Regulatory Impact AssessmentAnalysis
Regulatory Impact AssessmentAnalysis
Regulatory Impact Assessment: Why Sound Decisions Come Before Regulation
Before creating a rule, public authorities should explain what problem they want to solve, which alternatives they considered, and why they chose one path. That is what Regulatory Impact Assessment is for.
Imagine that power outages are becoming more frequent in a particular region. The first response might be to require distribution utilities to invest more, set new service quality standards, or increase penalties for missing performance targets. All are legitimate possibilities. But which of them would actually solve the problem? The answer depends on something that should come before any discussion of new rules: understanding why the outages are happening.
If the problem stems from inadequate maintenance, one type of intervention may work. If it results from extreme weather events, measures to improve resilience may be needed. If the main difficulty lies in operational management or compliance with existing rules, imposing new obligations may add costs without producing the expected results.
The example is hypothetical, but it illustrates a central issue in regulation. A rule can be legally sound, technically detailed, and adopted after public consultation, yet still fail to address the problem that prompted it. Regulatory Impact Assessment (RIA) exists to reduce that risk.
RIA seeks to structure public decision-making before a decision becomes a binding obligation. Its starting point is simple: identify the problem, understand its causes, define the intended objectives, examine alternatives, and compare their potential consequences. The outcome may be a new rule, an amendment to an existing regulation, a nonregulatory measure, or even a decision not to intervene at that time. What matters is that the choice has a clear rationale supported by the best available evidence.
RIA is now embedded in Brazilian law, but this way of thinking about regulation has a longer history. Knowing that history helps explain why the subject should matter even to people who do not work for a regulatory agency.
Where Did Regulatory Impact Assessment Come From?
RIA’s origins are linked to the international movement to improve regulatory quality, which gained momentum in the 1970s.
In the United States, successive administrations began requiring more systematic assessments of the economic effects of regulatory proposals. Early concerns centered largely on the costs that new requirements could impose on the economy and on the need to consider alternatives before adopting them. In 1974, under President Gerald Ford, agencies were required to assess the potential inflationary effects of significant regulations. In 1978, Jimmy Carter expanded the use of economic analysis in the regulatory process. In 1981, Ronald Reagan established, through Executive Order 12291, a more structured impact assessment framework for certain federal regulations, with strong emphasis on comparing costs and benefits. In 1993, Executive Order 12866, issued under President Bill Clinton, reorganized this regulatory review system and reinforced the consideration of alternatives and the assessment of the effects of public decisions [1].
These experiences do not amount to a single invention of RIA, nor do they mean that all these administrations shared the same view of the role of government. Different administrations used regulatory assessment with distinct priorities and political perspectives. What persisted was the recognition that decisions capable of significantly affecting society should undergo some structured assessment of their consequences.
The Organisation for Economic Co-operation and Development (OECD) played an important role in spreading this approach. In 1995, it published a recommendation on improving the quality of government regulation. In 1997, it released a comparative study of RIA practices in member countries, covering methods, institutional capabilities, and mechanisms for public consultation [2].
Over time, the debate moved beyond the economic cost of rules alone and began to encompass their social, environmental, distributional, and institutional effects. In its 2012 Recommendation of the Council on Regulatory Policy and Governance, the OECD consolidated an approach that treats public participation, ex ante impact assessment, and ex post evaluation of outcomes as parts of the same governance system [3].
This approach was developed further in the RIA best practice principles published in 2020, which call for identifying alternatives and assessing their effects before a decision is made [4]. The OECD Regulatory Policy Outlook 2025 notes that governments have begun examining social and environmental considerations alongside economic ones when they use RIA, and stresses that evidence-based decisions depend on adequate resources, skills, and institutional capacity [5].
The cost of regulation remains an important concern, but the question has become broader: how can public authorities choose interventions that produce better outcomes for society? Reducing unnecessary costs is part of that task. So are protecting rights, addressing market failures, promoting safety, ensuring quality services, and considering the effects on different groups. Regulatory quality depends on how these objectives are examined and balanced.
RIA Begins Before There Is a Draft Regulation
One of the most common misunderstandings is to treat RIA as a report attached to a regulatory proposal that has already been defined. In practice, that reverses the logic of the process.
