Administering a Chill Pill? Better Regulation and the Potential for Regulatory Chill in European Union Health Policy

Abstract

The European Union's “good governance” program, known as Better Regulation, seeks to improve the quality of EU legislation by controlling the policy-making process. Despite its importance, it is rarely accounted for in the EU health policy literature. Seeking to address this gap, this article introduces Better Regulation in the context of health policy making. It conceptualizes a model of regulatory chill, drawn from the literature on international trade, to interrogate the impact of Better Regulation on EU policy-making processes. Using examples from the literature and data from a series of interviews with EU officials, it explores potential pathways of response and anticipatory chill, identifying direct enforcement of Better Regulation, its utilization by corporate actors, interpretation of its provision by officials, and feedback loops as possible routes of influence. The article argues that such an approach not only presents methodological challenges but also offers a valuable way of conceptualizing the relevance of political institutions in general, and Better Regulation specifically, for health. As part of broader calls for attention to the political determinants of health, the article's findings highlight the particular, and often overlooked, importance of metaregulatory policy frameworks.

The European Union (EU) Better Regulation agenda seeks to improve the quality of EU legislation by strengthening its evidence base, increasing participation in policy making, and reducing the burden of legislation for businesses and citizens. As such, it is an example of a “good governance” program. Similar initiatives designed to provide transparency, accountability, and trust in policy-making processes have been adopted by the governments of many high- and middle-income countries, and are recommended by the Organization for Economic Cooperation and Development (OECD) as a way to promote national welfare and economic growth (OECD 2019). In the EU case, Better Regulation is based on three pillars: the routine evaluation of existing policies, an assessment of expected impacts before adopting new policies, and consultation of stakeholders throughout the policy-making process.

Better Regulation dictates the development of policy across all fields and sectors, yet very little is known about how its norms, principles, and tools affect or interact with EU health policy. Where its influence is recognized, it is commonly perceived as a threat to health, environmental, and social protection. Reflecting evidence that the design and adoption of the Better Regulation agenda was influenced by a handful of national governments and a coalition of corporate actors, including British American Tobacco (Smith et al. 2015), civil society organizations have highlighted the potential for Better Regulation to undermine EU legislation (CEO 2020; Smokefree Partnership 2010; WWF 2022). When the package of reforms that created the contemporary Better Regulation agenda was published in 2015, a group of civil society organizations launched the Better Regulation Watchdog in an effort to resist the weakening and neglect of essential regulations (BRW 2015).

Observing parallels with the impact of international trade and investment agreements (ITIAs), commentary in the spheres of civil society and academia has invoked the term “regulatory chill” to describe the effect of Better Regulation on policy-making processes and outputs (de Ville and Siles-Brügge 2017; NEF and EEB 2020; ten Brink 2021). Drawn from the literature on how ITIAs shape national regulatory decision making (Cooper et al. 2013; Milsom et al. 2021; Schram et al. 2018), the concept of regulatory chill characterizes situations where, driven by fear that governments or companies can and will seek arbitration against public policies that threaten trade or investment interests, governments choose to delay, weaken, or abandon planned regulation. Although acknowledging ITIAs as only one source of regulatory chill, existing models focus on these agreements and the mechanism of arbitration; they have yet to be adapted to the study of political institutions or administrative structures.

To introduce Better Regulation's role in health policy making and explore its potential to chill EU health policy outputs, this article conceptualizes Better Regulation as a political determinant of health (PDoH) and, more specifically, as a potential source of regulatory chill. Adopting a PDoH lens draws attention to influences that lie outside of the health sector, “upstream” of the social determinants of health (SDoH), and pertaining to the multilevel political and legal systems that govern our societies (Kickbusch 2015; Leimbigler et al. 2022). Better Regulation programs dictate how policies on employment, education, environment, and virtually every other SDoH are made as well as framing the purpose and role of regulation in society more broadly. They encompass norms, policies, and practices concerned with transparency, participation, burden reduction, and evidence-based policy making, reflecting the kind of institutional factors that definitions of the PDoH seek to capture (Ottersen et al. 2014). Far removed from the health sector, health institutions, and health decision makers, Better Regulation programs are examples of distal “determinants of the determinants” (Bambra 2016; Dawes 2020).

