Health Councils and Pharmaceutical Policy: Challenges and prospects for social participation in Brazil

Abstract

The National Pharmaceutical Policy (PNAF) originated from social participation, making its role in monitoring and addressing issues related to this policy essential. In this context, this article aims to identify and analyze how the Pharmaceutical Policy (PP) (considering access to medicines and pharmaceutical services) have been addressed and discussed in the Brazilian Health Councils from 2019 to 2021. It was conducted a quantitative and qualitative documentary analysis of documents from all the states (including the Federal District) and municipal councils in the Brazilian capitals. It was identified 806 excerpts referencing the PNAF, of which 186 excerpts were included in the thematic analysis. These excerpts were organized into eight analytical categories, indicating that while PP is a contemporary topic in the councils and gained prominence and qualification during the COVID-19 pandemic, there are still gaps in the discussion, particularly regarding service organization. The development of appropriate tools for monitoring and evaluating the PNAF, ongoing training for council members, and investment in dedicated committees are highlighted as key elements for advancing the role of social participation at all health organization levels.

Key words:
Community Participation; Formal Social Control; Pharmaceutical Services; National Pharmaceutical Policy

Resumo

A Política Nacional de Assistência Farmacêutica (PNAF) originou-se do protagonismo do controle social, tornando essencial sua atuação no acompanhamento e encaminhamento de questões relacionadas a essa política. Diante disso, este artigo busca identificar e analisar como a Assistência Farmacêutica (AF) foi pautada e discutida nos conselhos de saúde do Brasil, de 2019 a 2021. Trata-se de uma análise documental com abordagem quantitativa e qualitativa de documentos dos conselhos estaduais (incluindo o Distrito Federal) e municipais das capitais brasileiras. Foram identificados 806 trechos em documentos que faziam referência à PNAF. Destes, 186 trechos de atas foram incluídos na análise temática. Os trechos foram organizados em 8 categorias analíticas, indicando que, embora a AF seja um tema presente nos conselhos e tenha ganhado destaque e qualificação durante a pandemia de COVID-19, ainda existem lacunas na discussão, especialmente em relação à organização dos serviços. O desenvolvimento de ferramentas adequadas para o monitoramento e avaliação da PNAF, a constante formação dos conselheiros e o investimento em comissões dedicadas à pauta são elementos apontados para o avanço da atuação do controle social em todos os níveis de gestão.

Palavras-chave:
Participação da Comunidade; Controle Social Formal; Assistência Farmacêutica; Política Nacional de Assistência Farmacêutica

Resumen

La Política Nacional de Servicios Farmacéuticos (PNAF) surgió del control social, lo que hace esencial su papel en el seguimiento y la resolución de sus problemas. Así, este artículo tiene como objetivo identificar y analizar cómo el tema ha sido abordado y discutido en los consejos de salud brasileños de 2019 a 2021. Para ello, se realizó un análisis documental, utilizando enfoques cuantitativos y cualitativos, de documentos de todos los consejos estatales (incluido el Distrito Federal) y municipales de las capitales brasileñas. Se identificaron un total de 806 fragmentos que hacían referencia a la PNAF, de los cuales 186 fueron incluidos en el análisis temático. Estos fragmentos se organizaron en ocho categorías analíticas, lo que indica que, si bien la AF es un topico presente en los consejos y ganó prominencia y calificación durante la pandemia de COVID-19, todavía existen lagunas en la discusión, particularmente en lo que respecta a la organización del servicio. El desarrollo de herramientas adecuadas para el monitoreo y la evaluación de la PNAF, la capacitación continua de los miembros del consejo y la inversión en comités dedicados se destacan como elementos clave para el avance del papel del control social en todos los niveles de organización de la salud.

Palabras clave:
Participación comunitaria; Control social formal; Servicios Farmacéuticos; Política Nacional de Servicios Farmacéuticos

Introduction

After a long period of authoritarian governments and curtailment of political participation in Brazilian society, popular participation was established as one of the guidelines of the Unified Health System (SUS) in the 1988 Federal Constitution. Law No. 8,142/1990 establishes the guidelines for community participation in SUS management, indicating the Health Conferences and Councils as social participation bodies. Health Councils are deliberative bodies, present in all government spheres. They act in the definition, implementation, monitoring, and oversight of Health policies in the competent spheres¹.

