Sunday, April 11, 2021

Judge turns back and authorizes Association to produce marijuana-based drugs – Prime Time Zone

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Embrace assists 14,000 patients in the treatment of epilepsy, Alzheimer’s, Parkinson’s and autism

Reproduction / EmbraceEmbrace serves up to 14,000 patients who need marijuana-based drugs

A Brazilian Cannabis Hope Support Association (Abrace) received authorization on Friday, 05, to return to cultivate marihuana and produce plant-based medicines for about 14,000 patients. The decision was taken by Judge Cid Marconi, from Federal Regional Court of the 5th Region (TRF-5), which changed its position after pressure and a visit to Abrace’s headquarters. “The relevance and effectiveness of the extracts in the treatment of symptoms and the very diseases that severely afflict the author’s associates is impressive, even though this data has been collected empirically, without the scientificity that is desirable in a case like the present”, states the judge in his decision. On the 25th, Marconi had suspended Abrace’s authorization, at the request of the National Health Surveillance Agency (Anvisa).

In 2017, the entity has the approval of the Justice to plant marijuana, in addition to manufacturing and distributing plant-based medicines to treat epilepsy, Alzheimer, Parkinson e autism. Anvisa argued to the Court that the association does not meet the required requirements, disregarding the sentence that allowed the production. The organization denies, says it has already requested operating licenses and that rules on growing the plant for medicinal purposes are missing. The judge turned back after a strong reaction against Abrace’s prohibition of operation.

Deputies and senators from different ideological parties, as well as artists and patients, mobilized to review the suspension. In his decision, Marconi stated that he reached a consensus to allow the association to function “at the time when it provides for the regularization of its activities”. Abrace delivers products in the form of oil, nasal spray and ointment Prices range from R $ 70 to R $ 640. Products with similar indications authorized by Anvisa for sale in pharmacies cost around R $ 2 thousand.

Embrace will need to make adjustments

The judge determined that Abrace open, in 15 days, a protocol with Anvisa to regularize the expansion of its operation. In another 15 days, the entity must request the regularization of its current structure. After one month of this second Abrace protocol, Anvisa must examine the association’s project and point out “necessary adjustments”. These corrections must be made within 60 days, after the agency’s statement. “Term that can be extended at the discretion of Anvisa, depending on the peculiarity of the specific case”, noted the judge. Marconi argued that he changed his position based on “the peculiarities and the originality of the case under examination, and after the strong repercussion” of the ban on Abrace’s operation. The judge was at the headquarters of the association on Wednesday, 3.

“There is also a reasonable time for the Association to function (at least since 2015) without any news of accidents or relevant side effects, being certain that the testimonies that we encounter are going in the opposite direction, that is, of mitigation of serious effects, such as systemic and recurrent seizures, ”wrote Marconi. The decision also informs that a commission will be created, coordinated by the technical and legal areas of Anvisa, also counting on representatives of the Union, the Federal Police, the Public Defender of the Union and Abrace to inspect the headquarters of the association every 30 days.

Anvisa registered the first marijuana-based drug in 2017, Mevatyl. At the end of 2019, the agency eased rules for products of this type, in addition to production in Brazil. Under pressure from the Jair Bolsonaro government, however, the authorization for planting for medicinal purposes and for research in the national territory was forbidden. The agency’s rule is still seen as restricted by both associations and industry. Only one more drug has entered the market since then, manufactured by Prati-Donaduzzi. The two products authorized for sale at the pharmacy cost about R $ 2 thousand.

With the limited market, most patients receive drugs from associations, such as Abrace, or import them. Anvisa has granted more than 26 thousand import authorizations since 2015. The agency has been under pressure since at least 2014 to regulate the cultivation of marijuana, in addition to the production and use of plant-based medicines in Brazil. The first movements came from the parents of patients who received endorsement from the courts for the cultivation of marijuana.

* With information from Estadão Content

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