Despite this relevance, Better Regulation is rarely considered within EU health policy research. Traditional accounts focus on the core decision-making institutions (the European Commission, the Council of the EU, and the European Parliament), the health competences enshrined in the treaties and their enforcement by the Court of Justice of the EU, the role of council presidencies and the Health Policy Platform, and instruments such as the open method of coordination and the EU budget (Duncan 2002; Greer et al. 2014; Mossialos et al. 2010; Steffen 2005). Some more recent work discusses Better Regulation and similar horizontal structures—such as the EU's fiscal governance framework—for health policy making (Godziewski 2022; Greer et al. 2022; Greer and Brooks 2021), but consideration of Better Regulation as part of the institutional context relevant to health policy remains rare.

First this article introduces the Better Regulation agenda, characterizing it as a metaregulatory instrument, a political determinant, and a key institution of EU (health) policy making. Drawing on literature on ITIAs and related topics, it then describes and adapts a framework of regulatory chill induced by metaregulation. Supported by interview data and examples, it elaborates this model to identify a series of pathways via which the norms and tools of Better Regulation shape health policy outcomes and might thus induce chill. The discussion section addresses the value and limitations of this approach, challenges for future research, and implications for how we understand health policy-making processes and the PDoH. In so doing, the article contributes to existing work exploring how the institutional context of EU health policy shapes the EU's capacity to promote and protect health (Bartlett and Naumann 2021; Godziewski 2020, 2022). It also responds to wider calls for the application of social science tools, concepts, and methodologies to public health (Gómez 2022; Smith 2020) and the consideration of institutions, as well as structures, in the study of health governance (Ralston, Godziewski, and Brooks 2023).

Introducing the EU Better Regulation Agenda

Although individual tools and initiatives had been adopted throughout the 2000s, the EU's Better Regulation agenda, as a unified program, was introduced by European Commission President Juncker in 2015 (European Commission 2015a, 2015b, 2015c). In applying horizontally across all policy areas, Better Regulation is an example of a metaregulatory instrument, that is, a “set of institutions and processes that embed regulatory review mechanisms into the everyday routines of governmental policy-making” and a sector-neutral “general mechanism of governance” (Morgan 2003: 490). In practice, Better Regulation is a set of guiding ideas about the ends that all policies should serve as well as a toolbox—a set of physical documents describing the policy process, relevant tools, procedures, and responsibilities (European Commission 2021a, 2021c). Its norms include transparency, participation, evidence-based policy making, and burden reduction, while policy formulation is guided by principles such as “do no significant [environmental] harm,” “digital by default,” and the commitment to mainstream EU action in pursuit of the UN Sustainable Development Goals (Lauber and Brooks 2023, 2024). These norms and principles are implemented via tools including impact assessment, evaluation, and stakeholder consultation, and are enforced and coordinated by the commission's Secretariat-General (SG, a horizontal department working closely with the commission president), the Regulatory Scrutiny Board (RSB, an independent regulatory oversight body), and the commission's vice president for interinstitutional relations and foresight.

Among the most notable initiatives launched by President Juncker were the establishment of the RSB to review the quality of impact assessments and evaluations, the creation of a regulatory fitness (REFIT) platform to solicit input on the EU's burden-reduction program, the introduction of additional points of consultation and stakeholder feedback, and a commitment to “evaluate first” before introducing new or revised legislation. Upon taking office in 2019, Commission President von der Leyen introduced a series of Better Regulation reforms, streamlining the consultation process into one “call for evidence” instrument, integrating exercises in “strategic foresight,” and in 2021 introducing a one-in-one-out (OIOO) program to offset the burden of new regulations. The latter is relatively new, and how exactly it will operate remains unclear. Its methodology does not equate to removing an existing regulation for every new one—rather, costs are calculated across policy fields, and several flexibilities are inbuilt—but OIOO intensifies the emphasis on controlling the “stock” of EU legislation, and it introduces a requirement to quantify, as far as possible, all opportunities for burden reduction and simplification (European Commission 2021c: 12).

