Chapter 1. Regulatory impact assessment within the regulatory governance cycle

This chapter describes the relevance and need of evaluating the quality of regulations. It also introduces regulatory impact assessment, a tool used in several OECD countries for analysing the quality of regulations and implementing the best draft proposals that lead to net benefits for society. Moreover, it explains the link between regulatory impact assessment and the regulatory governance cycle.


The importance of evaluating draft regulations1 lies in the potential effects they may produce, either positive or negative. Ideally, regulatory proposals that are intended to be implemented must produce not only positive net benefits, but also the greatest possible benefit. This task implies the application of an evaluation process of the regulation that examines its design, selects the best alternative to solve the problem, and that identifies what are the benefits for society.

The need to assess regulation

Regulation is the set of rules of law from different hierarchical levels that defines the participation of people or companies in a market, a sector, or in some economic or social activity. The process by which these rules are established and enforced may define its relevance, importance, and effect on the subject and the purpose of the legislation. This implies that the process to issue regulations determines its quality, and it has a direct impact on the results or consequences of public policy.

It is important to emphasise this aspect, the quality in the process to issue regulations has a direct impact on the expected results once it is enacted (even, it often produces effects that were not identified). This means that the process to issue regulations has significant influence on the accomplishment of the stated goals and the possible net potential benefit; these and other aspects are discussed below.

In fact, specific rules can open or close markets, can promote the elimination or creation of monopolies, can produce entry barriers, can reduce or boost the incentives for innovation or entrepreneurship, and so forth. It can also ensure the quality of public services, such as education, health, etcetera. It is very important to review and improve the process followed to issue regulation, to ensure that it is rightly oriented, and it is aimed to address a specific problem.

The OECD, through the Regulatory Policy Committee, published the Recommendations of the Council on Regulatory Policy and Governance (OECD, 2012[1]). These recommendations explicitly emphasise the importance of implementing a process that monitors the quality of regulations (see Box ‎1.1).

For example, the first recommendation of the Council states the commitment at the highest political level of an explicit whole-of-government policy to monitor the quality of regulations. The second recommendation refers to the principles of open government, including the participation of stakeholders in the regulatory process, and the development of comprehensible and clear regulations. The fourth recommendation focuses on the Regulatory Impact Assessment (RIA), a specific tool to evaluate the possible effects of rules (OECD, 2012[1]).

The work performed by the OECD on regulatory policy has produced several documents, including those identifying the possible positive effects of a public policy of this nature. For instance, growth and economic development have been promoted through a policy that includes structural reforms, liberalisation of markets, opening of markets, and the creation of a non-very restrictive setting for business (OECD, 2014[2]). Furthermore, the link between the regulatory policy and a series of structural reforms is recognised, out of which the following ones have been documented:

  • The reciprocal relationship between an effective regulatory policy and the opening of markets, which in consequence opens channels for innovation, entrepreneurship, and strengthens the benefits for consumers.

  • The relationship between the principles of competition policy and those that promote the quality of regulation.

  • The relationship between the reform of regulated markets and infrastructure, and the positive effects on price reduction, innovation, quality of service, and consumer choice.

Box ‎1.1. Recommendation of the Council on Regulatory Policy and Governance
  1. 1. Commit at the highest political level to an explicit whole-of-government policy for regulatory quality. The policy should have clear objectives and frameworks for implementation to ensure that, if regulation is used, the economic, social and environmental benefits justify the costs, the distributional effects are considered and the net benefits are maximised.

  2. 2. Adhere to principles of open government, including transparency and participation in the regulatory process to ensure that regulation serves the public interest and is informed by the legitimate needs of those interested in and affected by regulation. This includes providing meaningful opportunities (including online) for the public to contribute to the process of preparing draft regulatory proposals and to the quality of the supporting analysis. Governments should ensure that regulations are comprehensible and clear and that parties can easily understand their rights and obligations.

  3. 3. Establish mechanisms and institutions to actively provide oversight of regulatory policy procedures and goals, support and implement regulatory policy, and thereby foster regulatory quality.

