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Submitted: December 12, 2024 | Approved: December 26, 2024 | Published: December 27, 2024

How to cite this article: da Silva DA, da Silva RM. The Police Power of the National Health Surveillance Agency – ANVISA. Arch Cancer Sci Ther. 2024; 8(1): 063-076. Available from:
https://dx.doi.org/10.29328/journal.acst.1001046

DOI: 10.29328/journal.acst.1001046

Copyright License: © 2024 da Silva DA, et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Keywords: National Health Surveillance Agency; ANVISA; Health surveillance; Police power; Brazilian legislation; Public health; Health regulation; Health inspection; Medicines; Food; Cosmetics; Health safety; Quality control; Health standards; Health licensing; Selective health; Health protection; Health services; Medicines and health products; Health intervention; Pharmacovigilance; Health technology; Unified health system; SUS; Ministry of health; Federal government

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The Police Power of the National Health Surveillance Agency – ANVISA

Dimas Augusto da Silva* and Rafaela Marinho da Silva

Belo Horizonte 31060-440, Brazil

*Address for Correspondence: Dimas Augusto da Silva, Belo Horizonte 31060-440, Brazil, Email: biologo.cb@gmail.com

The National Health Surveillance Agency (ANVISA) is a public institution created by Law 9782/1999, which integrates the field of Collective Health and acts in the prevention, control, and inspection of sanitary conditions in various sectors, such as food, health, pharmacies, hospitals, and commercial establishments. Its main objective is to guarantee the protection of public health, ensuring that products, services, and environments comply with established standards, to promote health and preventing diseases. To exercise its inspection and control function, Sanitary Surveillance has the power of sanitary police, which gives it the authority to apply necessary measures and curb practices that pose risks to the health of the population.

The performance of the Sanitary Surveillance is fundamental to prevent health risks in any part of society and to guarantee national programs for patient safety. It is also essential to prevent diseases, control risks, and monitor compliance with health standards and specific regulations. The police power of Sanitary Surveillance consists of establishing norms and technical regulations, carrying out inspections and inspections, issuing temporary or permanent interdiction orders in establishments that do not comply with the norms, as well as forwarding complaints to the Public Ministry in cases of crimes against public health. Arrests carried out by Sanitary Surveillance agents are extreme measures and applied in serious situations of risk to public health or when there is repeated disrespect for sanitary regulations. The prohibited establishments have the right of defense and may seek to regularize the situation to obtain the release of activities.

The performance of the Sanitary Surveillance has significant impacts on the prevention of disease outbreaks and epidemics. Identifying and correcting inappropriate practices helps to prevent the spread of pathogenic agents and reduce the risk of contagion in collective environments. The institution’s preventive and supervisory activities contribute to reducing risks to the population’s health, preventing disease outbreaks, food poisoning, and the proliferation of pests, among other problems. Finally, the importance of exercising police power with transparency, impartiality, and respect for individual rights is emphasized, always aiming at the collective interest and the promotion of the common good. In summary, Health Surveillance plays an essential role in protecting public health, seeking to ensure that the population has access to safe products and services, contributing to the improvement of quality of life and disease prevention.

The National Health Surveillance Agency (ANVISA) is a public organization and an agency linked to the Ministry of Health, which was created based on Law 9782, from the year 1999, and which is integrated into the field of Public Health and works on prevention, control and inspection of sanitary conditions in various sectors [1-3], such as food, health, pharmacies, hospitals, commercial establishments, among others that may pose risks to the health of the population [4-6]. Its role and function is to protect public health, ensuring that establishments and activities comply with health standards [7]. Its main objective is to ensure that products, services, and environments comply with established standards, aiming to promote health and prevent diseases [8]. To exercise its oversight and control function, Health Surveillance has the power of the health police [9], which gives it authority to apply necessary measures and prevent practices that pose risks to the health of the population [10].

The protection of public health is a constant concern to prevent health risks in any part of society [11]. Article 6 of law 9782, from 1999, describes the fundamental purpose of the National Health Surveillance Agency, with its primary objective of ensuring the safeguarding of the population’s health, which is achieved through rigorous health monitoring of the production and sale of products and services subject to health surveillance, and which is also responsible for supervising the environments, processes, inputs, and technologies related to these products and services, controlling activities at ports, airports, and borders to ensure health security [12].

To ensure that the population is safe from threats to their health, including national patient safety programs, it is essential to have a public organization responsible for monitoring and controlling health standards [13]. In this context, Health Surveillance, which is also integrated into the Unified Health System (Sistema Único de Saúde – SUS), emerges as a fundamental institution, playing a crucial role in preserving health and collective well-being [14]. To fulfill this mission, Health Surveillance has the power of health police, a set of legal prerogatives that gives it authority to act in a coercive and regulatory manner, to protect public health [15]. This police power consists of a specific attribution of the State, which allows, based on Administrative Law on Health Surveillance, to intervene and regulate situations that may pose risks to the health of the population [16]. In addition, the agency also has an educational and preventive role, seeking to raise awareness among those responsible for establishments and the population about the importance of good health practices [17-20].