Popular participation should foster shared responsibility between the State and civil society in the management of public policies, allowing the incorporation of social demands expressed by several collective subjects², toward promoting equity and comprehensive health care. However, some studies point to weaknesses in the influence of Councils and Conferences on public policies^3-6. It is necessary to understand the dynamics of these collegiate spaces to identify the challenges that hinder the whole exercise of social participation and, thus, formulate strategies that help overcome these obstacles and enhance its action^2,3,7,8.

Despite these challenges, Brazil is a world leader in social participation in the Health sector. At the 77^th World Health Assembly, a resolution was approved establishing social participation in health systems⁹, with significant involvement from the Brazilian government and the National Health Council (CNS) in proposing and approving the text. Among other points, the resolution emphasizes that countries must ensure that social participation influences transparent decision-making in health policies.

The origin of the National Pharmaceutical Policy (PNAF) is closely related to social participation. The 9^th National Health Conference, held in 1992, approved in its report the holding of a Conference on Medicines and Pharmaceutical Services, which would aim to discuss and present a proposal for a National Pharmaceutical Policy integrated with SUS principles and as per the National Medicines Policy (PNM). The same recommendation was approved at the 10^th and 11^th National Health Conferences, held in 1996 and 2000, respectively. However, the First National Conference on Medicines and Pharmaceutical Services was only convened in 2003. The Conference was held in September 2003, after the municipal and state stages, and its deliberations were the basis for the approval of CNS Resolution No. 338/2004, which approved the PNAF¹⁰. The PNAF is the first public policy instituted through social participation, with its promulgation by the CNS¹¹.

This policy celebrated its 20^th anniversary in 2024 and is a guiding policy that demands a set of intersectoral actions to ensure the right of access to medicines and their proper use¹⁰. In a backdrop of capitalist organization of the production and distribution of health products, which generates several distortions and irrationalities in the patterns of access to medicines, such as patents, exorbitant prices, technological dependence of the country and discontinuation of the production of certain medicines¹¹, social participation is crucial to foster national development strategies for the sector, identify problems in access to medicines, propose improvements in services and ensure continuous and quality access to pharmaceutical services. To fulfill its function, social participation needs to take ownership of these themes, internalize such debates, constantly monitor the reality experienced by the population, the direction and investments of public policies, to ensure that the interests of public health prevail, guaranteeing fair and equitable access to medicines for the population.

The COVID-19 pandemic (2019-2022) reinforced the importance of popular participation in defending health systems and science in guiding public policies¹². It also highlighted the importance of access to and national production of health technologies, such as medicines and vaccines. In this context, the Integra Project¹³ emerged, a partnership between the National Health Council (CNS), the National School of Pharmacists Institute, and the Oswaldo Cruz Foundation, with support from the Pan American Health Organization (PAHO), aiming to strengthen social participation and engagement in the topic and promote the integration of health policies and practices with community participation.

This study stems from the actions developed by the Integra Project. It aims to identify and analyze how the pharmaceutical policy were addressed and discussed in the Brazilian Health Councils from 2019 to 2021, considering access to medicines and pharmaceutical services, in order to support the development of strategies to strengthen and expand social participation within the PNAF.

Methods

This descriptive, quantitative, and qualitative documentary analysis study encompassed documents published by state Health Councils and Municipal Councils of Brazilian capitals from 2019 to 2021. Data were collected from July to November 2021 on the official websites and social media of the Health Councils by ten trained researchers with social participation knowledge. When official websites and social media were not found, the researchers contacted the council’s advisory service through the channels provided by the CNS. If this contact was ineffective, direct contact was sought with the Board of Directors or partner councilors. A sample loss was considered only after exhausting these attempts.

Data were collected through online Google Forms for categorization and extraction. In the first stage, a form was used to extract data on access to documents and the operational dynamics of the councils. The questions addressed the identification of the council, official communication channels, existence and characteristics of specific committees, regularity and composition of these committees, location of documents (minutes, resolutions, recommendations, and motions), and documents from the last Health Conference.

