SUS and Health Insurance Plans

São Paulo Regulates Medical Cannabis in the Public Health System (SUS), Other States and Municipalities Follow Suit

The state of São Paulo has taken a major step in regulating medical cannabis by publishing Decree No. 68.233 today, officially incorporating the substance into the state's Unified Health System (SUS), as established by Law 17.618/23. The legislation, authored by State Representative Caio França (PSB), was signed into law by Governor Tarcísio de Freitas (Republicanos) on January 31, 2023, and had been awaiting regulation ever since.

The clinical protocol—developed in collaboration between the State Health Department and a working committee—primarily focuses on treating refractory epilepsy, with emphasis on syndromes such as Dravet, Lennox-Gastaut, and Tuberous Sclerosis.

The acquisition and distribution of cannabis-based medications are set to begin after the conclusion of an ongoing bidding process. The procedures will strictly adhere to sanitary regulations, including Health Authorization or Drug Registration, as stipulated in Collegiate Board Resolutions RDC No. 327/2019 and RDC No. 753/2022.

The regulation aims to ensure controlled and safe access to treatment, benefiting patients with specific medical conditions. In addition to São Paulo, several other Brazilian states and municipalities are taking similar steps, considering medical cannabis regulation as a viable alternative for targeted treatments. The measure has the potential to significantly improve the quality of life for patients who benefit from the plant’s therapeutic components.

The national landscape shows growing acceptance and recognition of medical cannabis’s benefits, with several jurisdictions moving toward policies that ensure safe and regulated access to treatments involving the substance. The issue, already discussed on a national level, continues to evolve as a therapeutic alternative within Brazil’s public health system.

Medical Cannabis Regulation Across Brazilian States – See the List

At least 24 Brazilian federal units have made progress with legislation to ensure access to cannabis-based products for medical use through the SUS. A 2023 survey by Folha de São Paulo outlines the diverse regulatory landscape forming across the country.

Laws have already been approved in thirteen states: Acre, Alagoas, Amapá, Federal District, Goiás, Mato Grosso, Paraná, Piauí, Rio Grande do Norte, Rondônia, Roraima, São Paulo, and Tocantins. However, approval does not automatically imply implementation, highlighting the need for detailed regulatory analysis in each location.

Among the states, Pernambuco, Ceará, and Paraíba are the only ones that have not yet introduced any bills related to medical cannabis. The absence of such proposals in city councils was not factored into the count.

This movement gains momentum at a time when medical cannabis is not yet officially incorporated at the national level by the SUS. Two possible paths lie ahead for such integration: the approval of specific legislation by the National Congress or action by Conitec (National Commission for the Incorporation of Technologies in the SUS), under the Ministry of Health.

The lack of standardization across state initiatives is a concern raised by Bruna Rocha, CEO of BRCann, a representative body for the sector’s companies. Rocha emphasizes the lack of clarity regarding which conditions will be treated through the SUS and how the medications will be acquired, warning that differing rules across states could lead to a chaotic scenario.

São Paulo and the Federal District serve as examples of states that have advanced regulation. The São Paulo government has designated the distribution of CBD-based products through the SUS, prioritizing patients with Dravet Syndrome, Lennox-Gastaut Syndrome, and Tuberous Sclerosis. In the Federal District, cannabidiol oil is already being provided to epilepsy patients.

Attorney Helena Matos stresses the need for budgetary resources to ensure distribution. She also highlights how lawsuits have already placed financial strain on state budgets, making public procurement more costly.

Matos argues that the states’ movement toward passing medical cannabis laws could influence the advancement of national legislation, supporting the establishment of a legal framework in Congress.

At the federal level, several bills are already in progress to guarantee access to cannabis-based medications via the SUS. According to Health Minister Nísia Trindade, Conitec is expected to address the topic, highlighting the importance of scientific evaluation to support decisions on the efficacy and safety of these medications.

