Indústria farmacêutica e acesso a medicamentos: estratégias de patenteamento, registro e preço de medicamentos adquiridos por judicialização entre 2017-2021

Abstract

This thesis investigates whether pharmaceutical companies adopt strategies related to patent applications, registration, and pricing to achieve profitable sales of medicines – particularly those requested in lawsuits – to the Brazilian Ministry of Health (MS, in Portuguese). The research analyzed the public procurement of 30 active pharmaceutical ingredients by the Department of Health Logistics under the Brazilian Ministry of Health (DLOG/SE/MS, in Portuguese) between 2017 and 2021. The analysis focused on 19 active pharmaceutical ingredients with patents considered constraining in Brazil. The central hypothesis suggests that foreign pharmaceutical companies employ coordinated strategies to guarantee exclusive sales to the Ministry of Health, leveraging the judicialization of access to medicines. The methodology involved a retrospective analysis of timelines for patent applications, product registration, and pricing approvals with the relevant Brazilian institutions. This analysis was correlated with the amounts paid by the Ministry of Health, as well as other product characteristics, including registration with international regulatory agencies, requests for evaluation by the National Commission for the Incorporation of Technologies in the National Health System (CONITEC, in Portuguese), and the national regulatory framework. The findings revealed that medicines associated with the highest costs often experienced the longest delays between key regulatory events, suggesting deliberate postponement strategies by the companies. These delays allowed products already available on the international market to be sold in Brazil, by judicial decisions, bypassing standard regulatory procedures. Additionally, the research found that even in cases where purchases were made after obtaining regulatory approval from the Brazilian National Health Surveillance Agency (ANVISA, in Portuguese) and the maximum price definitions by the Drug Market Regulation Chamber (CMED, in Portuguese), public procurement often occurred under pricing conditions that conflicted with the public interest. The findings of the thesis can inform policies aimed at enhancing regulatory integration, optimizing the public procurement of medicines, and strengthening the innovative capacity of Brazil's pharmaceutical industry. These measures seek to ensure the financial sustainability of the National Health System (SUS, in Portuguese) and equitable access to medicines.