In the second stage, a new form was used to catalog and attach the documents systematically, collecting the following information: identification of the Council, identified policy (PNAF, National Health Surveillance Policy or National Policy on Science, Technology and Innovation in Health), document title and date, document type (minutes, motion, opinion, report, health plan, resolution, recommendation, others), approval by management, number of pages, and access method (official means or contact with the Executive Secretariat/Council members).

After identifying the documents, a third form was applied to examine their content and organize them by section, as per specific keywords defined by a group of experts. The following keywords were used: pharmaceutical services, pharmacist, pharmacy, medicines, remedy, medication, technology incorporation, innovation, input, medical-hospital material, and research and development. From the sections related to the PNAF, only sections referring to minutes and containing content on Pharmaceutical policy as a specific agenda item were selected for thematic analysis. Documents that addressed the topic only in the reports section, without leading to a debate on the subject, were excluded.

Reflexivity is central in qualitative research. It involves critical self-reflection at all stages of the study to recognize personal, social, and cultural influences. This process promotes a more conscious, ethical, and transparent analysis, enriching data interpretation and the discussion about social participation in Health Councils¹⁴. Two researchers repeatedly reviewed selected excerpts to obtain a holistic understanding of the data, both manifest and latent, as proposed by Pope et al.¹⁵. Preliminary codes were assigned to these excerpts, and information was extracted regarding the agenda item’s name, a summary of the discussion described in the minutes, the actions taken, and what was approved by the plenary session concerning the analyzed agenda item. A compilation was made after this preliminary analysis, and analytical categories (inductive analyses) were developed to facilitate data analysis and organization.

Notably, the researchers who conducted the qualitative analysis are experienced in matters related to pharmaceutical services and social participation, possessing both theoretical and practical experience in these areas. The qualitative analysis was conducted in several stages, and the researchers met and discussed frequently throughout the process, debating codes, inclusions, and exclusions of excerpts. Between each stage, the analyzed excerpts were shared among the researchers so that one could review the previous analysis of the other researcher. These aspects aim to harmonize the analysis and improve its quality.

According to CNS Resolution No. 510/2016, the research did not need to be registered or evaluated by the Research Ethics Committee (CEP) (CEP/CONEP system), since it used publicly available information.

Results and discussion

The research successfully retrieved documents of interest from 24 state Councils and 17 Municipal Councils in Brazilian capitals. The most frequently used means of communication for obtaining the documents were websites, email, Facebook, and telephone. Notably, 85.7% of the located documents were available without intermediaries, i.e., in open digital access. The remainder were obtained with the assistance of the Council’s organizational structure (13.7%), mainly through the Executive Secretariat, or with the support of Health Council members (0.6%). Although access to public materials was high, the unavailability of all documents compromises the principles of transparency in public management.

The research resulted in a total of 2,559 documents, totaling 21,166 pages, with the most frequent document types being resolutions (39%) and minutes of plenary meetings (35%). It is noteworthy that 41.7% of the researched documents were approved, either through ordinances (8.2%) or published in the Official Gazette (33.5%), and that it was impossible to locate the resolutions of the last Health Conference in 53% of the researched Councils.

These documents were categorized into 2,046 excerpts covering themes related to the PNAF, the Science, Technology, and Innovation in Health (S&TI) Policy, and the Health Surveillance Policy, sometimes encompassing more than one policy. Of these, 806 excerpts referred to the PNAF in isolation or in conjunction with the other policies, and the most frequent document types were plenary session minutes (65.6%), other (15.5%), resolutions (11.2%), document from the last Health Conference (5.9%), recommendations (1.5%), and motions (0.4%). This research will analyze the excerpts from the plenary session minutes to understand better the dynamics of the discussion of the subject in the Council.

Council structures - advisory committees

The committees advise the Board of Directors and the Council’s Plenary, providing input for deliberations on the formulation and control of Public Health policies. Five of the 41 councils analyzed have a specific Pharmaceutical policy committee, eight have a specific Health Surveillance committee, and one has a specific Science & Technology committee. In addition, two councils have unified committees that address both Pharmaceutical policy and Health Surveillance. However, these policies are also addressed in other existing committees within the Councils’ structure, as identified in six Councils in the case of Pharmaceutical policy, in seven in the case of Health Surveillance, and in four in the case of Science & Technology.