The objective of health surveillance is to protect and promote the health of the population using technical and scientific knowledge with the expectation of benefit to collective health [21], ensuring quality and safety in various sectors, such as food, medicines, personal hygiene products, cosmetics, basic sanitation, environment, health services, safety of products and services, areas of health-related environments [22]. This area of activity may enter into conflicts with other public and private entities to guarantee the safety of the collective [21] and provide partnerships with the Unified Health System (SUS), to ensure operational focus on Basic Health Care [23] and its purpose is to prevent diseases, control risks, and monitor compliance with health standards and specific regulations [24].

The National Health Surveillance Agency (ANVISA) also issues epidemiological information on its official portals of the Federal Government of Brazil, and is focused on collecting, analyzing, and monitoring data related to diseases, outbreaks, and adverse events that may impact public health in Brazil [25-27]. This information is essential to identify risk patterns, enable preventive and corrective actions, and ensure the safety of health-related products and services such as disease and outbreak monitoring, where the National Health Surveillance Agency (ANVISA) monitors and analyzes disease outbreaks and possible risks to public health, such as food poisoning, adverse reactions to medications and vaccines, and other high-impact health events [28-32]. These surveillance portals are divided into several categories of services and monitoring, such as Pharmacovigilance, where continuous monitoring of adverse events related to medicines, vaccines, and other health products is carried out, providing data that guides the regulation and safety of these products [33-36]. In Technovigilance, which is similar to pharmacovigilance, but focuses on the safety of medical devices, such as diagnostic equipment and therapies, the National Health Surveillance Agency (ANVISA) collects data on failures, malfunctions, or adverse events caused by these products [37-39]. Through Data on Health Products and Services, the National Health Surveillance Agency (ANVISA) provides data with political and regulatory typologies on the quality and safety of medicines, food, cosmetics, hygiene products, and other regulated products, to protect the health of the population [40-42]. Through Prevention and Control Actions, based on the epidemiological information collected, the National Health Surveillance Agency (ANVISA) implements prevention and control measures, such as recalls, product bans, and stricter regulation of certain sectors [43-45]. Finally, Partnerships with Other Entities where the National Health Surveillance Agency (ANVISA) also cooperates with other agencies, such as the Ministry of Health and state and municipal agencies, to gather and disseminate information on public health and epidemics, strengthening the response to health emergencies. It is committed to transparently guaranteeing information that is vital to support public health policies, responding to health emergencies, and ensuring collective health in the country [46-50].

Article 8 of law 9782, from 1999, determines that the National Health Surveillance Agency is responsible for regulating, controlling, and supervising products and services that may pose risks to public health, always respecting current legislation [12,51]. This article also offers an exemplary list of goods and products subject to this control and inspection. This list covers a variety of items, such as medicines for human use, inputs and active substances used in these medicines, as well as the processes and technologies involved in their manufacture. In addition, food, beverages, packaged water, pesticide residues, and veterinary medicine residues are also included. Medical-hospital, hematological, and chemotherapeutic equipment and materials, in addition to laboratory imaging diagnostic devices, are also included. Other controlled products are tobacco derivatives or any other smoking product. Finally, the list includes human and veterinary organs and tissues intended for transplants or reconstitutions [12,19,20]. The police power of Health Surveillance can be very well defined in Article 7 of Law 9782 of 1999, which is based on fundamental principles, such as the principle of prevention, which aims to avoid the occurrence of damage to health, and the principle of precaution, which guides the adoption of protective measures even in the face of scientific uncertainties. These principles are fundamental for decision-making and Health Surveillance actions, aiming to minimize risks to the health of the population [10,12]. The exercise of health police power involves a set of actions and instruments. Firstly, Health Surveillance establishes technical standards and regulations, based on scientific evidence, which define good practices to be followed in different areas [9,15].

These standards are regularly updated to adapt to emerging needs, changes in science, and societal demands [52,53]. Furthermore, the National Health Surveillance Agency (ANVISA) has the power to carry out inspections and inspections through specialized teams, where Health Surveillance agents visit establishments and check sanitary conditions, analyze production processes, and inspect the quality of products and services, among other activities. These actions aim to identify possible irregularities and guide those responsible for establishments in correcting non-conformities [54-56]. Due to its essence, the National Health Surveillance Agency (ANVISA) can also be understood as a field for the exercise of citizenship and the strengthening of social control. This is due to its ability to transform the quality of products, processes, and social interactions, which demands integrated action between different disciplines and institutions of public and legal interest, highlighting the functions and responsibilities of the National Health Surveillance Agency (ANVISA) in the exercise of its police power [57,58]. This concept involves the State’s action to limit or condition individual rights in favor of the collective interest, since the National Health Surveillance Agency (ANVISA) is involved in the continuous and systematic collection, analysis, and interpretation of data, providing decision-makers with strategic information to guide planning and ensure adequate and timely interventions in the face of a problem or some specific situation within public health. This attribution is fundamental to guarantee health security, especially in matters related to the surveillance of medicines, food, cosmetics, and endemic diseases [59-62]. These observations exemplify the regulatory functions to clarify the administrative nature of this power, and when necessary acting in partnership with public security agencies with legal police power, analyzing their limits and possibilities in light of Brazilian law and legislation, as well as their compatibility with the constitutional principles of legality, proportionality, and efficiency [62-64]. Furthermore, this review is timely to encourage discussion on the importance of technical action by the National Health Surveillance Agency (ANVISA), considering current challenges, such as regulation, partnerships with other security agencies with legal power, and new technologies in the area of ​​public health [14,29,58,65-67].

