The National Health Council in the COVID-19 pandemic: an analysis of the normative and non-normative acts between 2020 and 2022

The present article presents the outcomes of the normative research on the combat against the COVID-19 pandemic at the National Health Council (Conselho Nacional de Saúde – CNS) from February 2020 to March 2022. This is a documental, descriptive-analytical study, with qualitative approach, using the technical analysis of content. Seventy-seven acts were issued by the CNS Collegiate, there included 63 recommendations, 6 opinions, 5 motions, 2 technical notes and 1 resolution. Most part of the documents (59%) were worked out during the first year of the pandemic. Despite the Council’s performance when combating the COVID-19, non-binding acts may be highlighted, the CNS normative production concentrating in merely guidance recommendations.


Introduction
The social control consolidation in the health area took place as the 1988 1 Constitution was consolidated, followed by Laws Nr. 8080, as of 1990 2 , and Nr.8143, as 1990 3 , which did institutionalize both the guidelines and the principles of the Unified Health System (Sistema Único de Saúde -SUS).
The National Health Council (CNS), a permanent and deliberative organ of the SUS, counting on representatives of different social actors 4 , is legally in charge of formulating strategies and controlling the execution of the health policy, there included logistic, economic and financial aspects; and of supervising, accompanying and monitoring the health public policies, directing the population's need to health management.
The SUS was created under Law Nr. 378, as of January 13, 1937 5 , aimed at assisting the Education and Health Ministry as to subjects under its responsibility.As that ministry was separated into Health and Public Education, the CNS was ruled by Decree Nr. 34.347, as of April, 1954 6 , with nothing more than consultive competence.In 1970, as the Decree Nr. 67.300 7 was passed, it gained competence to issue non-binding opinions on health-related subjects.
On January 14, 1987, as the first glances of the social control growth came up in the country, the Decree Nr. 93.933 8 was issued meant to establish both the organization and the attributions of the CNS, with binding normative and advisement functions to assist the Ministry of Health.
Nevertheless, the Executive Power did not recognize the full competency of the CNS to produce normative resolutions but on July  11, 2006, when Decree Nr. 5.839 9 was issued.
Resolution Nr. 407/2002 10 , which approved CNS Internal Rules, determines that: Art. 57A -1 st pgf.-The Opinion is a public technical-political, well-founded and circumstanced pronouncement, which indicates the solution for one certain subject, consultation or administrative process on which the CNS is required to manifest.Art.57A -2 nd pgf.-The Technical Note is an internal act produced by the Executive Secretariat of the CNS, with instructional character, aimed at subsidizing the Directive Board and the Plenary Sitting of the CNS concerning subjects related to administrative, judicial and political matters that might require deeper consideration in order to guide debates and deliberations by the board.Art.58 -'The Resolution is a general act, with normative character.'Art.59 -The Recommendation is a suggestion, warning or advice concerning the content or execution procedures of sectorial and strategic policies, or on the convenience or opportunity of adopting one specific arrangement.Art.60 -The Motion is a means for manifesting approval, recognition or repudiation as to one certain subject or fact.[original not underlined].
Nevertheless, it must be remarked that, out of all the normative and technical-political types issued by the CNS, the Resolution is the only one with binding form of its content: they are the normative acts the Health Council makes use of to exert its social control 11 .
According to Di Petro's 12 definition, normative acts are general acts that reach all those in the same situation.They are practiced by the administration, and include orders, resolutions, decrees, rules, with either general or abstract effects.A number of administrative departments receive from their guiding laws the ability to rule the subjects affected by normative acts.Furthermore, provided issued respecting the Constitution and the laws, they are binding acts that oblige administrative authorities.
Within a few weeks, the COVID-19 pandemic led to a deep crisis that changed the economic, social, political and cultural dynamic worldwide.As they faced the crisis, governments reacted differently, and those differences reflected public policies options which led to different effects as well.In some cases, crises got even worse; in other cases, effects went softened, as well as the multiple inequalities that had previously gone deeper 13 .In this sense, actions had to be organized all over the health system management, and actions had to take place regarding both the economy and the legislation, there include the infra-legal level.
The CNS does not evade from its important role in the scenario of sanitary emergencies: its history tells actions in epidemics situations and as contributor to the process of formulating and executing health policies, as the HIV/ Aids (the Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome) and the Zika Virus (ZIKV).
