KEY POINTS:

• Health policymaking is defined as the dynamic process of events, decisions, and actions regarding public health.

• The stage model conceptualizes health policymaking as a cyclical process consisting of five sequential stages: agenda building, policy development, policy forma­tion, policy implementation, and policy evaluation. The sixth stage is policy termination. 

• The rounds model conceptualizes health policymaking as a sequence of decision rounds. The focus of analysis is on the interaction between actors in each decision round. 

• The crisscross model postulates that health policymaking intersects with other policy processes inside and outside the health sector.

• Agenda building is the process of asking for the attention of policymakers for salient problems in society. 

• Problem development involves the identification and investigation of policy alternatives.

• Policy formation involves the assessment of policy alternatives and final decision-making, including democratic control.

• Policy implementation is the process of putting a policy into practice.

• Policy evaluation involves the analysis and assessment of the policymaking process, policy results, and governance structure.

• Policy termination involves the ending of a policy, often by replacing it with an alternative policy. 

• A policy path passes through a series of consecutive cycles during a certain period. Cur­rent policy is the latest version of a policy in the process of consecutive accommodations to changing circumstances, new insights, and the political context.

• A distinction can be made between two types of paths: policy expansion and a path of policy contraction. 

Box 4.1. The introduction of the human papillomavirus (HPV) vaccination program in the Nether­lands After the authorization of Gardasil, a vaccine to prevent cervical cancer, by the European Medical Agency, members of Parliament asked the Minister of Health to investigate the usefulness of the vaccine for admission to the National Vaccination Program (NVP). Due to the fall of the government in 2006, it was not until March 2007 that the new Minister of Health formally asked the Health Council for advice (a requested procedure). Meanwhile, the European Medicines Agency authorized a second preventive vaccine (Cervarix) against cervical cancer.  In March 2018, the Health Council advised the Minister to extend the NVP with a vaccination program for girls aged 12 years and prepare a catch-up campaign for girls 13-16 old. The Council based its advice on the prevalence of cervical cancer, the scientific evidence of the effectiveness and safety of the new vaccines, and economic considerations. In July 2008, the Minister informed the Parliament that he would follow the positive advice of the Health Council and charge local public health agencies with the implementation of the vaccination program and the National Institute for Public Health and Environment with monitoring the vaccination rate. The start of the program was scheduled for September 2009 but was suspended for half a year because of the outbreak of the Swine Flu (H1N1 virus). In the meantime, concerned members of Parliament sent critical questions to the Minister about the high costs of the vaccine, the aggressive marketing of the pharma­ceutical industry, and the quality of the Health Council’s advice. Were the safety and effectiveness of the vaccine guaranteed? Other critical remarks concerned the incomplete information to the target population and the organization of a lottery to motivate girls to choose for vaccination (girls who had received all three doses could win an iPod).  Initially, the vaccination rate was disappointing: only 45.5% of girls born in 2003 had been vaccinated (RIVM, 2018). In response to questions about this result, the Minister announced an investigation to determine how the vaccination rate could be raised. In particular, what could the Netherlands learn from Belgium, where the vaccination rate had peaked at 90% (Letter to the Parliament, 12 July 2018)? Ever since the vaccination rate has risen. In 2019, 53% of all girls born in 2005 and 58,5% of all girls aged 14 years and older had chosen for vaccination. Source: Van der Putten et al., 2019; RIVM, 2020.

4.1 Introduction

The extension of the Dutch National Vaccination Program with HPV vaccination illus­trates a relatively simple policymaking process. The authori­zation of two newly developed vaccines against cervical cancer by the European Medicines Agen­cy set a process in motion that eventually resulted in a new national vaccination campaign. The introduction of the vaccination was delayed as a consequence of the unforeseen fall of the government and the outbreak of the Swine Flu. 

This chapter introduces the health policymaking process, the second building block in our model of health policy analysis. Health policy can only be well understood with knowledge of the health policymaking process. Health policy is the outcome of a process of initiatives, calls for action, political pressure, accommodation to altering circumstances, practical issues, and contextual factors. The chapter starts with a

description of three alternative policymaking models: the stage model, the rounds model, and the crisscross model. The following sections explore the health policy­making process in greater detail. Successively, attention will be paid to agenda building, policy development, policy formation, policy implementation, policy evalua­tion, and termination. The chapter ends with a discussion of the concept of policy path. 

4.2 Stage model 

The health policymaking process is defined in this book as the dynamic process of events, decisions, and actions concerning public health. Most policymaking processes miss a clear beginning and a clear ending. Consequently, there is no simple way of deline­ating a policymaking process. The resolution of this problem is to focus on policymaking during a preselected period. There are several analytical models of the policymaking process: the stage model, the rounds model, and the crisscross model. This section contains an introduction to the stage model of policymaking. The rounds model and the crisscross model are discussed in the next sections.

The stage model or phase model conceptualizes policymaking as a cyclical process consisting of several sequential and distinct stages (Hill, 2005; Howlett & Ramesh, 2003). The number and names of these stages vary in the literature. This book distinguishes between six stages: agenda building, policy development, policy formation, policy implementation, policy evaluation, and policy termination. 

The stage of policy formation comprises the process of decision-making on policy goals, policy instruments, and the organization of policy implementation. In the stage of agenda building problems are recognized and brought to the attention of policymakers. The policy development stage includes the exploration of policy alternatives to ap­proach these problems. The stage of policy formation comprises the process of decision-making on policy goals, policy instruments, and the organization of policy imple­mentation. Hereafter follows the stage of policy implementation during which the policy decisions taken are put into practice. The stage of policy evaluation comprises the analysis and assessment of the policy effects. If a policy does not work anymore or is heavily criticized, policymakers can decide to terminate it. A more likely outcome is that a new policy cycle starts.

