Propaganda - Regulation for Sponsors

All advertisement of drugs in scientific events must comply with the current Brazilian legislation regarding the matter

Resolution RDC N. 102/2000 establishes criteria for advertising, publicity and promotional messages and other practices which objective is to advertise, promote or sell pharmaceutics.

The norm initially deals with the GENERAL REQUIREMENTS that must be observed for advertising any kind of pharmaceutics, both for prescription and non-prescription drugs and regardless of the type of media used for its dissemination. Subsequently the norm describes the REQUIREMENTS FOR NON-PRESCRIPTION DRUGS that are applicable to advertisement of this category of pharmaceutics. Then, the norm presents the REQUIREMENTS FOR PRESCRIPTION DRUGS, and finally the document presents the REQUIREMENTS FOR VISITS OF FARMACEUTICAL PRODUCTS’ SALES PEOPLE.

With regards to Non-prescription Drugs (Medicamentos com Venda Isenta de Prescrição Médica -MIPs), the resolution establishes that these drugs can be advertised to the general public, as long as they comply with the minimum requirements for advertising. Article 12 of the norm establishes that all advertisements of these products must include the commercial name of the drug, its registration number at the Agência Nacional de Vigilância Sanitária (the National Health Surveillance Agency) and the name of the active principles according to the DCB, and, in its absence, the DCI, as well as the following warning: “IF SYMPTOMS PERSIST, CHECK WITH YOUR PHYSICIAN”. That is the mandatory information that must be present in any advertisement of non-prescription drugs, however, all the other criteria established by the norm, in the section that deals with this kind of product, must also be observed.

With regards to Prescription Drugs (Medicamentos de Venda Sob Prescrição Médica - MSPMs), all advertising, publicity or promotion of these products is restricted to specific media aimed exclusively at health professionals licensed to prescribe or administer these products. All advertising material must contain the following information: the commercial name of the drug, if there is one; the name of the active principle according to the DCB – or, in its absence, the DCI, the generic name and the registration number at the National Health Surveillance Agency; indications; contra-indications; precautions and warnings (including the most frequent adverse reactions and drug interactions); dosage and the classification of the drug in terms of prescription and administration. Once again we inform that, besides the mandatory information listed above, all advertising material must comply with all the criteria established by the Resolution for the advertising of non-prescription drugs.

It is important to emphasize that the “compulsory information”, both for prescription drugs and for non-prescription drugs must by presented in the advertising material clearly and visibly, allowing it to be readily seen and read. The aim is to provide a balance between that information and the information used in the advertising argument. In other words, the information must be presented in a way that allows the reader to assess both the risks and the benefits of the medication, allowing him/her to make an informed choice, based on the minimal information necessary to understand the therapy.

Clause 20 of Resolution RDC N. 102/2000 also establishes the following:

"Clause. 20 The sponsorship by a manufacturing laboratory or by a drug distributor, of any public or private events, symposia, congress, meeting, conference or similar type of event, be it partial or full, must be stated in all publicity documents of the event or any resulting or ensuing from the respective event.

§ 1º Any type of support to health professionals to participate in national or international meetings must not be conditioned to the promotion of any medication or institution and it must be clearly stated in the documents referred to in the caput of this clause.

§ 2º All speakers sponsored by the industry must include the name of their sponsor in the event’s publicity material ".

All advertisement of drugs based on substances that are subject to special control must observe the restrictions and warnings stated in the current public health legislation. In this case, Clause 90 of Ruling N. 344/1998 (altered by Resolution RDC N. 197/2004) must be observed. All advertising of this type of medication can be done exclusively in magazines with exclusively technical content, referring to pathologies and drugs, aimed directly and exclusively at health professionals licensed to prescribe and/or administer.

The fact that it is an international event does not change any of the rules applicable to the advertising of therapeutics, and thus all the rules and regulations must be fully observed, under pain of application of the appropriate legal sanctions.