Soon after the Administrative Rule Nr. 188/2020 14 was issued -the normative that declared the Public Health Emergency with National Importance (ESPIN) caused by the Human Infection by the Coronavirus -2019-nCOV -, the CNS organized its site atm the internet with both its normative and nonnormative production on the pandemic.Those data are grouped in the panel 'Special CNS in the confrontation with the COVID-19' (http:// conselho.saude.gov.br/especial-cns-no-enfrentamento-a-covid-19) 15 , thus indicating that the CNS did issue important acts aimed at the confrontation of the COVID-19.
The above led to the purpose of building up the documental study on the repository of normative and technical-political acts of the Council over the period since the ESPIN was declared until 2022, so as to get to know and to analyze the acts brought up by the CNS on the confrontation of the COVID-19 pandemic.

Methodology
This is a descriptive-analytical study with qualitative approach, with content analysis of both normative and technical-political documents produced by the CNS.
The research was built-up based on the following acts: resolutions, recommendations, motions, opinions and technical notes.The documents, free for public access, produced from February 3, 2020, to May 22, 2022 As the floating 17 reading of the acts was complete -that is, the normative and non-normative documents submitted to the analysis -, those that included at least one descriptor in the text or the list were chosen, those that did not fulfill the criteria were discarded, thus remaining 77 acts.
The documents were organized according to the type so as to identify the numeric ratio of each act studied herein.
As to the recommendations, because they were the larger number of documents, the option was to organize them and put them into categories based on the themes, defined after the complete reading of the acts, so as to compare the entire production.
The full wording of the opinions was accessed by means of documents annexed to the recommendations, as they were not available separately.Technical notes were located on the browser tabs 'CNS contra Covid', which include the panel 'Especial CNS no enfrentamento à Covid-19', following the subtopic 'Notas Públicas' on that panel.

Outcomes and discussion
Out of the total acts issued by the CNS over the period investigated, most part (59%) was concentrated on the first year of the pandemic (table 1).The search for the acts posed some complexity, as the site of the Council was nor updated on the dates the research was carried out.
Considering that the World Health Organization (WHO) declared pandemic state on March 11, 2020, warning it was an unknown disease, thus requiring every person to put into practice measures that would change as the natural history of the disease would be unveiled, the CNS proved diligent to a certain measure, as the acts would deliberate on different contents, such as health preservation and safety of workers in the health area and people in general; the approval and the use of extraordinary resources to confront the pandemic; and recommendations to the National tripartite Coordination for the Combat to COVID-19 and the Inquiry Parliament Commission on the COVID-19, in the Federal Senate House.
Acipreste et al. 11 consider that, in early moments, the CNS seemed to attach greater priority to both the health and the security of health workers, there included residents and trainees, rather than the population as a whole.However, those authors consider -and we agree on that -that the option to 'care of those who care' was correct, as by that time they were the most exposed to the virus, that was not yet properly known.As to the vaccines, the CNS suggested, in Recommendation Nr.21 18 , that workers should be the first group to be assisted, but not necessarily health workers.Recommendation was the most frequently used normative act (81%).It is an act issued by the collegiate or yet by the President of the CNS, ad referendum, consisting in suggestion, award or notice on the content, or in how to carry out sectorial policies and strategies, or yet on the convenience or opportunity to adopt one certain provision.It deals with specific themes or subjects not usually under the straight responsibility of the CNS, but which are relevant and necessary, aimed at institutional entities or the society itself, from whom one certain behavior or providence is expected or required 10 .In this sense, it is a not a very complex act, one that does not depend on homologation by the Minister of Health, and is meant to guide the management as to the need to follow the collegiate concerning the health policy.
In whole, the CNS issued 63 recommendations, dealing with a variety of themes (box 1).It must be remarked that most recommendations were issued on the very first day of the pandemic and became scarce over 2022.Although non-binding, the recommendation is an act requiring not much bureaucracy, which may be published by the collegiate meeting of the CNS ad referendum.On days of COVID-19 crises, this kind of act may be justified when decision-makers must be informed of the necessary provisions, as the act may be issued concomitantly to a number of addressees, being duly homologated by the collegiate the next meeting following the publication.Therefore, during the period under analysis, 97% of the recommendations were passed ad referendum.The exception was the Recommendation Nr. 71, as of December 11, 2020 19 , approved by the CNS plenary in its 66 th Extraordinary Meeting; and Recommendation Nr. 8, as of April 27, 2022 20 , approved by the plenary at its 329 th Ordinary Meeting.
