Date of publication: 7 September 2017
Irina Kirichenko, Patent Attorney of Ukraine
In view of the conflict situation around sorbent «Белый Уголь»-Здравофарм (White-coal Zdravopharm), we turned for the comments to Ilyashev & Partners Law Firm which represents the interests of OmniFarma Kiev LLC (owner of the registration certificate of the medical preparation «БЕЛЫЙ УГОЛЬ»® and dietary supplement «БЕЛЫЙ УГОЛЬ»®) where we were informed that under the complaint filed by the Company the Head Administration of the National Police in Kyiv initiated criminal proceedings (No. 12017100000000782, the date of introduction into the Unified Register of Pre-trial Investigations: July 21, 2017) under the signs of the criminal offence stipulated by Article 321(1)(3) of the Criminal Code of Ukraine (production, keeping with the aim of dealing and dealing in falsified medicines in especially large amounts). The situation is commented on by Ms Irina Kirichenko, Patent Attorney of Ukraine, lawyer of Ilyashev & Partners Law Firm.
Medicines represent the substances that cure illnesses: this is why this pharmacy product fundamentally differs from any other product. And the matter is not only that the preferences of the patients (who we all really are) are of little importance here. As distinct from so-called healthy-eating products, the necessary medicines are chosen for us by other people – doctors and/or pharmacists, although, many necessary medicines can be purchased individually without a prescription.
Even if the solution against simple food poisoning was given to us by an advertisement – everything is not so easy: to get “on TV” a TV-ad must go through strict censorship – the medicines must be, first and foremost, safe so that we – ordinary consumers – would not be deluded by their “health-giving powers” and would not ignore the instruction for their medical use.
“White cola” – is the leader in fighting wrongful foods!” – if we would wish to give an example of such positive superhero of commercial breaks on out TV it may undoubtedly be represented by an adsorbent produced by OmniFarma Kiev LLC – a company leader of Ukrainian market of producers of adsorbents.
The composition and the technology of production of the original enterosorbent «Белый Уголь»® are protected by the patents of Ukraine No. 41849, 75203, 85371, 99890, 113442 and the trade mark «Белый Уголь»® not only was registered by the patent authorities of most European countries, but was acknowledged in Ukraine as commonly known starting from January 01, 2011 along with such pharmaceutical brands as aspirin and Corvalol.
Good reputation of «Белый Уголь»® among the specialists in the field of gastroenterology, supported by many years of successful application, is confirmed by numerous publications in the specialized medical publications and by the clinical trial as a result of which OmniFarma Kiev LLC received a registration certificate for the medicine (UA/16126/01/01) under the procedure “well explored medical application”.
Pursuant to paragraph 2.15 of the Procedure for conducting examination of registration materials to the medicines submitted for the state registration (re-registration), as well as examination of the materials on introduction of amendments to the registration materials during the term of validity of the registration certificate approved by the Order of the Ministry of Health Protection of Ukraine No. 462 as of August 26, 2005 (hereinafter – the “Procedure”) and paragraph 6.3.2 of the Annex No. 4 of the Procedure well-established medicinal use means that medicinal use of an agent or agents included into the composition of a medicine has been duly explored, there effectiveness and satisfactory rate of safety was acknowledged (through submission of detailed bibliographical references to the published scientific data). It was the way how «Белый Уголь»® confirmed its effectiveness as an additional source of enterosorbents aimed at decreasing the level of consequences of eating poor-quality food and alcohol, restoration of normal functioning of gastrointestinal tract and other systems of the organism which was disturbed by pathogenic microorganisms, food and bacterial allergic agents through adsorption and removal of exo- and endogenous toxins of different origin from the organism.
With respect of dietary supplements in general – they fight nobody and nothing by definition: in such way: in such way, pursuant to Article 1(20) of the Law of Ukraine “On the main principles of and requirements towards food products” (hereinafter – the “Law”) dietary supplement – is a food product which is consumed in small established quantities in addition to an ordinary food ration, which represents a concentrated source of nutritional agents, including proteins, fats, carbohydrates, vitamins, minerals (this list is not exhaustive), and is produced in the form of tablets, capsules, pills, powders, fluids or in other forms.
Pursuant to Article 1 (91) of the Law “food supplement – is an agent which is normally considered to be a food product or its part, but is added to a food product with a technological aim in the process of production and, as a result, becomes an integral part of the product (the term does not include contaminating agents, pesticides or substances added to food products to improve their nutritious qualities)”.
Pursuant to Article 30 of the Law (the State registration of food additives) only those food additives which were included into the State register of food additives can be used in the production of food products and food products which are in the circulation.
The central executive authority, which is in charge of formation and performance of realization of the state policy in the sphere of health protection, carries out the state registration and maintains the State register of food additives. The State register, in particular, indicates the maximum allowed levels of such additives in case when their non-indication puts the health of consumers under threat. The register also indicates the food products in which such additives are used.
In this case the maintenance of the register of food and dietary additives is related to the competence of the Ministry of Health Protection of Ukraine. However, for a long period of time the Ministry has not been keeping this register, this is why the safety of dietary supplements introduced into the circulation is on the consciousness of the manufacturers.
If we talk about absorbents – the etymology of this word comes from the Latin word sorbens – to absorb – these are the substances which effectively tie exo- and endogenous substances, supermolecular structures and cells to cure and prevent diseases.
Sorbents actively tie and remove toxic substances (which come into intestinal lumen or form in the intestine) from the body. They are totally removed from the body within 36-48 hours .
Currently there are two types of sorbents – “black” (coal substances) and white (Enterosgel, Kaopectate, Smecta, Pectin etc.)*.
