Driven by a trend growing at a global scale, in which more and more countries move towards legalisation of marihuana, Brazil has decided to take its first step. Since the passage of Bill No. 5295 in 2019 by the Senate, Brazil approved hemp and medical marihuana regulation, as well as the import of its derivative products. Up to this moment, patients could only obtain medical products from abroad under a strict authorisation by the Brazilian Health Regulatory Agency (also known by its Portuguese acronym, ANVISA).
This has opened the way for products related to health and beauty, cellulose, textiles, and products for veterinary use, provided that their THC content does not exceed 0.3%. As to food products, only seeds will be allowed.
According to Lorenzo Rolim da Silva, president of the Latin American Industrial Hemp Association (also “LAIHA,” by its Portuguese acronym), hemp could offer a great opportunity for Latin American agriculture.
A Prominent Pharmaceutical Industry
Brazil, the largest among Southern American countries, is the fourth largest pharmaceutical market in the world. Experts claim that possibilities for medical cannabis could grow thanks to the adoption of this new law, with turnover expected to reach 4.7 billion reals for the industry over the next three years.
Several pharmaceutical and international trading companies have already undertaken operations in Brazil, seduced by the low investment costs of agriculture–generally lower in this country, and excellent climate conditions, which make Brazil the most competitive market in the world.
Pharma Industry Fuelled by Brazilian Cannabis
GW Pharmaceuticals, with headquarters in the UK, is already selling its CBD-based medicine at local chemists under the brand name Sativex. Brazilian pharmaceutical company Prati-Donaduzzi is also licensed to make and distribute certain cannabis products at pharmacies. Additionally, on Wednesday, May 4 this year, this company announced having reached the final stage of clinical trials of the first 100% CBD-extract-based medication in the world, a substance derived from cannabis that makes it possible to treat seizures of those suffering from refractory epilepsy, the most advanced stage of this disease.
Eder Fernando Maffissoni, CEO at Prati-Donaduzzi, introduces us to “Myalo”: a CBD formulation with a high degree of purity, obtained from enhanced hemp extract. This extraction process removes all THC, a compound responsible for the psychoactive effect of marihuana.
Since 2015, ANVISA allows for the sale of products containing cannabis in Brazil under a regulation that consists of two types of prescriptions. The first one refers to compounds that exceed 0.2% THC, only allowed for patients with a terminal-stage illness, while the second one comprises all products containing less than 0.2% THC.
Research: The Way Forward
Companies such as Prati-Donaduzzi invest in research and, in this way, the cannabis pharmaceuticals industry in Brazil makes progress with trials on different hemp derivatives. This company has set up a centre that will be exclusively dedicated to research on cannabinoids, and donated it to the School of Medicine of University of São Paulo (USP). The opening is set for August this year and it will be the first of its kind in the whole world.
Under the brand name “Myalo,” the first 100%-cannabis-based medication, made in South America’s largest country, is expected to reach stores by the end of 2021. Research has been carried out for three years now, in joint venture with Ribeirão Preto School of Medicine at University of São Paulo. Prati-Donaduzzi benefited from the passage of the 2019 legislation governing hemp and medical marihuana in this country.
Additionally, Merck, a giant German pharmaceutical company, has recently announced that it is landing in Brazil with the aim of supplying the market with technical knowledge related to research and development, quality control, and biometric applications to intensify hemp cultivation, claimed Fabio Demétrio, head of Research and Solutions at Merck Brazil.
Social and Economic Impact
The Advisory Board of the Brazilian House of Representatives has published a study titled “Economic Impact of Cannabis Legalization in Brazil.” This study does not only quantify the total income from taxes that would be generated if regulation was established, but also notes that such a decision would imply an annual saving of approximately one billion reals (259.8 million euros) in the federal budget.
According to the report, if legalisation were to be put into practice, trading would no longer be considered illegal trafficking, which would lead to a reduction in cost for the correctional system and police expenditure.
As a result of these new regulations, many products can find their way into pharmacies and stores, and a whole new category of goods related to medical cannabis would be available in Brazil. This transition will give patients almost immediate access to products, which would make a huge difference with respect to the current situation: a process that can take up to three months. All 4 million patients in Brazil will now be able to enjoy the benefits of medical cannabis much more easily: walking from the doctor’s office straight to the chemist’s.