Social Participation in Public Policies
Public policies and rights must take into account the specific needs of people with rare diseases and people with disabilities (PWDs). In Brazil, social participation in the development and oversight of public health policies (known as social control) is a legal right, established in Article 198 of the Federal Constitution and in subsequent regulations..
Public health policy must be a joint construction
People with rare diseases and persons with disabilities (PwDs) face specific barriers — from diagnosis to access to treatment, education, employment, and mobility. The universalization of rights will only be fair if it addresses real inequalities through affirmative and inclusive actions. It is important for patients with rare diseases and their families to be familiar with the concept of advocacy, but our focus on this page is social participation in the development and oversight of public policies.
⚠️ Creating new laws is not enough.
Passing laws is an important step, but social justice only happens when those laws are effectively implemented. Brazil already has a robust legal framework (e.g., the Federal Constitution, the Statute of Persons with Disabilities, the Brazilian Inclusion Law, Ordinance No. 199/2014 on rare diseases), but implementation is inconsistent. Many laws remain on paper due to lack of budget, professional training, and enforcement.
Public policy must be a collective effort, involving patients, their associations and families, public health managers, healthcare professionals, and legislators.
In this context, it is important to highlight that social participation—to contribute to and monitor the planning and execution of public policies—is a legal right (social control). The legal basis for this participation is Article 198 of the 1988 Federal Constitution, along with other infraconstitutional norms, such as the Organic Health Law (Law No. 8.080/1990) and Law No. 8.142/1990. The latter is a key law that establishes community participation in the management of Brazil’s Unified Health System (SUS) and regulates intergovernmental financial transfers in the health sector. It created Health Councils and Health Conferences as mechanisms of social oversight in the SUS.
There is a hierarchy among the various levels of citizen participation:
1. National Health Council (CNS)
A collegiate body linked to the Ministry of Health that oversees the SUS at the federal level. It includes representatives of the government, health workers, service providers, and users. It deliberates on national public health policies.
2. State Health Councils
Present in every Brazilian state, these councils play a role similar to the CNS but focus on formulating and overseeing state-level health policies. They are composed of users, healthcare workers, government, and providers.
3. Municipal Health Councils
These exist in every municipality and are responsible for monitoring, overseeing, and deliberating on local health policies. They are essential to ensure community participation in SUS-related decisions.
4. Local Health Councils
Operate at more localized levels, such as in primary healthcare units (UBS). They serve as dialogue spaces between users, professionals, and managers to resolve daily issues in healthcare services.
Two key entities in health management and social control are CONASS and CONASEMS. These structures are part of SUS’s tripartite management (Union, States, and Municipalities) and are essential for ensuring transparency, participation, and social control in public health decisions.
-
CONASS – National Council of Health Secretaries
Represents state health secretaries. It coordinates state-level efforts, defends the SUS, and provides technical and political support for state health management. -
CONASEMS – National Council of Municipal Health Secretariats
Represents municipal health managers. It has similar functions to CONASS, but at the municipal level, advocating for municipal interests and promoting training and political coordination.
Health councils, conferences, and public hearings are mechanisms of social oversight.
The involvement of civil society—especially patient and family associations—is essential to ensure that public policies reflect the real needs of the population. Unfortunately, many issues remain unresolved, especially in the field of rare diseases.
For example:
-
People with rare diseases (and there are about 8,000 types of rare diseases, affecting around 13 million Brazilians) face tremendous difficulties in obtaining a diagnosis.
-
Accessibility remains poor, despite existing regulations. Accessibility is more than just ramps and handrails (and even these are often inadequate). A simple test is to try taking a train in a wheelchair, or attempt to get from home to the nearest primary care unit while navigating urban obstacles.
-
Healthcare professional training on rare diseases and basic genetics is still very lacking, leading to many negative practical consequences. Of course, it’s unrealistic to expect a doctor to graduate as an expert in 8,000 different rare diseases—but a basic level of knowledge must be included in their education. The problem is even more severe in primary care, such as emergency care units (UPAs), where physicians often have never even heard of conditions like ataxias, among many other rare diseases. And it’s not just about doctors—this applies to all healthcare professionals: nurses, nutritionists, physical therapists, speech therapists, fitness trainers, psychologists, etc. In general, knowledge about rare diseases is very limited.
-
Ableism must be actively addressed through educational campaigns. There is still a great deal of ignorance and prejudice toward people with disabilities and rare diseases.
