RIO DE JANEIRO – The Brazilian government announced on Wednesday a series of measures to facilitate the import of medicines based on cannabidiol, one of the active ingredients in marijuana.
The move was in response to an increase in demand for these kinds of drugs and a long waiting time for patients.
Brazil’s National Sanitary Surveillance Agency (Anvisa), a regulatory body linked to the Ministry of Health, ruled there could be flexibility in a decree that limited the requirements to imported medicines based on cannabidiol with the presentation of a medical prescription.
Until now Brazilians with conditions treated with these medicines could import them, as their commercialization and production is still prohibited in the country, but for this they had to present several documents, such as a medical report describing the disease, a study on the benefits of the desired remedy and a term taking responsibility for the purchase.
Under the new regulation, Anvisa will authorize importation if the patient presents a medical prescription in a government services portal available on the internet.
The regulatory agency also increased the validity of the authorization issued for importation from one to two years.
Anvisa’s director Dr Antônio Barra said the measures seek to reduce the time patients had to wait to import the medicines and meet an increasing need for cannabidiol products.
Patients had been waiting an average of 75 days for Anvisa to grant them the import authorization.
“We don’t know how much that time will be reduced but we expect a very significant decrease,” Barra said.
He added long waiting times “can harm treatment and cause irreparable damage to people’s health.”
Anvisa has issued 13,863 authorizations for the admission of medicines to Brazil requested by 9,540 patients since importation was authorized in 2015.
There were 902 authorizations in 2015, 3,613 in 2018 and 6,276 by October 2019.
In December Anvisa approved a series of measures to allow the future sale of marijuana-based products in pharmacies in the country, but prohibited the cultivation of the plant in Brazil by companies interested in investigating its medicinal use.
The restriction was imposed by Brazil’s government, led by Jair Bolsonari, who said the authorization of the cultivation of marijuana for medicinal purposes would represent a step to legalize it in Brazil.
It is unknown when pharmacies will begin offering medicines derived from marijuana in the country, but Anvisa said interested distributors will submit the first registration requests in March.
Medicines that use active ingredients in marijuana, such as cannabidiol or tetrahydrocannabinol (THC), are recommended in Brazil for treatments for diseases such as epilepsy, multiple sclerosis, autism, chronic pain and Parkinson’s.
Brazil included cannabis on its list of medicinal plants in 2017.
Despite the greater acceptance of the medicinal use of marajuana in Brazil the law still punishes the cultivation, marketing, possession and consumption of the drug.