packaging at a lower price.
If a doctor has doubts about the origin of this product, he can provide us with such information, supported by appropriate photos or other documents; we transfer it to the manufacturer's factory, whose experts give a conclusion on the origin of the product.
After that, the information is sent to the competent authorities – to the State Service for Medicines and Drug Control, to the territorial divisions of the National Police and the Security Service of Ukraine. These competent authorities have repeatedly suppressed the criminal practice of selling illegal and counterfeit products.
Ed. How is IPSEN, if a legal product is used, responsible for the result of its use?
A.G. IPSEN Pharma, like all other legal market participants, has and operates a special pharmacovigilance system that allows you to track all issues, related to both quality and possible adverse events after using a legal product.
This is a mandatory requirement for a pharmaceutical manufacturer or its representative office in almost any country in the world. Naturally, in the case of an illegal product, there is no such system, and those persons who supply an illegal product to the Ukrainian market do not actually bear any responsibility, except for criminal liability (but only based on the results of an investigation by the competent authorized bodies).
Ed. What are the consequences of using illegal drugs?
A.G. Firstly, trafficking in illegal drugs is a criminal offense with corresponding consequences for those who engage in illegal activities (Articles 305 and 321 CCU).
Secondly, administrative and criminal liability is borne by persons who not only sell but also purchase illegal products, especially in the event of harm to the patient's health.
Thirdly, in the case of using illegal and/or falsified drugs, not only the patient's health is endangered and the doctor's reputation is endangered, but also the treatment method as a whole, the drug itself and the manufacturing company are compromised.
Purchasing a product of unknown origin at a price below the market price, you may become the subject of criminal prosecution by law enforcement agencies.
Rev. Which approach do you think is the most effective in the fight against counterfeiting and the "black market"?
A.G. We believe that manufacturers and distributors who operate legally can join forces in order to ensure transparency and security of the aesthetic medicine market, as for the doctor and for the patient.
The problem is that not all market participants representing a product made for Ukraine are in the legal field – some pretend to be authorized representatives and mislead potential customers.
It is important to understand that the registration of not only a trade name, but also a specific form of release, dosage and consumer packaging intended for Ukraine is important, since companies distinguish between markets: each of them has its own consumer packaging, taking into account language and other features .
The packaging must show the number of the relevant country's marketing authorization for the indicated dosage and form of presentation.
If all companies on the market comply with the conditions for working with medicines, which includes botulinum toxin type A, our patients can be confident in the quality of such products and the safety of procedures using them.
Read on the topic: "Falsification in cosmetology: how to deal with low-quality products"
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