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It was indeed a significant step forward for Anvisa (the Brazilian FDA) to establish the category of cannabis products through Collegiate Board Resolution (RDC) #327/2019, enabling their commercialization and expanding access in Brazil. In reality, this move wasn't the outcome of a proactive, premeditated approach by the Agency. Rather, it was a response to mounting pressure from circumstances: the surge in demand, largely due to court decisions mandating the Brazilian Public Healthcare System (SUS) to provide cannabis sativa-derived products not yet approved in the country. Consequently, Anvisa was compelled to permit their importation by citizens with medical prescriptions.

Such circumstances are even acknowledged in the administrative process leading to the issuing of RDC #327/2019, whether in the vote of the original rapporteur, director William Dib[i], or in the vote of director Fernando Mendes[ii], the regulatory proposal of which was approved to replace the initial proposal, resulting in RDC #327/2019.

The fact that Anvisa was “prompted” by circumstances to regulate the issue is not a problem; quite the opposite. Floriano de Azevedo Marques teaches that “in the concept of modern regulation, it is crucial for the state regulatory entity to engage in dialogue and interaction with agents subject to regulatory activity, aiming not only to legitimize their activity but also enhance the quality of regulation, thus more in line with the needs and perspectives of society”[iii]. Therefore, in this aspect, the agency must be congratulated.

This notwithstanding, it can be seen in the process leading to the issuance of RDC #327/2019 that Anvisa misinterpreted the circumstances, especially the court decisions mandating the supply of products by SUS and the authorization of imports based on medical prescriptions. And thus RDC #327/2019 imposed restrictions on the use of such products which fall outside its jurisdiction and do not even make sense for the market target of its regulation.

This is the case, for example, of Article 5 of RDC #327/2019, which stipulates that “Cannabis products may be prescribed when other therapeutic options available on the Brazilian market have been exhausted”. According to this language, the only plausible interpretation of the provision is that it imposes a restriction on the prescription process itself, requiring the physician, before prescribing cannabis products, to exhaust “other therapeutic options available on the Brazilian market”.

Incidentally, it falls outside Anvisa's jurisdiction to restrict prescription activity and impinge on a physician's autonomy when defining the best treatment. None of the provisions of Law #9,782/1999 grant Anvisa such a role. Furthermore, it is clear that Article 5 of RDC #327/2019 interferes with medical autonomy, given that it requires that “other therapeutic options available on the Brazilian market” must be prescribed before Cannabis products, even if a physician understands that this is not the best therapeutic strategy – otherwise, as per the strictness of the ruling, prescribing Cannabis products is irregular.

This is not to imply that Anvisa cannot in any way intervene in physicians' act of prescription. It can and does. For instance, Ordinance #SVS/MS 344/1998, which regulates substances and medicines subject to special control, requires physicians to use specific types of prescriptions depending on the product (Articles 35 to 60). This provision is also evident in RDC 327/2019 regarding cannabis products[iv].

However, this requirement is instrumental and relates to Anvisa's jurisdiction in the health control of products subject to regulation by the agency (Law #9,782/1999, Article 8), which is facilitated by the dynamics of differentiated prescriptions. It is very different to impose a therapeutic strategy on physicians as a condition to legitimize the act of prescribing cannabis products, which is a clear interference in their autonomy when defining the best treatment.

Interestingly, in the administrative process leading to the issuance of RDC #327/2019, there is no clear justification for the rule of Article 5. On the contrary, the vote of director Fernando Mendes states that the majority of the board approved the exclusion of an excerpt of a provision which regarded the medical prescription of cannabis products, making reference to the guidelines by Brazilian Medical Association (CFM) and the Ministry of Health, for understanding that “Anvisa’s regulations do not fall within the scope of the jurisdiction of class councils”[v].

Indeed, regulating the act of prescription, in terms of restricting medical autonomy when defining treatment for patients, falls under the jurisdiction of the CFM. Article 7 of Law #12,842/2013 provides that “the Brazilian Medical Association is responsible for issuing standards to define the experimental nature of procedures in Medicine, authorizing or prohibiting their practice by physicians”.

