End of the covid health emergency could impact legislation and public policies — Senado Notícias

The end of the Public Health Emergency of National Importance (Espin), announced last Sunday (17) by the government, could have impacts on several laws related to the pandemic passed by Congress since 2020. rules for transition are defined, is the authorization for the emergency use of vaccines that still do not have registration, as is the case of Coronavac.

Since the beginning of the pandemic, in 2020, the Civil House page has already added more than 660 normative acts related to covid-19, including laws, decrees, ordinances and resolutions. Of this total, 94 are laws, many of them with validity linked to Espin. This means that, if the government formalizes the end of the public health emergency, some of these rules may no longer have any effect.

According to health legislative consultant Flavio Palhano, it is still not possible to measure the precise impact of the possible end of the emergency without the government having formalized this decision, which will probably be done through an ordinance. One of the main rules that could be affected, in the consultant’s assessment, is the authorization for the emergency use of vaccines, provided for in a resolution by the National Health Surveillance Agency (Anvisa). The resolution provides for this use for the duration of the health emergency.

— Among the immunizers in use in the country, most already have the definitive registration. This is the case with vaccines from Pfizer, Janssen and AstraZeneca. In the case of CoronaVac, there is only authorization for emergency use. If the end of the emergency is made official, this authorization may no longer be valid, but it is a situation that could be resolved in an infralegal way, probably through a new resolution by Anvisa – he explained.

The Ministry of Health has already informed that it has asked Anvisa to extend the deadline for the emergency use of medicines and immunizations related to covid-19 by one year after the end of the health crisis. The Agency informed that the process of reviewing the resolutions has already started.

spin

A public health emergency of national importance as a result of human infection with the new coronavirus was declared by the government in February 2020. Soon after, the House and Senate approved a project to regulate the measures that should be adopted by health authorities in the event of an emergency. of public health caused by the coronavirus (PL 23/2020). The project was transformed into Law 13,979 of 2020.

It is in this law that the first measures linked to the emergency are found – such as the possibility of isolation and quarantine, temporary closure of ports, highways and airports and specific medical treatments –, which could expire with the end of Espin. According to Flavio Palhano, in practice, this is unlikely to happen. This is because the law was actually linked to Legislative Decree 6/2020, which expired in December 2020.

— Some rules of this law remain in force by a decision of the Federal Supreme Court (STF), which extended the validity of the provisions with sanitary measures to combat the covid-19 pandemic. The decision did not link the duration of the measures to the public health emergency, which makes it unlikely that the measures will be affected by the end of Espin – he explained.

The consultant also cited the constitutional amendment establishing the so-called War Budget (Constitutional Amendment 106, of 2020). The amendment facilitated federal government spending in the fight against the coronavirus pandemic by separating spending on the pandemic from the General Budget of the Union. This amendment, according to Palhano, is an example of the rules that will not be affected with the end of Espin, since the term was linked to the public calamity, which ended in 2020.

Inputs and vaccines

Other laws that cite the state of emergency and that may be impacted by the end of Espin are the one that prohibits the export of medical, hospital and hygiene products essential to combat the coronavirus epidemic in Brazil (Law 13,993, of 2020) and the which facilitates the purchase of vaccines against covid-19 (Law 14,124, of 2021).

For Palhano, in practice, some laws may not suffer major impacts because they deal with situations that are no longer present at the present time, such as the shortage of registered vaccines. This is the case of the law that allows the National Health Surveillance Agency (Anvisa) to authorize the import and distribution of medicines and equipment against covid-19 already released for use abroad (Law 14.006, of 2020). There are also cases of laws referring to practices that have already been consolidated, such as the use of telemedicine, authorized by Law 13,989 of 2020.

— It is yet another case in which it is unlikely that there will be an impact with the end of the emergency because this telemedicine care system has already been established.

He also cited Law 14,125 of 2021, which authorizes states, the Federal District and municipalities to assume civil liability in relation to adverse post-vaccination effects. This authorization was a requirement of manufacturers such as Pfizer and Janssen. According to the consultant, the practical effect of the end of Espin on this law is that there may be legal challenges for the manufacturer, instead of the government.

state regulations

Another concern with the end of the emergency is with regard to state and municipal regulations linked to the pandemic. According to the consultant, it is very difficult to measure the effects on federal entities because there are a multitude of laws and decrees made based on the health emergency, which would have to be adjusted and updated. The end of the emergency could affect local public policies.

On Tuesday, the National Council of Health Secretaries (Conass) and the National Council of Municipal Health Secretaries (Conasems) sent a letter to the Ministry of Health in which they expressed concern about the sudden end of the emergency.

In the document, the entities asked the ministry to keep the ordinance in force for another 90 (ninety) days and establish “agreed transition measures, focused on mobilization for vaccination and the elaboration of a recovery plan capable of defining indicators and control strategies”. with integrated surveillance of respiratory syndromes”.

Pandemic

According to experts, it is important to make it clear that the end of Espin is not the same thing as the end of the pandemic. At a meeting at Fiocruz’s Covid-19 Observatory, this Wednesday (20), Professor Ethel Maciel, PhD in Epidemiology, explained that the WHO decreed the pandemic on March 11, 2020 based on epidemiological criteria. Espin, on the other hand, is a situation provided for in the National Health Surveillance Policy and means a situation that demands urgent measures to prevent, control and contain risks.

— The revocation of the ordinance is in the operational dimension and needs to be anchored in epidemiological criteria, which we have not defined, internationally agreed upon. In addition, it is not enough to revoke Espin, it is necessary to have a transition plan – said the teacher.

For her, this transition period towards the end of the pandemic phase should be a preparation for the next, interpandemic phase, in which there could be new waves of contagion. She explained that there is still no consensus on how immunization against covid-19 will be incorporated into the vaccine schedule, but it will be necessary to think about campaigns for new biannual or annual booster doses.

In a note released last week, the World Health Organization (WHO) maintained the international health emergency related to the coronavirus, declared in January 2020. According to the organization, countries still have very heterogeneous vaccination coverage and the unpredictable behavior of the virus. contributes to the continuity of the global pandemic context.

Researcher Raphael Guimarães, professor at Fiocruz’s National School of Public Health (Ensp/Fiocruz) stated that the vaccination situation in Brazil is also uneven. According to the professor, there are states with almost 90% vaccination coverage, while others are close to 50%. He expressed concern about the demise of Espin, which, in his view, could hamper quick-response emergency measures.

— If we look at Brazil as a whole, the Brazil indicator is favorable, but the indicators at the subnational level are not. If we adopt a measure on a national scale, thinking that this will have a vertical induction for states and municipalities and that it will not have repercussions on the public health of these places, we are wrong – warned the researcher.

Agência Senado (Reproduction authorized with reference to Agência Senado)

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