The stage model conceptualizes policymaking as a linear process that is akin to the solution of technical problems (problem >> investigation >> decision >> action >> evaluation). Each stage gives direction to what happens in the next stage, and each stage logically follows upon the previous one. After the completion of the cycle from agenda building to policy evaluation, a new policy cycle commences. Policymaking is a process of continuous adjustments to changing circumstances. New insights and developments, disappointing policy results, and a political crisis are some critical factors that may set a new cycle in motion. The history of health policy can be conceptualized as a path of subsequent policy cycles (section 4.11).

Except for the stage of policy termination, all stages are clearly recog­nizable in the policy­making process concerning the extension of the National Vac­cination Program with HPV vaccination. Members of Parliament put the issue on the political agenda. In the stage of problem formulation, the Health Council investigated the safety and effectiveness of the vaccines against HPV. In the stage of policy formation, the Minister of Health decided to follow the positive advice of the Health Council. Despite critical remarks, the Parliament approved the extension of the National Vaccination Program. The stage of policy implementation included the planning and execution of the vaccination program, and the stage of policy evaluation the monitoring of the program. The disappointing vaccination rate motivated the Minister to start a campaign among girls to improve the vaccination rate (new cycle).

The duration and structure of policymaking cycles vary. The extension of the National Vaccination Program is an example of a relatively short cycle. Policymaking in an enduring crisis requires continuous accommodation of policy meas­ures to changing circum­stances and lessons learned. In these circumstances, policy­making follows a pattern of cycles rapidly following one after another. A textbook example is the policy­making process concerning COVID-19. Policymaking had the structure of a cyclical process of upscaling and down­scaling policy measures in a short period. The erratic course of the pandemic, including several mutations of the coronavirus, uncertainty about the spreading and infection rate of the virus, and lack of information on the effects of the policy measures taken, repeatedly compelled governments to revise their strategy. Table 4.1 presents a concise overview of the policy measures of the Dutch government to control the spread of the virus and avert the occurrence of the ‘black scenario’ in which hospital care would become completely overwhelmed. 

Table 4.1 Overview of the timeline of policy measures to suppress COVID-19 in the Netherlands

Source: Coronavirus tijdlijn|Rijksoverheid.nl

A strong aspect of the stage model is its heuristic value and its emphasis on the cyclical structure of policymaking. The model conceptualizes policymaking as a recursive process. If policy measures do not work well or circumstances have altered, reconsi­deration and adjustment may follow. Its heuristic value explains why the stage model has remained popular, not only in the analysis of policymaking but also in the analysis for policymaking (De Leon, 1999). The well-known Plan-Do-Check-Act (PDCA) cycle presupposes a stage model of policymaking. Nevertheless, the model has been criticized for its simplicity and descript­ive inaccuracy (Sabatier & Jenkins-Smith, 1999). The assumed logical sequence of the policy stages and central orches­tration of the policymaking process ignore the erratic structure of much policymaking. The assumption of clear boundaries between each stage is flawed. The transition from one stage to another stage is fluid, and stages often overlap each other to some extent.

4.3 Rounds model

The rounds model of policymaking (Teisman, 2000) does not conceptualize policymaking as a logical sequence of distinct stages, but as an interactive process between actors, each with their specific expertise, normative convictions, policy preferen­ces, interests, and bureaucratic procedures. The focal point of analysis is their interaction in each decision round. The model divides policymaking into a number of ‘decision-making rounds’ which may follow upon each other but also coincide in time. Decisions are taken at various moments by various actors and at various political/ administrative levels. While some actors participate in each round, other actors get involved at a later moment. Examples are the installment of ad-hoc expert committees to investigate new policy alternatives or the creation of an informal committee to work out a compromise that all participants are willing to accept. Actors playing a prominent role at the beginning of a policymaking process may fade into the background in later rounds. Although formal decision-making procedures cannot be bypassed, it is no exception that ‘real decision-making’ occurs in an informal setting.

The rounds model accentuates better than the stage model the complexity of policymaking. Much health policymaking has an erratic (non-linear) rather than a linear structure running straight from problem to solution. New (political) circumstances, new information, public resistance, unexpected developments, and setbacks are some factors that cause delays or motivate policymakers to reconsider earlier plans or policy decisions. Sometimes, policymaking even comes to a (temporary) standstill. The introduction of the market reform in Dutch health care which had started in the late 1980s was declared ‘politically dead’ in 1992 but resumed by the end of the nineties (Jeurissen & Maarse, 2021). The challenge for researchers using the rounds model as the conceptual basis for their analysis is to demarcate ‘the most crucial decisions of decision-making in retrospect’ (Teisman: p. 944).

The rounds model stipulates that policy decisions are not linked to a single actor. The outcome of a decision round is a collective ‘product’ that each actor will interpret and appreciate in their way. Furthermore, the model does not conceptualize policy­making as an orchestrated process as is implicitly assumed in the stage model. Policymaking on controversial issues is likely to pass through several rounds before the situation is rife for final decision-making. Deadlocks and delays are no exception. Actors sometimes even disagree on which stage of decision-making they are in. Box 4.2 illustrates how the settlement of a deep conflict between health insurers and self-employed medical specialists required several decision-making rounds. 

