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Le principe de précaution a acquis une place déterminante dans les ordres juridiques nationaux et dans le droit international. Il s’agit d’un principe d’action qui ne vise plus la prévention d’un risque connu avec une certitude scientifique avérée mais la précaution pour un risque inconnu et dont on ne peut même pas évaluer la probabilité avec des conséquences incommensurables. D’abord principe moral, il est devenu un principe juridique en étant consacré dans les textes internationaux, européens et nationaux. Son domaine initial d’application relatif à l’environnement s’est ensuite étendu à la santé et aux nouvelles technologies. Dans cet article, il s’agit de retracer une brève histoire de sa naissance et de son développement dans une perspective juridico-comparative.

Les politiques françaises, européennes et mondiales font du numérique en santé un pilier des stratégies portant à la fois sur la performance, la qualité du système de santé et la lutte contre les inégalités en santé. Cependant, l’acceptabilité sociale de ces politiques est un enjeu fort et nécessaire, non seulement pour le renforcement de droits collectifs – contribuant à faire vivre une démocratie sanitaire participative – et individuels. Ainsi, le droit du numérique en santé est un construit social. Cette construction dynamique proposée par le concept d’acceptabilité sociale vise l’appropriation du numérique en santé par l’ensemble de la population. Toutefois, ce concept issu des sciences sociales n’en demeure pas moins une notion juridique originale : elle renvoie à la légitimité de la norme autant qu’aux créateurs de celle-ci. Par ailleurs, elle imposerait une démarche semblable au principe constitutionnel de précaution. Mais la difficulté à faire « consensus » pour le numérique en santé, dans un espace globalisé, implique que les juridictions ne puissent faire peser de nouvelles obligations positives à la charge des Etats dans leurs choix de politique publique en santé numérique. Le droit à la protection de la santé serait alors à géométrie variable en Europe, son effectivité dépendrait de l’acceptabilité sociale et éthique du numérique.

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The objective of the article is to expose a possible generator of legal problems, in the sense of studying epigenetics and the variable conditions of the human program faced with environmental, social and legal factors. Likewise, we will describe the argumentative gaps that derive from the case under study, especially when they are related to such critical issues as, the theory of damage, non-contractual liability, labor discrimination, among others. This being the case, the argumentative gaps caused by epigenetics could translate into legal uncertainty that would imply an assumption of possible violations of fundamental rights. Analyzing, also, a solid response to said legal uncertainty will be another of the fronts to show in this article, which, may be presented under the importance of judicial decisions, as a main expression, but also public policies and the application of the precautionary principle. [ABSTRACT FROM AUTHOR]

Drug regulatory bodies aim to ensure that patients have access to safe and effective drugs; however, no matter the quality of pre-licensure studies, uncertainty will remain regarding the safety and effectiveness of newly approved drugs until a large and diverse population uses those drugs. Recent analyses of Canada’s post-market drug surveillance (PMDS) system have found that Canada’s PMDS system requires strengthening and that efforts must be improved to monitor and address the safety and effectiveness of approved drugs among vulnerable populations. Given the uncertainty that exists when drugs enter the market, some have suggested that the precautionary principle is relevant to guiding decision-making in this context. This paper responds to recommendations that the Canadian PMDS system should be responsive to the health needs of vulnerable populations by assessing the utility of deploying the precautionary principle to guide a post-market strategy for vulnerable populations. [ABSTRACT FROM AUTHOR]

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Le principe de précaution est très populaire aujourd’hui. Mais a-t-il un fondement économique ? Nous présentons deux théories économiques de la précaution. La première se base sur le cadre classique d’espérance d’utilité avec révision bayésienne des croyances. La seconde se fonde sur l’aversion à l’ambiguïté. Nous discutons l’intérêt, mais aussi les limites de ces deux approches.

