Quarantine is not a time to pause business, especially for pharmaceutical companies and pharmacies. At present, we can observe that the excitement caused by the introduction of quarantine has begun to subside, and the sales of medicines as well. Therefore, the topic of promotion of pharmacy basket products becomes especially relevant. How to do it effectively and with minimal legal risks? The seminar “Right to Promo: Limit of Risk” (Part 1) was dedicated to this topic, and took place on April 29, 2020. Speakers were Nataliia Mozgova, Senior associate, and Igor Ogorodniychuk, partner of Law offices of OMP, who discussed in details such relevant topics in the field of medicine advertising as sponsorship, common mistakes and problems in TV commercials, advertising slogans, the legitimacy of the services of offering to buy medicine, as well as the possibility of using (almost) identical names of different products in the company’s line, including Rx -medicine.
Nataliia Mozgova acquainted the participants of the seminar with the peculiarities of promotion using such a tool as sponsorship. Sponsorship – is a voluntary material, financial, organizational and other support of individuals and legal entities in any activity in order to promote only their name, name, mark for goods and services. Sponsorship issues are regulated by the Law of Ukraine “On Advertising”. The sponsored program should be marked with captions or narration at the beginning and/or end. At the same time, the question still often arises: can pharmaceutical companies be sponsors of radio/TV programs, because, according to the Law of Ukraine “On Advertising”, persons who produce or distribute goods whose advertising is prohibited by law can not be sponsors. On the other hand, it is now explicitly provided that persons who manufacture and/or sell medicine, medical equipment, methods of prevention, diagnosis, treatment and rehabilitation may sponsor television, radio and radio programs by providing information about them, their name, a mark for goods and services. At the same time, any references to Rx-medicine and medical equipment, methods of prevention, diagnosis, treatment and rehabilitation, the use of which requires special knowledge and training, should be absent (Article 21 of the Law of Ukraine “On Advertising”).
In TV, radio programs, materials in other mass media, entertainment and other events created and conducted with the participation of sponsors, it is prohibited to provide any information of an advertising nature about the sponsor and/or his products, except the name and mark for goods and services. Please note that the sponsor has no right to influence the content and timing of the broadcast, transmission or content of the sponsored publications. In addition, sponsorship of programs and news programs is prohibited.
In what form can the name or/and mark for the sponsor’s goods and services be placed on television? This can be an oral announcement, a message with captions or a moving line, or a notice about the sponsor by statically or dynamically displaying his name, name and/or mark for the goods and services he owns. The safest option from a legal point of view is to display the name of the pharmaceutical company and/or the image of the actual mark for goods and services in a static format. However, in practice there are materials developed in the format of a full-fledged video with a total duration of, for example, 10 seconds. The legislation of Ukraine today does not specifically define the legality of providing information about the sponsor in the format of a video. At the same time, paragraph 1 of the Decision of the National Council of Ukraine on Television and Radio Broadcasting of July 14, 2004 № 807 “On Approval of Recommendations on Advertising and Sponsorship” allows placing a notice about a sponsor by showing static or dynamic picture of his name, name and/or mark of goods and services belonging to him. Thus, there is no direct ban on the use of the video. In practice, all the textual information contained in the video, as well as key frames of the video are registered as a trademark (TM). This minimizes the risk of identifying such a video as covert/unfair advertising by regulatory authorities. Ideally, at the time of the start of the campaign in the information system of the State Enterprise “Ukrainian Institute of Intellectual Property” information about the certificate for trademarks for goods and services on identical textual wording and individual (main) frames of the material should be placed. In practice, usually obtaining such a certificate takes a long time and often the campaign begins after the application, because in accordance with paragraph 1 of Art. 16 of the Law of Ukraine “On Protection of Rights to Marks for Goods and Services” rights arising from the certificate are valid from the date of application. Obviously, the video of the sponsorship video consists not only of key cadres. Is the addition of secondary cadres a violation? The legislation of Ukraine does not explicitly determine whether it is legal to add such intermediate cadres (not registered as TM). However, this practice has been going on for a long time.
It should be remembered that standard advertising requirements (requisites, etc.) do not apply to announcing information about sponsor, and adding it “just in case” can only hurt, giving rise to additional questions. It is also recommended to carry out the analysis of the soundtrack of the video series: to check the absence of risk of misleading the consumer (compliance with official instructions of medicine, the correctness of general scientific information). It is not recommended to use a slogan (even registered as a TM) if the information is exaggerated/cannot be directly proven. The principle of unambiguity – it is not desirable to include wording that usually requires detail in footnotes (in ordinary advertising), etc. (even if the slogan is registered as a TM). It is not desirable to create sponsorship materials, the video series of which partially or completely repeats the existing commercials.