Thematic analysis of documents from state and Municipal Health Councils related to Pharmaceutical policy

One hundred eighty-six of the 529 excerpts from minutes related to the PNAF were analyzed. The others were excluded because they were not agenda items, did not specifically address Pharmaceutical policy, or, less frequently, due to the impossibility of locating the complete source document. Seventy-eight of these excerpts included in the analysis were from 2019, 76 from 2020, and 34 from 2021. After compilation, eight analytical categories were defined, with each excerpt being assigned to only one category, according to the predominant subject. Chart 1 shows the categorization of these excerpts extracted from the documents of state and municipal Health Councils related to Pharmaceutical policy.

Chart 1
Name, description, and number of excerpts by category of the analysis of the minutes of the state and municipal health councils (2019-2021).

Analytical category	What the categories address	Nº of excerpts
Access to medicines and supplies in the SUS	They address important issues regarding the judicialization, standardization, and distribution of medicines and supplies. Discussions focus on the impact of the high cost of lawsuits, the time required for medicine registration, shortages, and the lack of cancer treatments, as well as care strategies for chronic diseases and progress in access to medicines for people with HIV/AIDS. They also discuss the benefits of decentralizing medicine distribution and the challenges related to accessibility in pharmacies and the management of medicines for rare and chronic diseases, with suggestions for improvements in pharmaceutical services.	29
Acquisition and shortage of medicines and supplies	They highlight recurring problems of medicine shortages in units managed by health secretariats and in outsourced services. Council members discussed issues such as the lack of pharmaceutical professionals and the challenges of acquiring medicines due to problems with suppliers and bidding processes. There are some clarifications from management regarding acquisition processes, interstate consortia, and efforts to normalize supply. Actions were suggested to improve transparency, the structure of pharmacies, and the creation of commissions to address pharmaceutical services issues more frequently.	34
Pharmaceutical Services Committee or Working Group	They address discussions about the importance of creating or strengthening committees to deal with the complexities of pharmaceutical services, including medicine shortages and litigation. Some councils recognize the importance of creating the committee, but highlight challenges related to the excessive number of committees within the councils and quorum problems at meetings.	6
Financing and management tools of the SUS	They address issues such as reading and approving proposals from state and national conferences, presenting and analyzing the Previous Quarterly Detailed Report (RDQA), the Annual Management Report (RAG), the Multi-Year Plan (PPA), and the Annual Budget Law (LOA). The approval of funds transferred by a state secretariat to municipalities to structure pharmaceutical services is highlighted, as is the concern regarding the oversight of the use of these resources. The council members discuss the creation of committees and working groups to improve the management and execution of established goals. They reveal some mentions of the implementation of indicators and targets, the financing of pharmaceutical services, and a deficit in the payment of the state counterpart, reflecting a historical underfunding.	33
Organization of services and access to medicines and supplies during the COVID-19 pandemic	The discussions focus on conducting rapid COVID-19 tests in pharmacies, managing essential medications and supplies such as sedatives for intubation, the logistics and distribution of vaccines, and training pharmacy professionals. There are also mentions of difficulties in acquiring and distributing medications, including questions about the use of medications without proven efficacy in treatment, such as chloroquine and hydroxychloroquine. Finally, concerns about the transparency of stocks and the management of hospital supplies are highlighted, as well as criticisms of the pandemic response by municipal and state authorities.	45
Health services management	Several issues relate to the administration and management of health units and contracts, including the outsourcing of services and the role of social organizations. There is concern about the lack of transparency in contracts and their impacts, such as problems with medication logistics and the closure of specialized services, directly affecting access to medicines. The actions of social organizations are questioned regarding the purchase of medicines without bidding.	12
Pharmaceutical services	Discussions focus on the role of pharmacists in the SUS, highlighting the reduced number of these professionals in PHC units and hospitals, and concerns about the impact of this shortage on access to medicines and comprehensive care for users, especially in areas such as mental health and chronic diseases. The outsourcing of pharmaceutical services and the management of these units are also central themes, raising concerns about the safety and quality of medicine dispensing. The discussion includes advancements in the PP management services over the years, the expansion of access to medications from the Specialized Component, and the implementation of pharmaceutical care projects.	19
Integrative and Complementary Practices (ICPs)	They primarily highlight the development and implementation of Living Pharmacy Projects, focusing on the production of medicinal plants and herbal remedies. There are concerns about problems in the execution of resources allocated to the projects, the difficulty in acquiring supplies, and the sustainability of the projects. The advisors emphasized the importance of Integrative and Complementary Health Practices (ICPs) as a way to value traditional knowledge.	8

• Source: Authors.