Cet article analyse l'élaboration de législations nationales adaptées et conformes au Protocole de Cartagena en matière de biotechnologie et de biosécurité par certains pays d'Afrique de l'Ouest participant au 'Projet de Développement de Cadre Nationaux de Biosécurité' du PNUE-FEM. Les auteurs tentent de dégager les perspectives de réglementation et les difficultés potentielles auxquelles ces pays pourront être confrontés. Ainsi, sont analysés les différents moyens et outils choisis par les pays ouest-africains pour répondre aux droits et obligations découlant du Protocole ainsi qu'à leurs besoins et contraintes internes. Dans la mesure où ces pays n'ont pas encore adopté de réglementation nationale, cet article s'appuie prudemment sur les cadres nationaux de biosécurité développés pour traiter des questions clés de biosécurité: les questions institutionnelles et réglementaires, les procédures de décision, la participation du public ainsi que d'autres considérations pertinentes pour ces pays.

Résumé Depuis l’affaire du sang contaminé en 1983, il existait une exclusion des homosexuels masculins pour le don du sang en France. La remise en question de l’exclusion des HSH pour le don du sang est un débat animé dans de nombreux pays. En France, des réformes sont en cours pour un changement des pratiques. Il y a trois niveaux de réflexion : le sur-risque infectieux lié à une pratique sexuelle à risque, la faisabilité de tests performants mais laissant une fenêtre silencieuse biologique et la protection du receveur. Le risque infectieux des homosexuels masculins pour le virus de l’immunodéficience humaine (VIH) est plus élevé que le reste de la population. Bien que chaque personne présente son propre risque individuel selon ses pratiques, et n’ait donc pas le même niveau de risque, chacun est confronté à la même réglementation. La difficulté est de trouver un consensus entre principe de précaution, non-discrimination, et responsabilités individuelles et collectives. Since the context of the contaminated blood affair in 1983, the homosexual male were excluded from the blood donation in France. This exclusion is often called into question in several countries and is an actual lively debate. In France, reform process is ongoing for a practical change. Three issues make up the discussion: the infectious risk bound to sexual behavior, the feasibility of the powerful biological tests but having a silent window and the protection of the blood recipient. The infectious risk in the homosexual male is higher for the human immunodeficiency virus (HIV) than in the rest of the population. Even if every person has his/her own individual risk depending on his/her habits, everyone is confronted to the same law. The challenge is to build a consensus, along with the precautionary principle, the non-discrimination policy, and the individual and collective responsibilities. [ABSTRACT FROM AUTHOR]

Résumé De nos jours, en France, l’anonymat, le bénévolat, le volontariat et le non-profit sont reconnus comme des principes éthiques en transfusion sanguine. La responsabilité pourrait-elle être ajoutée au rang de ces principes ? Un logo « Responsang » pourrait-il être un moteur efficace au don de sang ? Cet article explore la réforme du concept de responsabilité entreprise par le philosophe Hans Jonas afin d’envisager son applicabilité et ses limites dans le champ de la transfusion sanguine. En effet, le concept repensé par le philosophe allemand semble pouvoir constituer un moteur qui évite les écueils du concept de « devoir » et ceux de la rémunération potentielle du don. Mais ne conduit-il pas aussi à une technophobie et à une heuristique de la peur qui pourraient compromettre radicalement la procédure de la transfusion sanguine ? Nowadays, in France, anonymity, gratuity, volunteering, non-profit are recognized as ethical principles in blood transfusion. Can we add responsibility to this list? Can a logo named “Responsiblood” efficiently encourage blood donation? This article explores Hans Jonas's reform of the responsibility concept in order to measure its applicabilities and limits in the field of blood transfusion. Indeed, this concept – rethought by Jonas – seems to be a good encouragement which avoids the pitfalls of the concept of duty and of the idea of payment for blood donation. But can’t we also see in this reform a threat to blood transfusion because of technophobia and the heuristics of fear that it involves? [ABSTRACT FROM AUTHOR]