Objective

The objective of this study is to explore the types of actions of the National Health Surveillance Agency, where administrative police power is used to guarantee the health security of the population, and the challenges and results achieved by these actions.

The health police power of the National Health Surveillance Agency (ANVISA) is exercised through a set of actions and legal instruments of administrative law, which aim to limit the exercise of individual rights for the benefit and protection of the public and collective interest, where and within these prerogatives, the National Health Surveillance Agency (ANVISA) has the power to establish technical standards and regulations, guide actions and conduct aimed at guaranteeing public health [9,16,68-71]. The method of this study was mainly investigation and documentary research in official channels of the Federal Government of Brazil, which is the main source of information on laws and standards published by the National Health Surveillance Agency (ANVISA), which cover official documents, laws and standards that deal with the administrative police power of health surveillance agencies in Brazil. And also the investigation in the literature on related topics and published academic works, to support the documentary information provided by the official channels of the Federal Government of Brazil, and legitimacy to the administrative police power regarding the National Health Surveillance Agency (ANVISA) in the exercise of its functions, and the verification of these standards that are constantly updated according to advances in science and the needs of society [17,19,52,56,72-74].

The National Health Surveillance Agency (ANVISA), within its responsibilities, has the power to adopt restrictive and corrective measures on a case-by-case basis when violations of health standards are found and can adopt in various situations to guarantee the safety and quality of products, medicines, foods, cosmetics and other items that are subject to its regulation. These measures can range from warnings and guidelines to the application of administrative sanctions, such as fines, sanitary barriers, temporary or definitive suspensions of activities, and even the total closure of the establishment [2,6,12,75]. In more serious cases, in which signs of crimes against public health are identified, the National Health Surveillance Agency (ANVISA) may forward complaints to the Public Prosecutor’s Office for appropriate legal action [73,76,77].

Furthermore, the National Health Surveillance Agency (ANVISA) has the power of supervision and inspection. Through inspection teams, Health Surveillance agents visit establishments and check whether health standards are being followed properly (Table 1). These inspections can occur routinely or in response to complaints and suspected irregularities, aiming to ensure the protection of public health, through their main types of action and inspection measures [15,16,52].

Table 1: Type of ANVISA activity.
Performance Description Ref.
Supervision and Inspection The National Health Surveillance Agency (ANVISA) carries out regular visits and inspections with or without reporting, in establishments such as restaurants, supermarkets, pharmacies, hospitals, and food industries, among others. Health inspection and inspection are fundamental activities carried out by the National Health Surveillance System (Sistema Nacional de Vigilância Sanitária - SNVS) whose purpose is to inspect and monitor establishments subject to its jurisdiction and supervision, and which comply with the standards of good practice for establishments, and which are complied with correctly and adequately. This aims to curb practices that may pose risks to the health of both individuals and the community, where the purpose of these actions is to guarantee total safety. During these inspections, sanitary conditions, compliance with rules and regulations, and the quality of products and services offered are checked, as well as the adequacy of processes and work environments. [5,56,78]
Guidance and Health Education Guidance and Health Education: Health Surveillance exercises its power within its prerogatives in the guidance, campaigns, and education of the population and those responsible for health surveillance establishments and the Unified Health System (SUS) through the Virtual Health Library, where fundamental strategies are used which are updated to adapt to new health realities, to promote public health and ensure compliance with health standards in establishments, services and in the community in general, through informative materials, lectures, training and educational campaigns, where knowledge is transmitted on good hygiene practices, food handling, disease prevention, appropriate use of medicines, among other topics related to public health. These approaches aim to raise awareness and inform people about the best hygiene, safety, and quality practices, contributing to the prevention of health risks and disease control. Some of its actions are carried out through educational campaigns, training and qualifications, lectures and workshops, distribution of educational materials, assistance and clarification of doubts, encouragement of self-care, and partnerships with the media. By providing guidance and education to the population and professionals, health surveillance strengthens collective awareness about the importance of health and safety, contributing to improving quality of life and preventing public health problems. [19,20,50,79,80,81]
Registration and Licensing The National Health Surveillance Agency (ANVISA) is responsible for the registration and licensing of establishments that operate in the health sector, such as clinics, laboratories, hospitals, and pharmacies, among others. This process aims to ensure that these locations comply with health standards, have qualified professionals, and offer adequate conditions for the provision of health services. [55,72,82-84]
Product Analysis The National Health Surveillance Agency (ANVISA) carries out analyzes and laboratory tests on products, such as food, cosmetics, medicines, and personal hygiene products, among others. This analysis aims to verify the quality, effectiveness, safety, and compliance of these products with established health standards. If irregular or adulterated products are identified, the Health Surveillance can take measures to remove them from the market. [4-6,21,22]
Epidemiological Investigation The National Health Surveillance Agency (ANVISA) works to investigate disease outbreaks and epidemics, seeking to identify the origin and causes of public health problems. This investigation involves collecting information, visiting affected locations, analyzing samples, interviewing infected people, and implementing measures to control and prevent the spread of diseases. [53,54,85]
Pest and Vector Control The National Health Surveillance Agency (ANVISA) carries out actions to control pests and vectors, such as mosquitoes, rodents, and insects, which can pose risks to public health. These actions include monitoring, the use of preventive measures, the application of chemicals when necessary, and educating the population on ways to prevent infestation of these organisms. [54,86-88]