Crucially, Better Regulation should be understood as a political tool. For the Commission as a whole, it contributes to strengthening “strategic actorness” (Jankauskas and Eckhard 2019) and, ultimately, its power in relation to the other EU institutions (Bürgin 2018). But the Better Regulation agenda is also about internal control. Meuwese and Gomtsian (2015: 490) describe it as curbing the commission's prelegislative discretion, and they conclude that the executive has “made a point of ‘self-regulating’ the discretionary space [that] it enjoys as the sole initiator of legislative proposals.” Successive presidents have introduced these seemingly constricting measures because the Better Regulation agenda increases the top-down control of the presidency over the rest of the commission (Becker et al. 2016; Wegrich 2015). Even before the Juncker reforms, impact assessment was understood to function as “a tool . . . to dilute proposals that did not fit [the president's] priorities” (Bürgin 2018: 840). Analyses of the Juncker reforms conclude that Better Regulation serves as “the chief institutional backer of the Juncker Commission's political agenda” and a core tool of executive control (Alemanno 2015: 345; Bürgin 2018; Wegrich 2015). In this sense, Better Regulation should be understood not only as an institution of EU health policy making but also as a PDoH that shapes the context, objectives, and governance logics of health policy.

Better Regulation and Regulatory Chill

The sense of threat conveyed in existing debates on Better Regulation resembles descriptions of regulatory chill found in the literature on the interaction between ITIAs and health and environmental protections (Barlow et al. 2018; Milsom et al. 2021; Schram et al. 2018). Put simply, this literature seeks to explain the role of ITIAs in shaping policy makers’ (lack of) willingness to adopt regulations such as plain packaging for tobacco (Kelsey 2017) and bans on unnecessary pesticides (Cooper et al. 2013). Much of this work focuses on investor-state dispute settlement (ISDS) mechanisms, which allow investors to challenge government policy that negatively impacts their venture through arbitration and are commonly included in ITIAs. Related literature approaches the World Trade Organization's (WTO) Committee on Technical Barriers to Trade, through which states can raise trade challenges against other governments, in a similar way (Barlow et al. 2018). In the context of ISDS, regulatory chill refers to the delay, weakening, or abandonment of bona fide regulation by governments as a result of a real or perceived threat of a dispute (Schram et al. 2018: 195). This literature differentiates between anticipatory chill, based on the perceived likelihood of a future dispute, and response chill, which results from a concrete threat or challenge (Schram et al. 2018; Shekar 2016).

Crucially, the literature on ITIAs positions ISDS as one possible source of chill, and the WTO framework as another; here, we posit that metaregulation frameworks, such as Better Regulation, are yet another. As noted above, regulatory chill has already been invoked in the context of Better Regulation. To explore and elaborate on the proposition that metaregulatory frameworks might cause regulatory chill, we adapt Schram and colleagues’ (2018: 195) definition, conceptualizing regulatory chill as the delay, weakening, or abandonment of government regulation as a result of real or perceived obligations related to metaregulation. Response chill, in this context, is conceptualized as a reactive adjustment to regulatory scope or ambition following enforcement or a challenge related to metaregulatory norms or procedures. Anticipatory chill, on the other hand, describes an adjustment because of anticipated enforcement or challenges, reinforced by internalization and subject to discursive construction that shapes the interpretation of metaregulatory rules and norms.

Applying the concept of regulatory chill in this context, we assert that in linking regulatory quality to adherence with a narrow set of rules and principles, Better Regulation may expose health regulation to contestation on procedural grounds. Such contestation may be brought externally by actors whose interests are threatened by proposed regulation, or internally by those pursuing a regulatory quality—or wider political—agenda. This framing highlights an important distinction between ISDS and metaregulation as sources of regulatory chill, and the actors involved in the chilling of regulation. In the context of ISDS, the main antagonists are commercial actors; the relevant literature is closely linked to that on the commercial determinants of health and the role of industry in fostering chill (Gilmore et al. 2023; McNamara 2021). By contrast, it is the governing executive that designs and enforces metaregulatory instruments, with the (sole or combined) purpose of improving the quality of legislative output and exerting control over the civil service or equivalent bureaucracy. While commercial actors and other external actors can and do make use of metaregulatory instruments to influence policy making and thus contribute to chill, they are not necessarily the central antagonists.

Conceptualizing Metaregulation as a Source of Regulatory Chill

Based on a review of the existing literature, Schram and colleagues (2018) identify the ITIA environment, the interference of commercial actors, and other political and economic factors as potential drivers of regulatory chill. Crucially, the authors posit a process of internalization whereby policy actors incorporate observed discourse and implementation of ISDS mechanisms into decision making. Adapting this model, we first characterize the context in which the norms, principles, and tools of Better Regulation have developed and now operate. Building on the distinction between response chill and anticipatory chill, we then outline four pathways by which policy responses might be chilled by the operation of metaregulatory programs such as Better Regulation. Finally, we explore the wider legal-political context of the EU health policy system as a potential mediator of regulatory chill. Our conceptualization of regulatory chill is presented in figure 1.

Evidence and examples to illustrate the pathways are drawn from the literature on EU health policy and Better Regulation, analysis of selected legislative files (see note 2), and a selection of interviews. Some of the latter were conducted for previous projects in 2017 and 2018; others are part of a dataset collected for a larger project on Better Regulation and health policy in 2022. Former and current officials from the European Commission, the RSB, and the European Parliament are quoted in the sections below, although a wider set of (formal and scoping) interviews informed the development of the conceptualization and the article. A full list of interviews is included in the  appendix.

Metaregulatory Content and Context

Regulatory chill is underpinned by the content of the metaregulatory instrument itself and the context in which it operates. The Better Regulation agenda that exists today was created in 2015 and subsequently amended in 2017, 2019, and 2021 (European Commission 2015c, 2017, 2019, 2021b), but its origins reach back to the 1990s and to programs adopted by national governments. Concern about the cost of regulatory compliance and the impact of administrative burden on economic activity underpinned initiatives such as the UK government's Deregulation Unit, created in 1986 and tasked with implementing an “anti-red tape” program (Baldwin 2005). The language of early EU activities similarly centered on simplifying the regulatory environment, reducing administrative burden, and cutting red tape (European Commission 2001, 2005, 2007; HLGAB 2014). President Juncker's consolidated Better Regulation agenda was introduced in the context of wider reforms responding to concerns about EU ineffectiveness and overreach, whose guiding ideology was to create an EU that is “big on the big things and small on the small things” (European Commission 2014a: 4). Although the commission rejected member state calls for burden reduction targets, in 2017 it published its first Annual Burden Survey and, a year later, created the Taskforce on Subsidiarity, Proportionality, and Doing Less More Efficiently. While the tools of Better Regulation are presented as neutral, technocratic instruments to improve regulatory quality, and the Commission strongly rejects any link between Better Regulation and deregulation, the (narrative) context in which the agenda has developed is likely to be internalized by policy makers and contribute to a chilling effect.

The Pathways of Regulatory Chill

Response Chill from Direct Enforcement by the Executive

A core critique of Better Regulation—one that has been voiced by officials within the commission as well as external stakeholders—is that it slows the policy-making process by introducing additional bureaucracy. Similar to the potential for “paralysis by analysis” that some stakeholders foresaw in the regulatory cooperation provisions of the Transatlantic Trade and Investment Partnership (EPHA, EHN, and EASL 2016), the implementation of Better Regulation delays the introduction of new initiatives by mandating the conduct of complex evaluations and impact assessments, enforcing periods of consultation, and requiring approval or sign-off at various political layers. From the perspective of policy makers working within its structures, an official with Directorate-General (DG) SANTE official gave this summary: “The so-called Better Regulation is frankly . . . absolutely not useful, [it creates] a lot more procedure. . . . You have to work just to produce paper. . . . [It] makes the life of everybody very difficult, and everything will be delayed” (interview 1). Similarly, an official observing from the European Parliament said: “From an administrative point of view . . . in all DGs it must be quite complicated. . . . I would say that production of any commission proposal now takes more [time]” (interview 2). A former member of the RSB concurred that, while the view differs across DGs, several of the services consider Better Regulation a burden and a source of delay (interview 4).¹

The requirement to undertake evaluation and impact assessment before launching any new initiative is widely identified as a source of legislative delay. Reviewing the implementation of REFIT within the social policy field, Laulom (2018: 17) finds that “during the entire period of the REFIT, the Commission avoided making any legislative proposals in the area of health and safety, until the evaluation of the entire body of EU OSH [occupational health and safety] legislation had been completed.” The OSH evaluation was a complex undertaking, covering 24 separate directives, and the publication of its various reports was postponed several times over a period of five years. The study goes on to present an extensive list of initiatives that were delayed or that the commission declined to engage with while the OSH evaluation was ongoing. These include measures on health and safety in the hairdressing sector, musculoskeletal disorders, and occupational cancers (Laulom 2018: 17–18). Such observations indicate that in these cases, findings of the REFIT program were only followed up when they coincided with political priorities, and that in the meantime the process itself might serve (whether intentionally or not) as an obstacle to policy development.