4.4 Crisscross model

The crisscross model draws upon the rounds model. Its central claim is that policy­making pro­cesses intersect. Policymaking on a given issue cannot be well understood without considering its ‘interaction’ with policymaking in other policy sectors. Health policymaking in a given sector (e.g. pharmaceutical care or prevention programs) can be closely linked to policymaking in other parts of health policy (e.g. healthcare cost control) and other public sectors. For instance, complex connections exist between health policy and public policymaking on social security, public finance, income policy, housing, privacy, public security, education, and international trade. EU regulations and policies often have significant consequences for health policymaking in the member states. Some­times, ‘neigh­boring’ processes create opportunities and fasten policymaking. In other situations, however, they restrict the room for policymaking or cause policy delays. Political factors such as electoral competition, party politics, the fall of the government, or the installment of a new government may heavily influence the course and outcome of health policymaking. Sometimes, a government change creates an unexpected opening in a process that has dragged on for years without the prospect of a soon way out. An example is the political switch of the UK government in the policymaking process on the European ban on tobacco advertisements. After Blair had won the electoral vote in 1997, the UK government gave up its resistance to introducing a European ban. The UK’s remarkable switch was followed by the Dutch government which had joined the UK in its political resistance to a ban because of economic interests. The switch of British and Dutch governments meant that the blocking minority in the European Council no longer existed (Boessen & Maarse, 2009).

The crisscross model differs in several respects from the stage model. It replaces the ‘vertical’ structure of policymaking that is implicitly assumed in the stage model with a ‘horizontal’ structure of policymaking in multiple settings. The criss­cross model also rejects the logical sequence of processes in the stage model. Another difference is the absence of a unitary actor who has the authority or power to steer policymaking top-down. The difference between the crisscross model and the rounds model concerns the focal point of analysis. While the focus in the rounds model is upon the interaction of actors in sequential decision-making rounds in public policy­making, the crisscross model puts the interaction between simultaneous policymaking processes and the impact of this interaction upon policymaking central. Much policymaking resembles simultaneous chess-playing.

4.5 Agenda building

The previous section gave a brief overview of three alternative models of health policymaking. This section and the following sections explore this process further based on the stage model. It is recalled that the boundaries of each stage are fluid, that stages may partially overlap, and that the assumed logical sequence of the stages mostly does not exist in the real world of policymaking. Furthermore, it should be noted that the rounds model and crisscross model are useful analytic models to study each stage in the policymaking cycle separately.

Agenda building is the process of asking the attention of policymakers for salient societal problems. Political parties, interest organizations of care workers and patients, research institutes and experts, government departments, international organizations, citizen groups, or other stakeholders call for attention to their problems, urge the government to make an additional budget available, insist on the coverage of a new experimental medicine, argue for the abolition of market competition in health care, warn of the risks of doing nothing, and so on. The media play an important role in agenda building by reporting on problems and scandals, posing critical questions, influencing public opinion, and conducting investigative journalism. Kingdon (1984: 3) describes the agen­da as ‘the list of sub­jects or problems to which governmental officials, and people outside of government closely associated with those officials, are paying some serious attention at any given time’.

As spelled out in the previous chapter, policy problems are never given or ‘object­ive’ but politically constructed or ‘subjective’. Actors trying to put policy pro­blems on the political agenda need an appealing narrative or policy frame to create public awareness. There is nothing more helpful to bridge the gap between public and political agendas (see below) than an effective problem frame. Persuading people with facts, arguments, analysis, or reason (logos) only does not work. The challenge is to convince policymakers that something can and should be done.

While some problems form a more or less institutionalized part of the health policy agenda (e.g. cost control, access to health care, payment of doctors and hospitals, quality of health care, or the market authorization of new medicines), other problems are relatively new. Technological innovations, demographic and epidemiological developments, and the growing body of knowledge on health and disease have fundamentally altered the health policy agenda. Examples of new themes are the aging of the population and the corresponding need for long-term care, the rising number of patients with multimorbidity, the call for more emphasis on the prevent­ion of disease and promotion of health, the reduction of health inequalities, the potential impact of e-health, big data, artificial intelligence upon health care and the penetration of the com­mercial sector into the health sector. Scandals and policy failures also influence the health policy agenda, albeit usually for only a short period. The issue-attention cycle (Downs, 1972) often appears short-lived. In contrast, COVID-19 radically changed the health policy agenda worldwide for some two years. 

Agenda building as a filtering process

Not each problem in health care draws the attention of policymakers. While some receive attention, others are ignored or, for whatever reason, put aside. In this respect, it is helpful to make an analytical decision between societal problems, the public agenda, and the political agenda. The public agenda refers to salient societal problems that are brought to the attention of policymakers (government). The political agenda comprises problems the government deals with. Regarding the political agenda, Kingdon distinguishes between the governmental agenda and the decision agen­da. He defines the governmental agenda as ‘the list of subjects that are getting attention’ and the decision agenda as ‘the list of subjects within the governmental agenda that are up for an active decision’ (p. 4).

Figure 4.2 demonstrates that societal problems must pass two barriers to reach the political agenda. First, they must reach the public agenda, and next the political agenda. Agenda building can be analyzed as a selection or filtering process in which actors compete for the attention of policymakers (Cobb et al., 1976). While some actors have plenty of resources and excellent venues to get an issue on the political agenda, other actors miss effective resources to pass the barrier from problems to the public and political agenda respectively. Differences in agenda power, defined as the power to set the political agenda, make that agenda building may be structurally biased to the advantage of some and disadvantage of others. Dominant values, political ideologies, the organi­zation of the policymaking process, power structures, and lack of knowledge or repudiation of what is happening in society influence agenda building (Bachrach & Baratz, 1970). The barrier model highlights the possibility of a structural gap between people who feel unheard and the government. Their problems do not reach the public or political agenda.

