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In Q4 of 2019, the Brazilian pharmaceutical regulator ANVISA (The National Sanitary Surveillance Agency) approved regulations that would pave the way for the introduction of medicinal cannabis-based products. ANVISA’s approval of the new regulations mean that Brazil could become a global leader in Medical Cannabis.
While domestic cultivations remain prohibited, the nature of the Brazilian industry could enable it to become a hub of innovation in the Medical Cannabis space. Unlike its South American neighbours Colombia and Uruguay, Brazilian medical cannabis companies will not be able develop its own vertically integrated medical cannabis sector. This means that all cannabis-based medicines that are prescribed in Brazil will have to be imported. However, there are draft laws that will look to change this and legalise the cultivation of cannabis for medical purposes in Brazil.
The law means that bulk imports and sales in pharmacies of medicinal cannabis products. Companies that are seeking to enter Brazil will have to overcome the following restrictions to succeed in the Brazilian market:
- All flower is banned in Brazil, regardless of THC content
- GMP requirements similar to what is prevalent in Europe
- The word medical cannot be used when describing a cannabis-based product
- Domestic cultivation is banned (for now)
- Brazilian doctors remain reluctant to prescribe cannabis
ANVISA has been approving the import of medicinal cannabis products and the number of approvals has been growing rapidly. This method of a patient acquiring a medical cannabis prescription was intended to operate on a special access scheme for exceptional cases, despite this Brazil has become the largest medical cannabis market in South America.
The non-registered medical cannabis products, irrespective of THC content, are allowed to be imported for individual patients only once a doctor and ANVISA have permitted and signed off the prescription. ANVISA does not restrict the imported products to solely CBD but CBD is currently making up the majority of imports.
CBD oil accounts for the majority of imports because the Federal Council of Medicine (Conselho Federal de Medicina) restricts the prescription of cannabis to CBD and is only used to treat epilepsy in children. However, ANVISA doesn’t limit the imports of non-registered cannabis-based products to just CBD and in practice many doctors also prescribe cannabis-based products that have high-THC concentrations for conditions other than childhood epilepsy conditions. It is understandably more difficult to acquire a prescription for high THC products; these products are also a lot more challenging to ship internationally, more expensive and require various export and import licenses.
During Q1 of 2020, just under 3,000 patients were given permission to import non-registered products which is a 25% increase over the previous quarter.
With Colombia and Uruguay working to be on the frontier of the global cannabis industry, Brazil may be seen to be a latecomer to the South American medical cannabis market. However, the size of the Brazilian population and the nature of the pharmaceutical industry in Brazil mean that the fact there is currently no marijuana being grown legally in Brazil will not stop the country becoming a global leader.
Uruguay was the first country to legalise the sale, cultivation and smoking of marijuana in December of 2013. Colombia has legalised medical cannabis and Mexico is very close to not only legalising medical cannabis but also the recreational use of cannabis and marijuana.
Paraguay’s initiation of a large-scale project to produce hemp on a huge scale may have kicked the tyres of this draft legislation and encouraged the Brazilian government to start moving.
Medicinal cannabis-based products are only be available for sale in registered pharmacies with a prescription from a doctor. There are three ways to obtain a medical cannabis prescription legally.
- Purchasing registered cannabis-based products
- Purchasing cannabis-based products with sanitary authorisation
- Requesting permission to import on an individual basis
Earlier in 2020, ANVISA authorised a THC free CBD product that is taken orally. This was a vital decision to open up the potential benefits of CBD to South America’s largest economy. The CBD product was registered by Prati-Dondaduzzi and it was the first medical cannabis product that was authorised for sale in Brazil under the new laws that came into force in December 2019.
The product contains 200mg of CBD per ml. The cost of the product is $450 for a 30ml bottle.
Brazil forbids both hemp and marijuana cultivation which means that Prat-Donaduzzi must import raw CBD extract before manufacturing the final medication. Brazil does not allow the use of synthetic active ingredients in cannabis-based products either.
Companies wishing to import cannabis-based products in bulk will have to apply for sanitary authorisation. Sanitary authorisation will allow the company to import in bulk, manufacture and distribute cannabis-based products.
Only licensed pharmacies will be allowed to sell these products to patients.
The distribution of the products is only allowed to commence once ANVISA grants an authorisation on a product by product basis. This approval is then published in the Brazilian Federal Government’s official gazette.