However, the CFM's jurisdiction must be exercised judiciously, recognizing the physician's right to determine the most suitable treatment for their patient (CFM's Rule #2,217/2018, Item XVI of Chapter I, and Item II of Chapter II)[vi], a right which stems from the constitutional guarantee of professional freedom[vii].

The CFM itself recognizes the need for moderation in the exercise of this jurisdiction[viii]. Recently, in response to market and public pressure, the CFM repealed Rule #2,324/2022 which restricted the prescription of cannabidiol-based products for the treatment of refractory epilepsy in adolescents and children.

Therefore, if it falls within the CFM's jurisdiction to regulate medical autonomy in selecting the most suitable treatment, rather than Anvisa's, what is Anvisa's rationale for including the restriction outlined in Article 5 of RDC #327/2019? As indicated, a clear justification cannot be discerned from the administrative process that led to the issuance of the standard, casting doubt on the legality of the restriction itself.

One possible explanation is that Anvisa deemed the restriction necessary, drawing inspiration from scenarios where court decisions mandated the provision of Cannabis sativa-derived products by SUS. Such decisions often conditioned the supply or authorization of import of such products – which, at the time, lacked Anvisa's approval – to the ineffectiveness of available therapeutic alternatives. However, such condition is tied to the Judiciary Brach's concern of avoiding impacts on the management of public resources, giving preference to the use of products which are already part of SUS policies to the detriment of those whose acquisition is outside of planning and are not even approved in Brazil.

Nevertheless, this concern cannot be used to justify the restriction outlined in Article 5 of RDC #327/2019, given that this standard is obviously not aimed at regulating the supply of such products by SUS, the resource management of which is also not Anvisa's jurisdiction.

Another possible explanation is that, given Anvisa's perspective on the lack of scientifically proven efficacy and safety of such products, the regulation authorizing their use in the country is provisional and exceptional, which could justify conditioning the prescription of such products to the exhaustion of all other therapeutic alternatives. This interpretation is supported, for instance, by an excerpt from director Fernando Mendes when he states that “it regards the proposition of an alternative model, aligning with the best international practices and pertinent contributions directly connected to the popular demand for legitimizing the use of such products when, within the context of illness and the patient, they are the only therapeutic option”.

Even in this scenario, the restriction outlined in Article 5 of RDC #327/2019 does not appear to be legally valid in our view. Anvisa's regulations even provide as a conditioning factor for the regular use of a product in the Brazil the fact that it is the only therapeutic option, but only when such a product is not approved by the agency.

This is the case of RDC #203/2017, which outlines the criteria and procedures for the exceptional importation of products not registered with Anvisa. In its Article 3, the norm allows imports under four specific situations, one of which is “unavailability on the Brazilian market, as well as its therapeutic alternatives or duly registered products used for the same purpose” (section I).

Incidentally, cannabis products receive approval from Anvisa after a technical analysis culminating in a positive conclusion regarding compliance with requirements set out in the regulation. Although approval does not occur through registration but rather through health authorization, both procedures, when analyzed from a legal standpoint, are public acts authorizing economic activity, pursuant to the Brazilian Economic Freedom Act (Law #13,874/2019), which explicitly makes no distinction between "authorization" and "registration" (see Article 1, Paragraph 6).

Hence, despite Anvisa's assertion that the regulation outlined in RDC #327/2019 is provisional and exceptional, there is no concept of a product being "partially" approved for use in the country — the product is either approved or not. Moreover, it is certainly not up to Anvisa to predicate the regularity of use on a factor outside the Agency's jurisdiction: the timing of the prescription of the Cannabis product within the treatment strategy by the physician.

Consequently, it appears to us that the restriction imposed by Article 5 of RDC #327/2019 is not legally valid. While it may seem like a benign stipulation, given that it lacks monitoring mechanisms by Anvisa in medical practice, our suggestion is to exclude it from the forthcoming standard that will supersede RDC #327/2019, which, as far as we know, awaits its Regulatory Impact Analysis by the Agency.

[i] Director William Dib's vote states that “the demand for immediate use of products containing cannabis has grown exponentially for a myriad health conditions. (…) Thus, a framework of intense judicialization emerged for obtaining these products: either in the search for access by importing products from other countries (given that there was no registered medicinal cannabis-based product on the Brazilian market), or by compelling the Government, by means of SUS, to cover the expenses for such imports” (Process #25351.915881/2019-24, vote #14/2019).

