Cannabis has around 400 components. Among them, the two most popular are tetrahydrocannabinol (THC), known for its psychoactive effect, and cannabidiol (CBD), with medicinal characteristics. In 2015, the RDC No. 17 the National Health Surveillance Agency (Anvisa) allowed the import of cannabidiol-based products for medical purposes. In 2019, the agency regulated the concession for manufacturing and importing these medical cannabis products.
Many issues related to stigma still hinder access to these products. Nevertheless, it is a market with great potential for growth, given that most of the conditions treated with medical cannabis are refractory - that is, when there is no answer even with the use of a gold standard treatment - and there is great progress around the world.
This substance acts on a system involved in many pathological and physiological processes, the endocannabinoid, acting to regulate temperature, stress, the immune system, among other functions. The imbalance of this system favors the onset of diseases and, thus, medical cannabis helps with this regulation. Studies indicate that cannabidiol-based products may help with autism spectrum disorder, schizophrenia, multiple sclerosis, Alzheimer's, and refractory epilepsy, among others.
Epilepsy, for example, is a brain disorder that affects around 1% of the world and can lead to brain damage. Refractory patients are those who do not control their seizures satisfactorily with any antiepileptic drug. According to CFM (Federal Council of Medicine), between 90% and 95% of patients using two to three antiepileptic drugs do not achieve complete remission of uncontrolled seizures. In addition, there has been no significant progress in controlling these crises over the past 40-50 years. This scenario highlights the importance of new treatments, and it should be noted that the antiepileptic effect was one of the first observed effects of medical cannabis.
Regulatory progress in Brazil
From a regulatory point of view, RDC No. 660 determined the procedures for importing the cannabidiol-based product, establishing that: it can occur by an individual, for personal use, based on a medical prescription; it can be made by the patient's legal guardian or legally constituted attorney; or, even, the import can be brokered by a health plan operator, hospital entity or government unit linked to health for the care of a patient already registered with Anvisa.
These issues surrounding importation via RDC No. 660 represent a point that makes access difficult. The patient must choose between import licensing at Siscomex, accompanied baggage or via express shipment. In addition, the Postal Service cannot transport these loads, complicating this process.
In the meantime, the RDC No. 327 made it possible to sell medical cannabis products in pharmacies, however, only with a prescription. Generally speaking, the THC content should be up to 0.2%. The regulations conditioned the sale to prior authorization from Anvisa and it is up to the person responsible for the product to request its regularization. For manufacturing and commercialization, the company must import the pharmaceutical input as a plant derivative, phytopharmaceutical, in bulk or industrialized product, and the importation of the plant is not allowed. This DRC allowed the entry of various products in the market. In addition, Anvisa prohibits the sale of the plant, cosmetics, and cannabis-based cigarettes.
In 2022, CFM Resolution No. 2,324 brought changes related to vetoes, specifying the use for children and adolescents with refractory epilepsy related to Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex, excluding other pathologies. The text also prohibited the holding of lectures and courses on this content outside the scientific environment, raising opposition from the medical community and patients.
The international context of medical cannabis
Globally, medical cannabis is already a reality in countries such as Germany, Israel, Argentina, Chile, Uruguay and the United States (more than 30 states), among others. A report published this year by Market Data Forecast pointed out that the increase in research in the field has generated a demand for medical cannabis. Still, population growth and the prevalence of chronic diseases such as brain disorders and cancers may boost revenue in this market. Another report, from Fortune Business Insights, estimated the size of this market just over US$ 6 billion in 2018 and estimated that it should reach almost US$ 27 billion in 2026.
Regionally, there is an absolute highlight of North America, whose medical cannabis market represented almost the entirety of US$ 6 billion in 2018. In addition, it is estimated that, with a stable growth rate, it will reach almost US$ 25 billion in 2026. The report predicts a boost due to the growing number of private and public funding for medical research surrounding cannabis.
After North America, Europe is the second largest region in the world that grows cannabis for medical purposes. Fortune Business Insights highlighted the growth of legalizations, the increase in investment by companies, and the focus of major players on the European market.
Latin America lags behind these regions, but regulatory scenarios in the countries have changed. O Market Data Forecast The size of the medical cannabis market in Latin America is expected to reach over US$ 3 billion by 2027. In addition, despite the obstacles in the Brazilian context, the market is promising.
Medical cannabis in the Brazilian market
According to the same Market Data Forecast report, in Latin America, Brazil has the largest shares within the marketplace of medical cannabis, which is mainly driven by the increase in the incidence of cancer. Some studies have already indicated its potential in treating chronic pain for different clinical conditions, such as in the case of cancer patients.
Regarding requests for the import of cannabidiol, Anvisa indicated that they went from 902 in 2015 to 6,267 in the third quarter of 2019. Still, the Post-Market Monitoring Newsletter According to Anvisa, from 2021 to 2022, the number of granted requests almost doubled, increasing from 26,861 to 57,974. A Kaya Mind, a market intelligence company focused on this segment, collected relevant data in 2021. The company estimated that medical conditions that can be treated or alleviated with medical cannabis products affect up to 18.6 million Brazilians. In addition, the report indicated a potential movement of R$ 9.5 billion with the medical cannabis market.
Another study, carried out by New Frontier Data in partnership with The Green Hub in 2018, it also collected relevant data regarding the potential of this market: about 3.4 million Brazilians could take advantage of the medicinal use of cannabis for the treatment of chronic pain. This would mean an annual revenue of R$ 4.6 billion with broader regulation in Brazil. Finally, a 2021 assessment of Brazilian Cannabis Industries Association (Abicann) indicated a potential to generate more than 300,000 jobs in ten years.