All of these problems—and many others—underscore the importance of social oversight and the need for public policies specifically aimed at people with rare diseases.
Social Control and Rare Diseases
In the context of rare diseases, an important milestone was Ordinance 199/2014 , from the Ministry of Health, which established the National Policy for Comprehensive Care for People with Rare Diseases .
🔎 It is worth noting that this important achievement was not obtained solely due to the "kindness" of the Ministry of Health - it took a huge struggle, with organized political pressure and the articulation of patient associations, that is, dialogue and proactive political construction, to achieve its approval.
Although the National Policy for Comprehensive Care for People with Rare Diseases (PNAIPDR, for short) is very important, there are many challenges in implementing some of its provisions. BRAZIL IS A LARGE AND UNEQUAL COUNTRY , with many regional socioeconomic differences.
Brazil presents:
Lack of specialized centers for rare diseases in many regions;
Long waiting times for diagnosis;
Lack of knowledge about rare diseases among health professionals;
Lack of regional equity.
In this context, it is not trivial to ensure diagnosis and treatment for patients with rare diseases with equity throughout the National Territory.
Aiming at greater effectiveness, other complementary Ordinances were created, with emphasis on Ordinance GM/MS 3,132/2024 , which recently (2024) established the Technical Advisory Chamber for Rare Diseases (CTA for Rare Diseases) within the Ministry of Health, a technical, consultative and educational body that aims to contribute to the improvement and effective implementation of the PNAIPDR.
Just as an example, one of the competencies of the Rare Diseases CTA (Art. 2) is the continuing education of Health Professionals in Rare Diseases, aiming to improve an already mentioned problem of the low level of knowledge about rare diseases among health professionals, especially in primary care in the SUS:
Art. 2º The CTA for Rare Diseases is responsible for:
II - propose actions for the continuing education of health professionals, through activities aimed at acquiring and improving knowledge, skills and attitudes for caring for the population affected by rare diseases;
⚠️ The continuing education of healthcare professionals mentioned above MUST BE IN PRACTICE . Although there are professionals trained in highly complex care, primary care is the gateway to the SUS (Unified Health System) — if frontline professionals fail to recognize the signs of a rare disease, the time to diagnosis and initiation of appropriate treatment increases significantly.
If you have ataxia or care for someone with ataxia (or another rare disease), the message we want to emphasize is this:
Active social oversight is necessary to ensure that promises of equity and comprehensive care don't remain just on paper. The fight for health improvements in rare diseases needs to be collective, informed, and organized—there are adequate channels for social participation, as well as defined processes for incorporating new medications into the SUS ( Unified Health System). There's no point in banging pots and pans in the wrong place or at the wrong time—it's important to understand these processes to act appropriately.
Social Participation and ATS
The Advocacy page explains in detail the HTA (Health Technology Assessment) process in Brazil.
In summary, the key milestones are as follows:
1. Preclinical phase (laboratory research):
The pharmaceutical company invests a significant amount of money in research, which may take several years, in order to discover a molecule (for example) that has the potential to cure or help treat a disease.
2. Clinical trials with human participants:
If the results from Phase 1 are promising, the drug undergoes a long and rigorous multi-phase process to evaluate its safety and efficacy in humans.
3. Registration and approval by regulatory agencies:
If the clinical trial results are favorable, the pharmaceutical company requests authorization from the regulatory agency to commercialize the drug. In the United States, the regulatory agency is the FDA; in the European Union, it is the EMA; and in Brazil, it is ANVISA.
4. Commercialization:
After regulatory approval and deliberations on pricing and other technical and logistical issues (such as labeling, delivery logistics, restrictions, etc.), the medication reaches the market and becomes available for patients to purchase.
In Brazil specifically, there is a Health Technology Assessment (HTA) process regulated by law, which involves several actors—the main ones being:
-
The pharmaceutical company or organization that developed the drug, therapy, or medical device (all of which are considered health technologies).
-
The regulatory agency (in Brazil’s case, ANVISA), which decides whether or not the drug can be authorized for commercialization in Brazil.
-
The CMED (Drug Market Regulation Chamber), which determines the maximum price for the drug—both for government procurement and for the final consumer.
-
CONITEC (National Commission for the Incorporation of Technologies in the Unified Health System – SUS), which evaluates health technologies within up to 9 months, based on scientific evidence. It considers efficacy, effectiveness, safety, and economic aspects to decide whether or not to recommend incorporating the drug into the SUS.
