The Better Regulation agenda is a “good governance” programme designed to ensure the quality of legislative output in the EU via a range of tools and activities, including mandatory impact assessment, stakeholder consultation and periodic review of the “fitness for purpose” of existing regulation. It shapes the policy process across all sectors, including health, and is therefore a core element of EU health governance.

The contemporary Better Regulation agenda, comprised of a toolbox and a set of guidelines to be utilised by officials in the three legislative institutions of the EU (European Commission, Council of the EU, and European Parliament) was adopted in 2015 by the Juncker Commission. However, the origins of the agenda reach much further back. The Single European Market project and ideas about the role of regulation in the European economy, the Subsidiarity Principle and concern about the appropriate exercise of EU law-making powers, and successive efforts to modernise and reform the organisation of the Commission, have all contributed to the objectives and instruments of Better Regulation as it is now known. Underpinning many of these influences is a set of wider neoliberal pressures that prioritise economic growth, competitiveness and the market, and frame regulation in relation to these priorities.

The Better Regulation programme has three objectives:

1. Ensuring EU policy making is based on evidence
2. Making EU laws simpler, and avoiding unnecessary burdens
3. Involving citizens, businesses and stakeholders in the decision-making process, which relates therefore to civil society engagement in policy-making.

Less clear is the intended purpose that is served by pursuing these objectives. The term Better Regulation is poorly defined, in that there is no single explicit statement of how “better” should be understood or assessed, or what the rationale of the agenda is. Most often, the Commission defines Better Regulation as a “way of working” – one that involves legislating only where necessary, maximising benefits and minimising costs, professionalising policy-making – and emphasises what Better Regulation is not, generally citing deregulation or less regulation. The current guidelines state that Better Regulation “seeks to design and prepare EU policies and laws in such a way that they achieve their objectives in the most efficient way”.

More concretely, recent revisions of the framework have directed it to simplify EU law and reduce unnecessary burdens, remove obstacles and red tape that hinder investment, mainstream the Sustainable Development Goals in EU policy-making, implement the “do no significant harm” and “digital transformation” goals, and integrate strategic foresight in the policy process. In this sense, Better Regulation combines a narrow focus on efficiency and burden (reflecting its earlier, deregulatory origins) with a much wider and fuzzier set of purposes (connected to contemporary political priorities) without explicitly addressing their coherence. As such, the BRBH project has approached Better Regulation from two different angles:

1. Firstly, as a regulatory tool and practical toolbox, which requires consultation of stakeholders and their involvement in policy-making;
2. Secondly, an ideological agenda and narrative, supporting the delivery of EU political priorities. 

Next, read our explainers on…The Better Regulation tools, and The Better Regulation narratives

The current version of the Better Regulation agenda is presented in a 2021 Communication and detailed in two core documents:

• The Better Regulation Guidelines, which set out requirements for the key steps in the policy cycle; and
• The Better Regulation Toolbox, which provides practical, hands-on guidance and operational details.

When explaining how Better Regulation is put into practice, the Guidelines highlight three initiatives that are of particular importance:

• The Regulatory Fitness and Performance (REFIT) programme, which systematically reviews the “fitness for purpose” of existing EU law and searches for opportunities to simplify and reduce burden.
• The one-in-one-out (OIOO) approach, which requires that the Commission offset administrative burdens created in new regulation by reducing equivalent burdens elsewhere.
• The quantification of costs and benefits wherever “feasible, relevant and proportionate”. 

The Guidelines identify five key instruments of Better Regulation:

• Forward planning and validation: Planning involves the advance arrangement of the timing and sequencing of initiatives, whilst validation is about gaining approval before substantive work begins. As regards the latter, the Better Regulation toolbox (tool #6) explains how initiatives are categorised to determine the appropriate level of political sign-off, based on their degree of political sensitivity and importance.
• Stakeholder consultation: Consultation is required for most impact assessments, and encouraged for most evaluations and fitness checks. The Better Regulation toolbox (tools #51 to #55) offers guidance on how to identify stakeholders, design a consultation strategy, conduct consultation activities, and analyse the resulting data.
• Evaluation and fitness checks: Evaluations (assessing one piece of legislation), and fitness checks (assessing groups of related legislation) are conducted ex post, to establish how existing legislation has performed. A key goal of the Better Regulation agenda is to use evaluations and fitness checks to inform the development of new initiatives, and to implement the REFIT programme by assessing the “fitness for purpose” of the existing acquis. Tools #45 to #50 explain when an evaluation is required, what criteria and questions might be used, and how to format the report.
• Impact assessment: Drawing on evidence (including that from evaluations), impact assessment is used to justify the necessity of a new initiative and establish how it can best meet its policy objectives. Impact assessment reports frame the policy problem and the possible solutions, identify the potential impacts of each solution, and describe how the eventual legislation will be monitored and evaluated. The Better Regulation toolbox offers extensive guidance on conducting an impact assessment (tools #7 to #17), identifying specific types of impacts, including health impacts (tools #18 to #37), and using different methodologies to analyse impacts (tools #56 to #69).
• Quality control: The above steps and processes are overseen by several groups of actors. Specialised Better Regulation Units exist within most DGs, to advise and support the development of initiatives. DG Secretariat General maintains a network of these Units and acts as the central guidance point on methodological issues and the overall implementation of Better Regulation across the Commission. It also chairs most interservice steering groups, which are an additional point of oversight and input into policy development. Finally, the Regulatory Scrutiny Board (RSB) is responsible for assessing the quality of all impact assessments and fitness checks, as well as selected evaluations. The procedures for obtaining RSB approval are outlined in the toolbox (tool #3), and include the conduct of “upstream meetings” to guide the development of the impact assessment. The Board’s mandate states that it does not comment on the substance of impact assessment, fitness checks or evaluations; rather, its role is to assess the quality of the analysis and adherence to the Better Regulation procedures. The RSB is also responsible for advising on the implementation of the Better Regulation agenda. The independence and expertise of the Board has been criticised by both civil society and industry stakeholders, and subject to review and recommendation from the EU Ombudsman.

Other Better Regulation tools:

• Mainstreaming the Sustainable Development Goals (SDGs): a further objective of Better Regulation is now to ensure that the SDGs are mainstreamed within the policy process. This involves specifically considering the impacts of policies upon relevant SDGs, via impact assessment and evaluation, and the Commission has created a KnowSDGs (knowledge base for the SDGs) platform to assist policy-makers in this process (see tool #19).
• Strategic foresight: the strategic foresight agenda encourages impact assessments and evaluations to account for “megatrends” and long-term scenarios when assessing the impact of (proposed) policies. Among the megatrends of relevance to EU policy-making, the Commission identifies shifting health challenges – specifically referencing unhealthy lifestyles, pollution, and infectious diseases – as well as climate change, demographic imbalances, governance and inequalities (see tool #20).
• The competitiveness and SME (small and medium enterprises) checks: since 2021, all impact assessments must systematically screen for specific impacts upon competitiveness and SMEs. This involves considering, to the extent relevant for a given initiative, impact upon cost/price, capacity to innovate, and international competitiveness, as well as conducting an “SME test” to identify and minimise negative impacts falling on SMEs (see tool #23).

Next, read our explainers on Better Regulation narratives, and Civil society participation in Better Regulation.

In addition to a set of tools, Better Regulation can be seen as a political agenda. In this sense, it is a narrative built around a particular regulatory philosophy, which shapes the political environment in which policies affecting health are developed. It does this directly, when used as a tool for implementing political priorities and agendas, and indirectly, by advancing a narrative of EU regulation and policy-making that “chills” the regulatory environment.

Whilst the tools of the programme (impact assessment, consultation, and more) are all individually political, the idea of a single coherent agenda was most clearly advanced by President Juncker in 2015. The Juncker presidency set out to establish a more political Commission, and Better Regulation was a central part of this goal. Substantively, the commitment to creating an EU that is “big on the big things, and small on the small things”, by focusing on a discrete set of priority projects and scaling back EU action in other areas, was translated into action using the various tools of Better Regulation.

Forward planning and political validation are used to identify initiatives supporting priority projects and exclude or restrict those addressing non-priority issues or not envisaged in the Commission’s work programme. The proportionality and added value of EU action are systematically examined within impact assessment processes, and the contribution to burden monitored via the Fit for Future Platform (previously the REFIT – regulatory fitness – Platform) and Have Your Say: Simplify! Portal (previously the Lighten the Load initiative). Its overarching objectives – evidence-based policy-making, burden reduction, and participation – should thus be understood in this context, as means to achieving the political goals of the Commission.

Due, in large part, to its origins in the neoliberal, market-driven reforms of the 1970s and 1980s, the dominant narrative of Better Regulation is a deregulatory one. It directs attention and action to obligations and economic cost, using language about red tape, regulatory burden and complexity. Though the policy documentation often opens with a statement of the importance of regulatory protections and the achievements of the EU in this regard, the substance of the agenda is not focused on the value of regulation, but on the need to measure, control and minimise its costs. Specific reforms – such as the introduction of the SME Envoy and the one-in-one-out principle – are undertaken in pursuit of economic-driven goals, with limited reference to social, health or environmental values. More fundamentally, the instruments and processes of Better Regulation are presented as technocratic; as objective, evidence-based, and insulated from political decision-making, ostensibly justifying a lack of transparency.

