(This story has been corrected to indicate the rules took effect in March, not April)
The cumulative number of authorizations for individual patients in Brazil to import nonregistered medical cannabis products exceeded 13,000 at the end of September 2019, according to data the country’s health regulator shared with Marijuana Business Daily.
The data shows growing demand despite the current restrictive program that allows only individual imports. With rules set to change in March 2020 allowing bulk imports, this market will only become more attractive.
The current trend suggests that total individual authorizations to import nonregistered cannabis products in 2019 will easily be double the previous year, thanks in part to greater media interest in the use of medical cannabis.
The program, which started slowly in 2014, experienced tremendous growth in 2019. Until now, individual import authorizations have been the only way to access medical cannabis in Brazil.
According to MJBizDaily calculations based on data from the Agência Nacional de Vigilância Sanitária – or the National Sanitary Surveillance Agency (ANVISA) – the maximum possible number of “active” patients at the end of September 2019 was 6,807. At the beginning of 2019, there were only about 3,500 active patients.
MJBizDaily considers active patients to be the sum of all new authorizations and renewals granted in the previous 12 months, because authorizations are valid for a year.
CBD dominates THC
CBD oil makes up most of the imports because the Federal Council of Medicine (Conselho Federal de Medicina) – the agency responsible for regulating the medical profession – restricts the prescription of cannabis to CBD and only to treat refractory epilepsy in children and adolescents.
ANVISA, however, does not limit imports of nonregistered cannabis products to CBD, and, in practice, some doctors also prescribe products with high-THC for conditions other than infant refractory epilepsy.
But it is harder to get a doctor’s prescription for THC-high products, and these are also more challenging to ship internationally.
With a higher level of control, the international trade of THC products involves more bureaucracy, which often makes case-by-case exports to individual patients economically unfeasible.
But that’s about to change.
New rules for importing, manufacturing and distributing CBD and THC cannabis products were approved in early December and go into effect in March.
In the meantime, medical cannabis imports are allowed only on a case-by-case basis. These imports will still be allowed starting in March.
This means the country will effectively have three different categories of cannabis products:
- Cannabis-based medicines registered like any other medicine, for which efficacy and safety needs to be proved. So far, that includes only GW Pharmaceuticals’ Sativex, sold under the name of Mevatyl in Brazil.
- Registered cannabis products with “sanitary authorization,” the new category created by ANVISA in December that goes into effect in March. These products do not require proven efficacy via clinical trials during the first five years but must be registered.
- Authorizations granted case-by-case to import nonregistered cannabis products, which also do not require clinical trials. This has been working since 2014 and is sometimes called “compassionate use.”
Starting in March, companies will be able to apply for a “sanitary authorization” to import in bulk, manufacture and distribute cannabis products.
Only pharmacies will be allowed to sell these products to patients.
Manufacturing authorizations will be granted only to companies that import the raw material, as commercial cultivation in Brazil remains prohibited.
Importing “the plant or its parts” also remains prohibited.
Distribution can commence only after ANVISA grants an authorization – one for each product – and that approval is published in the Brazilian federal government’s official gazette. This means the first products with “sanitary authorization” are unlikely to be available before mid-2020.
The new category created by ANVISA allows the commercialization of products without clinical trials for a period of five years after the authorization is published in the official gazette.
During that period, ANVISA can unilaterally request additional documentation, suspend or even cancel a product’s approval.
The five-year period cannot be extended. Once it is over, the company must have registered products for which efficacy and safety must be proved – as Sativex has done.
Documents required from sanitary authorization applicants include technical quality documentation and stability studies.
Extreme marketing restrictions apply, including not allowing commercial names for the products. Advertising of any kind is prohibited.
Sales of products approved must start within one year of authorization being granted; otherwise, the approval could be canceled.
Cannabis products can be prescribed only after all “other therapeutic options in the Brazilian market” have been tried, according to the regulations.
Products with more than 0.2% THC will be available only for palliative care for terminal patients “without any other therapeutic alternative.”
Only products for oral or nasal use are allowed. Flower is prohibited – even if it is pulverized.
Unlike Colombia, Germany or Italy, which all allow magistral preparations in pharmacies, the Brazilian rules do not allow any manipulation of these products by the pharmacies.
Following GMP is a must
Good Manufacturing Practice (GMP) is a requirement for all new “sanitary authorizations.”
That will severely limit the number of companies that, as of today, are able to capitalize on the upcoming opportunity.
The new regulations determined that until December 2022, ANVISA will accept GMP certifications issued by health agencies of PIC/S countries.
After December 2022, only ANVISA certifications will be allowed.
Those companies selling medical cannabis products in Brazil with a GMP certification from another country must get an ANVISA certification if they intend to continue selling after 2022.
For commercialization, ANVISA’s good storage and distribution practices certification is required.