  4. 4. Integrate Regulatory Impact Assessment (RIA) into the early stages of the policy process for the formulation of new regulatory proposals. Clearly identify policy goals and evaluate if regulation is necessary and how it can be most effective and efficient in achieving those goals. Consider means other than regulation and identify the tradeoffs of the different approaches analysed to identify the best approach.

  5. 5. Conduct systematic programme reviews of the stock of significant regulation against clearly defined policy goals, including consideration of costs and benefits, to ensure that regulations remain up to date, cost justified, cost effective and consistent, and deliver the intended policy objectives.

  6. 6. Regularly publish reports on the performance of regulatory policy and reform programmes, and the public authorities applying the regulations. Such reports should also include information on how regulatory tools such as Regulatory Impact Assessment (RIA), public consultation practices, and reviews of existing regulations are functioning in practice.

  7. 7. Develop a consistent policy covering the role and functions of regulatory agencies in order to provide greater confidence that regulatory decisions are made on an objective, impartial and consistent basis, without conflict of interest, bias or improper influence.

  8. 8. Ensure the effectiveness of systems for the review of the legality and procedural fairness of regulations and of decisions made by bodies empowered to issue regulatory sanctions. Ensure that citizens and businesses have access to these systems of review at reasonable cost and receive decisions in a timely manner.

  9. 9. As appropriate, apply risk assessment, risk management, and risk communication strategies to the design and implementation of regulations to ensure that regulation is targeted and effective. Regulators should assess how regulations will be given effect and should design responsive implementation and enforcement strategies.

  10. 10. Where appropriate, promote regulatory coherence through co-ordination mechanisms between the supranational, the national, and sub-national levels of government. Identify cross-cutting regulatory issues at all levels of government, to promote coherence between regulatory approaches and avoid duplication or conflict of regulations.

  11. 11. Foster the development of regulatory management capacity and performance at sub-national levels of government.

  12. 12. In developing regulatory measures, give consideration to all relevant international standards and frameworks for co-operation in the same field and, where appropriate, their likely effects on parties outside the jurisdiction.

Source: (OECD, 2012[1]), Recommendation of the Council on Regulatory Policy and Governance, Paris,

Currently, many countries have adopted a regulatory policy; however, there are important challenges in terms of regulation. For example; the lack of consistency and continuity in the implementation of regulation; the promotion of the participation of diverse actors interested in the regulatory process; the capability to implement an effective regulation, as well as the limited process to evaluate regulation. For these reasons, it is important to promote a regulatory policy programme that includes goals as the following ones (OECD, 2015[3]):

  • Reducing the perverse and unintended effects of regulation;

  • Reducing regulatory burdens by deregulating and the alternatives to the regulation;

  • Reducing inconsistencies in regulation and the lack of experience, and

  • Reducing the lack of institutional capacity and professionalisation in regulation.

As rules can have a positive or negative impact on the performance of an economic sector, an economic or social activity, it is urgent to conclude that it is necessary to study the process for the issuance of regulations to ensure that there are criteria guaranteeing their contribution to social welfare, that expected goals are achieved, and that the potential risks which gave rise to the regulations are reduced. One of the most widely used instruments to achieve this goal among OECD countries is the Regulatory Impact Assessment (RIA), a tool that enables to assess if the proposed regulation is the best option (whether regulatory or not) and if the net benefit is positive. In this way, the risk of designing and implementing draft proposals that have not been assessed is reduced.

Essential building blocks of RIA: introduction

The Regulatory Impact Assessment (RIA) is a tool that consistently examines the benefits, costs and potential effects of a draft regulation (or non-regulatory alternative), either a new one or the modification of a preexisting one. This tool is a diffused practice through virtually all OECD countries, as an instrument to monitor and ensure the effectiveness of regulation. In practice, all OECD countries use a version of RIA to analyse their regulation (see next section which provides a summarised description of RIA practices in OECD countries;, see also, Chapter 2 which presents a more thorough description of the RIA system in some OECD countries). Box ‎1.2 offers an example of the adoption of the regulatory impact assessment tool, particularly in the United States.