Cumulative effects assessment (CEA) is a sub-discipline of environmental impact assessment that is concerned with appraising the collective effects of human activities and natural processes on the environment. Aspirations for CEA have been expressed by many authors since 1969, when the foundation of environmental appraisal was laid by the US National Environmental Policy Act. This paper's purposes are ( i) to review aspirations for CEA, relative to current practice; and ( ii) to fully explain and critique the logic that connects CEA's operational steps and underlying philosophies. A literature review supports the following statements: Some conceptualizations emphasize the delivery of information to support decision making as the key purpose of CEA; others deem collaboration, debate, and learning as most important. Consensus on CEA's operational steps has been reached, but each step requires practitioners to make analytical decisions (e.g., about the scope of issues to include or the time horizon to consider) and objective rules for how to approach those decisions are lacking. Numerical methods for assessing cumulative effects are largely available, meaning that CEA's biggest problems are not scientific. CEA cannot succeed without substantive public engagement, monitoring, and adaptive management. CEA is best undertaken regionally, rather than project-by-project. CEA and planning are complementary, and should be merged. In its most enlightened form, CEA is a useful tool for ensuring that human undertakings ultimately conform to Earth's finite biosphere, but current practice falls short of the ideal, and CEA's logical derivation is not entirely sound. As regards CEA's big problems, sustainability has not been defined clearly enough to make criteria for judging the significance of cumulative effects indisputable; legal, regulatory, and institutional frameworks are poorly aligned for CEA; and objective criteria for judging the adequacy of CEA's scope, scale, and thresholds do not exist, which makes the question of how to provide general guidance to practitioners intractable. Recommendations call for sustainability goals to be clearly expressed as measurable targets. Furthermore, precaution in human enterprise should be exercised by avoiding, minimizing, restoring, and offsetting negative cumulative effects. CEA can assist by quantifying and optimizing trade-offs. [ABSTRACT FROM AUTHOR]

Jusqu’à une époque récente, les structures d’expertise des pays développés ont réalisé leur travail d’analyse du risque sanitaire des aliments selon un modèle « standard », élaboré pour l’analyse d’autres risques technologiques et dont nous rappellerons tout d’abord les caractéristiques et les principales options. Depuis le début des années 80, l’observation d’un certain nombre de dysfonctionnements dans la chaîne de l’alimentation a suscité dans l’opinion publique de plusieurs pays un scepticisme croissant sur la valeur de ce modèle. Le principe de précaution a donc été proposé comme un nouveau fil conducteur pour améliorer l’analyse du risque alimentaire. Nous en présenterons tout d’abord les conséquences sur la gestion du risque, en nous basant sur la définition « proportionnée » du principe de précaution qui émerge actuellement en Europe. Nous remonterons ensuite au niveau de l’évaluation des risques, pour montrer comment les nouvelles demandes des gestionnaires pour une bonne application du principe de précaution ont des conséquences importantes sur la démarche d’évaluation elle-même. Enfin, nous interrogerons la vision « standard » de la communication du risque, conçue comme la dernière phase du processus d’analyse de risque. Nous montrerons en quoi une contribution active de représentants de la société civile dès les phases d’évaluation et de gestion peut permettre à la fois d’améliorer la qualité et l’acceptabilité de l’analyse de risque. L’application du principe de précaution a donc des conséquences non pas sur une seule mais sur les trois phases de l’analyse du risque. L’ensemble de ces modifications permet de proposer un modèle alternatif, dit « constructiviste », qui, dans le cas du risque alimentaire, peut contribuer à une meilleure acceptabilité par la société des rares, mais inévitables, dysfonctionnements de la production de nos aliments.