Mozgova dwelled on the most common mistakes and risky statements that occurred in practice during the evaluation of advertising materials for medicines, dietary supplements and other products in the pharmacy basket. The main risks in this case are the discovery by regulators of hidden advertising or misleading information.
Hidden advertising – information about a person or product, if it serves advertising purposes and can mislead people about the true purpose of such programs, shows, publications. Hidden advertising can be found in materials for healthcare specialists and consumers. To avoid these problems, it is recommended that promotional materials for doctors and pharmacists contain only information that reflects objective scientific data and the specifics of the medicine and is useful for the professional activities of specialists. At the same time, the information material should not directly or veiledly agitate health professionals to prescribe the medicine to patients, because by law in the vast majority of cases the doctor must prescribe the medicine under an international non-proprietary name, rather than specify a specific brand. The content of advertising should correspond to the target audience, i.e. reflect the professional status of its recipients. The information material should not contain wording that could directly or covertly agitate healthcare professionals to purchase the medicine, or other theses aimed at a wide range of people.
Dissemination of misleading information is the communication by an entity, directly or through another person, to one, several persons or an indefinite number of persons, including in advertising, incomplete, inaccurate, false information, in particular due to the chosen method of presentation, omission of certain facts or vagueness of wording that influenced or may influence the intentions of these persons to purchase (order) or sell (sell, supply, perform, provide) goods, works, services of this entity. The information in the promotional materials for healthcare professionals should be comparable in the amount of information contained in the concise instructions and in accordance with the latest version of the approved instructions for use of the medicine. These statements should be accompanied by a reference to the approved instructions for use of the medicine or other primary sources, except in cases when well-known scientific data is specified.
Experts of Law offices of OMP recommend avoiding such formulations as “safe medicine”, “guaranteed therapeutic effect”, “no side effects”. It is not recommended to use the word “new” to describe a medicine that has been in circulation for more than one year. It is recommended to use such formulations as “fast”, “long-lasting” effect of the medicine, “reliable” only if it is possible to justify such characteristics. The word “natural” should be used with caution – it is inadmissible to link the safety or effectiveness of the product to its natural origin.
You should not “reinsure” and include the phrase “Self-medication can be harmful to your health” in the advertising of dietary supplements. This element is for advertising medicine, medical devices, methods of prevention, diagnosis, treatment and rehabilitation. The wording “non-addictive” should not be used without possibility to confirm the absolute correctness of this information by authoritative research and/or other primary sources. It is important to avoid statements that could be interpreted as a therapeutic effect of a cosmetic product/dietary supplement, as well as those that contribute to the possibility of self-diagnosis. Thus, if the video begins with a list of symptoms with reference to a specific disease, it may be necessary to add a warning: “To establish an accurate diagnosis, consult a doctor.” It is also recommended to avoid loud phrases about products (for example, “well-known”, as there is a formal procedure for recognizing a mark as well-known) (The procedure for recognizing the mark as well-known in Ukraine by the Appeals Chamber of the State Department of Intellectual Property, approved by Order No. 228).
The phrase “unique product” should be accompanied by an explanation of the reason for uniqueness, with the addition of date, territory. For example, “the word” unique “means a difference in composition (namely a combination [detail list of substances]) that distinguishes [the product] from similar ones [category] of other manufacturers on the Ukrainian market as of [insert date]”.
It should be remembered that for disseminating of misleading information, the Antimonopoly Committee of Ukraine has the right to impose a fine of up to 5% of income (revenue) from the sale of products of the entity for the last reporting year preceding the year in which a fine is imposed. And for violating the order of distribution and placement of advertising, non-compliance with the requirements for its content, distribution of advertising prohibited by law, the State Service of Ukraine for Food Safety and Consumer Protection may impose a fine of five times the cost of distributed advertising.
The use of so-called clone names to circumvent the ban on advertising of Rx-medicine is a common practice in the Ukrainian pharmaceutical market that has existed for a long time. However, the attitude of regulators to this phenomenon has recently begun to change. Igor Ogorodniychuk spoke about the latest trends in this area.
