The initial project (227/2017) was presented to the Brazilian Senate in 2017. It was replaced in the Chamber of Deputies by project 1438 of 2022.
The substituted project was approved by the Senate (July 12, 2023) and has been sent for the presidential signature of Ignacio Lula da Silva.
If approved, Brazil would be the fifteenth country in the world to approve the practice of ozone therapy. Although Brazil had already been approving its practice in different health professions since 2015.
Brazil is the country with the most current regulations on ozone therapy and that are specifically aimed at different health professions.
The then senator Valdir Raupp de Matos of the MDB (Brazilian Democratic Movement) presented in 2017 the Federal Law Project 227/2017 by which “the prescription of ozone therapy is authorized throughout the country.”
Upon being approved by the Senate, it passed to the Chamber of Deputies on November 1th of the same year. This replaced it with bill 1438 of 2022 and forwarded it to the Federal Senate on May 17, 2022.
Upon receiving the green light from the Social Affairs Commission (July 5, 2023), https://www12.senado.leg.br/noticias/materias/2023/07/05/cas-aprova-ozonioterapia-como-tratamento-de-carater-complementar
the plenary session of the senate approved it on July 12, 2023. Now bill 1438 of 2022 goes to the approval of the president of the republic Luiz Inácio Lula da Silva.
Content of the bill
The bill that “authorizes ozone therapy in the national territory” and that will be sent to the President of the Republic, for his signature, specifies the following:
Ozone therapy is authorized as a complementary procedure, subject to the following conditions (art. 1).
It can only be carried out by “a health professional with a higher education level registered in his professional supervision council.” (art 1, I)
It can only be applied with “medical ozone production equipment duly regularized by the National Agency for Sanitary Surveillance (Anvisa) or agency that replaces it.” (art. 1, II)
The “professional responsible for the application of ozone therapy must inform the patient that the procedure is complementary.” (art.1, III).
The main differences between the project initially presented in 2017 and the one that has now been sent for the presidential signature are the following:
In the 2017 project, only physicians could practice ozone therapy; Currently, it is extended to health professionals with a higher education level who are registered with their professional supervision councils.
This modification agrees with the authorizations given for the practice of ozone therapy by different federal councils of health professions. Indeed, Brazil has authorized and regulated the practice of ozone therapy in the following health professions: Dentistry (2015); human medicine (2018) but only in the public sector; physiotherapy (2018); pharmacy (2020); nursing (2020); veterinary (2020); and biomedicine (2020). For this reason, we have indicated that Brazil is the country with the most current regulations on ozone therapy and that they are specifically directed at different health professions.
https://ozonoterapia.org/en/legal-status-of-ozone-therapy-in-brazil-update/
The second difference is that in the 2017 project “the ozone therapy medical procedure was defined as being of “public relevance” (art. 3). At present this article has disappeared.
Regulations on ozone therapy in human medicine confronted
It should be remembered that in terms of human medicine, currently in Brazil there are two regulations that are openly contrary to each other. On the one hand, the practice of ozone therapy is authorized throughout the country’s public health system (Ordinance No. 702 of March 21, 2018 of the Ministry of Health); on the other, it cannot be practiced in the private health service by decision of the Federal Council of Medicine, but only on an experimental basis. The physician who practices in private medicine could be sanctioned according to the Medical Ethical Code (Resolution CFM No. 2.181/2018).https://ozonoterapia.org/en/a-step-forward-and-a-step-back-for-the-ozone-therapy-in-brazil/
On the confrontation of the two regulations, Otto Alencar, rapporteur of the bill in the senate pointed out: “As ozone therapy has not yet been properly regulated by the Federal Council of Medicine, we consider it appropriate to allow, by legal means, that higher-level health professionals duly trained in its use can offer it to their patients, if they understand that it can be beneficial to the improvement of the clinical condition.”
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