SP will produce marijuana-based medicine for the SUS – 12/27/2023 – Health

The government of São Paulo will develop studies for the manufacture of marijuana-based medicines to serve SUS (Unified Health System) patients starting next year.

The work will be conducted by Furp (Fundação para o Remédio Popular), a state public laboratory, which will import the IFA (active pharmaceutical ingredient) for the production of the medicines. The bidding process is already underway and should be completed by the end of January.

The ingredient will be used in the preparation of two new formulations of CBD oil (cannabidiol). After stability studies and technical analysis, the laboratory must request authorization from Anvisa (National Health Surveillance Agency) to distribute the product.

Approval by the regulatory body is the final step before the medicine reaches the SUS. The process is expected to be completed within 36 months (3 years).

Last Tuesday (26), the Tarcísio de Freitas (Republicans) administration published the guidelines for the free provision of cannabis medicine in São Paulo. Initially, treatment will be restricted to patients with three diseases that cause seizures and are difficult to control: Dravet Syndrome, Lennox-Gasteaux Syndrome and tuberous sclerosis.

With its own production by the São Paulo laboratory, the government hopes to reduce the costs of the medication in the future, which will initially be acquired by the State Department of Health through a tender open to the private sector.

Furp also wants to establish itself as a possible supplier to other states, given the prospect of growing demand for this type of treatment – ​​at least 13 states of the federation have already approved their own laws for the free distribution of CBD, which are awaiting regulation.

“Furp saw this as a business opportunity: to supply not only to São Paulo, but also eventually to other states in the future, where this legislation exists. Our challenge is to show that we can provide medicine with quality and a competitive price”, explains Fabiano Marques de Paula, superintendent of the foundation.

In addition to the price, he highlights the strategic importance of producing the medicine by an official laboratory to comply with public policy. “I always remember the recent example of the pandemic. If it weren’t for Fiocruz and Butantan, which are two public laboratories, we would have a much more difficult situation in being able to vaccinate the population.”

Dependence on imported IFA, however, could become a bottleneck for pharmaceutical assistance in the country with the expansion of access to treatment, assesses De Paula. “Right now we are still taking the first steps, but after this becomes more robust in other states it may become a case of rethinking this legislation. The country cannot be held hostage to purchasing some inputs only from abroad, it has to produce internally”, said the superintendent, who considers taking the issue to the Ministry of Health.

Expenditure on judicialization

Among the justifications cited by the São Paulo government in the Furp notice is the growing expenditure on cannabis medicinal product to assist with legal actions.

“Expenses arising from judicialization rose almost exponentially from 2019 to 2022, since all judged actions gave users a win, which is why the search for treatments using cannabidiol increased”, says an excerpt of the document. Around 70% of the products distributed during the period were imported.

Such as Sheet showed in October, the state of São Paulo had record spending on the purchase of marijuana-based medicines after court decisions in 2023. From January to October, R$25.6 million was allocated to meet 843 lawsuits filed by patients.

The amount corresponds to almost a third of everything the state has already spent on cannabis medicinal product since 2015, when Anvisa authorized the import of CBD products into Brazil for the first time. Total expenditure is close to R$85 million.