The delaying of legislation is relatively easy to observe, but examples of weakening or abandonment of initiatives are harder to identify. Laulom (2018) reviews the fitness checks/evaluations of three sets of social policy legislation. The findings indicate that although all three evaluations identify areas for strengthening the existing legislation, and each was shortly followed by initial consultations on new legislation to address these gaps, the new initiatives were subsequently abandoned for the first two packages. Similarly, reports by nongovernmental organizations identify the Carcinogen and Mutagens Directive, the Pesticides Regulations, and the Soil Framework Directive as casualties of legislative repeal, and proposals on OSH and antimicrobial resistance as evidence of “regulatory chill” (ALTER-EU 2018; CEO 2020). A detailed tracing of the precise pathways by which Better Regulation is influencing policy development in these cases is beyond the scope of this article, but it could establish the particular role of, for instance, quality and evidence thresholds in impact assessment, and the criteria used in ex ante evaluation. More widely, the commission records the number of legislative initiatives that have been subject to evaluation or adopted with a simplification or burden reduction objective (see, e.g., European Commission 2022). While these may represent genuine examples of overly complex or unnecessary laws, their presentation as evidence of success in controlling the “stock” of EU legislation feeds into a narrative that underpins anticipatory chill (discussed below). This dynamic is only likely to strengthen under the new OIOO program, which will see specific burdens removed to “offset” new regulation.

Response Chill from Utilization by Commercial Actors

A second pathway of regulatory chill occurs via the use of Better Regulation and its constituent parts in commercial actors’ efforts to delay, prevent, or weaken health regulation. While external stakeholders do not have formal powers to enforce or guide the application of Better Regulation, they harness these norms and rules in ways that can mobilize bias and reinforce the anticipatory chill pathway discussed below. Commercial actors, significantly more so than civil society representatives, draw on the institutions of Better Regulation discursively, to support their argumentation, and instrumentally, to support efforts to shape policy outputs (Lauber and Brooks 2023). In three initiatives relevant to food and alcohol policy,² for instance, the term “Better Regulation” was overwhelmingly used by commercial actors to support calls for more extensive consultation and impact assessment, the use of alternatives to regulation, and general caution around adding to the regulatory stock. In its response to the consultation on an initiative for sustainable food systems, for example, the World Federation of Advertisers (2022) refers to Better Regulation to support calls for self- and co-regulatory governance models: “Advertising self-regulation and self-regulatory codes should therefore continue to be recognised within the future legal framework and must be accounted for in any legislative initiative, in accordance with the . . . EU Commission's Better Regulation Agenda.”

The specific rules and guidelines associated with Better Regulation, such as those relating to impact assessment and consultation, have been invoked to challenge policy processes or outcomes on the basis that they did not follow due process. DG SANTE's impact assessment for the revised Tobacco Products Directive, for instance, was critiqued by Philip Morris International for its “failure . . . to adequately assess impacts on the tobacco market” (Peeters and Gilmore 2013: 112).

In addition to discursive challenges, corporate political activities aimed at preventing further regulation have made instrumental use of Better Regulation instruments. One strategy here is to mirror Better Regulation processes to contest their outcomes. In the context of EU health regulation, this has primarily concerned the production of alternative, competing impact assessments. A prominent example is documented in the literature on the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation, which saw chemical industry groups commission several impact assessments emphasizing regulatory costs for business. This resulted in a memorandum of understanding with the commission and the subsequent inclusion of these reports in the official assessment framework (Radaelli and Meuwese 2010; Smith et al. 2010). Another strategy is to target actors that have been empowered by the Better Regulation framework and present an additional avenue of potential influence. During the drafting stage of the Tobacco Products Directive, for instance, Philip Morris International sought to engage DG SG and other sectoral DGs, so as to exert indirect influence over the process being run by DG SANTE (Peeters et al. 2016). These examples of corporate political activity that uses Better Regulation norms and tools reflect evidence that industry was instrumental in promoting a Better Regulation agenda “that they hoped would shift the balance of power back towards business and economic interests” (Smith et al. 2015: 19).