When an institution begins preparing an RIA after deciding which rule it wants to adopt, it risks using the assessment merely to justify a prior choice. Alternatives are then examined in relation to the preferred solution, rather than to the problem they are supposed to address. A well-conducted RIA should leave room to question the proposed intervention itself.
Let us return to the example of power outages. Before proposing additional requirements for distribution utilities, it would be necessary to investigate the scope of the problem, its geographic distribution, the customers affected, its identified causes, and the limitations of existing measures. The next step would be to set measurable objectives. Reduce how often outages occur? Shorten their duration? Improve grid resilience in the face of extreme events? Protect particularly vulnerable customers?
These objectives are related, but not identical. A measure that effectively reduces average outage duration may not be the best way to prevent high-impact events. Only after making that diagnosis does it make sense to compare alternatives.
Those alternatives could involve stronger oversight and enforcement, revised economic incentives, planning requirements, new technical obligations, better information, or a combination of these measures. Keeping the existing rules while adopting administrative measures may also be an option worth considering. Each possibility would entail different costs, benefits, risks, and effects for consumers, businesses, and public authorities themselves.
This is where RIA helps structure the reasoning. The work involves defining the problem and its causes, identifying affected parties, setting objectives, examining options, estimating impacts, comparing expected outcomes, and proposing indicators that will later make it possible to assess whether the intervention worked [4].
This assessment does not require every effect to be expressed in monetary terms. Cost-benefit analysis is appropriate in some circumstances, but other problems call for multicriteria analysis, risk assessment, or different methodologies. Brazil’s Decree No. 10,411/2020 expressly recognizes different methods and requires the choice of methodology to be justified [11].
The depth of the analysis should be proportionate to the significance and complexity of the decision. Requiring a sophisticated study for an administrative change with limited effects may waste resources. Conversely, making a high-impact decision on the basis of superficial justifications is unlikely to fulfill the purpose of RIA. The choice of method matters, but what weighs most is keeping open the possibility that the assessment will lead to a conclusion different from the one initially envisioned.
Public Participation: An Opportunity to Discuss the Problem Before the Solution
RIA also creates better conditions for the public to take part in regulatory decisions.
Public consultation is already a well-established instrument in Brazil. Government bodies and agencies present proposals and receive comments from citizens, companies, associations, and other interested institutions. This mechanism matters. But there is a big difference between consulting the public on a rule that has already been drafted and allowing people to take part in discussing which problem needs to be solved and which solutions deserve consideration.
When participation takes place only after a draft has been prepared, some of the fundamental choices may already be settled. Participants can suggest changes to provisions, deadlines, and requirements, but they may have little opportunity to question whether the rule itself is necessary or to put forward alternatives of a different nature. Participation during the RIA process can open up that space.
A company may provide data on implementation costs that the regulator did not have. A consumer association may show that a particular requirement would affect low-income households differently. Researchers may challenge technical assumptions. Civil society organizations may point to distributional or environmental risks that had not been considered.
None of these participants necessarily has the right answer. Each brings information, interests, experiences, and limitations that must be examined critically. RIA provides a framework for organizing these contributions and testing them against the evidence. This does not mean that all opinions carry the same technical weight or that the decision should follow the most popular position. Public participation is not a vote. Its value lies in expanding the information available, allowing assumptions to be challenged, and bringing to light consequences that might otherwise go unnoticed.
There is, of course, a challenge. Well-organized economic actors generally have greater capacity to produce studies, hire experts, and follow regulatory proceedings. Dispersed consumers and vulnerable groups do not always have the same resources. That is why opening a public consultation does not, by itself, guarantee balanced participation. The language of the documents, the channels of access, the timing of the consultation, and the ability to understand the alternatives all influence who can actually take part. The quality of RIA also depends on an institution’s ability to listen to different perspectives without confusing participation with handing the decision to the best-organized groups.
Decree No. 10,411/2020 allows for public participation specifically on the RIA report before the best alternative is selected and sets rules for public consultation on proposed regulations, as applicable [11]. In other words, society can help both to understand the problem and to improve the solution.
