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Law 15,279, enacted on December 2 and published in the Official Gazette on December 3, redefines the tax treatment of drug donations, eliminating PIS, Cofins, and IPI in these operations and imposing rules for validity, oversight, and institutional allocation required for public bodies and charitable entities throughout the country.
Tax exemption for drug donations provided by Law 15,279 eliminates the charges of PIS, Cofins, and IPI following presidential sanction on December 2 and official publication on December 3 for public entities and charitable organizations nationwide.
The federal government established a tax exemption for drug donations intended for public bodies and charitable entities, according to Law 15,279 enacted on December 2 and published on December 3, a measure that is relevant because it removes specific taxes and reorganizes control rules.
Institutions Covered and Taxes Excluded
The regulation covers direct and indirect administrations of the Union, states, the Federal District, and municipalities, as well as Santas Casas, the Brazilian Red Cross, certified charitable entities, and social organizations defined in previous legislations.
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The text removes the charges of PIS, Pasep, Cofins, and IPI on these operations, maintaining the requirement that donated medications have at least six months of validity and are not to be used for profit.
Technical Conditions and Responsibilities in Oversight
The law prohibits donations to individuals and assigns the recipient institutions the responsibility to control the deadlines and conditions of the delivered units, avoiding tracking problems.
The Executive Power must regulate oversight and control processes, including operational adjustments to monitor validity, storage, and final allocation, according to parameters defined in the law itself.
Annual Waste and Legislative Justification
The Federal Council of Pharmacy reports that about 14,000 tons of medications are unused annually in Brazil and are discarded, often improperly, which harms the environment and prevents populations in need of treatment from receiving these products.
The regulation derives from Bill 4,719 of 2020, approved by the Chamber and confirmed by the Senate, where the rapporteur Fernando Farias stated that it is unreasonable for disposal to receive more advantageous treatment than donation.
The legislation is already in effect and concludes adjustments initiated in 2020, adding accessory parameters for responsibility and validity.
Source: SENATE.