Anticipatory Chill from Interpretation and Learning by Policy Makers

A third pathway refers to policy makers’ interpretation, understanding, and knowledge of Better Regulation, which can contribute to inducing chill. In much the same way that ITIAs create a policy-making environment that privileges the elimination of trade barriers over other policy objectives (de Ville and Siles-Brügge 2017: 1497), the narrative around Better Regulation creates a policy-making environment that prioritizes “regulatory quality,” where concerns about economic impact and regulatory burden overshadow other issues (Smismans and Minto 2017). The REFIT program, for instance, requires that opportunities for burden reduction and simplification are explored and identified in every new or revising initiative, feeding into a sense that this is the primary purpose of Better Regulation. Similarly, the emphasis on impact and cost quantification—as seen across the Better Regulation agenda, and required as part of the new OIOO program—contributes to a sense that what cannot be counted is less important. As a former member of the Stoiber Group (the predecessor to the REFIT Platform) summarized: “The cost side is always going to be way easier to assess, and there will be people that will voluntarily provide you that evidence, [more so] than the benefits side” (interview 5). A former member of the RSB noted that quantification is also problematic where provisions are designed to foster financial stability, the benefits of which can be difficult to assess (interview 4). In the meantime, the increasing emphasis on quantifiable impacts feeds into an understanding of Better Regulation as an exercise concerned with economic and market goals.

More widely, policy makers’ interpretations of how Better Regulation works and its purpose are shaped by the contested narrative of deregulation with which it is associated. In adopting a program to combat the perception that the EU creates red tape and burden for businesses, the commission risks confirming the (flawed) notion that this is the case, and thus “may feed the existence of the very problem it intends to solve” (Garben and Govaere 2018; Listorti et al. 2020: 1564). In addition to a genuine effort to improve regulatory quality, Better Regulation is a public relations exercise, a “ceremonial self-flagellation” designed to “allay criticism of the EU's supposedly excessive and inflexible regulation and red tape” (Kelemen 2018: 205, 209). Programs such as OIOO, which the commission rejected for many years before it was introduced in 2021, is similarly flawed in that it assumes and confirms that the problem is administrative cost and regulatory burden (Radaelli 2021; Smulders and Paquet 2018).³ Although this is difficult to evidence,⁴ we argue that the consistent framing of Better Regulation as a response to overregulation and unnecessary burden, and the failure to promote the value of (EU) regulation (Kelemen 2018), foster an interpretation liable to result in regulatory chill.

Anticipatory Chill from Previous Experience and Feedback Loops

A final pathway—which links closely to the third—highlights the importance of feedback loops as a source of anticipatory chill. Over time, sectoral DGs learn from repeated interactions with the institutions of Better Regulation and those that they empower, such as DG SG, the RSB, and internal Better Regulation Units. Officials have previously described this structure as a “glass ceiling” above DG SANTE and the health commissioner (interviewee cited in Brooks and Bürgin 2021). DG SG now screens all new policy proposals, seeks validation for major items before impact assessment commences, sets up and chairs the interservice steering groups that guide approved initiatives through development, and hosts the RSB (Dawson 2016). When asked what they had learned from their experience with conveying to DG SG the “added value” of EU health initiatives, a senior DG SANTE official explained: “We know what criteria [DG SG] will apply, and we apply them internally before. So if you know that you're going to put something on the table which is not really going to make the grade, you kind of take a decision internally” (interview 3). The official went on to identify the decline in EU action on alcohol during the early years of the Juncker commission as an example of this dynamic.

