Social Participation to Ensure Pharmaceutical Services in Brazil

Abstract

The National Pharmaceutical Policy (PNAF) is consolidated through historical and regulatory milestones that ensured its inclusion in the government agenda. Using Kingdon’s multiple streams model, this study describes how Health Conferences, Laws No. 8,080 and No. 8,142 of 1990, the National Medicines Policy, and the First National Conference on Medicines and Pharmaceutical Services led to PNAF’s approval by the National Health Council (CNS). The study conducts a documentary analysis of the proposals approved at the 17^th National Health Conference, identifying the PNAF’s strategic lines, emphasizing social participation. The multiple streams model is used to correlate decisions and issues identified throughout the policy formulation process, highlighting how the PNAF was structured and the influences of civil society. The sustainability of pharmaceutical services in the Unified Health System (SUS) stems from effective social participation, and CNS is the key body for this achievement, ensuring the continuity of pharmaceutical services as a public policy. The approved proposals reflect the commitment to the universalization and improvement of access to essential medicines, which are vital for the health of Brazilians.

Key words:
National Pharmaceutical Policy; Health Conferences; Social participation; Unified Health System

Resumo

A Política Nacional de Assistência Farmacêutica (PNAF) é consolidada por marcos históricos e normativos que garantiram sua inclusão na agenda governamental. Sob a perspectiva do modelo de múltiplos fluxos de Kingdon, este estudo descreve como as Conferências de Saúde, as Leis 8.080 e 8.142 de 1990, a Política Nacional de Medicamentos e a 1ª Conferência Nacional de Medicamentos e Assistência Farmacêutica convergiram para a aprovação da PNAF pelo Conselho Nacional de Saúde (CNS). O estudo realiza uma análise documental das propostas aprovadas na 17ª Conferência Nacional de Saúde, identificando os eixos estratégicos da PNAF com ênfase na participação social. O modelo de múltiplos fluxos é utilizado para correlacionar as decisões e problemas identificados ao longo da formulação da política, destacando como a PNAF foi estruturada e as influências do controle social. A sustentabilidade da Assistência Farmacêutica (AF) no Sistema Único de Saúde (SUS) resulta da participação social, sendo o CNS a instância para essa conquista, garantindo a continuidade da AF como política pública. As propostas aprovadas refletem o comprometimento com a universalização e a melhoria do acesso a medicamentos essenciais, fundamentais para a saúde da população brasileira.

Palavras-chave:
Política Nacional de Assistência Farmacêutica; Conferências de Saúde; Participação social; Sistema Único de Saúde

Resumen

La Política Nacional de Asistencia Farmacéutica (PNAF) se consolida a través de hitos históricos y normativos que garantizaron su inclusión en la agenda gubernamental. Desde la perspectiva del modelo de flujos múltiples de Kingdon, este estudio describe cómo las Conferencias de Salud, las Leyes nº 8.080 y 8.142 de 1990, la Política Nacional de Medicamentos y la 1ª Conferencia Nacional de Medicamentos y Asistencia Farmacéutica convergieron para la aprobación de la PNAF por el Consejo Nacional de Salud (CNS). El estudio realiza un análisis documental de las propuestas discutidas en la 17ª Conferencia Nacional de Salud, identificando los ejes estratégicos de la PNAF con énfasis en la participación social. Se utiliza el modelo de flujos múltiples para correlacionar decisiones y problemas identificados a lo largo del proceso de formulación de políticas. La sostenibilidad de los servicios farmacéuticos en el Sistema Único de Salud (SUS) es el resultado de la participación social, con el CNS siendo clave para garantizar la continuidad de la atención farmacéutica como política pública. Las propuestas aprobadas reflejan el compromiso con el acceso a medicamentos esenciales, vitales para la salud de la población.

Palabras clave:
Política Nacional de Asistencia Farmacéutica; Conferencias de Salud; Participación social; Sistema Único de Salud

Introduction

Health is a social right guaranteed by the State, as stipulated in Article 196 of the 1988 Federal Constitution¹. In this context, Pharmaceutical Services (PS) are part of the Unified Health System (SUS) and form one of the organizational bases of public health policies. Understanding their trajectory within the SUS requires revisiting the main legal and regulatory milestones that propelled their institutionalization.

