Due to its fractured state, fixing Brazil’s challenging regulatory landscape was a priority at the 2023 South America Summit. Lula emphasised the need to implement regulatory convergence norms to eradicate the restrictive pharma import and export conditions.
Almost 12 months later, Brazil’s regulatory environment remains a significant hurdle for the pharma industry to overcome. “Without legal certainty and stable rules, this is practically impossible,” says Nelson Mussolini, executive president of pharma industry association Sindusfarma (Sindicato da Indústria de Produtos Farmacêuticos) and a Brazilian Health Council (CNS) member.
Misunderstanding over intellectual property’s role is an area requiring reviews and updates. “Political and health leaders still persist in assuming that patent breaking, even temporarily, can encourage the production of medicines and vaccines and expand the population’s access to essential goods for public health,” Mussolini details.
Still he says the handling of the coronavirus in Brazil demonstrated its control was only possible due to technology transfer negotiations among national and international pharma industries, public laboratories, research centers and Brazilian and world authorities.
“It was not a haphazard success,” Mussolini says, commenting on Brazil’s approach to Covid-19. Clinical trials for new drugs involve complex processes, long and uncertain development stages, and high costs. “In Brazil and around the world, observing intellectual property rights is critical for the development and supply of new drugs and vaccines and the strengthening of the clinical trials system,” Mussolini adds.
Brazil’s broader political and legal landscape also raises questions. “The country loses investments of more than BRL 2bn ($382m) every year because of unnecessary bureaucracy and provisions that, by creating legal uncertainty, drive away sponsors of clinical trials,” Mussolini states.
“A government policy is still lacking,” Mussolini adds, highlighting that Brazil needs “a long-range plan allowing the country to explore the great potential of the pharmaceutical area as a vector for scientific, technological, economic and social development”.
“We are not advocating here for the withdrawal of individuals’ rights from research but for the modernisation of the regulatory framework,” Mussolini asserts.