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Résumé Largement étudié, souvent invoqué et pourtant encore fréquemment décrié, le principe de précaution, dont les potentialités d’influence en droit de la responsabilité civile ne sont plus à démontrer, constitue un instrument efficace au service de l’amélioration de la situation des victimes de dommages corporels laissées hors du champ de la réparation. En témoigne le sort des victimes atteintes de troubles neurologiques, après avoir été vaccinées contre l’hépatite B, dont l’indemnisation achoppe actuellement sur l’incertitude scientifique affectant le lien causalité entre le produit et le dommage. La percée en jurisprudence d’une responsabilité pour défaut de précaution dans le contentieux des victimes du vaccin contre l’hépatite B mérite d’être encouragée au nom d’une approche pragmatique du principe de précaution. Le souci d’égalité des victimes non seulement entre elles mais également face aux laboratoires pharmaceutiques légitime le recours à ce principe, dont la normativité n’est plus contestée, au moins à titre provisoire, le temps d’une prise en considération par le législateur escomptée par une large partie de la doctrine. Widely studied, often invoked and nevertheless frequently disparaged, the precautionary principle, whose potential influence on civil liability is well established, is an effective tool for improving the situation of victims of personal injury that are left out of the compensation field. The fate of victims with neurological disorders after being vaccinated against hepatitis B shows it. For them compensation stumbles on scientific uncertainty concerning the causal link between the vaccine and the damage. The precautionary lack breakthrough in litigation for victims of vaccine against hepatitis B should be encouraged in the name of a pragmatic approach to the precautionary principle. The concern for equality between victims and between victims and pharmaceutical companies legitimate the use of precautionary principle that normativity is no longer contested. It should be so at least temporarily before a legislative response as desired by a large part of legal doctrine. [ABSTRACT FROM AUTHOR]

The methodological approach proposed here combines textual statistical analysis and agent-based simulations. The controversy concerning the unusual disappearance of pollinating bees (Apis mellifera) covered in the French press over a period of 13 years was chosen to describe the different stages of this heuristic framework. First, the articles are categorized according to the origin they attribute to the phenomenon as a univariate cause, a multivariate cause or a lack of understanding. Then, the different proportions of agents supporting either of these causes are obtained and reproduced from a dynamic opinion model, which shows the existence of agents with pre-determined choices. The change in the proportions over time leads to questionning the consistency of the data concerning the independence of all agents. In particular, it becomes possible to assume the existence of networks of influence, a hypothesis that could be verified by other techniques such as qualitative, ethnographic or interview methods. [ABSTRACT FROM AUTHOR]

Résumé La transfusion est un acte médical délégué couramment effectué en unités de soins. L’hémovigilance nationale, suite à des évènements indésirables graves, dispose d’une réglementation fournie. Le recueil des données centralisées dans la base nationale e-FIT et son analyse nous permettent de détecter les dysfonctionnements survenant au décours de l’acte transfusionnel. La sécurité transfusionnelle repose sur un respect strict des étapes d’un processus qui va de la prescription des produits sanguins labiles et des examens immuno-hématologiques érythrocytaires nécessaires jusqu’à l’administration de PSL au receveur et à son suivi. Dans la circulaire relative à l’acte transfusionnel, plusieurs étapes du processus, moins explicites, peuvent être interprétées différemment par les professionnels et être à l’origine de dysfonctionnements graves. La protocolisation de la pose de la transfusion et de sa surveillance, permettrait d’uniformiser sa réalisation et son suivi de manière sécurisée et d’éviter un risque potentiel chez le patient. Blood transfusion is currently a delegated medical act in patient care services. Following severe adverse events, hemovigilance now disposes of a dense regulation. Data collection and analysis in the national hemovigilance “e-FIT” database allow detection of errors or malfunctions in the transfusion act. Blood transfusion safety depends on the strict respect of processes from the prescription of blood products and required patient immuno-hematology exams to the administration of blood products and follow-up of the patient. In the circular relative to the transfusion act, many steps of the transfusion process, less explicit, can be interpreted differently by health care professionals and thus lead to errors or severe adverse events. Standardization of procedures for the transfusion act and its surveillance would increase their safety and avoid potential risks for the patient. [ABSTRACT FROM AUTHOR]

