Anvisa and Brazilian House of Representatives yield to social pressure and move towards to the universalization of cannabis for medical purposes
As scientific evidence advances on the therapeutic benefits of medicinal products made from Cannabis sp. extracts, the number of countries with specific regulations also increases. Substances from cannabis are being used as an alternative to traditionally prescribed medicines.
In Brazil, the initial step to allow the use of cannabis sativa for medical purposes was taken in 2014, when the Judiciary granted the first injunction to authorize a patient to import and use cannabidiol-rich oil (CBD) for the refractory epilepsy treatment.
Since 2015 the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – Anvisa) has granted patients in health care treatment authorizations for the importation of medicines with parts of Cannabis sp. plant or substances obtained from it in its composition. In this same year, Anvisa also amended the Ministry of Health Ordinance No. 344/98, disqualifying CBD from the list of banned substances and classifying it as a substance subject to a special control in Brazil.
More recently, in June/2019, Anvisa submitted two proposals for Collegiate Board Resolutions (RDCs) for public consultation to address (i) the technical requirements for plant cultivation by pharmaceutical companies solely for medicinal and scientific purposes; and (ii) procedures for the registration and monitoring of cannabis-based medicinal products, their derivatives and synthetic analogues.
In tandem with Anvisa’s proposed regulations, there is a Bill on the floor of the House of Representatives to allow the commercialization of Cannabis sativa-based medicines. Bill No. 399/15 intends to amend article 2 of Law No. 11,343/06 (Brazilian Anti-Drug Law) by enabling the commercialization of medicines that contain extracts, substrates or parts of the plant Cannabis sativa in its formulation.
According to the proposed text, the commercialization is conditioned to the proof of therapeutic efficacy of the medication, duly attested by medical report for all cases of indication of use. In addition, PL No. 399/15 may extend the use of medicinal cannabis to other areas that have not been treated in Anvisa’s RDCs, by also authorizing associations to plant cannabis for medical use.
If on the one hand Bill No. 399/15 continues to be processed in the House of Representatives, with the establishment of the Special Commission and the beginning of public hearings, on the other hand Anvisa’s RDC await their return to the Collegiate Board of Directors’ agenda (Dicol).
During the Dicol Meeting held on October 15, two directors formally requested for adjournment to study both RDC proposals. Mr. Barra Torres has requested access to the RDC that addresses technical requirements for plant cultivation and research purposes, while Mr. Fernando Mendes has requested a deadline to review the project for drug registration and monitoring at the base of the plant.
As set forth in Anvisa’s Internal Regulations, the adjournment is granted only once per director for the term of two public ordinary meetings. Once the deadline is expired, the RDC proposal is automatically entered on the agenda of the subsequent meeting, unless further notice is required by the director who requested the adjournment.
The deadline for both RDC proposals to return to Anvisa’s meeting agenda has already expired and both issues were not included in the agenda of the next Dicol meeting scheduled for November 19. Both proposals are expected to be voted in the last Dicol meeting of November, which will take place on the 26th. There is a fear that the so-called cross-adjournment will take place at this meeting, which means that the RDC proposals may be exchanged between both directors. If it occurs, the voting will suffer a delay for at least two more weeks.
In December there are only three more Dicol meetings scheduled. Although Anvisa’s Chief Executive William Dib has already expressed his support for the use of cannabis for medicinal purposes, there is a fear that this issue will return to Anvisa’s agenda only in 2020.
Medical cannabis regulation in Brazil stems from societal pressure and, especially, in the increasing judicialization of requests to authorize patients to import cannabis-based medicinal products, grow marijuana for medicinal purposes, and/or oblige the State to supply them.
States of São Paulo and Goiás have already have bills for the free supply of cannabis-based medicines by the Unified Health System (Sistema Único de Saúde – SUS) (Bills No. 1,180/19 and 2,572/19, respectively). Pioneering, Federal District Law No. 5,625/16 already ensures the provision of cannabidiol (CDB) and comprehensive care to patients with epilepsy treated in the public health system.
Brazilian public policy on the use of cannabis sativa for medicinal purposes is moving slowly. Although some patients make use of Anvisa’s authorizations and judicial decisions to access cannabis-based treatments, the regulation of the use of cannabis sativa for medicinal purposes will allow universalization of access to cannabis sativa for medical purposes.
Isabela Amorim Diniz Ferreira,
Corporate lawyer from Farroco Abreu Advogados, specialized on regulatory matters and post-graduated in Economic Law by Fundação Getúlio Vargas de São Paulo (FGV/SP).