Since Katiele and her daughter made the news, we’ve had a little debate on the legalization of medical marijuana in Brazil. Katiele struggles to treat her daughter’s epilepsy with CBD (Cannabidiol), a substance extracted from marijuana.
One could ask what’s Anvisa — Brazil’s equivalent to the U.S. Food and Drug Administration — position on the matter. How do they justify their ban on the medical use of cannabis?
Researcher André Kiepper forwarded a few doubts to Anvisa and got replies that were, at the very least, peculiar from the substitute coordinator of controlled substances.
He asked, “Why am I not allowed to cultivate cannabis exclusively for my daughter’s and other families’ medical necessities?” The answer was that, “Cannabis sativa L. is listed under List E (List of proscribed plants that can originate intoxicating and/or psychotropic substances in Annex I from the Ministerial Order of the Ministry of Health no. 344 from 1998. Thus, it is forbidden to cultivate it in national territory.”
That means that, if you want to plant marijuana for medical use, your land may be expropriated without compensation, since the constitutional penalty for planting psychotropics is just that. Anvisa’s answer just shows the serious risks that a civil disobedient undergoes when planting weed to help sick children in this country. Minimizing children’s suffering is forbidden.
It was also asked whether Anvisa even had powers to authorize or not the planting, growing and harvesting of the vegetables listed under so-called List E. The reply was, “Every medical purpose should be proved to Anvisa through pre-clinical and clinical security and effectiveness studies, described in dossiers for the recording of medicines which should be filed to Anvisa by pharmaceutical companies interested in registering and selling them.”
Notice the bureaucratic hoops people would have to jump through to get their medical marijuana. Against the state, Katiele brought CBD in from other countries, with promising results to her daughter’s health.
You should also notice that authorization for growing weed depends on a pharmaceutical company filing for a license. Anvisa replies also that “the use of these substances should be restricted to medical or scientific facilities,” what should “prevent the cultivation by individuals.” Only corporations can ask for authorization to grow weed! Users are bound by their willingness!
Faced with this restriction, Kiepper asked how to get authorization for importation. Anvisa’s dehumanized reply is flabbergasting: “We inform you that we do not have a norm for that sort of procedure.”
Kiepper pressed the point and asked why they lack such norm. Anvisa then responds: “Up until this moment, no company has filed for registry of any medicine based on substances derived from Cannabis.” So, people who need to use medical marijuana have to wait for corporations to act so that there’s any regulation regarding it.
There is, however, a possibility to request an exemption for personal use, but it isn’t supposed to help patients out: “The exceptional authorization for the importation of controlled drugs without registration in the country and based on proscribed (prohibited) substances should be solicited in a case by case basis, for it is an exemption granted for the lack of therapeutic alternatives in the country. . . . [I]t is imperative that periodical reassessments be done to follow eventual changes in the prescription/forms of treatment that impact upon quantities previously authorized.” This answer was issued to deny the possibility of a yearly renewal or a registry to authorize the buying of medicine abroad.
There is also no rule to authorize the importation of CDB by a non-profit organization and “each authorization issued is specific to a single product (commercial name, if it has one, presentation, formula, etc.) and to a single manufacturer, patient and exporter, not authorizing the importation of any other product.”
Asked whether “Anvisa intended to facilitate the process to avoid the unnecessary death of children,” the agency informed they had no information about changes in procedures for importation, but they guarantee that “every effort and debate related to the importation containing Cannabidiol is being conducted by Anvisa, both in a national as well as in an international level, so that the right to health care is guaranteed, not forgetting, however, to continue to avoid the risk of improper, abusive and recreational use of any substance or plant.”
While bureaucrats debated, 1 year and 4 months old Gustavo Guedes, who suffered from Dravet Syndrome and waited for the liberation of CDB by Anvisa, died.
Translated into English by Erick Vasconcelos.
Translations for this article:
- Italian, Lo Stato Balia Uccide.