Has it ever crossed your mind that the Brazilian public healthcare system (SUS) might be paying billions of reais for medications that, in many cases, don't deliver the promised results?
If the answer to that question is yes, stay tuned as we will develop this topic further. If the answer is no, I invite you to reflect on this increasingly present dilemma in Brazil, especially in light of the judicialization of healthcare and the incorporation of innovative therapies at very high costs. On the one hand, the Constitution guarantees health as a fundamental right (articles 6 and 196 of the 88 Constitution), on the other hand, public managers face the daily difficult task of balancing this right with the responsibility of protecting the budget and ensuring efficient public policies.
It is in this dual scenario that a contractual solution gains relevance: here we are talking about risk-sharing agreements (RSAs), also known as risk-sharing agreements. In these popular agreements in the United Kingdom, Italy, and France, payment for the medication is conditional on actual clinical performance. In simple terms, the state only pays if the medication actually works. Otherwise, the bill does not fall on the public system, but on the pharmaceutical industry. Sounds like a perfect scenario, doesn't it?
In short, this model aims to resolve two existing and central tensions in this debate: the uncertainty about the effectiveness of innovative medicines in real-world use contexts and the budgetary pressure caused by litigation and the incorporation of technologies without robust evaluation.
In Brazil, although still in its early stages, the experience exists. In 2019, the Ministry of Health initiated a pilot project for a risk-sharing agreement for the drug nusinersen (Spinraza), indicated for spinal muscular atrophy. More recently, in 2025, the first performance-based risk-sharing agreement was signed within the SUS (Brazilian Public Health System), relating to onasemnogene abeparvovec (Zolgensma), a very high-cost gene therapy, whose payment was tied to clinical response indicators in patients with SMA type I.
Currently, the question is whether it would be truly feasible to expand this model in Brazil, both from a legal and institutional standpoint.
Constitutional and legal framework
To begin this analysis, we need to start with our illustrious Magna Carta, the Federal Constitution of 1988, which in articles 6 and 196 enshrines health as a fundamental social right, assigning to the State the duty to provide universal and equal access. The point worth highlighting is that this duty is not absolute: it must be interpreted in dialogue with the principles of administrative efficiency (article 37) and the reserve of the possible, which condition state action to the limitation of available public resources.
Thus, the RSA model emerges as a way to harmonize these principles, by seeking to guarantee access to innovative therapies without disproportionately compromising the public budget, since it links financial expenditure to the achievement of clinical results.
To avoid any confusion, it is also worth noting that Law 8.080/1990, which organizes the SUS (Brazilian Unified Health System), establishes the principles of universality, comprehensiveness, and equity. However, these principles do not prevent the adoption of innovative financing instruments, provided that they respect the logic of equal access. In this way, these agreements function as a kind of rationalized comprehensiveness, as they allow the provision of cutting-edge therapies under conditions of budgetary security.
Another point that deserves special attention is article 144 of Law 14.133/2021, the new Law on Bidding and Administrative Contracts. This provision expressly authorizes the adoption of variable remuneration linked to performance, which legally legitimizes the logic of RSAs (Remuneration for Performance Assignments), since this provision allows public notices and contracts in the health sector to link payment to effectiveness targets, increasing the legal security of these arrangements.
Additionally, the Supreme Federal Court's Case 500 (RE 657.718) ruled that, as a rule, the State cannot be compelled to provide medicines not registered with Anvisa, which reinforces the idea that RSAs should only be entered into for registered drugs, even in a context of uncertainty regarding cost-effectiveness.
Thus, it is evident that RSAs have strong legal support, not disrespecting the provisions in force in the Brazilian legal system. The challenge lies in translating them into clear contracts, with achievable goals, validated clinical indicators, and secure data governance, guaranteeing transparency and effectiveness.
What are risk-sharing agreements (RSAs)?
Despite the brief introduction to RSAs above, a more detailed explanation is necessary. RSAs are contracts entered into between the State and the pharmaceutical industry that aim to share the risks inherent in the incorporation of new health technologies.
They differ clearly from standard supply contracts, where payment is made simply upon delivery of the product. In RSAs, payment is contingent on performance targets, such as improvements in specific health indicators, reductions in hospitalizations, or increased survival rates.
Thus, the central concept of this type of agreement is that of real-world evidence , in which data are obtained under real treatment conditions, and not only in controlled clinical trials. This is because, by conditioning payment on the collection and analysis of this data, RSAs allow public policies to be based on local evidence, which is more representative of the population served by the SUS (Brazilian Public Health System).
From a theoretical standpoint, the RSAs (Regional Health Services) align with the principles of economy and efficiency, as stipulated in Article 37 of the 88 Brazilian Constitution. After all, these instruments do not restrict rights, but they ensure that every real spent by the State generates the maximum benefit in healthcare.
Recent case law from the Supreme Federal Court (STF) and the Superior Court of Justice (STJ)
Case law has been clearly defining the right to health and, consequently, the viability of health insurance agreements. In addition to the aforementioned Topic 500, there are other relevant topics related to the landscape of these agreements.
