Search

In deze bijdrage gaan we in op openbaarmaking van toezichtsresultaten door toezichthouders. We onderscheiden twee doelen van openbaarmaking: een marktordeningsdoel of een toezichtsdoel. In deze bijdrage zijn we geïnteresseerd in de wijze waarop toezichthouders in de praktijk invulling geven aan deze doelstellingen. Op welke wijze maken toezichthouders gebruik van openbaarmaking om marktordeningsdoelen of toezichtsdoelen te realiseren, welke problemen of dilemma’s ondervinden zij daarbij, en laat de doelstelling van marktordening zich verenigen met het toezichtsdoel? We proberen een eerste antwoord te formuleren op deze vragen op basis van de empirische bestudering van twee markttoezichthouders: De Nederlandse Zorgautoriteit (NZa) en de Autoriteit Financiële Markten (AFM). Voor beide toezichthouders geldt het marktordeningsdoel en het toezichtsdoel, maar de AFM en de NZa geven in de praktijk een verschillende invulling aan deze doelen.

The impact of converging technologies on legal practice and criminology is being investigated in a forward looking study intended for practitioners and policy makers in the field of legislation, crime prevention, and law enforcement. This report consists of three parts. The first part describes the state of the art and future expectations on nano-, bio-, ICT and cognitive science and technology, as well as their convergence. The second part describes the (future) applicability of converging technologies to our application domain, in particular in three cases. This part ends with scenarios that are used as a means to ‘visualize’ the developments and an input for the impact analysis. In the third part the scenarios are analysed on their ethical, legal and social implications. This part describes the major social and normative trends that are observed.

This thesis seeks to understand, and evaluate, the contribution of business associations within the United States (US) and German chemical sector, to the effective regulation of nanomaterials. In the effective regulation of new technologies characterized by high scientific uncertainty, with nanomaterials being an example of such a technology, it is useful to diverge from the traditional perspective on effective regulation. Rather than focusing on the outcome of rule compliant behavior in order to determine the effectiveness of regulation, it is more useful to investigate processes of learning that prepare for rule compliance. Associations can prepare compliance for companies with the legal obligation to conduct risk assessment for nanomaterials by making available, and extending, scientific data in collaboration with regulators. On this basis associations can develop guidance material (i.e., soft regulation) in order to support their members companies in conducting risk assessment for nanomaterials. A theoretical framework is developed that adopts three learning types: substantive learning (with the key characteristic ‘scientific expertise’), strategic learning (with the key characteristic ‘trust’), and institutional learning (with the key characteristic ‘rules’). Conditions under which these three learning types emerge are derived and used to empirically analyze and compare business association contributions to effective nanomaterials OHS regulation in two case studies: the American Chemistry Council’s (ACC) Nano Panel and the German Chemical Industry Association (VCI). Association collaborative activities are investigated through qualitative, semi-structured interviews with involved stakeholders and through publicly available (policy) documents supporting association activities. The empirical results indicate that the two associations have facilitated learning–to varying levels–relevant for preparing compliance of companies with existing OHS legislation. Overall, the VCI activities facilitated strong learning while the ACC Nano Panel facilitated limited learning. This thesis finds that for learning processes in collaborative activities among business associations and regulators it is important that relationships among collaborators are characterized by trust so as to facilitate knowledge exchange/generation and joint rule development. To prevent capture of public regulators, it is recommended that an independent body, responsible for identifying and communicating the goals of the involved actors, oversees the collaboration. Suitable bodies are federal research institutes.

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. All these characteristics of law taken together are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchic system of rules characterised by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created both at the international and regional level are directly applicable to national legal systems. Also norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project I use multilevel regulation as a term to characterise a regulatory space in which the process of rule making, rule enforcement and rule adjudication (regulatory life cycle) is dispersed across more than one administrative or territorial level amongst several different actors, both public and private. I draw on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is nonhierarchical. Lack of central ordering of the regulatory life cycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for legal certainty have attracted limited attention from scholars. The demand for legal certainty in regulatory practice is still a puzzle. I explore the idea of legal certainty in terms of perception and expectations of regulatees in the context of medical products. By medical products I mean pharmaceuticals and medical devices which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, this thesis is necessarily stepping into new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies this in the context of multilevel regulation.