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How the EAEU Rules affect the advertising of medicines

10 March 2021
GxPnews

From January 1, 2021, registration of medicinal products must be carried out in accordance with the EAEU Rules, and drugs previously registered under national rules are subject to re-registration by the end of 2025. These changes significantly affect the procedure and procedure for registration of medicines. However, the consequences are much broader and affect many aspects of drug circulation. In particular, the new registration procedure entails changes in the regulation of their advertising.

Any pharmaceutical company, as a conscientious advertiser, is interested in advertising not only attracting attention and promoting the drug on the market, but also complying with legal requirements. At the same time, drug advertising must comply not only with the general requirements for advertising, but also with special ones applicable to drugs, as to special objects of advertising (Article 24 of the Law "On Advertising").

One of the main special requirements is the requirement for advertising to comply with the instructions for medical use.

Notification in advertising about the properties and characteristics, including the methods of application and use, of drugs and medical devices is allowed only within the limits of the indications contained in the duly approved instructions for the use and use of such advertising objects (clause 6 of article 24 of the Law "About advertising").

With regard to the specified requirement for advertising of medicines, an extensive law enforcement practice of the FAS has developed [1]. The issue is also reflected in the recommendations of the professional community [2]. This practice clearly directs market participants that advertising materials about a medicinal product must comply with the duly approved instructions for medical use.

The problem is that this practice refers to the national procedure for the registration of medicines, while for medicines registered under the EAEU rules, it is not yet available.

The national procedure for registration of medicinal products of the Russian Federation provides for the mandatory instructions for medical use (hereinafter referred to as the “IMP”). The requirements for the IMP are contained in par. 5) part 4 of Art. 18 of the Law "On the Circulation of Medicines".

The EAEU rules, instead of a single instruction on the medical use of a medicinal product, provide for the validity of two documents:

• instructions for medical use (leaflet) (hereinafter referred to as “LP”) - a document approved by the authorized body of the Member State in accordance with the acts of the Union bodies, containing information for the consumer and accompanying the medicinal product in the package;

general characteristics of a medicinal product (hereinafter referred to as “SmPC”) - a document approved by an authorized body of a member state, in accordance with acts of the Union bodies, containing information for medical workers on the safe and effective use of a medicinal product.

Both documents are approved during the registration process according to the EAEU Rules, are part of the registration dossier and are posted in a single register. At the same time, the EAEU Rules contain a number of identical requirements for specifying the characteristics of medicines and the procedure for their use for both SmPC and medicinal products. However, the information in these documents may differ, since they are intended to familiarize different categories of persons with the medicinal product: specialists - in the case of SmPC and ordinary consumers - in the case of drugs.

Thus, a reasonable question arises about the application of paragraph 6 of Art. 24 of the Law "On Advertising" in relation to medicinal products registered in accordance with the EAEU Rules. Which of these documents must the advertising messages correspond to - LP or SmPC, two documents at once, or at least one of them?

It seems that the answer to this question cannot be unambiguous. Medicines are divided into two groups with very significant features in legal regulation: prescription and non-prescription medicines.

OTC medicines

The legislation does not limit either the range of subjects or the sources that may contain information on medicines sold without a prescription (part 2 of article 67 of the Law “On the Circulation of Medicines” No. 61-FZ dated 12.04.2010). Such information may be contained in publications and announcements of the mass media, specialized and general printed publications, instructions for the use of medicinal products.

At the same time, legal regulation tends to a specific goal - to bring to the consumer a sufficient amount of reliable and necessary information that allows him to make an adequate choice of goods. The same purpose is served by the information duty provided for by the legislation on the protection of consumer rights. It is envisaged that information is brought to the attention of consumers in the technical documentation attached to goods (works, services), on labels, marking or in another way adopted for certain types of goods (works, services). With regard to drugs, the instructions for medical use are precisely the document from which the consumer receives information about the drug.

Thus, in the case of medicinal products, it is necessary to proceed from the fact that any consumer should be able to familiarize themselves with the instructions included in the package of the medicinal product. It is in this document that information should be contained that is necessary and sufficient for the selection of a drug and its subsequent correct use.

This inevitably leads to the conclusion that in relation to medicines registered under the EAEU Rules, such a document that any consumer has access to is an insert leaflet, as the only document containing information for the consumer and accompanying the medicinal product in the package.

