In Brazil, health is "a right of all and a duty of the State" (Art. 196. Brazilian Constitution. 1988), which places the Unified Health System (SUS) as an international reference, due to its size, scope, free access and other aspects that differentiate it from health systems in other countries.
This right translates into a series of challenges for the Brazilian State, such as the standardization, promotion, management and control of SUS, as well as the regulation and control of actions, products and services available to its users. This article will address these points, map the market, the institutions responsible for regulation, and point out the main challenges in this area.
The health market
The health market, the sector so-called regulated by Anvisa, is extremely heterogeneous and complex in its different segments and subsectors, taking into account mainly the diversity of existing products and the use of highly sophisticated technologies both in their development and in production and use.
From an economic and market point of view, the pharmaceutical and medical device areas can be considered those that generate the greatest demands for health regulation, as they have large global companies coexisting with small and medium-sized local companies.
There is a dominance of large multinational companies in all pharmaceutical, medical device and even cosmetic segments. However, there is a large number of small and medium-sized manufacturers, which historically suffer the reflections of the weight of regulatory evolution and economic fluctuations in the Country and the world.
The pharmaceutical industry is a great example of this scenario. While in the period from 1996 to 2014 there was an increase in the number of companies manufacturing chemical products as a whole (23.1%), there was also a decrease in the number of companies in the classes of pharmachemical products (-43.8%), in the group of pharmaceutical products (-11.7%) and medicines for human use (-13.4%), which suggests the occurrence of industrial concentration in these sectors.
Such possible concentration corresponds to the international movement of the pharmachemical and pharmaceutical industries (VARGAS et al., 2014; MITIDIERI et al., 2015). According to the same author, the drops verified in the pharmachemical sector, both in the number of companies and in occupied personnel, suggest that, more than the occurrence of concentration, there would have been a deindustrialization in the sector.
The medical device segment is not much different. Data from the Brazilian Association of the Medical, Dental, Hospital and Laboratory Articles and Equipment Industry (ABIMO) point to a market of apparent consumption and participation of national industry, in the period 2015 to 2017, below 25% with a tendency for recovery in 2018, reaching 42%.
Such results are consistent with some hypotheses of reprimarization of the economy raised by several authors (CARCANHOLO, 2010; CANO, 2012; GONÇALVES, 2013; PINTO; GONÇALVES, 2016; GIOMO; BARCELOS, 2016). This condition demonstrates growing dependence on imports of medicines and health products and the vulnerability of the country's productive park, both from a sanitary and economic point of view.
Health regulation in Brazil
Health regulation in Brazil is not recent. Oswaldo Cruz, in the 1900s, already carried out control, regulation and containment actions, especially in the Port of Santos devastated by the bubonic plague, or even the imposition of vaccination of the population to contain the escalation of yellow fever. At the time, such actions of a sanitary nature also caused a commercial, market and social impact in Brazil.
Today is no different. Any action by Anvisa or agents that make up the Health Surveillance and Health Surveillance System (SVS) generates an impact on the Brazilian market and economy, and changes customs to population actions. A recent example is the global insecurity caused by the advance of the coronavirus COVID-19. Containment and control actions are causing significant losses in the global economy, in addition to the lack of certain types of protection and prevention products, due to excessive consumption and lack of raw material.
For each case or situation, the urgent use, by Health Surveillance, of prevention, control and mitigation measures for risks, damage and harm to public health in situations that can be epidemiological (outbreaks and epidemics), disasters, or lack of assistance to the population, can be the preponderant factor to obtain positive results in the eradication, elimination, reduction of incidence, reduction of severity and reduction of lethality/mortality.
The technical-scientific knowledge that one has of risk factors, transmission, clinical pathophysiology and therapeutics of the disease, as well as the availability of resources and the urgency/emergency that the case requires, influence the setting of decisions and strategic actions to be taken by public managers.
It is in this scenario that Health Regulation has presented itself over the years, in its regulatory framework, not only as a strategy to protect the health of the population, but also as an important institution for maintaining an isonomic and safe market for the national industry and the Brazilian population.