This new category of products that has been created by ANVISA enables the commercialisation of products without clinical trials for 5 years after the authorisation has been published in the Brazilian Federal Government’s official gazette. Throughout this 5-year period ANVISA can request additional information, data and documentation for the product and ANVISA can even suspend or cancel a product’s approval. Documents that are needed from sanitary authorisation applicants include stability studies and technical quality documentation.
Once this 5-year period has elapsed, it cannot be extended. The company must have registered products for which safety and efficacy has been proven. An example of a cannabis-based medicine that has successfully navigated this process is Sativex. Sativex is a CBD drug that is used to treat childhood epilepsy.
The marketing restrictions on these products is very stringent. These restrictions include not allowing commercial names for the products and all advertising of the products is banned.
The sales of an authorised product must begin within a year of authorisation otherwise ANVISA may cancel the approval.
Like many other countries, medical cannabis prescriptions can only be prescribed after all other therapeutic options available on the Brazilian market have been tried with no success.
Unlike the German, Italian and Colombian market, Brazilian rules don’t allow any manipulation of the final cannabis-based product by the pharmacy that is providing the prescription.
Good Manufacturing Practice (GMP) is a necessary requirement for all new sanitary authorisations that will be issued. This will limit the number of companies that are capable of capitalising on the opportunity of the Brazilian medical cannabis market.
The new regulations state that until December 2022, ANVISA will accept GMP certifications that have been issued by health agencies of PIC/S countries. Post December 2022, only ANVISA approved certifications will be compliant.
The companies that are selling medical cannabis products in Brazil using a GMP certification from another country must get an ANVISA certification if they intend on continuing to sell medical cannabis products in Brazil.
ANVISA’s distribution practices and good storage certifications are also required.
Is CBD Legal in Brazil?
Over-the-counter (OTC) CBD food supplements or products are currently illegal in Brazil.
The Number of Brazilian Medical Cannabis Patients Exceeds 20,000
The number of individual patient authorisations to import cannabis-based products into Brazil continues to rise. The number of monthly approvals by ANVISA has surpassed the 1,500 mark, this includes both renewals of expired authorisation and new patients being granted authorisation. The renewal time has been expanded from one to two years, this enables patients to be secure in the knowledge they will be able to receive their medication for a 2-year period. These figures are double the number of authorisations granted in 2019. As of August 2020, in the region of 20,000 patients have been given authorisation that allows them to import medical cannabis products into Brazil.
The vast majority of the cannabis prescriptions that have been issued so far have been for high-CBD products. Mainly because of the special authorisations that are required for products over 0.2% THC which are significantly more difficult to obtain. This means there is a clear distinction between Brazil and the majority of medical cannabis markets. In most markets such as the UK medical cannabis market, most prescriptions are granted to patients using high-THC products to people suffering from chronic pain conditions.
There is no limitation on the conditions for which medical cannabis can be prescribed in Brazil. However, the General Council of Medicine advises that it is only used in cases of refractory epilepsy.
The Future of Cannabis Laws in Brazil
Brazil has drafted a law that will be fast-tracked to allow the cultivation of medicinal cannabis and industrial hemp. Cannabis could become a huge business in Brazil as 80% of Brazil’s farmland could be deemed suitable for cannabis or hemp cultivation. The proposed law also has the objective of developing more affordable cannabis-based products, using cannabis that is grown within Brazil would irradicate the import costs and would allow Brazilian companies to compete on price with their South American competitors.
Brazil leads the world in many commodity markets and many of the country’s farmers are keen to expand their operations into hemp.
Brazil’s economy declined by 9.7% in Q2 2020. The ongoing COVID 19 pandemic means that the economy is in uncharted waters and the government may seek to discover alternative markets that drive the economy forward and create jobs.
Following a debate and a vote in the House of Deputies, the draft law will be sent to the senate and if it is passed, the bill will then be approved or vetoed by Jair Bolsonaro, the Brazilian President.
With the law in its current state, the Ministry of Agriculture and ANVISA will have 90 days to develop and implement the necessary regulations.
As a country that is heavily reliant on its commodity market and the products that are grown and produced within its borders, cannabis seems like an opportunity that Brazil cannot miss. The potential of the medical market is tremendous and once cultivation is permitted on Brazilian soil, the price of the medication will inevitably fall which will lead to more people being able to afford prescriptions and medical cannabis being more widely consumed and prescribed.