-
The Ministry of Health, which makes the final decision on whether or not to incorporate the health technology into the SUS.
An important aspect of this HTA (Health Technology Assessment) process—especially during the stage conducted by CONITEC—is that there are at least two key moments for SOCIAL PARTICIPATION. During these moments, patient associations, individual patients who may benefit from the drug, caregivers and family members, healthcare professionals, and other stakeholders may actively participate.
Patient perspective – CONITEC takes the patient’s experience into account when drafting its initial opinion on whether or not to recommend the incorporation of a drug into the SUS. At a specific point in the process, someone who lives with the disease (related to the drug or health technology under review) is given 10 minutes to speak in person about their experience and personal journey, providing additional insight for decision-makers. This is active social participation, offering a real-life perspective that complements the clinical trial data.
After these testimonials—and based on the scientific and technical information submitted by the pharmaceutical company—CONITEC prepares its Initial Recommendation on whether or not it supports the drug’s incorporation into the SUS.
Public Consultation – After CONITEC’s Initial Recommendation, there is a 20-day public consultation period, during which stakeholders (civil society) can contribute through an online form, stating whether they agree or disagree with CONITEC’s recommendation—and explaining why. These contributions are taken into consideration in a new analysis conducted after the public consultation. Based on this review, CONITEC then issues its Final Recommendation, which may uphold or modify its initial decision (YES or NO to the incorporation of the drug into the SUS).
It’s important to emphasize that a Public Consultation is not a “vote,” not a “petition,” not a space to “complain,” to “criticize the government,” or to engage in any kind of political campaigning. It is also not the place for copy-paste responses, where hundreds of people submit the exact same text copied from a source. What truly matters is the quality of your contribution—it must provide useful information to support decision-making. For example: “In my experience, this medication helps in such and such ways; without it, I experience these and those symptoms,” etc. Each person should speak from their own perspective (patient, doctor, caregiver, etc.) and contribute rationally and respectfully.
For more effective participation in these Public Consultations on drug assessments, it’s important to be well-prepared.
Read the available information about previous consultations on other medications on CONITEC’s homepage (via the Participa+ Brasil platform) to understand how this space should be used appropriately.
There are also many videos of past CONITEC committee meetings, and it’s worth watching a few of them to see how these sessions work—before submitting your own contribution through the public consultation form.
In addition to public consultations, there are other important spaces (meetings, events, etc.) where you can exercise your right to social participation in the development and oversight of public health policies.
See the section "BE WELL PREPARED TO CONTRIBUTE" further below.
Final decision on incorporation
The report with the Final Recommendation is sent to the Secretary of SECTICS (Department of Science, Technology, and Innovation and the Health Economic-Industrial Complex) of the Ministry of Health. The Secretary makes the final decision on whether or not to incorporate the technology into the SUS, and the decision is published in the Official Gazette.
-
If the incorporation into the SUS is DENIED, the law allows the SECTICS Secretary to request a Public Hearing (within a certain timeframe), during which an in-person discussion may take place. This would be a third opportunity for active social participation in the HTA process. However, this rarely occurs. In general, the SECTICS Secretary tends to follow CONITEC’s Final Recommendation.
-
If the incorporation into the SUS is APPROVED, the law requires that the medication be made available through the SUS within 180 days (though there may be slight delays). A PCDT (Clinical Protocol and Therapeutic Guidelines) must also be developed. This document standardizes the dispensing of the medication, guiding SUS professionals on diagnostic criteria, recommended treatment, dosages, clinical monitoring mechanisms, and follow-up of therapeutic outcomes.
CONITEC adopts a multidimensional approach in the Health Technology Assessment (HTA) process, based on four main pillars used to support its recommendations on the incorporation, exclusion, or modification of technologies within the Unified Health System (SUS). Social participation is one of these four pillars.
-
Economic axis – considers cost, cost-effectiveness, cost-utility, and the budget impact on the SUS.
-
Clinical axis – scientific evidence on efficacy, effectiveness, safety, quality of evidence, and the profile of the target population.
-
Organizational axis – impact on logistics, infrastructure, installed capacity, human resources, and processes required for implementation in the SUS.
-
Social/Patient Participation axis – analysis of social impact, patient acceptability and convenience, ethical aspects, equity, and increasing incorporation of real-world evidence and input from civil society and patient associations.