Résumé La loi du 5 juillet 2011 a été élaborée dans un contexte d’urgence et son écriture s’est caractérisée par une fragile recherche d’équilibre entre des inspirations et revendications diverses et souvent opposées. Après un rapide rappel de cette genèse et une présentation succincte des principales corrections législatives annoncées avec la réforme partielle du 27 septembre 2013, nous nous intéresserons à l’irruption du judiciaire dans la pratique psychiatrique quotidienne et à ses conséquences en termes de rédaction des certificats et de formation médicale. Ces développements nous amèneront à considérer le poids croissant des principes de précaution et de prévoyance dans une société dont le modèle du droit a basculé de celui de l’État-providence de l’après-guerre à un autre d’inspiration néolibérale, sur fond de mouvements contradictoires sécuritaires et libertaires. Cet article se propose d’en dégager quelques enseignements pour la pratique médicale quotidienne en psychiatrie, à la lumière du « nouveau » principe de responsabilité individuelle qui résulte de ces évolutions. A reform of the French mental health legislation has been due for a long time, but has been continually postponed. The entry into force of the Act of July 5th 2011 finally allowed France to comply with the European recommendations and showed that, following this, the Constitutional Council would provide encouragement to legislative reform through the procedure known as the “Question Prioritaire de Constitutionnalité” (an application for a preliminary ruling on whether a legislative provision is constitutional). The search for balance and the emergency context within which this reform has been developed both show its fragility, which explains why a partial reform was adopted in September 2013 in order to introduce legislative corrections. One of the main provisions of the Act of July 5th 2011 is the encroachment of the judiciary on daily psychiatric practice, since provision is made for the systematic control of all hospitalizations without consent lasting more than 15 days by the “judge ruling on civil detention cases” (“juge des libertés et de la détention”). This judicial review imposes greater rigour on the issue of medical certificates, since the prospect of legal inspection must now be taken into account. This underlines the importance of training in forensic psychiatry for psychiatric residents and practitioners. More generally mental health professionals should in the future be more involved in the drafting of the law. Current legal developments reflect the divided expectations of society and make the issue of the psychiatrist's responsibility more prevalent. The backdrop to this is a society in which the precautionary principle has gradually become a legal principle in its own right, in an overall context determined by the debate between those defending individual freedoms and those who subordinate these to safety. At the same time, we are witnessing a paradigm shift of law and the transition from the post-war welfare state model to a neoliberal approach. This is based on the principle that responsibility should be vested in the individual and that s/he is presumed to be rational. The outcome is a governmentalist attitude, based on the need to leave nothing to chance and entailing an extensive concept of the precautionary principle – in other words, giving priority to the principle of foresight, in order to ensure optimisation of the ability to pre-empt « the worst ». This concept has obviously implications in terms of individual responsibility, since responsibility for an act lies with those who should have foreseen it. In the field of medical practice, this responsibility can be questioned through the items noted in the medical file (history, diagnosis, consistency between medical and nursing records). It can also be questioned in relation to the means available to protect the patient (from himself), family members or any third party. This responsibility can also be related to prescriptions for medication, which can sometimes be interpreted as reflecting underestimation of the risk. [ABSTRACT FROM AUTHOR]

The article discusses the concept of due diligence which is an element of certain primary standards of the State including the obligations of prevention. It mentions that under due diligence the State is required to prevent certain damage including the protection of foreigners, the security of foreign States and protection of human rights. It mentions that due diligence has grown from a simple rule to a customary norm of general international law.