Transparency Means Explaining Why an Alternative Was Chosen
Another contribution of RIA is to make the decision-making process easier to understand and scrutinize.
A regulatory decision may involve conflicting interests. Consumers want reasonable prices and quality services. Businesses need conditions that allow them to invest and meet their obligations. Governments set policies and priorities. Regulators must act within their legal authority while balancing the objectives the law assigns to them. It will not always be possible to satisfy all these interests. What can be expected of a public decision is that its reasons are known and open to examination.
A well-prepared RIA makes it possible to understand which problem justified government action, what information was used, which alternatives were rejected, and which consequences weighed in the final choice. This transparency supports public and institutional oversight. It also helps distinguish legitimate disagreements from decisions built on weak assumptions.
If an agency chooses a particular rule even though another alternative would cost less, one should not automatically conclude that the choice is wrong. Differences in safety, reliability, equity, or effectiveness may justify the decision. What is expected is that those reasons be made explicit.
In Brazil, Decree No. 10,411/2020 itself provides that the RIA report does not bind the decision of the competent authority. The authority may adopt an alternative different from the one recommended by the assessment, provided that it gives reasons for that choice [11]. The rule recognizes that public decisions are not simply the result of mathematical calculations. There is room for institutional judgment, setting priorities, and weighing competing objectives, and RIA helps ensure that this room is used in an informed and accountable way. The authority still makes the decision. The difference is that there is a clearer basis for understanding and evaluating that choice.
How Did RIA Take Root in Brazil?
In Brazil, RIA was institutionalized gradually, even before a broad federal legal requirement existed.
An important milestone was the creation in 2007 of the Programa de Fortalecimento da Capacidade Institucional para Gestão em Regulação (PRO-REG), or Program for Strengthening Institutional Capacity for Regulatory Management, through Decree No. 6,062. The program emerged from an initiative of Brazil’s federal government in partnership with the Inter-American Development Bank (IDB), aimed at improving regulatory coordination, strengthening institutional capacity, and enhancing transparency, participation, and accountability mechanisms [6].
At that time, Brazilian regulatory agencies were still consolidating administrative practices and governance arrangements developed in the wake of the institutional reforms of the 1990s. PRO-REG helped place regulatory quality more systematically on the federal agenda, and RIA came to be discussed as part of a broader set of tools intended to improve government action.
Some institutions moved ahead before the general legal requirement. Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa), for example, created its Program for Improving the Rulemaking Process in 2008, which paved the way for bringing impact assessment into its regulatory process, and later developed its own procedures and methodologies [7].
In 2018, the Office of the Chief of Staff of the Presidency (Casa Civil) coordinated the preparation of the Diretrizes Gerais e Guia Orientativo para Elaboração de Análise de Impacto Regulatório (General Guidelines and Guidebook for Regulatory Impact Analysis), with the participation of federal government bodies, regulatory agencies, and Brazil’s National Institute of Metrology, Quality and Technology (Inmetro). The document brought together recommendations and methods for disseminating good regulatory assessment practices [8].
From 2019 onward, RIA gained greater legal force. Law No. 13,848/2019, known as the General Law on Regulatory Agencies, established in Article 6, subject to implementing regulations, an RIA requirement for the adoption and amendment of regulatory acts of general interest to economic actors, consumers, or service users [9]. That same year, Law No. 13,874/2019, the Economic Freedom Law, also provided for RIA within the federal public administration [10].
Decree No. 10,411, of June 30, 2020, implemented these provisions, defining concepts, minimum requirements, methodologies, and circumstances in which RIA does not apply or may be waived. Its requirements took effect in stages during 2021, first for certain federal institutions and later for the other government bodies and entities within its scope [11].
Efforts to strengthen regulatory governance continued. In October 2023, Decree No. 11,738 reorganized PRO-REG, repealed the original decree, and reaffirmed the goal of supporting good regulatory practices and improving the coordination of the regulatory process within the federal public administration [12]. In August 2024, Decree No. 12,150 established, within PRO-REG, the Estratégia Nacional de Melhoria Regulatória (National Regulatory Improvement Strategy), known as Regula Melhor, with long-term guidelines for regulatory quality, public participation, institutional capacity building, and the use of evidence in public decisions [13].
