Understand the law that provides for medical cannabis in the SUS – 02/01/2023 – Health

The supply of medicinal Cannabis by SUS in the state of São Paulo should still take some time to materialize. After the law predicting the measure is sanctioned by Governor Tarcísio de Freitas (Republicans), it should be discussed how it will be put into practice.

One of the points to be discussed, for example, is for which diseases medical cannabis will be offered in the public health network.

Understand, below, the next steps for the law to enter into force, the concerns regarding compliance with the law and the criticisms regarding the project.

What are the next steps for the law to take effect?

Sanctioned this Tuesday (31st) and published in the Official Gazette this Wednesday (1st), the policy is now the responsibility of the Secretary of Health, who must define the competencies at each level of action.

Within 30 days, the folder needs to create a working commission to implement the law’s guidelines with the participation of technicians, representatives of non-profit associations supporting and researching Cannabis and associations representing patients. After publication in the Official Gazette, the law must enter into force within 90 days.

Is the law unprecedented in Brazil?

Do not. In 2016, a law was enacted in the Federal District that includes cannabidiol in the list of drugs distributed by the public health network within the Program for the Prevention of Epilepsy and Comprehensive Assistance to People with Epilepsy. In Búzios (RJ) and Goiânia (GO), city halls adopted the use of medicinal Cannabis in the public network to help low-income families.

However, according to experts, there is a question in these places. Cannabis products are not medicines and are not registered as medicines. They are categorized by Anvisa itself as a product derived from Cannabis.

“In all bidding and acquisition law, medicine is mentioned. Therefore, there is a gap between the medicine supply law and the regulation of Cannabis. These states and municipalities need to build a bridge [para solucionar] this hiatus”, says Emilio Figueiredo, a lawyer at Rede Reforma.

Why were articles of the law vetoed?

Of the ten articles that the law contained, six were vetoed by the governor. One of the justifications was that the state government understood that the text restricted concepts to definitions that may be changed by Anvisa in the future. Therefore, the law could become outdated, harming patients.

Functional neurosurgeon and technical director of the CEC (Cannabinoid Center of Excellence), Pedro Pierro said that the law is very well written because it puts all the criteria in charge of Anvisa.

But he makes a caveat: the law does not detail which diseases can be treated. “If the law is restricted to a few diseases, people will continue to go through the Judiciary to get it,” said Pierro.

During the law sanctioning ceremony, Tarcísio explained that the vetoes occurred so that the team responsible for regulation would be in charge of the more specific sections of the law.

Emilio Figueiredo, a lawyer for Rede Reforma, welcomes the decision. “If this is agreed by the regulatory group, it will be great because the law brings a very large limitation in terms of product. Since it says that it can only be a medicine derived from cannabidiol, the text is not covering the thousands of products that exist in the international market.”

What is the origin of the products?

The law provides for the free supply of plant-derived medicines to
cannabidiol base, in association with other cannabinoid substances, including THC, on an exceptional basis.

Anvisa already authorized the importation of medicinal Cannabis and has already released the sale of about 20 Cannabis-based products in Brazilian pharmacies and drugstores. Before the law, what happened is that families needed to pay for the importation of medicines or file lawsuits for the medicine to be funded by the government.

Can CFM’s positioning hinder the process?

Last year, the CFM (Conselho Federal de Medicina) published a resolution that made the indication of cannabidiol (CBD) for medicinal use even more restrictive. After criticism, the entity revoked the resolution.

Cannabinoid pharmacologist, Fabricio Pamplona says that the CFM’s position has no weight before Anvisa or laws. But the entity’s stance, he says, may confuse public opinion. “The CFM has the prerogative to file an ethical lawsuit against a doctor who prescribes against the advice of the council itself. So, this is a mechanism that inhibits the behavior of doctors. It is a kind of threat.”