This study aims to analyze the consolidation of the National Pharmaceutical Policy (PNAF) based on the current agenda for debate on pharmaceutical services (PS) through social participation, which materialized in the deliberations on the subject at the 17^th National Health Conference held in 2023. The contribution of this study, within the framework of the PNAF’s 20^th anniversary, lies in the coordination between the strategic lines of this policy, the Conference’s deliberations, and John Kingdon’s multiple streams model, adopted as a methodological reference.

Historical and regulatory milestones

The Brazilian PS trajectory is marked by important historical and normative milestones that shaped public health policy in the country. This trend started in 1971 with the creation of the Medicines Center (CEME), which aimed to guarantee low-income people’s access to medicines, focusing primarily on the purchase and distribution of medicines². However, CEME was dissolved in 1997, and the responsibilities related to pharmaceutical services were transferred to different bodies and areas of the Ministry of Health³.

The 1988 Federal Constitution was a milestone for Brazilian Public Health, declaring health as a right of all and a duty of the State, implemented by Law No. 8,080/1990, establishing SUS principles and guidelines and including pharmaceutical services as a recognized right within this new policy.

This law established that PS should be comprehensive and universal, guaranteeing that all citizens have access to the necessary medicines for the promotion, protection, and recovery of health⁴.

The landscape of Brazilian Public Health has changed since the establishment of the National Health Council (CNS) in 1937⁵. While Decree No. 35,347/1954⁶ limited the CNS to being merely an advisory body to the Ministry of Health, Law No. 8,142/1990, which complements Law N°8.080, expanded the attributions of social participation and the importance of health councils in the construction and implementation of health policies. Law No. 8,142/1990 establishes social participation as a SUS guideline, guaranteeing community participation in decisions about the health policy. This Law establishes the Health Conference and the Health Council as collegiate bodies for social participation in each government sphere⁷.

The Health Conference, with representation from the society’s diversity, proposes guidelines for the formulation of health policy at the corresponding levels. The Health Council, composed equally of representatives of users, health professionals, service providers, and government, formulates strategies and is in control of the implementation of health policy at the corresponding level, whose decisions, according to Law No. 8,142/1990, “will be ratified by the head of the legally constituted power in each government sphere”⁷. Thus, the regulations establish Social Participation and PS as structuring fields of the SUS, reinforcing the right to health and consolidating the mechanisms for social participation and democratic management of the SUS, including PS.

The Ministry of Health advanced the discussion of PS with Ordinance No. 3,916/1998, which approved the National Medicines Policy (PNM). The PNM aimed to guarantee the necessary safety, efficacy, and quality of products, promote the rational use of medicines, coordinate pharmaceutical services with other health services, and ensure access for the population to those considered essential⁸.

In Rech’s view⁹, Health Conferences are crucial for consolidating public health policies that meet the interests and needs of the population. They are one of the most important spaces for dialogue within civil society for the construction of SUS public policies. The proposals approved in these participatory democracy venues guide the implementation of health policies for the coming years.

It is common to hold Thematic Conferences, which are usually proposals originating from the National Health Conferences. In the case of Pharmaceutical Services (PS), the need for a Thematic Conference on this topic originated from proposals from the 9^th, 10^th, and 11^th National Health Conferences, held in 1992, 1996, and 2000, respectively. These Conferences contributed to the holding of the First National Conference on Medicines and Pharmaceutical Services (CNMAF)¹⁰.

As pointed out by Leite et al.¹¹, the First CNMAF was a space for the collective construction of guidelines for PS, in addition to promoting the social understanding that the agendas are not exclusively academic, but demand the participation and contribution of society, since it involves people who influence as endogenous factors for the maintenance and strengthening of public health policy.

The guidelines and proposals approved at the First CNMAF provided input for the standardization of government actions in PS, culminating in the PNAF in 2004, approved through CNS Resolution No. 338/2004¹².

The PNAF established a regulatory framework that ensured the continuity and expansion of access to medicines, reaffirming SUS commitment to guaranteeing universal and quality public health.

According to Cruz¹³, four principal players were involved in the creation of the PNAF. In universities, studies on national medicine production and the health industry’s economic complex strengthened the agenda of national sovereignty. Among professionals, the engagement of pharmacists through unions, associations, and pharmacy councils helped to place access to medicines on the political agenda. In the legislature, the Parliamentary Commission of Inquiry (CPI) on Medicines (1999-2000) brought the topic to the center of debates.