Inspections by the National Health Surveillance Agency (ANVISA) play a fundamental role in promoting public health, ensuring that establishments, products, and services comply with health standards, reducing the risk of disease, and promoting the safety and well-being of the population [22,89]. During these inspections, agents check several issues, such as hygiene and cleanliness of environments, adequate storage and handling of food, the regularity of health documents, the adequacy of working conditions, and waste management, among other aspects related to the health and safety of workers and consumers [5,12].

If irregularities are identified, the National Health Surveillance Agency (ANVISA) may adopt, within the law, a series of corrective measures. These measures range from warnings and guidelines to the imposition of fines, temporary or permanent closure of the establishment, and even the forwarding of complaints to the Public Prosecutor’s Office, when there is evidence of crimes against public health (Table 2). The choice of corrective measure depends on the severity of the situation, the risk to public health, and the recurrence of infractions, and the actions of these bodies are essential to guarantee the quality and safety of products and services offered to the population, as well as to prevent disease outbreaks and protect public health broadly [12,52,55,72,73,88,89]. The National Health Surveillance Agency (ANVISA) has a variety of inspection measures adopted to ensure compliance with health standards and the protection of public health [19,56,81].

Table 2: ANVISA Inspections Measures
Oversight Description Ref.
Inspections and Surveys The National Health Surveillance Agency (ANVISA) carries out regular inspections in establishments, such as restaurants, bars, supermarkets, pharmacies, hospitals, among others. During inspections, agents check compliance with health standards, and analyze hygiene conditions, physical structure, product storage, and food handling, among other aspects related to health and safety. [18,53,54,85,87,90,91]
Documentation Analysis The National Health Surveillance Agency (ANVISA) checks the regularity of the health documents required from establishments, such as permits, health licenses, registrations, and certificates, among others. This analysis includes checking expiration dates, authenticity of documents, and compliance with legal requirements. [12,55,56,72,82-84,92]
Sample collection The National Health Surveillance Agency (ANVISA) can collect samples of products, such as food, medicines, cosmetics, and water, among others, for laboratory analysis. These analyzes aim to verify the quality, safety, and compliance of these products with established health standards. [53,54,82,85-87,89]
Audits and Assessments The National Health Surveillance Agency (ANVISA) carries out audits and assessments in healthcare establishments, such as hospitals and clinics, to verify compliance with specific rules and regulations for these institutions. These audits evaluate everything from the physical structure to management processes, including patient safety, waste management, and the quality of services provided, among other aspects. [8,13,56,84]
Checking Working Conditions The National Health Surveillance Agency (ANVISA) also monitors working conditions in establishments, aiming to protect workers. This inspection covers aspects such as safety in the workplace, the appropriate use of personal protective equipment (PPE), accident prevention, and ergonomics, among other factors related to occupational health. [5,6,89]
Notifications and Penalties If irregularities are identified, the National Health Surveillance Agency (ANVISA) may issue notifications and apply penalties. Notifications can be made so that those responsible for the establishments correct identified non-conformities within established deadlines. Penalties can range from fines, seizure of products, temporary or definitive suspension of activities, to closure of the establishment, depending on the severity of the infractions. [12,56]

The partnerships with legal security systems and health surveillance are essential to guarantee safety, well-being, public health protection, and compliance with standards and regulations related to health and hygiene, for the protection and safeguarding of the population [52,73,78]. The administrative police power has limits of action, so a partnership or joint action with the legal police security forces is necessary, whose purpose is to contain illicit acts typified in criminal legislation, thus guaranteeing health surveillance, and security in public health [73,82,93]. These collaborations aim to protect public health and allow the two institutions to combine their resources and expertise to face problems that involve risks to the health of the population and situations that require a coordinated response to prevent risks, and through joint action work to face a variety of situations, such as emergencies and disasters that may affect the health of the community, entry into homes to comply with complaints, inspections at private company sites or inspection of establishments and incidents arising from complaints [46,48,78].