[ii] In the vote of director Fernando Mendes, he states that the decision to regulate the topic was made because “the proposal enhances the contributions reflecting the concern with validating the use of cannabis-based products, (…) it regards the proposition of an alternative model, aligning with the best international practices and pertinent contributions directly connected to the popular demand for legitimizing the use of such products when, within the context of illness and the patient, they are the only therapeutic option.” (Process #25351.421833/2017-76, vote #92/2019).

[iii] MARQUES NETO, Floriano de Azevedo. Agências Reguladoras Independentes. Belo Horizonte: Editora Fórum, page 32.

[iv] For example, prescription A must be used for cannabis products with a THC content above 0.2%, whilst prescription B for cannabis products with a TCH content of up to 0.2%, according to Articles 51 and 52.

[v] Process #25351.421833/2017-76, vote #92/2019, page 11.

[vi] CFM's Rule #2,217/2018 (Code of Medical Ethics), Chapter I, Item XVI: “no statutory or regulatory provision of a hospital or institution, whether public or private, will restrict the choice by the physician of scientifically recognized means to be practiced when establishing the diagnosis and carrying out treatment, except when for the benefit of the patient”.

CFM's Rule #2,217/2018 (Code of Medical Ethics), Chapter II, Item II: “indicating the appropriate procedure for the patient, observing scientifically recognized practices and respecting current legislation”

[vii] Brazilian Constitution, Article 5th, XIII “the practice of any work, trade or profession is free, observing the professional qualifications which the law shall establish.”

[viii] In its Opinion #4/2020, which regards the possibility of using chloroquine in the treatment of COVID-19, the CFM had suggested that it is up to physicians’ to prescribe this medication even having little to none scientific evidence regarding its effectiveness, with the physician's autonomy prevailing to define the treatment.

[1] Director William Dib's vote states that “the demand for immediate use of products containing cannabis has grown exponentially for a myriad health conditions. (…) Thus, a framework of intense judicialization emerged for obtaining these products: either in the search for access by importing products from other countries (given that there was no registered medicinal cannabis-based product on the Brazilian market), or by compelling the Government, by means of SUS, to cover the expenses for such imports” (Process #25351.915881/2019-24, vote #14/2019).

[1] In the vote of director Fernando Mendes, he states that the decision to regulate the topic was made because “the proposal enhances the contributions reflecting the concern with validating the use of cannabis-based products, (…) it regards the proposition of an alternative model, aligning with the best international practices and pertinent contributions directly connected to the popular demand for legitimizing the use of such products when, within the context of illness and the patient, they are the only therapeutic option.” (Process #25351.421833/2017-76, vote #92/2019).

[1] MARQUES NETO, Floriano de Azevedo. Agências Reguladoras Independentes. Belo Horizonte: Editora Fórum, page 32.

[1] For example, prescription A must be used for cannabis products with a THC content above 0.2%, whilst prescription B for cannabis products with a TCH content of up to 0.2%, according to Articles 51 and 52.

[1] Process #25351.421833/2017-76, vote #92/2019, page 11.

[1] CFM's Rule #2,217/2018 (Code of Medical Ethics), Chapter I, Item XVI: “no statutory or regulatory provision of a hospital or institution, whether public or private, will restrict the choice by the physician of scientifically recognized means to be practiced when establishing the diagnosis and carrying out treatment, except when for the benefit of the patient”.

CFM's Rule #2,217/2018 (Code of Medical Ethics), Chapter II, Item II: “indicating the appropriate procedure for the patient, observing scientifically recognized practices and respecting current legislation”

[1] Brazilian Constitution, Article 5th, XIII “the practice of any work, trade or profession is free, observing the professional qualifications which the law shall establish.”

[1] In its Opinion #4/2020, which regards the possibility of using chloroquine in the treatment of COVID-19, the CFM had suggested that it is up to physicians’ to prescribe this medication even having little to none scientific evidence regarding its effectiveness, with the physician's autonomy prevailing to define the treatment.