Agenda building is not only a matter of drawing the policymakers’ attention to specific problems but also a matter of effective problem-framing. This aspect is known as second-level agenda setting (Bleich, 2002) or the politics of problem definition (Roche­fort & Cobbs, 1994). Policy problems such as cost control, obesity or the moral consequences of research on rest embryos can be framed in many ways. Viewed from this perspective, agenda building can be analyzed as a process in which alternative problem frames or narratives compete for attention. Agenda power also involves definition power. The framing of policy problems is an essential element of political communication.

Sometimes, stakeholders or policymakers have an interest in keeping issues off the political agenda or, as Bachrach and Baratz put it, in ‘non-decisions’. There are several strategies for nondecision-making, ranging from raising formal barriers, and post­poning decision-making to controlling the media or silencing opponents. Another common tactic is to remove a contentious issue from the political agenda by installing a commission of wise men and women who are requested to study the issue, investigate the evidence, and formulate policy recommendations. 

Models of agenda building 

Drawing upon the distinction between insiders and outsiders in public policymaking, Cobb distinguishes between three agenda building models. The leading question is: who initiates agenda building? The outside initiative model is characteristic for pluralist societies. In this model, ‘issues arise in nongovernmental groups and are then expanded sufficiently to reach, first, the public (….) agenda and, finally the formal (political HM) agenda’. Groups articulate grievances and urge the government to take action. To be successful, they forge alliances with other groups by framing their grievances as part of a wider public problem or opportunistically join in other public issues on the political agenda (e.g. the ban on tobacco advertisements also hurts the advertisement business or set restrictions to freedom of speech). Although agenda building is conceptualized as an open process, the outside-initiative model does not assume equal agenda power. Some stakeholders are more successful than other stakeholders in lobbying policy­makers to pay serious attention to their problems. The mobilization model is the opposite of the outside initiation model. In this model, leading policymakers put policy problems on the political agenda and seek public support for their policies. The third model is the inside initiation model. In this model influential groups with special access to policymakers are able to place their issues on the political agenda but, contrary to the mobilization model, abstain from mobilizing the public for pragmatic or political reasons (Cobb et al., 1976).

Kingdon (1984) has worked out an alternative approach to agenda building. He investigates under which conditions problems will most likely reach the political agenda. In response to this question, he proposes an analytical distinction between three imaginary streams. The problem stream consists of the set of conditions that are viewed as problems that should be addressed. The policy stream involves a set of ideas and alternatives to address these problems. The political stream’ refers to the political climate. His central thesis is that the chance of a public problem reaching the political agenda is greatest if the problem stream, policy stream, and political stream intersect. Pressing problems, new policy ideas, or changed political conditions are not enough to reach the political agenda, and particularly the governmental agency. The intersection of the three streams creates a window of opportunity for successful agen­da building. Critical is the presence of an experienced political entrepreneur who seizes the mo­mentum and builds political support for policy change. Kingdon’s model is akin to what Tuohy has called ‘accidental logics’: some policy changes have only a chance of success under specific conditions (Tuohy, 1999). 

4.6 Policy development

Modern health policy analysis underscores the need for analysis in policy development. Designing an effective problem-solving strategy requires a systematic analysis of problems and the potential effects of alternative policy instruments or a combination of policy instruments. Handbooks are filled with analytical models and techniques to perform this task. Examples are forecasting techniques, scenario writing, econometric modeling, cost-benefit analysis, cost-utility analysis, cost-effectiveness analysis, disease modeling, and budget impact analysis.

However, policy development goes beyond the technical or instrumental investi­gation and elaboration of policy alternatives. It also involves a critical analysis of the underlying assumptions undergirding these alternatives and a critical normative assessment of alternative policy choices. For instance, what are the policy goals to be achieved, and how could they best be formulated? How to judge the economic and political feasibility of these choices and their longer-term consequences? What is the general public expecting from the government, and how might it respond to alternative policy choices? How to communicate policy choices?

Policy development can, just like agenda building, pass through several cycles. Policymakers ask for new analyses or a critical review of the available studies or alternatives before entering the policy formation stage. New developments or accidental events may let them consider the time for decision-making not yet ripe for decision-making. Policymakers may also feel a need for extra input from experts, some­times for no other reason than postpone decision-making (see rounds model). Political arguments also influence the choice of organizations or experts that are requested for advice, or the formulation of the policy questions they must answer (Cairney, 2021).

Organization of policy development

Policy development is a matter of organization. Stakeholders are invited to give their opinion and articulate their policy preferences in consultation meetings. Standing advi­sory bodies and research institutes are requested to inform the government about public problems and alternative policy proposals. Commissioning research, installing ad-hoc expert committees, consulting interest organizations, and organizing hearings are other common strategies to investigate policy problems and explore policy alternatives. Box 4.3 contains a concise overview of important advisory bodies in Dutch health policy­making.

