November 25, 2021
The unrestricted bans of Cannabis products taking place are not in line with Anvisa's regulatory microsystem.
The challenges of regulating Cannabis products are not exclusive to a single country. Regulators surround themselves with normative arrangements which border with social prejudice and the difficulty of finding an ideal equation for the topic. In Brazil, the last regulation issued on cannabis products – and its use for medicinal purposes – was the ANVISA’S Board of Director Rule (RDC) #327/19, issued on December 9, 2019.
The regulation category of “Cannabis Products” was created with the RDC as an official Anvisa class of product, so as to bridge the framing gap of such products. Historically, there was an increase in demand for such products and Anvisa chose to regulate the marketing under a new temporary category, so that companies may continue to develop research for the potential registration of such products as drugs . Cannabis products which do not fit into the category of drugs within the period stipulated in the RDC will have their approval canceled.
Among the challenges of regulation, the issue of advertising stands out. Articles 9 and 12 prohibit the use of “commercial names” and prohibit “any advertising” of Cannabis products. According to public information, there is no justification for such prohibitions in the process other than an official letter from the General Coordination of Police Enforcement Against Drug and Criminal Factions, which mentions that advertisement prohibition was necessary, but without justifying why.
The legal validity of such prohibitions is questionable. The Brazilian Constitution provides that the commercial advertising of medicines and therapies “shall be subject to legal restrictions” (Article 220, Paragraph 4). For the purposes of applying Article 220, Cannabis products fall under “therapies”. The Brazilian Constitution does not authorize the complete and unrestricted prohibition of a company's efforts to differentiate their medicines and therapies. Instead, it only limits them to any restrictions imposed by law, which must be aimed at protecting consumer health, pursuant to Item II.
Article 220, items II and Paragraph 4, is regulated by Statute #9,294/96 and establishes that advertising of medicines and therapies “of any type or kind” (i) shall contain a warning concerning the damages which may be caused by their use (Article 3, Paragraph 2); (ii) it may be done in specialized publications and should be directed to health professionals and institutions (Article 7); and (iii) cannot deceive the consumer, generating a false perception on effects and risks thereof (Article 7, Paragraphs 2 and 5).
Hence, there is no complete and unrestricted prohibition of advertising in Statute #9,294/1996 solely the provision of rules aimed at protecting the consumer. Statute #6,360/76 has provisions regarding a company's efforts to differentiate its products subject to health surveillance, but it also does not provide for a general and unrestricted prohibition.
At the regulatory level, there is no provision establishing prohibitions – nor could they do so. Instead, they seek to standardize companies' advertising practice. Ordinance #344/98 (Technical Regulation on Substances and Medicines Subject to Special Control), applicable to Cannabis products, and RDC #96/08, which regulates the practices for disclosing medicines, are applicable to the case. Both impose conditions (for example, advertising may only be done in techno-scientific publications or magazines) and specific, delimited prohibitions (such as restricting medicine use).
Even when there is a prohibition in Anvisa's regulation regarding brand usage or advertising, the standard allows for some type of product differentiation effort by the company. For example, generic medicines cannot have commercial names, and may only be identified by their active ingredient (Law #6,360/1976, Article 3, Item XXI1). However, publicity thereof in general is allowed (Law #9,294, Article 7, Paragraph 42). Companies are also allowed to market the exact same products in the regulatory category of similar medicines from a technical standpoint, for which the use of a trade name and brand is allowed, as well as specific advertising regarding the product3.
The unrestricted bans of Cannabis products advertising are not in line with Anvisa's regulatory microsystem. Interestingly, the RDC does not even allow for specialized advertising aimed at physicians – despite entrusting physicians with the decision to prescribe cannabis products (and the consequent analysis and verification of “absence of therapeutic alternatives”, as the prescription requirement from Article 48 of RDC #327/19). The RDC seems to ignore that advertising aimed at said physicians leads to a more informed choice regarding the product which suits the patient's needs by providing them with information about the products' compositions and effects on the body.
National court precedents4 converges in the sense that any restriction to constitutionally guaranteed rights, such as the right to advertising, must be proportionate and justified. There is no motivation for the advertising bans in the administrative process that led to the edition of RDC #327/2019, which is subject to criticism in on itself. There is not even a regulatory impact analysis report to support the decision.
The Brazilian courts have already corrected Anvisa's excesses in terms of medicine advertising. TRF-1 (Federal Court of Appeals for the o 1st Circuit) even decided that RDC #96/085 has gone beyond the limits of Statute #9,294/96 by establishing specific prohibitions not provided for by the Statute. Indeed, TRF-1 has long held a critical view of Anvisa's regulation on medicine advertising, having invalidated some penalties imposed based on the rule prior to RDC #96/2008 (RDC #102/2000)6.
In another example, in 2011, TRF1 judged a law suit proposed by Sindusfarma (largest pharma industry association), in which they questioned the act by Anvisa that had prohibited the use of trademarks for vaccines7. Anvisa's justification was that the restriction was intended to allow for broad, unrestricted access to vaccines at a minimum cost and to avoid economic exploitation, cartel formation, or price increases. At the time, for several reasons, including the benefit that product brand identification would bring to consumers, TRF1 confirmed the favorable ruling which deemed the prohibition illegal.
The prohibition on commercial name usage and the prohibition on advertising cannabis products, in a broad and unrestricted manner through an infralegal rule, does not seem to fit the Brazilian constitutional system. RDC #327/19 neglects the beneficial effect which brand names and advertising can have on consumers, in terms of physician access to information, for example.
From a strictly legal standpoint, the prohibitive formula of the RDC also contradicts Anvisa's regulatory scenario regarding advertising. Through the lens of the Brazilian courts, the case law regarding the regulation of medicine advertising and the like lead to the potential conclusion that Articles 9 and 12 are questionable. It is necessary to go beyond prejudice in order to assess whether this prohibition actually fits what seems to be the rule's object: facilitating access to medicines, ensuring ample information for physicians and for consumers-users.
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