Box ‎1.2. The RIA model in the United States

The main reasons that led to the introduction of RIA in the United States were: i) the need to ensure that federal agencies justify regulatory interventions before issuing a regulation, and consider lighter interventions before committing to a heavy regulation; ii) the need of the central government of controlling the conduct of agencies, upon which regulatory powers were conferred; and iii) the need to promote the efficiency of regulatory decisions by introducing the obligation of carrying out a cost-benefit analysis in the RIA.

Underlying the introduction of RIA, from a general point of view, was the idea that policy makers should make informed decisions, based on all available evidence. In the case of the United States, this idea was initially associated with a clear emphasis on the need to avoid imposing unnecessary regulatory burdens on business, a result that —on principle— was guaranteed by introducing the general obligation of performing a cost-benefit analysis of the alternatives to the regulation and justify the adoption of such regulation with net benefits. Although the US system has remained almost unchanged, the initial approach was partially modified: from cost reduction to a better balance between the benefits and regulatory costs.

The first steps of the RIA included a reform of the governance arrangements adopted by the administration to develop draft proposals.

  • RIA was introduced as a mandatory procedure within an existing set of administrative rules.

  • The introduction of RIA required the creation of a central oversight body in charge of evaluating the quality of the RIAs produced, the Office of Information and Regulatory Affairs.

  • A focus on cost-benefit analysis. The RIA system in the United States is clearly and explicitly based on the practice of the cost-benefit analysis.

Source: (OECD, 2015[4]), Regulatory Policy in Perspective: A Reader’s Companion to the OECD Regulatory Policy Outlook 2015, Paris,

One of the main reasons for the widespread dissemination of RIA is that it helps to improve the decision-making process that defines the regulation. Regulatory impact assessment promotes a systematic process, with a comparative approach on policy decisions (OECD, 2008[5]), and it makes the agency issuing regulations aware of the accurate identification of the problem that needs to be addressed, as well as of the different alternatives to achieve it. Additionally, RIA asks about the financial sustainability of implementing a regulation or, in other words, that its costs be lower than the benefits.

Another advantage of RIA is that it provides a method of analysis based on evidence and empirical information that compares different proposals or alternatives, it promotes the identification of benefits and costs (direct or indirect) derived from the regulation, it establishes a rational decision-making system, and evaluates regulation on a cross-cutting basis, etcetera. Table ‎1.1 shows the essential stages of RIA which, if correctly addressed, will translate into an effective evaluation of the quality of regulation (Chapter 5 includes the assessment of each one of these stages in the process to issue regulations in Peru).

The ex ante evaluation provided by the RIA should ideally include an analysis of the need to regulate or, even, of government intervention through the identification of a specific problem, such as market failures, asymmetry of information, the need to protect citizen rights, and so forth (definition of the problem). This analysis produces not only a clear and concise identification of the problem but the best option for government intervention, if it is justifiable (public policy objective); which can be a regulatory instrument or another of different sort (alternatives to the regulation).

Table ‎1.1. Essential building blocks of RIA

Building block

Definition of the problem

Public policy objectives

Alternatives to the regulation

Impact evaluation

Compliance with regulation

Monitoring and evaluation

Public consultation

During the decision-making process, regarding the alternative of government intervention (which may be regulatory or non-regulatory), officials should:

  • Assess the economic, social and environmental impacts, considering the possible special and long-term effects;

  • Evaluate if the adoption of international instruments can reduce the public policy problems that have been identified and promote coherence at global level, with minimum alteration of domestic and international markets,

  • This analysis always must consider, as an alternative, the option of not acting at all, which will be the baseline for the comparative analysis.

The impact evaluation aims to identify the costs and benefits of regulation, whether direct or indirect, for later quantification if possible. The impact evaluation can be considered as the core of RIA, because the main role of this tool is to understand the impact that regulation may have on individuals, industry, and the government itself. According to the OECD Recommendation, in the case of draft proposals with potentially important impacts on society, the ex ante analysis of the proposals should preferably be quantitative. This evaluation should include direct (administrative, financial, etcetera) and indirect costs (opportunity costs or spillover effects).

However, the mere fact of identifying costs and benefits in a qualitative manner is an important step that can help to improve the process. In any case, it is important to make a qualitative description of the costs and benefits identified, before their quantification (if this is possible).