Anecdotally, the RSB seems also to have gained a reputation, and the power that it wields over the progression of an initiative shapes policy makers’ approach to impact assessment. An interviewee involved in numerous initiatives in the health field said: “Just from a desk officer level they were all so terrified of the RSB. Months and months and months, like the entire duration of drafting anything, they were already terrified of what the RSB might say. . . . They were also really worried about interservice consultation because they knew they were going to be attacked by [DG Competition] and [DG Enterprise and Industry]. . . . Then the RSB was like a level of terror on top of that” (interview 5). A former RSB member even recalled a Christmas party featuring a voodoo doll that represented the collective membership of the board (interview 6). It is reported that, within DGs, tensions exist between the policy officials and the Better Regulation Units that were created to coordinate Better Regulation work within DGs (interview 4).

Political and Legal Context

As Schram and colleagues (2018) note, (health) policy makers’ assessment and internalization of the sources of regulatory chill is likely to be mediated by (their perception of) the wider political and legal context. In the case of EU health policy, this context relates to the EU's competences in health, the relative power of DG SANTE within the Commission, the external political support (i.e., among the member states) for EU action on health, the political priorities of the commission through which the provisions of Better Regulation are interpreted, and the overarching paradigm or ideology underpinning EU action on health. The EU's health powers are limited—by comparison to, for instance, its powers to regulate the internal market—and DG SANTE is a relatively weak directorate within the commission. The legal mandate for health has existed since the Maastricht Treaty came into force in 1993, but it restricts EU action to that which supports and complements, rather than compels or replaces, national action (for an overview see, e.g., Greer et al. 2022). Moreover, the future of the health agenda has looked uncertain at various points in recent years, most notably during the second tenure of President Juncker between 2014 and 2019 (Brooks and Bürgin 2021). The principles of subsidiarity and proportionality, which exist outside of Better Regulation but are implemented within its framework, are thus particularly pertinent to the development of new initiatives in the area of health policy. Proposals must be supported by close alignment with the political priorities, which did not mention health under President Juncker, and must make clear that they do not stretch or overstep the EU's mandate (Brooks and Guy 2021).

More broadly, the EU is based on a “constitutional asymmetry” wherein regulation to promote economic objectives is easier to adopt than regulation to promote social objectives (Scharpf 2002). Political support from national governments has traditionally been sparse, save for specific areas of shared (and often crisis-induced) concern, such as the fight against HIV/AIDS, the regulation of food safety, and the purchase of vaccines to fight COVID-19 (Brooks et al. 2023; de Ruijter 2019). In the absence of a strong legal mandate or consistent political will, EU health policy has often been driven by entrepreneurialism and opportunism on the part of Commission officials, supported by the Court of Justice of the EU, in exploiting EU powers in tangential fields, such as competition, occupational health and safety, and the internal market (Brooks and Guy 2021; Greer 2006, 2008; Lamping and Steffen 2009). These features of the legal and political environment set a context in which health policy officials seeking to introduce ambitious change may already feel that the deck is stacked against them.

Discussion

The conceptualization outlined above faces limitations, requires caveats, and raises additional questions. In this article, our aim is to develop and illustrate the conceptualization; it now requires testing and challenging, using studies of specific pieces and aggregated sets of legislation, from the EU as well as other jurisdictions and levels of governance. In the EU case, it is already clear that some pathways are easier to observe—and corroborate with data—than others. Delays to legislation and overt corporate political activity can more easily be established than the interpretation, feedback, and learning patterns of individual policy officials. That said, for all pathways, demonstrating evidence of chill requires opening the “black box” of policy making to gain information that is not often publicly available in written form and can be difficult to access via interviews. Here and in other work we have used access-to-document requests and sought interviews with former and current policy officials with some success, but data collection remains challenging.

A more fundamental methodological challenge is presented by the political nature of Better Regulation. The agenda was created as part of President Juncker's wider reform of the commission's working practices, designed to establish a more political executive and to shed the commission's image as a technocratic bureaucracy (Bürgin 2018; European Commission 2014b: 2). This makes separating the influence of Better Regulation from that of the wider political agenda difficult, if not impossible. Restrictions on the adoption of alcohol policy initiatives, for instance, may have been enacted using the tools of Better Regulation but result from political decisions. Similarly, it might be argued that a lengthier and more complex legislative process is justifiable in the service of creating better-quality regulatory outputs. In short, policy officials’ interpretation of Better Regulation as requiring the delay, weakening, or abandonment of (health) initiatives may be accurate and intentionally directed by the commission leadership. Moreover, the conceptualization presented above does not preclude the possibility that, under different political circumstances, Better Regulation might operate differently. Instead of producing “chill,” its tools and processes might be used to “warm”—meaning to increase, strengthen, and improve—the body of EU health policy. The REFIT program, for instance, may result in the proposal of new, better health legislation, while a shift in political context may enable political entrepreneurs within DG SANTE, SG, or the RSB to promote particular approaches or priorities. In short, a commission leadership more amenable to a strong EU role in health—with the necessary mandate from national governments—might use Better Regulation to sponsor and advance EU health policy.