The categories with the highest number of excerpts in the minutes were organization of services and access to medicines and supplies during the COVID-19 pandemic (24.2% of excerpts), acquisition and shortage of medicines and supplies (18.3%), financing and management tools of the SUS (17.7%), and access to medicines and supplies in the SUS (15.6%) (Chart 1). These data indicate that Pharmaceutical policy is a recurring theme in the discussions of Health Councils, highlighting the role of social participation in monitoring and developing the PNAF.

Part of the research was conducted during the COVID-19 pandemic, and it was possible to follow how the Councils acted during this period, which, even with the suspension or reduction of face-to-face meetings, adapted to the use of digital technologies, which became essential tools for the continuity of the councils’ activities¹⁶. The pandemic brought the topic of Pharmaceutical policy and Science and Technology to the forefront, and issues such as the acquisition and production of active pharmaceutical ingredients (APIs), national sovereignty in the production of vaccines and medicines, and the role of the National Health Surveillance Agency (Anvisa) were found in the plenary sessions. Like the CNS, the state and municipal councils studied were very active in defending Science and the SUS, positioning themselves against the use of medicines without evidence, reinforcing the role of social participation in confronting the most significant health crisis experienced to date¹⁶.

Another issue that deserves highlighting is the recognition of commercial pharmacies as service providers during the pandemic, with the performance of rapid COVID-19 tests and the administration of vaccines, and the need to link these services to the health network to promote care and health surveillance (Chart 2). As a result, one acknowledges the need to offer personal protective equipment (PPE) and prioritize vaccines for these workers.

Chart 2
Name and examples of excerpts by category from the analysis of minutes from state and municipal health councils (2019-2021).

