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The evolution of transparency regulations in the Brazilian healthcare system

Sergio Sztajnbok ( is Compliance Associate Director at Alexion Pharma Brazil.

Natasha Trifun ( is LATAM Compliance Director at Alexion Pharmaceuticals.

In January 2016, I published an article in Compliance Today about the emergence of the first Brazilian healthcare transparency regulation.[1] The regulation, CREMESP Resolution No. 273/2015, made it mandatory for physicians registered in the State of São Paulo to provide written reports to CREMESP about their engagement as consultants and/or speakers for pharmaceutical, orthotic, prostheses, and other healthcare-related companies, as well as the name of the company. In that article, I questioned the effectiveness of a regulation stipulated by a professional board compared with a law enacted by a legislative body. It was clear to me at the time that Brazil needed effective legislation for healthcare transparency, preferably legislation that required the industry to report on its relationship with healthcare professionals as well. I concluded the article by arguing that only laws enacted by the legislative branch (precisely for their coercive power) could be effective at making the pharmaceutical company and healthcare professional relationship more transparent; however, I believed we had a long way to go before such laws were adopted.

Many things have changed in Brazil since then, and society has become more intolerant of corruption and, consequently, more engaged in fighting it. It was precisely in this setting, namely in the fight against corruption, that the discussion about regulations that require transparency regarding any and all relationship between private enterprises and the public sector, or even exclusive relationships in the private sector (e.g., law 22440/16, issued by the State Department of Health of Minas Gerais—the reason for this article) or public sector (e.g., website Portal da Transparência),[2] was further expanded. It was a pleasant surprise when, less than one year after publishing my article, more specifically on December 21, 2016, the government of the State of Minas Gerais approved the Law 22440, which became the first healthcare transparency law in our country.[3]

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