This trajectory shows an important change. RIA moved from being a practice of certain institutions to a formal part of the federal regulatory governance framework. That does not mean, however, that all regulatory processes began using it with the same frequency, depth, or quality.
What Do the Studies Tell Us About RIA in Brazil?
A legal requirement is only one of the elements needed to consolidate an institutional practice. Recent studies help us understand what happened after RIA was regulated.
A study by Regulação em Números (Regulation in Numbers), a project of FGV Direito Rio, examined 1,415 regulatory acts issued by eleven federal regulatory agencies during the first three years in which Decree No. 10,411/2020 was in effect [14]. Only 17.8% of these acts were prepared with the support of an RIA. In 32.1% of cases, the agencies invoked an exemption. The remaining 50.1% were adopted with neither an RIA nor an exemption, in situations treated as cases where the assessment did not apply.
These percentages call for a careful reading. Brazilian law provides for situations in which RIA does not apply and others in which it may be waived with proper justification. The absence of an RIA therefore does not automatically constitute a legal violation. Even so, the findings raise questions about how the instrument is being incorporated into day-to-day decision-making. The research also identified qualitative limitations in some of the assessments produced: shallow evaluations, few alternatives considered, methodological weaknesses, and a lack of public participation mechanisms.
Another study, by Luiz Felipe Monteiro Seixas and Nilo Luiz Saccaro Junior, published by the Institute for Applied Economic Research (Instituto de Pesquisa Econômica Aplicada, Ipea) in January 2025, broadened the scope to 146 federal government bodies, from April 2021 to April 2024 [15]. The study distinguished institutions whose core activity is regulation from those in which regulation is only part of their responsibilities. The results showed significant differences in institutional maturity. In general, institutions whose primary function is regulation showed greater consistency and transparency in preparing and publishing RIAs. The study also identified challenges related to institutional support, coordination, training, technical quality, and transparency.
The two studies differ in their methods and in the populations they examine. It would be incorrect to compare their findings directly, as though they measured the same phenomenon. Still, both feed a discussion that goes beyond formal legal compliance: what conditions allow RIA to actually improve decisions?
This debate is not unique to Brazil. The OECD itself, in the Regulatory Policy Outlook 2025, points out that sound rule design is not enough: it must be followed by effective implementation, with adequate resources, skills, and capacities to support evidence-based decisions [5].
The Brazilian findings deserve closer examination, which will be the subject of upcoming articles in this series. For now, the studies help identify a fundamental issue: establishing RIA is not the same as embedding it in an institution’s decision-making culture.
When RIA Becomes a Mere Formality
RIA loses much of its value when it is treated as a mandatory document, prepared simply to complete an administrative step. The risk begins when the solution has already been chosen. If an institution decides in advance that it needs to impose a new obligation and only then conducts the assessment, the process tends to look for evidence supporting the prior decision. Alternatives may appear in the report without having been seriously considered.
The same happens when the problem is vaguely defined. Phrases such as the need for modernization, stronger oversight, or better quality may describe legitimate objectives, but they are no substitute for a diagnosis. Without understanding the cause and scale of a problem, it becomes difficult to assess which measure is likely to solve it.
Another difficulty lies in overly generic assessments, with lengthy descriptions of the context and no verifiable link between alternatives and their impacts. A lengthy report is not necessarily a good RIA. Likewise, a relatively short assessment may provide sufficient grounds for a less complex decision. What counts is the quality of the reasoning and the proportion between the analytical effort and the significance of the intervention.
The practical limitations of institutions also need to be acknowledged. Assessments require data, trained professionals, appropriate methods, and time. Requiring RIA for every decision, regardless of its significance, can overwhelm teams without improving outcomes. That is why Brazilian law sets specific grounds for waiving the requirement, such as urgency, low impact, and situations in which a higher-level rule leaves no room for regulatory alternatives [11].