Analytical category	Examples of excerpts from state/district councils (CE) or municipal councils (CM)
Access to medicines and supplies in the SUS	Regarding women experiencing homelessness [...] for the subdermal implant, Service X is the one that has the project. However, she points out that the amount is small. Together with the Ministry of Health, she reinforces that they have tried several times to include both Implanon and the Mirena IUD, and they can't - CONITEC always blocks it, not including these methods, which is one of the things she considers fundamental to be in the range of reproductive planning options (CE16). There is a lawsuit asking for the trade name of a medicine, when we are prohibited from bidding with the trade name. [...] She believes that there is a deviation from the judicialization process when a person takes this route to guarantee a right that is not for everyone, but only for her. A right is valid when it is for everyone. When a trick is used so that it only serves me, a problem is created (CE6).
Acquisition and shortage of medicines and supplies	Councilor U2 says she is happy with the presentation [made by management], but has in hand a list of the 28 medicines that are missing. She understands that there is a whole process, but the medicine that has been missing for two or three months, elderly users travel a distance to get there, and have to return. This communication is not happening, and the user is having to buy the medicine (CE11). [...] He adds that last Friday, he and the State Secretary of Health were at the first meeting of the Northeastern Consortium of State Health Secretaries, and that the proposals are quite interesting - to standardize some procedures, such as the issue of acquiring medicines and necessary supplies, expanding the potential for acquisition to obtain better prices and advantageous purchases (CE16).
Pharmaceutical Services Committee or Working Group	Councilor U1 calls on the Council to reactivate the Pharmaceutical Services Committee [...], and says that these situations may be the result of some irresponsibility on the subject, recalling that the committee ceased to exist in 2010. Councilor P1 puts the proposal to reactivate the Pharmaceutical Services Committee to a vote, which is approved with only one abstention (CE20). Councilor P5 recommends that the Municipal Council prioritize Pharmaceutical Services more frequently, with a committee solely to address this demand. He concludes by saying that the lack of medicines is a Public Health issue and, as such, should be addressed. Social Participation is responsible for this process (CM16).
Financing and management tools of the SUS	Councilor G3 says, "I can speak authoritatively about the rural region. However, I can say the following: the process of debt credits for Pharmaceutical Services in the capital and the rural region was handled in different processes [...]. So even though it is less time, the municipalities had already been 4 years without receiving the Pharmaceutical Services' funds from the State. Now, in the last CIB, we approved and are transferring two years at once of these delayed funds [...] (CE4). In Guideline VIII - Qualification of pharmaceutical services, management of the logistics of acquisition, storage, and distribution of health supplies, Councilor P2 said that the mandatory demands and supply of the units served, the medicines for linked programs, and specific, acute, or chronic conditions served. The number of users served in the specialized component of pharmaceutical services left something to be desired when the low financial investments for this guideline were seen (CE2).
Organization of services and access to medicines and supplies during the COVID-19 pandemic	Councilor P1 mentions that in May, shortages of anesthetic and sedative medicines, necessary for intubating patients, began to emerge. [...] Councilor P3 also asks that the government respect science, as it is disrespectful for the federal government to insist on medicines that have not been proven to combat COVID-19 (CE20). People were asked to wait or return a few hours later to pick up some medicines [...] Azithromycin was out of stock at the UPA for a few hours, but this is not a lack of medicines in the city; it was a logistical issue due to increased demand. The demand for this medicine was reviewed, as its use was considered unnecessary for what was being prescribed [for early treatment of COVID-19] (CE11).
Health services management	We know that some Social Organizations (OSS) in our municipality have been receiving money for some time to manage municipal Public Health [...]. The big problem with OSS is that they run rampant, they do what they want, because most managers, when they hire an OSS, are outsourcing the problem because they have difficulty managing people, managing the purchase of supplies, equipment, medicines, and the like, which should follow the rules of the legislation [bidding, public competition] (CM6). [...] He suggested that the conditions under which the operator has to perform the service should be analyzed before implementation. He used as an example a case of the warehouse, in which the medicines spoiled due to the lack of a cold storage chamber (CM23).
Pharmaceutical services	[...] At the time of the visit, we did not have the physical structure and sufficient pharmacists, so we decided that the implementation of the Project would begin at the Pharmacy School of University X, which has an agreement with the SES for the provision of the Specialized Component of Pharmaceutical Services (CE11). [...] Regarding Pharmaceutical Services and Mental Health, some planned actions involve expanding pharmacies, increasing the number of pharmacists, and other management aspects [...] (CM23).
Integrative and Complementary Practices (ICPs)	Councilor P4 reports that the Call for Proposals for the implementation of living pharmacies is open at the Ministry of Health and that this call for proposals occurs annually. In 2013, the Municipal Health Secretariat submitted a project that was approved but has not yet yielded results, and one of the requirements to participate in subsequent calls for proposals is that the project has had results [...]. It also questions why these resources are not being used; consequently, phytotherapy is not progressing in the municipality (CM14). The Local Productive Arrangement Project, known as Living Pharmacy, which produces phytotherapeutic plants, which are medicines made from medicinal plants, is accompanied by manipulation, production, and dispensing. It is an instrument of the SUS of the municipality, and consequently, the sale will be prohibited, as the Health network itself produces it. He also says that it is a project that has been in place since 2014, where there were many difficulties in moving forward, because the inputs are very uncommon, which hinders procurement (CM16).

• Source: Authors

Questions related to access to medicines, especially shortages, predominate in discussions, showing that many issues emerge in response to problems faced daily by health services, after the problem has already been established. Shortages are recognized as a global public health problem and significantly impact the health care of the population¹⁷. Given its multifactorial nature¹⁸, the debate in Health Councils should delve deeper into the discussion on coping strategies, highlighting both the actions already adopted and those that should be implemented by management. However, the analysis of the minutes reveals a tendency for the problem to be merely presented by the Council’s members, with management reporting that it is working to resolve it, without deepening the discussion or proposing concrete solutions that impact not only the situation at hand, but also the reorganization of Pharmaceutical policy and innovative proposals.