In social participation, PS became widely discussed, becoming relevant for the creation of a health policy. Throughout this process of building PS as a governmental agenda, up to the decision to approve the PNAF, social participation played a leading role in consolidating and updating this agenda.

Methods

To achieve the objective of this study, a documentary analysis was conducted on the PNAF’s text¹¹ and CNS Resolution No. 719/2023¹⁴, which provides for the proposals approved at the 17^th National Health Conference held in Brasília from July 2 to 5, 2023.

As a methodological framework, we adopted the multiple streams model developed by John Kingdon¹⁵, which seeks to understand how governments establish public policy agendas and why specific problems gain visibility to the point of becoming policies. Kingdon argues that the government agenda consists of a set of issues that require the attention of public managers, but only some are prioritized.

To explain how specific issues gain centrality in the decision-making agenda, the model proposes the existence of three streams: the problem stream, the solution (or alternative) stream, and the political stream (Figure 1). The convergence of these streams opens a “window of opportunity” for formulating public policies.

Figure 1
Representation of Kingdon’s multiple streams model.

The document analysis was conducted by reading the PNAF, where its strategic lines were identified, and by reading CNS Resolution No. 719/2023¹⁴, to identify the proposals developed and voted on by the council members during the national stage of the 17^th National Health Conference. After this identification, a correlation was made between the PNAF’s lines and the approved proposals to analyze which lines were discussed and addressed at the Conference and how social participation has guided their continued presence on the agenda.

Thus, this work aims to understand the relationship between the PNAF and the deliberations of the 17^th Health Conference, using the multiple streams model as a basis and considering participatory democracy in health.

Results and discussion

The PNAF establishes strategic axes for the organization, structuring, and management of pharmaceutical services at all healthcare levels, aiming to ensure the availability, accessibility, quality, and rational use of medicines¹². Chart 1 presents the PNAF lines that will be studied in this work.

Chart 1
PNAF’s lines.

Key pillars of the National Pharmaceutical Policy
I - Ensuring access to and equity in healthcare services necessarily includes pharmaceutical services;
II - Keeping pharmaceutical services within the public health network, across different care levels, considering the necessary coordination and adherence to regional priorities defined by the SUS management bodies;
III - Improving existing pharmaceutical services, in coordination with state and municipal managers, at different care levels;
IV - Decentralizing actions, with the definition of responsibilities for the different management levels, in a negotiated manner and aiming to overcome fragmented, uncoordinated programs;
V - Developing, appreciating, training, retaining, and building the capacity of human resources;
VI - Modernizing and expanding the installed and production capacity of Official Pharmaceutical Laboratories to supply the SUS and fulfill their role as cost and quality benchmarks in drug production, including the production of herbal medicines;
VII - Adopting the National List of Essential Medicines (RENAME), updated periodically, as a tool for streamlining actions within the pharmaceutical services;
VIII - Agreeing on intersectoral actions to internalize and develop technologies that meet the needs for products and services of the SUS at different care levels;
IX - Implementing intersectorally, particularly with the Ministry of Science and Technology, a public policy for scientific and technological development involving Brazilian research centers and universities to develop technological innovations that meet national interests and the needs and priorities of the SUS;
X - Defining and agreeing on intersectoral actions to adopt medicinal plants and herbal medicines in the healthcare process, respecting incorporated traditional knowledge, based on scientific evidence, adopting policies to generate employment and income, training and retaining producers, involving health workers in the process of incorporating this therapeutic option, and based on incentives for national production, using the biodiversity available in the country;
XI - Developing a Health Surveillance Policy that guarantees people's access to safe, effective, and high-quality services and products;
XII - Establishing appropriate mechanisms for regulating and monitoring the market for strategic health supplies and products, including medicines;
XIII - Promoting the rational use of medicines through actions that regulate prescription, dispensing, and consumption.

• Source: Authors, based on CNS Resolution nº 338/2004¹².

Based on CNS Resolution No. 719/2023¹⁴, we identified that 58 of the 981 proposals voted on by 3,526 delegates at the national stage of the 17^th National Health Conference were about PS, as shown in Table 1.