4.7 Policy formation

Policy formation is commonly viewed as the ‘beating heart’ or the central stage of the policymaking process. It is the stage of decision-making on policy goals, policy instru­ments, and the organization of implementation. The stage of policy forma­tion is closely interwoven with the preceding stage of policy development. Policy formation may even largely boil down to putting a stamp on ‘predigested’ policy proposals. However, policy formation can also evolve as a complex process consisting of multiple decision rounds in various networks at various levels before the time is ripe for final decision-making. Legal issues, technical details, political divided­ness, coordination problems, altering conditions, uncertainties, and risks require further research and intensive consultation. If policy proposals are politically sensitive or the stakes are high, there is a big chance that policy formation politicizes and that the final outcome remains uncertain until the last moment. Other factors influencing policy formation are deficient rules for policymaking, lack of enforcement power, and involvement of many stakeholders (‘problem of the many hands’). 

Policy formation as a two-stage process

Much health policy formation has the structure of a two-stage process. The first stage involves decision-making on a general policy framework and the second stage the elaboration of this framework in concrete policy decisions. The general policy frame­work sets out the direction and organization of second-stage policy formation. Second-stage policy formation can be delegated to the accountable Minister or regulatory agencies at arms’ length of the government. An alternative model is to decentralize second-stage policy formation to lower political-administrative levels in the state hierar­chy (states in a federal system, provinces, regions, municipalities).

The organization of health policy formation as a two-stage process is a common model in health policymaking. In their scoping study of the organization and financing of public health in Europe, Rechel and his colleagues (2018) give an overview of the great variation in the organization of health policymaking. For instance, Germany has decentralized a great deal of policymaking to the states (Länder) and Italy to the regions. In the Netherlands, municipalities fulfil a policymaking role in public health. France, on the other hand, has traditionally a more centralized struc­ture (see Chapter 6 for more information).

A critical aspect of policy formation as two-stage process concerns the degree of policy discretion left to policymakers in the second stage. Do they have sufficient decision power to accommodate first-stage policymaking to local or regional circumstances, or is their decision power (quite) constrained? This question is a recurring and delicate theme in political discussions on the distribution of power and decision rules in governance (see Chapter 6). 

The politics of policy formation

What frequently complicates health policy formation is political resistance because of conflicting interests or ideological struggle. Building a majority in a divided parliament can be an immense political challenge requiring intensive consultations and substantial concessions. Last-minute changes in legislation are common. Policy formation in an ideologically divided political landscape may drag on for many years. Even if the necessity of hard decisions is broadly recognized, political resistance can block forceful interventions. In these circumstances, policymakers have no other option than waiting for a window of opportunity to strike a deal that had been unfeasible until then. A breakthrough requires more than appealing policy ideas. Equally necessary are favorable political conditions and a deeply felt sense of urgency. Other preconditions for successful policy formation are politi­cal leadership, resoluteness, and a good antenna for seizing opportunities and avoiding pit­falls.

Political resistance frequently results in political compromises and incre­mentalism. Policy formation involves lengthy negotiations before an agreement is within reach. Policymakers must accept considerable concessions or reconcile them­­­selves with a halfway compromise. The failure of national health insurance in the United States demonstrates that Presidents Roosevelt and Truman missed the necessary power base to pass through a comprehensive health insurance scheme, even though there was ample public support for such a scheme (Box 4.4).

The history of national health insurance in the United States is emblematic of much health policy formation. Health policy formation has repeatedly turned out to be a politi­cally sensitive issue because proposals conflicted with vested interests or deep-seated moral beliefs. Policy decisions restricting access to health care or associated with the rise of the ‘nanny state’ (Wiley et al., 2013) are always good candidates for raising opposition and offering politicians an opportunity to profile themselves. Poli­cy forma­tion on contro­versial issues is not the outcome of rational design, based upon infor­ma­tion, analysis and a well-thought policy paradigm, but rather the outcome of a complex mixture of ration­al design, institutionalized beliefs, vested interests, power factors, and political com­promise.

Health policy formation in pluralist political systems involves intensive consult­ations with interest organizations within and outside the health sector. Power­ful stake-holders representing the interests of doctors, hospitals, health insurers, patients, the corporate sector and other groups, lobby government officials and members of Parliament in formal and informal settings to ask attention to their problems and demands. Due to political pressure, the government may be unable to break through the clay layer of organized interests. Its actual decision power is often more constrained than its formal decision power suggests.

A state of emergency can radically change the standard rules for policy formation. How the necessity of an imme­diate state response can erode democratic control has been well described by Wagner in his book ‘Emergency State’ on health policy formation on COVID-19 in the United King­dom (Box 4.5).

4.8 Policy implementation

Policy implementation is the process of putting a policy into practice or, in other words, the process of converting words into concrete activities. Policy implementation is the hour of truth in policymaking because ‘the proof of the pudding is in the eating.’ Policies show their real face during policy implementation. What a policy concre­tely means for people or orga­nizations manifests in policy implement­ation. This explains why policy imple­mentation can politicize, sometimes even more than policy forma­tion. Implemen­tation decisions are not abstract; they have concrete consequences for concrete people and organizations. Implementation lays bare the consequen­ces of ill-thought policies.

Policy implementation is a crucial stage in every policymaking process. Imple­men­tation problems are due to many factors, including ambiguous and conflicting policy goals, lack of resources (people, knowledge, money, organizational capacity or time), a hasty preparatory trajectory, or neglect of the organization of implementation. Political compromises are another important cause of implementation pro­blems, parti­cularly, if policymakers demonstrate little interest in their practical feasibility. Other factors are coor­dination and communication problems, unclear accountability structures, ICT problems, (inter)organizational rivalries, failing central steering and oversight, lack of public support, or unexpected setbacks.