Abstract: Nanosciences and nanotechnologies come into a pre-existing legal system. Their arrival, and how they are received are worthy of analysis. Such an effort shall at first include simply lexical considerations, in order to penetrate, via their origins, the traces of these specific objects into the territory of law. The goal of this article is to explore the effects of “nanos” in various legal fields, including their relevance to the principle of precaution, patent law, and the applicable laws for chemical substances. [Copyright &y& Elsevier]

This paper traces the logics underpinning obscenity and indecency law in Canada from R. v. Hicklin (1868) to the present day in R. v. Labaye (2005) to discuss the emergence of a precautionary principle in the law governing sexually explicit materials and conduct. The most recent Supreme Court decision on obscenity and indecency law (R. v. Labaye 2005) is interesting for its appropriation of a security inspired logic of pre-emption (or precautionary governance) into the heart of obscenity and indecency law. The replacement of the community standards of tolerance test for the undue exploitation of harm with a new, socalled objective test for risk of harm, obviates the need for empirical evidence of harm to justify the exercise of state power. Today, risk of harm becomes a stronger element within the rubric of obscenity and indecency law thus enabling criminalization on the basis of a judge's perception of the imagined negative effects of sexual conduct and materials on constitutional values such as liberty and equality. [ABSTRACT FROM AUTHOR]

Abstract: To develop a complete and informative biodiversity observation system, it is necessary to compare the strengths and limits of various monitoring schemes. In this article, we examine the various advantages of extensively monitoring fine-grained spatial variations of biodiversity, where the prominent traits of many species within a community (abundance, phenology, etc.) are regularly recorded at numerous sites over a large territory, usually via human observation networks. Linking these variations with environmental factors sheds lights on the major mechanisms leading to changes in biodiversity, thus increasing our knowledge of macroecology and community ecology. This extensive monitoring allows us to assess diffuse effects, contributing to the sound use of the precautionary principle. Combined with site-focused monitoring, information gathered from extensive monitoring provides the raw material necessary to build biodiversity scenarios. [Copyright &y& Elsevier]

Geoengineering: reduction, adaptation and the scenario of despair. Starting with a short inventory of the state of the climatic issue we show that, whatever the possible scenario might be, it will include an irreducible part of adaptation. In this perspective we approach the question of geoengineering with a brief state of the art of the most reliable projects. Following we propose three scenarios for a possible recourse to geoengineering technologies. This leads us ultimately to re-examine the stakes of the precautionary principle. [ABSTRACT FROM AUTHOR]

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The debate surrounding CMOs is a recurring one; it is unclear and often conveys the picture of a general brawl. Our article argues that this situation is linked to the crisis context in which we live, a modernity crisis in general and especially a rationality crisis. It tries to put some order in the sphere of debate and to contribute a clarification which avoids drifts and amalgamations that usually blight discussions. We propose to distinguish three levels of debate. The first is a purely scientific and technical debate concerning knowledge, in particular the assessment of risks. The second is political and deals with the merits of decisions to be taken, in particular regarding the application or non application of the precautionary principle. And the last involves a philosophical debate about values, in particular ideas about what "good life" is and about the relationships between man and nature. These distinctions justify that we consider a practical rationality, which we seek to define, alongside with theoretical rationality. Building a relevant practical rationality, not as a replacement but as a complement to theoretical rationality, is the first condition towards "civilizing" debates on CMOs. It is also a necessary step forward in the direction of participatory democracy, an imperative for the twenty-first century. [ABSTRACT FROM AUTHOR]

The Canadian government indicated recently that it will not meet its Kyoto targets but will develop a "made in Canada" solution to deal with the reduction of climate-changing greenhouse gas emissions. Canada is still legally obligated to achieve its Kyoto reduction requirements and has indicated that it will participate in the second round of Kyoto Protocol talks. However, as a co-signatory of the North American Free Trade Agreement (NAFTA), Canada may be impeded from introducing and maintaining greenhouse gas-reducing initiatives as there are elements of NAFTA which may be used to challenge or block efforts that are considered discriminatory to trade. In particular, Chapter 11 may be used as a vessel by private investors to challenge climate change measures that conflict with other NAFTA chapters. Unless these conflicts are addressed, the Canadian government will fail in its initiatives. [ABSTRACT FROM AUTHOR]