These partnerships can be especially relevant during emergencies, disease outbreaks, and other activities that involve risks to the health of the population and are crucial to ensuring a more efficient and coordinated response to issues that affect public health and community safety. Which may vary according to the specific needs of each region and local circumstances [66,75,94]. The entities involved must maintain efficient communication and coordinated work to obtain the best results in protecting public health and the safety of the population. Collaboration between police and health surveillance can contribute to a healthier and safer environment for everyone [52,66,94]. Joint action between the police and health surveillance is an effective way to ensure the protection of community health and compliance with health regulations (Table 3). This collaboration must be based on open communication, mutual respect, and understanding of the responsibilities of each institution to obtain the best possible results in promoting public health and safety for the collective [46,78,82,95].

Table 3: Joint actions and partnerships between the Security System and ANVISA.
Actions Description Ref.
Information Sharing The Police and the National Health Surveillance Agency (ANVISA) can provide and share relevant information on public health issues, to strengthen preventive and corrective actions concerning potential public health risks, such as infectious disease outbreaks, environmental risks, poisonings, or biological threats. [52,66,94]
Action in health emergencies In situations of infectious disease outbreaks, natural disasters or accidents, or other public health events, the security system can collaborate with health surveillance to provide logistical support, safe evacuation, and emergency medical assistance, and ensure the safety of the healthcare team and the affected population, and ensure the safety of the healthcare team and assist in the implementation of containment measures, facilitating access to affected areas. [52,78,79,82,94]
Inspection of establishments and sanitary barriers The police and/or other security bodies can assist the National Health Surveillance Agency (ANVISA) in joint operations to inspect commercial establishments, bars, restaurants, markets, and other facilities, to check whether they are complying with health and safety standards. The Police can provide security or support during inspections to ensure the process runs safely. [5,48,75,96,97]
Joint training and capacity building The police and the National Health Surveillance Agency (ANVISA) can carry out courses and training to work together, training professionals and sharing knowledge and skills in the area of security and health surveillance, to deal with specific situations involving public health and safety issues. [49,95,89]
Investigating complaints The police or the legal authorities can investigate and execute reports related to activities that pose risks, and that could compromise the health of the population, the police can then work together with health surveillance to identify and address situations of risk to public health. [52,78,94]
Preventing and combating illegal acts and activities related to health The police can work together with the National Health Surveillance Agency (ANVISA) to identify and combat the illegal marketing of health products, counterfeit medicines, adulterated food, or other illicit activities that may pose a risk to the health of the population [48,82,90,96]
Awareness campaigns and integrated communication Administrative and legal institutions can work together to develop educational campaigns to inform the population about health, hygiene, and safety issues, promoting awareness and prevention of problems related to public health. [46,48,82,96]
Planning for large events In events that bring together a large number of people, such as festivals, demonstrations, or sports games, the security system and the National Health Surveillance Agency (ANVISA) can work together to guarantee the safety and health of participants. [52]

Notification is the most common way to deal with irregular situations, that is, those that may pose health risks and require immediate corrective action. Based on the assessment of technicians and agents, considering current legislation and the nature of the irregularity, a deadline is set for adjustments to be made. When corrections are made within the stipulated period, the health license may be granted or reactivated. Otherwise, a new deadline is set, or punitive measures are taken, such as issuing a notice of violation or closing the establishment, depending on the degree of danger to public safety [58,76,99]. It is important to highlight some initiatives carried out by the National Health Surveillance Agency (ANVISA) in Brazil, among them, the National Program for Verification of the Quality of Medications stands out, intending to monitor the quality of medications used by the population. Another relevant project is the Notifying Pharmacies, which aims to expand the sources of notification of possible adverse reactions and technical problems related to medications. It is also worth highlighting the EducAnvisa project, which aimed to develop actions and strategies focused on health education and communication, seeking to reach different groups in society [58,100-102]. The sanitary inspection within its regulatory attributions is concluded with the preparation of a report that describes the characteristics and sanitary conditions of the establishment, in addition to the measures taken during the process. This report follows a standard model that includes information such as the identification of the establishment, details about the inspection carried out, its objective, the people consulted, the record of the situation found, the actions adopted, and the final considerations, among other items [58,67,103,104].

The administrative police power is an essential prerogative of the State and consists of the ability to condition or restrict the use and enjoyment of goods, rights, and activities in the public interest. In the context of the National Health Surveillance Agency (ANVISA), this power is exercised to protect the health of the population, and regular economic activities, and ensure standards of quality, safety, and efficacy of health-related products and services. The National Health Surveillance Agency (ANVISA) uses its police power to establish technical standards, and inspections and apply assessments when necessary (Table 4), to protect public safety and society as a whole [71,105,106]. Its focus is on activities such as the regulation of medicines, food, cosmetics, health products, sanitizing products, and health services. The approach adopted by the agency combines preventive, normative, and repressive aspects, in line with the constitutional principles of legality, proportionality, and efficiency [107-109].

