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Responsive regulation and the enforcement pyramid: between theory and evidence.

Bomhoff, M., Friele, R. Responsive regulation and the enforcement pyramid: between theory and evidence. Abstract. In abstract book. EHMA annual conference 2015 'Evidence-based management: better decisions, better healthcare' 15-17 june 2015, Breda.
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Context
Responsive regulation is a dominant analytic framework in regulation. The Dutch Healthcare Inspectorate has explicitly embraced this theory for its own regulation and enforcement strategies, also because it would make their enforcement more transparent and proportional to healthcare providers. Quite literally aspects of the theory, as for instance an enforcement pyramid, can be found in policy documents. But how does the theory of responsive regulation fit into the reality of and the evidence on making enforcement decisions? The focus of this research is on the translation of responsive regulation into an enforcement guideline and on the actual decision-making process.

Methods
The study focussed on the decisions inspectors of the Dutch Healthcare Inspectorate make concerning enforcement. We investigated how these decisions are made, which (type of) arguments play a central role and how inspectors may or may not be helped by their current guideline for enforcement. First, documents were analysed and interviews conducted with persons who had commissioned, written or helped setting up the guideline. This was done in order to get to a reconstruction of policy theories. Next, to gather evidence on the decision making process we conducted interviews with the principal actors in this process, (senior) inspectors and legal advisors. Also, an internal schooling day on enforcement decisions at the Inspectorate was observed. Finally, a group discussion was organised to see whether the findings could be validated and generalised and to arrive at the formulation of key points and suggestions. Finally, policy objectives and evidence were compared and recommendations were made.

Results
The study shows how the regulatory theory of responsive regulation has been translated in practice and brings to the fore several practical and juridical impediments that hinder truly responsive regulation. In practice for instance, the proportionate 'weight' of an enforcement measure that forms the core of the regulatory pyramid, is much harder to determine and much more subject to sector specific variation than the theory states. Also, the supposed effectiveness of the measures plays a great role in practice but finds hardly any mention in the guideline. The study thus provides further insights into the decision-making process and the legal, practical and ethical dilemmas that individual inspectors may encounter during their enforcement work.

Discussion
Since there is growing criticism on the lack of empirical tests to prove the validity of the assertions made in Responsive Regulation (Six, 2013) this study is a welcome addition to the body of evidence on regulatory theories. It shows which aspects of the decision making process are and which aren't suited for further protocolisation. Since enforcement measures may have great impact on care providers, this knowledge may help to further increase uniformity in practice and transparency about the decision-making towards care providers. The study demonstrates the need for a further elaboration of concepts such as the 'weight' of regulatory measures and the supposed effectiveness of measures. It stresses the need for further evidence on regulatory decisions, their outcomes and effects on care providers and provides suggestions as to which aspects of the regulatory decision-making process would be helped by standardisation in the form of a guideline.