Table 1
Number of proposals related to Pharmaceutical Services approved at the 17^th National Health Conference, by thematic area. Brazil, 2023.

Thematic area	Number of proposals
1. The Brazil we have, the Brazil we want.	15
2. The role of social control and social movements.	9
3. To guarantee rights and defend the SUS, life, and democracy.	19
4. Tomorrow will be another day for everyone.	15
Total	58

• Source: Authors, based on CNS Resolution nº 719/2023¹⁴.

In the proposals presented at the 17^th National Health Conference within the framework of Line 1, entitled “The Brazil we have, the Brazil we want”, a wide range of themes related to Science, Technology, and Pharmaceutical Services (PS) can be observed, seeking to implement actions aimed at improving access to services, with comprehensive actions, and working on the compulsory licensing of supplies, medicines, vaccines, and other health technologies. These proposals are directly related to strategic Line I of the PNAF. We note an alignment between this PNAF line and the proposals of the Conference, which emphasize the need to make pharmaceutical services more accessible and comprehensive. There was a proposal on compulsory licensing of inputs, medicines, vaccines, and other health technologies, which converges with the PNAF’s strategic lines VI, VIII, and IX. Compulsory licensing, or “patent breaking”, is a legitimate measure to foster technological innovation and guarantee universal access to technologies. Melecchi et al.¹⁸ emphasize the importance of placing this issue on the government agenda so that, in pandemic times, the collective right to the defense of life prevails over intellectual property interests, ensuring that the products resulting from scientific advances are universally and freely accessible. The CNS aligns with the PNAF and continues to seek ways for Brazil to be sovereign in the production of medicines and other health technologies for the population. Examples of this include CNS Resolutions No. 52/2005¹⁹ and 7/2017²⁰, which required the compulsory licensing of the drugs efavirenz, lopinavir, tenofovir, and sofosbuvir; CNS Recommendation No. 067/2020²¹ to guarantee access to vaccination during the COVID-19 pandemic; CNS Recommendation No 013/2021²² and CNS Technical Opinion No. 030/2021²³ in support of compulsory licensing for technologies related to combating COVID-19.

In the analysis of Line 2, themed “The Role of Social Participation and Social Movements in Preserving Lives”, the discussion focuses on the importance of social participation in guaranteeing access to medicines and health technologies. The proposals within this line highlight the need to develop leaders who can advocate for the advancement of science, public policies, national sovereignty, and social participation in health. The approved proposals identified in Line 2 converge with the PNAF’s strategic lines V, X, and XI. Since the PNAF is a policy that was built and created by the social participation body of the SUS, the proposals from Line 2 of the 17^th National Health Conference ensure the full development of this policy with the involvement of all segments that make up the CNS. An example that shows this continuity is the Integra Project. Integra emerged in 2021 from the joint work between the Health Surveillance Committees (CIVS) and the Science, Technology and Pharmaceutical Services Committees (CICTAF) of the CNS, resulting in the realization of the Project for the Integration of Science, Technology and Innovation Policies in Health, Pharmaceutical Services, and Health Surveillance, based on the needs identified by the social participation in health²⁴. The project addresses the relevance of continuous training and the active participation of people to expand access to health, through educational strategies, public debates, and the production of educational materials²⁵.

Lines 3, themed “Guaranteeing Rights and Defending the SUS, Life, and Democracy”, presents proposals that reflect the need to improve PS, expanding human and financial resources, investment in technology and innovation, and positioning the pharmacist as an essential stakeholder in the health service. The main PNAF’s lines that show the most significant relationship with the proposals of Line 3 are lines II, V, VI, VIII, IX, and X.

Melecchi et al.²⁶ understand that in light of technological innovations and recent updates to legislation involving personal data policy, such as the General Data Protection Law (LGPD), society should be assured that the Government will review and update its technologies to improve services.

Pharmaceutical services cannot be left out of this context. However, despite advances in legislation and the health industrial economic complex on the government’s agenda, Bermudez et al.²⁷ identified that the production of medicines by Official Laboratories has progressed little, indicating a limited capacity to respond to the PS vulnerabilities in the SUS. The debate on the local production of technologies is constantly on the agenda at CICTAF/CNS, generating recent Recommendations on the subject, such as CNS Recommendations No. 027/2020, 042/2020, 013/2021, and 036/2021^22,28-30.

