While some high-income countries are considering specific actions to address the growing burden of antimicrobial resistance (AMR), efforts among low- and middle-income countries are less common. This case study analyzes current efforts in Brazil, a middle-income country, to improve antibiotic stewardship, access, and innovation.
We carried out a desk review of current active efforts, national policies, and procurement processes within the Brazilian Unified Health System (SUS) related to antibiotic access, stewardship, and innovation. We complemented this analysis with 11 expert interviews. All interviewees are currently working within the Brazilian health sector and have direct knowledge of and/or decision-making authority on AMR-related initiatives.
Our desk review and interviews highlighted the importance of three institutions. First, ANVISA, the national health regulatory authority, oversees new drug approvals and is responsible for health surveillance. Second, the Drug Market Regulation Chamber (CMED) regulates drug pricing in Brazil. And third, the Ministry of Health (MoH) manages public health policies and purchases highly specialized health products for SUS.
To further strengthen antibiotic access, stewardship, and innovation in Brazil, we suggest leveraging existing infrastructure. Our proposed model builds upon the traditional Partnerships for Productive Development (PDP) model, in which contract arrangements between the MoH and an official laboratory aim to transfer and absorb the technology and the production of a health product from a private pharmaceutical company over 10 years. The traditional PDP model offers incentives for the partners involved, which include pharmaceutical companies, public laboratories, and SUS. It provides pharmaceutical companies with indirect access to SUS; official local laboratories with advanced technological expertise; and SUS with potential access to new, more affordable products. The PDP model could support the innovative capabilities of local laboratories through the technology transfer process, which is likely to have spillover effects in the development of new drugs.
Our proposed model, the annual fee PDP, recommends minor changes to the traditional PDP. Like subscription models promoted in Sweden and the United Kingdom, the annual fee PDP involves fixed annual payments to pharmaceutical companies in exchange for access to their drugs. Such a measure would delink revenues from sales volumes, hence reducing pharma companies’ incentive to oversell their drugs, while also justifying investments to register new antibiotics which are not yet available in Brazil. We conclude our analysis with a discussion of the appropriate scope, implementation, and political palatability of the annual fee PDP.
- Almost 140,000 people die with a drug-resistant bacterial infection in Brazil every year. This burden of AMR is likely rising, due in large part to shortcomings in access, stewardship, and innovation for antimicrobials.
- Brazil’s existing Productive Development Partnerships system could be modified to reduce incentives for overselling and leveraged to improve antimicrobial procurement in Brazil and possibly across the region. This policy option would also support local manufacturing goals set by the Brazilian government.
- Brazil can further address antimicrobial market challenges in its AMR response by modifying pricing policies for new antibiotics, scaling up priority regulatory review processes, expanding AMR stewardship policies, leveraging AMR data for decision-making, and increasing access to diagnostics for antibiotic-resistant infections.
- With the largest pharmaceutical sector in Latin America and the Caribbean and one of the largest in the world, Brazil could lead the way in addressing the access and stewardship gaps for critical antimicrobials.
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