August 28th, 2020
For two consecutive months now, monthly approvals by ANVISA have surpassed the 1,500 mark. This includes both new patients being granted an authorisation and renewals of expired authorisations, the validity of which has recently been expanded from one to two years. This is double the reported figures of 2019 and represents a five-fold increase from two years ago. As of August 2020, approximately 20,000 patients have been granted an authorisation allowing them to import medical cannabis products in Brazil.
Most cannabis prescriptions in Brazil have been issued for high-CBD products. Special authorisations are required for products over 0.2% THC which are significantly harder to obtain. This sets a clear distinction between Brazil and most medical cannabis markets, where chronic pain patients using high-THC products represent the wide majority of patients.
On top of the special importation of mainly CBD products, in December 2019 new regulations were signed, allowing ANVISA to grant sanitary authorisation of Brazilian-manufactured CBD products, which can be dispensed under prescription in any pharmacy, without the need for a special licence.
Since cultivation is still illegal in the Latin American country, raw materials for the manufacture of Brazilian CBD products are imported from elsewhere. In April, pharmaceutical company Prati-Donaduzzi got the green light to produce its first product under this scheme, an oral solution intended for the treatment of epilepsy, containing 200mg of CBD per ml.
Despite the fact that there is no limitation on the indications for which medical cannabis can be prescribed in Brazil, the General Council of Medicine only advises on its compassionate use in cases of refractory epilepsy.
The future of Brazilian cannabis laws
All eyes are on the Brazilian congress now, as a law is expected to be voted in the first half of September proposing to authorise the cultivation of cannabis and industrial hemp nationwide, aiming to boost the national industry in a country where 80% of its farmland is suitable for cannabis hemp cultivation.
The proposed law also aims to allow the development of cheaper products using national raw materials, therefore improving the affordability for patients. The proposed legislation does not allow for individual cultivation, but allows for cultivation by cannabis associations.
Earlier this month the Federal Court ruled in favour of including cannabis-based products on the public healthcare system, in another major development in this emergent market.
For a more thorough understanding of the current state of the supply-demand balance in the LatAm market please contact our consulting team at email@example.com.