Boletim do Instituto de Saúde - BIS

Social participation in Health Technology Assessment in the SUS

2024-11-12T08:34:28-03:00

In its 13 years, the National Committee for Health Technology Incorporation into the Brazilian Public Health System (Conitec) is
recognized for its excellence in institutionalizing Health Technology Assessment (HTA) in Brazilian Public Health System (SUS).
In this sense, the Committee has improved its actions, making them more transparent, and it has been expanding spaces for
Patient and Public Involvement. This article aims to describe the mechanisms, strategies and advances in Patient and Public Involvement at Conitec. Since its creation in 2011, Conitec has been commited to the expansion of access to health technologies and
social rights. In addition, the Committee reinforces the promotion of a fairer and more equitable society, in accordance with the
principles of SUS. Finally, this article also describes the challenges faced by Conitec in improving its actions to involve society in the Brazilian HTA process.

State, civil society, and democracy from the perspective of social participation in the incorporation of technologies in the SUS

2024-11-12T08:34:25-03:00

The paper aims to present a theoretical overview of the concepts of State, civil society and democracy, in order to contextualize the
background where the processes of patient and public involvement (PPI) for health technologies adoption in the Brazilian public health system (SUS) are inserted and under which they can be analyzed. It is pointed out that Brazilian democracy is aligned with the vision of participatory democracy. However, it is observed that the mechanisms of PPI in Brazil still depend on the political context.
Thus, despite advances in PPI in the adoption of technologies into the SUS, it is necessary to remain vigilant in defending the maintenance and improvement of established processes, with special attention to which groups (and interests) actually influence decisions to adopt technologies into the SUS and with processes that move towards a more democratic perspective.

Social Control of Patient Associations and Associative Movements in the SUS

2024-11-12T08:34:23-03:00

The 1988 Constitution marked Brazil's democratization by recognizing and valuing social rights, incorporating social participation
not only as state oversight but as a fundamental element of social policies. Law No. 8,142/90 established community participation in
the management of the Unified Health System (SUS), ensuring Health Conferences and Health Councils as spaces for deliberation
and social control. Associative movements, or organized coalitions of individuals, including patient organizations, have driven this participation, standing out in the mobilization for recognition and the inclusion of demands on the governmental agenda. Since 2010, there has been an increase in movements led by patients and their families, challenging the paternalistic model of care. This study aims to understand the profile of patient associations and social movements regarding forms of social participation in health across the Executive, Legislative, and Judicial branches, as well as the demands and needs to enhance this participation. This information was collected through a structured questionnaire, divided into five thematic blocks, using the Survey Monkey platform. The analysis shows that, while there is significant interest and interaction, gaps still persist in understanding interactions with the government and in identifying the needs to strengthen public policies.

Social participation as an essential element in the decision-making process in Health Technology Assessment

2024-11-12T08:34:21-03:00

Since the founding of National Commission for the Incorporation of Technologies into the Unified Health System (Conitec) in 2011,
the Health Technology Assessment (HTA) process by the commission has been transformed in order to expand the opportunities
for social participation. The article seeks to discuss possible ways to improve existing spaces, as well as potential changes in Conitec's HTA process to include patient experiences as an essential decision-making factor. The first axis of discussion focuses
on the role of civil society organizations as allies in the process of qualifying and expanding contributions in social participation
spaces; the second focuses on the adaptation of HTA processes to properly value patient experiences, based on national and international discussions and experiences. The article then highlights the importance of understanding patient experiences as a guiding element throughout the entire Health Technology Assessment process.