Status of States and the Federal District Regarding Medical Cannabis Legislation

Approved:
Acre, Alagoas, Amapá, Federal District, Goiás, Mato Grosso, Paraná, Piauí, Rio Grande do Norte, Rondônia, Roraima, São Paulo, Tocantins

In Progress:
Amazonas, Bahia, Espírito Santo, Maranhão, Mato Grosso do Sul, Minas Gerais, Pará, Rio de Janeiro, Rio Grande do Sul, Santa Catarina, Sergipe

No Proposals:
Ceará, Paraíba, Pernambuco

Challenges and Solutions for Free Access to Cannabis-Based Medications in Brazil

Since 2015, when Brazil’s National Health Surveillance Agency (Anvisa) published RDC No. 17, exceptionally allowing cannabidiol (CBD) imports, the outlook for patients seeking cannabinoid therapy has evolved—but challenges remain.

Companies have been seeking authorization to cultivate cannabis for medical and research purposes, which has significantly boosted imports and demand for this treatment. However, many still face hurdles accessing these medications and often must resort to legal action to obtain them for free due to high import costs.

Key Steps for Free Access via SUS or Private Health Insurance:

Getting Started

The first step is finding a qualified physician to prescribe cannabis. After the consultation, the patient receives a prescription detailing dosage, usage, and the rationale for treatment. Lists of doctors who prescribe cannabis-based medications are available to aid in the process.

With the prescription, the next step is registering the medication with Anvisa, usually through an import process. While some pharmacies now sell cannabis-based drugs, sanitary approvals face legislative challenges that limit affordability.

The Role of the Judiciary

Dr. Ladislau Porto, a lawyer specializing in medical cannabis cases, emphasizes the importance of legislation for facilitating access. In places lacking specific regulation, patients can sue private insurance plans or even the SUS to obtain the medication.

Courts have consistently ruled that if a medical prescription justifies the need for treatment—even if the medication isn’t listed by the National Health Agency (ANS)—both SUS and health plans must cover it. Attorney Dr. Elton Fernandes reinforces that exclusion from the ANS list or the drug’s label does not exempt insurers from responsibility.

Amid ongoing challenges, the legal system and legislation remain crucial tools in securing free access to cannabis-based medications, offering hope to patients pursuing this form of therapy in Brazil.

Health Plans and the Right to Cannabidiol (CBD)

A judge in Paraná ruled that CBD must be provided to a patient to prevent a health plan from "replacing the doctor in choosing the appropriate therapy."

Health plans are required to cover cannabidiol (CBD) when prescribed by a doctor, according to Paraná attorney Diogo Maciel, a specialist in medical law. However, it's common for insurers to deny coverage, citing that the drug isn’t included in the ANS’s list of approved procedures. When denied, patients often have to go to court.

Regardless of the provider, the typical justification for denial is the drug's exclusion from the ANS list. Still, the lawyer explains that the list is illustrative—not restrictive—setting only a minimum standard for coverage.

One challenge with CBD is that patients often struggle to get formal written denials from insurers—documents needed to begin legal action. Hiring a lawyer is often necessary just to obtain this denial and pursue the right to treatment.

A case in Curitiba illustrates this scenario: after a patient developed ataxia due to cancer, her family began importing a CBD medication with their own funds. Even after trying to resolve the issue amicably with Unimed, the courts ordered the health plan to provide the medicine monthly.

Unimed claimed the treatment wasn’t on the ANS list, but the Paraná State Court disagreed. The judge emphasized that even if true, the plan was still obligated to pay, because restrictive clauses can't be interpreted broadly.

She also noted that ANS’s purpose is to guarantee minimum medical coverage—and the absence of a treatment on its list cannot limit a doctor’s authority. Once a prescription is properly justified, health plans cannot override a physician's decision.

This case highlights the importance of patients knowing their rights and, when necessary, seeking legal assistance to ensure access to prescribed treatments. It also reinforces the need for health insurers to clearly interpret contractual clauses, respecting medical autonomy and the patient’s right to appropriate care.

Brazil’s Superior Court Rules Health Insurers Aren’t Obligated to Provide Oral Medications for Home Use

In August 2024, Brazil’s Superior Court of Justice (STJ) ruled that health insurers are not obligated to cover oral medications for home use. This decision sets a significant legal precedent, directly impacting the relationship between patients and insurance companies—especially concerning cannabis-based treatments. Learn more.