Usually a well-known brand is taken, the line of which is supplemented by products with similar names (for example, with the addition of the words “gel”, “spray”, “baby”, etc.). This allows you to save on the promotion of new products, promote multiple products at once and circumvent the ban on advertising Rx-medicine. The legislation does not directly prohibit the introduction on the territory of Ukraine of dietary supplements / cosmetics / OTS-medicine, the name of which is similar to a registered prescription medicine. Market practice is diverse and includes a number of examples of similar / eponymous medicine, one permitted and the other prohibited for advertising. Also, the lines of individual pharmaceutical companies include the names of medical devices, dietary supplements that are similar to the names of available medicine (especially over-the-counter ones).
The position of government agencies on this issue is quite dynamic and in recent years we have seen an increase in interest in promotion, which may cause confusion/substitution of product categories, and similar labeling. Last year, the Antimonopoly Committee even fined for mixing while advertising a dietary supplement and medicine. In turn, the Ministry of Healthcare developed a draft order “On Amendments to the Criteria Applicable in Determining Medicinal Products, advertising of which is Prohibited”, which proposed, inter alia, to classify a medicinal product as prohibited for advertising during (re)registration, if the trade name of the medicine is the same or contains in the name the name of the prescription medicine. The project has not yet been approved, but its presence indicates that the Ministry of Healthcare understands the problem, and this should be taken into account when naming medicines and planning promotions.
Ogorodniychuk proposed a number of recommendations based on the company’s practical experience and which should protect pharmaceutical manufacturers from unreasonable risk. In general, it is now advisable to avoid duplicating the names of prescription and over-the-counter medicine, experts prefer to use clone names in pairs such as medicine and dietary supplement/cosmetic, etc. It is also recommended to label the packaging of a new product in such a way that it is impossible to unambiguously mix the two products. Packages should be different. In addition, the additional name should have an explanatory meaning (for example, to clarify the action or composition of the product), and not just the form. The label should include a reference to the type of product (dietary supplement / medicine, etc.). In general, the greater the differences are, the lower the risk is. The introduction of a new product should not have only one purpose – to advertise another product. Sales must meet the advertising budget. However, it is not yet possible to completely minimize the risks if the clone contains the name of the Rx-medicine. In this case, you should be especially careful with sponsorship, because when announcing information about the sponsor is often only the name and it can be very similar to the name of another product, reference to which is prohibited in the sponsorship materials.
During the quarantine, it was officially allowed to deliver medicine and, accordingly, to buy them online. This has given impetus to the development of online pharmacies and promotions through pharmacy websites and aggregators of data on medicines. This is stipulated by the Resolution of the Cabinet of Ministers of 23.03.2020 № 220 “On Amendments to the Licensing Conditions for Economic Activity in the Production of Medicines, Wholesale and Retail Trade in Medicines, Import of Medicines (except Active Pharmaceutical Ingredients)”.
Licensees may deliver independently or with the involvement of postal operators on a contractual basis. The document does not provide for the involvement of other business entities (intermediaries, agents) in the delivery of medicines, but this problem is solved by concluding a power of attorney. It is expected that an amendment to the licensing conditions for the transportation of medicines will be developed soon.
The possibility of ordering medicine via the Internet has given rise to a new legal way of promotion, namely: placing a button on the websites of pharmaceutical companies or products to go to the website of a pharmacy or aggregator where you can buy this medicine. On the other hand, there is an interest of pharmaceutical companies in promoting their products on the websites of pharmacies and intermediaries. In this context, the question arises: how should such privileges be considered (for example, the appearance in the list of analogues, automatic merging with other products and privileges in search, etc.) – as information at points of sale, information for the consumer; or as advertising – in the case of over-the-counter drugs, and as information for the consumer, which is communicated to him with the help of remote means – in the case of prescription medicine. Thus, Art. 15 of the Law of Ukraine of 12.05.1991 № 1023-XII “On Consumer Protection” stipulates that the consumer has the right to receive the necessary, accessible, reliable and timely information about the product, which provides the opportunity for conscious and competent choice. Product information is not considered advertising. Such information may be placed where it is sold and, with the consent of the consumer, communicated to him by means of remote communication.
Experts of Law offices of OMP consider it expedient and sufficient to identify data about product as ” Information for consumer” if only general information on labeling (packaging, instructions, package leaflet), price information and terms of purchase are provided (without advertising slogans, etc.) and if the product is not promoted additionally on the basis of an agreement with a pharmaceutical company in the order of advertising. In this case, before using the relevant site, it is recommended to provide a window that follows, in which the user once marked “yes” (with a choice of “yes” or “no”) to agree to remotely receive information about product.