Bairo GonzalezLeandro · Martinez

In the world · Cannabis · 26 December 2023

Decree 68,233: how São Paulo regulated cannabis in the SUS

Published in December 2023, Decree 68,233 put Law 17,618 into practice: who can apply, which documents to bring and how long the supply lasts.

bairogonzalez.com team, drawing on Bairo's story · Published

São Paulo State Decree 68,233, of December 22, 2023, published in the State Official Gazette on December 26, regulated Law 17,618 and got the supply of cannabis products through the SUS (Brazil's public health system) in São Paulo off the ground. The initial clinical protocol prioritizes epilepsies that do not respond to conventional treatments, and supply is provided for periods of up to six months, renewable with updated documentation.

What happened

Almost eleven months after the law was signed, the São Paulo government defined the practical rules. According to Agência Brasil, the decree establishes that:

  • the Health Department carries out the policy and defines which medicines and products will be offered;
  • the request is made by the patient or their legal representative, and goes through the department's assessment;
  • the indication is outpatient, with a prescription and documents filled out and signed by a doctor;
  • the department may request tests, reports and an assessment of the patient, in person or remotely;
  • supply is valid for up to six months from the initial dispensing, and may be renewed;
  • recipients may not donate, lend or resell the product;
  • treatment may be discontinued if efficacy or the patient's safety is compromised.

According to the specialized portal Sechat, the clinical protocol, drawn up by the Department with a permanent working committee, prioritizes refractory epilepsies, especially Dravet and Lennox-Gastaut syndromes and tuberous sclerosis complex.

Why it matters

A law says what the state wants to do. The decree says how. Without it, Law 17,618 would be a promise with no way in. With it, patients gained an administrative path, with defined documents and a renewal period, instead of depending only on lawsuits.

The choice of refractory epilepsies as a priority is not random. It is the field in which the evidence for cannabidiol is most solid and in which there are already products studied in clinical trials. Starting where the science is firmest is a prudent way to open a new public policy. The other side is that patients with other conditions are still waiting for the protocol to be expanded, a recurring request from associations and legislators.

At Alesp (the São Paulo Legislative Assembly), the parliamentary front for medical cannabis and industrial hemp, coordinated by Deputy Caio França, follows the implementation. In August 2024, the front announced R$ 1 million in budget amendments for research at São Paulo's public universities and advocated expanding the protocols and training staff at high-cost pharmacies.

In Bairo's view

For Bairo Leandro Gonzalez Martinez, the decree is a good example of how a health policy should begin: with what has evidence, with clear rules and with patient follow-up. In his reading, the clause allowing supply to be discontinued when efficacy or safety is compromised is as important as the one guaranteeing access. It shows that the goal is to care, not merely to hand over a bottle.

Bairo also sees a language challenge in the decree. Documents, deadlines, renewals and protocols intimidate those already tired of fighting for a treatment. For him, clear and accessible information, in human language, is part of access. Without it, the door exists, but few people know where it is.

Where this meets the ecosystem

Xperienc Global Labs, founded by Bairo in London, proposes bringing together laboratories, teleconsultation with a clinical assistant validated by a professional and the Global Language translator for a second clinical opinion, not a medical report. The idea of following the patient's history, always with human validation, speaks to the logic of renewal and reassessment the decree requires.

The orchestrator CLAIN, under development, starts from the proposal of bringing organized information to those who cannot pay for it. On a subject like this one, that would mean explaining the path, never recommending a product or deciding for the doctor.

The grading of what science already knows is in The plant and the science. Rules change and protocols are revised; for your case, confirm with the health team that follows you.

Sources

  • Agência Brasil, "Governo de SP regulamenta fornecimento de cannabis medicinal pelo SUS" (São Paulo government regulates supply of medical cannabis through the SUS), Dec. 2023: agenciabrasil.ebc.com.br
  • Sechat, "São Paulo regulamenta uso de cannabis medicinal no SUS" (São Paulo regulates medical cannabis use in the SUS), 12/26/2023: sechat.com.br
  • Alesp, record of Law 17,618/2023 and its regulation: al.sp.gov.br
  • Alesp, "Frente defende pesquisa e regulamentação da cannabis medicinal e do cânhamo industrial" (Front advocates research and regulation of medical cannabis and industrial hemp), 08/22/2024: al.sp.gov.br

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