ANS opens public consultation on regulation of regulatory process

Following up on Government initiatives to provide transparency and optimization to regulatory processes, which began with the publication of Decree No. 9203/2017 which provides for federal public administration policy governance, the National Agency for Supplementary Health (ANS) published a Call for Public Consultation No. 72/2019 asking for contributions regarding ANS´s regulatory process, which would include a Regulatory Impact Analysis (RIA), Social Participation and finally, a Regulatory Result Assessment (RRA).

According to the text under consultation, with a few exceptions, ANS should only publish a new normative act if, after performing a Regulatory Impact Analysis, it is decided that this is the best solution to solve a given problem.

An RIA generally consists of a systematic process, designed to identify the following: (i) the problem to be solved, (ii) the objectives to be achieved, (iii) the actors involved, (iv) the negative and positive effects resulting from the drafting of a new normative act; and (v) the possible alternatives for solving the problem. An RIA may be Level I or II, depending on the complexity of the matter.

At the end of the RIA process, the ANS should prepare a Regulatory Impact Report with all data, information, and elements collected or produced during the RIA. The Regulatory Impact Report should indicate the appropriate regulatory action to address the identified problem.

If the Regulatory Impact Report indicates that the publication of a normative act is the appropriate regulatory measure for the resolution of the problem, the ANS shall submit the draft of the text of the new resolution for Broad Social Participation, through consultation or public hearing.

Although the draft resolution establishes that an RIA is mandatory whenever ANS identifies a regulatory problem that may require the adoption or amendment of a normative act, or influence rights and obligations, the text proposes a few exemptions, from which we have highlighted the ones which depend on the ANS Board of Directors’ (known as DICOL) decision: (i) urgency, (ii) normative acts aimed at regulating rights and obligations defined by law or hierarchically superior normative acts that do not allow for a different regulatory alternative, and (iii) normative acts of low regulatory impact. When an RIA is waived, Broad Social Participation is not required.

The draft under consultation also provides for a Directed Social Participation mechanism for more technical discussions and a Regulatory Result Assessment (RRA).

The proposed text is very confusing regarding the RRA, but it is understood that the normative acts that have passed through RIA Level II, and those exempted from an RIA as a matter of urgency, should be further evaluated for regulatory impact monitoring once they come into force.

Those interested in contributing to the text of this important resolution may do so from February 18, 2019 through March 19, 2019, through this link.

The Life Sciences team at Kestener, Granja & Vieira Advogados is available to provide further clarification or assistance as needed.