In the Brazilian Supreme Court (STF), for example, Topic 793 addressed the joint and several liability of federative entities, recognizing that the Union, states, and municipalities are jointly responsible for the provision of healthcare. This means that risk agreements entered into at the national level can have a direct impact on all entities, and there must be clarity regarding the distribution of responsibilities.
Furthermore, the issuance of Binding Precedent 61 in 2024 established cumulative criteria for the judicial granting of medications not incorporated into the SUS (Brazilian Public Health System), namely: (i) registration with Anvisa (Brazilian Health Regulatory Agency); (ii) lack of a therapeutic substitute on the SUS list; (iii) recommendation from Conitec (National Commission for the Incorporation of Technologies in the SUS) or unreasonable delay in analyzing the incorporation; (iv) proof of clinical indispensability; and (v) financial incapacity of the patient.
Supporting this understanding, the Superior Court of Justice (STJ), in its jurisprudence on administrative contracts, legitimizes the adoption of clauses conditioned on performance, provided they are stipulated by law, which is in line with Law 14.133/2021. This demonstrates that current jurisprudence is not only compatible with performance-based payment clauses but also points to them as a way to reconcile the right to health, budgetary security, and administrative efficiency.
This analysis ultimately demonstrates that the RSAs, in addition to being compatible with the national legal framework, from the Constitution to sub-constitutional legislation and recent jurisprudence, represent a practical response to the judicialization of health and the growing budgetary pressure on the SUS (Brazilian Public Health System). By linking payment to real clinical results, the RSAs promote efficiency, transparency, and security in public spending, without renouncing the essential core of the fundamental right to health.
The challenge now is to transform isolated experiences, such as those of Spinraza and Zolgensma, into structured public policy, with clear clinical protocols, data monitoring compliant with the LGPD (Brazilian General Data Protection Law), and robust institutional governance. In this way, Brazil can consolidate a model for access to innovation that is sustainable, fair, and truly value-oriented in healthcare.
REFERENCES
BRAZIL. Constitution of the Federative Republic of Brazil of 1988. Brasília, DF: Federal Senate, 1988.
BRAZIL. Law No. 8.080, of September 19, 1990. Provides for the conditions for the promotion, protection and recovery of health, and the organization and operation of the corresponding services. Official Gazette of the Union, Brasília, DF, September 20, 1990.
BRAZIL. Law No. 12.401, of April 28, 2011. Amends Law No. 8.080, of September 19, 1990, to provide for therapeutic assistance and the incorporation of health technology within the scope of the SUS (Unified Health System). Official Gazette of the Union, Brasília, DF, April 29, 2011.
BRAZIL. Decree No. 7.646, of December 21, 2011. Provides for the National Commission for the Incorporation of Technologies in the Unified Health System – CONITEC. Official Gazette of the Union, Brasília, DF, Dec. 22, 2011.
BRAZIL. Law No. 13.709, of August 14, 2018. General Law on the Protection of Personal Data (LGPD). Official Gazette of the Union, Brasília, DF, August 15, 2018.
BRAZIL. Law No. 14.133, of April 1, 2021. Law on Bidding and Administrative Contracts. Official Gazette of the Union, Brasília, DF, April 1, 2021.
BRAZIL. Supreme Federal Court. Extraordinary Appeal No. 657.718/MG. Rapporteur: Justice Marco Aurélio. Full Court. Decided on May 22, 2019. General Repercussion Theme 500.
BRAZIL. Supreme Federal Court. Extraordinary Appeal No. 855.178/SE. Rapporteur: Justice Luiz Fux. Full Court. Decided on May 23, 2019. General Repercussion Theme 793.
BRAZIL. Supreme Federal Court. Binding Precedent No. 61. Establishes the requirements for the provision of medicines not included in the SUS (Brazilian Public Health System). Approved on October 3, 2024.
BRAZIL. Superior Court of Justice. Special Appeal No. 1.657.156/RJ. Rapporteur: Justice Benedito Gonçalves. First Panel. Decided on September 26, 2017.
BRAZIL. Ministry of Health. Ordinance GM/MS No. 1.297, of June 12, 2019. Establishes a pilot project for a Risk Sharing Agreement (ACR) for the drug nusinersen (Spinraza®). Official Gazette of the Union, Brasília, DF, June 13, 2019.
BRAZIL. Ministry of Health; CONITEC. Agreement will enable the offering of Zolgensma® gene therapy for patients with SMA in the SUS. Brasília, DF, March 31, 2025. Available at: https://www.gov.br/saude/pt-br/assuntos/noticias/2025/marco/acordo-vai-viabilizar-oferta-do-zolgensma-para-pacientes-com-ame-no-sus.
Organisation for Economic Co-operation and Development (OECD). Pharmaceutical Innovation and Access to Medicines. Paris: OECD Publishing, 2021.