The organization of policy implementation

There are various basic organization models of policy implementation. The first model is to charge one’s organization and staff with policy implementation. This model enables policymakers, at least in theory, to exert direct control of the implementation process. An alternative model is to delegate implementation to lower-level administra­tive levels (e.g. region or municipality), non-profit organizations (e.g. non-profit health insurers), or regulatory agencies at arms’ length of the state (e.g. the Dutch Healthcare Authority or the Care Quality Commission in the United Kingdom). A third model is to outsource implementation to private companies by public tenders. The implementation of a great deal of health policy rests upon a combination of these models (Chapter 6). While the implementation of some tasks is kept under central control, other implementing tasks are delegated or outsourced.

The organization of health policy implementation usually has a complex structure. On closer inspection, even the implementation of a relatively simple policy may consist of numerous activities that must be coordinated. Another complicating factor is the involvement of many actors at various administrative levels. Coordination and information problems are always lurking and may have unexpected consequences for policy outcomes (Pressman & Wildavsky, 1973). Many factors, including institu­tionalized practices, ideological considerations, the capa­bility and expertise of organizations, political lobby, and power relations influence policy implementation. Large-scale outsourcing or delegation of policy implementation is not without risks. If the policy­making organi­zation (e.g. the Health Department) is hardly involved in the daily practice of policy implementation, a kind of ‘mental gap’ may develop between the world of policymakers and implementing agencies. This risk of two separate worlds is even more acute if policymakers demonstrate little interest in practical implementation issues or ignore the warnings of implementing agencies of feasibility problems. A risk of large-scale outsourcing of implementation to private companies is that policymakers become heavily dependent on the expertise of the market sector.

Levels of implementation

An analytical distinction can be made between macro-implementation, meso-imple­mentation, and micro-im­ple­mentation. Macro-implementation encompasses the (politi­cal) steer­ing of imple­mentation, meso-implementation the development of an implemen­tation strategy at the local level, and micro-implementation the implement­ation of a policy in individual cases. Macro-implementation corresponds with a top-down perspective on policy implementation and micro-implementation with a bottom-up perspective. Meso-implementation takes a middle position. Agencies involved in meso-implementation must develop an implementation strategy. Examples of issues in meso-implementation are organization-building and maintenance, priority setting in the context of scarce resources, and developing guidelines for decision-making in individual cases. Micro-implementation is concerned with the interaction between implementing agencies and policy clients. In his study of street-level bureaucracy, Lipsky (1980) investigated how front-line implementers may interact in practice with policy clients. They develop coping strategies in their contacts with clients in response to scarce resources, ambiguous or conflicting guidelines, or non-voluntary clients. Aggressive behavior of patients has necessitated the development of such mechanisms in health care (Harwood, 2017). Micro-implementation can also involve (lengthy) negotiations between implementing agencies and policy clients, for instance, on a license, a recovery plan, or a time schedule.

Successful implementation presupposes well-informed clients. However, this condition can cause problems: clients may not be well-informed, may not understand or read the regulations, may forget to respond timely, may make mistakes in filling in forms, and so forth. Resistance to participation in national vaccination programs does not only arise out of skepticism or religious grounds but may also result from information problems, health illiteracy, and misinformation. The number of clients experiencing problems with the digitalization of implementation is substantial (Plugmann & Plugmann, 2021).

Two models of policy implementation

There are two alternative models of policy implementation: the control model and the evolution model. The control model conceptualizes implementation as a largely programmed process. Implementing agencies are bound by detailed regulations. Policy implementation has the structure of a technical, bureaucratic, and increasingly digita­lized process. Policy implementation contrasts with policy forma­tion by its emphasis on expertise, neutrality, and loyalty. The downside of detailed programming is the absence of sufficient leeway for accommodation to individual circumstances. The digitalization of policy implementation has aggravated this problem. Policy clients risk getting lost in the labyrinth of detailed bureaucratic regulations, or becoming the victim of regulations that do not fit their specific situation.

The evolution model of policy implementation draws upon the notion that the complete regulation of policy implementation is an illusion. The course of policy imple­mentation is paved with obstacles many of which were unforeseen or ignored during policy formation. During implementation, numerous problems may arise for which a practical solution must be found. Policy implementation requires adaptive behavior in response to situations like these. It is for this reason that Majone and Wildavs­ky (1978) conceptualize policy implementation as an evolu­tionary pro­cess. While it is true that policy shapes implementation, it is equally true that implementation shapes policy. Policy implementation is a learning process and requires adjustments to the ‘reality of practice’.

The control and evolution model are ideal types. In practice, policy implemen­tation is mostly a combination of both models. Policy decisions and regulations set out a clear direction of what policymakers strive for but also create room for accommodation in practice (see below). Even tightly formulated norms require interpretation in practice. This may lead to a situation in which the legal framework remains unchanged but practice has changed. An example is the practice of euthanasia in the Netherlands (see Box 9.7 for more information on Dutch legislation). In its fourth evaluation of this practice, a research group signaled some noteworthy developments in how legislation is put into practice. One of these developments is that the patient’s subjective experience of suffering is given more weight in the current practice than in the past in assessing whether the physician has met the legal criteria of due care (ZonMw, 2023).