We should understand medicines as an integral part of the healthcare process, and not in isolation. Analysis of the minutes reveals the need for better organization of pharmaceutical policy and the availability of pharmacists in healthcare services, including the provision of clinical services. However, this issue is still rarely addressed and requires greater expertise for its strengthening.

Another much-debated topic in Pharmaceutical policy concerns aspects related to its financing, especially in the form of discussions and presentations on Management Reports, Four-month Reports, and other management instruments. Monitoring and approving the accountability process are essential social participation functions. In 2019, medicines represented approximately 10% of the total health budget¹⁹, highlighting the relevance of this item in health expenditures. However, how accountability is currently conducted does not reveal the necessary details of the field, as evidenced in one of the analyzed excerpts, where the CE20 advisor considers that “how data is presented does not help to assess the dimension of pharmaceutical policy”. Often, only the total amounts invested are presented, without specifying the acquisition methods, prices paid, amounts allocated to litigation, the origin of the funds (own funds or from other sources), or even the type of purchase (with or without bidding or consortium). Since this category involves a significant amount of resources, mainly destined for the purchase of medicines and supplies directly from the private pharmaceutical market, it is crucial to improve the monitoring of resource utilization.

Resources allocated to Pharmaceutical policy within the SUS, primarily for the purchase of medicines, have been insufficient to meet the growing demand, especially in municipalities²⁰. Only by understanding the actual funding needs can social participation effectively engage in requesting increased funds and their better use. Therefore, it is vital to improve the accountability of pharmaceutical policy within Health Councils, adopting specific tools and structures that facilitate understanding by Council members, allowing for more effective and participatory monitoring and the proposal of new financing and acquisition forms.

We should underscore the excerpts that revealed discussions about the outsourcing of health services management, including pharmaceutical policy, mainly by Social Health Organizations (OSS). Regarding Pharmaceutical policy, the Council’s members commented on their concern about the procedures for the procurement and management of medicines by these organizations. The expansion of OSS in the management of health units is not recent and has been expanding throughout Brazil. Studies reveal significant financial investments in this service provision²¹. However, further research is needed to determine the effects of this contracting on the management of medicines and the provision of pharmaceutical policy in the SUS.

Notably, some discussions have occurred regarding the incorporation of non-standardized medicines into the SUS. In one case, a Council member submitted a request to incorporate the medication Spinraza® (nusinersen) for the treatment of patients with Spinal Muscular Atrophy, and requested a response from the administrators during a plenary session. However, we should emphasize that health councils are not the appropriate forums to address this demand, since there are specific bodies within the SUS, such as the National Committee for the Incorporation of Technologies in the Unified Health System (CONITEC) and the state and municipal Pharmacy and Therapeutics Committees, which are responsible for defining the regulations on the incorporation of new medicines and for conducting specific technical analyses to recommend or not the incorporation of medicines²².

One of the ways to better address the issue of Pharmaceutical policy is through the Advisory Committees. As identified in the research, there are still quite a few Councils that have established committees, whether exclusively dedicated to the topic or those discussed in other existing committees. The Intersectoral Commission on Science, Technology, and Pharmaceutical policy (CICTAF) of the National Health Council recommends that all Councils, especially state or capital city Councils, have a committee to address the topic. In the minutes analyzed, the existence of the committee in the Council indicates a more qualified and proactive discussion on pharmaceutical policy.

Reinforcing the relevance of the relationship between Pharmaceutical policy and social participation, Barros et al.²³, in analyzing data from the National Survey on Access, Use and Promotion of the Rational Use of Medicines, highlight that complete access to medicines was more frequent, among other factors, when those responsible for pharmaceutical policy reported regularly participating in the Municipal Health Council’s meetings. The analysis of the minutes shows a greater depth of discussion of the topic when the coordinators of pharmaceutical policy participate in the meetings.

The inclusion of this topic on the agenda does not necessarily stem from a specific Pharmaceutical policy agenda. However, it arises from other demands, such as discussions on Women’s Health policy, with concerns about access to condoms, intrauterine devices, and implants, or discussions on services for the elderly population and the concern about guaranteeing access to medicines for this population. These situations highlight the PNAF’s intersectoral nature.