Thus, developing tools and carrying out surveillance actions (prevention, control, management and risk management, monitoring and evaluation) that provide knowledge, detection and identification of any change in the determining and conditioning factors of individual and collective health caused by diseases, including the production, commercialization and use of medicines, medical devices, cosmetics and sanitizing products, is strategic and of public relevance.
On the other hand, repeated failures of government or governance in the face of a state public sector subjected to various political-administrative problems make up the arguments that invigorate the doctrine of the free market or that of the self-regulating market.
However, it is valid to clarify that, at the same time, not all market liberalization experiences have been successful. Clear examples are the results in the world economy in the crises of 2003, 2008, 2013, 2015 and the current 2020, generating difficulties in the production chain and access to products and services to the population.
During this period, it became evident that, regardless of ideological trends, there is a convergence towards understanding the point of view that pointed to the State as necessary, to correct market vices such as monopolies, negative externalities, piracy and informational asymmetry.
Agencies and Public Policies
The performance and competencies of regulatory agencies in Brazil is a subject of frequent debate. The institutional understanding of the distinction between the roles of regulatory and supervisory bodies and the Ministries, one as a formulator of Public Policies and the other as executor of these policies through regulatory activities, is part of the work agendas of the Executive, Legislative and Judiciary branches, fostered by the market, but with little active and real participation from civil society.
However, considering that such debates are far from over, frequently the competencies of the agencies, especially that of Anvisa, have been questioned and distorted, in addition to being urged to manifest on possible extrapolations of their normative power, with the definition of rules that would not be grounded in hierarchically superior legal structures.
Thus, the National Congress continues with creations of laws that oppose the role and decisions of regulatory agencies, such as, for example, the release of a list of pesticides, until then, prohibited by Anvisa.
These questions lead to a reflection on the strategic alignment between the regulation process and sectoral public policies, in addition to coordination between regulatory bodies, the respective ministries to which they are linked and the National Congress itself.
Strategies such as signing a management contract between Anvisa and the Ministry of Health help better define their roles, the best way to execute and support Public Policies, establishing goals and execution controls for their actions.
Agencies in the Brazilian State scenario
It is clear and evident that regulatory agencies play a fundamental role in the economy, especially with regard to the regulation of monopolies, the establishment of rules that discipline market competition and the so-called social regulation (in which the objective is not economic regulation, but the guarantee of universal service provision).
These autarchies present a great capacity to influence the implementation and effectiveness of Public Policies. However, it is essential to have real understanding that the competencies and focus of action of regulatory agencies, provided by law, is to guarantee security, protection and control of risk through the use of goods and services.
In this sense, the constitutional principles that guide their state normative activities are legality and separation of powers, historical instruments of balance of power and citizen protection, being indispensable, the verification of the compatibility of these principles, interpreted according to our Constitution, with the regulatory power destined, by infra-constitutional laws, to the Regulatory Agencies.
The federal Regulatory Agencies already created in our order and that have a direct relationship with the productive chain and health sector market are:
• National Electric Energy Agency - ANEEL, created by Law nº 9.427 of 12/26/96, linked to the Ministry of Mines and Energy, whose purpose is to regulate and supervise the production, transmission, distribution and commercialization of electric energy;
• National Telecommunications Agency (ANATEL), created by Law nº 9.472 of 07/16/97, linked to the Ministry of Communications, as the regulatory body for telecommunications;
• National Petroleum Agency (ANP), created by Law nº 9.478 of 08/06/97, linked to the Ministry of Mines and Energy, with the purpose of promoting regulation, contracting and inspection of economic activities integrating the oil industry;
• National Institute of Metrology, Quality and Technology (Inmetro) is a federal autarchy, linked to the Special Secretariat for Productivity, Employment and Competitiveness, of the Ministry of Economy. The Institute acts as Executive Secretariat of the National Council of Metrology, Standardization and Industrial Quality (Conmetro), inter-ministerial collegiate, which is the normative body of the National System of Metrology, Standardization and Industrial Quality (Sinmetro). Created by Law 5.966, of December 11, 1973.
