The administration of governor Tarcísio de Freitas (Republicans) published this Tuesday, 26, a decree that regulates the supply of medicines based on cannabidiol (CBD) and other medicinal cannabis compounds through the Unified Health System (SUS).
The measure comes almost a year after the sanction of Law 17,618, of January 31, 2023, which provided for the free distribution of these medicines and which should have come into force by the end of April.
At the beginning of February, the state secretary of Health of SP, Eleuses Paiva, told the Estadão which provided for the start of distribution of medicines within 45 days, which did not happen.
The signing of the decree that regulates the law only took place on the 22nd and was published this Tuesday in the Official State Gazette. The rule provides that the supply of products is made upon “request from the patient or their legal representative, subject to evaluation by the Department of Health, in accordance with clinical protocols and state technical standards”.
Only medicines “containing cannabidiol registered with the National Health Surveillance Agency (Anvisa) and products derived from Cannabis for medicinal purposes, industrialized and with health authorization by Anvisa” are covered by the law”, says the rule.
Requests with therapeutic indications on an outpatient basis will be received and analyzed, accompanied by documents and prescriptions completed and signed by a doctor. When prescribing, the doctor must comply with Anvisa's requirements and inform the name of the patient and the medicine, name of the product, dosage, amount required, treatment time, date of issue, name, signature and CRM. The doctor and patient (or their representative) must also complete a clarification and responsibility form regarding the use of the product.
If the request is approved by the secretariat, the medicine will be delivered to Specialized Medicine Pharmacies. Regardless of the treatment time recommended by the doctor, the authorization to supply will be valid for a maximum of six months. After this period, the patient will be able to request renewal of the request, but will have to submit a new request with the respective requested documents.
The decree also provides for the creation of a monitoring committee to monitor patients using cannabidiol-based medicines, analyze information and propose the use of new medicines to the National Commission for the Incorporation of Technologies into the SUS (Conitec).
The doctor prescribing the medicines must notify Anvisa of suspected adverse reactions related to the products, inform the patient or their legal representative about the risks, contraindications and possible adverse reactions described in the leaflet and notify the Health Surveillance Center about deviations in the quality of the medicines.
The rules for the supply of cannabidiol-based medicines have been discussed by a working group created by the secretariat and made up of experts on the subject. In June, state management reported that there was already a consensus to offer the medicine to patients with the following conditions:
– Dravet syndrome – a type of severe epilepsy that affects children from the first months of life and causes recurrent seizures;
– Lennox-Gastaut Syndrome – another serious and rare form of epilepsy, also characterized by frequent seizures and delayed development of the child;
– Tuberous sclerosis – a disease characterized by the appearance of benign tumors, but which can compromise the functions of organs, generally accompanied by epilepsy and intellectual disability
The secretariat was questioned, but has not yet informed whether it has included or intends to include other diseases or conditions in the list of pathologies that can be treated with cannabidiol-based medicines. O Estadão He contacted the department in the early afternoon of this Tuesday to also find out the reasons for the delay in regulating the law and the deadline for delivery of the medicines after the requests were granted, but was still awaiting a response. The report will be updated as soon as the secretariat sends its position.
Source: CNN Brasil
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