Alesp Audience Discusses Multiple Sclerosis Inclusion, SUS Supplier Change, and Review of Medicinal Cannabis Working Group

The Medicinal Cannabis and Industrial Hemp Parliamentary Front of the São Paulo State Legislative Assembly (ALESP), coordinated by State Deputy Caio França (PSB) and under the vice-coordination of Deputy Eduardo Suplicy (PT), held its 3rd public hearing on Thursday (09/04) at the Teotônio Vilela Auditorium.

The meeting was attended by Dr. José Luiz Gomes do Amaral, coordinator of the Cannabidiol Working Group of the State Department of Health, who presented an overview of the first year of cannabis distribution in the São Paulo SUS, a result of the implementation of State Law No. 17,618/2023.

Association representatives questioned the position of the coordinator of the Medicinal Cannabis Parliamentary Front working group, who insists on the lack of evidence regarding the efficacy of cannabis in treating other pathologies.

"From the beginning, we have been asking for broader SUS access, covering various pathologies, but the argument is: it must be done responsibly. But this responsibility should not harm the health of so many Brazilians. The SUS is the place to provide access to those who cannot afford it. Regarding the 0.3% THC, it ends up being exclusionary because it turns its back on various pathologies, such as multiple sclerosis. MS requires high THC, not just multiple sclerosis. There are epilepsy patients who respond better to THC-rich oil," said Cidinha Carvalho, a patient's mother and president of the Cultive association. 

According to Cidinha, the argument against is always the same "THC has psychoactive effects," she explained, adding: "My daughter uses anticonvulsants. The anticonvulsants she used to take also had psychoactive effects, which left her like a zombie, without even going to the backyard."

José Luiz emphasized that medicine should be guided by "reception, scientific evidence, and ethics" when explaining the basis for defining the pathologies covered by the Law granting access to medicinal cannabis in the São Paulo SUS. He also considered that the inclusion of multiple sclerosis, which has spasticity as a symptom, should be evaluated for inclusion in the list of diseases covered by the law granting access to medicinal cannabis in the São Paulo SUS. Currently, the system only provides the product for three diseases: tuberous sclerosis, Dravet syndrome, and Lennox-Gastaut syndrome.

"Next week we should have a meeting with the working group. We should present to the committee the review of the evidence we have found and, from there, start a new work cycle for the team."

Another topic that sparked debate was the change of supplier for cannabis-based products in the São Paulo SUS, resulting from the new bidding process required by law. The risk of the change was discussed in the ALESP plenary.

"It can bring harm, nothing may happen, or it can bring benefits. We don't know what will happen. However, when we are talking about the health of a child, an adult, or anyone, we cannot gamble. We need to be sure of what is happening. Even if there is a greater benefit, it is a risk. What if it doesn't work?", evaluates José Wilson, doctor and president of APMC (Pan-American Cannabinoid Medicine Association).

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The doctor emphasized the need for careful analysis before the substitution:

"Can the supplier change? Yes! But the product must be analyzed before that, and we need to be sure that the cannabinoid concentrations and the oil composition are the same as those that have worked previously for the patient."

There were also criticisms of the composition of the working group.

"The working group is composed of excellent doctors, but completely ignorant when it comes to endocannabinology. They are discussing a subject they have no knowledge about. It is not to remove them, but to include people who understand the subject, provide validated information, and thus discuss based on scientific evidence. Those discussing this do not understand the subject," said José Wilson. 

The working group coordinator was also questioned about the lack of scientific and technical knowledge of professionals regarding the medicinal use of cannabis. He acknowledged that changes can be made:

"The changes that have been made are for people who cannot attend as often as desired, who are replaced. But the medical specialty societies can also modify their representations. If the psychiatric society understands that it is convenient to indicate, representing the psychiatrists, a doctor with more clinical experience with cannabidiol, they are the ones who have to resolve it. It will not be us who will modify the composition of the specialty representations."

State Deputy Caio França read the motion sent to President Lula, an appeal to Anvisa to reassess the draft that establishes 0.3% as the maximum limit of tetrahydrocannabinol (THC) in cannabis cultivation in Brazil. The request considers the agronomic infeasibility of applying this parameter in a tropical climate, the approval of medications with a higher THC proportion already available in pharmacies, such as Mevatyl, the decision of the Superior Court of Justice (STJ) recognizing the need for regulation of cultivation in the country, and the relevance of patient associations, essential to ensure access to therapies not yet offered by the State or the market.

"It is another tool that the federal government has to delve into. This parliamentary front is a front that meets periodically, with a serious agenda. We have made progress in São Paulo, being a reference for other states. So, let the federal government take a good look and make use of the plant as a whole, so that a product is not too restrictive for other pathologies. We know that cannabidiol has therapeutic potential, but we cannot disregard the therapeutic potential of THC."

During the hearing, the 3rd call for proposals from the Front was also launched, which this year will allocate R$ 1.25 million to finance projects aimed at the development and application of medicinal cannabis and industrial hemp. The initiative covers areas such as health, science, technology, innovation, education, culture, communication, and social impact, with the aim of encouraging research, expanding population access, and strengthening innovation in the sector.

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