Considerations on the limits and perspectives of public consultation as a management tool and social participation in the Health Technology Assessment process in the SUS

2024-11-12T08:34:19-03:00

Social participation is one of the constitutional pillars of the right to health in Brazil and of the organization of the United Health System (SUS). In Brazil, there was an increase in participatory institutions in the 2000s, with the expansion of participation and social control in the scope of public policies and innovations in the field of socio-state interactions. In the health sector, especially in the area of Health Technology Assessment (HTA), this process of institutionalization of social participation has contributed to the inclusion of participatory mechanisms in this field, such as public consultations. This paper aims to discuss aspects related to advances, limits and potentialities of public consultation as a tool for management and social participation in the HTA process in the SUS, having as a background the experience of institutionalized participation in Conitec. Among the main advances, we highlight the gains related to active transparency, the ways of including citizens’contributions to the decision-making process, as well as the insertion of methodological strategies to address these data. As limitations, issues related to the inclusivity and representativeness of the consulted population can be pointed out, which opens perspectives for mobilization of public consultation also as an instrument for management and democratic deepening of State-society relations in the field of health.

The role of qualitative evidence in Health Technology Assessment

2024-11-12T08:34:17-03:00

This article developed as a theoretical essay, aims to discuss the introduction of qualitative evidence in the Health Technology
Assessment (HTA) process. To this end, firstly, the potential contributions of qualitative data to support this decision-making
were addressed. Secondarily, this epistemological reformulation was approached within the scope of National Commission for the
Incorporation of Technologies into the Unified Health System (Conitec). In this sense, this paper presents the current uses and
perspectives for qualitative evidence in HTA in the Brazilian Public Health System (SUS) and its strategic function in promoting
patient and public involvement, as well as the consideration of experiential aspects in the HTA process in Brazil.

Technology incorporation in oncology

2024-11-12T08:34:15-03:00

Cancer is one of the leading causes of morbidity and mortality worldwide, with significant growth in recent years, especially in
developing countries. Health policies for the prevention and control of cancer face the challenge of dealing with the increasing
incidence while the costs associated with the use of new treatments are rising. In Brazil, Law 14.758, which established the
National Policy for Cancer Prevention and Control within the Unified Health System (SUS), was approved in 2023. This law, among
other provisions, prioritizes the process of incorporating technologies in the field of cancer and defines ways to implement these
incorporations. Based on the analysis of the law's text, the process of effectively incorporating Blinatumomab, and the development
of the Clinical Protocol and Therapeutic Guidelines (PCDT) for breast cancer, the main advances, and challenges in providing access to oncology treatments for the population are presented. The participation of civil society in this process is fundamental to
help understand the real problems that create barriers to access and to jointly propose solutions to this issue.

Contributions to public consultations and reversals of recommendations by Conitec

2024-11-12T08:34:13-03:00

The paper explores the contributions of civil society in the public consultations held by Conitec on the incorporation of drugs indicated for the treatment of rare diseases, and analyzes the processes carried out between 2012 and 2023, showing the evolution of incorporations and types of contributions. In addition, the main arguments used by the Medicines Committee to justify the reversal of the initial opinion were described, indicating that the manufacturer's contribution and economic motivations underpin most of the recommendation reversals.

Editorial

2024-11-04T16:01:25-03:00

A participação social no processo de Avaliação de Tecnologias em Saúde (ATS) para incorporação de tecnologias é guardiã dos interesses do Sistema Único de Saúde (SUS). Esse tema tem despertado crescente interesse e consenso na literatura, destacando
a importância de ampliar as estratégias de participação social, incluindo a voz da sociedade no processo decisório. Aliás, a efetiva participação da sociedade no processo de incorporação de tecnologias no SUS é crucial. Ela não apenas promove a confiança nas
decisões em saúde, mas também contribui para a implementação e adoção das novas tecnologias, além de ter o potencial de reduzir desigualdades e ampliar o acesso. Nesta edição, uma gama diversificada de especialistas traz suas perspectivas sobre os avanços, experiências e desafios enfrentados nos 13 anos da Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec).