As it is performed by someone without unlimited authority, the ad referendum act will only be valid upon ulterior ratification by the competent authority 21 .
One must keep in mind that such situation came up as both ordinary and extraordinary meetings turned to be not presential, thus making more difficult those discussions involving the themes of recommendations under analysis.
Under CSN Resolution Nr. 645/2020 22 , Art. 4, the collegiate decided that, as long as the ESPIN would in force, meetings should be remote, thus making it easier to carry out previous approvals for the recommendation, which did not occur.It is not clear why remote meetings were not carried out more often, which would have enabled for documents to be issued reinforced by the Plenary Assembly decision.Nevertheless, the CSN President is not hindered from using the ad referendum institute to adopt measures that cannot wait for the regular meeting chronogram, either presential or remote: the President is allowed to do it immediately, giving science to the collegiate as soon as possible.
Graph 1 next presents the addressees of the recommendations.The Ministry of Health was the main addressee, as it is the responsible department for the SUS direction at the Union level.However, the CSN did not disregard the recommendations to all remaining institutions, either direct or indirectly connected to the combat to the pandemic, there included even organs of the justice system.
Among the recommendations issued, one must be remarked: the one on 'Public action specifically by the health service', with 29 documents.Ita content involved different areas, such as health surveillance promotion, pharmaceutical assistance and primary, secondary and tertiary attention, there included measures meant to ensure the health services security.The proposal proves the CSN commitment with facing the sanitary emergency, with special attention to the most vulnerable populations affected by the pandemic.
One example is recommendation Nr. 26/2020 23 , which guided SUS managers to require private beds and to promote one single regulation, thus granting equalitarian assistance.The CSN did acknowledge the importance of the national coordination to guide assistance resources, there include private property hospital beds, to fulfill sanitary priorities case to case.Such measure was an answer to the insufficiency of available beds in the health system -a clear reality as one would observe the waiting roles even in situations of epidemic control.Lack of beds turned to be a concern, revealed by data related to judicial processes against the public health system in Brazil 24 .
Another guideline considered refers to actions related to health care for vulnerable groups.Recommendation Nr. 4/2021 25 stressed the importance of anti-racist actions at health attention services and stimulated full accomplishment of the National Policy od Basic Attention.Data collection on race/color was also stimulated to reduce health inequalities and to protect vulnerable communities.
Those documents are not fully effective, as they lack normative strength and do not enforce any public authority.It is well acquainted that, considering its history and national importance, CNS counts on institutional force to bind authorities, institutions and even private persons to act for granting everyone's health.However, unfortunately, as the recommendations lack normative force, it may every now and then be disregarded by the addressees.
Among the recommendations, those related to 'Revocation, alterations, norms approval or guidance suspension issued by the Ministry of Health' represent 26% of the total.Those acts have specific contents concerning governmental actions in the health area and are meant to influence public policies and rules to combat the pandemic.This theme covers a number of issues, such as the destination of financial resources to acquire materials for COVID-19 prevention procedures, emergence measures for family agriculture and compulsory license for new drugs in cases of national or international emergency, public interest or state of public calamity.
On March 24, Recommendation Nr. 16/2000 26 , one of CSN actions, suggested the immediate revocation of Provisional Measure (PM) Nr. 927/2020 27 , which changed labor rules to combat the pandemic.However, this recommendation was not accepted, as the PM remained in force until July that same year and did only lack validity as the validity term of 60 days as established in the Federal Constitution was over 1 .
The reach of all nine recommendations concerning 'Vaccination as combat strategy' was larger, aimed at important authorities and institutions, meant to ensure access to vaccination and widen the protection for the population.The measures proposed were sent to the Presidency of the Republic, the Ministry of Labor, the Ministry of Health, the Secretariats of Health, the National Congress, the Federal Public Ministry, the National Agency of Sanitary Surveillance (ANVISA) and other relevant entities.The measures proposed included: the withdrawal of materials that could discourage the vaccination; the accomplishment of international commitments; the enlargement of the National Vaccination Plan to reach priority groups; strengthening the Primary Health Care; the protection of pregnant women, those who had just given birth and those who were nursing; and priority to workers exposed to the virus.Such recommendations aimed at holding back the advancement of the pandemic and promoting a coordinate and effective answer for the combat of the sanitary crisis.