Table 4: Analysis of ANVISA Police Power approaches.
Approaches Description Ref.
Normative Aspects of Police Power One of the most important aspects of the administrative police power of the National Health Surveillance Agency (ANVISA) is the issuance of technical standards and regulations. The agency defines mandatory requirements that aim to ensure that products and services sold in Brazil meet the established health standards. These regulations are based on scientific evidence and aim to balance economic development with the protection of public health. [58,65,110,111]
Supervision and Control The National Health Surveillance Agency (ANVISA) also exercises its administrative police power through regular inspections and surveillance. These processes verify the compliance of companies and products with current regulations. Inspections can be carried out at facilities, factories, ports, airports, and borders, ensuring that only items suitable for public health enter or remain on the market. [112-115]
Sanctioning Power The sanctioning power or administrative sanctioning law is one of the main expressions of the police power exercised by the National Health Surveillance Agency (ANVISA). It is the administrative authority to apply in advance to individuals or companies that fail to comply with health regulations or put public health at risk. This power is essential to ensure compliance with regulations and guarantee the protection of public health. [68-70,116]
Principles and Limits The National Health Surveillance Agency (ANVISA) plays a fundamental role in the protection and promotion of public health, and as a regulatory institution, its actions are guided by principles that ensure transparency, legality, and justice, in addition to limits by legal principles that avoid excesses such as reasonableness, proportionality and due process of law, and ensure respect for the fundamental rights of citizens and companies. These limits are essential to avoid abuses and ensure that state intervention occurs only when there are necessary intentions, and in a manner appropriate to the action and need for the exercise of the administrative police power of the National Health Surveillance Agency (ANVISA). [47,74,117-119]
Impact and Relevance The actions of the National Health Surveillance Agency (ANVISA) in the use of police powers have a direct impact on the health of the population and the strengthening of the Brazilian regulatory system. By ensuring that standards are complied with and harmful practices eliminated, the agency contributes to collective protection and sustainable development. [120-122]
Legal Basis The sanctioning power within the legal basis of the National Health Surveillance Agency (ANVISA) is provided for in several laws, such as Law No. 6,437/1977, which deals with violations of federal health legislation, and Law No. 9,782/1999, which created ANVISA and distributes its powers. In addition, the Federal Administrative Procedure Code in Law No. 9,784/1999 guides the sanctioning procedure, guaranteeing due process and the rights of the citizen. [3.123-126]
Violations and Sanctions The National Health Surveillance Agency (ANVISA) is competent to identify and punish situations of infractions in several areas under its administrative regulation in situations or cases of irregular manufacturing or marketing of medicines, failure to comply with labeling and advertising standards, and infractions in health services. The applicable provisions vary in severity, according to the nature of the infraction, and include fines proportional to the severity of the infraction, and may even result in arrests in partnership with the police power and the public security of the legal power in situations of flagrant crime, closure of establishments or suspension of activities. Also, in the administrative sphere, the collection of private materials that threaten public health and the temporary or permanent cancellation of registration or health license may occur. [127-130]

The health police power exercised by the National Health Surveillance Agency (ANVISA) has been fundamental in ensuring the quality and safety of products and services offered to the population. Through inspection actions, the ANVISA has been able to identify and correct irregularities that pose risks to public health, avoiding disease outbreaks and preventing harm to the population [2,12,55]. Through inspection actions, the National Health Surveillance Agency (ANVISA) has led to the improvement of sanitary conditions in establishments, encouraging the adoption of good practices and compliance with standards. This results in a safer environment for consumers and workers, contributing to the reduction of risks of contamination and food poisoning, for example [10,18,52,53,90,91]. The police power of Health Surveillance also has an educational and preventive role. Through the guidelines and corrective measures applied, the National Health Surveillance Agency (ANVISA) contributes to raising awareness among those responsible for establishments and to the dissemination of good health practices. This results in greater adherence to sanitary standards and a general improvement in sanitary conditions in establishments [13,15,18-20,52,55,56,73].

The detentions carried out by ANVISA agents are extreme measures and are generally applied in situations where there is a serious risk to public health or when there is repeated disregard for health standards. The purpose of these arrests is to immediately stop activities that pose a danger to people’s health and lives. Upon finding a situation of serious irregularity, the ANVISA agent may issue an interdiction order, which is an administrative measure that determines the suspension of the establishment’s activities. This order is notified to the person responsible for the establishment and can be communicated through a formal document [131,132]. The interdiction order can be temporary or definitive, depending on the severity of the situation. In the case of a temporary closure, the establishment is prevented from operating until the non-conformities are remedied and the National Health Surveillance Agency (ANVISA) carries out a new inspection to verify regularization. In the case of definitive closure, the establishment is permanently prevented from operating, due to chronic problems, irreparable risks, or recurrence of serious infractions [12,17,18,90,92,133]. The National Health Surveillance Agency (ANVISA) has the power to close establishments in various sectors, such as restaurants, bars, food industries, pharmacies, clinics, and hospitals, among others. The interdiction decision is based on technical criteria, taking into account the potential health risk and non-compliance with health standards [12,17,90,131,133].