In June 2024, at a meeting of the Executive Group of the Health Economic-Industrial Complex (GECEIS), National Health Councilor Ana Lúcia Paduello emphasized that this topic was widely debated at the 17^th National Health Conference, which reflects the relevance of the topic for social participation.

This topic, for us users, represents a significant addition because it is about guaranteeing that we will have equal and quality access (to health services). It is necessary to bring innovation with respect to issues of race and gender, involving users and workers, together with researchers and investors, to achieve our sole objective: to deliver health care in the SUS with quality, effectiveness, and safety³¹.

The proposals of Line 4 of the 17^th National Health Conference, entitled “Tomorrow will be another day for everyone”, encompass timely themes for PS, including guaranteeing access to essential medicines, promoting rational use, strengthening the PNAF from the perspective of integration with other health policies, social participation in drug pricing policy, defending the national production of immunobiologicals, and research with medicinal plants for the incorporation of herbal medicines into the SUS. The PNAF’s lines I, V, VI, VII, VIII, X, XII, and XIII are related to the proposals approved in Line 4 of the Conference. Notably, Line 4 proposals are interconnected with the proposals of the lines already discussed. We should underscore the proposals that were not highlighted in the lines already discussed, especially those addressing the National List of Essential Medicines (RENAME), the Chamber for the Regulation of the Medicines Market (CMED), and research with herbal medicines.

The National List of Essential Medicines (RENAME) guides the selection and rational use of medicines, ensuring that the population has access to medicines for the treatment of the most prevalent diseases in Brazil³². The proposals approved in Line 4 of the Conference corroborate what Nascimento Júnior et al.³³ present in their analyses, highlighting the need to keep RENAME constantly updated in order to consider scientific advances, the incorporation of new technologies, as well as the review of technologies already included in the list to exclude or change them if necessary.

CMED is responsible for defining criteria and limits for drug prices in the country, based on technical parameters and public interest. Its actions seek to balance the population’s access to medicines by defining maximum prices for commercialization, regulating periodic readjustments, and monitoring the dynamics of the pharmaceutical market³⁴. A proposal in Line 4 underscores the inclusion of social participation in health in CMED, to guarantee the transparency of the regulatory process, providing fairer prices for the Government and the population.

Bermudez³⁵ criticizes the dispute between social and market interests, represented by the dichotomy between health and commerce, highlighting the country’s socioeconomic vulnerabilities and commercial interests in the context of pharmaceutical market regulation. This fact shows how the pharmaceutical industry lobby, in collaboration with legislative and executive powers, disregards the social determinants of the Brazilian people.

Regarding herbal medicines, research with these medications promotes the use of medicinal plants, the biological and cultural diversity of the country, and expands therapeutic alternatives within the SUS. Strengthening and encouraging research and development of herbal medicines, and consequently incorporating these products into the RENAME values traditional knowledge and Brazilian biodiversity, expanding therapeutic alternatives for the SUS. This strategy is economically viable, allows for greater autonomy for the country in the production of medicines, and guarantees our sovereignty³⁶.

Besides the 17^th National Health Conference, in November 2022 and December 2023, we had the Sixth National Indigenous Health Conference and the Fifth National Mental Health Conference, respectively. These conferences discussed the National Policies on Medicinal Plants and Phytotherapeutic Products and on Integrative and Complementary Health Practices, generating resolutions that consolidate PS as a public policy duly integrated into the practice of SUS health care services³⁷.

The decision to include PS on the government agenda reflected the social mobilization process continuity, strengthened by the 9^th, 10^th, and 11^th Health Conferences and the First CNMAF^10,38-40. These events emphasized the need to improve PS as a public policy and a social right, as expressed in Law No. 8,080/1990⁴. In this context, we can affirm that social participation ensured that PS held a prominent place on the public health agenda in the country. This situation can be better understood from the perspective of Kingdon’s multiple streams model, in which the process of building and consolidating the PNAF occurred through the window of opportunity created by the First CNMAF. This conference was a point of convergence for the three streams (problems, solutions, and political), enabling the inclusion of PS in the government agenda in a strategic and consolidated way.

