Anvisa is expected to enact rules for the use of Cannabis for medical purposes as early as 2019
Eyes and attention are focused on the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – Anvisa), the Brazilian regulatory agency responsible for the execution of sanitary control, regulation, approval and supervision of pharmaceutical, health services, medical devices, among others. It is expected to establish a new regulation on the use of hemp for medical purposes by the end of the year. If enacted, the new regulation from Anvisa will allow the controlled cultivation of Cannabis sativa for medicinal purposes and the registration of medicines produced with active ingredients of the plant in the country.
This regulatory agenda is not essentially a Brazilian hot topic. This subject has been mobilizing the society, the scientific community and the sanitary/health authorities around the world. Approximately forty countries have already authorized the use of Cannabis for medical purposes. If Anvisa meets the international health trend, Brazil will also be part of this avant-garde group.
Regulating the use of substances extracted from this plant will not only bring social gains – since there are numerous scientific researches attesting therapeutic benefits on the substances found in Cannabis -, but also will bring economic benefits. The American consultancy New Frontier Data estimates that the Cannabis business may attract US$ 5 billion in investments over the next three years.
There is a pent-up national demand that may be met with such measure. Studies and researches in the fields of neurology, psychiatry, immunology and oncology have shown positive results for the health and well-being of patients with severe ailments such as epilepsy, Parkinson’s disease, multiple sclerosis, autism and malignant neoplasms.
Over the last few years, Anvisa has demonstrated a more flexible view on this subject. Since 2015, year in which the Collegiate Board Resolution RDC 17/2015 was enacted, Anvisa allows the importation of Cannabidiol-based products in combination with other cannabinoids, including THC, for patients undergoing healthcare. Current data provided by this regulatory agency indicates that between 2015 and 2019 more than 9,000 authorizations were granted to import medicines made from the extract of Cannabis.
In 2017 Cannabis sativa was included in the list of medical plants and Anvisa granted the first registry of Cannabidiol and THC-based medicine – the Mevatyl used in the multiple sclerosis treatment.
Anvisa regulation for medicinal Cannabis has gained relevance on the Brazilian scene since the number of court decisions authorizing the import of medicines with such substances in its composition and the cultivation of plant for therapeutic purposes has dramatically increased in the past years. Hence, the push towards regulation to allow the controlled cultivation of Cannabis sativa for medicinal purposes makes sense.
A recent Brazilian judicial decision has authorized the parents of an autistic child with severe epileptic seizures to grow Cannabis plant for medicinal use. In another case, a stomach cancer patient was granted a Habeas Corpus not to be arrested for importing and planting Cannabis seeds to extract its own Cannabis oil for medicinal purposes. And earlier this month a company filed a lawsuit against the Union and Anvisa to obtain the right to plant non-psychoactive Cannabis, intended to produce medicines, tissues and food.
Even to prevent the Judiciary from “regulating” this matter, Anvisa – the regulatory agency entitled to enact rules for use of medical Cannabis – has held two public consultations to debate clear and transparent rules on the use of Cannabis (Public Consultation No. 654/2019 for registration and monitoring of Cannabis spp. -based drugs and Public Consultation No. 655/2019 to address technical requirements for plant cultivation).
Although the society has highlighted positive effects regarding both proposals (such as advances in scientific research, increased safe access to medication, reduced cost, improved quality of life for patients, economic growth, job creation, increased tax collection, reduction of lawsuits for the purchase of Cannabis medicines), there is a strong societal concern whether or not this agency will give in to political pressure as well as from the pharmaceutical industry.
The minutes of resolutions under discussion do not contemplate the possibility of cultivation of Cannabis plant by individuals, associations and small companies, which may be considered as favoring large industries. There is a fear that pharmaceutical companies will market the drugs at high prices, or even that this scenario may contribute to the formation of oligopolies and monopolies.
Although Anvisa has legal prerogative to uniquely regulate the use of cannabis-derived substances for medical purposes, part of the Brazilian Federal Government gives signals on the contrary regarding the liberation of cropping. The conservative administration believes that any flexibilization related to Cannabis could lead to an increase in recreational use. For this reason, the raw materials should not be planted in Brazil, but imported from abroad.
It is up to us to await Anvisa’s position as to whether this regulatory agency will give in to political and pharmaceutical pressures or cherish the democratization of medicinal cannabis. This initiative could be an important first step to extending the horizon of cannabis use beyond its medical purpose.
Bearing in mind that Cannabis can also be used in the production of fibers for the pulp and paper industry and also as a raw material for the textile industry in place of cotton, we are wondering if we are facing a new agricultural commodity.
Considering that agribusiness is a fundamental point in the national economy, and Brazil is one of the world’s leading suppliers of agricultural products, we look forward to see the next chapters of the national public policy on this matter.
Isabela Amorim Diniz Ferreira, Corporate lawyer from Farroco Abreu Advogados.