It is important to highlight that, upon being closed, establishments have the right to present a defense and seek to regularize the situation. After regularizing non-conformities, the establishment may request a new inspection from the ANVISA to re-evaluate its condition and, if approved, obtain authorization to resume its activities [17,133]. In extreme cases, in which there is evidence of crimes against public health, the National Health Surveillance Agency (ANVISA) may forward complaints to the Public Prosecutor’s Office or competent authorities, so that appropriate legal and judicial measures can be taken [12,17,72,92,131,132]. The arrests carried out by ANVISA agents aim to guarantee the safety and health of the population, immediately interrupting activities that pose serious risks. These detentions occur through interdiction orders, whether temporary or permanent and are based on technical and legal criteria. Establishments have the right to defense and can seek to regularize their situation to obtain authorization for activities [17,18,90,92,133].

The effective performance of Health Surveillance also has significant impacts on preventing disease outbreaks and epidemics. By identifying and correcting inappropriate practices, the National Health Surveillance Agency (ANVISA) helps prevent the spread of pathogenic agents and reduce the risk of contagion in collective environments, such as hospitals, daycare centers, schools and restaurants. Through these prerogatives, the police power of ANVISA is an essential tool to protect public health [75]. Through standards, inspection, and corrective measures, the ANVISA plays a fundamental role in the principles of public administration under the police power with distinct mentions in the economic, health, and legal-political areas, which assist in the prevention of diseases and the promotion of a safe environment for the population [134]. It is necessary to recognize and value the work carried out by this institution, which directly contributes to the well-being and quality of life of everyone, through the construction and contribution of a culture of health responsibility and by strengthening the population’s trust in products and services offered [19,70,75].

The National Health Surveillance Agency (ANVISA) also faces some public security challenges, with recent highlights including the main types of attacks suffered by the civilian population, private business sectors, some politicians from the legislative and executive branches, in the environments of open television networks and newspapers in public concession broadcasters, in virtual environments and invasion of hospitals by denialists with conspiratorial agendas, which occurred mainly in 2017 and 2018 and also during the SARS-Cov-2 pandemic [135-140]. Among them, Fake News has seen a significant increase, accompanied by other crimes, such as political corruption, institutional theft, misappropriation of public funds earmarked for health, and certain types of fraud related to health security. It is worth noting that in the health area, the most commented and researched topics include attacks by anti-vaccine people, medications that are not proven to work for certain types of diseases, health misinformation on social networks, and the possible side effects of some medications or vaccines and suggestions of possible “miracle diets” not proven by science [77,135,136,140-145].

Compliance with health standards promotes the quality and safety image of establishments, increasing consumer satisfaction and promoting competitiveness in the market [18,90,91,131]. The results achieved by the Health Surveillance police power are significant and impactful. The institution’s preventive and supervisory activities contribute to reducing risks to the population’s health, preventing disease outbreaks, food poisoning, and the proliferation of pests, among other problems [15]. Furthermore, the Health Surveillance police power also promotes health education, encouraging the adoption of good practices by establishments and raising awareness in society about the importance of public health [18-20,88,91]. However, it is important to emphasize that the exercise of police power by Health Surveillance must be guided by transparency, impartiality, and respect for individual rights. It is necessary that inspection actions are based on clear technical criteria and that there are communication channels so that those responsible for establishments can present their defenses and resolve any doubts [13,15,16,52,90,146].

Inspection is one of the main activities carried out by the National Health Surveillance Agency (ANVISA), to ensure that good operating practices and other requirements established by current health legislation are strictly complied with. To improve the operations and efficiency of the ANVISA sector, it is recommended to adopt additional tools and technologies capable of automating repetitive tasks, such as the initial evaluation of documents and monitoring of license deadlines, aiming to reduce risks to both individual and collective health. Another important point would be to increase the inspection team, which would allow for more comprehensive coverage of establishments, in addition to improving response to complaints and strengthening preventive inspection actions [147-150].

Another recommendation would be the sanitary inspection of Health Services and Services of Interest to Health (SSIS), which is one of ANVISA’s main actions, and the standardization of inspection processes and documents (POP-GTT) that aims to improve the process of sanitary inspection of Interest to Health. The implementation of standardized processes is an optional practice for states and municipalities, and for its effectiveness, the professionals involved must have technical knowledge, considering regional particularities and federal standards. The presence of qualified inspectors and agents is essential to ensure the uniformity and effectiveness of the process. Invest in programs to organize registration information, for better tracking of possible occurrences among establishments and education sectors, and to increase awareness among private owners, improving control and inspection processes to encourage practices that reduce the occurrence of infractions, as well as reoccurrences and consequently, reduce the number of complaints. These initiatives aim to optimize work processes, alleviate team overload, and simultaneously strengthen public health through more efficient preventive actions [147,149,151,152]. Most importantly, the police power of the National Health Surveillance Agency (ANVISA) plays an essential role in protecting public health. Through standards, inspection, and corrective measures, this institution seeks to ensure that the population has access to safe products and services, contributing to improving quality of life and preventing diseases [9,15,52]. The police power of ANVISA is a valuable tool that must be exercised with responsibility and commitment, always aiming for the collective interest and the promotion of the common good [2].