A Story with a Human Name

2024-11-12T08:34:30-03:00

Certainly, the evolution of social participation in Health Technology Assessment (HTA) in Brazil is a historical process of institutional
change that intersects with the very formation of the Unified Health System (SUS), involving the Brazilian population and social control in health policy formulation. More recent than the Brazilian health system, HTA was institutionalized with the premise of social participation. This history, documented through laws, ordinances, and decrees, has evolved over the years, sometimes in large strides, other times more slowly, always written by people. After all, institutions are made up of people. Indeed, the evolution and deepening of society's involvement in HTA is a story that cannot be told without mentioning the involvement of certain individuals. Vania Canuto is undeniably one of them. A pioneer in the field, Vania was one of the first to work with HTA in the country. A public servant and Specialist in Public Policies and Government Management, she experienced significant milestones in this process, such as the creation of the Brazilian Network for Health Technology Assessment (Rebrats) and the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec), where she served as deputy director and later as director.
Recognized for her work in the field for over twenty years, Vania is one of the key voices in this journey. Listening to her is, undoubtedly, understanding what laws, ordinances, and decrees cannot capture. It is a retrieval of the understanding of how SUS has been, and continues to be, arduously built by people. Above all, it is a fair and necessary record of an important fragment of our history. In an interview conducted remotely on June 12, 2024, by journalist Bruna Viana, Vania recounts the deepening of the social participation process in Conitec, which has made Brazil an international reference on the subject, and highlights milestones of this trajectory.

Social participation in the Conitec

2024-11-12T08:34:02-03:00

This paper aims to present an experience report of the self-managed activity entitled “Participa Conitec: diversifying social participation in the incorporation of technologies in SUS'', conducted during the 17th Nacional Health Conference. This activity is part of the Participa Conitec project, overseen by the Executive Secretariat of the National Committee for Health Technology Incorporation (Conitec) by the Brazilian Public Health System. The initiative sought to engage with diverse segments of health activism, with the goal of informing and involving social actors about Conitec and its mechanisms for social participation. The activity involved 90 participants, who collectively proposed 10 recommendations for enhancing social involvement in Conitec. The outcomes obtained significantly contributed to both the capacity building of the social actors involved and the development of operational strategies for Conitec.

Social participation in the Conitec

2024-11-12T08:34:00-03:00

This article aims to present an experience report about Patient Perspective, an initiative of the Comissão Nacional de Incorporação
de Tecnologias no Sistema Único de Saúde (Conitec), that is responsible to evaluate health technologies to integrate the brazilian
public health system. Created in 2020, the Patient Perspective ensures citizen participation in mentioned evaluations, to present
their experiences with a health condition or with the technology under evaluation. From the beginning of the initiative, in October
2020, until February 2024, 188 public calls were opened, which had 4,265 registrants and totalized 112 participations in Conitec
meetings. After three years, was observed that Patient Perspective underwent important changes that sought to improve the process and strengthen it, given its relevance in the Health Technology Assessment process.

Value in health and patient experience

2024-11-12T08:34:07-03:00

Health Technology Assessment (HTA) is a systematic process of analyzing clinical, economic and social evidence of health technologies, to support decision-making processes in health. In Brazil, although social participation in these processes has been
growing in recent years, there are still challenges to be associated with value-in-health in public policies. But value-in-health
can only be achieved through understanding the entire patient's journey within their healthcare lines. The objective of this manuscript is to contribute to promoting equity in access to healthcare through the inclusion of broader criteria during the evaluation of technologies, criteria that incorporate the patient's perspective. This text is, therefore, an essay that describes methods used to measure the patient experience, and which can be included as complementary analyzes in HTA processes. Understanding the itinerary followed by patients in their lines of care and a more inclusive and transparent dialogue with society in health decision-making processes are ways to, ultimately, better integrate health care networks, as well as promote better cost management and sector regulation.

