State of São Paulo approves clinical protocol for cannabidiol and tetrahydrocannabinol

The government of the state of São Paulo has approved the clinical protocol and therapeutic guidelines for the use of Cannabidiol (CBD) and Tetrahydrocannabinol (THC) in the Unified Health System (SUS). This measure, published through Resolution SS 107 of 07/05/24, aims to guide physicians in the prescription and criteria for the use of these medications for patients with specific syndromes.

Patients suffering from syndromes such as Dravet, Lennox-Gastaut, and Tuberous Sclerosis Complex, and who have pharmacoresistant and difficult-to-control epilepsies, will now be able to access Cannabidiol and Tetrahydrocannabinol through SUS, provided they reside in the state of São Paulo. The initiative, which is already in effect, allows patients to present their documents and prescriptions filled out by professionals from the public or private network, to obtain the medications at the Specialized Medication Pharmacies of the State (High-Cost Pharmacies).

The development of the protocol involved the collaboration of the State Health Department and a working committee established after the approval of State Law 17.618/23, proposed by State Deputy Caio França (PSB). França celebrated the effective start of the implementation of the public policy, highlighting it as a victory of science and life over misinformation and stigma. He expressed his confidence in the success of the policy, which could be expanded to address other diseases in the future.

The company responsible for the production of Cannabidiol is Ease Labs Pharma, headquartered in Belo Horizonte (MG), the winner of the bidding process carried out by the state government earlier this year.

However, there are restrictions on the use of the medication, contraindicated for children under two years old, a decision that sparked debates within the working group, especially among mothers of patients. The Health Department justified this restriction following guidelines from Anvisa, which recommend its use for children over 2 years old.

The protocol establishes strict criteria for distribution, including medical prescription, administration schedule, exams, and necessary documentation. In addition, the frequency of epileptic seizures will be monitored every six months, with the possibility of treatment interruption in cases where there is no adequate therapeutic response.

Although initially focused on refractory epilepsies, the São Paulo protocol does not exclude the possibility of analyzing other conditions, such as Autism Spectrum Disorder (ASD), within the Neurology/Pediatrics subgroup. The expansion of the range of pathologies covered by SUS may occur as clinical studies evolve and results are published.

This initiative represents a significant advancement in ensuring access to appropriate treatments for patients with complex medical conditions, as well as marking an important step towards expanding the debate on the therapeutic use of cannabis-derived substances in Brazil.