Ambiguous rules

A general problem with rules is that they often appear ambiguous, multi-interpretable, and sometimes even conflicting in individual cases. It is up to policy implementers to find a way out. Sometimes, ambiguous regulations undermine the legitimacy of state intervention, particularly if they impose severe restrictions on social action. They are both confusing for policy implementers and ordinary citizens who have no clear notion of what is permitted or forbidden. An illustration of this situation occurred in the United Kingdom during COVID-19 (Box 4.6).

Ambiguous rules frequently elicit litigation procedures to challenge their interpretation in concrete cases. Court rulings may compel policy implementers to revise their decisions or implementation strategy.

4.9 Policy evaluation

Policy evaluation includes the analysis and appraisal of policymaking. A great deal of policy evaluation focuses on policy outcomes. Have the policy goals been achieved and which (unforeseen) side effects have occurred? What are the short-term and long-term outcomes of health policymaking, and for whom? Does a policy have political effects? Plenty of handbooks describe how to set up policy evaluation studies in a systematic and methodologically appropriate way (Paw­son & Tilly, 1997; Greener & Bent, 2014; Patton, 1990).

The policymaking process can also be the object of evaluation. For instance, did stakeholders have sufficient opportunity to voice their opinion? Was policymaking dominated by corporate interests? Did policymakers listen to their advisors and critically question the information and recommendations they received from them? Was policy implementation given sufficient attention and did oversight work? In the case of policy failures, the focus in process evaluations is not on the question of which failures have occurred (these are known) but on the question of why they have occurred and which lessons could be learned from them (Box 4.7).

The governance of policymaking is another important theme in policy evaluation. For instance, how do decision-making rules influence the effectiveness and legitimacy of policymaking? What are the strengths and weaknesses of centralized or decentralized governance systems in times of an enduring public health crisis? How transparent is the policy­making process? Why does the coordination of policymaking fall short?

In a pluralist society policy evaluation is not confined to what policymakers make of it. The Parliament can start a systematic investigation on its own and interro­gate respondents under oath. Non-governmental organizations, research institutes, observatories, and interest organizations frequently publish critical evaluations to inform policymakers and the wider public about their findings and judgments. The task of the ombudsman is to critically review policymaking from a citizen’s perspective. Besides, the media play an important role by reporting on what is going on, fiascos, scandals, and so on. Courts can hold policymakers formally accountable for misconduct.

Policy evaluation as policy learning

The purpose of much policy evaluation is policy learning. Policy evaluation should policymakers inform on what has gone well or wrong and what should be done to perform better. An example of a policy learning study was published by the House of Commons on how the UK government had handled the first year of the COVID-19 pandemic. The report titled ‘Lessons Learned to Date’ called the UK’s failure to do more to stop the spread of the coronavirus early in the pandemic one of the worst-ever public health failures. The initial government approach, backed by its scientific advisors, to abstain from an immediate lockdown had cost thousands of lives. At the same time, the report called the roll-out of the vaccination program a great success. It even described the whole approach to the vaccination program - from research and development through to the rollout of the jabs - as "one of the most effective initiatives in UK history" (House of Commons, 2021).

Policy learning is no sinecure. There are many potential pitfalls restricting its usefulness. Reliable and timely data are often lacking and nobody knows what would have happened if the government had followed another approach. Simple comparisons with policymaking in other countries may be deeply biased. A simple causality argumentation model that solely focuses on what has gone wrong and why without taking relevant contextual factors into account runs the risk of simplification and policy recommendations that do not work. Another problem concerns the choice of evaluation criteria. For instance, an evaluation of how Western countries had anticipated the outbreak of COVID-19 is likely to conclude that their preparedness for crises like this one has ostensibly failed. The countries’ documents on how to handle these circumstances appeared ‘phantasy documents’ in practice. This is a conclusion that governments should certainly take seriously. However, evaluation may take an alternative perspective and focus on the resilience of a country’s health system to deal with unknown pandemics. Such an evaluation may sketch a more nuanced picture of how governments have handled a pandemic, despite all unavoidable errors made (De Bruijn & Van der Steen, 2021).

The politics of policy evaluation

Policy evaluation is closely connected with accountability. In a well-functioning democratic system, public authorities are requested to accept the accountability of their policy decisions. Accountability is an instrument for reflection and policy learning. Public authorities demonstrate accountability for policy failure by resigning. In a deeply polarized political atmosphere, however, policy evaluation no longer works as an instrument for reflection and policy learning but as a stick for firing political opponents. Evaluation turns into a blame game (Hood, 2011).

The politics of evaluation may prompt a struggle on methodological issues such as the formulation of the research questions, the delimitation of the research topic, the choice of the evaluation standards, the design of the research model, the selection of the information sources and data, the composition or independence of the evaluating body, and so forth. Other sensitive issues are the formulation of conclusions and policy recommendations. The conclusions of an evaluation from the perspective of policy clients or stakeholders may radically differ from the conclusions from the perspective of the policymakers’ policy goals. Political contest­ants bombard each other with alternative evaluations and policy recommendations.

The political dimension of evaluation (Bovens et al., 2009) also pertains to communication. Drawing public attention to one’s evaluation and influencing public opinion requires carefully crafted public messages. There are many ways to com­municate the conclusions of policy evaluation. For instance, disappointing policy results can either be framed as lessons to learn, as a policy failure, as a big and foreseeable mess, or as the such-and-such evidence of incompetence.

4.10 Policy termination

In the stage model of the policymaking process, policy evaluation is followed either by policy adjustments or policy termination. There are several reasons for policy termi­nation. A policy does not work, has adverse consequences, turns out to be costly, meets strong public resistance, or is simply perceived as outdated. Several arrangements for cost-sharing that were introduced in Dutch health care to control health­care expendi­tures in the late 20^th century were only short-lived because of the fierce opposition of the medical profession, high administrative costs, protests from patients and doctors, and disappointing results.