The health police power exercised by Health Surveillance is fundamental to guarantee the quality, safety, and conformity of the products and services offered to the population. Through rigorous inspection actions, the institution identifies and corrects irregularities that pose risks to public health, preventing disease outbreaks and harm to the population. Furthermore, the activities of Health Surveillance promote the dissemination of good health practices, contributing to the general improvement of health conditions in establishments. The arrests carried out by Health Surveillance agents are extreme measures, applied in situations of serious risk to public health or repeated disregard for health standards. Temporary or definitive closure orders aim to immediately stop dangerous activities, but establishments have the right to present a defense and seek to regularize the situation. The preventive and supervisory actions of Health Surveillance are crucial in preventing disease outbreaks and epidemics, contributing to protecting the health of the population. The institution also plays an educational role, raising awareness of the importance of public health. The exercise of police power by the Health Surveillance must be transparent, impartial, and respectful of individual rights. Action must be based on clear technical criteria, providing communication channels for presenting defenses and clarifying doubts.

The National Health Surveillance Agency (ANVISA) plays a crucial role within the scope of administrative police power, ensuring the protection of public health and the application of health standards throughout Brazil. Its preventive and supervisory nature is highlighted by its constitutional exercise of police power, which combines preventive and supervisory actions, seeking to balance individual rights and collective well-being. The National Health Surveillance Agency (ANVISA) regulates activities related to medicines, food, cosmetics, health services, and other products and services of health interest, ensuring compliance with legal and technical standards. All of ANVISA’s actions are based on specific legislation that guides its powers and limits its interventions. The police power exercised must respect the constitutional principles of legality, proportionality, and efficiency. The agency is responsible for inspecting establishments, products, and services, in addition to granting health authorizations for the operation of regulated activities. This action aims to minimize health risks and promote consumer safety. When violations of health regulations are identified, the National Health Surveillance Agency (ANVISA) may adopt coercive measures, such as fines, bans, and product recalls, always following legal procedures. These actions aim to correct irregularities and protect the population from possible harm to health. In addition to punitive actions, the National Health Surveillance Agency (ANVISA) invests in educational and awareness programs aimed at companies, health professionals, and society, to promote voluntary adherence to standards and strengthen the culture of health safety. The work is strengthened by partnerships with other institutions, such as state, municipal, and federal public safety services, as well as inspection agencies, which allows for an integrated and more effective approach to the exercise of police power. The National Health Surveillance Agency (ANVISA) is always seeking to innovate its practices, incorporating new technologies and monitoring methods to optimize its performance, increase transparency, and improve the efficiency of its regulatory activities.

The work of the National Health Surveillance Agency (ANVISA) is essential to guarantee the safety and efficacy of products and services that impact public health. In this context, it is always necessary to make some recommendations that can contribute to improving its regulatory and surveillance actions, and to increase investments in technical training programs and partnerships with universities and research centers, to ensure faster and more robust analyses of medicines, vaccines, and other health technologies. Strengthening pharmacovigilance and technovigilance systems, with special attention to the use of BIG-DATA and artificial intelligence, to identify adverse events and problems related to products in use by the population at an early stage. Intensifying communication strategies to inform society in a clear and accessible manner about regulatory decisions, risks and benefits of products, and ongoing actions. This strengthens public confidence in the work of the National Health Surveillance Agency (ANVISA). Develop more agile mechanisms for approving technological innovations, such as biological drugs, gene therapies, and cutting-edge medical devices, maintaining scientific rigor but reducing unnecessary bureaucracy. Expand collaboration with international regulatory agencies to align regulatory standards, exchange critical information, and expedite the entry of essential products into the national market. Implement educational programs aimed at pharmacologists, physicians, and other health professionals on the rational use of medicines and reporting of adverse events, creating a continuous flow of information between ANVISA and leading professionals. Consider regional specificities when implementing policies, ensuring that populations in remote or less-favored areas have safe and equitable access to health products and services. Create ongoing campaigns to debunk false information about medicines, vaccines, and treatments, promoting the dissemination of reliable, science-based content.

In short, the observations reinforce the crucial importance of the National Health Surveillance Agency (ANVISA) as the highest authority in guaranteeing health security, intending to protect public health in Brazil. The agency firmly and uncompromisingly exercises its administrative police power to regulate, monitor, and intervene in activities related to medicines, food, cosmetics, health services, and other essential products. As the guardian of public health, ANVISA ensures strict compliance with health standards, eliminating risks to public health and promoting the quality of products and services consumed. The administrative police power of the National Health Surveillance Agency (ANVISA) is not just a tool, but an indispensable imperative to ensure the balance between individual rights and collective well-being. Its role is decisive in protecting public health, ensuring that only safe and regulated products and services are accessible to the population, preventing diseases, and promoting quality of life effectively and ethically.

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