The cumulative number of authorizations for individual patients in Brazil to import nonregistered medical cannabis products reached 18,650 at the end of March, according to data shared with Marijuana Business Daily by the country’s health regulator.
National Sanitary Surveillance Agency (ANVISA) approvals to import the products have been growing rapidly in the past year, and although this route is intended to be a special access scheme for exceptional cases, Brazil has become the largest market in Latin America.
Nonregistered medical cannabis products, regardless of THC content, can only be imported by individual patients after a doctor and ANVISA have signed off.The health agency does not restrict the products to only CBD, but in practice CBD represents the majority of imports.
During the first quarter of 2020, almost 3,000 patients received authorization to import nonregistered products, an increase of 25% over the previous quarter 123% higher compared the same period in 2019.
Authorizations granted through 2019 were originally valid for one year, but earlier this year the health regulator automatically extended those allowances for 12 more months.
MJBizDaily estimates the maximum number of patients authorized to import was 11,317 as of the end of March.
There is no over-the-counter CBD or foodstuffs with CBD authorized in Brazil.
This type of access to nonregistered products – often called “compassionate use” – is common throughout the region.
While it certainly represents an opportunity, it also comes with disadvantages, as it is inefficient to ship to individual patients.
At the end of 2019, Brazil approved new rules allowing the registration of cannabis products without requiring proven efficacy via clinical trials during the early years of commercialization. Unlike nonregistered products imported by individual patients, these can be manufactured domestically and distribution to pharmacies is allowed.
The new rules, which came into effect in March, created enthusiasm in the industry. But so far, expectations that the registration of products in this new category would expand access – and business opportunities – largely failed to materialize.
On July 16, ANVISA told to MJBizDaily that there was only one product registered under these rules so far, and that the agency did not have a single pending application to evaluate.
Although proven efficacy through clinical trials is not needed in the early years of commercialization of these registered products, other pharmaceutical quality requirements are required by Brazilian health regulations, including:
- GMP certification. 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.
- Stability data to demonstrate that the quality of the product remains stable throughout its shelf life in the climatic conditions commonly found in Brazil.
These and several other requirements are proving to be a challenge for cannabis companies.
The registration of these products can only be granted for a maximum of five years – including possible renewals.
After the fifth year, the company must be able to prove efficacy and safety, and the medical cannabis product must be registered like any normal medicine, or it would need to be removed from the market.