The existence of Official Pharmaceutical Laboratories (Laboratórios Farmacêuticos Oficiais – LFOs), institutions responsible for producing medicines primarily intended to meet public health program demands, constitutes one of the defining features of the Brazilian pharmaceutical industry (OLIVEIRA, 2007). Public production of medicines and other health technologies became effectively linked to the Brazilian Unified Health System (Sistema Único de Saúde – SUS) following the 1988 Federal Constitution and, more prominently, through Law No. 8,080 of 1990.
Article 196 of the 1988 Constitution establishes the conception of health as “a right of all and a duty of the State,” complemented by the guidelines governing public health actions and services and by the foundational principles of the SUS set forth in Articles 198 to 200. The latter provision explicitly connects the production of health technologies to the activities to be carried out within the SUS framework, assigning the system responsibility for “controlling and inspecting procedures, products, and substances of interest to health, as well as participating in the production of medicines, equipment, immunobiological products, blood derivatives, and other inputs,” among other duties (BRASIL, 1988; CHAVES; HASENCLEVER; OLIVEIRA, 2016).
Law No. 8,080/1990, in turn, includes within the scope of SUS activities “the formulation of policies regarding medicines, equipment, immunobiological products, and other health-related inputs, as well as participation in their production” (Article 6, VI). Article 19-W further provides for the production of active pharmaceutical ingredients intended for the treatment of socially determined diseases (BRASIL, 1990). It is precisely this emphasis on addressing the needs of Brazil’s public health system that distinguishes LFOs from private pharmaceutical laboratories (MACHADO, 2021).
The Pharmaceutical Laboratory of the State of Pernambuco Governor Miguel Arraes (Laboratório Farmacêutico do Estado de Pernambuco Governador Miguel Arraes – Lafepe) ranks among the three largest public pharmaceutical laboratories in Brazil, alongside Farmanguinhos/Oswaldo Cruz Foundation and Butantan Institute. Lafepe is the only laboratory in Brazil, and one of the few worldwide, to manufacture benznidazole, a medication used in the treatment of Chagas disease. In addition, it is one of the principal suppliers of antiretroviral drugs (ARVs) provided through the SUS for the treatment of HIV/AIDS1, as well as sodium hypochlorite 2.5% for cholera control and the antipsychotic medications clozapine, quetiapine, and olanzapine (BRASIL, n.d.; G1, 2025; LAFEPE, n.d.).
Despite its relevance to the Brazilian public health system, specific studies addressing Lafepe, its institutional characteristics, production profile, and challenges as a public pharmaceutical manufacturer remain scarce. References to the laboratory are found primarily in the literature dedicated to Productive Development Partnerships (Parcerias para o Desenvolvimento Produtivo – PDPs2). Notably, in 2017, the Pernambuco-based laboratory became the first institution in Brazil to complete all stages of a PDP since the program’s creation. Nevertheless, existing studies on such partnerships merely include those developed at Lafepe and do not focus exclusively on the institution itself. In light of this gap, the present case study treats Lafepe as its primary object of analysis, compiling the broadest possible range of information to address the identified deficiency in the literature.
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