A recent cannabis bill (399/15) provides for the legalization of the cultivation of medical cannabis will extend authorization to companies and associations to cultivate cannabis for therapeutic and industrial purposes. And while the bill will not cover individual cultivation, it does encourage patients who already consume or want to consume the substance, mainly for the treatment of epilepsy.
Society has been affected by the polarization of opinions in many sectors. In the case of cannabidiol, which is legalized in more than 40 countries, it was no different. Recently, cannabis bill 399/15, which provides for the legalization of the cultivation of medical cannabis with restrictions, generated great repercussion, as it seeks to extend authorization to companies and associations to cultivate cannabis for therapeutic and industrial purposes.
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Cannabis Bill Great News For Patients
Cannabidiol, known as CBD, is one of the chemical substances contained in the cannabis sativa plant, and acts on the central nervous system. However, it is not that which produces the consciousness-altering effect associated with cannabis, nor does it cause intoxication.
Despite the controversy over the issue, the cannabis bill does not cover individual cultivation. But, it does encourage patients who already consume or want to consume the substance, mainly for the treatment of epilepsy, multiple sclerosis, Parkinson’s, schizophrenia, autism, and psychiatric disorders, as they will benefit from the increased supply and, consequently, from the reduction of the final cost.
Cannabis Bill Expands on Individual Authorizations
It should be clarified that individual authorization has been allowed since 2015, before the introduction of this recent cannabis bill. This was when Anvisa defined the criteria and procedures for the importation of cannabis products for therapeutic purposes, for a period of two years, per individual and for own use, provided there was a medical recommendation.
The Federal Council of Medicine (CFM) approved the compassionate use of CBD, through Resolution 2.113 / 14, for refractory epilepsies in children and adolescents, that is, in cases in which, even with the use of some medications, seizures persist.
Patients Currently Face High Costs
It is important to mention that, being a therapy for continuous use, the cost remains high for many families. Full access for these patients is hindered by the absence of registration of some products in Anvisa itself. In addition, for those with health plans, inclusion in the National Supplementary Health Agency (ANS) list is lacking.
So far, only the pharmaceutical companies Prati-Donaduzzi and Nunature have obtained authorization from the regulatory agency in Brazil. In this context, with no therapeutic alternative, many patients are prevented from obtaining essential and proven effective drugs by the absence of this cannabis bill endorsement, and by bureaucratic obstacles in the incorporation of the competent body.
In this context, the recent decision of the Federal Supreme Court (STF), subscribed in the sentence of Extraordinary Appeal 1165959, determined that it is the duty of the State to provide, in exceptional terms, the medicines that have the import authorized by the Anvisa cannabis bill, provided that the economic inability of the patient and the indispensability of the treatment are proven, as well as the impossibility of substitution by another similar contained in the official lists of dispensing medicines and in the protocols of the SUS.
Further Clarification Through Cannabis Bill Needed
Likewise, the conduct of the health insurance to contractually grant coverage for the disease is inconsistent. But, on the other hand, prohibiting the supply of the drug capable of protecting life, under the allegation that it does not appear on the list of the ANS, an obvious affront to the Consumer Defense Code and Law No. 9,656 / 98.
Therefore, the understanding consolidated by the Judiciary is that the individual authorization of the Anvisa cannabis bill is equivalent to registration, especially because it aims to safeguard the physical and mental health of the patient. It is up to the Judiciary to curb abusive behavior and health operators, who insist on delimiting the therapeutic conduct, as well as the unjustified refusal of SUS.
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First published in Noticias RTV, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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