Chapitre 2. Bien-être animal et alimentation : l'éthique en élevage par la grâce de la science ?

Animal welfare has become the key concept in EU animal protection law and is often used as a slogan in political speeches. It is a complex concept, however, that is often misunderstood. Its politico-scientific origins leave their mark, blurring its ethical purpose. Its implementation is as promising as it is chaotic, as shown by the example of cage farming. A case study of the European Citizens’ Initiative (ECI) “End the Cage Age” shows that the ethical purpose is both served and undermined by the necessary mobilization of scientific data.

Chapitre 2. L'intelligibilité des algorithmes dans les systèmes d'aide à la décision médicale.

Advances in medical informatics and the widespread collection of patients’ data have led to the development of new medical decision support systems. Some of them are simply used to guide the medical practicioner, while others automatically generate decisions. Known under various names (“expert systems”, “decision support systems”, “medical AI”), they can be used for diagnosis, prognosis or care. They all function by means of algorithms that process data. These algorithms are more or less complex, more or less supervised, but they are also frequently opaque. Yet these tools are becoming increasingly important in the medical world. It seems therefore necessary to better inform users and beneficiaries – doctors and patients – of their operating logic, their limits and their possible biases. This study suggests strengthening European law (and French national law) on this point. A greater intelligibility of algorithms in decision support systems would meet the ethical requirements of medical decision making and the objective of shared medical decision making in conscience.

DBS: a compelling example for ethical and legal reflection-a French perspective on ethical and legal concerns about DBS.

Deep brain stimulation (DBS) is an approved treatment for neurological diseases and a promising one for psychiatric conditions, which may produce spectacular results very quickly. It is also a powerful tool for brain research and exploration. Beyond an overview of the ethical and legal literature on this topic, this paper aims at showing that DBS is a compelling example for ethical-legal reflection, as it combines a highly technical surgical procedure, a complex active medical device and neuromodulation of the human brain to restore lost abilities caused by a chronic and evolving disease. Some of the ethical and legal issues raised by DBS are not specific, but shed new light on medical ethics and law. Others are more DBS-specific, as they are linked to the intricacies of research and treatment, to the need to tune the device, to the patients' control over the device and its effects and to the involvement of family caregivers.

Animal Models and Animal Experimentation in the Development of Deep Brain Stimulation: From a Specific Controversy to a Multidimensional Debate.

In this article, we explore a specific controversy about animal experimentation and animal models in the recent history of deep brain stimulation (DBS), and we question its ramifications. DBS development intertwines clinical practice with fundamental research and stands at the crossroads of multiple legacies. We take up the various issues and controversies embedded in this rarely addressed dispute, from a standpoint that combines socio-anthropological and legal aspects. Our starting point is a debate on the role of animal experimentation in the development of DBS between Jarrod Bailey, a researcher promoting the abolition of animal experimentation, and Alim Louis Benabid, Marwan Hariz, and Mahlon DeLong, three key figures in the area of DBS and neuroscience. By clarifying the positions of the different protagonists and retracing the issues raised in these discussions, our objective is to show how this specific debate has extended from its initial space and how it provides an object of study with heuristic scope. We first present this partially polemic discussion about the history of DBS, and its link with a more general debate on the validity and use of animal models and the need for animal experiments. Then, we raise the issue of the relations and interactions between experiments on animals and on humans in the logics of biomedical innovation. The third step is to situate the discussion within the wider framework of opposition towards animal experimentation and the promotion of animal' rights. Finally, combining these interweaved issues, possible implications emerge regarding the future of DBS. We show that behind these several controversies lie the question of translational research and the model of medicine upheld by DBS. We describe how the technology contributes to blurring the lines between research (fundamental, preclinical and clinical research) and care, as well as between humans and animals as substrates and objects of knowledge. The dynamics of DBS future development might then become a point of convergence for neuroscientists and animal rights defenders' interests.

Patient's lived experience with DBS between medical research and care: some legal implications.

In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient's experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient's lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation.