With high judicialization, Ministry of Health evaluates offering cannabidiol in SUS – 05/01/2021 – Balance and Health

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With the increase in lawsuits forcing the Union, states and municipalities to supply products derived from cannabidiol (CBD), the Ministry of Health is evaluating the incorporation of one of them in the public health network. It would be the first product of its kind to enter the SUS list.

Since 2015, when Anvisa (National Health Surveillance Agency) authorized for the first time the import of products with an active ingredient from Cannabis for medical use, requests continue to escalate, many made through lawsuits.

In 2020, there were about 16 thousand orders, almost double the previous year (8,500). In 2018, it had been 3,500. There is no consolidated number of lawsuits against the three entities of the federation, but only the volume observed in the state of São Paulo gives an idea of ​​the increase.

In five years, the number jumped from 1 to 198 lawsuits in 2020. This year, until April, there were 58 more. In 2020, the São Paulo government spent R $ 63 million to comply with these lawsuits. This year, it was over R $ 20.6 million.

According to Paula Sue de Siqueira, coordinator of strategic health demands at the State Department of Health, the lawsuits involving products based on Cannabis they privilege individual rights to the detriment of public policies established in SUS, in addition to not having an evaluation of safety and effectiveness of Anvisa (National Health Surveillance Agency).

At the request of the Ministry of Health, Conitec (national commission for the incorporation of technologies in the SUS) is analyzing the inclusion of cannabidiol 200 mg / ml (from the pharmaceutical company Prati-Donaduzzi) in the SUS list. For now, the only indication foreseen would be for the treatment of childhood and juvenile epilepsies refractory to conventional therapies.

The process went through a public consultation, which ended at the end of March, and is awaiting a final opinion from the commission.

In a report that served as a basis for the consultation, Conitec’s directors did not recommend incorporating the product. They consider that the available evidence has a questionable clinical benefit, in addition to a high budgetary impact.

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The product is registered with Anvisa as a phytopharmaceutical derived from cannabis, which can be prescribed at the discretion of the physician but which has not demonstrated sufficient evidence for approval as a medicine.

Conitec estimates that the incorporation of cannabidiol in SUS, to serve 1,000 patients, would cost R $ 80 million a year to public coffers. In pharmacies, the value of each box (80 ml oral solution) costs around R $ 2,300. According to the pharmacist’s calculations, there would be 700,000 people eligible for treatment in Brazil.

At the same time, another movement is beginning to take shape in the country, from partnerships between public institutions and the private sector to transfer technology in the production and commercialization of products based on Cannabis.

The first agreement was signed last October between the Oswaldo Cruz Foundation and Prati-Donaduzzi. The pharmaceutical company has another public-private partnership with the Ribeirão Preto School of Medicine at USP, for a cannabidiol-based drug that is in the final stage of clinical study.

The agreement with Fiocruz is for five years and is under industrial secrecy. In February, the company obtained a patent for CBD oil, developed in partnership with USP, but Inpe (Industrial Property Institute) recommended the document to be null and void.

The opinion was issued after three petitions challenged the inventiveness of the drug. Sought, Prati-Donaduzzi reported that the spokesman would not be able to answer the report.

By means of a note, Fiocruz said that the objective of the agreement is to allow the availability of a drug that can meet, in a safe and appropriate way, current legislation, to the public interest involved in SUS demands.

He also informed that the terms of the signed contract are restricted to the transfer of technology and that all information about the supply, including the delivery schedule, will be negotiated in future negotiations.

As part of this agreement, on March 23, Fiocruz applied for authorization from Anvisa to produce cannabidiol in Brazil, with the intention of supplying it to SUS.

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The initiative has motivated others. Tecpar (Paraná Institute of Technology), official public laboratory of the Paraná government, seeks partnerships with the same purpose, that is, technology transfer for the production and commercialization of medicines and products based on Cannabis.

As a result of an announcement published last month in the Official Gazette, three companies were qualified. In a note, the institute says that it evaluates the business model proposed by each company to develop the partnership.

One of the companies qualified by Tecpar is the Canadian Verdemed. According to José Bacellar, founder and president of the company, the proposal is to transfer to the institute three products that are still awaiting registration with Anvisa.

During the technology transfer period, according to him, the state laboratory buys the company’s finished product and sells it to governments. Then, the company transfers the raw material so that the public laboratory itself manufactures the product and, finally, it takes over the entire production process.

For companies, the advantage is privileged access to public procurement, without the need for bidding, in the initial years. For the public sector, more affordable products. The estimate is that today they would be at least 30% cheaper.

Market report on government cannabidiol purchases, ordered by VerdeMed, shows that public acquisitions totaled around R $ 20 million between 2018 and 2019.

The states were the largest buyers (R $ 16.3 million), followed by the municipalities (R $ 2.6 million) and the Union (R $ 868 thousand).

Of this total, most acquisitions were made through direct purchases, without bidding, to comply with court orders that need to be fulfilled in a short period of time. Out of 380 procurement processes, only 6 were tendered (3 in Goiás and 3 in the Federal District).

For Reinaldo Guimarães, professor at the bioethics nucleus at UFRJ (Federal University of Rio de Janeiro), these agreements come to meet a real demand for these products, especially in cases of refractory epilepsy.

But he does not believe that these partnerships can stop cannabidiol judicialization. “They will continue to happen for other therapeutic indications.”

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São Paulo State Attorney José Luiz Souza de Moraes, professor of international law at Unip (Universidade Paulista), believes that, based on clear parameters and protocols on the use of cannabidiol, prepared by renowned public institutions, and with the product available in SUS, there will be a decrease in the increasing judicialization.

“Today there is a panacea in the use [do canabidiol], many injunctions granted without any criteria. With the merger, access through the judicial system will be more restricted. The judge himself, having the clearest grounds for use, will be cautious [em conceder liminares] for other ‘off label’ or experimental uses. Today it has no parameter. If nothing can, everything can. ”

In his opinion, although the scientific evidence for many of the indications for the use of cannabidiol is still fragile, it is essential that public laboratories do research and produce the product.

“The transfer of technology and national production is extremely beneficial. In lawsuits, we see very expensive imports, with the dollar now high, the public sector also spending on logistics, ”he says.

Moraes says that the taboo involving Cannabis in Brazil, which he considers irrational and distant from scientific discussion, he has delayed the development of more in-depth studies on the subject and regulation itself.

“There are many drugs made with opiates, cocaine analogues, heroin. Intubation kits, for example, have these drugs. Do we give ritalin, an analogue of cocaine, to the child who is not quiet, without the slightest parsimony, and is discussing cannabis oil? It is the o of the borogodó. ”

In addition to Prati-Donaduzzi, which today has three versions of cannabidiol authorized by Anvisa, recently the American company Nunanature also entered the Brazilian market, with two different concentrations of the product.

Sanitary authorizations are valid for five years and follow 2019 resolution, which allowed the production of products with Cannabis in Brazil, but with imported inputs, since the proposal for cultivation was vetoed by the agency.

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