Sometimes, policy termination is planned by ‘horizon legislation’. For instance, several policy measures of the Dutch government to control the spread of the coronavirus were based upon new temporary legislation that permitted the govern­ment, after approval of the Parliament, to impose freedom restrictions (e.g. lockdown or curfew) but only for a three-month period. The duration of the legislation could be prolonged for a new three-month period but only after approval of the Parliament. The refusal of the Upper Cham­ber to accept prolongation in 2022 automatically meant the termination of the legislation.

4.11 Policy path

All health policymaking roots in the past and is part of a policy path. A policy path passes through a series of consecutive cycles during a certain period. Cur­rent policy is the latest version of a policy in a process of consecutive accommodations to changing circum­stances, new insights, and the political context. The policymaking process concerning the outbreak of COVID-19 and alcohol consumption exemplifies the unfolding of a policy path. However, the structure of these paths was quite different. Whereas policymaking on COVID-19 had the structure of cycles swiftly following upon each other to adjust policy measures to the latest information, the path of alcohol policy is characterized by relatively long cycles. Alcohol policy has been regularly revised but mostly only after a longer period.

The concept of policy path invites policy analysts to carry out a historical analysis of health policymaking and the cycles it has passed through. A historical view on health policymaking gives insight into the redefinition of health problems over a longer period and the impact of social, political, economic, and other factors upon the (re)definition of health problems. The analysis of a policy path may further contain important lessons on how state interventions play out in practice and the politics of state intervention.

The development of alcohol policy is an example of the evolution of health policy over a longer period. The reasons for framing alcohol consumption as a social problem warranting state intervention have changed over time. The history of alcohol policy is not simply a history of how alcohol-related harms were addressed but also a history of how they were identified and constructed. Was alcohol consumption in the past primarily framed in terms of public disturbance, social decay, or immoral behavior (think of the influence of the Victorian temperance movement in some countries), presently its adverse health effects get more emphasis. The international scene has also dramatically changed. The production of alcoholic beverages has developed as a transnational industry with huge economic interests and a powerful lobby to influence political decision-making on age limits, selling points, tax instruments, and so on. The emergence and growing popularity of non-alcoholic beers and wines may mark a new stage in alcohol policy (Nichols & Kneale, 2015).

An approach to investigating a policy path is to make a distinction between two paths: policy expansion and policy contraction. The evolution of alcohol policy in the Netherlands is a good illustration of policy expansion. With time, its goals have been broadened and policy measures to reduce alcohol consumption have been extended and intensified. The publicization of public health since the beginning of the nineteenth century is another illustration of policy expansion. State intervention to protect and promote public health nowadays radically differs in scope and intensity from state intervention in earlier times. Policy expansion also affects the policymaking process at later stages. Past policy decisions restrict the room for new decision-making. Once–fought rights will be heavily defended. Moreover, the health policy arena has become much more crowded than in the early stage of the policy path. The impact of path dependency on health policymaking will be discussed in Chapter 11.

Policy contraction is the opposite of policy expansion. Examples are the termination of a policy program, the removal of health services from the benefits catalog of statutory health insurance, the restriction of the scope of regulation, the tightening of eligibility criteria, and the imposition of expenditure cuts. Some contract­ions occur subtly, for instance, by not adapting the healthcare budget to the increasing demand for health care or by not adding new medical services to the benefits catalog of public health insurance.

4.12 Conclusion and suggestions for doing health policy analysis

Health policymaking is a second basic concept in health policy analysis. The focus is not on the content of health policy but on the dynamic process of events, decisions, and actions with regard to health problems. Each stage of the policymaking process influences the content and results of health policy. Health policy and its outcomes cannot be well understood without an analysis of the health policymaking process. The study of this process helps explain why certain public problems have reached the political agenda, how policy decisions have been made, and why health policy has proven success or failure or a combination of success and failure. The study of health policymaking is an important part of health policy analysis.

There are various strategies to study health policymaking processes. The first strategy is to focus on the stages policymaking passes through. Some leading questions are: who put a policy problem upon the political agenda and how was the problem framed? Who won the framing contest? Has agenda building been successful? Which actors were involved in the processes of policy development and policy formation? Did the formal locus of decision-making coincide with the informal locus? How did policy implementation unfold? How was it organized? Did policymakers pay serious attention to policy implementation? Has policy implementation proven a bottleneck and if so, why? How did policy evaluation evolve? Is there evidence of a politics of evaluation?

An alternative strategy is to focus on preselected decision rounds. The first step in this strategy includes the identification and selection of decision rounds and the second step the identification of the actors in each decision round and their input to decision-making. Another research theme is the relationship between the selected decision rounds. Did they follow each other logically or linearly or in a non-linear structure, for instance, because earlier decisions were revoked at a later moment?

A third strategy is to investigate the intersection of policymaking processes and its impact on the policymaking process under study. This strategy is particularly suited to the investigation of how health policymaking has been influenced by public policymaking in other areas.

A final strategy is to study the policy path over a more extended period. This strategy requires the selection of a starting point and end point of the policy path. The study of a policy path can give insight into how a policy has evolved over a certain period and, in particular, how it has been accommodated to changing circumstances and changing insights. Does policymaking follow a path of policy expansion or policy contraction or a combination of expansion and contraction?

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