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This chapter explores the lessons that can be drawn from how adaptive drug licensing processes cope with legitimacy issues of regulatory connections. The exploration assumes that a responsive approach to technology regulation offers opportunities to meet legitimacy requirements. Looking at existing and proposed adaptive drug licensing pathways through the lens of this theoretical frame we see a realistic responsive approach to regulation. By indicating that adaptive licensing can bring beneficial medicinal drugs earlier to patients this approach seems to be equipped to transcend the myth of law’s stifling technological innovation. The evaluation of the current stage of adaptive drug licensing leads to three tentative lessons. First, a shared interest, accompanied by strong drivers and enablers, is crucial; second, ongoing prudent coordination of a leading regulatory agency is essential; third, to ensure that new responsibilities and the norms of participation, transparency, integrity, and accountability are taken seriously a new social contract can be supportive.

This chapter explores effectiveness aspects of two governance arrangements that have been recently launched in the European Union (EU) to align nanotechnologies to requirements of the responsible research and innovation agenda. Emerging technologies do not materialise in a governance vacuum. Pre-market research, development and testing, for example, are subject to-at least in most jurisdictions-a myriad of governance requirements. This may include, for example, occupational health and safety (OH&S) requirements, compliance with certain industry/government standards, and general law obligations, such as the law of torts. Entry of the technology and/or its products onto to market will similarly attract, or trigger, a multitude of governance arrangements, which will include components of hard and soft regulation. It is the applicability and the effectiveness of these regimes for managing the uncertainties associated with the latest wave of emerging technologies that have been increasingly questioned in relation to emerging technologies [14-16].

Soft regulation is a widely used instrument in the governance of emerging technologies, especially in the governance of nanotechnologies. So far, evaluations on the effects of nano-specific soft regulation cannot build on a coherent and consistent typology. Characterization of soft regulation is important for empirical research (case selection) and policy recommendations. This chapter develops a characterization scheme that serves to depict soft regulation that is established to support risk assessment and risk management of emerging technologies. The characterization scheme is tested in four examples of nano-specific soft regulation that focus on occupational health and safety issues. The preliminary evaluation of the testing exercise indicates that the classification scheme can stimulate critical reflection on the quality of the regulatory design by touching on gaps and problems of clarity and consistency. It shows also how beneficial the scheme can be to signal potential effectiveness problems. The scheme is a very first step towards a more sophisticated typology with refined and extended categories that provide a broader frame for the evaluation of the effectiveness of technology-related regulation.

This article analyses the emerging European regulatory activities in relation to nanopharmaceuticals. The central question is whether the regulatory responses are appropriate to cope with the regulatory problems nanomedicinal development is posing. The article explores whether the medical product regulations are robust enough, whether there are certain regulatory gaps, and whether the competent bodies have the expertise to evaluate nanomedicinal products when approval is applied for. Based on a social-constructive approach, the article identifies significant regulatory actors, their ideas on regulatory problems, and preliminary governance responses to them. It finds that the current dynamic regulatory structure appears robust enough to adapt to some of the technological challenges posed by nanomedicines. It concludes that regulators have not yet responded adequately to regulatory gaps related to definitions, classification and specific safety, quality, and efficacy standards that nanopharmaceutical development seems to require. As a consequence of these deficiencies legal certainty, a principle of high priority in European medical regulation policy, cannot be sufficiently provided.

The hybridization of regulatory modes and instruments is currently a popular way to improve public regulation. However, it is still unclear whether combinations of hard law and soft law, co-regulation, and legally enforced self-regulation really make regulation more effective. Using the analytical framework of the “really responsive regulation” approach, in this article we explore effectiveness problems in a hybrid regulatory system that tries to protect minors from harmful media. In our analysis of low compliance rates in the context of system failures, we argue that effectiveness problems seem to arise from poorly informed staff members, lack of internal and external controls, low rule enforcement, insufficient overlap between public and private interests, poor social responsibility in the Dutch media sector, deficiencies in the institutional framework, an inconsistent regulatory strategy, and inadequate responses from responsible regulators. Furthermore, based on our case study we argue that institutional dynamics of standard-setting activities can be detrimental to regulatory goal achievement if there is no compensation at the systemic level. Ongoing “regulatory care” through control, corrective responses, and rule enforcement seems to be crucial for a hybrid regulatory system to perform well.

Rapidly emerging technologies, such as nanotechnologies, are posing significant challenges to regulatory governance due to the uncertainties of development trajectories, product properties, and potential risk problems (Davies 2009). While nanotechnology-based products and processes fall within the scope of current regulatory instruments (European Commission 2008a; Ludlow, Bowman, and Hodge 2007; van Calster 2006), there is increasing concern that such frameworks may not be appropriate for adequately or effectively regulating all dimensions of the technology (see, for example, House of Lords Science and Technology Committee 2010; European Parliament 2009a; Chaudhry et al. 2006; Taylor 2008, 2006; Royal Society and Royal Academy of Engineering 2004). The traditional approach of evidencebased regulation is not equipped to cope with myriad uncertainties surrounding the development and commercialisation of nanotechnologies. This does not mean that public policy can wait and see, however. Even in the case of evidence deficiencies, public responsibility goes beyond a laissez-faire approach to risk regulation. In the European Union and some other countries, precautionary regulatory action is required when basic values like human dignity, health, safety, environment, property, and privacy are at risk (Fisher 2007; European Commission 2000).

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.