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The monetary update of the values of the Health Surveillance Inspection Fee (TFVS) was discussed in a recent decision by the 4th Federal Civil Court of the Judiciary Section of the Federal District, which denied the security requested by the Union of Pharmaceutical Products Industries of the State of São Paulo ( Sindusfarma), pursuant to a collective writ of mandamus. The objective was to suspend the enforceability of the aforementioned fee, established by article 23 of Law 9,782/1999, with the adjustment determined by Provisional Measure 685/2015 and implemented by Ministerial Ordinance 701 of August 31, 2015. The sentence has not yet been published .
This is a monetary update of the TFVS B2B Lead values, which had not been readjusted since its institution in 1999. With this aim, in August 2015, Interministerial Ordinance MF/MS 701 was published, which updated the rate values, increasing them by up to 193%. This update, however, contradicts the command provided for in paragraph 1, of article 8, of Law 13,202/2015, which establishes:
Art. 8 The Executive Branch is authorized to update monetarily, as long as the value of the update does not exceed the variation in the official inflation index calculated in the period since the last correction, at a frequency of not less than one year, in accordance with the regulation, the value of the established fees:
§ 1 The first monetary update relating to the rates provided for in the caput is limited to the amount of 50% (fifty percent) of the total recomposition value relating to the application of the official index since the institution of the rate.
That is, in accordance with the norm, the aforementioned values could only be increased within the limit of 50% of the rate used at the time. These increases were also established in Provisional Measure 685 of 2015 and in Decree 8.510 of 2015.
According to the Federal Attorney General's Office, the TFVS is intended to fund the regulatory agency's inspection activities on the manufacture, distribution and sale of products and services that may involve risks to public health. And since the value remained unchanged for a period of 16 years, the rate remained outdated and with accumulated inflation, no longer reflecting the costs of health surveillance.
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