Brazilian President Lula da Silva signed Law 14,648 on August 4, 2023
The initial project was presented in the Senate in 2017
Brazil becomes the 14th country in the world to regularize the practice of ozone therapy. Although Brazil had already been approving its practice in different health professions since 2015.
The law eliminates the regulatory contradiction existing in human medicine, between authorization in the public sector and prohibition in the private sector.
AEPROMO, since its foundation in 2008, has been supporting the efforts of Brazilian colleagues to regulate ozone therapy.
The current law began its parliamentary journey in 2017 when then-senator Valdir Raupp de Matos of the MDB (Brazilian Democratic Movement) presented Federal Bill 227/2017, which “authorizes the prescription of ozone therapy throughout the country.”
The project was replaced by the Chamber of Deputies in 2022. Substitution approved by the Senate on July 12, 2023. On August 4, the project was signed by the President of the Republic Luiz Inácio Lula da Silva and entered into force, from its publication in the Official Gazette of the Union, on August 7, 2023. https://www.in.gov.br/en/web/dou/-/lei-n-14.648-de-4-de-agosto- from-2023-501165161
Brazil had been, since 2015, authorizing the practice of ozone therapy in different health professions: Dentistry (2015); human medicine (2018) but only in the public sector; physiotherapy (2018); pharmacy (2020); nursing (2020); veterinary (2020); and biomedicine (2020). Now (2023) it is approved in human medicine. 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://aepromo.org/en/brazil-bill-that-authorizes-ozone-therapy-in-the-national-territory-sent-for-the-signature-of-the-president-of-the-republic-lula-da-silva/
The confrontation between the two regulations on ozone therapy in human medicine that were in conflict disappears
Until August 6, 2023, in human medicine, two openly conflicting regulations faced each other. One that authorized ozone therapy throughout the country’s public health system (Ordinance No. 702 of March 21, 2018 of the Ministry of Health). Another that prohibited ozone therapy in the private health service; and it was only authorized on an experimental basis (Federal Council of Medicine, 2018).
Law 14,648 on August 4, 2023 puts an end to this confrontation because it “authorizes ozone therapy throughout the national territory”, regardless of whether it is practiced in the public or private sector.
Content of the law
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).
AEPROMO support for the regularization of ozone therapy in Brazil
Since the foundation of AEPROMO in 2008, the association has dedicated efforts to ensure that ozone therapy was regularized both in Spain and in other countries around the world. Their support has materialized and continues to materialize in drafting legal projects for regularization, and scientific-legal documents in favor of ozone therapy.
Several members of AEPROMO participated in the 2nd Brazilian Congress of Ozone Therapy in 2011, where they expressed their support for the regularization of ozone therapy in Brazil.
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