Advertising of OTC drugs to a wide range of consumers is allowed, subject to the restrictions established by law. In particular, special restrictions established by Art. 24 of the Law "On Advertising". One of the goals of the Law "On Advertising" is to implement the consumer's right to fair and reliable advertising (Art. 1 of the Law "On Advertising"), which means preventing the consumer from being misled by advertising. According to paragraph 2 of Art. 67 of the Law "On Circulation of Medicines", advertising materials about an over-the-counter medicinal product must comply with the instructions for use.

Thus, in the case of advertising of over-the-counter drugs registered under the EAEU Rules, the advertising materials must correspond to the medicinal product as an informational material intended for acquaintance with the information of the end consumer.

It is important that the Federal Antimonopoly Service (FAS Russia) comes to a similar conclusion. In response to specific requests for clarification, which of the documents provided for in the EAEU rules (LP or SmPC) must be followed, FAS Russia indicates that in order to comply with Part 6 of Article 24 of the Federal Law "On Advertising", it is required to be guided by the instructions for medical use, due to the fact that this manual is a direct insert and is intended to familiarize the end user with it.

Prescription drugs

 The legal regulation of prescription drugs has significant features. Legislation limits the range of subjects who can receive information about prescription drugs. According to paragraph 1 of Art. 67 of the Law "On the Circulation of Medicines" dated 12.04.2010 No. 61-FZ, information on prescription drugs should be contained only in specialized publications intended for medical and pharmaceutical workers. Such information can be contained in monographs, reference books, scientific articles, in reports at congresses, conferences, symposia, scientific councils, as well as in instructions for the use of drugs.

Thus, the average consumer does not have free access to information about the prescription drug. His acquaintance with the information is limited to familiarity with the instructions included in the package. Moreover, the access of ordinary consumers to advertising of prescription drugs constitutes an administrative offense [3] and entails administrative liability for the advertiser and advertising distributor, which is confirmed by the current law enforcement jurisprudence [4] and the practice of the FAS [5].

The analysis of these provisions of the legislation leads to the conclusion that the addressee of advertising of prescription drugs can only be medical and pharmaceutical workers who have access to information both from the instructions for medical use (leaflet) and from the general characteristics of the drug. Thus, advertising messages must comply with at least one of the above documents: either the SmPC or the LP.

However, it should be borne in mind that with regard to prescription drugs, the law enforcement authorities may have a stricter approach and a different, restrictive interpretation of the law. Thus, in response to specific requests for clarifications, the FAS Russia suggests comparing prescription drugs with the drug (package insert) and not with the SmPC when analyzing advertising messages. At the same time, FAS Russia motivates this approach by the fact that the direct use of the drug is still carried out by the end user, who has access only to information about the drug from the drug (package insert). That is, the reasoning is reproduced about the need to protect a consumer who does not have access to the SmPC and is able to familiarize himself only with the drug.

This argumentation is not devoid of logical contradiction. With this approach, advertising of a prescription drug is distributed among a special audience: medical and pharmaceutical workers, but the advertising messages are compared not with the information available to these specialists (SmPC), but with the information (LP) available to another audience - the end consumers who obviously do not have access to such advertising.

Undoubtedly, the end consumer has the right to reliable and sufficient information about the product. This is what LP exists for. However, for specialists, much more detailed and detailed information about the drug can be provided, which is available and useful to medical professionals, but is unnecessary for the average consumer. Undoubtedly, advertising of a prescription drug aimed at attracting the attention of specialists to it should refer to broader and more detailed information, and not to the minimum that is necessary for an unprepared consumer.

At the same time, pharmaceutical companies, as advertisers, should take into account that such a restrictive approach can be carried out by the FAS until a judicial and arbitration practice develops on it.
When registering medicines in accordance with the EAEU rules, pharmaceutical companies should take into account their marketing policy to generate interest in the drug and to promote it on the market. In this regard, all advertising stamps (a message in advertising about the properties and characteristics of the drug) must be based on the information contained in the medicinal product. This is, in any case, true for over-the-counter drugs. In the case of prescription drugs, this applies at least until there is adequate practice to base advertisements on SmPC data.

This approach requires the most responsible preparation of medicinal products, which should reflect all the characteristics and properties of the drug that will be used to promote it on the market. This feature also requires close interaction of such divisions of a pharmaceutical company as a marketing service and a drug registration service when drafting registration documents.

 

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