However, references to their pharmacological faculties as of dietary (food) supplements (pharmacological activity of which has been proven) is expressly forbidden by law (Article 39 of “The requirements towards product marking”):
• forbidden is circulation of the food products marking of which does not comply with the requirements of the legislation on safety and certain quality parameters of food products;
• pursuant to Article 39 (7) of the Law “the marking may mention certain substances and their quantity without indication of properties which a food product has due to such substances. At the same time a market operator must hold proof regarding contents of such substances which, in particular, may be represented by the results of research (trials), and owned by the market operator, of other subjects or information of the suppliers of the ingredients”.
• pursuant to Article 39 (8) of the Law “it shall be forbidden to use the following for the advertising of the dietary supplements”:
1) expressions about possible, pain relief;
2) thank-you letters, declarations, advice if they are related to treatment or easement of the course of the disease, as well as references to such information.
However, as the text of the marking and of the “Recommendations for use” of the “dietary supplement” (which is not registered by the Ministry of Health Protection of Ukraine), «Белый Уголь-Здравофарм» (Internal Technical Specification of Ukraine 10.8-36458995-012:2017) – is a “dietary supplement to the food ration for improvement of the functional state of gastro-intestinal tract, has detoxification faculties”.
According to such logic of a respected sorbent manufacturer any substance which has certain pharmacological effect may be “reproduced” without special state registration by printing “not a medicine” in fine font between the lines containing main information about the product and adding own commercial name (for example, Aspirin-Farmozdrav) to the “borrowed” trade name.
If this “idea” was founded on legitimate grounds it would probably have been long used by the manufacturers of other products who would give simple and recognizable names to their products: “Coca-Cola-Droplet”, “Adidad-Sportgame, “Hummer-Autocity” etc. (Any coincidences are accidental)”.
This “logic” has been used as a basis of marking “«Белый Уголь-Здравофарм»” manufactured by company Zdravofarm. Such “parallel” activities may lead to blending of the products manufactured by Zdravofam LLC with corresponding products manufactured by OmniFarma Kiev LLC as a result of which the reputation of the former may be damaged.
So, production, storage, offering for sale and sale of sorbent «Белый Уголь-Здравофарм» contains the signs of unlawful activities – deliberate use of another person’s mark for products (OmniFarma Kiev LLC), the responsibility for which is stipulated by Article 229 of the Criminal Code of Ukraine.
Considering for the common awareness of the specialists about helpful properties and quality of enterosorbent «Белый Уголь»® (OmniFarma Kiev LLC) one may make a conclusion not only about unlawful use by Zdravofarm LLC of the reputation of a well-known mark for goods and services among the specialists in the sphere of gastroenterology and consumers suffering from gastrointestinal upsets, but also about more grievous criminal offence, namely – falsification of a medical product.
Pursuant to Article 2 (3) of the Law of Ukraine “On medicines” a falsified medical product is represented by a medical product which was labeled non-identically (not in accordance) to the information (in full or in part) about a medical product with corresponding name introduced to the State register of medicines of Ukraine, as well as a medical product which was deliberately falsified in other way and does not correspond to the information (in full or in part), including the information about composition, about a medical product with corresponding name introduced to the State register of medicines of Ukraine
In this particular case the marking of packing of both adsorbents differs only in the secondary characteristics and an average consumer will not be able to tell the difference between the package of a well-known adsorbent «Белый Уголь» (OmniFarma Kiev LLC), quality, safety and effectiveness of which have been acknowledged in accordance with the procedure established by law, and a package of the same-name product manufactured by Zdravofarm LLC with unacknowledged quality characteristics.
In such way the medical drug «Белый Уголь-Здравофарм» is a falsified medicine as regards to the adsorbent «Белый Уголь» owned by OmniFarma Kiev LLC.
The aforesaid demonstrates that there is an ongoing unlawful activity on systematic commission of serious crimes – organization and performance of unlawful production, acquisition, transportation, carriage, storage with the aim of sale and sale of knowingly falsified medicines in large quantities (constituting elements of a criminal offence stipulated by Article 321 (1) of the Criminal Code of Ukraine). The activities on production, storage and distribution of falsified medicines pose a great danger to public as soon as threaten life and health of population and such criminal activities, as well as the criminal omission, seriously damage the interests of the state and the society.
Pursuant to Article 321(1)(1) of the Criminal Code of Ukraine the activities on production, acquisition, transportation, carriage, storage with the aim of sale and sale of knowingly falsified medicines are punished with deprivation of freedom for the term from three to five years.
Summarizing the aforesaid we consider that the activities of Zdravofarm LLC, as well as the activities of of the distribution and pharmacy chains (involved into the circulation of infringing products «Белый Уголь-Здравофарм»), are directed at the achievement of the common economic result – gaining of excessive profits at the expense of the use of other persons’ trademark and falsification of the well-known medicine «Белый Уголь»®, and contain the signs of unlawful activities related to production, transportation, storage with the aim of sale, as well as sale of falsified medicines aimed at gaining unlawful profits from this type of criminal activities.
As soon as under the complaint lodged by OmniFarma Kiev LLC the Chief Administration of the National Police in Kyiv initiated criminal proceedings (No. 12017100000000782, the date of introduction into the Unified Register of Pre-Trial Investigations – July 21, 2017) we ask all the operators of the pharmaceutical market of Ukraine to attentively treat the products purchased for further retail sale in order to not get involved into the circulation of the falsified «Белого Уголь» with all the legal consequences stipulated by the Article 321(1) of the Criminal Code of Ukraine.