It was definitely an important step forward for Anvisa (the Brazilian FDA/EMA) to create the category of products called “Cannabis Products” through Rule No. 327/2019, enabling their marketing, and expanding access in Brazil. Such move wasn't the result of a proactive, premeditated approach by the Agency. It was actually a response to pressure created by following circumstances: increase in demand of those products, largely due to court decisions ordering the Brazilian Public Healthcare System (called “SUS”) to provide for free Cannabis sativa-based products not yet approved in the country, as well as ordering Anvisa to authorize their importation by citizens with medical prescriptions.
Such circumstances are even acknowledged in the administrative procedure for issuing Rule No. 327/2019. This can be seen either in the vote of the first Rapporteur, Director William Dib[i], or in the vote of Director Fernando Mendes[ii], whose draft proposal has been approved to replace the first one, resulting in Rule No. 327/2019 as it was issued.
The fact that Anvisa has been “prompted” by circumstances to regulate the issue is not a problem at all. Floriano de Azevedo Marques teaches that “in the concept of modern regulation, it is crucial for the regulatory agency 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 society’s needs and perspectives”[iii]. Therefore, on one hand, the Agency is to be congratulated.
However, on the other hand, it can be noticed in the administrative procedure which lead to issuance of Rule No. 327/2019 that Anvisa misinterpreted the circumstances, especially said court decisions ordering SUS to supply Cannabis-based products and Anvisa to authorize imports based on medical prescriptions. As a consequence, the Agency included in Rule No. 327/2019 restrictions on the use of such products which fall outside its jurisdiction and do not even make sense for the target market of its regulation.
This is the case of Article 5 of Rule No. 327/2019, which sets that “Cannabis Products can only be prescribed when other therapeutic options available on the Brazilian market have been exhausted”. According to this language, the only interpretation is that the provision imposes a restriction on the act of prescription, requiring the physician to exhaust “other therapeutic options available on the Brazilian market” before prescribing Cannabis Products.
The problem is that it falls outside Anvisa's authority to restrict prescription activity, as this interferes in physicians' autonomy in defining the best treatment. None of the provisions of Statute No. 9,782/1999 grant Anvisa such a role. Furthermore, it is clear that Article 5 of Rule No. 327/2019 interferes with physicians’ 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 strategy. Otherwise, as per the provision’s wording, prescribing Cannabis Products is irregular.
This does not mean that Anvisa cannot in any way interfere with medical prescriptions. The Agency actually can and already does that. For instance, Ministry of Health’s Ordinance No. 344/1998, which governs the marketing and related activities with controlled substances, requires physicians to use specific types of prescriptions depending on the product (Articles 35 to 60). This provision is also evident in Rule No. 327/2019 regarding Cannabis Products[iv].
However, this requirement is related to Anvisa's authority to control products subjected to its regulation (Statute No. 9,782/1999, Article 8), which is facilitated by the dynamics of differing 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.
During the administrative procedure which lead to issuance of Rule No. 327/2019, it is not clear on which grounds Article 5 was based. On the contrary, Director Fernando Mendes stated in his vote that the majority of Anvisa’s Board of Directors had decided to exclude a provision’s excerpt which dealt with prescription of Cannabis Products, making reference to guidelines of the Federal Medical Board (called “CFM”) and of the Ministry of Health, for understanding that “Anvisa’s regulations do not fall within the scope of the authority of professional boards”[v].
The prescription activity, in terms of defining patients’ treatment, is subject matter of CFM’s regulation. Article 7 of Statute No. 12,842/2013 provides that “the Federal Medical Board is responsible for issuing rules to define the experimental nature of procedures in medicine, authorizing or prohibiting their practice by physicians”. Even CFM shall carefully exercise this responsibility, since it is also the physician's right to determine the define the best treatment for his/her patient (CFM's Rule No. 2,217/2018, Item XVI of Chapter I, and Item II of Chapter II)[vi]. This right stems from the constitutional guarantee of professional freedom[vii].
CFM itself recognizes the need to be careful in this situation[viii]. Recently, in response to market and public pressure, CFM decided to revoke Rule #2,324/2022, which restricted the prescription of cannabidiol-based products only for the treatment of refractory epilepsy in adolescents and children.
Therefore, considering that it is CFM’s role to regulate physicians’ autonomy in defining the best treatment, what was Anvisa's grounds for setting the restriction set forth in Article 5 of Rule No. 327/2019? As mentioned, it is not possible to identify a clear justification within the administrative procedure for issuing the rule, casting doubt on whether such restriction is legally valid.
One possible reason is that Anvisa deemed the restriction necessary, drawing inspiration from scenarios where court decisions ordered SUS to provide Cannabis-based products. Such decisions often conditioned the supply or authorization of import of such products – which, at the time, did not receive Anvisa’s approval – to the lack of available therapeutic options. However, such condition is tied to the courts’ 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 Rule No. 327/2019, given that it 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 reason is that, given Anvisa's perspective on the lack of scientific proof of safety and efficacy of such products, the regulation authorizing their use in the country is provisional and exceptional, which could justify conditioning the prescription to the exhaustion of all other therapeutic options. This interpretation is supported, for instance, by an excerpt from Director Fernando Mendes’ vote, stating that “the draft is a proposal 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 Rule No. 327/2019 does not seem to be legally valid. 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.
It is the case of Rule No. 203/2017, which establishes the criteria and procedures for exceptionally importing products not yet approved by Anvisa. Said rule allows imports under four specific situations, one of which is when the “product is unavailable on the Brazilian market, as well as its therapeutic options or products duly approved for the same purpose” (Article 3, section I).
However, before approving a Cannabis Product, Anvisa technically analyzes submitted data and concluded that it complies with regulatory requirements. Although such approval is a bit different from marketing authorization granted to drugs, from a legal standpoint, both are defined as public acts which authorize the practice of an economic activity. The Brazilian Economic Freedom Act (Statute No. 13,874/2019) makes clear that there is no distinction between them (see Article 1, Paragraph 6).
Hence, despite Anvisa's understanding that the regulation outlined in Rule No. 327/2019 is provisional and exceptional, there is no such thing as a product "partially" approved for use in the country — the product is either approved or not. And it is certainly not up to Anvisa to condition the regularity of use on a matter that it is not its decision: best timing for the physician to prescribe the Cannabis Product within his/her patient’s treatment strategy.
In view of all, it seems that the restriction imposed by Article 5 of Rule No. 327/2019 is not legally valid. While it may look like a benign stipulation, given that it lacks monitoring mechanisms by Anvisa in medical practice, our suggestions is to exclude it from the forthcoming regulation that will replace Rule No. 327/2019. The new regulation, as far as it is known, it is awaiting its Regulatory Impact Analysis by the Agency.
[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.” (Administrative Procedure #25351.421833/2017-76, Vote No. 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] Administrative Procedure #25351.421833/2017-76, Vote No. 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 drug even having little (or none) scientific evidence regarding its effectiveness, with the physician's autonomy prevailing to define the treatment.