Estratégias de produção e aquisição de produtos farmacêuticos em contexto de dependência

Abstract

This article is published in Open Access under the Creative Commons Attribution license, which allows use, distribution, and reproduction in any medium, without restrictions, as long as the original work is correctly cited. In 1899, an epidemic of the bubonic plague struck the port city of Santos, São Paulo State, Brazil, a strategic hub for Brazil's exports. The event was at the heart of the Butantan Institute's subsequent creation. The Pasteur Institute in Paris (France) was the sole producer of anti-plague serum, which created difficulties for its rapid importation. The director of the São Paulo Health Service at the time, Emílio Ribas, thus proposed a solution to the provincial government to decrease foreign dependency: the founding of a lab to produce antisera in Brazil 1. This story is an example of Brazil's efforts to free itself of foreign dependency in the production and purchase of essential goods such as drugs, antisera, and vaccines. Unfortunately, this dependency has become more acute over time. The pharmachemical industry, among others, suffered a process of accelerated deindustrialization. In the last 40 years, the production of active pharmaceutical ingredients (API) dropped from 55% to 5%, according to the Brazilian Pharmachemical Industry Association (Associação Brasileira da Indústria de Insumos Farmacêuticos-Abiquifi) 2. The issue has come under discussion again in recent months, due to the need to import active ingredients for production of the two vaccines approved for emergency CO-VID-19 use in Brazil. This dependency has become more evident, since in November 2020 some 50% of the volume of vaccines in advanced stages of development had been reserved by European Union countries, Canada, United States, United Kingdom, Australia, and Japan 3 , leaving middle-and low-income countries uncovered and prompting World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus to condemn "vaccine nationalism" 4. Beginning in the 2000s, various industrial policy proposals aimed to reverse the situation of deindustrialization, including Brazil's domestic pharmaceutical industry among their targets. Dependency on imports of APIs and medicines, reflected in a trade balance deficit for the sector, sustained the argument of vulnerability of the Brazilian Unified National Health System (SUS) in the face of high prices and health technologies supply. This argument allowed the adoption of a series of instruments to promote domestic production of active ingredients and medicines. These have included the so-called Productive Development Partnerships (PDP), which use temporary exclusive reserve of the public market

Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia

“…The pricing collection method varies across these countries. These findings corroborate the findings reported by Chaves et al (2021) , who mentioned the lack of clarity in the information made available by Brazil on the prices charged on the public market. The information found for the countries in the present study was not related to the exact data of purchases of medicines, regulatory purposes for medicine’s prices, or price catalogs reported by surveys of manufacturers or retailers.…”

Vacinas no Brasil: análise histórica do registro sanitário e a disponibilização no Sistema de Saúde

“…A construção do banco de dados de registro de produtos ocorreu a partir do recadastramento realizado conforme a Portaria nº 801, de 07 de outubro de 1998 17 . Por-2014 (5) 2016 (6) 2017 (7) Bacilo Historicamente, para entender o sucesso do setor de vacinas é preciso considerar desde o século XIX, em que diversos laboratórios marcaram o desenvolvimento no setor como: o Instituto de Tecnologia em Imunobiológicos/Bio-Manguinhos que produziu a vacina contra a febre amarela, utilizando a cepa 17DD; o Instituto Butantan que consolidou a produção da vacina tríplice bacteriana (DTP); a Fundação Ataulpho de Paiva que passou a produzir as vacinas contra tuberculose; e o Instituto do Paraná (Tecpar) que desenvolveu a produção de vacina contra raiva 5,8,19 .…”

Vacinas no Brasil: Análise Histórica do Registro Sanitário e a disponibilização no Sistema de Saúde

“…Therefore, any information about registrations prior to 1998, which have not been renewed due to alack of interest by the holder company or cancellation of the registration, has not been kept and is not included in that data bank. Historically, in order to understand the success of the vaccine sector in Brazil, it is worth to consider the first developments, which occurred in the 19th century, when several state-owned institutions began the development of this sector, such as: Instituto de Tecnologia em Imunobiológicos / Bio-Manguinhos which produced the yellow fever vaccine using the 17DDstrain; Instituto Butantan, which consolidated the production of the triple bacterial vaccine (DTP); the Fundação Ataulpho de Paiva, which began to produce vaccines against tuberculosis; and Instituto do Paraná (Tecpar), which developed the production of the rabies vaccine 5,8,19 .…”