The key here is that regulatory chill should be understood as resulting from the use of instruments such as ISDS and Better Regulation in ways that are not necessarily in line with their stated intention. In the former case, the literature is concerned with instances in which corporate actors use ISDS to illegitimately target regulation that is neither protectionist nor discriminatory but which they perceive to be detrimental to their interests (for example, because it imposes an additional cost). In the latter case, this refers to situations where, for example, the status quo or weak progress results from ruling out viable policy options during seemingly objective and evidence-based impact assessment processes, or where a strong emphasis on burden-reduction opportunities within evaluation exercises leads to an interpretation of their purpose and practice that results in the proposal of weaker initiatives.

Conclusion

Conceptualizing metaregulation as a potential source of regulatory chill facilitates exploration of how policy makers interact with the institutional structure within which they operate, both explicitly and via internalization processes. It also accounts for the role of nonstate actors and their engagement with the structures of policy making, enabling a bridge to concepts like the commercial determinants of health (Gilmore et al. 2023) and other aspects of the PDoH literature. A particular benefit of Schram and colleagues’ (2018) conceptualization is the attention it draws to the context in which the instrument is adopted and framed, and the wider political, legal, and economic context in which it is implemented. The former emphasizes the importance of narratives, language, and policy framing, highlighting the ways in which Better Regulation's origins in deregulatory programs, and continued emphasis on burden reduction and “red tape,” may shape its implementation and effect.

The latter helps to address a gap in the existing literature—namely, the absence of research into how Better Regulation operates within individual policy sectors—by bringing attention to the relevance of legal competence, political context, and underpinning paradigms. Health is an area of EU policy where the mandate to act is limited, political support for integration has traditionally been weak, and the progress of initiatives has often relied on entrepreneurial commission officials. The conceptualization of regulatory chill outlined above illustrates how these factors mediate the internalization of Better Regulation norms and narratives and offers some indication of why the agenda might be implemented differently or produce different effects in health policy, compared to other policy sectors. Put another way, it contributes to comprehending and reconciling the view among civil society actors that it has become harder (although not impossible) under Better Regulation to advance health protections at the EU level.

Not all Better Regulation initiatives are the same—the UK program, for instance, diverged from the EU's “regulatory quality” approach in the early 2000s, instead pursuing a “war on red tape” (Dunlop and Radaelli 2022)—but the analysis above highlights their relevance to health policy making and the value of conceptualizing metaregulation as a PDoH. The OECD considers the EU's Better Regulation agenda to be an example of best practice, and the EU actively engages in exporting its model to other jurisdictions. Far beyond the EU context, the use of Better Regulation and related ideas of good governance within corporate rhetoric, not only against public health regulation but also against conflict of interest safeguards, has been documented internationally (Fooks et al. 2017; Fooks and Godziewski 2020; Lauber et al. 2020; Lie et al. 2018; Smith et al. 2009; Ulucanlar et al. 2014). Metaregulation distributes power, shapes policy processes, and sets the conditions under which health determinants are addressed. As such, it warrants closer attention within health policy research and necessitates the integration of political science and public health approaches.

Acknowledgments

We would like to thank the two anonymous reviewers for their helpful comments and the guest editors for their support. We are grateful to participants at the EUHealthGov “Maastricht at 30” workshop, held in Brussels in April 2023, for useful feedback. This work was supported by UK Research and Innovation (Medical Research Council grant reference MR/T023244/1). The funder had no role in study design, data collection, analysis, decision to publish, or preparation of the manuscript. For the purpose of open access, the author has applied a Creative Commons Attribution (CC BY) license to any author-accepted manuscript version arising from this submission.

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