Tarcísio regulates medical cannabis law in the SUS – 12/26/2023 – Health

Governor Tarcísio de Freitas (Republicans) regulated the law that provides for the supply of medicines based on medicinal cannabis by the SUS (Unified Health System) in São Paulo. The decree was published in the Official Gazette this Tuesday (26).

The regulation comes almost a year after the law was sanctioned, which took place on January 31st. The decree provides that the supply of medicines is the responsibility of the Secretary of State for Health.

At the end of November, the government stated that the delay in regulation, which had an initial deadline of 90 days, was due to the government’s need to gather scientific studies that proved the effectiveness and safety of the treatment.

In June, the diseases that could be treated with medicinal cannabis through SUS provision were defined, such as Dravet Syndrome, Lennox Gastaut Syndrome and Tuberous Sclerosis. The decision regarding the diseases that can be treated was made through the evaluation of a working group that was created after the law was sanctioned.

Specialized medical societies claim that they have not found clear indications for the application of cannabinoids in chronic pain, psychiatric, ophthalmological, gastroenterological and oncological diseases. However, as the Working Group is permanent, it is possible that the list of diseases that can be treated with cannabinoid-based products will be expanded.

The possibility of analyzing the use of cannabis-based medications for other refractory epilepsies and Autism Spectrum Disorder (ASD) was not excluded.

Through X (former Twitter), state deputy and author of the law Caio França signed the decree. “It took a while, but we did it! Our fight was not in vain,” he wrote.

The deputy stated that this decree will serve as a reference for other states and municipalities in the country. “We are innovating on several fronts. This is just the beginning of the work as we have a long way to go. Regulation does not end after the publication of the final text with the rules, guidelines and procedures because the government understands and is determined to continue studying and incorporating new studies that may arise at all times.”

Now, the decree provides that the supply of medicines and cannabidiol-based products for medicinal purposes must occur upon request from the patient or their legal representative — the decision can be submitted for evaluation by the Department of Health.

The department will receive and analyze requests with therapeutic indications on an outpatient basis and also accompanied by documents and prescriptions completed and signed by a doctor.

With authorization, the medicine or cannabis product will be made available in Specialized Medicine Pharmacies, upon presentation of documentation specified by the Clinical Protocols and State Technical Standards.

During treatment with cannabidiol-based medicines, the department may require additional medical examinations and reports, as well as assessment of the patient, both in person and virtually, with a doctor appointed by the secretariat.

Furthermore, it is anticipated that the supply of medications may be interrupted if, through a technical assessment, the effectiveness of the treatment or patient safety is compromised.

The decree also provides that medicines will be provided exclusively to the patient or their legal representative. Donating, lending, transferring, selling or offering to third parties is prohibited.

Such as Sheet showed in October, the state of São Paulo’s spending on the purchase of marijuana-based medicines after court orders reached a record in 2023. From January to October, R$25.6 million was allocated to responding to 843 lawsuits filed by patients.

The amount corresponds to almost a third of everything the state has already spent on cannabis medicinal product since 2015, when Anvisa (National Health Surveillance Agency) authorized for the first time the import of products with CBD (cannabidiol) into Brazil. Total expenditure is close to R$85 million.

However, when Tarcísio sanctioned the law in January, he stated that there was no expectation that the state would save money with the new legislation.

“From the moment public policy becomes available, the state of São Paulo may see an increase in the number of prescriptions”, said the governor at the time.

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