SOCIAL PARTICIPATION IN THE HTA PROCESS IS IMPORTANT, and it reinforces that the decision to incorporate a health technology into the SUS is not solely technical or economic—it also involves social, ethical, and equity-related dimensions. It is not merely a bureaucratic or symbolic gesture, but an integral part of the final assessment, helping ensure that CONITEC’s decisions are more focused on the real needs of the SUS user population.
CONITEC HAS A REGISTRATION SYSTEM FOR SOCIAL PARTICIPATION.
In fact, there are three types of registration:
-
Health Experts
-
Patients and Associations
-
SUS Managers
Access requires authentication through the gov.br portal.
Suggestions for social participation
1. RARE PATIENT LIVES SOMEWHERE. START YOUR ACTION NEAR HOME.
A person with a rare disease lives in a municipality. This is where social participation should begin . After all, the life of a person with a rare disease unfolds in their neighborhood, at the nearest UBS (Basic Health Unit), and at the local school.
Starting with local advocacy is more accessible, less costly, and more effective. Given the bureaucracy, the increasing complexities of political relationships, and even the costs (logistics of travel), it's easier for patients to approach and collaborate (give their testimony, make suggestions) with their Municipal Health Council than to initially try to act at the federal level, such as the National Council or even the State Council.
For example, go to the City Council and see what the councilors in your municipality (whom you helped elect) know (or don't know) about rare diseases.
Then there are the other levels of action, that is, the state and federal levels.
- What do State Representatives know about rare diseases? They directly influence state health policies.
- What do Federal Deputies and Senators know about rare diseases? They can legislate, allocate parliamentary amendments , and influence national policies.
The fight for rights must begin where life happens: close to home . Strengthening local activism is an important step toward creating change at the state and national levels. Every voice counts—and it starts in your municipality.
2. BE WELL PREPARED TO MAKE YOUR CONTRIBUTION
It is not effective to convey to health managers phrases such as "the SUS takes too long to provide care!" or "health is a right for everyone and a duty of the State!"
These realities are already known, but they are very generic. They have symbolic value, but not operational value, and they won't help managers make decisions about how to improve this reality. Instead, provide a contribution that helps managers better understand the reality of those living with a rare disease . Share your experience .
For example, how does a mother with two children in wheelchairs take them to physical therapy regularly?
Do you only take one at a time?
Rent a van? With what money?
And what happens when the mother herself is in a wheelchair and needs to take her child to medical appointments?
These are real-life situations , and by understanding them, managers will be better equipped to decide how to help. These stories mobilize resources, spark empathy, and inform bills or administrative actions. For example, depending on the number of people in the same situation, would it be possible to offer free medical transportation to support travel to treatment centers?
Those who experience the reality of rare diseases have a lot to say—but it needs to be said clearly, with purpose, and with a willingness to develop solutions alongside policymakers.
3. POLITICS IS DIALOGUE, NOT FIGHTING AND SEALING ON SOCIAL MEDIA
As experts say (such as Ana Lúcia Paduello , social health activist and member of the CNS (National Health Council), social participation in health councils (at any level) is political work (not in the sense of "party politics" of being "left" or "right", but in the sense of politics itself, of dialogue, respect and collaboration in search of shared solutions to difficult problems).
Politics is dialogue, listening, and collective construction;
Politics is not synonymous with fight or ideological dispute;
It is a space where experience becomes a concrete proposal for change.
If you want to be heard, be respectful and learn to live with differing opinions. Anyone who can't do this isn't "political" in the true sense of the word.
4. INFORMATION EMPOWERS.
Rare diseases are little known, even among healthcare professionals. We've already mentioned that, with few exceptions, professionals working at the primary care level in the Unified Health System (SUS) are unfamiliar with rare diseases , which delays diagnosis and the initiation of appropriate management of the condition, which is very detrimental to the patient. While continuing education for healthcare professionals is the responsibility of the Ministry of Health, as well as states and municipalities, you can be part of the solution, not just another part of the problem of the lack of information about rare diseases.
Seek reliable sources for information about your condition so you can share what you've learned, or at least have more pertinent questions, when speaking with healthcare professionals or health managers seeking care or improvements. Quality information provides:
Power to demand;
Power to dialogue based on;
Power to resist and build.