These exceptions are part of the system. The problem is not using them, but turning them into a routine way of avoiding a discussion that should take place. A properly justified waiver may be entirely legitimate. A formally complete assessment prepared only to confirm a predetermined choice may offer far less public value. The challenge is to create conditions in which RIA is seen as support for the decision, and not merely as a documentary requirement.
What Happens After a Regulation Takes Effect?
There is one limitation that no ex ante assessment can eliminate: the future remains uncertain. Even a well-conducted RIA relies on estimates, assumptions, and the information available at the time of the decision. Technological change, the behavior of regulated actors, economic conditions, and external factors may produce outcomes different from those anticipated. That is why a sound regulatory decision must include mechanisms for checking its effects afterward.
This is where Avaliação de Resultado Regulatório (ARR), or Regulatory Outcome Evaluation, comes in. While RIA seeks to anticipate the consequences of the available alternatives, ARR examines what happened after a measure was implemented. Decree No. 10,411/2020 also provides for the integration of ARR into federal regulatory activity [11].
Returning to the example of power outages, suppose an intervention was adopted to shorten the duration of service interruptions. After some time, it would be necessary to determine whether conditions improved, how much of the improvement can be attributed to the intervention, what costs were actually incurred, and whether any unintended effects emerged. If the outcomes differ from expectations, the regulator needs to be able to revisit the measure.
This learning cycle matters even more in markets subject to rapid technological change, where solutions that are appropriate today may stop making sense a few years later. RIA helps select the initial course of action. ARR makes it possible to examine whether that course remains justified in light of accumulated experience.
Connecting these two tools keeps regulatory quality from being judged solely by the number of rules issued or by formal compliance with administrative procedures. Ultimately, what matters is whether government action produced the outcomes that justified it in the first place.
Sound Decisions Come Before Regulation
There is an understandable tendency to associate a regulator’s work with making rules. When a problem emerges, a response is expected. When new technologies appear, pressure to update regulations grows. When failures occur, proposals for new obligations, controls, and penalties multiply.
In many situations, new rules will be necessary. But regulation is a form of public intervention, not an outcome to be chosen in advance. Poorly designed regulation can impose disproportionate costs, hinder innovation, create competitive distortions, or simply fail to deliver the expected benefits. A decision not to intervene may also have serious consequences when risks or problems call for government action. A proper comparison must consider all these possibilities.
RIA does not eliminate conflicts of interest, uncertainty, or legitimate disagreements about regulatory objectives. Nor does it guarantee that a decision supported by studies will produce the best outcome. Its value lies in requiring a discipline that does not always arise naturally in decision-making: clarify the problem, examine alternatives, make consequences explicit, and justify choices.
For society, this means being better equipped to understand and question the decisions that affect people’s lives. For economic actors, it increases predictability and creates opportunities to discuss impacts before obligations are finalized. For government itself, it is a chance to learn, reduce errors, and demonstrate the reasonableness of its interventions.
Brazil’s legal advances have created an important foundation for this process. Recent studies show, however, that consolidating it depends on institutional capacity, transparency, and the effective use of evidence. That is the challenge I intend to explore in the next articles, taking a closer look at the FGV and Ipea studies and discussing what their findings reveal about the quality of regulatory decisions in Brazil.
Perhaps RIA’s greatest contribution is changing the starting point of the discussion. Before asking what rule we need to create, we should ask what problem we want to solve, why it is happening, and what options we have for addressing it. It may seem like a small change. Yet this reversal is what can make the difference between producing more regulation and producing better regulation.
References
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The opinions and analyses expressed in this article are personal and do not represent the institutional positions, decisions, or views of the Brazilian Electricity Regulatory Agency (ANEEL).
How to cite this article
ALCÂNTARA, Márcio. Regulatory Impact Assessment: Why Sound Decisions Come Before Regulation. Regulador.org, 2026. Available at: https://www.regulador.org/en/2026/10/15/regulatory-impact-assessment-sound-decisions-before-regulation/. Accessed on: Oct. 15, 2026.
Dr. Márcio Alcântara
Electrical engineer with a master's degree and a PhD from UNICAMP. A civil servant at ANEEL since 2008. Writes about regulation as a discipline: how public decisions are built, what evidence supports them, and how they can be more transparent.