At last, with small number of documents issued, recommendations include contents on 'Execution of Technical Opinion' and 'Budget and Finances'.Contents involve carrying out technical opinions issued by the CNS itself, as well as the guidance for budgetary and financial actions, focused on expenses execution and resources transfer for actions meant to combat the pandemic, reaching a reduced number of authorities and institutions.
One recommendation to be highlighted as 'Execution of Technical Opinion' was issued to the Ministry of Education, the Ministry of Health and to the Programs of Residence in Health.Considering the declaration of sanitary crisis, this recommendation would guide those departments to execute the Technical Opinion Nr. 106/2020 28 , on guidance for the work/ performance of residents in health, and male and female workers in health services during the pandemic.Actually, the recommendation would reinforce the importance of technical opinions issued by the CNS, aimed at promoting more adequate and safe performance of health professionals involved in the sanitary emergence.This initiative was intended to grant an efficient answer aligned with the health protocols in a critical moment for public health in the country.
On the other hand, recommendations on 'Budget and Finances' produced greater impact, mainly directed to the Presidency of the Republic and the National Congress.They demanded urgent corrective measures aimed at a more agile budgetary and financial execution of the Ministry of Health, there included transfer of resources for State and Municipal Health Funds and control of health-related public expenses.Furthermore, they involved SUS sub-financing and the importance of fulfilling constitutional financing obligations to make sure the population would be properly assisted during the pandemic.
As to opinions issued by the CNS, they represent 7% of the acts produced over the period.These are about a technical-political-public pronouncement -that is, not normative -, grounded and detailed, which points out to a solution for one certain subject, consultation or administrative process the CSN is called to manifest on.The subject must be analyzed by the CSN Collegiate and may be produced by any of its organs -Directive Board, Inter-sectorial Commissions, Work Groups and Technical Chambers 10 .
Considering that all opinions analyzed were issued to support CNS recommendations, these recommenda tions were organized as indicated by the Commission responsible for the act produced, the subject and the recommendation connected (box 2).
The opinions must be analyzed by the CNS Collegiate, thus suggesting that their validity and relevance are evaluated in a wider context, involving representatives of different sectors of the Collegiate.This collaborative approach and the review by the Collegiate may help granting well grounded, balanced opinions, which represent a more comprehensive vision of health issues on screen, thus considering different points of view and specialties.
By providing solid and well-grounded technical information, such opinions may contribute for the formulation of more effective policies and actions in the public health field.Nevertheless, for not counting on normative character, they do not bind the manager.Furthermore, during the pandemic a common situation was the creation of emergency committees to deal with COVID-19 subjects and, in one certain way, the transfer of the councils to a secondary position.Thus, one may not state that those opinions for the combat of the COVID-19 did actually produce some impact.Motions represent 6% of all acts analyzed.This is a means for the Council to manifest approval, acknowledgement or denial concerning one specific subject or fact 10 .The motions issued by the CNS are described in box 3. Two motions issued are related to projects of law that were under discussion at the National Congress.It is acknowledged that one motion to support the approval or denial of the approval of normative acts under discussion at the National Congress counts on the political force at the Council 29 , although this may not be determinant for the proposal to be either approved or rejected by the Federal House of Laws.The Support Motion Nr. 1/2021 30 was motivated by press news on the situation the Amazonas population has been submitted to due to the lack of oxygen and of adequate treatment conditions.Motions Nr. 8/2021 31 and Nr.10/2021 32 resulted from pronouncements by the President of the Republics -the later, with strong media reaction, due to statements contrary to both scientific authorities worldwide and the WHO.Due to the enormous negative repercussion of the facts, the CNS could not avoid presenting a denial motion.
As to technical notes issued, they represent 25 of CNS acts and represent one internal act, produced by the Executive Secretariat.They have instructive character and are meant to subsidize the Directive Board and the CNS Collegiate on subjects related to administrative, judicial and political processes that might require deeper analyzes as they are to guide debates and deliberations 10 .
Both technical notes identified were produced in 2021, and dealt with vaccination against COVID-19 and actions related to the pandemic control, such as: immediate progress of full vaccination; active search for people who had not received full vaccination; transparency and access to information on the rhythm of doses disaggregated per social markers; implementation of a national plan on surveillance and testing of the population; and implementation of a national plan on monitoring of the epidemiological status in order to identify risk groups to premature reduction of immunity for serious infections etc.
