How a proposal to Congress reduces the autonomy of Anvisa and ANS – and why the entities are against it

A parliamentary proposal provides that the modification of legislation, currently under the responsibility of regulatory agencies, goes to councils with members of the Executive, which would open a door for political meddling

The amendment proposed by federal deputy Danilo Forte (União-CE) and which could remove the autonomy of federal regulatory agencies is now being targeted by health authorities, who see serious risks for the country’s health policies and standards if the law is approved and will become affect the activities of National Health Surveillance Agency (Anvisa) and the National Integrative Health Agency (ANS).

The text was presented by the parliamentarian as an amendment to the Provisional Provision 1.154/2023, edited by the management Luiz Inácio Lula da Silva (PT) the first day of government to reorganize the attributions of bodies and ministries. The MP is valid for 60 days, renewable for another 60, a period which must be elaborated and approved by Congress.

In the deputy’s wake, however, Forte presented an amendment which establishes that the edition of regulatory acts, currently the responsibility of the agencies, becomes the attribution of advice linked to the ministries and secretariats of federal bodies.

These councils would be composed of representatives of the ministry to which the activity refers (in the case of ANS and Anvisa it would be Healthcare), of the institution, of the regulated sectors of economic activity, of the academic world and of consumers, approved by the Council National Congress. In practice, the agencies would lose their independence and their decisions would be more subject to political interference.

Acts such as the release of registration of medicines and other pharmaceutical products, the approval of clinical trials, the suspension and recall of products that put the consumer at risk and the definition of health measures aimed at the collective interest, such as the mandatory use of masks in airports and on planes.

In the case of the ANS, it could impact the entire regulation of the health insurance market, including measures such as the setting of readjustment rates for individual insurance companies, the definition of the procedures envisaged by the operators and the imposition of sanctions on companies that do not comply with the rules .

In motivating the amendment, the deputy argues that his proposal, by redistributing functions, creates mechanisms for a “better relationship and execution of tasks in the public administration” and that the council model would allow for “greater interaction between members, in order to discriminate between regulatory and judicial functions, with greater transparency, accountability and democratic participation”. For Forte, the performance of a council would guarantee “the control and surveillance of one power over the other in relation to the fulfillment of constitutional duties”.

Approval of the amendment would put the population at risk, the bodies say

This Tuesday 14, representatives of the health sector published a manifesto against the approval of the amendment and in defense of regulatory agencies. The text is signed by 30 subjects, including the main associations of hospitals, pharmaceutical companies, laboratories, operators and medical equipment industries in the country.

In the manifesto, the institutions argue that the amendment “damages the constitutional and legal order, which establishes administrative independence, the stability of managers, financial autonomy and, consequently, the decision-making and political independence of these autarchies” , and underline that the agencies have specialists in the subject to be regulated to guarantee decisions of a technical nature.

Regarding the author of the proposal’s argument that the change in the law would bring “greater transparency and democratic participation”, the bodies say that the current laws already provide for “mechanisms of control and social participation, such as the assumption of subsidies and public consultations , which ensure the legitimacy of the agency’s decisions.”

Industry representatives also recall that Anvisa and ANS “are responsible for the entire technical-normative framework that guarantees the safety and efficacy of the products and services made available to the Brazilian population”, with decisions taken “based on evidence, despite external pressures, which increases its credibility and trust in society in defense of health, as experienced in the covid-19 pandemic?.

During the pandemic, the agency has come under pressure from the Jair Bolsonaro (PL) administration against approving vaccines and adopting health measures such as the mandatory wearing of masks. The former president’s government has also defended ineffective drugs against the virus, such as hydroxychloroquine.

“The agencies are autonomous, their activity cannot be influenced by political opinions and decisions. Look at what happened during the pandemic. Even in a government with all its authoritarianism, the agency, in view of its responsibility, position and power , did what was right for our country. We cannot accept that there is a setback”, says Dr. Francisco Balestrin, president of the Union of Hospitals, Clinics and Laboratories of the State of São Paulo (SindHosp) , one of the signatory entities.

According to Nelson Mussolini, executive president of the pharmaceutical industry union (Sindusfarma), another supporter of the manifesto, the amendment would also damage the development of the sector. “The certainty of the law and predictability, which are the raw materials for the development of the health area in any country, are lost. Autonomy must be guaranteed regardless of the government. Agencies are state bodies”, he says.

For Tacyra Valois, executive director of the Brazilian College of Health Executives (CBEXs), also a signatory of the manifesto, the agencies, in establishing rules for the market, guarantee citizens “minimum safety conditions” for the use of health services. “The loss of autonomy would mean the loss of the power to define operational and safety standards in its areas of activity.”

For the institutions, the approval of the amendment would lead to the “dismantling of the Brazilian regulatory framework”, resulting in high legal uncertainty for the health sector and jeopardizing the predictability of actions and investments in the country, as well as putting the population at risk . “The transfer of regulatory competence from Anvisa to a junta will represent a setback in regulatory and health control policies”, reads the text.

For Mário Scheffer, a professor at the Faculty of Medicine of the University of São Paulo (FMUSP), regulatory agencies need more autonomy, not the other way around. “Certainly the loss of autonomy of collegial bodies with a mandate would further increase the already existing risks of an entity acting in favor of those it regulates. criteria in choosing agency directors and more rigidity towards civil servants or agency directors who take on positions in the private sector, for example, ”he says.

wanted by StadiumANS and Anvisa have not taken a position on the amendment nor have they detailed the impacts that the standard would have on their activities if approved.

In a statement, MP Danilo Forte said that “the amendment creates effective mechanisms to guarantee equal treatment for consumers, which have been ignored by agencies to the detriment of excessive benevolence towards regulated companies. With the creation of councils, there will be an effective participation of civil society in the regulatory process, always technically, with indication through a triple list to be approved by the Chamber and the Senate.The same applies to the National Health Agency (ANS) and the National Surveillance Agency healthcare (Anvisa)”.

Again according to the parliamentarian, “what will happen, in practice, is the strengthening of regulation based on the responsibility of entities towards society, as is already the case in other areas of public administration. We therefore propose not to abolish these bodies. , but the improvement of its rules of governance”.

Source: Terra

Ben

Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.