• National Health Surveillance Agency (ANVISA), created by Law nº 9.782 of 01/26/99, linked to the Ministry of Health, with the purpose of promoting the protection of the population's health, through the health control of the production and commercialization of products and services subject to health surveillance, including the environments, processes, inputs and technologies related to them, as well as the control of ports, airports and borders;
• National Supplementary Health Agency (ANS), created by Law nº 9.961 of 01/28/00, linked to the Ministry of Health as a body for regulation, standardization, control and inspection of activities that guarantee supplementary health care, regulating sectoral operators, including regarding their relations with providers and consumers.
From the scenario presented, it appears that the economic activities covered by the control of the created Agencies present high public interest and directly affect citizens' fundamental rights.
Furthermore, as a rule, they are activities that involve substantial investments, and therefore, in general, are exercised by companies with large size and economic power and low level of competition, which makes state regulation demanding.
As mentioned earlier, regulation itself presents itself as an important part of a complex control system for health care products and services, acting with the aim of protecting population health, supported by strategies and actions aimed at reducing risks associated with the consumption of these products.
It is worth remembering that historical crises involving adverse events, lack of quality or control of health products and/or services justify a robust, efficient and secure regulatory process. We can present some examples: accident with radioactive product cesium 137 in Goiânia in 1987, the hemodialysis tragedy in Caruaru and region in 1996, the metallosis process – implants in 2003, PIP breast prostheses in 2012, among many others, that we could have a long publication exclusively on the topic and we would not be able to exhaust it and more recently the coronavirus – COVID-19 generating widespread panic in the world due to the fragility of information and the cult of fear.
The product-subject-institution-society relationships, movements generated or imposed on the health sector by the 4th industrial revolution (Industry 4.0 and Health 4.0) – involving interoperability of technologies, Artificial Intelligence, connectivity between points of care (patient, health professional, services / products), augmented reality among others – challenge regulation to support the process of innovation and technological development while coexisting with facing the different health crises in the country and the world.
In this sense, the agencies play a fundamental role in the process of research, development and technological innovation, and especially in facing some challenges brought by the movement of Industry and Health 4.0:
• Remodeling of social insertion.
• Increase partnerships between companies, universities and research institutes;
• Map and understand the country's technological competencies;
• Stimulate interaction and technological exchange between industrial sectors and Universities;
• Understand the role of equity in health valuation;
• Health centered on the patient and not on the professional and/or service;
• Consider the territory as an important variable in the value model;
• Socialize information intersectorally (justice, market, professionals, citizens, sectors of organized civil society)
Thus, the regulatory process will potentialize the agenda for a new context of development and market in health, in the relationship with health professionals and managers and organized civil society.
* Joselito Pedrosa
Has a degree in Biology, from the University of Taubaté/SP (1996), Specialization in Educational Processes in Health with emphasis on competence evaluation, from the Teaching and Research Institute - IEP of the Sírio Libanês Hospital-HSL (2017), Specialization in Health Surveillance, also from IEP/HSL (2107), in Active Teaching Methodologies and Hospital Clinical Management from IEP/HSL and Dom Cabral Foundation-FDC (2010), Specialization in Health Care Management from IEP/HSL and FDC (2009), Specialization in Molecular Biology from the University of Taubaté/SP (2001) and Specialization in Clinical Pathology from the University of Mogi das Cruzes/SP (1997). With solid experience in public management, built over 24 years of activity, in his last activity as a public manager he accumulated the functions of General Coordinator of Regulatory Affairs and Substitute Director of the Department of the Industrial Complex and Innovation in Health of the Secretariat of Science and Technology and Strategic Inputs of the Ministry of Health. Currently, CEO – founder of Navegador JP2 Consultoria Empresarial e Gestão em Saúde.