Finally, the resolution represents the kind most seldomly used by the CNS (1%).It is a general act with normative character, resulting from deliberations in the Council that must necessarily be homologated by the State Ministry of Health within 30 days, at most, to assign it the respective official publicity.Should the resolution not be ratified or should no alteration or rejection proposal be sent to the CNS by the manager, the Council may try to validate it judicially and/or by means of the Prosecuting Council, if so required 33 .
Actually, the CNS issued Resolution Nr. 671, as of April 2022 34 , on directives concerning definitions of priorities for health actions and public services in planning processes in the health area for 2023, determining that budgetary and financial programs by the Health Ministry should assign sufficient resources for both the combat do the COVID-19 and other actions and health services.Nevertheless, that resolution was not homologated by the Minister of Health, probably due to insufficiency of time for the sanitary authority to provide the President of the Republic with information to produce the competent Project of Law of Budgetary Directives (Projeto de lei de Diretrizes Orçamentárias -PLDO).According to 1988 Constitution 1 , the National Congress must receive that Project of Law every year until April 15, maximum.
As the resolution was published five working days before that deadline, its nor homologation is justified for untimeliness.However, that does not reflect low effectivity of an act issued by the CNS in actions meant com combat the COVID-19, nor does it reflect lack of prestige, as the PLDO and even the Annual Budgetary Law (Lei Orçamentária Anual -LOA) -included the proposal in the Resolution Nr. 671 34 .

Conclusions
A number of acts have been issued by the CNS, a locus of permanent deliberation when confronting the COVID-19 pandemic, as long as ESPIN was in force.
The CNS site is outdated, particularly browser tabs meant to inform on normative and ethnic-political acts, putting all together files referring to years 2020 and part of 2021.Furthermore, the way those tabs are organized makes quite difficult the interaction with the user, requiring much time to find acts like those analyzed in this paper (opinions associated with recommendations, technical notes on tabs referring to public notes).
During the most critical period of the pandemic, the CNS focused on its nonnormative performance, those acts that do not oblige the public manager.Besides, the only resolution issued was passed as late as 2022, no longer feasible due to the lateness and the lack of homologation by the Minister.Considering its national importance, the CNS should have used more often this normative expedient, as this is the only one with binding effect.But it did not.
Over the period from 2020 and 2022, the CNS was quite profitable when issuing recommendations that, although not binding, could be delivered to any public department, even simultaneously.Almost all recommendations issued over that period were ad referendum -an alternative that, although accepted in the rules, points out to difficulty for the members to get together, which is not desirable, mainly considering the possibility to carry out remote meetings, which is duly accepted.
One must consider that social control is a complex process that faces a number of obstacles to turn effective.However, we must keep in mind the priority of health conscience as an indivisible asset that requires the commitment and the cooperation of all actors involved -health authorities in special.It is therefore suggested that other studies should be carried out, so as to give rise and divulge issues concerning the CNS operation, aiming at strengthening the participation of the community in the health context, so that it may hold on and support itself over time.

Art. 4
th : CSN remote meetings carried out as long as the Public Health Emergence and the public calamity state should be in force due to the COVID-19, respected CSN Internal Rule, will be carried out by means of a digital platform, using remote access […].

Box 3 .
Synthesis of Motions issued by the CSN over the period from 02/03/2020 to 05/22/2022 Number Content 3/2020 Support to Bill Nr. 1462/2020 on the concession of compulsory, temporary and not exclusive license for patent exploitation 1/2021 Support to Amazonian population and both male and female workers at the front line of combat against the COVID-19 2/2021 Opposition to the approval of Bill Nr. 28/2020 on the General Budget of the union for 2021 8/2021 Opposition to live statements by the President of the Republic on October 21, 2021 10/2021 Opposition to live statements by the President of the Republic on December 16, 2021 Source: Prepared by the authors based on CNS 16 .
Graph 1. List of institutional subjects and number of times they appeared as addressees of Recomendations issued by the CNS over the period from 02/03/2020 and 05/22/2022 Source: Preparate by the authors based on the CNS 16 .SAÚDE DEBATE | RIO DE JANEIRO, V. 47, N. 139, P. 830-843, Out-DEz 2023 Box 2. Resumé of Opinions by the CNS, authorship, theme and indication of the act related to the period from 02/03/2020 to 05/22/2022 SAÚDE DEBATE | RIO DE JANEIRO, V. 47, N. 139, P. 830-843, Out-DEz 2023 Source: Prepared by the authors based on the CNS 16 .