The evaluation of public policy must consider the strategies and resources necessary to ensure the compliance with regulation. In order to achieve the objective that has been set out, it is necessary to ensure that regulated parties meet the obligations that are intended to be established. The monitoring and evaluation of the draft proposal will make it possible to clearly identify if the public policy objectives are being reached, as well as to determine if the proposed regulation is needed, or how can it be more effective and efficient to achieve the stated objectives.

The results of the evaluation exercise (RIA) should be made available to the public along with the regulatory proposal, in order to receive comments from the interested parties and, based on that, to develop a second and improved draft of the proposal (public consultation), if applicable. According to the Recommendation of the Council, carrying out the public consultation as part of the RIA process is a good practice. |

In addition to the essential RIA stages, a condition for the proper development of the evaluation process is that it must be monitored by an entity that has as one of its key objectives to ensure that the process of issuing regulations goes beyond the controls designed with defined standards (oversight body). This process should clearly identify the priorities, risks, exceptions, and impact (see Recommendation 3 in (OECD, 2012[1]). The tasks of such entity normally go beyond those related with the Regulatory Impact Assessment; if possible, they should include the entire cycle of regulatory governance. Table ‎1.2 shows the tasks of the supervisory agencies of regulatory policy.

Table ‎1.2. The functions of oversight bodies

Areas of responsibility



Consultation/stakeholder engagement

Quality assurance

Within government

Legal quality

  • Scrutinise evaluations

  • Centre of government (e.g. PMs office, cabinet office)

Administrative simplification

  • Challenge unsatisfactory tools or processes

  • Ministry of Finance / Ministry of Economy / Treasury


  • Review legal quality

  • Ministry of Justice

Ex post evaluation

Identifying areas of policy where regulation can be more effective

  • Other ministries

Other (e.g. de-regulation agenda or e-government)

  • Gather opinions from stakeholders on areas in which regulatory costs are excessive and submit them to individual departments/ministries

External to government

  • Reviews of existing regulation

  • Independent bodies

  • Analysis of stock and/or flow of regulation

  • Parliament

  • Advocate for particular areas of reform

  • Advisory group

Systematic improvement of regulatory policy

  • Office of Attorney General

  • Institutional relations, e.g. co-operation with international for a

  • Co-ordination with other oversight bodies

  • Monitoring and reporting, including report progress to parliament/government to help track success of implementation of regulatory policy

Co-ordination of regulatory tools

  • Encourage the smooth adoption of the different aspects of regulatory policy at every stage of the policy cycle

Guidance and training

  • Issue guidelines

  • Prove assistance and advice to regulators for performing assessments

Source: Based on (OECD, 2012[1]), Recommendation of the Council on Regulatory Policy and Governance, Paris,; Renda, A. (2015), “Regulatory Impact Assessment and Regulatory Policy” in (OECD, 2015[4]), Regulatory Policy in Perspective: A Reader’s Companion to the OECD Regulatory Policy Outlook 2015, Paris; and OECD 2014 Regulatory Indicators Survey results,

The international practice of the RIA

Regulatory impact assessment is a tool that, ideally, should be applied to primary and subordinate laws; otherwise, the quality that is earned in a segment can be undermined by its subordinate regulations. Figure ‎1.1 includes a composite indicator showing the level of adoption of the RIA. This means, the formal requirements provided for in the regulatory framework to implement this tool, including institutional arrangement. It also includes the methodology used, that is, how the impacts of regulation are assessed, considering the costs and benefits, the regulatory and non-regulatory alternatives, the risks assessment, as well as the existence of a guide for the application of the methodology defined. The third component of the indicator considers the supervision throughout the process, which implies having tasks formally established to oversee the RIA practice and requirements in place to ensure the quality of the analysis of the regulation, and transparency among the OECD countries. The former is understood as the capability of the RIA process to open itself to interested parties and the extent to which they can participate in it. As it can be confirmed, the United Kingdom, Mexico, and the European Union are the ones with the most outstanding practices for primary laws.