This study highlights the relevance of social participation in the context of Pharmaceutical policy. However, although the topic is identified in discussions, the documents analyzed indicate that the handling of demands is scarce, generally limited to a response from management to requests from council members. Authors point to the challenges faced by Councils in proposing and monitoring public policies, and the need to review the dynamics established in the councils to place public policies at the center of discussions, rather than acting to serve specific interests⁸.

Council members should understand the subject matter, including its methods and terminology, especially in complex areas such as pharmaceutical services and science and technology²⁴. This can be a challenge for those without a background in Health. Therefore, ongoing education for Council members is recommended, considering the specificities and updates in these fields, as well as the fact that Councils undergo periodic elections, resulting in the renewal of their members. The creation of a committee or working group can be an important strategy to deepen discussions and improve decisions on the subject.

Several initiatives stand out, aimed at developing continuing education actions within the National Policy for Continuing Education for Social Participation in the SUS. The Intersectoral Committee for Continuing Education for Social Participation of the SUS (CIEPCSS), linked to the CNS, has been developing the “Participa+” project in partnership with the Center for Popular Education and Assistance (CEAP) to improve the participation of health counselors and social leaders in the SUS¹⁶.

Emphasizing strengthening popular participation in Pharmaceutical policy, the work of the CNS’ CICTAF and the Integra Project stand out. Created in 2021, the Integra Project aims to create and strengthen an intersectoral and integrated network of leaders to act collaboratively in defense of the development of science, public policies, national sovereignty, and social participation of Health¹³. In 2024, the project published the book “Right to pharmaceutical services: Protagonism of social participation - Guidelines for action of health councils” (Our free translation from the Portuguese)²⁵, which presents practical guidelines to strengthen social participation in the defense of this essential policy for the Brazilian population.

Considering the PNAF’s strategic lines, we can affirm that the agenda of pharmaceutical services and their organization within the healthcare network is rarely debated in the Councils, making discussions more restricted to the logistical aspects of medicines and, therefore, focused on the product and not on the services. Although topics related to the rational use of medicines, science, technology, and technology development appeared, they were limited to the COVID-19 pandemic period. Finally, topics related to Integrative and Complementary Practices, such as medicinal plants and phytotherapeutic products, were the least frequently mentioned in the analysis of the Councils’ documents.

Although the research is comprehensive, its results should be interpreted with caution, as the data refer exclusively to discussions that occurred at the state and municipal levels, respecting the competencies and specificities of these federative entities. Furthermore, being a qualitative study, the analysis is limited to documents obtained during the study period, without the possibility of inferences for other periods. Another important point is that only the municipal councils of the capital cities were analyzed, making it inappropriate to generalize these findings to other municipalities.

Final considerations

Following the recommendations of the World Health Organization (WHO) for social participation in health systems, Brazil reveals a pioneering spirit in this field. This research highlights the relationships with the PNAF, showing that the topic of Pharmaceutical policy is relevant and frequently addressed by state and Municipal Councils in Brazilian capitals, even when not explicitly presented in the agenda items, evidencing its intersectoral nature.

During the pandemic, this issue became even more apparent, including qualified discussions about dependence on external production of medicines and vaccines and allegations of the use of medicines without scientific evidence, reinforcing the role of social participation in addressing the crisis¹².

However, the topic is mainly restricted to issues focused on medicines and little on pharmaceutical policy. Discussions about the quality of medication use, its financing, goals, and indicators appear strongly in the debates. However, few actions and decisions are still observed.

Research on this topic is limited in the literature, which highlights the importance of this study’s findings. The results indicate that Health Councils are aware of and mobilized regarding the issue of pharmaceutical policy and have contributed to advancing the topic in states and municipalities. The development of appropriate tools for monitoring and evaluating the PNAF, the ongoing training of council members on the subject, and investment in committees dedicated to the agenda are fundamental elements identified by the analysis of the councils’ output in recent years for advancing the role of social participation over the PNAF at all management levels.

Acknowledgments

We are grateful to the researchers involved in data collection and the Executive Secretariats and Health Advisors who kindly provided the information necessary for this study.

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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
  26 Jan 2026
• Date of issue
  Jan 2026

History

• Received
  30 Sept 2024
• Accepted
  24 July 2025
• Published
  26 July 2025