La « préparation magistrale » en droit français : un lot exclusif par patient ?

Outpatient pharmaceutical needs are not always met by industrial products and do not necessarily justify hospitals activation. Preparing in advance and storing a batch of compounded drugs for one or more patients with identical/recurrent needs – as part of compound outsourcing in ambulatory sector – raises issues. While the french law does not expressly provide (and according to prevailing interpretations excludes) this hypothesis, it seems to us to be possible – in contrast to the prominent french judicial and administrative courts, as well as to the European Court of justice. We here propose to reset the debate within both the existing laws and a systemic perspective, and call for a normative clarification.     

Are Two Reasons Better Than One? The Role of Appeal Type in Consumer Responses to Sustainable Products

In the face of the growing prevalence of multiple appeals to sustainable consumption in marketers’ sustainable product communications, we examine the efficacy, in terms of consumer reactions, of adding an extrinsic appeal (e.g., “Purchase this green product to save money!”) to an intrinsic appeal (e.g., “Purchase this green product to save the environment!”) based communication for a sustainable product. Three studies provide support for our basic assertion that, compared to an intrinsic appeal, joint appeals (i.e., an intrinsic and extrinsic appeal together) reduce consumer preference for sustainable products. As well, these studies demonstrate that this adverse effect of joint appeals is based on a lowering of consumers’ attributions of the company's sustainability efforts to intrinsic motives (e.g., to the company's genuine concern for the environment). Finally, not all consumers react adversely to joint appeals; relative to intrinsic appeals, such appeals increase, rather than decrease, the intrinsic attributions and sustainable product preferences for consumers with lower involvement with sustainable consumption.     

An Adaptive Algorithm for Pairwise Comparison‐based Preference Measurement

The Pairwise Comparison‐based Preference Measurement (PCPM) approach has been proposed for products featuring a large number of attributes. In the PCPM framework, a static two‐cyclic design is used to reduce the number of pairwise comparisons. However, adaptive questioning routines that maximize the information gained from pairwise comparisons promise to further increase the efficiency of this approach. This paper introduces a new adaptive algorithm for PCPM, which accounts for several response errors. The suggested approach is compared with an adaptive algorithm that was proposed for the Analytic Hierarchy Process as well as a random selection of pairwise comparisons. By means of Monte Carlo simulations, we quantify the extent to which the adaptive selection of pairwise comparisons increases the efficiency of the respective approach. Copyright © 2011 John Wiley & Sons, Ltd.     

Dispositifs médicaux : responsabilité civile du mandataire après l’entrée en vigueur des règlements 2017/745 et 2017/746

The new European regulation of medical devices presents today a considerable stake for the economic operators. In addition to strengthening their requirements, the 2017/745 and 2017/746 regulations describe with greater precision their respective roles. Compensation for damage caused by medical devices is also a major challenge for the European legislator. In addition to an obligation of insurance towards the manufacturer, he has defined a regime of strict responsibility of the agent, modeled on the directive 85/374/EEC on responsibility for defective products.     

Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK

ABSTRACT

Emerging flexibilities are apparent in gatekeeping regimes applicable to regenerative medicine products, raising issues about the extent to which and forms in which such flexibilities might promote emerging products as a sector warranting special treatment, in the context of recent policy developments in the UK and wider European Union. Concepts of ‘gatekeeping’, ‘gatekeeping regimes’ and ‘gateways’ can point to the ways in which regulatory institutions, health technology assessment organisations, and national planners and purchasers of health services together define and control entry to the medical product marketplace and the adoption of products into the public health-care system. Flexibilities in existing regimes and new gateways are a way of maintaining ‘connection’ between gatekeeping regimes and technoscientific innovation in order to steer innovation pathways. The gateways concept has affinity with that of Callon’s ‘obligatory passage points’. A wide set of recent policy documents show that the measures promoted exhibit a range of alternative gateways that are being constructed around central, legal, restrictive gatekeeping regimes. However, it would be easy to overestimate the significance of these developments as relaxations that would favour innovative producers and their products on a large scale with wide public health impacts. The concepts of gatekeeping regimes and gateways enable understanding of hybrid developments of exceptions and exemptions to dominant regimes which bridge across the arenas of market regulation, health technology assessment and health-care system planning. These arenas are being drawn closer together as a means of politically managing stakeholders’ aims in the UK, EU and other innovating biomedical health systems globally.     

Interpolation and Amalgamation; Pushing the Limits. Part II

This is the second part of the paper [Part I] which appeared in the previous issue of this journal.