Studies such as those by Nagem and Silva⁴¹, Capella⁴², Abreu et al.⁴³, Czermainski⁴⁴, Gomide⁴⁵, Monteiro⁴⁶, and Machado⁴⁷ were highlighted by Metten et al.¹⁷ and Gottems et al.¹⁶ as they applied Kingdon’s model to the analysis of Brazilian public policies. This literature supports the choice of the model as a tool to correlate the PNAF’s strategic lines with the deliberations of the 17^th National Health Conference, allowing an analysis of how social participation influences the permanence of PS on the government agenda.

Analyzing the flow of problems, we should include the responsibility of society in identifying health problems, since SUS users are living daily under the social determinants of health. Health problems are constituted and influenced by social determinants such as poverty, low schooling level, inadequate housing environments, and unemployment; all these are situations that hinder access to health services, including pharmaceutical services. Social and epidemiological indicators describe the problems found in the health sector that influence the formation of the government agenda^16,17.

These problems reveal and exacerbate the fragility when governments do not prioritize essential social rights. The consolidation of a public health policy, in this case the PNAF, attempts to reduce these inequities. This situation shows that health has a broad conception as an inducer of people’s quality of life in all aspects.

Thus, in the flow of solutions or alternatives to address the PS-related problems in the country, the construction of a public policy that aims to reduce inequalities and allow the participation of all stakeholders are acceptable, compatible, and budgetarily viable proposals that increase society’s confidence in the State to consolidate the SUS principles and guidelines¹⁶.

Despite the efforts of social movements, the creation of a public policy focused on PS needed the commitment of the Federal Government to be included in its priority agenda. Kingdon¹⁵ cites three elements considered for the political flow: the national climate, organized political forces, and changes in government.

The favorable national context for consolidating the PS agenda within the SUS was driven by the country’s redemocratization and the Brazilian health reform, which strengthened the participation of civil society in governmental decision-making and consolidated health as a citizen’s right. The change in the federal government from 2003 onwards, with the implementation of a government plan more open to social participation⁴⁸, culminated in the holding of the First CNMAF. This conference represented a great window of opportunity for consolidating the PS agenda within the SUS.

The analysis of the proposals approved at the 17^th National Health Conference, based on Kingdon’s multiple streams model, shows the coordination between social demands, viable alternatives, and a political context favorable to the consolidation of PS as a public policy. The stream of problems appears in the deliberations that address difficulties in accessing medicines, judicialization, and weaknesses in the structuring of services. The flow of alternatives is found in proposals to strengthen public production, the update of the National List of Essential Medicines (RENAME), and in economic regulation. The political flow is manifested in the Conference’s deliberations, which value social participation as an expression of participatory democracy. The convergence of these flows, according to Kingdon’s model, indicates favorable conditions for the PNAF to remain on the government agenda, reaffirming the leading role of social participation in the process of formulating, implementing, and evaluating public policies, such as the PNAF.

Final considerations

This study aimed to analyze the consolidation of the PNAF based on the current agenda of debate on PS through social participation, reflected in the deliberations of the 17^th National Health Conference held in 2023. From the perspective of social participation, these points were related to John Kingdon’s multiple streams model, in order to obtain a comprehensive view of the PNAF consolidation process and the role of society in this process.

Adopting the multiple streams theory, we understood that the construction and consolidation of the PNAF occurred through the window of opportunity opened by health conferences, especially the First CNMAF. This conference was a point of convergence of the three streams (problems, solutions, and political), allowing the permanent inclusion of PS on the governmental agenda.

The analysis of the deliberations of the 17^th National Health Conference revealed an alignment with the PNAF’s line, indicating that social participation continues to play a leading role in the agendas related to PS within the SUS, which allows us to affirm that the objective of this work was achieved.

However, notwithstanding this, a deeper analytical focus is needed on the effectiveness of incorporating the conference deliberations into government planning instruments.

References

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• Data availability statement
  The data sources adopted in the research are indicated in the article’s body.

• Chief editors:
  Maria Cecília de Souza Minayo, Romeu Gomes, Antônio Augusto Moura da Silva, Vania de Matos Fonseca

Data availability

The data sources adopted in the research are indicated in the article’s body.

Publication Dates

• Publication in this collection
  30 Jan 2026
• Date of issue
  Jan 2026

History

• Received
  30 Sept 2024
• Accepted
  11 Aug 2025
• Published
  13 Aug 2025