From Impact Assessment to the Policy Cycle: Drawing Lessons from the EU’S Better-Regulation Agenda
Authors: Renda Andrea 
Published: January 2025

The European Union launched its first comprehensive better-regulation agenda in 2002 and has since then been constantly modifying and improving its toolkit aimed at guaranteeing the quality of its legislation. The first better-regulation agenda followed the pioneering experience of some of its member states and introduced a formal procedure of ex ante impact assessment (IA) as well as minimum criteria for stakeholder consultation.1 Different variables explain the rise of EU-level IA, such as reactions to the overuse of the precautionary principle in risk analysis and health policy (especially in chemicals and tobacco);2 pressure from finance ministers in countries such as the U.K. and the Netherlands to introduce evidence-based procedures in policy formulation, thus increasing accountability;3 and organizational developments within the European Commission, with an expansion to regulatory policy of tools originally crafted for sustainable development policies.4 The EU IA model was introduced together with a communication aimed at simplifying and improving the regulatory environment and promoting “a culture of dialogue and
participation” within the EU legislative process.5 As a result, the commission decided to integrate all forms of ex ante evaluation and various tests by building an integrated impact-assessment model, to enter into force on Jan. 1, 2003.6 This model was tasked with the heavy responsibility of ensuring that adequate account was taken, at an early stage of the regulatory process, of both the competitiveness and sustainable-development goals, which ranked among the top priorities on the EU agenda. Over the past 14 years, the better-regulation toolkit of the European Commission has been strengthened from a methodological standpoint, and expanded into a more comprehensive system that involves ex ante IAs, ex post evaluations, “fitness checks” focused on clusters of laws, and cumulative cost assessments that address specific industry sectors. At the same time, the system gradually involved other institutions, such as the European Parliament (especially from 2012) and, to a lesser degree, the Council. And in May 2015, the European Commission further re-launched the system with a much stronger emphasis on ex ante political validation of proposals, stakeholder consultation at all phases of the policy process, and comprehensive, well-structured retrospective reviews. The European Commission has completed more than 1,000 IAs since 2003 and this provides a solid basis for observing the main virtues and challenges of the system as it has evolved to date. This paper looks at the lessons that can be drawn from the EU experience and highlights the challenges that have been successfully addressed and the ones that still remain unsolved. In discussing challenges, reference will be made to other legal systems, such as those in the United States, Canada, Australia and the United Kingdom. The paper also discusses the main novelties introduced by the recently adopted new EU Better Regulation Package, as well as the content of the proposed new Inter-Institutional Agreement on Better Lawmaking, both presented by the European Commission on May 19, 2015. Section 1 of the paper analyzes the current role played by major EU institutions in better lawmaking and aspects of the current inter-institutional agreement that would be worth reconsidering. Key issues include the use of ex ante impact assessments in major EU institutions; the frequency, timing and relevance of stakeholder consultation throughout the policy process; problems related to the ex post evaluation, fitness checks and other forms of analyses of the stock of legislation (e.g., cumulative cost assessments). Section 2 focuses on methodology and discusses the taxonomy of costs and benefits that is now the basis for both ex ante impact assessments and ex post evaluations, including fitness checks and cumulative cost assessments. Section 3 briefly summarizes the main activities carried out in the realm of financial regulation and describes the recent consultation launched by the European Commission for a thorough revision of the whole stock of legislation in this domain. Section 4 concludes by briefly comparing the EU experience with the Canadian one.