Figure ‎1.2 shows the same indicator for subordinate laws. At this hierarchical level, the United Kingdom, Mexico, and the European Union countries continue as the ones with the highest score in the application of the methodology, the transparency process, the adoption and supervision of the RIA. It is important to mention that in those countries the practice of implementing RIA stands out, according to their principles and legal framework. It does not imply, however, that there are not several areas for improvement in the application of these systems, since one of the main challenges within the regulatory quality processes is, precisely, their implementation.

The OECD has closely monitored the work performed in Latin America regarding the development and application of RIA, particularly in countries such as Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, and Peru. In this region, the use of RIA is being more common, but the dissemination of this tool still requires a significant boost. In Latin America, only three countries have the formal requirement of conducting RIA; in two of them it was formalised for all subordinate regulations, and in one of them for a subset of the regulation (Querbach and Arndt, 2017[6]). Nevertheless, RIA is applied in four countries; in one of them to all the regulation, and in the other three to a subset. This implies that, at least, there is one country lagging in the use of the RIA although it is a formal requirement and one country uses this practice without included it in legal instruments (see Figure ‎1.3).

Figure ‎1.1. Composite indicators: regulatory impact assessment for developing primary laws
Figure ‎1.1. Composite indicators: regulatory impact assessment for developing primary laws

Notes: The results apply only to processes for the development of primary laws initiated by the Executive. The vertical axis represents the total aggregate score across the four separate categories of the composite indicators. The maximum score for each category is one, and the maximum aggregate score for the indicator is four. The figure excludes the United States, where all primary laws are initiated by Congress. In most countries, almost all primary laws are initiated by the Executive, with the exception of Mexico and Korea, where a large part of them is initiated by Parliament / Congress (90.6% and 84%, respectively).

Source: OECD 2014 Regulatory Indicators Survey results,

Figure ‎1.2. Composite indicators: regulatory impact assessment for developing subordinate laws
Figure ‎1.2. Composite indicators: regulatory impact assessment for developing subordinate laws

Notes: The vertical axis represents the total aggregate score across the four separate categories of the composite indicator. The maximum score for each category is one, and the maximum aggregate score for the indicator is four.

Source: OECD 2014 Regulatory Indicators Survey results,

Figure ‎1.3. The adoption of RIA: formal requirements and practices in Latin America
Figure ‎1.3. The adoption of RIA: formal requirements and practices in Latin America

Source: (Querbach and Arndt, 2017[6]), “Regulatory policy in Latin America: An analysis of the state of play”, OECD Regulatory Policy Working Papers, No. 7, Paris,

Among the countries where a RIA is conducted, Mexico is probably the best example, because it was implemented for all subordinate regulation originated in the Executive. Costa Rica has enforced RIA, but only for the regulation that creates formalities. Finally, Brazil has different public entities with an important degree of independence that have adopted RIA, but it is not a cross-cutting practice within the government.

RIA as an element of the regulatory governance cycle

The goals of a regulatory policy programme are part of a broader process that includes RIA. For instance, there are additional elements to ensure the quality of regulations such as the public consultation and the regulatory impact assessment. Taken together, these tools are key elements of, what the OECD calls, the regulatory governance cycle, which is the model that it uses to ensure the effectiveness of regulation (see Figure ‎1.4). In fact, among the most important recommendations from the OECD in this regards, is the adoption of the complete cycle, under an approach based on evidence and risk identification.

According to the OECD, it is important to adopt a method of assessing regulations during the design stages (ex ante), that considers proportionality and cost-benefit criteria. Therefore, RIA is a key element for a proper management of the regulatory governance cycle. In fact, a relevant practice as to regulatory governance – and considered necessary to achieve the results planned in the public policies designed – involves a process of cyclical analysis that links the conception of the regulation with its performance, once it is enforced and produces its first effects.

Figure ‎1.4. Cycle of regulatory governance
Figure ‎1.4. Cycle of regulatory governance

Source: (OECD, 2011[7]), Regulatory Policy and Governance: Supporting Economic Growth and Serving the Public Interest, OECD Publishing, Paris,

The regulatory governance cycle has four main stages: development of public policy and choice of instruments; design of new regulation (or review of the existing one); implementation of regulation; and monitoring and evaluation of its effects (OECD, 2011[7]). The prelude to this analysis, however, is the identification of the policy problem and that it requires government intervention.