Better Regulation establishes four key points or opportunities for stakeholders to participate in policymaking:

1. The “call for evidence”, usually launched as part of the evaluation or impact assessment, and including a public consultation (OPC) that must be open to the public at large for a minimum of 12 weeks.

Less commonly utilised is the provision to offer feedback on the consultation strategy. Consultation strategies are required and guided by the Better Regulation toolbox, and set out the Commission’s plans for the OPC and various other consultation activities, such as conferences, focus groups, targeted surveys and workshops. In the call for evidence, consultation strategies must be open for feedback from stakeholders, providing a valuable opportunity to shape the later points of engagement available.

2. Feedback on legislative proposals, once agreed and published by the Commission, which are usually open for 8 weeks.

This feedback is generally unstructured, written input that can be submitted by stakeholders and the general public. It is required for the European Commission to forward a summary of the feedback received to the European Parliament and the Council of the EU.

3. Feedback on draft delegated acts, implementing acts, and measures subject to regulatory procedure with scrutiny, open for 4 weeks by default.

Feedback on legislative drafts and delegated/implementing acts is a pathway of engagement less commonly utilised by CSOs but it offers a crucial benefit over OPC input, in that it is usually unstructured. Feedback is entered into a “free text” box, rather than being based on a questionnaire or survey, giving greater freedom to convey information. For these exercises, the Commission is required to report on how feedback is accounted for via the comitology register.

4. Feedback on any existing EU law, via the Have Your Say: Simplify! Portal, which feeds into the Fit for Future high-level expert group.

Overall, the Have Your Say: Simplify! portal is perhaps the least well-known and well-utilised avenue of participation for civil society actors. Its purpose is to allow citizens to identify existing EU laws that are burdensome or problematic, making its relevance to civil society unclear, and framing it as a tool that advantages economic and commercial actors. However, the remit of the Fit for Future Platform – the high-level expert group which receives submissions from the portal and delivers opinions to the Commission – is broader than burden reduction. Have Your Say: Simplify! assists in “making EU laws more efficient and fit for future, while achieving the policy objectives”. Carefully used, there exists here an opportunity to use the portal as a tool for focusing attention on legislation that fails to achieve its (social/health) objectives, imposes too great a burden upon specific groups, or is in need of future-proofing in order to reach its goals.

Other consultation exercises are implemented, such as:

• Conferences and public hearings: large public events, generally open to anyone who wishes to register and attend, that are directed at conveying information about the initiative to a larger audience of stakeholders. They may involve Q&A sessions but are primarily about dissemination. They can take place in-person or online.
• Workshops and seminars: smaller events, generally “closed” (invitation-only), that are directed at gathering information about the initiative from a smaller audience of stakeholders. They are more interactive in style and can be in-person or online.
• Interviews and focus groups: in-person or web-based activities to which selected stakeholders and experts are invited, aimed at collecting views and information on specific aspects of an initiative.
• Bilateral and small group meetings: closed meetings with European Commission officials that organisations may attend (virtually or in-person) to exchange views on an initiative. Such meetings can be arranged or accepted by the European Commission.

The RSB opinion on the impact assessment accompanying the revision of the General Pharmaceutical Law (GPL) in November 2022 acknowledges the low benefit-cost ratio of the proposals. It recommends that:

“The report should better compare the options, based on overall cost-benefit estimates for each option and each affected key group (including their presentation in consolidated comparison tables). It should be clear if a net positive benefit is expected as the preferred option shows a very low benefit-cost ratio.”

European Commission (2023) Annex 1, page 5.

Responding to the Commission’s ‘stocktaking’ of Better Regulation in 2018, Cefic – the European Chemical Industry Council – published a position paper praising the progress made by the Juncker Commission. In particular, it focused on the Regulatory Scrutiny Baord’s efforts ‘to guide Commission Services towards compliance with better regulation guidelines and tools’, as well as the ‘evaluate first’ principle, and the publication of draft implementing and delegated acts for stakeholder feedback. It goes on to call for publication of all draft measures affecting chemicals stakeholders – including agency decisions – and for ‘more tangible burden reduction results’. 

https://cefic.org/app/uploads/2019/02/Better-reguation-Stocktaking_BetterREgulation_PP-2018.pdf

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• Deregulation Watch: https://www.corporateeurope.org/en/2025/03/deregulation-watch

• EU Health Policy Platform: https://webgate.ec.europa.eu/hpf/  

• Have your say: https://ec.europa.eu/info/law/better-regulation/  

• Transparency Register: https://transparency-register.europa.eu/index_en