Doctor points out bottlenecks in access to cannabis through São Paulo's SUS

Pediatric neurologist Dr. Karen Baldin pointed out obstacles in accessing medical cannabis through São Paulo's SUS during a public hearing held this Thursday (13) at the Legislative Assembly of the State of São Paulo (Alesp). Among the main points raised by the physician are the bureaucracy for prescription and access, restrictive criteria for patient inclusion, and the need for adequate monitoring when the supplied product is changed.

The remarks were made during the 3rd public hearing of the Parliamentary Front for Medical Cannabis and Industrial Hemp, which debates the two years of implementation of the distribution of cannabis-based products in São Paulo's SUS.

Chaired by State Deputy Caio França (PSB), with State Deputy Eduardo Suplicy (PT) as vice-chair, the Front brings together lawmakers, healthcare professionals, administrators, and association representatives to discuss the results of the policy established under State Law No. 17,618/2023 and the next steps to expand access.

Bureaucracy may limit access for families

Reflecting on her clinical experience, Baldin drew attention to the amount of documentation and requirements needed for patients to fit into the state protocol.

"The paperwork you need to prescribe, to fill out for your patient... has various data points, multiple pages, multiple copies, and a very detailed explanatory report as to why, proving the pathology. So it's laborious, it's bureaucratic... and that bureaucracy can limit, and in fact has limited, access for some families even though they have the pathology."

The pediatric neurologist also questioned the requirement for recent exams for patients who, in certain cases, have clinical conditions that make these procedures more complex.

"For example, the protocol states that they require a recent CT scan and a recent electroencephalogram, as well as blood tests... Now, placing them under sedation, taking them to do an electroencephalogram, especially if it's a SUS patient, that is extremely difficult."

The point raised by the physician brings into question not only what criteria should exist to ensure safe dispensing, but also whether the established requirements are compatible with the reality of patients served by the public healthcare network.

Product switch raises alert about monitoring

Another point highlighted during the presentation was the change in the product supplied to patients. According to Baldin, there was a switch from a 100 mg/ml formulation to a 200 mg/ml one, in addition to a change in the carrier oil used in the formulation.

"In an abrupt manner, the product was switched. Previously it was 100 mg per ml, and then it was switched to 200 mg per ml. But another concerning factor is that... there is an issue of bioequivalence, right? And with cannabidiol it's no different. The carrier for the 100 mg per ml product was palm oil, and the current one being supplied is corn oil. There is a difference there; just because it is cannabidiol of the same milligram strength does not mean they are bioequivalent."

In the pediatric neurologist's assessment, the change should have been accompanied by a specific transition protocol and patient monitoring.

"I kept asking: what will this transition protocol look like to transition from one type of CBD to the other? When will this patient be seen, by whom?... That protocol was missing."

The concern voiced during the hearing therefore involves not only product availability, but also clinical monitoring following changes in formulation or supplied concentration.

Physician questions restriction to three disease groups

The scope of the São Paulo protocol was also at the center of the statement. Baldin highlighted that the supply is currently concentrated on isolated cannabidiol for specific groups within drug-resistant epilepsies.

"Today we are talking about isolated cannabidiol for three disease groups within drug-resistant epilepsy, but many people were left out. So I believe all patients in São Paulo's SUS should be monitored in a standardized way..."

The doctor also questioned whether offering exclusively isolated cannabidiol is sufficient given the different clinical needs encountered in practice.

"Is it enough to only supply isolated cannabidiol? A large portion will remain unserved."

Among the examples presented are children with drug-resistant developmental encephalopathies who present clinical conditions similar to those observed in diagnoses covered by the protocol, but who cannot access the product free of charge through the state policy.

"Among these children who have drug-resistant developmental encephalopathies, I cannot prescribe free cannabidiol. They do not have that right, yet their clinical condition is similar to Lennox, or Dravet, or tuberous sclerosis..."

Her statement places the expansion of covered conditions among the topics that must remain in the debate on the evolution of São Paulo's public policy.

Judicialization is cited as a consequence of limitations

For Baldin, expanding access must occur in a planned manner, with protocols capable of organizing follow-up and generating data on the outcomes achieved within the public healthcare network.

"We need to expand the criteria for treatment with cannabis-based products, but in a planned way, and in a way that is more cost-effective and safe... which is better than maintaining what has been happening today via injunctions, literally through lawsuits with lawyers."

The pediatric neurologist argued that securing treatments individually through court orders hinders standardized care and the organized generation of patient data.

"Because then each person requests a different one, each pursues their own case, and we cannot conduct a study or build stronger evidence... But this is currently being done without a protocol, in an unorganized way, right?"

The doctor's proposal is that patients treated under São Paulo's SUS be monitored in a standardized manner, allowing clinical outcomes to be evaluated while building data that can inform future decisions on public policy.

Two years of medical cannabis in São Paulo's SUS

Thursday's hearing comes as the implementation of medical cannabis distribution through São Paulo's SUS marks its two-year anniversary.

The Parliamentary Front meeting seeks to evaluate the progress made since the implementation of the policy and the bottlenecks that persist in patient care. Topics under discussion include training for healthcare professionals, supply logistics, patient inclusion criteria, and potential expansion of covered conditions.

The debate also takes place amid new research initiatives in the state. Among them is a R$ 1.75 million call for proposals for cannabis-related research and innovation projects, expanding the discussion on evidence generation and sector development in São Paulo.

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