Essay on the bioethical analysis of the Conitec Patient Perspective Mechanism from the Human Rights Framework of the Patient

2024-11-12T08:34:05-03:00

Health Technology Assessment (HTA) stands out as an essential approach for the sustainability of health systems. Within HTA, patients have the right to participate in the decision-making process, which is grounded in the human right to health and the right to socialn participation in the formulation of public health policies, both of which are part of the Patient Human Rights (PHR) framework. In Brazil, the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec), which is part of the Ministry of Health, adopts, among other mechanisms, the "Patient Perspective." This essay aims to analyze Conitec's "Patient Perspective" through the lens of the PHR framework. From this perspective, the right to patient participation in HTA is examined in terms of the conditions for exercising this right, the realization of the right itself, and the state's obligations to ensure its fulfillment. It is concluded that the adoption of participatory mechanisms by HTA agencies constitutes an ethical and legal duty stemming from states' obligations to respect and promote human rights in accordance with democratic values such as human dignity, legitimacy, and transparency.

Social Participation in Health Technology Assessment in the territories

2024-11-12T08:34:11-03:00

Social participation, also known as public engagement, constitutes an essential organizing principle within Brazilian Unified Health
System (Sistema Único de Saúde, SUS) and serves as a pivotal component in the Health Technology Assessment (HTA) process.
Nonetheless, there is a paucity of studies examining social participation in HTA at the local level. The aim of this article was to
elucidate the current status of public engagement in Franco da Rocha, a city in the metropolitan region of São Paulo - Brazil, in
2021. The methodology employed was a structured online questionnaire to assess participants' knowledge of social participation
in Health Technology Assessment (HTA) and their engagement with this theme. Participants included citizens, patients, and healthcare professionals from Franco da Rocha. Findings indicate that the topic is primarily discussed among experts. Although
participants reported having knowledge about the importance of social participation for HTA, there was little interest in active contribution, suggesting that there are still challenges to be addressed in promoting public engagement in this context. Therefore, it is imperative for society and HTA specialists to recognize the importance of public engagement in HTA processes.

Criteria for analyzing and utilizing patient contributions in the Conitec public consultations

2024-11-12T08:33:57-03:00

Patient participation in public consultations (PCs) within Health Technology Assessment (HTA) processes can enhance the quality
of healthcare decisions. However, the methods for analyzing and utilizing these contributions remain unclear. This descriptive exploratory case study, conducted through document analysis, aimed to identify the methodologies used to analyze patient experience and opinion contributions in three PCs for cystic fibrosis drugs—ivacaftor (M1); lumacaftor/ivacaftor (M2); tezacaftor/ivacaftor (M3) -how these contributions were presented to the plenary, and whether they influenced decisions. Contributions from the M1 and M2 PCs were analyzed and presented through a "word cloud," without patient narratives that provided evidence of drug use. In the M3 meeting, a structured qualitative methodology was used to analyze and present patient reports demonstrating drug use. However, there was no evidence of discussion among decision-makers regarding these contributions or any indication that they influenced the final recommendation. Since PCs are the main mechanism for public
participation in Conitec, it is suggested that contributions be analyzed using appropriate methodologies and effectively utilized,
recognizing the value of patient experience and ensuring the credibility of public participation in decision-making.

The importance of social participation in the technology incorporation process in the Unified Health System

2024-11-12T08:34:09-03:00

The National Commission for the Incorporation of Technologies in the SUS adopts strategies that improve society's involvement in
the health technology assessment process in an effort to promote decisions that better correspond with the population´s demands.
Public involvement in this process guarantees individuals their right to full exercise of citizenship and the materialization of participatory democracy. This article presents a case report on social participation in the decision-making process regarding the incorporation of the button gastrostomy tube in children and adolescents in the SUS. During the evaluation, the patient's perspective was exercised by a mother of a child who had used the technology. She presented several benefits that the tube provided to her child, such as a reduction in the risk of complications and an increase in the child's time in family life and leisure moments. This report was considered relevant by decision-makers who decided to incorporate the technology. The case is an example of how social participation can be a transformative element in decision-making by providing greater understanding and visibility to patients' expectations, bringing decision-makers closer to the reality of those who will benefit from the technology.