RIA is an element that allows measuring the relevance of the regulations versus the public policy objectives. Consequently, RIA should be conducted between steps 1 and 3: the definition of the public policy problem and the application and enforcement of the regulation. RIA takes part in the identification of the problem through an early consultation with the interested or possible affected parties, in order to prepare a description of the problem, make adjustments, or elaborate on the problem identified by public officials. With this information, it is possible to prepare a public policy proposal and choose the intervention instruments (step 1).

Afterwards, the RIA helps to choose the best option for the government to step in, either with regulatory or other type of mechanisms; to this end, it uses the cost-benefit analysis, among other cost-analysis tools. The final design of the regulation is part of the RIA process, which includes an additional consultation process that should be more open and aimed to adjust the regulatory instruments used (step 2). This consultation process is very important so that regulations are as adequate as possible, because it allows identifying omissions, biases, unidentified effects, and so forth. Box ‎1.3 shows an example of how the consultation process is carried out in one of the OECD countries.

Box ‎1.3. Public consultations in Canada

In Canada, the adequacy of consultations conducted by the ministries with the representatives involved—prior to seeking the Cabinet’s weighing of a regulatory proposal, along with the result of the consultations, such as the support from the interested parties—plays an important role to determine if the Cabinet will approve the pre-publication of the proposal to obtain feedback from the general public.

In 2009, the government of Canada issued a Guide for an Effective Regulatory Consultation, the guidelines offer information on the components of effective regulatory consultations, along with checklists about:

  • Ongoing, constructive, and professional relationship with stakeholders

  • Consultation plan

    • Statement of purpose and objectives

    • Analysis of the public environment

    • Development of realistic timelines

    • Internal and interdepartmental co-ordination

    • Selection of consultation tools

    • Selection of participants

    • Effective budgeting

    • Ongoing evaluation, end-of-process evaluation, and documentation

    • Feedback/follow-up

  • At the moment of conducting the consultations

    • Communicating neutral, relevant, and timely information

    • Ensuring that officials in charge of the consultation have the necessary skills

Source: (Government of Canada, 2007[8]), “Guidelines for Effective Regulatory Consultations”, (accessed July 2018).

The regulatory governance cycle continues with the implementation of regulations and its monitoring and evaluation. This stage closes the loop, by identifying new problems and public policy objectives that should lead to adjustments in the instruments created, either at design or implementation level.

It should be noted that the implementation of the regulatory governance cycle should be carried out considering four principles of efficiency and modern governance: consultation, co-ordination, co-operation, and communication. These principles should align the participation of civil society with the different government entities and national and international organisations.


[8] Government of Canada (2007), Guidelines for Effective Regulatory Consultations -, (accessed on 26 April 2018).

[3] OECD (2015), OECD Regulatory Policy Outlook 2015, OECD Publishing, Paris,

[4] OECD (2015), Regulatory Policy in Perspective: A Reader’s Companion to the OECD Regulatory Policy Outlook 2015, OECD Publishing, Paris,

[2] OECD (2014), Regulatory Policy in Mexico: Towards a Whole-of-Government Perspective to Regulatory Improvement, OECD Reviews of Regulatory Reform, OECD Publishing, Paris,

[1] OECD (2012), Recommendation of the Council on Regulatory Policy and Governance, OECD Publishing, Paris,

[7] OECD (2011), Regulatory Policy and Governance: Supporting Economic Growth and Serving the Public Interest, OECD Publishing, Paris,

[5] OECD (2008), Introductory Handbook for Undertaking Regulatory Impact Analysis (RIA), OECD, (accessed on 3 August 2017).

[6] Querbach, T. and C. Arndt (2017), “Regulatory policy in Latin America: An analysis of the state of play”, OECD Regulatory Policy Working Papers, No. 7, OECD Publishing, Paris,


← 1. In this survey, regulations, rules and regulation are synonymous, and they refer to the legal instruments issued by a government authority that establish obligations, restrictions, or rights for companies and citizens in a specific jurisdiction.

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