Possibility of shared decision-making with physicians about rare disease management. It's important to keep in mind that the traditional roles in the "doctor-patient" relationship seen in conventional diseases (a physician who knows a lot and makes decisions alone, treating a patient who knows nothing about their disease) DO NOT APPLY in the case of rare diseases, where physicians generally don't know much, and patients know a lot. This suggests that a collaborative, shared-decision approach between physician and patient makes a lot of sense.
Seeking information doesn't mean patients have to take on the role of the government, but rather that they can work more collaboratively with healthcare professionals, correct misinformation circulated online, and educate others (friends, family, and society at large) about their rare condition. Well-informed patients not only improve their own health journey—they also pave the way for others.
🌐 In the case of ataxias (which are rare diseases), the ataxia.info portal is an EDUCATIONAL TOOL . In a digital environment saturated with misinformation, the information shared on ataxia.info is reliable, carefully curated, and access is public and free.
Quality information allows people with a rare disease to reframe many things. Ataxia is a disabling neurological disease, often progressive, and a chronic, still incurable condition that, depending on the type, will remain with the person until the end of their life, requiring ongoing management. If it's impossible to "escape" the disease, the best thing to do is learn to live with it .
Furthermore, the ataxia.info portal is also an EMPOWERMENT INSTRUMENT , in the sense that it increases the ability of patients with ataxias to make better informed decisions, and thus act with greater autonomy in managing their health.
5. HEALTH IS A BROAD CONCEPT
The concept of "health" is broader than "the absence of disease." It's necessary to develop a differentiated perspective that encompasses other dimensions of life (this applies to patients, caregivers, professionals, and health managers) that goes beyond the purely biomedical aspect of health. Health in this biomedical context certainly matters, but access to education, the job market, accessibility to public services, and social life for people with rare diseases also matter:
Having education is health.
Having a job is healthy.
Having full and dignified access to public spaces is health.
Having a balanced social and emotional life is also healthy.
After all, a person is not the disease they have .
A person with a rare disease, or PCD, is a wife, mother, daughter, sister, father, son, husband, student, teacher, professional.
It is necessary to separate the DISEASE (as a biological dysfunction) from the PATIENT (a person).
A disease has an ICD. A person has a name.
One thing is the diagnosis, the academic aspect of the disease.
Another thing is how each person feels about that diagnosis, what meaning they give it, and what their personal and non-transferable experience of living with their illness is like. People with the same diagnosis can have very different experiences.
How each person deals with their condition on a daily basis has significant consequences. Some say, "Ataxia doesn't define me," and move forward with acceptance and purpose, doing their best one day at a time. Others become depressed and withdrawn, having great difficulty accepting the reality of the disease. Both reactions require different responses from the healthcare system and society.
Here, the community (Patient Associations, support groups, social networks) plays an important role, as having a rare, progressive and incurable disease means being in a place that can be very lonely .
Finding others who share and understand the condition helps, giving them the strength to move forward, as well as a sense of belonging and hope. Many find purpose in sharing their journey on social media profiles, which allow them to share experiences in a safe, non-judgmental space. This way, they can help others.
All of this helps people with rare diseases take on the role of protagonists in their own story and health process . This is an important turning point—the recognition that, even when faced with limitations, people can be the authors of their own decisions, feelings, and bonds, and can also help promote social transformations and improve public policies.
Health begins in the body, but it doesn't end there. It inhabits the way we relate, learn, work, dream, and strive. Therefore, Caring for people with rare diseases means caring for their dignity and their voice, not just managing symptoms.
Selected references
Below are listed the references and sources consulted to generate the content of this page.
Amends Annex XXXVIII of GM/MS Consolidation Ordinance No. 2, of September 28, 2017, to establish the Technical Advisory Chamber for Rare Diseases - CTA for Rare Diseases, within the scope of the Ministry of Health.
Law No. 8,080 of September 19, 1990, is the Organic Health Law, which establishes the guidelines for the organization and operation of the Unified Health System (SUS) in Brazil. It defines the conditions for the promotion, protection, and recovery of health, the organization and operation of health services, and provides other measures related to public health.
Provides for community participation in the management of the Unified Health System (SUS) and intergovernmental transfers of financial resources in the health area, among other measures.
Law No. 8,080 of September 19, 1990, is the Organic Health Law, which establishes the guidelines for the organization and operation of the Unified Health System (SUS) in Brazil. It defines the conditions for the promotion, protection, and recovery of health, the organization and operation of health services, and provides other measures related to public health.