An assessment of the hospital exemption landscape across European Member States: regulatory frameworks, use and impact.

The hospital exemption (HE) (Article 28(2) of Regulation (EC) No 1394/2007; the "ATMP Regulation") rule allows the invaluable opportunity to provide patients with access to innovative, potentially life-saving treatments in situations of unmet clinical need. Unlicensed, developmental advanced therapy medicinal products (ATMPs) - cell-, gene- or tissue-based therapies - can be used to treat patients under certain conditions. Such products should be produced on a non-routine basis, custom-made for an individual patient under the responsibility of the requesting physician, for use in a hospital setting within the same Member State in which they are manufactured. The HE rule, and the specific requirements permitting its use, is further regulated at the Member State level, which has led to divergence in the implementation of HE across the European Union (EU). As a result, HE use varies significantly across Member States depending on their respective national legal implementation, policy makers' interpretation of HE, clarity of guidance at the national level, reimbursement opportunities and level of ATMP research and development activities carried out by academic and commercial organizations. With important variations in how quality, safety and efficacy standards are implemented and controlled across EU Member States for ATMPs provided via the HE rule and a lack of transparency around its use, the HE rule draws concern around its potential impact on public health. In this article, the authors report results of a legal analysis of the implementation of HE across the UK, France, Germany, Italy, Spain, Poland and the Netherlands and research findings on its current utilization, highlighting divergences across countries as well as gaps in legislation and control in these countries. The significance of these divergences and the differing levels of enforcement are discussed as well as their associated impact on patients, industry and health care professionals.

[Interests of applied anthropology to oncology]. / Les apports de l'anthropologie appliquée au champ de la cancérologie.

From now on the introduction of social and human sciences studies in the field of oncology has not always been conclusive. This article aims to analyze the bounds that border the meeting and the understanding between physicians, patients and anthropologists. It also treats the problems due to the introduction of applied anthropology in the field of oncology and points up the interests and practical contributions that this disciplinary bring and could bring.

[Patients and physicians: cross representations anthropological study of the construction of individuality in radiation therapy]. / Soignant contaminé et malade imaginé: étude anthropologique de la construction de l'individualité en radiothérapie.

The methods of anthropology allow us to understand group dynamics by bringing to light a web of linked causalities in order to describe human and social relationships. The density and dimension of the relationship with a patient have direct repercussions on professional motivation. But this proximity has its drawbacks. The process of identification to patients is inevitable and the fear of "contamination" is not medical but symbolic: it is expressed in the difficulty of appreciating the distance, the difference between the "other" (the patient) and the self (the physician). Health professionals have therefore to find a delicate compromise between proximity and strategies of distance. The temptation is therefore great, of considering the patient only through his pathology. This "imagined patient" allows the clinician to define the frames structuring his relation to the patient. But at the same time, this creates a loss of identity for the patient. In this context, the relation between patient and clinician should be based primarily on a necessary individual acknowledgement of the patient who expresses it in a re appropriation of his illness. Thus he sets himself as an actor of the therapeutic relation and no longer as an object of clinical care.